- Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Dec 19, 2023 · IPR2023-01033 · APJ Sheridan K Snedden · IPR · Institution
The Board denied institution of IPR challenging claims 1–30, finding substantially the same art had been presented to the Office and no material error was shown under § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dInstitution denied
“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 [the] 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. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6, 8 (PTAB Feb. 13, 2020) (precedential). The Becton, Dickinson factors provide useful insight into how to apply the framework under 35 U.S.C. § 325(d). Id. at 9 (referencing Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8, 17– 18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph)).” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Not reached
“presented to the Office, and (2) Petitioner has not demonstrated that the Office erred. We therefore conclude that it is appropriate to exercise discretion under 35 U.S.C. § 325(d) to deny the Petition. III. CONCLUSION For the foregoing reasons, we exercise discretion under 35 U.S.C. § 325(d) to deny institution of an inter partes review. IV. ORDER In consideration of the foregoing, it is hereby: ORDERED that the Petition is denied, and no trial is instituted.” slip op. at 21
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“enzyme complex” and “nucleic acid insert element.” Pet. 21. Patent Owner, for its part, states that “[n]o terms require construction for considering institution.” Prelim. Resp. 18. We determine that neither of the two limitations identified by Petitioner requires an express construction for purposes of this Decision. It bears mentioning, however, that the ’357 patent states that “[t]he insertional enzyme can be a transposase.” Ex. 1001, 3:47–48. There is no dispute that Grunenwald discloses the use of a transposase and, thus, an insertional enzyme complex. See Pet. 16 (citing Ex. 1003 ¶¶ 17, 93–94, 162); Prelim. Resp. 13 (“Grunenwald further defines ‘transposase’ to mean ‘an enzyme that is capable of forming a functional complex . . . and catalyzing insertion or transposition of the transposon end-containing composition into the double-stranded target DNA with which it is incubated in an in vitro transposition reaction.” (citing Ex. 1003 ¶ 93)).” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed board ownDecided for patent owner
“express construction of the term “chromatin.” The ’357 patent itself provides a definition, stating: The term “chromatin,” as used herein, refers to a complex of molecules including proteins and polynucleotides (e.g. DNA, RNA), as found in a nucleus of a eukaryotic cell. Chromatin is composed in part of histone proteins that form nucleosomes, genomic DNA, and other DNA binding proteins (e.g., transcription factors) that are generally bound to the genomic DNA. Ex. 1001, 12:61–67. This is the meaning that we apply in this Decision.” slip op. at 6
Claim constructionDiscretionary denialPatents in suitUS 10,738,357 - PTAB · Dec 19, 2023 · IPR2023-01038 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on all challenged claims 1–29 and all petition grounds, finding a reasonable likelihood of success and declining § 325(d) denial.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’745 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportInstituted
“Conclusion Based on the preliminary record, we determine that Petitioner is reasonably likely to prevail in establishing that the challenged claims are not entitled to a priority date that is earlier than October 7, 2016. Accordingly, Corteva ’437, which was filed May 2, 2005, and published November 17, 2005, is prior art under 32 U.SC. § 102. Ex. 1021, codes (22), (43).” slip op. at 55
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“missing in the disclosures of the priority applications. See, e.g., Paper 9 at 2 (citing evidence). Because the only issue in dispute at this time for Petitioner’s grounds based on Corteva ’437 is the applicable priority date for the challenged claims, the Office’s error is plainly material to Petitioner’s challenge under Grounds IA & IB, covering all claims. We do not further address the parties’ arguments about § 325(d) as applied to the obviousness challenge under Grounds IIA and IIB. Even if we agreed with Patent Owner’s arguments for discretionary denial of those grounds, we would not find that § 325(d) is sufficiently implicated based on our determination of error concerning the priority issue as explained above. For the foregoing reasons, we do not deny the Petition on the basis of discretion under 35 U.S.C. § 325(d).” slip op. at 74
§ 102 anticipationDiscretionary denialcites KSR · GrahamPatents in suitUS 11,299,745 - PTAB · Dec 19, 2023 · IPR2023-01037 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–29 and 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
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’283 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“35 U.S.C. § 325(d). In evaluating whether to deny institution under 325(d), the Board has considered several non-exclusive factors: (a) the similarities and material differences between the asserted art and the prior art involved during examination; (b) the cumulative nature of the asserted art and the prior art evaluated during examination; (c) the extent to which the asserted art was evaluated during examination; (d) the extent of the overlap between the arguments made during examination and the manner in which a petitioner relies on the prior art or a patent owner distinguishes the prior art; (e) whether a petitioner has pointed out sufficiently how the Office erred in evaluating the asserted prior art; and (f) the extent to which additional evidence and facts presented in the petition warrant reconsideration of the prior art or arguments. See Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 at 17–18 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first para.). Factors (a), (b), and (d) relate to whether the art or arguments in the Petition are the same or substantially the same as those previously presented to the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 10 (PTAB Feb. 13, 2020) (precedential) (“Advanced Bionics”). Factors (c), (e), and (f) “relate to whether the petitioner has demonstrated a material error by the Office” in the Office’s prior consideration of that art or arguments. Id. Under Advanced Bionics’s two-part framework, we first determine whether the same or substantially the same art or arguments previously were presented to the Office. Id. at 8, 10. If “either condition of [the] first part of Office has been shown. Id. at 8, 10.” slip op. at 68
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contentions are, at this stage, unavailing. Petitioner’s proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’283 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1002, 18:44–50 (citing Hogan (Ex. 1027)), 50:51–55 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about the POSA’s perspective at the time of the invention, appears to have academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the” slip op. at 23
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“C. Claim Construction In inter partes review, we construe claims using the same claim construction standard used to construe claims in a civil action before the courts under 35 U.S.C. § 282(b), including construing claims in accordance with the ordinary and customary meaning as understood by the POSA and the patent’s prosecution history. 37 C.F.R. § 42.100(b). We need only construe terms that are in controversy and only as needed to resolve the matters in dispute. Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019). 17 The closest work we see from Dr. Nair related to herbicide resistant transgenic plants is his 2019 paper co-written with the applicant’s employees (e.g., Dr. Wright), which paper appears to be a follow-on investigation into the AAD-1 proteins of the patent. Ex. 1008, 594–595; Ex. 1019, Abstr. proceeding. Pet. 17; Prelim. Resp. 20. It is not apparent at this stage that any terms need further interpretation to resolve the matters in dispute.18” slip op. at 24
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 11,149,283 - PTAB · Dec 19, 2023 · IPR2023-01036 · APJ Timothy G Majors · IPR · Institution
The Board instituted IPR on claims 1–34 and all petitioned grounds, finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314(a), an inter partes review may not be instituted unless it is determined that there is a reasonable likelihood that the petitioner will prevail with respect to at least one of the claims challenged in the petition. Considering the parties’ arguments and evidence, for reasons explained below, we conclude that Petitioner shows a reasonable likelihood that it will prevail with respect to at least one of the ’555 patent’s challenged claims. We decline to deny the Petition on the basis of discretion under § 325(d). We institute an inter partes review on all challenged claims. See SAS Inst. Inc. v. Iancu, 138 S. Ct. 1348, 1355 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“proposal could have been more specific, but it is not so lacking that the institution burden is unmet. It is reasonably clear that, in indicating that a POSA would have an advanced degree (like a Ph.D.) and years of experience in a “relevant discipline,” Petitioner is referring to the technical areas it cited previously, such as protein/enzyme biochemistry. Pet. 17–18. Petitioner’s definition does not ignore subject matter like “transgenic plants” because it states that the POSA would be able to apply key scientific concepts here (e.g., protein biochemistry, enzyme activity, and substrate selectivity) to such plants. Moreover, although Patent Owner complains about Petitioner’s POSA definition, it does not offer its own or explain why Petitioner’s challenge fails under any alternative definition. At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22
- Expert testimonyPetitioner expert creditedDecided for petitioner
“At this stage, Patent Owner’s suggestion that Dr. Hausinger lacks relevant expertise or qualifications of at least a POSA is unpersuasive. The ’555 patent relies on Dr. Hausinger’s own prior work. See, e.g., 1001, 18:2– 7 (citing Hogan (Ex. 1027)), 51:6–12 (citing Fukumori (Ex. 2001)) (both references co-authored by Dr. Hausinger). Patent Owner also cites Dr. Hausinger’s work as evidencing what “skilled artisans” understood about the claimed and prior art technology, including αKGD dioxygenases, which is a focus of the parties’ arguments. See, e.g., Prelim. Resp. 7–8 (“Thus, as reflected in Hogan and Hotopp [(co-authored by Dr. Hausinger)], skilled artisans understood the structure-function relationships of Group II αKG-dependent dioxygenases . . . .”); Ex. 1029 (Hotopp 2002)). During prosecution, Dr. Wright’s declaration relied on Dr. Hausinger’s research. See, e.g., Ex. 1008, 462 (Wright I ¶ 13 (citing Hotopp)), 658 (Wright II ¶¶ 10–13 (describing the research in Hogan and Hotopp as that of “skilled artisans”)). And, Applicant’s other declarant, Dr. Nair, who testified about academic and prior work history focused on chemistry, biochemistry, and enzymology without significant background in subjects like “controlling weeds” about which Patent Owner questions Dr. Hausinger’s qualifications. See, e.g., Ex. 1008, 590–591.17 Patent Owner will have the chance to cross-examine Dr. Hausinger in this proceeding. If Patent Owner feels we should discount Dr. Hausinger’s testimony due to lack of qualifications, it may raise such argument in trial. For now, we apply Petitioner’s proposed POSA level, with the clarifications noted above, which appears consistent with the level of skill shown in the prior art references of record. See Daiichi Sankyo Co. v. Apotex, Inc., 501 F.3d 1254, 1256 (Fed. Cir. 2007).” slip op. at 22
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“We agree with Petitioner that the priority applications do not disclose sufficient representative species compared to the breadth of the claims. As Petitioner contends, SEQ ID NO: 9 and the two AAD-1 variants that differ from SEQ ID NO: 9 by just one or two amino acids do not fairly represent the diversity of proteins within genus of at least 2044 variants. Pet. 30–31; Ex. 1054 ¶¶ 81–82 (showing the minimal sequence differences in AAD-1 v2 (alanine substituted for histidine at position 2, and cysteine substituted for arginine at position 212), and v3 (alanine insertion at position 2)); Ex. 1001, Dr. Hausinger testifies persuasively that the > 99% identity shared by these three AAD-1 variants “are simply not representative of proteins having as little as 85% sequence identity to AAD-1 v1 (SEQ ID NO: 9).” Ex. 1054 ¶¶ 83–86 (testifying, e.g., that the specification “does not provide any structural information that might have allowed the POSA to make inferences about the effect of a given change” and that nothing in the disclosure “would have suggested to the POSA that changes at [the positions in which v2 and v3 differ] would be particularly informative.”). Patent Owner provides no argument or evidence to the contrary on the question whether sufficient representative species are disclosed.27” slip op. at 43
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites KSR · GrahamPatents in suitUS 10,947,555 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Dec 18, 2023 · IPR2023-00955 · APJ Michael J Fitzpatrick · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that any challenged claim would be obvious, including a reasonable expectation of success in adding a distinguishing second tag.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an inter partes review, it is the Petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotation marks and citations omitted). Based on the information presented here, there is not a reasonable likelihood of Petitioner prevailing in showing that a skilled artisan, even if motivated to combine the teachings of the prior art references as proposed by Petitioner, would have had a reasonable expectation of success in achieving the claimed invention, including “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.”” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“In an inter partes review, it is the Petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotation marks and citations omitted). Based on the information presented here, there is not a reasonable likelihood of Petitioner prevailing in showing that a skilled artisan, even if motivated to combine the teachings of the prior art references as proposed by Petitioner, would have had a reasonable expectation of success in achieving the claimed invention, including “a second tag sequence distinguishing said sample polynucleotide from other sample polynucleotides from said cell.”” slip op. at 16
§ 103 obviousnesscites GrahamPatents in suitUS 10,240,197 - Parse Biosciences, Inc. v. 10x Genomics, Inc.Institution deniedPTAB · Dec 13, 2023 · IPR2023-00958 · APJ Michael J Fitzpatrick · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood of proving claims 1–28 obvious over the asserted combinations.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“In an inter partes review, it is the Petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotation marks and citations omitted). Based on the information presented here, there is not a reasonable likelihood of Petitioner prevailing in showing that a skilled artisan, even if motivated to combine the teachings of the prior art references and knowledge of the person of ordinary skill in the art to achieve the subject matter of claim 1, would have had a reasonable expectation of success in doing so.” slip op. at 16
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot reached
“In an inter partes review, it is the Petitioner’s “burden to demonstrate both that a skilled artisan would have been motivated to combine the teachings of the prior art references to achieve the claimed invention, and that the skilled artisan would have had a reasonable expectation of success in doing so.” In re Magnum Oil Tools Int’l, Ltd., 829 F.3d 1364, 1381 (Fed. Cir. 2016) (quotation marks and citations omitted). Based on the information presented here, there is not a reasonable likelihood of Petitioner prevailing in showing that a skilled artisan, even if motivated to combine the teachings of the prior art references and knowledge of the person of ordinary skill in the art to achieve the subject matter of claim 1, would have had a reasonable expectation of success in doing so.” slip op. at 16
§ 103 obviousnesscites GrahamPatents in suitUS 10,697,013 - Arthrex, Inc. v. P Tech, LLCAll claims unpatentablePTAB · Nov 21, 2023 · IPR2022-01043 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1–20 are unpatentable: claims 8, 11, 13, 14, 16, and 18–20 are anticipated by Fumex, and the remaining claims are held unpatentable on obviousness grounds.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“After considering the above factors and Petitioner’s proposed level of skill in the art, for purposes of our Institution Decision, we defined a person of ordinary skill in the art as someone having a medical degree and at least two years of experience performing surgeries with implantable medical devices, such as suture anchors. Inst. Dec. 10. Patent Owner and its expert Dr. Pedowitz agree with our analysis in the Institution Decision, and employ our definition of a person of ordinary skill in the art. PO Resp. 16; Ex. 2001 (Pedowitz Decl.) ¶ 21. After institution, Petitioner did not dispute our definition. See generally Reply. Accordingly, and for the reasons discussed in our Institution Decision, we maintain our definition of a person of ordinary skill in the art as someone having a medical degree and at least two years of experience performing surgeries with implantable medical devices, such as suture anchors. See Inst. Dec. 8–10.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“In the absence of any meaningful claim construction analysis of this term from the parties, and because we find that for purposes of resolving the disputes at issue in this Decision, a construction of “passage” is unnecessary, we decline to construe this term. See Realtime Data, LLC v. Iancu, 912 F.3d 1368, 1375 (Fed. Cir. 2019) (“The Board is required to construe ‘only those 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 13
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“In sum, the Specification and prosecution history use the terms “knotless” and “knot” in ways consistent with their known meanings in the art. “[T]o deviate from the plain and ordinary meaning of a claim term to one of skill in the art, the patentee must, with some language, indicate a clear intent to do so in the patent.” Hill-Rom Servs., Inc., 755 F.3d at 1373. The Specification and prosecution history are devoid of any clear intention to deviate from the so-called “legacy” meaning of “knotless,” as admittedly used in the context of “knotless suture anchors.” We see nothing in the intrinsic record that supports Patent Owner’s argument that it “coined” a different meaning for this term in connection with the claimed fasteners. We agree with Petitioner that “it strains logic that [inventor] Dr. Bonutti would include ‘knotless’ within a lengthy list of characteristics that a fastener could take on—and without any further explanation, definition, or stated benefits—if he intended ‘that it wasn’t the way the term might commonly have been used at that time.’” Reply 5–6 (quoting Ex. 1018 (Pedowitz Depo. Tr.), 20:15–22); see also Ex. 1018 (Pedowitz Depo. Tr.), 24:6–26:1, 27:12–18 (Dr. Pedowitz unable to identify any other portions of the Specification that use or define the term “knotless”), 27:19–24 (admitting that the Specification does not identify any benefits of a “knotless fastener” (per Patent Owner’s proposed construction)).” slip op. at 23
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“In accordance with our construction of the term “knotless” fastener, we agree with Petitioner that because Fumex’s sleeve can be retained in place without tying a knot at the site where it is secured in place, Fumex discloses a “knotless” fastener as recited in claims 19 and 20. See Pet. 37– 38; Ex. 1002 (Jordan Decl.) ¶¶ 111–15. We adopt Petitioner and Dr. Jordan’s reasoning as our own. See id. We note that Patent Owner does not dispute that a knot is not tied in connection with securing Fumex’s fastener.20 See, e.g., Sur-reply 21 (arguing that “Fumex’s bone anchor retains the anchor in place in bone – not by tying a knot – but by forming a knot by pulling on one or both strands of the suture”). Instead, Patent Owner’s argument for why Fumex fails to teach a “knotless” fastener is based on its proposed claim construction. See PO Resp. 20 (“Fumex does not disclose a flexible hollow fastener that is ‘knotless’ as Patent Owner and Dr. Pedowitz have construed this term in this Proceeding.”); Sur-reply 1 (“It is undisputed that the claim construction of a ‘knotless’ fastener will decide this case.”), 23 (“If Patent Owner’s construction of “knotless” fastener is adopted, then claims 19 and 20 of the 20 In this regard, although Dr. Jordan referred to a “bigger knot” when discussing Fumex, he did not describe Fumex as requiring tying of a knot. See Ex. 2002 (Jordan Depo. Tr.), 19:21–20:8. Our construction requires elimination of knot-tying; it does not encompass the elimination of any structure that could be considered a “knot” in the general sense of the word. See Reply 21 n.6; Tr. 16:10–17:10. ‘453 Patent are not anticipated by Fumex, which fails to disclose a knotless fastener.”); see also Reply 21 (asserting that “Patent Owner has not disputed that Fumex meets Petitioner’s proposed construction of ‘knotless.’”). Because we reject Patent Owner’s proposed construction of “knotless” (see supra Section II.C.2), Patent Owner’s argument that Fumex fails to teach a “knotless” fastener is unavailing. In sum, for the reasons discussed above, we determine that Petitioner has shown by a preponderance of the evidence that Fumex anticipates claims 8, 11, 13, 14, 16, and 18–20.” slip op. at 45
Patent outcomesUS 9,814,453 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,814,453 - Arthrex, Inc. v. P Tech, LLCAll claims unpatentablePTAB · Nov 21, 2023 · IPR2022-01066 · APJ Jeffrey N Fredman · IPR · Final written decision
Claims 1–26 are unpatentable under § 103, principally over Fumex and Grafton and the additional combinations; the Board did not reach alternative grounds 1, 3, 5, 7, and 9.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“In our Institution Decision we considered these factors and determined based on the record before us that “a person of ordinary skill in the art would have had a medical degree and at least two years of experience performing surgeries with implantable medical devices, such as suture anchors.” Inst. Dec. 9. Patent Owner agrees with this determination, stating Patent Owner and Dr. Pedowitz, Patent Owner’s expert, agree with the Board’s analysis at pages 7–9 of the Institution Decision that a POSITA [person of ordinary skill in the art] would have a medical degree and at least two years of experience performing surgeries with implantable medical devices, such as suture anchors. Ex 2001, ¶ 18. PO Resp. 21. After institution, Petitioner did not dispute our definition and did not further address the level of ordinary skill in the art in the Petitioner’s Reply. See generally Pet. Reply. Accordingly, we maintain our definition of a person of ordinary skill in the art as someone having a medical degree and at least two years of experience performing surgeries with implantable medical devices, such as suture anchors.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“The ’259 Specification is permissive of multiple flexible elongated fastening members, generally termed sutures, teaching “the device may allow for the implantation of multiple sutures and fasteners in tissue with little or no repositioning of the device.” Ex. 1001, 4:61–63. The ’259 Specification does disclose a situation where “two passages 162 and 164 may be drilled in tissue, like a fractured bone 166, and two sutures or fastening members may be positioned through the passages, tensioned, and secured.” Id. at 18:11–14. But the ’259 Specification is also permissive of a single flexible elongated fastening member where a “suture 56 is looped through or connected with the fastener 52 such that one, two, or more sections, legs, strands, or portions of the suture 56 extend from the fastener 52.” Ex. 1001, 6:44–47. The intrinsic evidence therefore is open to Patent Owner’s interpretation of “a” as “one or more.” Nor does anything in the ’259 Specification supply a clear and manifest disavowal of that meaning.” slip op. at 11
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“not established the necessary predicate that they coined the term “knotless” in the ’259 patent. The standard for “coining a term” or an inventor serving as their own lexicographer in a patent is set forth in Paulsen, which states Although an inventor is indeed free to define the specific terms used to describe his or her invention, this must be done with reasonable clarity, deliberateness, and precision. “Where an inventor chooses to be his own lexicographer and to give terms uncommon meanings, he must set out his uncommon definition in some manner within the patent disclosure” so as to give one of ordinary skill in the art notice of the change. In re Paulsen, 30 F.3d 1475, 1480 (Fed. Cir. 1994). When Petitioner and Dr. Jordan point to prior art showing that there was a legacy meaning of “knotless,” and that this meaning of “knotless” differs from Patent Owner’s reliance on a meaning of “knotless” not stated or discussed in the ’259 patent, Petitioner reasonably relies upon the prior art meaning of “knotless.” See Ex. 1002 ¶ 46. On the full trial record, Patent Owner has not identified statements within the Specification which provide notice that the term “knotless” was intended to have a meaning distinct from the use as a fastener in a location without the use of a knot, as understood by Dr. Jordan. Ex. 1002 ¶ 44. And Dr. Jordan expressly stated that he considered jumbled sutures pressed into a hole and pulled tight as not a knot (i.e., knotless) but rather simply functioning as an anchor. Ex. 2002, 40:11–41:9. 3. Conclusion We therefore interpret the term “knotless” in the context of the fasteners on this trial record as reading on a suture-restraining structure that can be retained in place without tying a knot at the site where the fastener is secured in place.” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableMotivation foundUnpatentable
“Petitioner asserts that a “POSITA would have found Grafton’s braided suture to be an obvious choice of suture thread for use in Fumex’s bone anchoring device” because “a suture including polyethylene could have been chosen by a POSITA for applications requiring a relatively higher suture strength. Grafton expressly describes suture strength as being ‘an important consideration in any surgical suture material.’ Ex. 1005, ¶[0004]; Ex. 1002, ¶153.” Pet. 49–50. Petitioner also asserts Grafton specifically states that the suture is “ideal” for “rotator cuff repair, Achilles [sic] tendon repair, patellar tendon repair, and ACL/PCL reconstruction”—some of the very types of procedures for which Fumex’s bone anchoring device is intended to be used. Ex. 1004, 4:38-41, 1:7-12, 2:1-8; Ex. 1005, ¶[0009]; Ex. 1002, ¶152-53. Pet. 50. Petitioner asserts a “POSITA would have had a reasonable expectation of success in combining Fumex’s bone anchoring device with Grafton’s suture thread. Ex. 1002, ¶154.” Pet 51. Petitioner asserts “a POSITA would have expected Grafton’s flexible suture to be as capable of being threaded through Fumex’s flexible sleeve as any other suture. Ex. 1002, ¶¶155-56.” Pet. 51. Patent Owner asserts that “Fumex fails to describe or suggest that at least a portion of its thread is fabricated with polyethylene as required in claim element [1.3]. For this reason alone, claim 1 is not obvious from Fumex.” PO Resp. 28. Patent Owner does not, however, dispute the obviousness of claim element [1.3] in Ground 2 based on “the combination of Fumex and Grafton due in part to the high suture strength of polyethylene as disclosed by Grafton. Petition, 50, Ex 1002, ¶ 153.” Id. at 38–39. We agree with and adopt Petitioner’s undisputed analysis.” slip op. at 39
Patent outcomesUS 10,376,259 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,376,259 - PTAB · Nov 21, 2023 · PGR2023-00026 · APJ Susan L C Mitchell · PGR · Institution
The Board denied institution because Petitioner did not show it was more likely than not that claims 1–19 were unpatentable, including because the proposed prior-art combination lacked a sufficient reason to select Ruminococcus for skin …
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Institution of post-grant review is authorized by statute only when “the information presented in the petition . . . demonstrate[s] that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.”1 35 U.S.C. § 324; see 37 C.F.R. § 42.4. Upon considering the Petition, Preliminary Response, and the cited evidence, we conclude that Petitioner has not satisfied its burden under 35 U.S.C. § 324 to show that it is more likely than not that at least 1 of the claims challenged in the Petition is unpatentable.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsNot reached
“7 Patent Owner requested that we exercise our discretion to deny institution under 35 U.S.C. § 325(d). See Prelim. Resp. 11–49. Because we determine on the merits that no post-grant review should be instituted, we will not address Patent Owner’s arguments concerning Section 325(d).” slip op. at 44
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner counters that Petitioner has set the level of skill of a person of ordinary skill in the art too low. Prelim. Resp. 9–11; Ex. 2001 ¶ 25. Patent Owner asserts that a POSA would have a more advanced degree than a bachelor of science and would have more specific work experience. Id. For instance, Patent Owner asserts: A POSA for the ’838 Patent typically would have an advanced degree, such as an M.D. or a Ph.D., with experience and training in oncology, have several years of experience with administering oncology treatments to subjects and evaluating results of such treatments, and have experience or knowledge in microbiome science and its modulation, inclusive of studies that involve stool microbiome profiling, as well as experience in, or knowledge of, related research and development of bacterial-based cancer treatments. A POSA may also have worked as part of a multi-disciplinary team and drawn upon not only his or her own skills, but also taken advantage of certain specialized skills of others in the team, to solve a given problem. For example, such a team may include a clinician, an immunologist, microbiologist, bioinformatician, molecular biologist, manufacturing specialist, and/or pharmaceutical formulator. Prelim. Resp. 9–10 (citing Ex. 2001 ¶¶ 26–27). Patent Owner concludes that by applying the inappropriately low level of skill of a POSA, “Petitioner overstates the amount of guidance needed in the specification to describe and enable the claimed methods.” Prelim. Resp. 11. Patent Owner confirms, however, that all arguments on all grounds presented in the Preliminary Response “apply regardless of which party’s POSA definition is used.” Prelim. Resp. 11 n.2. We disagree with Patent Owner that a POSA is required to have a” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Patent Owner acted as its own lexicographer and expressly defined “isolated” and “purified” as follows. The term “isolated” encompasses a bacterium or other entity or substance that has been (1) separated from at least some of the components with which it was associated when initially produced (whether in nature or in an experimental 6 Available at https://www.uspto.gov/sites/default/files/documents/IndefinitenessMemo.pd f?utm_campaign=subscriptioncenter&utm_content=&utm_medium=email& utm_name=&utm_source=govdelivery&utm_term=. setting), and/or (2) produced, prepared, purified, and/or manufactured by the hand of man. Isolated bacteria may be separated from at least about 10%, about 20%, about 30%, about 40%, about 50%, about 60%, about 70%, about 80%, about 90%, or more of the other components with which they were initially associated. In some embodiments, isolated bacteria are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. As used herein, a substance is “pure” if it is substantially free of other components. The term “purify,” “purifying” and “purified” refer to a bacterium or other material that has been separated from at least some of the components with which it was associated either when initially produced or generated (e.g., whether in nature or in an experimental setting), or during any time after its initial production. A bacterium or a bacterial population may be considered purified if it is isolated at or after production, such as from a material or environment containing the bacterium or bacteria population, and a purified bacterium or bacterial population may contain other materials up to about 10%, about 20%, about 30%, about 40%, about 50%, about 60% about, 70%, about 80%, about 90% or above about 90% and still be considered “isolated.” In some embodiments, purified bacteria and bacterial populations are more than about 80%, about 85%, about 90%, about 91%, about 92%, about 93%, about 94%, about 95%, about 96%, about 97%, about 98%, about 99%, or more than about 99% pure. In the instance of bacterial compositions provided herein, the one or more bacterial types present in the composition can be independently purified from one or more other bacteria produced and/or present in the material or environment containing the bacterial type. Bacterial compositions and the bacterial components thereof are generally purified from residual habitat products. Ex. 1001, 28:40–29:11. In reviewing the express definitions of “isolated” and “purified,” it is not surprising that the two similar terms, “isolated” and “purified,” may have overlapping definitions. We agree with Patent Owner that such overlap does not mean the definitions lack “reasonable clarity, deliberateness, and precision” that would inform a POSA with reasonable certainty about the scope of claim 1. We also agree with Patent Owner that a POSA would understand the two parts of the definition of “isolated” set forth above.” slip op. at 30
Claim construction§ 103 obviousness§ 112 disclosureDiscretionary denialcites Phillips · Graham · NautilusPatents in suitUS 11,395,838 - PTAB · Nov 17, 2023 · IPR2023-00894 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–15 on all petitioned grounds, finding a reasonable likelihood of prevailing and declining discretionary denial under Fintiv and § 325(d).
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (2012) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review).” slip op. at 7
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownNo construction neededOther
“to be construed.” 37 C.F.R. § 42.104(b)(3). But only those terms that are in controversy need be construed, and only to the extent necessary to resolve the controversy. Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999); see also Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (applying Vivid Techs. in the context of an AIA trial proceeding). For the purpose of this Decision, we need address only the terms “bore” and “at a terminal end.”” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“Contrary to Patent Owner’s analysis, we preliminarily construe a “bore” as “a hole or passage made by or as if by the turning or twisting movement of a tool such that its interior walls have a cylindrical cross-section, and which do not exclude and may include holes or passages having tapered or stepped longitudinal cross-sections.” See supra Section II.C.1. As such, and on the limited record before us, Cognet discloses a bore and further satisfies all elements of claim phrase 1[c][iii]. c) Conclusion as to Ground 1 In view of the above preliminary construction, Petitioner establishes sufficiently that Cognet discloses claim element 1[c][iii]. Patent Owner does not dispute any other element of Ground 1 in its Preliminary Response. Having considered the evidence of record, we determine that Petitioner has established sufficiently that these remaining elements are also disclosed in Cognet. According, and solely for the purpose of institution, Petitioner has demonstrated a reasonable likelihood that Cognet anticipates claim 1.” slip op. at 19
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“On the present record, we decline to speculate whether the pending motion to stay might be successful. Accordingly, Fintiv Factor 1 is neutral.” slip op. at 29
Claim construction§ 102 anticipationDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,166
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.