- PTAB · Jan 11, 2023 · IPR2022-01226 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and all petition grounds, finding a reasonable likelihood that claim 34 is anticipated by Dixon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’601 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“General Plastic, Paper 19 at 9–10. The purpose of the analysis thus established in General Plastic is to deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“an Interim Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited December 22, 2022) (the “Interim Procedure”). The Interim Procedure explains that “to benefit the patent system and the public good, the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Interim Proc. 2. Specifically, the Interim Procedure states that: Where the information presented at the institution stage is merely sufficient to meet the statutory institution threshold, the PTAB has the authority, where warranted, to exercise discretion to deny institution in view of the other Fintiv factors. In contrast, where the PTAB determines that the information presented at the institution stage presents a compelling unpatentability challenge, that determination alone demonstrates that the PTAB should not discretionarily deny institution under Fintiv.” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Consequently, we first turn to an analysis of Becton, Dickinson factors (a), (b), and (d) under this framework to determine whether the same or substantially the same art previously was presented to the Office or whether” slip op. at 26
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,888,601 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Jan 6, 2023 · PGR2021-00107 · APJ Robert A Pollock · PGR · Final written decision
The Board canceled claim 3, found substitute claim 22 unpatentable as anticipated by Gille503, Gille501, and Mohl996, and granted the motion to amend in part.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“claims.” 35 U.S.C. § 326(d)(1)(B); see 37 C.F.R. § 42.221(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are canceled, i.e., a one-to-one substitution of claim 3 with proposed substitute claim 22. MTA 1. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4. Petitioner does not argue otherwise.” slip op. at 28
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision we provisionally adopted Petitioner’s proposed definition of a person of ordinary skill in the relevant art (sometimes referred to herein as a “POSA”) as having “an M.D. or a Bachelor’s or Master’s degree in mechanical engineering, biomedical engineering or a similar field, as well as two or more years of work experience with catheters or similar medical devices” or would have “a Ph.D. in mechanical or biomedical engineering, or in a similar field.” DI 10 (citing Pet. 15; Ex. 1002 ¶ 72). This definition is uncontested and we continue to apply it here. See MTA 4–5. D.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner’s contention that we should read “baseline blood pressure measurement” as limited to a single measurement determined prior to, or at the beginning of a procedure, nothing in claim 22 prohibits the device from recalculating a baseline blood pressure measurement, or comparing current blood pressure to the updated baseline. Proposed substitute claim 22 is not a method claim, but is directed to a device that is agnostic as to when a “baseline blood pressure measurement” is determined, as well as its source. Thus, even if the flow diagrams shown in Figure 11A and 11B of the ’069 Patent do not contain instructions to update the baseline pressures acquired in steps 302 and 354, respectively, this is not forbidden by proposed substitute claim 22 as written, and Patent Owner does not persuade us that such a limitation should be imported into the meaning of “baseline blood pressure measurement.”” slip op. at 34
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“For the reasons discussed above, we do not read the exemplary embodiments described in paragraph 14 of Gille503 as representative of the reference as a whole. Rather, we find more persuasive Dr. Day’s testimony that Gille503 satisfies Element 22[h] because one of ordinary skill in the art would have understood that “comparisons performed by the feedback loop would detect a change in blood pressure either when current sensed blood pressure ceases to equal the target blood pressure, or when current sensed blood pressure begins to equal target blood pressure after previously not equaling the target pressure.” Ex. 1014 ¶ 114; see generally, id. ¶¶ 111–119. Dr. Leschinsky also opines that the analysis in our Preliminary Guidance fails to satisfy the requirements of claim 22 because “the control module must specifically perform a comparison between a baseline measurement and another measurement.” Ex. 2006 ¶ 69 (emphasis added). We find it self-evident that this function is carried out by a control module, and agree with Petitioner and its expert that one of ordinary skill would understand Gille503 to describe a feedback loop comprising a control module “controlling balloon inflation based on sensor data to achieve a ‘target’ pressure.” Opp. MTA 13; Ex. 1014 ¶¶ 120–125. In view of the above, we find that one of ordinary skill in the art would understand Gille503 to disclose the “in a vein” and “comparing” limitations of the proposed substitute claim (elements 22[c]/[e] and 22[h], respectively). We have also considered Petitioner’s arguments and evidence with respect to the uncontested limitations. Considering the record as a whole, Petitioner has shown by a preponderance of the evidence that claim 22 is unpatentable as anticipated by Gille503. F.” slip op. at 45
Patent outcomesUS 10,926,069 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,926,069 - Genus PLC v. Inguran, LLCAll claims unpatentablePTAB · Dec 8, 2022 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Dekkers, Maxwell, Garner, and Kim; the Board did not reach the alternative obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner agrees with Petitioner’s first portion of the definition, specifically, that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine.” PO Resp. 16. Patent Owner, however, objects to the inclusion of the second portion of Petitioner’s definition because it is “improperly injecting a purported knowledge of the claimed invention into the definition of a” person of ordinary skill in the art. Id. at 17 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016); In re Sang Su Lee, 277 F.3d 1338, 1345 (Fed. Cir. 2002)); Sur-reply 2–4. Petitioner responds, that its proposed definition reflects the level of skill in the art as supported by the various cited prior art. Pet. Reply. 5. Having considered the arguments and evidence, we agree with Patent Owner that Petitioner’s definition of one of ordinary skill in the art unnecessarily recites specific knowledge, whereas the art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Accordingly, we agree with Patent Owner and determine that one of ordinary skill in the art is a person having at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and this definition is reasonably consistent with the ’734 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“Having considered the record as a whole, we determine that Petitioner’s position with respect to the interpretation of “genetic nucleus” is reasonably supported within the record. At oral argument, however, Petitioner acknowledged that omitting the language “wherein certain offspring of the herd are used for breeding within the herd” from the claim construction would not change whether the challenged claims read on the applied references. See Tr. 14:6–16:28. Because the additional language proposed by Petitioner is unnecessary in order to resolve the disputed issues in this case, we do not adopt it here. We, therefore, construe “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure. 2. Remaining Claim Terms We find that it is unnecessary to expressly construe any remaining claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). D. Ground 1A: Anticipation of Claims 1–5 by Dekkers, as evidenced by either Maxwell or Garner (claims 1–4), or Kim (claim 5)” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that in an anticipation challenge under 35 U.S.C. § 102, Petitioner cannot rely upon specific disclosures in Maxwell or Gardner based on the generic reference to these publications cited Dekkers. Merely citing Maxwell or Gardner in association with sorting sperm as discussed in Dekkers is not incorporation by reference with any level of particularity. See PO Resp. 29 (citing Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009) (To incorporate matter by reference, “a host document must contain language clearly identifying the subject matter which is incorporated and where it is to be found; a mere reference to another application, or patent, or publication is not an incorporation of anything therein.” (internal quote and citations omitted, emphasis in original)); see also Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365, 1376 (Fed. Cir. 2006) (“To incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.”). The disclosure in Dekkers relied on by Petitioner recites: “The technique involves the separation of spermatozoa carrying either X or Y chromosomes (Maxwell et al., 2004; Garner, 2006).” Ex. 1004, 396. We note that Maxwell and Garner are review articles discussing the state of sperm sexting technology generally. See Ex. 1005; Ex. 1006. We agree with Patent Owner that the generic citation to these review articles as set out in Dekkers is not an incorporation by reference of any specific detail from these articles. Unlike the disclosures at issue in Callaway and Cook, Dekkers does not use language such as “reference is made to” (Callaway, 576 F.3d at 1346) or “the disclosure of which is expressly incorporated herein by reference” (Cook, 460 F.3d at 1376) in conjunction with identifying a particular portion of the cited reference that our reviewing court has held to be sufficient to indicate to one of skill in the art that the referenced material is fully incorporated in the host document. Because Dekkers does not incorporate by reference the level of sorting accuracy as required by the claims – at least 80% – the preponderance of evidence of record does not support Petitioner’s position the Dekkers anticipates claims 1–5 of the ’734 patent.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that Petitioner has the better position. Here, Patent Owner is identifying the scope of the invention as the commercial tier at the bottom of the pig production pyramid. However, the scope of the claimed invention is directed to the substantially smaller herd sitting at the top of the commercial pig breeding pyramid. As explained in Teva, “[t]he reasonable-expectationof-success analysis must be tied to the scope of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the ... claimed invention in evaluating the reasonable expectation of success ... constitutes a legal error ....”); see also Intelligent Bio-Sys., Inc., 821 F.3d at 1367.” Teva, 18 F.4th at 1381. Above, we construed “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy in a commercial herd breeding structure. See above II.C.1. The herd at the top of the pyramid comprises far fewer animals than the multiplication and production tiers. See Ex. 1097 ¶¶ 65 (“the relatively smaller herd size of the genetic nucleus (e.g., hundreds or thousands as compared to millions at the production level) makes the use of sexed semen far easier than in vastly larger multiplier and production herds”), 84; Ex. 1096, 36:21–37:4; Ex. 2004, 39:6–22 (millions of animals at the production level). Petitioner contends that sperm sorting combined with lowdose insemination would have been practical for the much smaller herds found at the genetic nucleus. Pet. Reply 21. Both Maxwell and Garner reasonably suggest that deep-uterine insemination (DIU) allows for the use of sex sorted boar sperm. See Ex. 1005, 88; Ex. 1006, 952. Patent Owner admits that the use of sex-selected semen in the laboratory environment works. See PO Resp. 39. Even if the genetic nucleus (i.e. nuclear herd) comprises in excess of 100 or even 1000 animals it is not clear why using artificial insemination in conjunction with sex-selection would not work at the level of the genetic nucleus as argued by Patent Owner. See PO Resp. 39 (“sexed semen has not been implemented outside of a research setting”). Absolute predictability is not necessary to reach an obviousness determination; only a reasonable expectation of success is needed. Pharma Stem Therpeutic, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (2007); In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009); In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success . . . . For obviousness under § 103, all that is required is a reasonable expectation of success.”). In particular, Dekkers teaches that sorted sperm can be used for artificial insemination. Specifically, acknowledging that “new developments in sperm sexing technology allow for the production of either male or female offspring for sire or dam lines, and this can be very useful for the nucleus and multiplication tiers.” Ex. 1004, 396; Ex. 1002 ¶ 48; see also Ex. 1055, 80 (“The main application by pig producers is for the use of sex-sorting technology in nucleus herds, particularly for producing female lines.”). Here, the evidence supports Petitioner’s contentions that given the” slip op. at 32
Patent outcomesUS 10,542,734 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,542,734 - PTAB · Nov 17, 2022 · IPR2022-01029 · APJ Tina E Hulse · IPR · Institution
The Board instituted IPR on claims 1–20 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority under 35 U.S.C. § 314, which provides that an inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented in the papers, we determine that Petitioner has established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we institute an inter partes review of claims 1–20 of the ’431 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. Person of Ordinary Skill in the Art Petitioner contends that a person of ordinary skill in the art at the time of the invention would have had: a Masters or a Ph.D. degree in nutritional science, chemistry, biology, biochemistry, or a related discipline or an M.D. or doctor of optometry (“O.D.”), and a few years of practical experience in the nutritional supplement area, including an understanding of formulations that could be considered for promoting eye health, including preventing or treating eye disorders such as macular degeneration. Alternatively, such a person could have been a person with a Bachelor’s degree with a greater number of years of experience. The POSITA would have, or would have access to, general information regarding eye health and eye disorders, the convenience and needs of patients who suffer from eye disorders, such as macular degeneration, and background information. And to the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’431 Patent. Pet. 8–9 (citing Ex. 1024 ¶ 16) (citations omitted). We adopt Petitioner’s definition as it appears to be consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown” (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985))).” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Petitioner contends the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a person of ordinary skill in the art would have understood this term to mean that the zeaxanthin that is present in the 3R-3R' stereoisomer form is “largely but not wholly free of meso-zeaxanthin stereoisomers.” Pet. 20–22 (citing Ex. 1024 ¶ 62; Ex. 1031, 3). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 9–10. 2. “mixed tocopherols” Petitioner contends the term “mixed tocopherols” should be construed to mean “a mixture of tocopherols such as alpha-, beta-, gamma-, and deltatocopherols.” Pet. 23–24 (citing Ex. 1024 ¶ 69). The Board adopted this construction in the -089 IPR. -089 IPR, Paper 7 at 10. 3. Conclusion At this stage of the proceeding, we adopt Petitioner’s proposed constructions as consistent with the plain and ordinary meaning of the terms Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“2. Analysis Anticipation requires that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” In re Robertson, 169 F.3d 743, 745 (Fed. Cir. 1999) (citation omitted). “To establish inherency, the extrinsic evidence ‘must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill.’” Id. (citation omitted). Moreover, to anticipate, a prior art reference must “disclose[] within the four corners of the document not only combined in the same way as recited in the claim.” Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1371 (Fed. Cir. 2008).” slip op. at 10
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,045,431 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00928 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–6 are unpatentable as anticipated by Stafford and obvious over Stafford, alone or with Manno and Schuettrumpf.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See DI 11 (citing Ex. 1003 ¶ 48; Ex. 1094 ¶ 19). We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Plain and ordinary meaningOther
“In the Petition, Petitioner proposed constructions for five terms: “vector,” “percentage identity,” “promoter,” and “percentage homology,” and “polypeptide precursor.” Pet. 12–14. In our Decision on Institution, we determined that we did not need to explicitly construe any claim terms at that stage of the proceeding. DI 12. Patent Owner “does not believe any term requires construction for this proceeding.” PO Resp. 13. Considering the arguments and evidence of record, we agree with Patent Owner and apply the plain and ordinary meaning to all claim terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“we need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In sum, Stafford discloses (and claims) preferred Factor IX variants for the treatment of hemophilia B, wherein arginine 338 is replaced with, at most, one of three amino acids having similar properties: alanine, leucine, or valine. Ex. 1004, 5, claims 3–5, 10, 14; Ex. 1094 ¶ 104. Stafford further discloses vectors and associated control elements that “may be used in gene therapy to administer the expression cassette to targeted [sic] cells within the patient and produce the Factor IX in the patient.” Ex. 1004, 6–7. In addition to listing various general classes of potential expression vectors, Stafford specifically names four DNA-based viruses including AAV for the construction of vectors: “papillomavirus, adenovirus, adeno-associated virus, [and] cytomegalovirus.” Id.; Ex. 1003 ¶¶ 41, 77–78, 315. Because Stafford’s claims 15 and 17–19 describe a DNA viral vector encoding a FIX variant (of which Stafford names four), and because Stafford specifies three (if not two) preferred amino acid variants, “a POSA would have faced twelve possible combinations of DNA vector and preferred FIX variant for gene therapy.” See Ex. 1003 ¶¶ 321–323.8 Moreover, crediting 8 As previously noted, Dr. Wang misstates, in part, the dependency of Stafford’s claims. See DI 27 (citing Ex. 1003 ¶ 323). Although Stafford’s Dr. Wang’s testimony that, as of the time of the invention, “AAV vectors were considered the leading candidate for useful human gene therapy vectors, and were being used routinely in the hemophilia B field” (Ex. 1003 ¶ 39; see also id. at ¶¶ 32–36, 88, 323), we find that one of ordinary skill in the art would read Stafford as disclosing all elements of claim 1, “arranged as in the claim.” See Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359, 1369 (Fed. Cir. 2008). As noted above, Patent Owner does not separately argue dependent claims 3–6. We have reviewed Petitioner’s evidence and argument, and agree with Petitioner that Stafford discloses all limitations of claims 3–6.” slip op. at 26
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“recited in the challenged claims. In sum, considering the record as a whole, we agree with Dr. Wang’s testimony that one of ordinary skill in the art would have found the challenged claims obvious in view of Stafford. Ex. 1003 ¶¶ 348–370. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be expressed. As discussed above, Stafford discloses successful expression of R338A in vitro. As Dr. Wang explains, given that Stafford demonstrated in vitro expression for numerous other variants in the 330–338 helix region of FIX, only R338P showed reduced expression, and unlike leucine, “proline [P] is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113–116, 225; see also Ex. 1100 ¶¶ 117–121. As such, we agree with Dr. Wang that one of ordinary skill in the art would not have expected difficulties in the expression of R338L. We also find unavailing Patent Owner’s argument that a person of ordinary skill would not have expected in vivo expression of FIX-R338L at levels similar to that of wild-type FIX. To the contrary, Schuettrumpf supports a conclusion that a person of ordinary skill would have expected that gene therapy with FIX-R338A expressed in vivo from liver cells at levels similar to wild-type FIX. See Reply 13 (citing Ex. 1005, 2, 4; Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113–116, 225). As Dr. Wang testified, this would have suggested to a person of ordinary skill that FIX-R338L would express at a similar level. Ex. 2114, 53:13–55:14; Ex. 1100 ¶¶ 113– 16; see also Ex. 1001, 4:45–58 (’180 patent’s teaching that it was expected that conservative amino acid substitutions (e.g. alanine and leucine) “would not change phenotype of the proteins”). We do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art reading Stafford would have had serious concerns regarding whether R338L would be active. To the contrary, we credit Dr. Wang’s testimony that one of ordinary skill in the art would have expected the R338L variant to exhibit higher activity than wild-type Fix based, for example, on Stafford and Schuettrumpf showing that R338A exhibited higher activity in vitro and in vivo, respectively, and the similarities between alanine and leucine. See, e.g., Ex. 1003 ¶¶ 40, 42, 158, 219, 383, Ex. 1100 ¶¶ 101–112; see also Ex. 1094 ¶¶ 41–45, Ex. 1100 ¶¶ 23–36 (Dr. Pederson’s explanation of why one of ordinary skill would have expected replacing arginine 338 with leucine would have a similar effect as replacing it with alanine). Stafford’s disclosure that numerous mutations in the FIX 330–337” slip op. at 44
Patent outcomesUS 10,465,180 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,465,180 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00926 · APJ Julia Heaney · IPR · Final written decision
Claims 2, 4–6, 11–13, 17, and 18 are unpatentable as obvious over Stafford and Manno; claims 2, 5, 6, 11–13, 17, and 18 are also anticipated or obvious over Monahan.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. See Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include “(1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering;” and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of the coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedReference is prior artDecided for petitioner
“the earlier application must disclose the claimed invention “in the manner provided by § 112(a) (other than the requirement to disclose the best mode).” 35 U.S.C. §§ 119(e), 120. Section 112(a) requires that the specification contain a written description of the claimed invention. 35 U.S.C. § 112(a). “[T]he hallmark of written description is disclosure.” Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc). The written description requirement is met when the specification “conveys to those skilled in the art that the inventor had possession of” and “actually invented” the claimed subject matter. Id. The purpose of the written description requirement is to ensure that a patent’s claims “do[] not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.” Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). The Federal Circuit has stated: The question is not whether a claimed invention is an obvious variant of that which is disclosed in the specification. Rather, a prior application itself must describe an invention, and do so in sufficient detail that one skilled in the art can clearly conclude that the inventor invented the claimed invention as of the filing date sought. Lockwood v. Am. Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997).” slip op. at 21
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 9,982,248 - Pfizer, Inc. v. Uniqure Biopharma B.V.All claims unpatentablePTAB · Nov 15, 2022 · IPR2021-00925 · APJ Julia Heaney · IPR · Final written decision
Claims 1, 3, 7–10, 14–16, 19, and 20 are unpatentable as obvious over Stafford and Manno, and Stafford, Manno, and Schuettrumpf.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Decision on Institution, although we agreed with Patent Owner that the ordinarily skilled artisan would have experience in the treatment of coagulopathy, we applied a broader definition of a person of ordinary skill in the art, as articulated by Drs. Wang and Pedersen. Dec. Inst. 22; see Ex. 1003 ¶ 48; Ex. 1094 ¶ 19. We determined a person of ordinary skill in the art would have the skill of a research team working to develop factor IX variants and gene therapies, where that team would include (1) one or more researchers with experience in the fields of molecular biology and virology and the use of gene therapy for treatment of coagulopathies, working together with (2) one or more individuals with experience in protein structure or engineering; and where the individuals working on the team have an advanced degree and several years of experience in a relevant discipline. See id. Patent Owner states its positions on patentability of the challenged claims “would not change under that construction or Petitioner’s proposed definition ....” PO Resp. 13. Accordingly, we apply the definition of a person of ordinary skill in the art set forth supra and in our Decision on Institution.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“We agree with Petitioner that the ’248 patent provides an express definition of “treat” and “treatment.” The Specification states, “[i]n the present text the term ‘treat’ or ‘treatment’ of a pathology means the prophylaxis and/or therapy and/or cure of this pathology.” Ex. 1001, 5:19– 21. This definition includes “cure” as a separate concept from therapy, and further provides that therapy includes “partial or total” alleviation of symptoms. Id. at 5:21–24. The ’248 patent does not define or otherwise describe “treating a coagulopathy” as requiring any specific duration of therapeutic efficacy; therefore, a person of ordinary skill in the art would understand that partial alleviation of symptoms and a shorter duration of therapeutic efficacy is encompassed in “treating a coagulopathy” as recited in claim 1. Claim 16, which depends from claim 1, supports a construction of “treating a coagulopathy” that does not require complete alleviation of symptoms or permanent therapeutic efficacy. Claim 16 recites the “modified FIX polypeptide is expressed at a level that reduces and/or prevents hemorrhages.” Ex. 1001, 46:34–36. Because claim 16 depends from claim 1, this means that “treating a coagulopathy” as recited in claim 1 encompasses merely reducing hemorrhages, i.e., partial alleviation of symptoms. Accordingly, based on the intrinsic evidence, including the express definition of the terms “treat” and “treatment,” we construe “treating a coagulopathy” as prophylaxis and/or therapy and/or cure of this coagulopathy which includes partial alleviation of symptoms, for any duration of therapeutic efficacy. We determine that we need not explicitly construe any other claim terms.” slip op. at 10
- Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner
“Accordingly, Patent Owner has failed to show that it is entitled to a presumption of a nexus between the objective evidence and the claimed invention. Patent Owner argues that it “need not rely on such presumption [of nexus]” under the Polaris and Fox Factory analysis. PO Resp. 67. Although Patent Owner does not fully explain its position, we note that Fox Factory provides, “[a] finding that a presumption of nexus is inappropriate does not end the inquiry into secondary considerations”; rather, “the patent owner is still afforded an opportunity to prove nexus by showing that the evidence of secondary considerations is the ‘direct result of the unique characteristics of the claimed invention.’” Fox Factory, 994 F.3d at 1374 (quoting In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996)). Here, we find that Patent Owner presents insufficient evidence to establish a nexus by this alternative route. Patent Owner does not present argument as to the “unique characteristics” of the claimed invention, or provide evidence to support such an analysis. See PO Resp. 66–67; PO Sur-reply 26–28. In addition, as discussed above, Patent Owner’s evidence is broadly directed to FIX- R338L, which was in the prior art and does not suggest non-obviousness of the claimed invention as a whole. In summary, Patent Owner does not meet its burden to show a presumption of nexus or show a nexus to the alleged long-felt need for an effective gene therapy for hemophilia B, industry praise, and unexpectedly superior efficacy of AAV-FIX-R338L. Weighing the evidence and arguments presented, we determine that even if there is some nexus, it is weak. See Merck & Cie, 808 F.3d at 837 (Where objective indicia “result[ ] from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention.”). The failure to show a nexus is fatal to Patent Owner’s contentions regarding objective indicia.” slip op. at 26
- Expert testimonyPatent owner expert discountedDecided for petitioner
“We also find Dr. Pedersen’s opinion with regard to a leucine substitution in FIX-R338 more credible than Dr. Spiegel’s, who states “there is no such thing as ‘conservative amino acid substitutions’ in the sense Dr. Pedersen asserts.” Ex. 2101 ¶ 72. The ’248 patent itself refers to “conservative amino acid substitutions” and states “[i]t is expected that substitutions between these homologous amino acids [including alanine and leucine] would not change the phenotype of the proteins.” Ex. 1001, 4:48– 61. Although Dr. Spiegel notes that substitution is context dependent and “the specification recognizes ... various properties of each unique amino acid all contribute to the amino acid’s interactions” (Ex. 2101 ¶ 75, citing Ex. 1001, 4:48–61; Ex. 1002, 4:45–58; Ex. 1039, 51), his opinions do not account for the knowledge of a person of ordinary skill in the art as to the properties of alanine and leucine and the structure of FIX. See Ex. 1101 ¶¶ 36–39. Further, Dr. Spiegel’s surface-exposure opinion (see, e.g., Ex. 2101 ¶ 99) is undercut by Stafford’s teaching that the 330–338 region of wild-type FIX contains two solvent-exposed leucines. Ex. 1101 ¶ 41 (citing Ex. 1004, 34). Dr. Spiegel’s opinion that a leucine substitution would reduce solubility or increase susceptibility to aggregation also lacks credibility because it is based on the protein hemoglobin S, and not on a modification to FIX positions 330–338. Ex. 2101 ¶ 62; Ex. 1103, 78:15–18; see Ex. 1101 ¶ 60. We also do not find persuasive Patent Owner’s argument that a person of ordinary skill in the art would have had serious concerns whether R338L would be expressed, based on Stafford. As discussed above, Stafford discloses successful expression of R338A in vitro, and as Dr. Wang explains, the understanding of a person of ordinary skill of similarities between R338A and R338L would have supported the understanding that R338L would express at a similar level to R338A, given Stafford’s disclosure that only R338P showed reduced expression, and unlike leucine, “proline is a known ‘helix breaker.’” Ex. 1004, 14–15; Ex. 1100 ¶¶ 113– 116. Stafford’s disclosure that mutations at 330–337 cause severe hemophilia due to loss of FIX activity (Ex. 1004, 19:16–20) does not support Patent Owner’s argument, because Patent Owner’s experts do not persuasively explain why the risk of severe hemophilia from single amino acid substitutions at positions 330–337 would be predictive of a similar risk at position 338. See Ex. 1100 ¶¶ 115–119; Ex. 1101 ¶¶ 48–51. As such, we agree with Dr. Wang that a person of ordinary skill in the art would not have expected difficulties in expression of R338L.” slip op. at 38
Patent outcomesUS 9,982,248 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,982,248 - PTAB · Oct 26, 2022 · IPR2022-00886 · APJ John G New · IPR · Institution
The Board instituted review of claims 1–4 on all petition grounds, finding a reasonable likelihood that Mutz anticipates the claims.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, June 21, 2022 available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited October 11, 222) (the “Guidance”). As stated by the Guidance, the Board will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation when: (1) a petition presents compelling evidence of unpatentability; (2) a petitioner presents a stipulation (a “Sotera stipulation”) not to pursue in a parallel proceeding the same grounds or any grounds that could have reasonably been raised before the PTAB9; and (3) if all other Fintiv factors weighing against exercising discretion to deny institution, or are neutral, the proximity to trial should not alone outweigh all of those other factors.10 Guidance at 1–8.” slip op. at 40
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential).” slip op. at 45
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“of claims 1–4 of the ’816 patent. Patent Owner argues, however, that Mutz cannot anticipate claims 1–4 because the reference is not enabled. See Gleave, 560 F.3d at 1334 (holding that, to anticipate, “the reference must “enable one of ordinary skill in the art to make the invention without undue experimentation.” (citing Impax Labs., Inc. v. Aventis Pharms. Inc., 545 F.3d 1312, 1314 (Fed. Cir. 2008))). Specifically, Patent Owner contends that, because Mutz does not disclose a method for making fingolimod HCl, it is not enabled and therefore cannot anticipate the claims of the ’816 patent. We disagree.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,266,816 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00012 · APJ Sheldon M Mcgee · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the remaining anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“Synthes USA, LLC v. Spinal Kinetics, Inc., 734 F.3d 1332, 1344 (Fed. Cir. 2013). And, although there are no bright-line rules for the amount of disclosure needed in an unpredictable art, that amount “necessarily changes with each invention” and “changes with progress in the field.” Ariad, 598 F.3d at 1351. Here, we find that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. Thus, we conclude that the ’525 application requires a more-detailed disclosure than would be required in a predictable field to adequately demonstrate possession of a heat-transfer composition consisting essentially of HFO-1234yf and PAG for use in AAC. (iii) Disclosure in the ’525 Application With these background findings in mind, we now turn to the four corners of the ’525 application—and we find that the ’525 application does not contain the detailed disclosure needed in this case to reasonably convey possession of a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for use in AAC.” slip op. at 37
- Skill levelSkill level board ownDecided for patent owner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“Tr. 114:15–115:18 (emphases added). Thus, we find that Patent Owner does not contest that a heat-transfer composition consisting essentially of HFO- 1234yf and PAG for AAC was in public commercial use before the March 26, 2014, filing date of the ’017 patent. Accordingly, we find that Petitioner’s evidence, together with Patent Owner’s concessions, demonstrates by a preponderance of evidence that the claimed subject matter of the ’017 patent was in commercial use before its March 26, 2014, effective filing date. See Ex. 1002 ¶¶ 399–409. In particular, as to claims 1, 3–10, 12, 13, and 15–20, we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant AAC composition of the Ford Transit Custom Bus, the Mazda CX 5 (2.0i and 2.2D), and the Opel Mocca used HFO-1234yf and a PAG lubricant as early as 2012. Ex. 1002 ¶ 399 (citing Ex. 101324, 2, 38, 55, 70). We also credit Dr. Brown’s 24 Behr Hella Services, Refrigerant and Oil Filling Quantities Passenger Cars & Commercial Vehicles 2014–15. PGR12 Ex. 1013. (“Service Guide”). PGR12 Ex. 1013. The Service Guide provides tables setting forth specifications for refrigerant type, refrigerant quantity, vehicle manufacturers’ original equipment compressor oil type, and oil filling quantity for the air-conditioning system of each vehicle listed in the tables. Id. at 2–3. Petitioner and Dr. Brown direct us to the Sevice Guide’s entries calculations, which show that the Ford Transit Custom Bus had an AAC refrigerant-lubricant composition of 26.7% of PAG lubricant and 73.3% of HFO-1234yf (Ex. 1002 ¶ 401 (citing Ex. 1013, 38)); the Mazda CX 5 2.0i had 16.7% PAG lubricant and 83.3% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 55)); the Mazda CX 5 2.2D had a 17.5% PAG lubricant and 82.5% HFO-1234yf (id.); and the Opal Mocca had 11.6% PAG lubricant and 88.4% HFO-1234yf (Ex. 1002 ¶ 402 (citing Ex. 1013, 70)). As to dependent claims 2, 11, and 14, which all require that the lubricant is present “in an amount from about 30% to about 50% weight,” we credit Dr. Brown’s uncontested testimony that the refrigerant-lubricant composition of the Ford Transit Custom Bus recited lubricant amount. Ex. 1002 ¶ 403. In particular, we agree with Dr. Brown that, because the lubricant accounts for 26.7% of the AAC refrigerant-lubricant composition in the Ford Transit Custom Bus, the lubricant makes up “about 30%” of the refrigerant-lubricant composition as claimed. Id. For these reasons, we find that Petitioner has met its burden to show that claims 1–20 are unpatentable for anticipation under § 102(a)(1).” slip op. at 55
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017 - Arkema Inc. / Arkema France v. Honeywell International Inc.All claims unpatentablePTAB · Aug 25, 2022 · PGR2016-00011 · APJ Grace Karaffa Obermann · PGR · Remand
Claims 1–20 are unpatentable under § 102(a) for prior public use; the Board did not reach the other anticipation, obviousness, and enablement grounds.
RulingsRemand decision- RemandOther
“On October 1, 2019, the Federal Circuit held that we “abused [our] discretion by assuming the authority that 35 U.S.C. § 255 expressly delegates to the Director: to determine when a Certificate of Correction is appropriate,” and vacated our Final Written Decision. Honeywell Int’l Inc. v. Arkema Inc., 939 F.3d 1345 (Fed. Cir. 2019). The Federal Circuit instructed us to “authorize Honeywell to file a motion seeking leave to petition the Director for a Certificate of Correction.” Id. at 1351. Pursuant to the Federal Circuit’s mandate, we gave our authorization, and Patent Owner filed its Motion for Leave to Request a Certificate of Correction. PGR11 Paper 61; PGR12 Paper 41. After additional briefing from the parties was complete, we granted Patent Owner’s Motion. PGR11 Paper 77; PGR12 Paper 57. Patent Owner filed its Request for a Certificate of Correction, as well as a Petition to Accept [Unintentionally] Delayed Claim to Priority under 35 U.S.C. § 120 and 37 C.F.R. § 1.78. PGR11 Ex. 2174; PGR12 Ex. 2172.” slip op. at 3
- Skill levelSkill level board ownDecided for petitioner
“develops new refrigerants for use as heat transfer fluids. Ex. 1002 ¶ 149. Such a person would have had a Ph.D. in Chemistry, Chemical Engineering, Mechanical Engineering, Material Science, or a related field or discipline and at least 3 to 5 years of experience, or alternatively an M.S. degree and 5 to 10 years of experience. Id. Patent Owner’s Declarant, Dr. Bivens, provides a similar description of the person of ordinary skill in the art, stating that such a person would have a B.S. degree in Chemical Engineering or Chemistry, and five years of work experience, or a Ph.D. or M.S. degree and 2–3 years of experience. Ex. 2001 ¶ 23. Based on these descriptions, we find that the parties’ definitions of ordinary skill in the art are substantially the same, and agree with the parties that an ordinarily skilled artisan would be educated in the Chemical and Chemical Engineering arts or related disciplines. We also agree with the parties that a person having less formal education, such as a B.S. or M.S. degree, would require more years of experience than a person with more formal education, such as a Ph.D., to qualify as an ordinarily skilled artisan. We also find that neither party states how any difference in the parties’ articulated levels of skill impacts this proceeding. Thus, our analysis would be the same regardless of any minor differences between the parties’ respective articulations. Finally, we note that the level of ordinary skill in the art is reflected by the prior art of record. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (the prior art itself can reflect the appropriate level of ordinary skill in the art).” slip op. at 20
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateNot shown unpatentable
“We agree with Petitioner that the ’525 application’s statement that the compounds are “adaptable for use” weighs against a finding of adequate written description. First, “adaptable for use” is vague, as Dr. Bivens acknowledges. See Ex. 1177, 151:15 (testifying that “adaptable for use can have a wide range of meaning”). Second, the ’525 application gives no direction on how a skilled artisan would need to adapt any particular composition for use in AAC, or even if any “adaptation” was necessary. We find that such a teaching is important in this case to show that the inventors had possession of the claimed invention, given our findings above that the art of AAC was unpredictable and that a heat-transfer composition for AAC required specific technical features that were unpredictable and unexpected. For completeness, we again reject Patent Owner’s argument that “[t]o show the inventors possessed claim 1 requires no more” than the statement in the written description that “‘the compositions of the present invention are believed to be adaptable . . . with or without system modification.’” PGR12 Resp. 27–28 (quoting Ex. 1001, 7:4–8). Regardless of the exact wording of claim 1, the inventors “still [had to have] describe[d] some way of performing the claimed methods.” Ariad, 598 F.3d at 1355. And here, with merely a passing reference to AAC, the ’525 application fails to provide any credible “technologic knowledge” to demonstrate to an ordinarily skilled artisan that Patent Owner “was in possession of the invention that is claimed.” Id.” slip op. at 43
- Novelty / Anticipation (§102) › Prior-art status of a reference › On-sale bar (Pfaff, Helsinn)UnpatentableUnpatentable
“unless . . . the claimed invention was . . . in public use . . . before the effective filing date of the claimed invention.” 35 U.S.C. § 102(a)(1). “The proper test for the public use prong . . . is whether the purported use was accessible to the public or was commercially exploited.” Delano Farms Co. v. Cal. Table Grape Comm’n, 778 F.3d 1243, 1247 (Fed. Cir. 2015) (quotation omitted). “Commercial exploitation is a clear indication of public use . . . .” Invitrogen Corp. v. Biocrest Mfg., L.P., 424 F.3d 1374, 1380 (Fed. Cir. 2005).” slip op. at 53
Patent outcomesUS 9,157,017 unpatentable§ 102 anticipation§ 112 disclosurePatents in suitUS 9,157,017
Holdings, summaries, rulings, issues, outcomes, winners and claim constructions shown for a decision were generated by a large language model reading the opinion. They are a guide to the decision, not the decision. Confirm every one against the court's own text before relying on it. Outcomes read from the patent owner’s side. Party names are extracted from the decision and are missing on about 900 short Director denials and scans, which carry the trial number instead.