Patent Decisions

"Examiner must articulate "a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does."

noreply@blogger.com (Patent Decisions) — Thu, 11 Jun 2009 20:57:00 +0000

BPAI CASE
Ex parte FRANCIS X. HURSEY
Appeal 2009-003346
Application 10/939,687
Technology Center 1600
Decided: June 11, 2009

Claim at issue:
1. A composition for promoting the formation of clots in blood, said composition comprising: a binder; a zeolite disposed in said binder, said zeolite having an adjusted calcium content via the addition of a calcium-containing compound to said zeolite, said calcium content being between about 75 wt.% to about 83 wt.%, said composition being operable to reduce a heat of hydration when exposed to blood.

Examiner had found two references that described combining a zeolite with a binder and zeolite with calcium oxide. The prior art did not teach the exact percentage or that it would lead to a reduced heat of hydration. The Board found that reducing the heat of hydration is in contrast to what the prior art taught. The Examiner argued that it was obvious because it was just about optimization of the amount of calcium and that would it would have been obvious to optimize it. The Examiner then contended that the reduced heat of hydration would have been an inherent property in the optimized composition. The Board disagreed that it would have been obvious.

The Board stated:

In order to support such a conclusion the Examiner must articulate “a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does.” KSR, 550 U.S. at 418. The Examiner has failed to articulate such a reason on this record. More particularly, the Examiner has failed to explain why a person of ordinary skill in the art would optimize the calcium content to a weight percentage that reduces the heat of hydration when the evidence the Examiner relies upon expressly teaches that it is advantageous to utilize a zeolite that generates heat as it absorbs moisture (FF 6). Simply stated the evidence relied upon by the Examiner directs one of ordinary skill in this art away from Appellant’s claimed invention.

The rejection was reversed. Full opinion can be found here.

To sue under 35 U.S.C. § 256 Inventor must have sufficient financial interest to have standing

noreply@blogger.com (Patent Decisions) — Fri, 05 Jun 2009 16:36:00 +0000

In Larson v. CORRECT CRAFT, a joint inventor sued to rescind the assignments he had signed, which gave ownership to the company that employed him, and to remove two other named co-inventors. The court dismissed the case for lack of federal jurisdiction because he did not have standing to sue under 35 U.S.C. § 256 to correct inventorship. The court stated that his financial interest was contingent upon rescission of the assignments and that there was no financial interest that would change if he was able to correct inventorship since the assignments were not related to any increased financial interests.

This was in contrast to Chou v. Univ. of Chi., 254 F.3d 1347, 1358 (Fed. Cir. 2001) where the inventor wanted to be added. There the inventor was already under an obligation to assign so the issue did not involve ownership but being a named inventor gave the inventor access to royalties and other financial streams. Therefore, in Larson, there was no sufficient injury until the assignments were rescinded, if they were at all, to have standing.

There was some suggestion about reputational interest being sufficient for standing but that was not pleaded so they left that question open--that is whether someone's reputation as an inventor or being a sole inventor is enough to give standing.

The full opinion can be found here.

At Preliminary Injunction Stage Trial Court must determine whether it is more likely than not that the challenger will be able to prove at trial, by clear and convincing evidence, that the patent is invalid

noreply@blogger.com (Patent Decisions) — Thu, 04 Jun 2009 17:02:00 +0000

TITAN TIRE CORPORATION
and THE GOODYEAR TIRE & RUBBER COMPANY,
v.
CASE NEW HOLLAND, INC., CNH AMERICA LLC,
and GPX INTERNATIONAL TIRE CORPORATION,

This was a design patent case but importantly the case describes the standard for a preliminary injunction and the burdens that each party has in determining the likelihood of success. There was a design patent regarding a tractor tire. The defendant challenged the validity of the design patent arguing that the feature was functional. This district court found that the patentee "was not likely to withstand Case’s challenge to the patent’s validity on obviousness grounds." "While finding that the other three preliminary injunction factors—irreparable harm, balance of the hardships, and public interest—weighed in favor of granting an injunction, the trial court concluded that Titan’s failure to establish a likelihood of success on the validity issue was sufficient to defeat the motion for a preliminary injunction."

The CAFC stated the four factor test:

The factors the trial court considers when determining whether to grant a preliminary injunction are of longstanding and universal applicability. As the Supreme Court recently reiterated, there are four: “[a] plaintiff seeking a preliminary injunction must establish [1] that he is likely to succeed on the merits, [2] that he is likely to suffer irreparable harm in the absence of preliminary relief, [3] that the balance of equities tips in his favor, and [4] that an injunction is in the public interest.” Winter v. Natural Res. Def. Council, Inc., 129 S. Ct. 365, 374 (2008) (citing Supreme Court cases).

The CAFC did note that some cases state the first factor as requiring a “reasonable” likelihood of success on the merits, but that "it is not clear whether the addition of “reasonable” adds anything substantive to the test, but in any event, for our purposes the Supreme Court’s current statement of the test is the definitive one."

In discussing the "likelihood of success prong" the district court framed the question as this: "the trial court specifically stated that Titan had the burden of demonstrating a likelihood of success on the merits, including a showing that Titan will likely withstand Case’s challenge to the validity of the ’862 patent...The trial court also made reference to a requirement that Case demonstrate a “substantial question” regarding the patent’s validity."

The CAFC explained:

With regard to the first factor—establishing a likelihood of success on the merits—the
patentee seeking a preliminary injunction in a patent infringement suit must show that it will likely prove infringement, and that it will likely withstand challenges, if any, to the validity of the patent...In assessing whether the patentee is entitled to the injunction, the court views the matter in light of the burdens and presumptions that will inhere at trial."
The CAFC then explained the different burdens at trial and prior to trial:

At trial there is a presumption of validity according to the CAFC under 35 U.S.C. § 282. "Because of this presumption, an alleged infringer who raises invalidity as an affirmative defense has the ultimate burden of persuasion to prove invalidity by clear and convincing evidence, as well as the initial burden of going forward with evidence to support its invalidity allegation...Once the challenger presents initially persuasive evidence of invalidity, the burden of going forward shifts to the patentee to present contrary evidence and argument….Ultimately, the outcome of the trial on this point will depend on whether, in light of all the evidence, the party challenging the patent’s validity has carried its burden of persuasion to prove by clear and convincing evidence that the patent is invalid."

"Before trial, when the question of validity arises at the preliminary injunction stage, the application of these burdens and presumptions is tailored to fit the preliminary injunction context. To begin, the patent enjoys the same presumption of validity during preliminary injunction proceedings as at other stages of litigation. Thus, if a patentee moves for a preliminary injunction and the alleged infringer does not challenge validity, the very existence of the patent with its concomitant presumption of validity satisfies the patentee’s burden of showing a likelihood of success on the validity issue...If, instead, the alleged infringer responds to the preliminary injunction motion by launching an attack on the validity of the patent, the burden is on the challenger to come forward with evidence of invalidity, just as it would be at trial. The patentee, to avoid a conclusion that it is unable to show a likelihood of success, then has the burden of responding with contrary evidence, which of course may include analysis and argument."

The court then explained the different question burden prior to trial:
While the evidentiary burdens at the preliminary injunction stage track the burdens at trial, importantly the ultimate question before the trial court is different. As this court explained in New England Braiding Co. v. A.W. Chesterton Co., the trial court “does not resolve the validity question, but rather must . . . make an assessment of the persuasiveness of the challenger’s evidence, recognizing that it is doing so without all evidence that may come out at trial...Instead of the alleged infringer having to persuade the trial court that the patent is invalid, at this stage it is the patentee, the movant, who must persuade the court that, despite the challenge presented to validity, the patentee nevertheless is likely to succeed at trial on the validity issue."

Quoting New England Braiding:
The district court cannot be held to have erred in deciding that the patentee failed to make a sufficient showing of likelihood of success required to support a preliminary injunction where the evidence presented in support of invalidity raises a substantial question, although the defense may not be entirely fleshed out. . . .While it is not the patentee’s burden to prove validity, the patentee must show that the alleged infringer’s defense lacks substantial merit.

The court finds that this quote can be interpreted two different ways.
"To begin, the trial court might assume that only the evidence the challenger presents is relevant to the question of whether the challenger succeeds in raising a “substantial question” of invalidity, and that that evidence alone could be the basis for the trial court to deny the injunction...Alternatively, the trial court could understand its task to involve not only examining the alleged infringer’s evidence of invalidity, but also considering rebuttal evidence presented by the patentee and determining whether the patentee can show that the invalidity defense “lacks substantial merit...This latter understanding more properly acknowledges both parts of the above quote from New England Braiding, and our cases have made clear that the patentee’s rebuttal of the challenger’s invalidity evidence is an important part of the court’s overall evaluation of the evidence."

What does "the challenger’s evidence “raises a substantial question” of invalidity." mean?
"On the one hand, a trial court could understand that phrase to describe a procedural step involving assessment of evidence that the challenger has put forward initially. If the trial court determines that the challenger’s evidence is sufficient to raise “a substantial question” of invalidity, the trial court must then afford the patentee the opportunity to show that the invalidity defense “lacks substantial merit.” In other words, the trial court’s determination that a “substantial question” has been raised by the alleged infringer could be considered a trigger for the patentee’s opportunity to respond to the evidence presented by the challenger."

"An alternative to that way of understanding the phrase “raises a substantial question” is to see it as a description of the question a trial court must resolve regarding the evidence of invalidity at the preliminary injunction stage, after necessarily taking into account the patentee’s responses. That is, it refers to the net of the evidence after the trial court considers all evidence on both sides of the validity issue available at this early stage of the litigation. Under this view, a finding of a “substantial question” of invalidity is a substantive conclusion by the trial court, a conclusion that the patentee is unlikely to succeed on the merits of the validity issue because the patentee is unable to establish that the alleged infringer’s invalidity defense “lacks substantial merit.”

"our precedents establish that the phrase refers to a conclusion reached by the trial court after considering the evidence on both sides of the validity issue...Thus the trial court first must weigh the evidence both for and against validity that is available at this preliminary stage in the proceedings. Then, as explained in New England Braiding, if the trial court concludes there is a “substantial question” concerning the validity of the patent, meaning that the alleged infringer has presented an invalidity defense that the patentee has not shown lacks substantial merit, it necessarily follows that the patentee has not succeeded in showing it is likely to succeed at trial on the merits of the validity issue."

"Even with that understanding in mind, there remains yet further clarification necessary to assess the trial court’s responsibilities in this preliminary injunction setting. First, the weight of evidence necessary for a showing of a “substantial question” regarding invalidity should not be confused with the similarly phrased but quite different test usually known as “substantial evidence” in the record. This latter is a low evidentiary threshold applicable to review of jury verdicts and certain administrative law matters, including matters on appeal to us from the United States Patent and Trademark Office...It is not an evidentiary test applicable to a trial court’s decision whether to grant or deny a preliminary injunction."

"At the same time, the alleged infringer at the preliminary injunction stage does not need to prove invalidity by the “clear and convincing” standard that will be imposed at trial on the merits...As we have noted, the trial court must decide whether to grant a preliminary injunction in light of the burdens the parties will bear at trial, sometimes requiring the court to make its decision based on less than a complete record or on disputed facts whose eventual determination will require trial...Thus, when analyzing the likelihood of success factor, the trial court, after considering all the evidence available at this early stage of the litigation, must determine whether it is more likely than not that the challenger will be able to prove at trial, by clear and convincing evidence, that the patent is invalid...We reiterate that the “clear and convincing” standard regarding the challenger’s evidence applies only at trial on the merits, not at the preliminary injunction stage. The fact that, at trial on the merits, the proof of invalidity will require clear and convincing evidence is a consideration for the judge to take into account in assessing the challenger’s case at the preliminary injunction stage; it is not an evidentiary burden to be met preliminarily by the challenger….This decision process, which requires the court to assess the potential of a “clear and convincing” showing in the future, but in terms of what is “more likely than not” presently, rests initially in the capable hands and sound judgment of the trial court."

The CAFC explained that even if the question is phrased in other ways that this is the standard for evaluating likelihood of success. The CAFC affirmed the denial of the Preliminary injunction finding that Titan did not show that the patent would likely survive the validity challenge. The CAFC said that even though the trial court used the phrase "substantial question" the analysis was the same as they discussed above.

The full opinion can be found here

Standard for Claim Construction in Interference

noreply@blogger.com (Patent Decisions) — Thu, 04 Jun 2009 15:38:00 +0000

In Agilent Technologies v. Affymetrix, Agilent challenged the BPAI's and district court's finding that Affymetrix's claims satisfied the written description requirement. This case was based upon an interference between the two companies. After an Agilent patent issued Affymetrix copied the claims into a continuation application. Agilent challenged the claims claiming that they did not have written description support. Part of determining whether there was written description was how to construe the claim that was involved in the interference. There are two options to use the specification from where the claims were copied from or to use the copier's specification. The court reviewed two previous cases that appear contradictory but are applied in two separate situations. The cases were In re Spina, 975 F.2d 854 (Fed. Cir. 1992), and Rowe v. Dror, 112 F.3d 473 (Fed. Cir. 1997). After reviewing the cases the court in this case stated the following rule:

To be clear, as this court explained in Rowe, when a party challenges written description support for an interference count or the copied claim in an interference, the originating disclosure provides the meaning of the pertinent claim language. When a party challenges a claim’s validity under § 102 or § 103, however, this court and the
Board must interpret the claim in light of the specification in which it appears.

Since the claims were construed using the wrong specification, the CAFC reconstrued the claims and ultimately found that the claims did not have adequate written description support. Affymetrix attempted to argue that the element was inherently produced in the method described but this was rebutted by an admission of their own expert. As the court explained inherency is not mere probabilities but always be present. This panel also included language that it must be recognized by one of skill in the art but did not elaborate on this point.

The CAFC also discussed whether the new evidence presented during the district court trial had been given proper review. The district court however "discarded this evidence, concluding that “Agilent does not present any new evidence concerning this issue, [so] the Court reviews [the Board’s decision on written description] for substantial evidence.” The CAFC rejected this review holding:

The district court’s decision to deferentially review the Board’s written description holding in the face of newly submitted conflicting evidence constituted legal error. Section 146 affords a litigant the option of shoring up evidentiary gaps that may have been evident by the end of the inter partes interference procedure. In this case, the Board explicitly notified Agilent of such gaps, and Agilent endeavored to fill them. Thus, Section 146 permits such new evidence and authorizes the trial court to review the Board’s treatment of the written description issue. This court will examine Agilent’s newly proffered testimony without deference to the Board’s finding.

Ultimately, Affymetrix lost the interference. The full opinion can be found here.

Patents are not barred just because it was obvious to explore a new technology that seemed to be a promising field of experimentation

noreply@blogger.com (Patent Decisions) — Thu, 14 May 2009 21:03:00 +0000

In The Procter & Gamble Co. v. Teva Pharmaceuticals USA, Inc., the Federal Circuit held that the patent covering the active ingredient of ACTONEL was not obvious. Teva had argued that the claim covering the compound (risedronate) was obvious in view of an expired patent also owned by Procter. The previous patent did not claim or disclose the specific compound. The previous patent only disclosed a an intermittent dosing method for treating osteoporosis and listed 36 polyphosphonate compounds and Teva contended that the structural similarities between ACTONEL and one of the listed compounds rendered the claim covering ACTONEL obvious. The district court concluded that the earlier patent would not have led a person of skill in the art to identify the specific compound as the lead compound. The district court also found that due to the extremely unpredictable nature of bisphosphonates at the time of the invention there would not have been any motivation to make the specific modifications. The district court also found that the unexpected results of the potency of ACTONEL and the low toxicity rebutted any alleged obviousness and that the secondary considerations also supported its conclusions.

The court agreed with the district court explaining that "an obviousness argument based on structural similarity between claimed and prior art compounds 'clearly depends on a preliminary finding that one of ordinary skill in the art would have selected [the prior art compound] as a lead compound.'"

The CAFC framed the issue as stating that to decide whether residronate was obvious the court must determine whether there would have been a "reason to attempt to make the composition" known as risedronate and "a reasonable expectation of success in doing so." The court explained that even if a lead compound had been identified there was no factual support to find the reason to make the composition or that would have been a reasonable expectation of success. The CAFC and the district court relied upon Procter's expert witnesses that testified to the unpredictable nature of bisphosphonates and an article by the "preeminent authority on bisphosphonates that stated that "to infer one compound the effects in another is dangerous and can be misleading." The federal circuit agreed that the field was unpredictable and and that the district court had properly found that Teval failed "clear [the] hurdle, establishing insufficient motivation for a person of ordinary skill to synthesize and test risedronate."

The CAFC also agreed that there was no reasonable expectation of success. The court emphasized that there where there are a finite number of identified predictable solutions it is likely that the invention is obvious, but that where there are numerous possible choices "where the prior art [gives] either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful" the "courts should not succumb to hindsight claims of obviousness." The court explained that "patents are not barred just because it was obvious "to explore a new technology or general approach that seemed to be a promising field of experimentation, where the prior art gave only general guidance as to the particular form of the claimed invention or how to achieve it." Here, the CAFC found that it was not routine to make the structural modification. Therefore, the claims were not obvious.

The court also found that Proctor had provided sufficient evidence of unexpected results and secondary considerations of non-obviousness to rebut any prima facie obviousness even if it had been properly made. The court found that Proctor had satisfied a long-felt need at the time the application was filed. Teva had argued that the long-felt need must be unmet at the time the invention becomes available on the market, when it can actually satisfy that need. Actonel came on the market after Fosamax so it couldn't fill any need because it had already been met. The CAFC disagreed finding that they look to the filing date to asses the presence of a long-felt and unmet need.

As an alternative ground Proctor had attempted to show that the patent used by Teva to show obviousness was not prior art. Proctor only had a notebook page that was dated but was unwitnessed and was not corroborated by any other evidence. Since there was no other corroboration other than the dated page it was not sufficient to disqualify the patent as prior art.

The full opinion can be found here.

A proposed modification that would render the reference unsuitable for its intended use cannot be used to render a claim obvious

noreply@blogger.com (Patent Decisions) — Fri, 08 May 2009 15:59:00 +0000

BPAI Case

Ex parte PAUL K. WOLBER,
ROBERT H. KINCAID, DOUGLAS AMORESE,
DIANE ILSLEY-TYREE, ANDREW S. ATWELL,
MEL N. KRONICK, and
ERIC M. LE PROUST,
Appeal 2009-2252
Application 11/008,6031
Technology Center 1600
Decided: April 24, 2009

Claim at issue:
1. A method comprising:
(a) subjecting an array comprising a plurality of features, each comprising nucleic acids immobilized on a surface of a solid support via a cleavable domain having a cleavable region, to conditions sufficient to generate a solution phase composition of nucleic acids;

(b) contacting said solution phase composition of nucleic acids with one or more reactants to produce a mixture of product nucleic acids; and

The Examiner alleged that the claims were obvious based upon the combination of the two references. The appellants argued that the primary reference required an element that if modified would have made the invention unsatisfactory. The Board agreed with the appellants explaining:

"Thus, while [the primary reference] does not require the capture probes to be covalently linked to the affinity matrix, the Examiner has not explained why one of ordinary skill in the art would have attached the capture probes of Lipshutz to its affinity matrix with a technique which allows for the capture probes to be released from the affinity matrix during use due to competitive hybridization between the complementary nucleic acids in the matrix array and the complementary nucleic acids in the sample."

Therefore, the invention was not obvious because "Appellants have shown that the Examiner's proposed modification of the affinity matrix of Lipshutz by Nallur would render the affinity matrix of Lipshutz unsuitable for its intended use."

Full opinion can be found here.

Acceptance of Animal Model is sufficient for Enablement

noreply@blogger.com (Patent Decisions) — Fri, 08 May 2009 15:47:00 +0000

Ex parte LAWRENCE M. BLATT, HUA TAN and
SCOTT D. SEIWERT
Appeal 2008-6024
Application 11/370,535
Technology Center 1600
Decided: April 27, 2009

1. A method of treating a flavivirus infection in an individual, the method comprising administering to an individual in need thereof an effective amount of an agent that inhibits enzymatic activity of a membrane-bound α-glucosidase, wherein the agent is not an imino sugar.

The Examiner rejected the claims for not being definite, for lacking utility and for not being enabled.

Indefiniteness:
The Examiner alleged that the phrase "wherein the agent is not an imino sugar" was indefinite. Appellants provided exhibits to support their position that imino sugars are recognized by those of skill in the art to be sugars in which the ring oxygen is replaced by a nitrogen atom. The Examiner argued that a compound in a dependent claim "“is arguably ‘an imino sugar’” but the Examiner had no evidence to support this argument. Therefore, the claims were definite.

Utility:
Examiner argued that it lacked utility because treatment included preventing the disease, which is "very unlikely to ever be demonstrated to be possible as a consequence of a medicinal treatment." The Appellants responded by pointing to the definition which included treating symptoms as well. The Board explained, "The Specification defines “treating” as including “completely or partially preventing a disease or symptom thereof” (FF 10); that definition does not require complete, 100% effective prevention of virus infection of any cell of the treated individual. The Examiner has not provided sufficient evidence to support a conclusion that the claimed method would not be useful for “completely or partially preventing a disease or symptom thereof,” as “treating” is defined in the Specification."

Enablement:
The Examiner alleged that the claims were not enabled because it only used an model of flavivirus infection but did not enable treating an HCV infection. The Examiner pointed to a reference that said that the prior art stated, "“validation of the utility of the BVDV surrogate virus model is incomplete, since most of the few drugs that are known to be active against HCV have not been tested against BVDV." However, the rest of the reference stated that although validation was not complete the BVDV model is used by the field and accepted as a model. The Board explained, "Based on that acceptance, persons of skill in the art would expect that a drug that is shown to be effective against BVDV would reasonably be expected to also be effective against HCV."

The Examiner also objected to another claim that used the phrase "and at least one additional therapeutic agent" because it could be an infinite number of agents. The Examiner explained "“reliance on the term ‘at least one’ extends the possible number of ‘additional therapeutic agents’ to infinity, a circumstance which is clearly not enabled by the instant disclosure." The Board reversed finding that this is not sufficient evidence to show that it is not enabled and that the Examiner has not shown that it would require undue experimentation.

The Board Explained:

"The Examiner has provided no reasonable basis for concluding that a person of ordinary skill in the art could not have practiced the method of claim 6 without undue experimentation. The Examiner has posited a potentially inoperative embodiment encompassed by the claim but that by itself does not show nonenablement without evidence that the number of inoperative embodiments is so large that distinguishing between operative and inoperative embodiments would itself require undue experimentation. No such evidence has been presented."
All rejections were reversed.

Full opinion can be found here.

BPAI rejects Examiner's Argument that "the meaning of the claims should be clear from the wording of the claim[s] alone"

noreply@blogger.com (Patent Decisions) — Fri, 08 May 2009 15:27:00 +0000

Ex parte PETER N. KAO, RONALD G. PEARL,
TOSHIHIKO NISHIMURA, and JOHN L. FAUL
Appeal 2008-5150
Application 10/801,729
Technology Center 1600
Decided: April 29, 2009

Claim at issue had the following phrase:
1. A method of treating a lung proliferative vascular disorder in a patient comprising administering an HMG-CoA reductase inhibitor,

wherein the HMG-CoA reductase inhibitor is present in an amount effective to reduce vascular occlusion in the pulmonary arteries of the

patient, and which does not substantially increase endothelial cell nitric oxide synthase activity in the endothelial cells of the pulmonary arteries of

the patient; and wherein said lung proliferative vascular disorder is selected from the group consisting of primary pulmonary hypertension, secondary pulmonary

hypertension, Eisenmenger’s syndrome, chronic thromboembolic disease, pulmonary fibrosis, obliterative bronchiolitis, and lymphangioleiomyomatosis.

The Examiner alleged that the underlined phrase was indefinite because “the meaning of the claims should be clear from the wording of the claim[s] alone” The Board rejected this argument and found that the specification clearly defined the term for one of skill in the art. The term was specifically defined in the specification. Because of the definition the indefiniteness rejection was reversed. The claims were found to be anticipated and obvious for other reasons.

Full opinion can be found here.

Later-developed alternative processes are relevant in the product-process "patentably distinct" inquiry

noreply@blogger.com (Patent Decisions) — Tue, 14 Apr 2009 17:58:00 +0000

In Takeda v. Doll, the issue was what filing date is relevant to an obviousness-type double patenting rejection that was between a product patent filed in 1975 and a process patent filed in 1990. The court explained, "The novel legal question in this case asks if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry." The court found that they are up to a point.

Takeda filed an application to compounds in 1975, which issued as U.S. Patent No. 4,098,888. On January 8, 1990 Takeda filed a secondary application covering the process for making the claimed compounds, sixteen years after the priority date of the product claims. The process patent issued as U.S. Patent No. 5,583,216 (the ’216 process patent) on December 10, 1996, claiming the sole process known and disclosed in the Japanese priority patent application. The ’216 process patent led to the double patenting issue in this appeal. The process patent was subject to re-exam to determine if the process patent was invalid for obviousness-type double patenting in view of the prior product patent and other prior art. During reexamination, Takeda relied upon the declaration of Dr. Wuest disclosing an alternative process (displacement process) for making the claimed compounds the ’216 patent. The Board found the declaration unconvincing and affirmed the obviousness-type double patenting rejection. Takeda appealed to the district court and provided a new declaration showing that there are other processes that could be used, although some were developed after the priority date of the '216 process patent. The district court concluded that “subsequent developments in the art [are relevant to] determining whether alternative processes exist” when weighing patentable distinctions for double patenting. The district court found that the processes were patentably distinct and overturned the double patenting rejection.

The CAFC reviewed the double patenting doctrine.

"Non-statutory, or “obviousness-type,” double patenting is a judicially created doctrine designed to foreclose “claims in separate applications or patents that do not recite the ‘same’ invention, but nonetheless claim inventions so alike that granting both exclusive rights would effectively extend the life of patent protection.” Perricone, 432 F.3d at 1373."In other words, the double patenting doctrine is designed to prevent “unjustified imewise extension of the right to exclude.” In re Van Ornum, 686 F.2d 937, 943-44 (CCPA 1982). For instance, the doctrine bars an applicant from obtaining separate patents with separate terms for both a product and process for making that product, unless the product and process are “patentably distinct.” See In re Taylor, 360 F.2d 232, 234 (CCPA 1966); In re Cady, 77 F.2d 106, 109 (CCPA 1935) (instructing that “double patenting is not sustainable when the product can be fabricated by processes other than that secured by the issued process patent”) The PTO’s Manual of Patent Examining Procedure (MPEP) explains that a product and its process are patentably distinct if “the product as claimed can be made by another materially different process.” MPEP § 806.05.

The parties agreed that product and process claims are patentably distinct if multiple processes for creating a product exist at the time of the invention.

The CAFC framed the question this way:

The novel legal question in this case asks if later-developed alternative processes are relevant in the product-process “patentably distinct” inquiry. The PTO contends that the date of invention, in this case December 19, 1974, governs the relevance of products and processes in the double patenting context. Thus, the PTO submits that the date of invention governs the timing of double patenting analyses because other issues relating to patentability are judged from the date of invention. For example, the patentability requirements set forth in §§ 112, 102, and 103 are judged as of the date of invention or filing. See 35 U.S.C. §§ 112, 102, 103. The PTO does not cite statutory or case support for the “date of invention” approach other than analogizing to these other patentability requirements. In the alternative, the PTO posits that alternative processes must at least appear before issuance of the primary patent application.

Takeda argued the opposite side saying later arising technology to the product claims is relevant.

The CAFC didn't like either approach and came up with its own:

The secondary application (in this case, the process application of January 8, 1990) actually triggers the potential of an “unjustified extension of patent term.” When filing the secondary application, the applicant essentially avers that the product and process are “patentably distinct.” Thus, the relevant time frame for determining whether a product and process are “patentably distinct” should be at the filing date of the secondary application. This rule gives the applicant the benefit of future developments in the art. At the same time, however, it prevents the inequitable situation that arises when an applicant attempts to rely on developments occurring decades after the filing date of the secondary application. This approach should encourage the swift development of materially distinct, alternative processes.

Takeda argued that it disclosed a process in the earlier issued product patent that is not now claimed, but the PTO disputed the viability of that process. The court held there were questions of material facts to be resolved and therefore reversed the finding of summary judgment.

The full opinion can be found here

Distribution of Manuscript With No Legal Obligation to Keep Confidential is Not a Printed Publication ""[w]here professional and behavioral norms entitle a party to a reasonable expectation" that information will not be copied or further distributed"

noreply@blogger.com (Patent Decisions) — Tue, 31 Mar 2009 19:09:00 +0000

CORDIS CORPORATION,
v.
BOSTON SCIENTIFIC CORPORATION
and SCIMED LIFE SYSTEMS, INC., (FEDERAL CIRCUIT)

In the ongoing stent battle, Cordis and Boston Scientific appealed another case to the Federal Circuit. The issue most interesting is where the court further explained what constitutes a printed publication under 35 U.S.C. § 102(b). The facts are as follows:

In 1980 the inventor of the ’762 patent, Dr. Palmaz, prepared a ten-page paper describing his work on stents. This paper is the “1980 monograph.” At that time he was a resident at a hospital in California. His name was not on the paper.
He gave copies of the paper to approximately six of his teachers at an oral presentation of his work to these physicians and several other colleagues.
Pursuant to agreements, Palmaz later gave copies of the monograph to two companies (Vascor, Inc., and Shiley, Inc.) while attempting to commercialize his stent technology.
Neither agreement required confidentiality, and the Shiley agreement specifically stated that Shiley “shall not be committed to keep secret any idea or material submitted.”
In 1983 Dr. Palmaz revised the paper; the revised paper became the “1983 monograph.”
In 1983 he also gave a copy of both monographs to Werner Schultz, a technician from whom Dr. Palmaz was seeking fabrication assistance.
When Dr. Palmaz joined the faculty in 1983 at the University of Texas, San Antonio, he gave a copy of the 1983 monograph to a doctor there (who then gave it to the technician setting up Dr. Palmaz’s laboratory) and to the university as part of a research proposal. Dr. Palmaz applied for the patent that became the ’762 patent in 1985.

The court explained the different scenarios that have been evaluated previously:

A document is publicly accessible if it “has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it and recognize and comprehend therefrom the essentials of the claimed invention without need of further research or experimentation.” In re Wyer, 655 F.2d 221, 226 (CCPA 1981) quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743 (S.D.N.Y.1966)). In general, “[a]ccessibility goes to the issue of whether interested members of the relevant public could obtain the information if they wanted to.” Constant v. Advanced Micro-Devices, Inc., 848 F.2d 1560, 1569 (Fed. Cir. 1988). Many of our cases in this area have concerned publications available in libraries, and the question has been whether the publication has been sufficiently indexed to be publicly accessible. See, e.g., In re Cronyn, 890 , 655 F.2d at 226. Other cases have involved widespread distribution so that the public could easily obtain copies of the publication. , 545 F.3d 1340, 1350-51 (Fed. Cir. 2008). F.2d 1158, 1161 (Fed. Cir. 1989); In re Hall, 781 F.2d 897, 899 (Fed. Cir. 1986); In re WyerSee, e.g., Kyocera Wireless Corp. v. Int’l Trade Comm’n

The Issue here was framed this way:

Here we have a somewhat different question: whether the distribution to a limited number of entities without a legal obligation of confidentiality renders the monographs printed publications under § 102(b).

We have held that where a distribution is made to a limited number of entities, a binding agreement of confidentiality may defeat a finding of public accessibility. But we have also held that such a binding legal obligation is not essential. Klopfenstein, 380 F.3d at 1351. We have noted that “[w]here professional and behavioral norms entitle a party to a reasonable expectation” that information will not be copied or further distributed, “we are more reluctant to find something a ‘printed
publication.’” Id. at 1350-51.

The court found that the norms here were biased towards confidentiality:

The record here contains clear evidence that such academic norms gave rise to an expectation that disclosures will remain confidential…Therefore, the distribution to the academics did not render the monographs as printed publications under 35 U.S.C. § 102(b).

Boston Scientific urged that, "even if the academic and hospital distributions did not create public accessibility, the distribution of monographs to two commercial entities did so. "

The court noted:

"There is no claim here that the two commercial entities provided any express agreement to keep the document confidential; indeed, one entity’s disclosure agreement did not discuss the entity’s confidentiality obligations, and the other entity’s disclosure agreement specifically disclaimed such obligations (most likely to avoid a lawsuit resulting from inadvertent disclosure)."

Boston Scientific argue[d] that under the decision of our predecessor court, the Court of Claims, in Garrett Corp. v. United States, “[w]hile distribution [of a government report] to government agencies and personnel alone may not constitute publication, distribution to commercial companies without restriction on use clearly does.” 422 F.2d 874, 878 (Ct. Cl. 1970) (citation omitted).

However, [according to the court] "the evidence here was sufficient to support a conclusion that there was an expectation of confidentiality between Dr. Palmaz and each of the two commercial entities."

While the Shiley legal agreement executed before development discussions disclaimed a confidentiality requirement, Dr. Palmaz testified that he requested confidentiality during subsequent discussions and was “surprise[d]” when he was shown the language of the Shiley agreement. J.A. at 8517; id. at 19,354. There is no suggestion that the request for confidentiality was not, in fact, honored. Dr. Palmaz confirmed that the entities kept their copies of the monograph confidential, whether or not they were legally obligated to do so. J.A. at 8502. The district court noted that “there is no evidence that [the commercial entities] would have distributed, or in fact did distribute, the 1980 Monograph outside of the company.” Cordis Corp. v. Boston Scientific Corp., Civ. No. 03-027-SLR, 2005 WL 1331172, at *4 (D. Del. June 3, 2005). There was no showing that similar documents in the past became available to the public as a result of disclosure by these or similar commercial entities, that these or similar commercial entities typically would make the existence of such documents known and would honor requests for public access, or that these or similar commercial entities had an incentive to make the document available, etc. The mere fact that there was no legal obligation of confidentiality—all that was shown here—is not in and of itself sufficient to show that Dr. Palmaz’s expectation of confidentiality was not reasonable."

Other issues in the case involved claim construction, obviousness, or anticipation but were generally ordinary.

The full opinion can be found here.

A list that fails to disclose a species can anticipates the species if that species is "at once envisaged"?

noreply@blogger.com (Patent Decisions) — Thu, 26 Mar 2009 19:40:00 +0000

IN RE MARTIN GLEAVE (Fed. Cir. March 26, 2009)
Claims at Issue:

1. A bispecific antisense oligodeoxynucleotide, wherein substantially all of the oligodeoxynucleotide is complementary to a portion of a gene encoding human IGFBP-2 and substantially all of the oligodeoxynucleotide is also complementary to a gene encoding human IGFBP-5, and wherein the oligodeoxynucleotide is of sufficient length to act as an antisense inhibitor of human IGFBP-2 and human IGFBP-5.

4. The antisense oligodeoxynucleotide according to claim 1, wherein the oligodeoxynucleotide consists essentially of a series of bases as set forth in any of Seq. ID. Nos. 3 through 7. [Those sequences range from eighteen to twenty-two DNA bases in length and SEQ ID NO: 5 is a 20mer.]

The claims were rejected as anticipated by Wraight.

"In Wraight, the applicants listed every fifteen-base-long sense oligodeoxynucleotide in the IGFBP-2 gene. The list includes more than 1400 sequences. Wraight also disclosed the general concepts that antisense oligonucleotides are preferably between fifteen and twenty-five bases in length, and that some antisense oligonucleotides may be bispecific (i.e., capable of inhibiting “an IGFBP such as IGFBP-2 and/or IGFBP-3”). Finally, Wraight states that “[a]ntisense oligonucleotides to IGFBP-2 may be selected from molecules capable of interacting with one or more” of the sense oligonucleotides described in the long list. "

The court explained what constitutes a proper 102(b) rejection

A reference is anticipatory under § 102(b) when it satisfies particular requirements. First, the reference must disclose each and every element of the claimed invention, whether it does so explicitly or inherently. Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 471 F.3d 1369, 1375 (Fed. Cir. 2006). While those elements must be “arranged or
combined in the same way as in the claim,” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1370 (Fed. Cir. 2008), the reference need not satisfy an ipsissimis , 545 F.3d 1312, 1314 (Fed. Cir. 2008); , 339 F.3d 1373, 1380–81 (Fed. Cir. 2003); verbis test, In re Bond, 910 F.2d 831, 832–33 (Fed. Cir. 1990). Second, the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” Impax Labs., Inc. v. Aventis Pharms. Inc.see In re LeGrice, 301 F.2d 929, 940–44 (CCPA 1962). As long as the reference discloses all of the claim limitations and enables the “subject matter that falls within the scope of the claims at issue,” the reference anticipates—no “actual creation or reduction to practice” is required. Schering Corp. v. Geneva Pharms., Inc.see In re Donohue, 766 F.2d 531, 533 (Fed. Cir. 1985).

Gleave (the appellant) argued that

“Wraight does not describe any particular individual antisense species,” because Wraight merely gives the public “ink, formed into strings of letters, without inventive thought and without placing the public in possession of anything new. There is no guidance to make particular selections, and no understanding of which of the targets would be useful, and what the properties of the related antisense would be.”

The Federal Circuit, however, stated that the enablement requirement of 102 is not how to use for a composition, just how to make.

"A thorough reading of our case law, however, makes clear that a reference need disclose no independent use or utility to anticipate a claim under § 102. E.g., Novo Nordisk Pharms., Inc. v. Bio-Tech. Gen. Corp., 424 F.3d 1347, 1355 (Fed. Cir. 2005)"

The court explained that any confusion about utility or use comes from case law related to method claims. The court explained to enable a method you have to be able to use it not make it.

"Gleave’s claims are to compositions of matter—oligonucleotides—and therefore a reference satisfies the enablement requirement of § 102(b) by showing that one of skill in the art would know how to make the relevant sequences disclosed in Wraight. "…"Thus, the fact that Wraight provides “no understanding of which of the targets would be useful” is of no import, because Gleave admits that it is well within the skill of an ordinary person in the art to make any oligodeoxynucleotide sequence. See Appellant’s Br. 10. As such, Wraight is an enabling disclosure sufficient to anticipate Gleave’s invention under § 102(b). "

Applicant also argued that the prior art did not teach any oligo with antisense activity. The appellant's lawyer even admitted this even with the following phrase "sufficient length to act as an antisense inhibitor " in the claim. Therefore, they viewed the antisense inhibitor limitation as an intended use and not relevant for 102 analysis. "Certainly where the claims themselves do not require a particular activity, we have no call to require something more from the anticipating reference. "

Gleave argued that a long list should not be anticipatory and should be treated more like a generic statement. Court explained that lists and generic terms have always been treated differently except when a genus can anticipate a species when:

compounds that falls within the genus is so limited that a person of ordinary skill in the art can “at once envisage each member of this limited class.” Eli
Lilly, 471 F.3d at 1376. In that limited circumstance, a reference describing the genus anticipates every species within the genus. See Perricone, 432 F.3d at 1377.

The court explained this argument regarding the two types of claims fails for two reasons:

First, Wraight expressly lists every possible fifteen-base-long oligodeoxynucleotide sequence in IGFBP-2, and under our precedent, this list anticipates Gleave’s claims. Second, even if we were to accept Gleave’s invitation to treat Wraight as equivalent to the statement that one “could make antisense that targets IGFBP-2,”4 which we decline to do, a person of ordinary skill in the art equipped with an IGFBP sequence is admittedly capable of envisioning how to make any antisense sequence. Thus, even
if we were to adopt Gleave’s policy position, Gleave’s claims would not be entitled to a patent over Wraight.

The explained that at most Gleave has invented a method of use not a claim for the composition itself.

What wasn't explained is why the claims to the specific sequences were anticipated since only 15mers were disclosed in Wraight and those in claim 4 were from 18-22 and the elected species was a 20mer. The only explanation that I can think of is that Wraigh said an antisense oligo that is from 15-25 can be made and therefore all oligos 18-22 could be at once envisaged? Thoughts?

The full opinion can be found here.

"Public use bar applies to obvious variants of the demonstrated public use"

noreply@blogger.com (Patent Decisions) — Wed, 25 Mar 2009 19:30:00 +0000

In CLOCK SPRING v WRAPMASTER (Fed. Cir., March 25, 2009) the federal circuit invalidated a a claim due to a public use under 35 U.S.C. § 102(b). The claim at issue was:

A method for repairing a pipe
adapted to carry an internal load directed radially outward therefrom, said
pipe having a defective region defined by at least one cavity extending from
an outer surface of said pipe toward the center of said pipe but not extending
completely through the wall of said pipe, said method comprising the steps of:
providing a filler
material having a workable uncured
state and a rigid cured state,
filling said cavity to at
least said outer surface of said pipe with said filler material in said workable
state,
providing at least one band
having a plurality of elastic convolutions of high tensile strength material,
while said filler material is
in said workable state, wrapping said
plurality of convolutions of said high tensile strength material about said pipe
to form a coil overlying stud filler material[,]
tightening said coil about said
pipe so that said filler material completely fills that portion of said cavity
underlying said coil[,]
securing at least one of said convolutions to
an adjacent one of said convolutions, and
permitting said filler material to cure to said rigid
state, whereby a load carried by said pipe is
transferred substantially instantaneously from said pipe to said coil.

“[A] public use includes any public use of the claimed invention by a person other than the inventor who is under no limitation, restriction or obligation of secrecy to the inventor.” Adenta, 501 F.3d at 1371 . "In order for a use to be public within the meaning of § 102(b), there must be a public use with all of the claim limitations. "

There was no dispute that the use was public and there was no control over the people demonstrating the use or observing it. "(“An invention is in public use if it is shown to or used by an individual other than the inventor under no limitation, restriction, or obligation of confidentiality.”). They found that the filling cavaties would have been obvious in view of the demonstration. Therefore, even though the exact limitation may not have been in public use it still qualified because, as the Federal Circuit stated: "We have held that the public use bar applies to obvious variants of the demonstrated public use. Netscape Commc’ns Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed. Cir. 2002)."

They further found that all other elements were part of the demonstration and therefore it was barred under 102(b). Patentee also tried to argue that it was an experimental use. The Federal Circuit found that there was no control, which although not dispositive indicates that it may not be experimental. "A use may be experimental only if it is designed to (1) test claimed features of the invention or (2) to determine whether an invention will work for its intended purpose—itself a requirement of patentability. " The patentee argued that the demonstration was done to determine the durability of the method and end product but there was no evidence of record indicating that this was indeed true. "Clock Spring’s problem, however, is that no report in the record states, or in any way suggests, that the 1989 demonstration was designed to test durability for the purposes of the patent application to the PTO. " Rather there was evidence that durability was for the end user rather than for patentability.

Interestingly, the district court had decided that there was an issue of material fact regarding the public use and found the claims invalid for being obvious. The CAFC reversed the public use decision and did not decide obviousness.

The case can be found here.

It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art.

noreply@blogger.com (Patent Decisions) — Fri, 20 Mar 2009 20:31:00 +0000

Ex parte ALA FISHMAN et al.
Appeal 2009-1258
Application 10/096,840
Technology Center 1600
Decided: March 20, 2009

Claims at issue:
22. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety.

29. A pharmaceutical composition comprising the chimeric protein of claim 22, wherein said composition is in a form suitable for injection, intra-nasal, intra-thecal, intra-dermal, trans-dermal, inhalation, topical application, oral administration, sustained release, or ethereal administration.

43. A chimeric protein for therapy of allergic responses by targeted elimination of FCεRI expressing cells wherein the chimeric protein comprises a cell targeting moiety consisting of an Fc region of an IgE molecule genetically fused to a cell killing moiety, and the chimeric protein does not cause degranulation of target cells.

Examiner rejected claims as lacking written description because the specification "does not reasonably provide a written description of any and all chimeric protein comprising any cell targeting moiety consisting of an Fc region of any IgE molecule genetically fused to any cell killing moiety as set forth in claims." The Board following Capon v. Eshhar and Falkner v. Inglis reversed the Examiner.

"Simply stated, there is no evidence on this record to support a conclusion that the cell killing and cell targeting moieties set forth in Appellants’ claims were not known to those of ordinary skill in this art at the time the invention was made. It is unnecessary for the Specification to provide a description of proteins which are already known in the prior art. Capon, 418 F.3d at 1357-58."

The Board affirmed that the claims were obvious, in part, because the appellants mischaracterized the prior art (according to the Board) and, therefore, the contention was not persuasive.

Case can be found here

X-ray Powder Diffraction Pattern is Relevant for Obviousness Analysis regardless of whether or not the compound has unexpected properties. (BPAI)

noreply@blogger.com (Patent Decisions) — Thu, 19 Mar 2009 14:54:00 +0000

Ex parte MANNE SATYANARAYANA REDDY et al (BPAI)
Appeal 2008-4197
Application 10/651,306
Technology Center 1600
Decided: March 18, 2009

Claims at issue:
1. A hydrous compound of the formula …

42. Hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid made by a process comprising:…

44. A solid pharmaceutical composition comprising a hydrous (S)-5-methoxy-2-[[4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole magnesium in the form of an amorphous solid, wherein the esomeprazole magnesium has substantially the same X-ray powder diffraction pattern as shown in Figure 1, and a pharmaceutically acceptable carrier.

45. A method for reducing gastric acid secretion in a subject which comprises administering to the subject a solid pharmaceutical composition comprising an amount of the compound of claim 1 effective to reduce gastric acid secretion by said subject.

The Examiner rejected claim 42 under 112, second paragraph for the use of product-by-process claim language. The Examiner argued that since they could describe the product as evidence by claim 1, product by process claims are improper. The Board reversed citing, SmithKline Beecham Corp. v. Apotex Corp., 439 F.3d 1312, 1315 (Fed. Cir. 2006), citing that rule the Examiner was using is not the correct standard.

The Examiner rejected claims 44 and 45 for lack of written description and enablement. The Board emphasized that written description and enablement are distinct and noted that the Examiner did not provide any argument regarding written description and therefore reversed that rejection. With regards to enablement the Examiner was concerned that the form claimed could transform in the solid form and therefore the claim was not enabled for some reason. Appellants pointed out that if there was a transformation that changed the x-ray diffraction pattern then it would be outside the scope of the claim and thus not part of the claim. Appellants also supplied evidence stating that conversion from one form to another is "so slow as to be negligible" and that even if it was converted it does not impact the activity of the compound. Examiner never responded to these arguments and therefore they reversed.

The claims were also rejected as obvious. The Examiner cited references describing related compounds that disclosed that some drugs may exist in amorphous forms but do not refer to the claimed compound. The Examiner also stated that an X-ray diffraction pattern although a property is not enough to overcome obviousness unless the X-ray form has an advantage or unexpected results. The prior art references failed to show any compound with a similar X-ray powder diffraction pattern. Therefore, the Board found that the claims were not obvious and reversed the Examiner.

Case can be found here.

BPAI holds that "paving the way" to the claimed invention does not enable the entire scope

noreply@blogger.com (Patent Decisions) — Thu, 19 Mar 2009 14:38:00 +0000

Ex parte WENDELL LIM, JOHN DUEBER, and BRIAN YEH (BPAI)
Appeal 2008-3676
Application 10/613,380
Technology Center 1600
Decided: March 18, 2009

The claim at issue:

1. An autoregulated fusion protein comprising an output domain and a plurality of input domains, wherein at least one of the input domains is heterologous to the output domain, and the input domains interact with each other to allosterically and external ligand-dependently regulate the output domain.

The Applicants provided one working example and described how one of skill in the art would use their techniques to screen other "output domain" (catalytic domains) and "input domain" (regulatory domains, i.e. SH3 domain) to create the autoregulated fusion protein. The Examiner, which the Board agreed with, found that the specification did not provide a person to "predictably produce" a desired fusion protein and that an "extremely large amount of experimentation would be required." The Board instead characterized the specification as "an interesting avenue of further research." The Board explained:

They, may have even paved the way for further research
(see e.g., App. Br. 6). What they have not done is provide an enabling
description of the claimed invention that would allow a person of ordinary skill
in the art to practice the claimed invention without undue
experimentation. Other than the recommendation that one do the screens and
figure it out for yourself, Appellants have provided no guidance on how to
successfully select the appropriate plurality of input domains that can be
fused, with or without a linker, to an output domain to successfully obtain a
fusion protein with the properties one would desire.

Applicants had submitted a declaration stating that “[t]hose skilled in the art have recognized that the invention is not limited to a single embodiment, but that Applicants’ teachings ‘…pave the way for creating new signal-response elements by protein design[’]” The Board found this unconvincing because "providing an interesting avenue for further research (e.g., paving the way) is not the same as providing a disclosure that enables a person of ordinary skill in the art to practice the claimed invention without undue experimentation."

Case can be found here.

An abbreviation in a claim need not be spelled out when it would be understood when read in light of the specification

noreply@blogger.com (Patent Decisions) — Mon, 09 Mar 2009 20:58:00 +0000

Ex parte BRUCE KERWIN, BYEONG CHANG, and LEI SHI
Appeal 2008-4371
Application 10/461,839
Technology Center 1600
Decided: March 9, 2009

Claim at issue:
1. A stable pharmaceutical formulation comprising at least 45 mg/ml PEGsTNF-R1, at least one tonicity modifier that is not NaCl, a surfactant and a buffer, wherein said pharmaceutical formulation is between pH 4.0 and 5.5 and wherein the viscosity is less than 400 cP.

The claim used the term "PEGsTNF-R1". The Examiner acknowledges that Appellants’ Specification defines PEGsTNF-R1 but insists that “the acronym ‘PEGsTNF-R1’ as recited in the claims should be spelled out and/or defined the first time it is recited in the claims." The Examiner acknowledges on this record that a person of ordinary skill in the art would understand the bounds of the claimed invention when read in light of the Specification. The Examiner argued that looking to the specification to define PEGsTNF-R1 would be adding an extraneous limitation. The Examiner relied upon In re Van Geuns, 988 F.2d 1181, 1184 (Fed. Cir. 1993), to find that “[a]lthough the claims are interpreted in light of the specification, limitations from the specification are not read into the claims” (Ans. 7). The Board disagreed holding that “[I]t is entirely proper to use the specification to interpret what the patentee meant by a word or phrase in the claim.” In re Paulsen, 30 F.3d at 1480." Therefore, the claim was definite.

The claims were found to be obvious for standard reasons such as overlapping ranges and optimization of dosages requiring nothing more than routine experimentation.

Case can be found here

Bilski applied to kill another patent application

noreply@blogger.com (Patent Decisions) — Fri, 06 Mar 2009 20:35:00 +0000

In Re Ferguson (Federal Circuit, March 6, 2009)

The Federal Circuit made another decision applying Bilski, this time from an appeal from the PTO's BPAI. Here, there were two claims at issue:

A method of marketing a product, comprising:
developing a shared marketing force, said shared
marketing force including at least marketing channels, which enable marketing a
number of related products;
using said shared marketing force to market a
plurality of different products that are made by a plurality of different
autonomous producing company, so that different autonomous companies, having
different ownerships, respectively produce said related products;
obtaining a share of total profits from each of said
plurality of different autonomous producing companies in return for said using;
and
obtaining an exclusive right to market each of said
plurality of products in return for said using.
A paradigm for marketing software, comprising:
a marketing company that markets software from a
plurality of different independent and autonomous software companies, and
carries out and pays for operations associated with marketing of software for
all of said different independent and autonomous software companies, in return
for a contingent share of a total income stream from marketing of the software
from all of said software companies, while allowing all of said software
companies to retain their autonomy.

The BPAI reversed the Examiner's 102 and 103 rejection and entered a new ground of rejection under 101 applying Bilski. The Federal Circuit held that the method claim although a process failed the machine or transformation test laid out in Bilski. The stated, that the method claim is "not tied to any particular machine or apparatus." The Federal Circuit defined what counts as a machine relying upon In re Nujiten, "As this court recently stated in In re Nuijten, 500 F.3d 1346 (Fed. Cir. 2007), a machine is a “‘concrete thing, consisting of parts, or of certain devices and combination of devices.’ This ‘includes every mechanical device or combination of mechanical powers and devices to perform some function and produce a certain effect or result." The court explained, "Applicants’ method claims are not tied to any concrete parts, devices, or combination of devices."

"Nor do Applicants’ methods, as claimed, transform any article into a different state or thing. At best it can be said that Applicants’ methods are directed to organizing business or legal relationships in the structuring of a sales force (or marketing company). But as this court stated in Bilski, “[p]urported transformations or manipulations simply of public or private legal obligations or relationships, business risks, or other such abstractions cannot meet the test because they are not physical objects or substances, and they are not representative of physical objects or substances.” 545 F.3d at 963."

Applicants argued that their "paradigm" claim is a company and as such is "analagous to a machine." The Federal Circuit rejected this argument. "But the paradigm claims do not recite “a concrete thing, consisting of parts, or of certain devices and combination of devices,” Nuijten, 500 F.3d at 1355, and as Applicants conceded during oral argument, “you cannot touch the company.” The called the "paradigm" an abstract idea--"a business model for an intangible marketing company."

Newman concurred in the judgment in that she would have affirmed the Examiner's 103 rejection. Newman is concerned about the policy effects of the way Bilski is being used to strike down innovation. She would have found the paradigm to satisfy 101 because it is concrete and limited but found them invalid under 103. Newman remarked:

"This court’s retreat into the methods of the past is
unworthy of our responsibility to support innovation in the future. Major
adjustment in established law should be based on changing industrial or
intellectual or equitable needs – of which no evidence is before this court. The only need of
which I am aware is that of the current harsh economic times, when the need is
of enhanced incentives to innovation and investment in new things and new
industries, not reduction in the existing incentives."

Case can be found here

Post-filing art can be used to show that there is no reasonable expectation of success (BPAI)

noreply@blogger.com (Patent Decisions) — Fri, 06 Mar 2009 05:02:00 +0000

Ex parte ATUL VARADHACHARY

Appeal 2008-3921

Application 10/732,429

Technology Center 1600

Decided: March 5, 2009

The claims at issue were

1. A method of treating tissue or organ transplant rejection in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to attenuate the tissue or organ transplant rejection.

34. A method of modulating the immune response against an organ or tissue transplant in a recipient comprising the step of orally administering to the recipient an effective amount of a lactoferrin composition to modulate the response against the organ or tissue transplant.

Claim 1 was rejected as being inherently anticipated by a single reference; claims 1 and 34 were rejected as allegedly obvious. A prior art reference taught the administration of lactoferrin in organ transplant patients and immunocompromised patients. However, the reference only taught that it could be used to prevent infections not to attenuate rejection or modulate the response against the organ transplant. The case nicely summarizes inherent anticipation

"To anticipate a claim, a prior art reference must disclose every limitation of the claimed invention, either explicitly or inherently." In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). Thus, "[n]ewly discovered results of known processes directed to the same purpose are not patentable because such results are inherent." Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1376 (Fed. Cir. 2001). "Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient." In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citations and internal quotation marks omitted). Therefore, the Examiner cannot establish inherency merely by demonstrating that the asserted limitation is probable or possible. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981). However, "'[i]n general, a limitation or the entire invention is inherent and in the public domain if it is the 'natural result flowing from' the explicit disclosure of the prior art.'" Perricone v. Medicis Pharm. Corp., 432 F.3d 1368, 1377 (Fed. Cir. 2005) (quoting Schering Corp. v. Geneva Pharms., Inc., 339 F.3d 1373, 1379 (Fed. Cir. 2003). Therefore, "when considering a prior art method, the anticipation doctrine examines the natural and inherent results in that method without regard to the full recognition of those benefits or characteristics within the art field at the time of the prior art disclosure." Perricone, 432 F.3d at 1378.

The Examiner appeared to be arguing that since the compound was used in organ transplant cases it was necessarily and always being used to prevent rejection. The Board noted that some transplant patients will not have rejection and only infection and therefore the result will not always necessarily result from the prior art. "No evidence has been put forward by the Examiner that all, or even substantially all, transplant patients with infection are also experiencing rejection" Therefore, no anticipation.

With regards to obviousness the Examiner found a reference that discussed the oral administration of lactoferrin. However, the applicant submitted a post-filing reference that stated "[i]t has been reported in the literature that oral lactoferrin is not absorbed systemically through the mature gut to any significant degree." The Board when stating the law regarding obviousness stated, "An obviousness analysis requires that the prior art both suggest the claimed subject matter and reveal a reasonable expectation of success to one reasonably skilled in the art. In re Vaeck, 947 F.2d 488, 493 (Fed. Cir. 1991)." Here, the BPAI found no reasonable expectation of success because of the post-filing reference. The Board concluded: "Thus, while [the primary reference] teaches that oral administration may be contemplated, the prior art at the time Appellants' claimed invention was made establishes that a person of ordinary skill in the art would have no expectation of successfully using orally administered lactoferrin in [the primary reference's] method." Therefore, "A person of ordinary skill in the art would not have a reasonable expectation of successfully practicing the claimed invention in view of the combination of" the cited references.

Case can be found here

No Abuse of Discretion When an Appointed Neutral Expert Testifies; Section 103 requires an inquiry regarding "whether the improvement is more than the predictable use of prior-art elements according to their established function"

noreply@blogger.com (Patent Decisions) — Thu, 05 Mar 2009 22:12:00 +0000

MONOLITHIC POWER SYSTEMS, INC. (MPS), v. O2 MICRO INTERNATIONAL LIMITED (Fed. Cir. March 5, 2009)
District Court Did Not Abuse Its Discretion When it Appointed a Neutral Expert to Testify; and "Section 103 of Title 35 requires this court to inquire “whether the improvement is more than the predictable use of prior-art elements according to their established functions.”

This was a DJ action and the patentee is 02 Micro.

The district court was struggling with the technical complexities of the case. At a case management conference the judge stated the following:

On the technical issues here . . . I find this extremely difficult to
understand. And the notion that a jury is going to understand it, to me, is
foolishness. You can talk for months and the jury isn’t really going to
understand this in the sense of being able to make a reasoned, rational decision
about it.They will make a decision, we hope. Maybe they will hang
because they’ll say that we can’t possibly understand this, but in my
experience, they make a decision. But what is it based on? . . . It is kind of
trial by ordeal or by sort of a champion, like a jousting contest rather than on
the actual scientific merits of who is right and who is wrong.

Over the objection of 02 Micro the district court ordered the parties to confer on a Rule 706 expert, which was eventually appointed and who testified. The court-appointed expert, Dr. Santi, offered testimony largely consistent with MPS’s theory of the case, including MPS’s position that it did not infringe O2 Micro’s asserted claims. The district court instructed the jury that the appointed expert was “an independent witness retained by the parties jointly at the court’s direction to assist in explaining the technology at issue in this case.” The Federal Rules of Evidence allow a court to appoint an expert either “on its own motion or on the motion of any party.” Fed. R. Evid. 706(a). It is reviewed under circuit law and this was in the ninth circuit.

The Federal circuit noted that "While commentators have observed that district courts rarely make Rule 706 appointments . . . this court acknowledges that the Federal Rules do authorize those appointments." O2 Micro argued that it violated its 7th amendment rights to a jury trial because it was taking issues out of the jury's hands. The Federal Circuit that this was not the case because the parties agreed on an expert, the jury instructions were proper, and they could call their own experts to attack, support, or supplement the 706(a) appointed expert. The district court instructed the jury in the following manner:

You should not give any greater weight to Professor Santi’s opinion testimony than to the testimony of any other witness simply because the court ordered the parties to retain an independent witness. In evaluating his opinion, you should carefully assess the nature of and basis for Professor Santi’s opinion just as you would do with any other witness’ opinion.

The Federal Circuit noted that the jury's verdict did not track the expert's testimony. For example the CAFC stated, "Whereas Dr. Santi opined that only claim 12 of the ’722 patent was obvious, the jury found all claims obvious." The Federal Circuit ultimately held that O2's argument is a policy argument and it was rejected by Congress.

The Federal Circuit did not like the rule but followed it, they stated, " The predicaments inherent in court appointment of an independent expert and revelations to the jury about the expert’s neutral status trouble this court to some extent," but found that it did not violate the Ninth Circuit's liberal interpretation of circumstances of when the rule can be used.

The claims were also found to be obvious and this was upheld by the Federal Circuit. The CAFC found that the elements were known and there was motivation to make the combination. In framing whether the invention was obvious the court stated, "Section 103 of Title 35 requires this court to inquire “whether the improvement is more than the predictable use of prior-art elements according to their established functions.” KSR Int’l Co. v. Teleflex Inc., 127 S. Ct. 1727, 1740 (2007)." They found that the combination was nothing more than a predictable use.

Case can be found here

An individual who provides an insignificant contribution that is the element recited in a dependent claim is generally not an inventor

noreply@blogger.com (Patent Decisions) — Thu, 05 Mar 2009 20:49:00 +0000

NARTRON CORPORATION v. SCHUKRA U.S.A., (Fed. Cir. March 5, 2009)

The District court granted summary judgment of dismissal of the infringement suit for failure of the patentee to join an alleged co-inventor on the patent being asserted. The CAFC reversed because "the alleged co-inventor, provided only an insignificant contribution to the invention of claim 11 of the ’748 patent." Claim 1 and claim 7 of the patent were being asserted. Claim 11 the defendant alleged was also invented by an individual who was not listed as an inventor. The listed inventors admit that they did not "invent the lumbar support adjustor including an extender recited in claim 11." Benson, who is the alleged unlisted inventor, claimed to have provided the listed inventors with the idea of the extender. Benson admitted that the extender was part of the prior art in an automobile seat. The district court held that Benson was a co-inventor because Benson "had conceived of the extender element of claim 11, and, as a co-inventor, he was required to have been joined as a plaintiff in any infringement suit." Therefore, the case was dismissed.

The patentee argued that the extender element was in the prior art and therefore could not have supported a claim of co-inventorship. The patentee argued that the invention related to the controller of the seat not the lumbar support or the extender. The patentee also argued that regardless of whether the element was in the prior art the contribution was insignificant to the invention. The alleged infringer argued that because the combination was patentable Benson should be listed. The defendant also argued that an aspect of a claim cannot be insignificant simply because it appears in a dependent claim.

The Federal Circuit reversed the District court. The Court held "Any contribution Benson made to the invention described in claim 11 by contributing an extender was insignificant and therefore prevents Benson from attaining the status of a co-inventor." “One who simply provides the inventor with well-known principles or explains the state of the art without ever having a firm and definite idea of the claimed combination as a whole does not qualify as a joint inventor.” Ethicon, 135 F.3d at 1460. Moreover, a joint inventor must “contribute in some significant manner to the conception or reduction to practice of the invention [and] make a contribution to the claimed invention that is not insignificant in quality, when that contribution is measured against the dimension of the full invention.” Pannu v. Iolab Corp., 155 F.3d 1344, 1351 (Fed. Cir. 1998); see Caterpillar, 387 F.3d at 1377 (quoting Fina Oil & Chem. Co. v. Ewen, 123 F.3d 1466, 1473 (Fed. Cir. 1997)). The court held that Benson's contribution was no more than "the exercise of ordinary skill in the art."

The court also looked at the specification and noted that the specification focused on the controller not the elements of the seat. They also pointed out, "The specification mentions the extender only once in a twenty-column patent." and it was discussing the background upon which the controller was built, implying that the number of times and where an element is stated may impact whether it is significant or not. The court further explained, "Benson’s contribution of the extender amounted to “nothing more than explaining to the inventors what the then state of the art was and supplying a product to them for use in their invention.”

The court did limit the holding to facts such as these. The court stated, "This is not a case in which a person claims to be an inventor because he has suggested a non-obvious combination of prior art elements to the named inventors. Such an individual may be a co-inventor. There is not, and could not be, any claim that the addition of the extender here was anything but obvious. Benson’s contribution therefore does not make him a co-inventor of the subject matter of claim 11."

Case can be found here.

"Conclusive Evidence" showing possession is not required for Written Description; "Mere Assertions" not enough to show lack of enablement (BPAI)

noreply@blogger.com (Patent Decisions) — Tue, 03 Mar 2009 18:32:00 +0000

Ex parte SAMUEL LOCKWOOD et al. (BPAI)
Appeal 2008-5693
Application 10/793,676
Technology Center 1600
Decided: March 2, 2009

Claim:
A method of reducing C-reactive protein (CRP) levels in a subject comprising administering to a subject who would benefit from such treatment, an effective amount of a pharmaceutically acceptable formulation to reduce the level of circulating CRP in the subject, said pharmaceutically acceptable formulation comprising a non naturally occurring carotenoid analog or derivative; wherein the synthetic carotenoid analog or derivative has the structure …

The Examiner rejected the claims as lacking written description and lacking enablement. The Examiner alleged that the specification "fails to disclose any treatable diseases caused by increased C-reactive protein (CRP), and how reducing CRP is the same as treating the diseases” and characterized the claims as reach through claims, which according to the Examiner are unpatentable. Applicants countered showing that there is a correlation with CRP and certain known diseases.

The Board stated reversed the Examiner. The Board found that the "specification provides direct descriptive support of an association between many ischemic disease states and reperfusion injury (FF 1-2). The Specification directly teaches that levels of C-reactive protein are associated with reperfusion injury and that treatment of these conditions with carotenoids “is expected to inhibit and/or ameliorate . . . disease conditions” (Spec. 7, ll. 2-5; FF 3-4). The Specification also teaches possession of a large number of specific carotenoids (FF 5)." The Examiner had argued that there was no "no conclusive evidence that reduction of circulating CRP is ‘a powerful anti-inflammatory therapeutic modality’ and/or ‘a strong therapeutic modality’” The Board held that for written description this standard is incorrect you only have to show possession of the invention, not conclusive evidence of a link.

The claims were also rejected as being non-enabled. The Examiner did not provide any evidence other than opinion that the claims were not enabled. The Examiner seemed to rely upon the step of detecting and diagnosing CRP to perform the claim. The Board noted that this is routine and not undue. The Examiner also argued that it is not known all diseases arising from CRP are known. The Board held that it is not a requirement and there can be some inoperative embodiments. The Examiner argued that there could be some mutations that cause constituve expression of CRP rather than heart injury. But this argument was not supported by any evidence just Examiner opinion.

The Board Concluded: "The Examiner has not provided the required evidence or scientific reasoning to show that one of ordinary skill in the art would find that reduction of CRP levels in a patient would have required “undue experimentation”. The Examiner's mere assertions to that effect are not sufficient for establishing a prima facie case of lack of enablement. Balancing the factors in the Wands analysis, upon which the rejection is based, demonstrates that there is no prima facie case of lack of enablement.

The claims were rejected for being indefinite but the Examiner failed to say why and thus the rejection was reversed. The claims were also rejected for containing new matter because an R group was not in the specification. This was a new ground of rejection and was remanded to the Examiner for further prosecution.

Case can be found here

Prior art must teach all the elements for obviousness

noreply@blogger.com (Patent Decisions) — Thu, 26 Feb 2009 16:32:00 +0000

Ex parte ROGER B. QUINCY, III and JOHN G. MACDONALD (BPAI)
Appeal 2009-0441
Application 10/328,730
Technology Center 1600
Decided: February 26, 2009

25. A substrate that contains an odor control composition in an amount of from about 0.5 wt.% to about 25 wt.% of the substrate, wherein said odor control composition comprises a silicon oxide compound and a transition metal that constitutes from about 0.2 wt.% to about 10 wt.% of said odor control composition,

wherein said silicon oxide compound is formed from a silicon source and a cyclodextrin template.

The Examiner argued that a composition with a chelating agent is the same as a metal ion because it can chelate metal. The Board thankfully disagreed. The reference “[s]uitable odor control agents also include chelating agents typically suitable to chelate metal ions like iron and manganese.” (FF3.) [The reference] did not say that metal ions are odor control agents. [The Reference] taught making an odor control composition with a chelating agent, but did not teach making a composition with the metal ion a chelating agent could bind. [The reference] also did not teach using a “chelate” of agent and metal as the Examiner argues..."Put another way, the cited prior art did not contain all the elements of the claimed composition. The Office’s case for obviousness did not account for the differences."

Case can be found here

Just because the group of obvious variants may be large does not make the use of any [one] any less obvious.

noreply@blogger.com (Patent Decisions) — Thu, 26 Feb 2009 04:55:00 +0000

Ex parte JACQUES DEGELAEN et al. (BPAI)

Appeal 2008-5883

Application 10/702,507

Technology Center 1600

Decided: February 25, 2009

The claim at issue was an assay kit for detecting one or more antibiotics containing a β-lactam ring in a liquid dairy product. The prior taught a similar assay but with a different receptor for recognizing the antibiotic. The Examiner found the claim to be obvious. The Board affirmed. The applicant argued that there were a large number of bacterial receptors to choose from and no guidance to pick the one they chose and there was no expectation of success. The Board disagreed and sided with the Examiner. The Board stated:

"We recognize that there are a large number of bacteria from which beta-lactam receptors may be obtained, but just because the group of obvious variants may be large does not make the use of any specific-binding protein for a beta-lactam antibiotic any less obvious."

With regards to the expectation of success the Board stated that the applicant had not provided any scientific or other evidence to show that there would not have been a reasonable expectation of success. The Board once again reiterated that arguments of counsel are not sufficient.

Case can be found here

Written Description Requires Specification to be Read as a Whole (BPAI)

noreply@blogger.com (Patent Decisions) — Fri, 20 Feb 2009 17:17:00 +0000

Ex parte FREDERICK KHACHIK (BPAI)
Appeal 2009-25571
Application 11/702,486
Technology Center 1600
Decided: February 20, 2009

21. A lutein composition suitable for human consumption which
comprises:
(a) at least about 90% lutein having been extracted and purified from plant extracts which contain 10% or less of non-lutein carotenoids,

(b) no traces of toxic chemicals that would render the lutein composition unsuitable for human consumption, and
(c) significantly less than about 10% of non-lutein carotenoids obtained by purification of said plant extracts.

The examiner rejected the claim for lacking written description. The Examiner alleges that the specification would be understood to only include a limitation of at least 97%, not 90%. The patent disclosed two statements that are relevant:

1. "after recrystallization, the purity of “the resulting lutein is usually greater than 90%, most often greater than 97%." with two working examples of greater than 97%.

2. The specification also disclosed “[w]hile 70% pure lutein may be acceptable for use in animal feed, further purification of this compound may be employed to produce lutein with purity greater than 97% for human consumption”

The examiner relied upon the second to state that specification only described greater than 97% while ignoring the first statement. The Board disagreed finding that read as a whole the specification adequately described the 90% limitation. The Board stated that the second phrase only says that further purification may be employed, "but [the specification] does not say that only lutein compositions with 97% purity are suitable for human consumption." Therefore, the claim satisfied the written description requirement.

Case can be found here

A correlation step is an element for anticipation purposes (BPAI)

noreply@blogger.com (Patent Decisions) — Fri, 13 Feb 2009 16:40:00 +0000

Ex parte FLORIAN KRONENBERG (BPAI)
Appeal 2008-4087
Application 10/485,039
Technology Center 1600
Decided: February 13, 2009

The claims below were ultimately found to be anticipated and obvious based upon other references than the one I describe below but I have seen a rejection in a case I am working on where the correlation or diagnosing step is ignored when determining whether something is anticipated. The definiteness issue is also helpful because it slaps the Examiner for making an illogical argument.

19. A method of diagnosing early stage renal impairment in humans, comprising:
measuring an amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing early stage renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

50. A method of diagnosing coronary heart disease in humans who suffer from renal impairment comprising:
measuring the amount of apoA-IV in a plasma sample or a serum sample of a human;
comparing the measured amount of apoA-IV with a reference value; and
diagnosing coronary heart disease in humans who suffer from renal impairment based on the comparison of the measured amount of apoA-IV with the reference value.

The Examiner alleged that claims 19 and 50 were indefinite because "the interrelationships of the steps are not clear because it is not clear in what or for what diagnosing is being made or how diagnosing is “based on” the comparison. There are no limitations found in the claims limiting the human (patient) population, defining “early stage” from any other renal impairment, or other, condition wherein a patient has an elevated apoA-IV level, or even setting forth that the diagnosis is for the condition in the human providing the sample."

The Board reversed finding when read in light of the specification the terms were clear. In part, the Board stated: "We disagree with the Examiner’s finding that “it is not clear in which humans or human, or in what manner, one is to diagnose the condition with the measurement comparison”"…"That manner of diagnosis in either of claim 19 or claim 50 would be any manner that would measure the amount of apoA-IV in a plasma or serum sample of a human."

The Examiner also rejected a kit claim as being indefinite because it included a calibration curve. The Examiner found that “[c]laim 49 provides no further limitation of the components of the kit. The curve, essentially printed matter, merely relates to the intended use for the components of the kit” The Board reversed holding: A person of ordinary skill in this art understands what is meant by the term “calibration curve.” Further, we know of no prohibition against the inclusion of language relating to the intended use of article of manufacture (e.g., a kit). Accordingly, the term is not indefinite even if it represents printed matter and relates to the intended use of the kit’s components.

The Examiner also rejected the claims as anticipated. The Examiner found a reference that disclosed the measuring steps but did not include the diagnosing step and because there is nothing "other than a mental step setting forth an intended result, or a characterization of the results, from the active measuring and comparing steps." the claim was anticipated. The Board reversed and agreed with the Appellant finding that the reference did not disclose the diagnosing step. The Board stated, "There is no evidence on this record that [the reference] correlated apoA-IV levels to early stage renal impairment or coronary heart disease in humans who suffer from renal impairment is diagnosed. The fact that [the reference] teaches an ELISA for detecting apoA-IV is not sufficient to anticipate Appellant’s method claims."

Case can be found here