Result-Effective-Ugh…a Bridge Too Far?
| April 25, 2024
Pfizer Inc. v. Sanofi Pasteur Inc.
Decided: March 5, 2024
Result-Effective Variable; Obviousness
Before LOURIE, BRYSON, and STARK, Circuit Judge. Opinion drafted by LOURIE.
Summary:
Pfizer appealed to the Federal Circuit following rulings from five inter partes review proceedings petitioned by Sanofi challenging all claims of Pfizer’s U.S. Patent No. 9492559 (‘559 Patent). The ‘559 Patent claims immunogenic compositions comprising glycoconjugates of various Streptococcus pneumoniae serotypes for use in pneumococcal vaccines. Independent claim 1 is as follows (emphasize added):
- An immunogenic composition comprising a Streptococcus pneumoniae serotype 22F glycoconjugate, wherein the glycoconjugate has a molecular weight of between 1000 kDa and 12,500 kDa and comprises an isolated capsular polysaccharide from S. pneumoniae serotype 22F and a carrier protein, and wherein a ratio (w/w) of the polysaccharide to the carrier protein is between 0.4 and 2.
The Board instituted review based on each petition and issued final written decisions which, taken together, found all claims unpatentable. Pfizer raised four challenges on appeal. The first, which will be the only challenge discussed herein, alleged that the Board erred in determining that the ‘559 Patent was obvious based on prior art references PCT Patent Application Publication 2007/071711 (“GSK-711”) and U.S. Patent Application Publication 2011/0195086 (“Merck-086”).
The Board recognized that neither GSK-711 nor Merck-086 disclosed any molecular weight for a S. pneumoniae serotype 22F glycoconjugate, as required by claim 1 of the ’559 Patent, but nevertheless concluded that, based on the evidence of record, glycoconjugate molecular weight is a result-effective variable that a person of ordinary skill in the art would have been motivated to optimize to provide a conjugate having improved stability and good immune response. It is here that Pfizer argued the Board erred, because it is undisputed that the prior art does not disclose any molecular weight for the claimed serotype 22F glycoconjugate, there could be no presumption of obviousness. The CAFC disagreed.
The CAFC begin by stating that “the determination whether or not a claimed parameter is a result-effective variable is merely one aspect of a broader routine optimization analysis.”
The CAFC followed that “an overlap between a claimed range and a prior art range creates a presumption of obviousness that can be rebutted with evidence that the given parameter was not recognized as result-effective. See Genentech, Inc. v. Hospira, Inc., 946 F.3d 1333, 1341 (Fed. Cir. 2020) (citing E.I. DuPont, 904 F.3d at 1006); In re Applied Materials, Inc., 692 F.3d 1289, 1295 (Fed. Cir. 2012).” However, they emphasized that this “does not mean that the determination whether or not a variable is result-effective is only appropriate when there is such an overlap.” Rather that “a routine optimization analysis generally requires consideration whether a person of ordinary skill in the art would have been motivated, with a reasonable expectation of success, to bridge any gaps in the prior art to arrive at a claimed invention. Where that gap includes a parameter not necessarily disclosed in the prior art, it is not improper to consider whether or not it would have been recognized as result-effective. If so, then the optimization of that parameter is “normally obvious.” In re Antonie, 559 F.2d 618, 620 (CCPA 1977).”
Thus, the CAFC concluded that the Board did not err in considering, as part of its obviousness analysis, whether or not the claimed molecular weight of a S. pneumoniae serotype 22F glycoconjugate was a result-effective variable, dispute the cited references being silent thereon.
It was ultimately concluded that “substantial evidence supports the Board’s conclusion that the molecular weight recited in claim 1 would have been obvious over the references.” Such evidence included the fact that GSK-711 gave the molecular weights for fourteen other S. pneumoniae serotype glycoconjugates, and that Expert Testimony showed that, at the time of the invention, conjugation techniques and conditions were routine such that a person of ordinary skill in the art would have understood the claimed molecular weight to be “typical of immunogenic conjugates.”
Comments:
An argument against a Result-Effective Variable assertion may be weakened, even when the prior art is silent on said variable, if a PHOSITA can bridge the gaps in the teaching with a reasonable success based on the evidence overall. Thus, it may be necessary to demonstrate more than simply the variable not being recognized by the reference. That is, one may also have to show there is no reasonable expectation of success in said variable
Written Description Compliance Requires Lack of Different Inventions Achieved by Claimed and Disclosed Ranges
| April 19, 2024
RAI STRATEGIC HOLDINGS, INC. v. PHILIP MORRIS PRODUCTS S.A
Decided: February 9, 2024
Chen, Stoll, and Cunningham. Opinion by Stoll.
Summary
The CAFC addressed a question of written description compliance where a numerical range set forth in a patent claim is narrower than and encompassed by a disclosed range in the specification. The CAFC found that the written description requirement is met under fact-specific circumstances where substantial evidence indicates that a skilled artisan would see no different inventions resulting from the claimed range and the disclosed range.
Details
RAI appealed a final written decision by the Patent Trial and Appeal Board in a post-grant review (PGR) finding certain claims of RAI’s U.S. Patent No. 10,492,542 (“the ’542 patent”) unpatentable. RAI challenged, among other issues,[1] the Board’s finding that claims 10 and 27 of the ’542 patent lack adequate written description under 35 U.S.C. § 112.
The ’542 patent relates to electrically powered “smoking articles” which, as in e-cigarettes, use an electrical heating element to heat tobacco or like substance to form an inhalable vapor or aerosol. Claims 10 and 27—added by preliminary amendment in the underlying application which is a continuation from a former application having no such claims in the original filing—specify that the heating element has a certain range of length, which is not disclosed verbatim in the specification.
The written description requirement is a question of fact subject to substantial evidence review. The CAFC prefaced the written description analysis with the general threshold for compliance: the disclosure must “reasonably convey[ to a skilled artisan] that the inventor had possession of the claimed subject matter as of the filing date.” The CAFC then discussed precedents finding written description support, or lack thereof, for claimed ranges that are narrower than ranges described in specifications.
Courts finding adequate written description: Wertheim, Blaser, Kolmes[2]
In Wertheim, the parameter at issue was “solids content of the concentrated coffee extract.” The claimed range “between 35% and 60%” was found adequately supported by the specification disclosing a broader range of “25% to 60%” along with specific examples where the parameter was either “36% or 50%.” The Wertheim court held that presence of a clear indication that “the broad described range pertains to a different invention than the narrower (and subsumed) claimed range” (emphasis added) would negate adequacy of written description, whereas absence of such indication would support written description compliance.
Two subsequent courts followed Wertheim. InBlaser, the claimed range of temperature for heating a reaction blend for acylation, “80º to 200º C.” was found adequately supported by the disclosure of a broader range of “between 60º and 200º C.” In Kolmes, the claimed range of wrapping rate for cut-resistant yarn, “8–12 turns per inch,” was found adequately supported by the disclosure of a broader range of “4–12 turns per inch, with 8 turns per inch being preferred.”
Courts finding no adequate written description: Baird, Indivior[3]
Baird involved a patent application which included claims copied from an issued patent for an interference proceeding, i.e., the applicant was not the original author of the copied claims. The parameter at issue was a quench bath temperature in production of stretch-orienting polypropylene. The claimed range was “from about 40[º F] to … about 60 [º F].” While this range was explained in the issued patent as having certain criticality, the applicant’s specification disclosed a broader range of “between 32º F and 176º F,” while silent on the narrower range. Finding lack of adequate support, the Baird court reasoned that the copied claim pertained to a “different” invention from that disclosed in the specification.
In Indivior, the parameter at issue was a concentration of certain polymers in thin film formulation. Disputed claims recited two numerical ranges: (A) “about 40 wt % to about 60 wt %” and (B) “about 48.2 wt % to about 58.6 wt %.” The specification disclosed broader ranges—or lower bounds without express upper bounds—of “at least 25” and “at least 50,” as well as specific instances of “48.2” and “58.6” gleaned from data tables. The specification also stated that the parameter may be at “any desired level.” The claimed range (A) failed the written description requirement because the specification did not literally recite the range or the endpoints, while the “any desired level” statement obscured the scope of the invention. The claimed range (B) also failed the written description requirement because, although the endpoints were disclosed at least implicitly, it was unclear that the specification described the range bound by these endpoints.
Application to Claims 10 and 27 of the ’542 patent
After summarizing the precedents, the CAFC turned to the claims at issue. Claims 10 and 27 both recite that a heating member used in the smoking device has “a length of about 75% to about 85% of a length of the disposable aerosol forming substance.” The specification describes four progressively narrow, nested ranges for the parameter: “about 75% to about 125%,” “about 80% to about 120%,” “about 85% to about 115%,” and “about 90% to about 110%.” The Board’s finding of no written description was driven by the fact that the upper endpoint “85%” of the claimed range does not have a corresponding upper endpoint in any of the disclosed ranges.
The CAFC found that the written description requirement is met. To reach the conclusion, the CAFC centered its analysis on “different invention” test set forth in Wertheim, restating that “[t]he specification need not expressly recite the claimed range to provide written description support.” The factual inquiry looked to specific factors, including:
- Express disclosure in the specification: Although the claimed range itself is not literally disclosed, both of its endpoints are identified as part of the disclosed ranges.
- Predictability and complexity of the invention: Since the smoking device invention relates to a relatively predictable, electro-mechanical field, and the claim language is simple, the level of clarity or details required to satisfy the written description requirement is low.
- Lack of indication that the claimed parameter affects the invention: The specification nowhere indicates that “operability, effectiveness, or any other parameter” of the invention is impacted by changing the claimed parameter.
Based thereon, the CAFC found no “different invention” arising from the claimed range than that disclosed in the specification.
The CAFC distinguished Indivior and Baird relied upon by the Board. Unlike Indivior, the ’542 patent discloses the endpoints and contains no inconsistent statements regarding the range (e.g., that “any desired level” may work); plus the predictability of the electro-mechanical invention is higher than the chemical invention set forth in the Indivior claims. Also, unlike Baird where the claimed range was shown to have criticality over the boarder disclosed range, no evidence was presented in the present case that the broader disclosed range operates differently than the claimed range.
Additionally, the CAFC dismissed an expert testimony offered by Phillip Morris pointing to different center points of the disclosed range (100%) and the claimed range (80%). The expert evidence was not enough to overcome the intrinsic evidence and the case law supporting adequacy of the written description.
Takeaways
This case exemplifies one way in which a court may apply case-by-case analysis of written description compliance. Where the claimed range is narrower than and subsumed in the disclosed range, the “different invention” test may not only examine the express disclosure and the nature of the technology, but also may consider whether varying the parameter inside and outside the claimed range would make any difference.
While the test could be useful in establishing written description support—given that a patent specification typically describes numerical ranges in connection with one general inventive concept—caution should be used in asserting lack of different inventions emanating from different numerical ranges; such admission might be used by an opponent to support obviousness of the claimed range. The dilemma may be avoided, for example, by drafting an original disclosure to describe both commonalities and differences across broad and narrow ranges as well as specific values of a key parameter.
[1] RAI’s other argument challenged the Board’s obviousness finding of other claims of the ’542 patent, which was affirmed by the CAFC on appeal.
[2] In re Wertheim,541 F.2d 257 (C.C.P.A. 1976), In re Blaser, 556 F.2d 534 (C.C.P.A. 1977), and Kolmes v. World Fibers Corp., 107 F.3d 1534 (Fed. Cir. 1997).
[3] In re Baird,348 F.2d 974 (C.C.P.A. 1965), and Indivior UK Ltd. v. Dr. Reddy’s Laboratories S.A., 18 F.4th 1323 (Fed. Cir. 2021).
Depends On How You Slice It: CAFC reverses PTAB on Weber v. Provisur IPR ruling
| April 5, 2024
Weber, Inc. v. Provisur Tech. Inc.
Decided: February 8, 2024
Before Reyna, Hughes and Stark. Authored by Reyna
Summary: The Court reversed the PTAB’s finding that Weber’s instruction manuals did not qualify as printed publications under 35 USC §102. The Court also reversed key claim construction taken by the PTAB in upholding Provisur’s patents.
Background:
Provisur sued Weber for patent infringement on two patents, USP 10,639,812 (“’812 patent”) and 10,625,436 (“’436 patent”) relate to high-speed mechanical slicers used in food-processing plants. Weber countered by filing IPR proceedings against both patents at the USPTO Patent Trial and Appeal Board (PTAB). The PTAB found both the ‘812 and the ‘436 patentable. During the PTAB proceeding, Weber had attempted to use their own instruction manual for the slicer they sold as a prior art publication under 35 U.S.C. §102. The Board found that the instruction manual was not a “printed publication” under §102 on the basis that the manuals were controlled in their circulation to only customers or potential customers by a strict copyright and confidentiality clause.
Further, the PTAB had construed three terms from the slicer components, (1) the “food article loading apparatus”; (2) the “food article feed apparatus”; and (3) the “food article stop gate” in a manner that maintained the patents’ validity while excluding the disclosures in Weber’s manuals.
Weber appealed the Board’s finding that their instruction manual was not a printed publication under §102 and the claim construction of the three terms.
Decision:
(a) Weber’s Instruction Manual as a “Printed Publication”
The Board had relied upon the CAFC’s prior holding in Cordis Corp. v. Boston Scientific Corp., 561 F.3d 1319 (Fed. Cir. 2009), in finding that Weber’s manuals were not “printed publications.” In Cordis, the references in question were two academic monographs describing an inventor’s work that were only distributed to a handful colleagues and two companies potentially interested in the technology.
The CAFC was quick to distinguish the current case from Cordis. First, the CAFC noted that the statutory phrase “printed publication” from § 102 has been defined to mean a reference that was “sufficiently accessible to the public interested in the art,” citing In re Klopfenstein, 380 F.3d 1345, 1348 (Fed. Cir. 2004) and that “public accessibility” was based on the relevant public being able to “locate the reference by reasonable diligence,” citing Valve Corp. v. Ironburg Inventions Ltd., 8 F.4th 1364, 1376 (Fed. Cir. 2021). Next, the Court found that Weber’s operating manuals were created for dissemination to the interested public to provide instructions for Weber’s slicer. The Court stated the Weber manuals were in “stark contrast” to the confidential monographs in Cordis which were subject to “academic confidentiality norms.” The Court went on to describe that the evidence provided by employees of Weber, stating that the manuals were readily provided to potential buyers, clearly indicated that the manuals did in fact qualify as “printed publications” under §102.
The Court also found the Board’s reliance on the copyright and confidentiality of Weber’s manuals to be misplaced. The Board had keyed in on the copyright language restricting the reproduction or transfer of the manuals and Weber’s “terms and conditions” stating that documents related to a sale of a slicer “remain the property of” Weber. The CAFC was not convinced that these statements made the manuals confidential to the point of not being a “printed publication”, stating:
Weber’s assertion of copyright ownership does not negate its own ability to make the reference publicly accessible. Cf. Correge v. Murphy, 705 F.2d 1326, 1328–30 (Fed. Cir. 1983) (“A mere assertion of ownership cannot convert what was in fact a public disclosure and offer to sell to numerous potential customers into a non-disclosure.”). The intellectual property rights clause from Weber’s terms and conditions covering sales, likewise, has no dispositive bearing on Weber’s public dissemination of operating manuals to owners after a sale has been consummated.
The Court reversed the PTAB’s finding that Weber’s instruction manuals were not “printed publications” within the meaning of 35 U.S.C. §102.
(b) Claim Construction – “disposed over” and “stop gate”
The Court next addressed the PTAB’s claim construction as to the term “disposed over” as used in the claims. The Board had construed the term “disposed over” to require that the “feed apparatus and its conveyor belts and grippers are ‘positioned above and in vertical and lateral alignment with’ the food article loading apparatus and its lift tray assembly.” The Court rejected this interpretation asserting that it reads elements into the claim which are not present. The Court noted that the specification and prosecution history did not impart any limited meaning to the term “disposed over” and therefore there was no basis for including the additional aspect that the feed apparatus and loading apparatus were in alignment. Citing Cyntec Co. v. Chilisin Elecs. Corp., 84 F.4th 979, 986 (Fed. Cir. 2023), the Court held that “Had the patent drafter intended to limit the claims” to address the alignment of the conveyor belts and lift tray assembly between the apparatuses, “narrower language could have been used in the claim.”
Running Provisur through the figurative slicer, the Court noted that Provisur did not dispute that Weber’s manuals satisfy the limitation under Weber’s proposed construction (i.e. that alignment is not required between the feed and loading apparatus). Hence, they concluded that their review of the Board’s claim construction is dispositive of the issue and that the Weber manuals do disclose the “disposed over” limitation.
As to the “stop gate” term in the claims, Weber asserted that the Board erred in determining that the “product bed conveyer” disclosed in Weber’s operating manuals (as shown in Figures 10 and 227 thereof), does not disclose the “stop gate” limitation.
After analyzing the figures, the Court only commented that given these disclosures of the Weber manuals there was no substantial evidentiary support for the Board’s finding. Thus, the Court again reversed on the “stop gate” determinations.
Take aways:
- The Court clarifies the meaning of “printed publication” in 35 U.S.C. §102 by further defining the line between documents primarily intended to be confidential, such as the monographs in Cordis, and those primarily intended to be disseminated to the interested public, such as Weber’s manuals.
- By reversing the PTAB’s claim interpretation that had read a required alignment of parts into the claim where no such requirement was present, the Court also reiterates the standing law of claim construction that claim terms have their ordinary meaning unless intrinsic evidence demonstrates otherwise.
