- Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - PTAB · Feb 8, 2023 · IPR2022-01328 · APJ Bart A Gerstenblith · IPR · Institution
The Board instituted review of claims 10–18, 31, and 32 under § 103 over Hardin ’665 and Salmre, finding a reasonable likelihood of unpatentability.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“presented in the petition . . . and any [preliminary] 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.” 35 U.S.C. § 314(a) (2018). For the reasons below, Petitioner has established a reasonable 1 Petitioner’s Preliminary Reply is limited to the issue of discretionary denial pursuant to Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 (PTAB Mar. 20, 2020) (precedential), and, particularly, the effect of Samsung’s stipulation in related litigation, in accordance with Sotera Wireless, Inc. v. Masimo Corp., IPR2020-01019, Paper 12 (PTAB Dec. 1, 2020) (precedential as to § II.A). likelihood that it would prevail in showing the unpatentability of at least one of the Challenged Claims. Accordingly, we institute an inter partes review of the Challenged Claims on all grounds raised in the Petition.” slip op. at 2
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateOther
“Accordingly, for the reasons set forth in IPR2022-01327, Paper 13, we: (1) determine, based on the present record, that the Challenged Claims of the ’387 patent are not entitled to the priority date of the ’094 application, and, therefore, Hardin ’665 is available as prior art to the ’387 patent; (2) determine that, on balance, considering the record presently before us, Petitioner has established a reasonable likelihood that it would prevail in showing that the combination of Hardin ’665 and Salmre would have rendered the subject matter of claims 10–18, 31, and 32 of the ’387 patent obvious to one of ordinary skill in the art at the time of the invention; (3) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Fintiv; and (4) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 325(d).” slip op. at 17
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date, deniedOther
“Accordingly, for the reasons set forth in IPR2022-01327, Paper 13, we: (1) determine, based on the present record, that the Challenged Claims of the ’387 patent are not entitled to the priority date of the ’094 application, and, therefore, Hardin ’665 is available as prior art to the ’387 patent; (2) determine that, on balance, considering the record presently before us, Petitioner has established a reasonable likelihood that it would prevail in showing that the combination of Hardin ’665 and Salmre would have rendered the subject matter of claims 10–18, 31, and 32 of the ’387 patent obvious to one of ordinary skill in the art at the time of the invention; (3) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Fintiv; and (4) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 325(d).” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Accordingly, for the reasons set forth in IPR2022-01327, Paper 13, we: (1) determine, based on the present record, that the Challenged Claims of the ’387 patent are not entitled to the priority date of the ’094 application, and, therefore, Hardin ’665 is available as prior art to the ’387 patent; (2) determine that, on balance, considering the record presently before us, Petitioner has established a reasonable likelihood that it would prevail in showing that the combination of Hardin ’665 and Salmre would have rendered the subject matter of claims 10–18, 31, and 32 of the ’387 patent obvious to one of ordinary skill in the art at the time of the invention; (3) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 314(a) and Fintiv; and (4) decline to exercise our discretion to deny institution pursuant to 35 U.S.C. § 325(d).” slip op. at 17
§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,049,387 - PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses “secondary doses” are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001 col. 3, ll. 36–44. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,130,681 - 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 - PTAB · Jan 5, 2023 · PGR2022-00046 · APJ Robert L Kinder · PGR · Institution
The Board instituted PGR on the design claim, finding PayPal more likely than not anticipates and renders the claim obvious; it also instituted on all other petition grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“We have authority to determine whether to institute a post-grant review under 35 U.S.C. § 324(a) (2018), which provides that review may not be instituted unless “the information presented in the petition,” if “not rebutted, would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Applying that standard, for reasons explained below, we grant the Petition and institute a post-grant review of the challenged claim.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner further asserts that “[t]he designer of ordinary skill would be someone with a background in designing animated GUI’s, such as animated GUI’s that facilitate financial transactions.” Id. at 64 (citing Ex. 1003 ¶ 109). Based on the record before us, we adopt Petitioner’s identification of the ordinary observer and designer of ordinary skill in the art for purposes of this Decision because they are consistent with the disclosures of the asserted prior art references and the ’453 patent, supported by witness testimony, and unopposed by Patent Owner at this juncture.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“portion with animated [GUI].” Ex. 1001, code (57). “Petitioner proposes that the ’453 Patent claim should be construed as a display screen portion with an animated graphical user interface displaying a series of images including the elements shown in non-broken lines in FIGS. 1-4,” and “in accordance with its explicit statements that the broken lines and the dot lines ‘form[] no part of the claimed design’ and that ‘[t]he process or period in 8 Petitioner refers to a graphical user interface as a GUI. which one image transitions to another image forms no part of the claimed design.’” Pet. 43–44. For purposes of this Decision, we agree with Petitioner’s proposed construction that the claim encompasses a display screen portion with an animated graphical user interface displaying a series of images including the elements shown in non-broken lines and agree that the broken lines and dot lines in the figures form no part of the claimed design. See id. To the extent that the features of the claimed design require further discussion, however, we provide it in our assessment of the challenges, which we turn to next.” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Petitioner explains that PayPal was publicly accessible because “MPEP § 2128 states that YouTube videos ‘can be sources of prior art, provided the public accessibility requirements . . . are met,’” where “‘[p]rior art disclosures on the Internet . . . are considered to be publicly available as of the date the item was publicly posted,” and, here, PayPal is a YouTube video that was publicly posted on April 8, 2021 “and has received over 107,000 views,” with “a corresponding April 8, 2021 article posted by CNET [having] linked to this video.” Pet. 20 (citing MPEP § 2128; Ex. 1028). Petitioner also points out that “persons interested and having ordinary skill in cashless payment applications could locate PayPal exercising reasonabl[e] diligence . . . by searching the Internet for videos concerning QR code payment systems payments,” and that “PayPal has been viewed over 100,000 times, suggesting that PayPal is a well-known payment system and that persons interested and having ordinary skill in cashless payment applications could have easily located PayPal.” Id. at 20–21. Petitioner argues that PayPal qualifies as “otherwise available to the public” prior art because “the U.S. Patent & Trademark Office’s training materials specifically list YouTube videos as prior art that should be considered ‘otherwise available to the public’ under 35 U.S.C. § 102 (a)(1) . . . [,] [a]nd the evidence described above confirms that PayPal was otherwise available to the public as of its publication date of April 8, 2021.” Pet. 21 (citing Ex. 1032, 15). Based on the record before us, we determine it is more likely than not that PayPal qualifies as prior art, either as a printed publication or as otherwise available to the public.” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousness - 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 - Resmed, Inc. v. New York UniversityInstitutedPTAB · Dec 5, 2022 · IPR2022-00989 · APJ James A Tartal · IPR · Institution
The Board instituted IPR on all challenged claims and all petition grounds, finding a reasonable likelihood of success on obviousness over Sullivan995 and Sullivan460.
RulingsInstitution decision- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“§ 315(b) is unavailing. Rule 42.104(b) requires a petitioner to state in its petition “[h]ow the challenged claim is to be construed” and “specify where each element of the claim is found in the prior art.” 37 C.F.R. §§ 42.104(b)(3), (b)(4). The Petition states “[t]he Board construes the claims ‘using the same claim construction standard that would be used’ in district courts.” Pet. 20. We disagree that Rule 42.104(b) or the CTPG requires Petitioner to make any specific statement if it takes the position that no express construction of claim terms is required. Rather, the CTPG states that “a petitioner may include a statement that the claim terms require no express construction.” CTPG 44.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“We use a two-part framework to analyze a request to exercise discretion to deny institution under § 325(d). First, we determine “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.” Advanced Bionics, Paper 6 at 8. Second, if either condition of the first part of the framework is satisfied, then we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of [the] challenged claims.” Id. In applying this framework, we refer to the non-exclusive factors delineated in Becton, Dickinson & Co. v. B. Braun Melsungen AG, IPR2017-01586, Paper 8 (PTAB Dec. 15, 2017) (precedential as to § III.C.5, first paragraph). These factors are: a) the similarities and material differences between the asserted art and the prior art involved during examination; b) the cumulative nature of asserted art and the prior art evaluated during examination; c) the extent to which the asserted art was evaluated during examination, including whether the prior art was the basis for rejection; d) the extent of overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art; e) whether Petitioner has pointed out sufficiently how the Examiner erred in its evaluation of 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. Id. at 17–18.” slip op. at 13
- Skill levelSkill level petitioner adoptedDecided for petitioner
“may be considered, including the “type of problems encountered in the art; prior art solutions to those problems; rapidity with which innovations are made; sophistication of the technology; and educational level of active workers in the field.” In re GPAC Inc., 57 F.3d 1573, 1579 (Fed. Cir. 1995) (citation omitted). Petitioner contends that a person of ordinary skill in the art “in 2003 would have had at least a bachelor’s degree in mechanical engineering, biomedical engineering, or a similar technical field, with at least two years of relevant product design experience” and “[a]dditional experience could substitute for less education, and additional education could likewise substitute for less experience.” Pet. 19 (citing Ex. 1003 ¶ 77). Petitioner further states that the “Petition does not turn on this precise definition, and the challenged claims would be unpatentable from the perspective of any reasonable person of ordinary skill in the art at the relevant time.” Id. (citing Ex. 1003 ¶ 78). Patent Owner, at this stage of the proceeding, does not dispute Petitioner’s definition of the person of ordinary skill in the art. Prelim. Resp. 9. We find, on the current record, that the ’539 patent and the cited prior art references reflect the appropriate level of skill at the time of the claimed invention and that the level of appropriate skill reflected in these references and in the ’539 patent is consistent with the definition of a person of ordinary skill in the art proposed by Petitioner. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Accordingly, we adopt Petitioner’s proposed level of ordinary skill in the art for purposes of this Decision.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Petitioner propose no express construction for any claim term, at least with regard to the alleged obviousness grounds of unpatentability. See Pet. 20. In regard to the alleged anticipation grounds, Petitioner contends “the patient is in an awake state when there is an absence of obstructions or other breathing patterns indicative of sleep,” and asserts this is an “implied construction of ‘an awake state’ based on [Patent Owner’s] infringement allegations” in district court. Id. at 68, 70. Patent Owner proposes no express construction of any claim term and states “no claim terms are in controversy.” Prelim. Resp. 10. In light of our determinations below, we find that an express construction of any claim term is not necessary for purposes of rendering 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))).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 9,427,539 - 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
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.