"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."

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

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

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

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

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

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

(c) contacting said product nucleic acids with an addressable array of probe nucleic acids.

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

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"

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

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"

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.