IPR obviousness decision vacated and remanded as patent expired and Sumimoto had no “interest in any forward-looking exclusion” or past infringement by unlicensed sales (IPR addresses “patient” vs. population but not discussed here)

Sumitomo Pharma Co., Ltd. v. USPTO (Intervenor)

Docket No. 2022-2276 (IPR2020-01053) (https://cafc.uscourts.gov/opinions-orders/22-2276.OPINION.4-5-2024_2296961.pdf)

TARANTO, HUGHES, CUNNINGHAM

April 5, 2024

Brief Summary:  Sumimoto’s appeal of IPR obviousness decision vacated and remanded for dismissal as the disputed patent was expired as of the appeal and Sumimoto had no interest in past or future infringement.

Summary:   Sumimoto appealed IPR decision finding all 75 claims of US 5,532,372 directed to “[a] method for treating schizophrenia in a patient without a clinically significant weight gain” (“weight gain being a recognized adverse side-effect of many antipsychotic drugs”) using lurasidone.  The FC panel opinion is focused on the Board’s construction of “a patient” (and “the patient”) to have its “ordinary and customary meaning of ‘one or more patients,’ as opposed to a ‘patient population’” and its finding that the prior art did not “affirmatively disclos[] the claimed result for a patient so treated, but it noted a suggestion of favorable weight-gain effects for lurasidone” in some, in part because “Sumitomo acknowledged that ‘there will always be some outliers’ in side-effects in a pool of patients.”  In this appeal, Sumimoto argued “that the Board did not properly consider certain safety-related evidence” or the prior art “and that it made an erroneous, or at least unclear, use of inherency doctrine in addressing at least the motivation-to-modify, reasonable-expectation-of success, and unexpected-results components of the obviousness analysis.”  The FC panel explained that the patent expired “[j]ust before appeal” and found Sumimoto lacked an “interest in any forward-looking exclusion based on the patent” (ABS, FC 2021; MOAC Mall, US 2023; TransUnion, US 2021) or “a concrete interest in pursuing damages for pre-expiration infringement” (Sony, FC 2019; Munsingwear, US 1950).  For instance, “Sumitomo expressed no interest in seeking damages for direct infringement from any persons who engaged in pre-expiration use of the claimed methods, including those who may have acquired lurasidone from a firm that had not labeled it for a use covered by the ’827 patent’s claims” and admitted “there was only a theoretical possibility that…firms” that made unlicensed sales “even existed”.  The Board decision was therefore vacated and remanded for dismissal.

DC grant of motion to dismiss due to 101 ineligibility affirmed (abstract idea, no “improvement in computer technologies”)

AI Visualize, Inc. v. Nuance Communications, Inc., Mach7 Technologies, Inc.

Docket No. 2022-2109 (https://cafc.uscourts.gov/opinions-orders/22-2109.OPINION.4-4-2024_2296276.pdf)

MOORE, REYNA, HUGHES

April 4, 2024

Brief Summary:  DC grant of motion to dismiss due to 101 ineligibility affirmed.

Summary:   AI appealed DC grant of a motion to dismiss (12(b)(6)) that the claims of its US 8,701,167; 9,106,609; 9,438,667; and 10,930,397 asserted against Nuance are “directed to an abstract idea and failed to provide an inventive step that transformed that abstract idea into a patent-eligible invention” and therefore ineligible under section 101.  The patents related to systems for “advanced visualization of medical scans using a dedicated web portal”.  The claims were categorized into group 1 (“displays the user’s requested virtual view”), group 2 (group 1 “assigned a ‘unique identifiable key’”), and group 3 (not including “the step of initially checking to see whether any frames for the user’s requested virtual view are stored locally”).  After Nuance moved to dismiss AI’s complaint for failure to state a claim, AI filed an amended complaint that Nuance argued was directed to patent-ineligible subject matter.  Under Alice step one (Alice, US 2014), the DC “concluded that all the asserted claims are directed to the abstract idea of ‘retrieving user-requested, remotely stored information’” and “rejected AI Visualize’s arguments that the claims are directed to improvements in computer functionality.”  Under Alice step two, the DC concluded “that no claim limitations transformed the representative claims into a patent-eligible applications of an abstract idea” (e.g., “claimed functionally, at a high level of generality”).  The FC panel reviewed the DC decision de novo under Third Circuit law (Endo, FC 2019; Ballentine, 3d Cir. 2007; Bell Atl., US 2007 (“enough facts to state a claim to relief that is plausible on its face”)).  Eligibility under 101 was reviewed under FC law (Smart Sys., FC 2017; SAP, FC 2018).  Under Alice step one, the FC panel reviewed “the character of the claims as a whole to determine whether they are ‘directed to’ patent-ineligible subject matter” and agreed with the DC (Hawk Tech., FC 2023 (“converting information from one format to another . . . is an abstract idea”); Enfish, FC 2016; Affinity Labs., FC 2016 (“by examining the ‘focus of the claimed advance over the prior art’”); Elec. Power, FC 2016 (“improvement in computer technologies, rather than the mere use of computers”); McRO, FC 2016 (“claims must ‘focus on a specific means or method that improves the relevant technology’”); Free Stream, FC 2021 (“consider[] the claim limitations that are purported to describe the claimed advance over the prior art”)).  The FC panel also agreed with the DC’s finding under Alice step two (e.g., “AI Visualize’s amended complaint also failed to adequately allege an inventive concept in the ordered combination of claim limitations”) (Two-Way, FC 2017; Mayo, US 2012 (“[w]hat else is there in the claims before us?”); BSG Tech, FC 2018 (“claim cannot rest on the patent-ineligible concept alone to transform the invention” or rely on “elements or combinations of claim elements that are routine, conventional, or wellknown transform the claims”)).  The DC decision was therefore affirmed.

DC obviousness and procedural ANDA-related decisions affirmed

Salix Pharm., Ltd. et al. v. Norwich Pharm. Inc.

Docket No. 2022-2153, -1952 (https://cafc.uscourts.gov/opinions-orders/22-2153.OPINION.4-11-2024_2300049.pdf)

LOURIE, CHEN, CUNNINGHAM

April 11, 2024

Brief Summary:  DC obviousness of method of treatment and polymorph patents and ANDA-related (FDA cannot approve current ANDA, correctly denied ANDA amendment) decisions affirmed. 

NOTE: Salix argued it “actually succeed[ed]” and did not expect to succeed because the beta form “remained undisclosed”, which the FC panel summarized as incorrectly suggesting “that no unknown entity could ever be obvious, as one cannot reasonably expect what was hitherto unknown”.

Summary:  Salix appealed DC judgment holding claim 2 of US 8,309,569, claim 3 of US 10,765,667, claim 4 of US 7,612,199, and claim 36 of US 7,902,206 relating to rifaximin (the active ingredient of Xifaxan^®).  The FC panel opinion explains that rifaximin was first approved as an antibiotic in Italy in 1985 and by the FDA in 2004 and 2010 (200 mg tablets for travelers’ diarrhea and 550 mg tablers for hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea (IBS-D)).  Norwich filed an ANDA in 2019 with a para. IV certification of invalidity.  The patents are grouped into the HE patents (‘573, ‘195, and ‘397), the IBS-D patents (‘569 and ‘667), and the polymorph patents (‘199 and ‘206).  Salix appealed the DC holding that the IBS-D and polymorph patents were infringed but invalid for obviousness. 

The IBD-S patents claim a method “comprising…administering 1650 mg/day” and “500 mg three times per day”.  The DC found a published clinical trial “Protocol” and the Pimentel journal article “disclose each and every limitation of the challenged IBS-D claims, and further found that a skilled artisan would have been motivated to combine those two references to arrive at what is claimed with a reasonable expectation of success.”  Salix argued the DC erred because the prior art does not provide a reasonable expectation of success for a dose above 1200 mg/day, but the FC panel disagreed because while Protocol and Pimentel used a 1200 mg/day dose, Pimentel “further teaches that ‘[r]ecent data suggest that the optimal dosage of rifaximin may, in fact, be higher than that used in our study’” (e.g., the FC panel writing that “the next higher dosage unit from the Protocol was 550 mg” and citing Almirall (FC 2022) and Acorda (FC 2018) (neither “absolute predictability of success” nor “clinical efficacy” required); also OSI Pharms., FC 2019 (““efficacy data [are] always required”); background knowledge consistent with reasonable expectation of success (In re Applied Materials, FC 2012 (where “general conditions” disclosed, it is not “not inventive to discover the optimum or workable ranges by routine experimentation”)).  The DC decision that the IBD-S patents are invalid for obviousness was affirmed.

The polymorph patents claim polymorphic form beta with a particular x-ray powder diffraction pattern and water content.  The DC concluded expert testimony supported its decision that the Cannata patent “discloses that rifaximin exists in crystalline form with ‘outstanding antibacterial properties’” and “several preparation protocols…that include solvents used for crystallization.”  Salix argued Grunenthal (FC 2019 (not obvious with no disclosure of particular conditions to produce Form B)) and Pharmacyclics (FC 2022) “compel the opposite result” as the DC “applied the wrong test”, but the FC panel disagreed (within DC’s discretion not to apply Pharmacylics) (“Here, the prior art included a process… the dispute centered around characterizing the crystalline form resulting from that process”; citing Graham, US 1966; Salix did not dispute motivation to explore potential polymorphs).  Salix argued it “actually succeed[ed]” and did not expect to succeed because the beta form “remained undisclosed”, which the FC panel summarized as incorrectly suggesting “that no unknown entity could ever be obvious, as one cannot reasonably expect what was hitherto unknown”.  The FC panel found the DC correctly found Cannata showed “potential polymorphism using routine, conventional methods and skill” (citing KSR, US 2007 and Pfizer, FC 2007).  It therefore affirmed the DC’s decision that the polymorph patents were shown to be obvious.

Norwich cross-appealed two ANDA-related issues:  1) the DC’s interpretation of “35 U.S.C. § 271(e)(4)(A)” under which it ordered the FDA not approve its ANDA, including a new noninfringing ANDA (delays ANDA for ““the drug . . . involved in the infringement”); and, 2) DC’s denial of Norwich’s request “to amend its ANDA to carve out the infringing HE use after final judgment”.  The FC panel agreed with the DC on the first point (e.g., restricts approval of “this infringing ANDA” but “said nothing that would prevent approval of a new non-infringing ANDA”).  The FC panel also found the DC “reasonably held that “consideration of the amended ANDA would be inequitable and inappropriate” (Rule 60(b)).

LNC’s unclean hands defense affirmed; no obviousness or inequitable conduct findings vacated and remanded

Luv N’ Care, Ltd., Nouri E. Hakim v. Lindsey Laurain, Eazy-PZ, LLC

Docket No. 2022-1905, -1970 (https://cafc.uscourts.gov/opinions-orders/22-1905.OPINION.4-12-2024_2300689.pdf)

REYNA, HUGHES, STARK

April 12, 2024

Brief Summary:  DC grant of LNC’s unclean hands defense affirmed; DC findings of no obviousness or inequitable conduct vacated and remanded.

Summary:   EZPZ appealed DC judgment against it for “unclean hands”, which the FC panel affirmed here.  LNC appealed DC judgment for EZPZ of no inequitable conduct (IE), which the FC panel vacated and remanded here.  The FC panel also vacated the DC’s grant of partial summary judgment (SJ) of invalidity for obviousness and order denying attorney fees and costs.  EZPZ’s patent-at-issue (US 9,462,903) is directed to a “rubberlike” (independent claim 1), “nontoxic polymeric” (independent claim 5), or “silicone” (independent claim 9, also including “wherein” clauses) “surface contact self-sealing dining mat integrated with tableware” (e.g., a bowl affixed to a mat). 

Regarding LNC’s unclean hands defense, the DC “found that EZPZ engaged in litigation misconduct, including by failing to disclose certain patent applications during discovery, attempting repeatedly to block LNC from obtaining Ms. Laurain’s prior art searches, stringing LNC along during settlement negotiations, and providing evasive and misleading testimony.”  Also, while the DC litigation was pending, EZPZ obtained a USPTO reexamination certificate but did not provide it to the DC (only after the judgment). The FC panel agreed (e.g. no “good faith justification for its delay”, “EZPZ tried to block LNC’s efforts to discover Ms. Laurain’s prior art searches”), citing Keystone Driller (US 1933) and Gilead (FC 2018) (“violations of conscience…affect the equitable relations”, “totality of the evidence”), and meaning EZPZ “no longer has the ability to enforce the ’903 patent against LNC’s accused products”.  For at least this reason, the FC panel vacated and remanded the attorney’s fee issue.

On IE, the DC “found that although Ms. Laurain and her patent agent, Benjamin Williams (“Williams”), made misrepresentations to the PTO – namely, that the prior art Platinum Pets mat did not exhibit self-sealing functionality – that misrepresentation was not but-for material to the patentability of the ’903 patent, given that the Platinum Pets mat itself had been disclosed to the PTO”, that other references “Ms. Laurain and Mr. Williams withheld from the PTO were also not material because they were cumulative of the Platinum Pets mat”, and that “their submission of declarations containing false or misleading information, did not demonstrate a specific intent to deceive the PTO.”  The FC panel vacated and remanded this judgment (e.g., actions “amounted to affirmative egregious misconduct and is, therefore, per se material”), citing Therasense (FC 2011, material information withheld “with the specific intent to deceive the PTO”; cumulative if “a reasonable examiner would consider to be taught by the prior art already before the PTO” (see also Cal. Inst. Tech., FC 2022), Aventis (FC 2012, “but-for materiality”), and TransWeb (FC 2016, “even disclosed reference may be but-for material where patentee mischaracterized it as non-prior art”).  The DC found the Platinum Pets mat disclosed the self-sealing functionality and that “Ms. Laurain and Mr. Williams misrepresented the Platinum Pets mat to the PTO as not possessing” that function.  The FC panel also found the DC did not apply the proper legal to determine whether intent could be inferred by the patentee’s “pattern of lack of candor” (Nilssen, FC 2007; Ohio Willow, FC 2013; Apotex, FC 2014) (and not “only…gross negligence” (Am. Calcar, FC 2014 (“partial disclosure…cannot absolve”); Semiconductor, FC 2000).  The DC’s IE judgment was therefore vacated and remanded.

The DC granted LNC’s motion for partial SJ for obviousness based on a combination of the Bass combined with the Webb Publication and the Webb Patent (together, the “Webb Prior Art”), because “it would have been ‘common sense to a person of ordinary skill in the art’ to make ‘the integrated tableware and dining mat disclosed in Bass out of the rubberlike, nontoxic material disclosed in the Webb Publication’” and a lack of convincing secondary considerations evidence.  The FC panel concluded that “the record contains sufficient evidence from which a reasonable factfinder could find that this disputed claim element is not disclosed by the Webb Prior Art”, “[a] reasonable factfinder might also choose to place weight on the fact that during the ex parte reexamination of the ’903 patent, the PTO considered the Webb Prior Art and found it does not teach self-sealing”, and there are questions regarding secondary considerations.  Therefore, the FC panel found, “there is a genuine dispute of material fact” and remanded this issue (citing Strathclyde (FC 2021), Perfect Web (FC 2009), and Plantronics (FC 2013) regarding the content of prior art; and Medtronic (FC 2023), Merck (FC 2005), and Pro-Mold (FC 1996) regarding secondary considerations)).

DC grant of SJ based on determination of 271(e)(1) safe harbor affirmed

Edwards Life Sciences Corp. et al. v. Meril Life Sciences PVT. LTD. et al.

Docket No. 2022-1877 (https://cafc.uscourts.gov/opinions-orders/22-1877.OPINION.3-25-2024_2290338.pdf)

LOURIE, STOLL, CUNNINGHAM

March 25, 2024

Brief Summary:  DC grant of SJ to Meril based on determination of 271(e)(1) safe harbor affirmed. Summary:   Edwards appealed DC grant of summary judgment (SJ) finding “Meril’s act of importation of the two transcatheter heart valve systems fell within the safe harbor provision of 35 U.S.C. § 271(e)(1).” Meril is an India-based company that started clinical trials for its system (“Myval”) in India in October 2018 and was approved for sale in the European Economic Area in April 2019.  In early September 2019.  Meril started working preparing its FDA premarket approval and later than month “sought out potential clinical researchers for FDA clinical trials at the 2019 Transcatheter Cardiovascular Therapeutics Conference in San Francisco (‘TCTC’)” and “had a booth at TCTC from September 26 through September 28, 2019.”  Meril instructed its employees attending the conference that they could not make any offers for sale in the US market but could offer sales for other countries.  An employee brought two sample systems to San Francisco with a “written declaration stating” those were for “demonstration purpose only” and “not for sale” and to TCTC “where the bag was kept in a storage room overnight” and “never taken out of the bag or shown to anyone.”  Meril presented information on the systems at TCTC, including discussing the systems “with several U.S. doctors to identify potential clinicians for its premarket approval application” but did not include pricing or commercial promotions.  The first employee gave the samples to a second employee to take to Europe on Sept. 30.  In Dec. 2019, Meril submitted its premarket approval submission to the FDA, the FDA responded in Feb. 2020 requiring Meril to include at 50% human test subjects to be at US clinical sites, with which Meril complied by May 2020.  Edwards filed suit in Oct. 2019.  The FC panel wrote that the question presented here is whether Meril’s importation to TCTC “was reasonably related to recruiting investigators for a clinical trial to support FDA approval”, and held that it did.  The FC panel explained that “[t]he safe harbor “provides a wide berth for the use of patented [inventions] in activities related to the federal regulatory process” (Merck KGaA (US 2005) (reasonably related to the development and submission of any information)) and “is not limited temporally” (“irrespective of the stage of research and even if the information is never ultimately submitted to the FDA”) (Amgen, FC 2019 (“reasonable basis for believing”); Momenta, FC 2015 (“extends even to activities the ‘actual purpose’ of which may be ‘promot[ional]’ rather than regulatory, at least where those activities are ‘consistent with the collection of data necessary for filing an application with the [FDA]”); AbTox, FC 1997).  And within 271(e)(1), the FC panel explained, “‘solely’ modifies ‘for uses’” (i.e., “only for acts or uses that bear a reasonable relation to the development and submission of information to the FDA”).  Here, the FC panel found, the DC correctly granted SJ based on its determination that Meril’s importation was reasonably related to obtaining FDA approval.  Judge Lourie dissented, arguing that the safe harbor is only for the “development of information for the FDA.”

IPR obviousness finding reversed for no motivation to combine affirmed

Virtek International ULC v. Assembly Guidance Systems, Inc., DBA Aligned Vision

Docket No. 2022-1998, -2022 (IPR2021-00062) (https://cafc.uscourts.gov/opinions-orders/22-1998.OPINION.3-27-2024_2292085.pdf)

MOORE, HUGHES, STARK

March 27, 2024

Brief Summary:  IPR obviousness finding reversed due to no motivation to combine; IPR non-obviousness finding affirmed as substantial evidence supported conclusion of no motivation to combine.

Summary:   Virtek appealed USPTO Board IPR holding that certain claims of Virtek’s US 10,052,734 directed to a “method for aligning a laser projector with respect to a work surface” to be invalid for obviousness.  ­­­Aligned Vision (AV) appealed the finding it did not show certain claims to be invalid for obviousness.  Regarding the obviousness finding, “the Board found a skilled artisan would have been motivated to use the 3D coordinate system disclosed in Briggs instead of the angular direction systems in” the prior art, that “this combination would have been obvious to try because Briggs discloses both 3D coordinates and angular directions.”  The FC panel concluded this analysis was erroneous, writing that “[i]t does not suffice to meet the motivation to combine requirement to recognize that two alternative arrangements such as an angular direction system using a single camera and a 3D coordinate system using two cameras were both known in the art” and the “disclosures…do not provide any reason why a skilled artisan would” do so (Belden, FC 2015 (“[O]bviousness concerns whether a skilled artisan not only could have made but would have been motivated to make the combinations or modifications of prior art to arrive at the claimed invention.”)).  Further, the FC panel wrote, “[t]he mere fact that these possible arrangements existed in the prior art does not provide a reason” for the substitution, also noting AV’s expert did not provide a reason or an “argument about common sense” (KSR, US 2007 (“If [the reasoning] to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.”))  The FC panel also wrote that “KSR did not do away with the requirement that there must exist a motivation to combine various prior art references in order for a skilled artisan to make the claimed invention.”  The Board decision of obviousness was therefore reversed. 

AV’s appeal was rejected as the FC panel found the Board correctly concluded AV did not provide substantial evidence of a motivation to combine (AV’s arguments that “because the additional elements in the dependent claims are disclosed in ’094 Rueb and are used for their intended purposes, a skilled artisan would have been motivated to combine the references as a matter of ‘common sense’” not being supported by evidence; KSR (“[A] patent composed of several elements is not proved obvious merely by demonstrating that each of its elements was, independently, known in the prior art. . . . [I]t can be important to identify 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.”)).  Thus, this part of the Board’s decision was affirmed.

DC analysis improper to support finding Teva did not show obviousness of Janssen’s schizophrenia drug OB claims

Janssen Pharmaceuticals, Inc. et al. v. Teva Pharmaceuticals USA, Inc., Mylan Labs. Ltd.

Docket No. 2022-1258, -1307 (https://cafc.uscourts.gov/opinions-orders/22-1258.OPINION.4-1-2024_2293991.pdf)

DYK, PROST, HUGHES

April 1, 2024

Brief Summary:  DC obviousness decision vacated and remanded; no indefiniteness finding affirmed. Summary:   Teva appealed DC bench trial decision that it had not proved the obviousness of the asserted claims of Janssens’ Orange Book (OB) US 9,439,906 relating to an extended-release intramuscular injectable paliperidone palmitate (PP) for treating schizophrenia (sold as Invega Sustenna).  The ‘906 patent claims “[a] dosing regimen…comprising” intramuscular (im) administration of “about 150 mg-eq sustained release PP “in the deltoid” on day 1 (“first loading dose”),  about 100 mg-eq sustained release PP in the deltoid from about days 6-10 (“second loading dose”), and then “about 25 mg-eq. to about 150 mg-eq.” sustained release PP “in the deltoid or gluteal muscle” per month.  Dependent claim 2 claims a dosing regimen of “about 25 mg-eq. to about 150 mg-eq.” sustained release PP “in the deltoid or gluteal muscle” at monthly intervals “after administration of the first maintenance dose”.  Claims 10 (“aqueous nanoparticle suspension”) and 13 (25-50 mg-eq. for the maintenance dose) depend from independent claim 8 relate to renally impaired patients, while claims 19-21 are “particle-size claims” (“about 1600 nm to about 900 nm”).  The ‘906 patent explains that “‘[p]aliperidone is the major active metabolite of risperidone,’ an antipsychotic that was developed in the 1990s” and that a tablet formulation was already on the market but patients are not compliant with daily dosing.  The ‘906 patent also explains that “deltoid injections result in a faster rise in initial plasma concentration” and is therefore used for the “initial loading dose[s]”, and preferred subsequent injections are in the gluteal muscle.  Teva relied on three prior art references, the ‘548 Phase III PP clinical study protocol that “does not contain any results”, the Invega OB ‘544 patent disclosing 90% PP particles “of less than 2,000 nm” and im administration to beagles, and Janssen’s WO ‘384 publication directed to “‘a process for preparing aseptic crystalline’ paliperidone palmitate” and “matches both the composition elements of claims 20 and 21 and the Invega Sustenna formulation”.  Teva argued the DC required it to show that “it would have been obvious to use the recited dosing regimens for the general population of patients—i.e., a generalized dosing regimen” (e.g., “population-wide safety and efficacy”), which Teva argued was improper because the claims are not directed to a population but to “a” patient.  The FC panel agreed with Teva (e.g., DC should have “focus[ed] its findings on single patient administration”).  Teva also argued the DC “also read a ‘mild’ limitation into the renal-impairment claims, whereas the claims do not specify a level of renal impairment” and the FC panel agreed (e.g., DC improperly concluded that “if a prior art reference does not contain safety and efficacy data, there is no reason to combine it with other prior art references” (United Ther. (FC 2023), Allergan (FC 2013) (cannot import FDA requirements); Alza (FC 2006), Adapt Pharma (FC 2022), Bayer (FC 2017) (motivation to combine, “suitable option”)).  The FC panel also instructed the DC to reconsider its secondary consideration determinations, which favored Janssen, that the FC panel wrote “might well be inadequate to support a conclusion of nonobviousness” (Tokai, FC 2011; Bristol-Myers, FC 2014; Henny Penny (FC 2019), Merck (FC 2015) (nexus); Forest Labs., FC 2019 (“surprising or unexpected” results; would the skilled artisan have been aware of side effects?); Kao, FC 2006) (e.g., “unclear how, if at all, the unexpectedness of these [clinical trial] failures relates to the claims”, effect of blocking patents /safe harbor (271(e)(1) (Acorda, FC 2018).  Teva also argued the claims are indefinite because there were multiple methods for measuring particle size and one was not specified, but the FC panel disagreed that the differences “would be significant or meaningful.”

Patents NPE Filing Receipt DC finding of noninfringment partially affirmed; ineligibility under 101 affirmed

Chewy, Inc. v. International Business Machines Corp.
(IBM)

Docket No. 2022-1756 (https://cafc.uscourts.gov/opinions-orders/22-1756.OPINION.3-5-2024_2280474.pdf)

MOORE, STOLL, CUNNINGHAM

March 5, 2024

Brief Summary:  DC finding of noninfringment partially affirmed; ineligibility under 101 affirmed.

Summary:   IBM appealed DC grant of summary judgment (SJ) of noninfringement of certain claims of US 7,072,849 and its 35 USC 101 ineligibility determination regarding the claims of US 7,076,443, both patents being related to improvements in web-based advertising.  The FC panel opinion explains that “[i]n the prior art, advertisements would be downloaded at the same time as applications” resulting in a “diminished service response” while the claimed methods avoid this by “‘storing and managing’ advertising at the user reception system before it is requested by the user”.  The DC determined that “a skilled artisan would understand the claimed invention requires pre-fetching of advertising objects”, and the FC panel agreed (Verizon, FC 2007 (“When a patent . . . describes the features of the ‘present invention’ as a whole, this description limits the scope of the invention.”); Absolute Software, FC 2011 (“use of the phrase ‘present invention’ or ‘this invention’ is not always so limiting”); Hormone, FC 1990 (“[i]t is not unusual that separate claims may define the invention using different terminology”)).  The FC panel also agreed with the DC that Chewy’s system does not perform the pre-fetching function as described in the ‘849 patent specification and therefore affirmed noninfringement of ‘849 claims 1, 2, 14, and 18 (e.g., “no material factual dispute as to whether Chewy performs this limitation”).  The FC panel reversed the DC’s grant of SJ of noninfringement of ‘849 claim 12 because “there is a genuine dispute of material fact regarding whether Chewy ‘establish[es] characterizations for respective users’” and remanded that portion of the decision.  IBM also appealed the DC’s determination of ineligibility of the ‘443 patent under section 101.  Under step one of the Alice test (Alice, US 2014), the DC held the claims “are directed to the abstract idea of identifying advertisements based on search results” and the FC panel agreed (like Customedia Techs., FC 2020 and Intell. Ventures, FC 2015), distinguishing this case from Packet Intelligence (FC 2020 (“eligible claims directed to ‘a specific improvement in computer technology’”) as argued by IBM.  The FC panel found that the ‘443 claims “are not directed to any challenges unique to computer networks, or specific improvements to the functionality of the computer itself” and “are directed to the abstract idea of identifying advertisements”.  The DC also found the ‘443 claims “fail to recite an inventive concept at Alice step two” and the FC panel agreed (e.g., “[t]he concept of data collection, recognition, and storage is undisputedly well-known” (Content Extraction, FC 2014), ““claiming the improved speed or efficiency inherent with applying the abstract idea on a computer [does not] provide a sufficient inventive concept” (Intell. Ventures), “the abstract idea of correlating advertisements with search results…is not an inventive concept” (Secured Mail, FC 2017), no inventive ordered combination, only a generic process (Weisner, FC 2022).

Board IPR FWDs finding Pfizer’s S. pneumoniae vaccine claims unpatentable for obviousness affirmed

Pfizer Inc. v. Sanofi Pasteur Inc. et al. (Merck)

Docket No. 2019-1871, -1873, -1875-76, -2224 (IPR2017-02131-32, -02136, -02138, IPR2018-00187) (https://cafc.uscourts.gov/opinions-orders/19-1871.OPINION.3-5-2024_2280462.pdf)

LOURIE, BRYSON, STARK

March 5, 2024

Brief Summary:  Five IPR FWDs finding Pfizer’s S. pneumoniae vaccine claims unpatentable for obviousness affirmed.

Summary:   Pfizer appealed five IPR final written decisions (FWDs) concluding claims 1-45 of its US 9,492,559 directed to S. pneumoniae glyconjugates (pneumonia, febrile bacteremia, and meningitis vaccines) are unpatentable for obviousness.  Independent claim 1 relates to a composition comprising the S. pneumoniae serotype 22F glyoconjugate having “a molecular weight [MW] of between 1000 kDa and 12,500 kDa” and a carrier protein.  Dependent claims 3 and 4 add the 15B and 33F saccharides (claim 3), and the 12F, 10A, 11A, and 8 glyconjugates (claim 4).  Merck and Sanofi argued Pfizer’s claims would have been obvious in view of two patent applications (GSK-711 directed to a composition of “at least ten serotypes of S. pneumoniae” including 22F; and Merck-086 directed to “multivalent immunogenic composition[s] having 15 distinct polysaccharide-protein conjugates” including 22F).  The Board and Sanofi acknowleged that “neither GSK-711 nor Merck-086 discloses any [MW] for a S. pneumoniae serotype 22F glycoconjugate” but the Board concluded MW “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” and therefore obvious.  Pfizer argued the “‘result-effective variable doctrine’…is only appropriate in circumstances where there is actual overlap between a range in the prior art and a claimed range”, but the FC panel disagreed.  The FC panel explained that “result-effective variable is merely one aspect” of the basic obviousness analysis and that “it is not inventive to discover the optimum or workable ranges by routine experimentation” (In re Aller, CCPA 1955; E.I. DuPont, FC 2018).  And, “[i]n the context of numerical ranges”, as in this case, “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” (“[t]hat does not mean, however, that the determination whether or not a variable is result-effective is only appropriate when there is such an overlap”; Genentech, FC 2020; In re Applied Materials, FC 2012).  It also explained that one must determine “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” and if “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” as “optimization of that parameter is ‘normally obvious’” (and “where optimization requires case-specific considerations, then the results must be unexpected”).  Based on these principles, the FC panel found the Board’s obviousness conclusion to be supported by substantial evidence, including expert testimony (e.g., “conjugation techniques and conditions were routine”; “a prior art reference is not limited to its specific working examples” (In re Mills, CCPA 1972); “expectation of success need only be reasonable, not absolute” (Pfizer, FC 2007)).  The FC panel also agreed with the Board’s denial of Pfizer’s request to amend the claims as those would still have been obvious (e.g., “the prior art here does not evidence ‘only failures to achieve that at which the inventors succeeded’” (Univ. Strathclyde, FC 2021).

IPR decisions of no obviousness vacated and remanded for improper public accessibility and claim construction determinations

Weber, Inc. v. Provisur Technologis, Inc.

Docket No. 2022-1751, -1813 (IPR2020-01556, -01557 (https://cafc.uscourts.gov/opinions-orders/22-1751.OPINION.2-8-2024_2267070.pdf)

REYNA, HUGHES, STARK

February 8, 2024

Brief Summary:  Board IPR decisions reversed and vacated for improper determination of public availability of instruction manuals and claim construction determinations.

Summary:   Weber appealed two IPR final written decisions (FWDs) finding that Provisur’s US 10,639,812 and 10,625,436 relating to “high-speed mechanical slicers used in food-processing plants to slice and package food articles, such as meats and cheeses” were shown to be unpatentable for obviousness.  The Board first concluded that “Weber’s operating manuals were not prior art printed publications” because those “were distributed to just ‘ten unique customers’” and “subject to confidentiality restrictions based on the Board’s interpretation of the operating manuals’ copyright notice and the intellectual property rights clause in Weber’s terms and conditions underlying the sales of each slicer product.”  The Board also found that, even if the manuals were prior art, the “asserted prior art combinations do not disclose the ‘disposed over’ and ‘stop gate’ limitations from claim 1 in each challenged patent”.  The FC panel reviewed the Board’s legal conclusion regarding whether the manuals are prior art de novo (102(b); Valve, FC 2021).  The FC panel explained that “[t]he statutory phrase ‘printed publication’ from § 102 has been defined to mean a reference that was ‘sufficiently accessible to the public interested in the art’” (In re Klopfenstein, FC 2004; Jazz Pharms., FC 2018; Valve (“whether interested members of the relevant public could locate the reference by reasonable diligence”)).  Weber argued the Board misapplied Cordis (FC 2009) in which descriptions of “an inventor’s work on intravascular stents that were only distributed to a handful of university and hospital colleagues as well as two companies interested in commercializing the technology” were not public disclosures because there was “clear evidence that such academic norms gave rise to an expectation that disclosures will remain confidential” nor a showing “that these or similar commercial entities typically would make the existence of such documents known and would honor requests for public access.”  This situation was determined to be “readily distinguishable” as the manuals “were created for dissemination to the interested public to provide instructions” and guidance regarding the slicer, were accessible to interested members of the public (e.g., by purchasing a slicer or upon request, available at trade shows) (e.g., “a publication’s purpose is ‘dialogue with the intended audience,’ that purpose indicates public accessibility” (Valve); cost alone is not dispositive (GoPro, FC 2018 (also trade show)).  The Board relied on the copyright notice, finding it “require[s] confidentiality” (Correge, FC 1983) and Weber’s IP provisions associated with the slicer, but the FC panel found these findings to be unsupported by substantial evidence (e.g., “no dispositive bearing on Weber’s public dissemination of operating manuals to owners after a sale has been consummated”).  The FC panel also found that Weber’s prior art discloses the “disposed over” limitation (as determined from the claim language and specification (3M, FC 2013; Phillips, FC 2005; Malvern, FC 2023; Genuine Enabling, FC 2022).  The FC panel also reversed the Board’s construction of the “stop gate” limitation.  The decisions were therefore reversed-in-part, vacated-in-part and remanded.