- Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00875 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because the ’696 patent anticipates each claim.
RulingsFinal written decision- Skill levelSkill level board ownDecided for patent owner
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 16; PO Resp. 21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education” slip op. at 8
- Expert testimonyPetitioner expert creditedDecided for patent owner
“have significant background in P(III) chemistry. Id. at 19; Sur-reply 12–13. According to Patent Owner, Dr. Baran published only about a dozen papers that relate to oligonucleotide synthesis, and the focus of those papers appears to be on P(V) chemistry, which is fundamentally different from P(III) chemistry. PO Resp. 19–20; Sur-reply 12–13. Although it does not challenge Dr. Baran’s qualification to provide opinion in this proceeding, Patent Owner asserts that “Dr. Baran’s lack of experience in P(III) synthesis[] should be strongly considered” in our evaluation of the weight of Dr. Baran’s testimony. Sur-reply 13. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 50–105. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 9
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim 2 US Patent No. 5,869,696, issued Feb. 9, 1999 (Ex. 1014, “the ’696 patent”). element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 6
- PTAB / AIA Trials › Motions to amend / substitute claimsOther
“Resp.”) and a Motion to Amend Claims (Paper 11, “MTA”). In the MTA, Patent Owner proposed to replace claims 1 and 2 with substitute claims 4 and 5. MTA 1–2. Petitioner filed an Opposition to Patent Owner’s MTA (Paper 13) and a Reply to Patent Owner’s Response (Paper 14, “Reply”). After we entered Preliminary Guidance on Patent Owner’s Motion to Amend (Paper 15), Patent Owner requested authorization to withdraw its MTA (Ex. 3003). We granted that request. Paper 17. Thereafter, Patent Owner filed a Sur-reply to Petitioner’s Reply (Paper 20, “Sur-reply”).1” slip op. at 2
Patent outcomesUS 8,309,707 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 8,309,707 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Oct 17, 2024 · IPR2023-00862 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1 and 2 are unpatentable because Aerschot anticipates them.
RulingsFinal written decision- Expert testimonyPetitioner expert creditedDecided for petitioner
“Patent Owner’s argument that Dr. Baran is principally experienced in P(V) chemistry presupposes that experience indicates an ignorance of P(III) chemistry. We do not find this position consistent with the breadth of Dr. Baran’s experience as indicated by his Curriculum Vitae. See Ex. 1003, 47–102. We weigh the testimonies of both Dr. Baran and Dr. Hrdlicka, against the cumulative weight of the evidence of record in assessing their credibility and probative value.” slip op. at 8
- Skill levelSkill level board ownOther
“The parties’ proposed definitions of the level of ordinary skill, although different facially, are similar substantively. For example, both parties argue that a POSA would have high levels of skill, with advanced degrees and/or extensive work experience in organic chemistry.3 See Pet. 12; PO Resp. 20–21. In addition, Petitioner contends that a POSA would have had experience in the development of oligonucleotide building blocks. Pet. 16. Similarly, Patent Owner asserts that a POSA would have had education and/or experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids.” PO Resp. 20–21. After considering the parties’ arguments and the prior art, we determine that a POSA would have had a Ph.D. (or equivalent degree) in organic chemistry or medicinal chemistry, with at least two to three years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis. In addition, an individual with a Bachelor’s or Master’s degree and at least five years of work experience in these fields also would qualify as a POSA.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Claim terms need only be construed to the extent necessary to resolve the controversy. Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011). On this record and for purposes of this Decision, we see no need to address the construction of any claim term.” slip op. at 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“To show anticipation under 35 U.S.C. § 102, each and every claim element, arranged as in the claim, must be disclosed in a single piece of prior art. Net MoneyIN, Inc. v. VeriSign, Inc., 545 F.3d 1359 (Fed. Cir. 2008). For a claim directed to a genus, if a prior art reference discloses a species falling within the claimed genus, the species anticipates the genus. In re Slayter, 276 F.2d 408, 411 (CCPA 1960); see also Fresenius USA, Inc. v. Baxter Int’l, Inc., 582 F.3d 1288, 1298 (Fed. Cir. 2009) (stating that when a claim element is written in Markush form, “the entire element is disclosed by the prior art if one alternative in the Markush group is in the prior art”).” slip op. at 5
Patent outcomesUS 8,541,569 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,541,569 - Shanghai Hongene Biotech Corp. v. Chemgenes Corp.All claims unpatentablePTAB · Jul 18, 2024 · IPR2023-00490 · APJ John G New · IPR · Final written decision
Claims 1–5 are unpatentable: claim 1 is anticipated by Reddy; claims 2–4 are obvious over the stated combinations; claim 5 is anticipated by Gaur.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“However, we prefer Patent Owner’s definition of the required 2–3 years of experience in “the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” to Petitioner’s more generalized requirement of having experience in “medicinal chemistry, synthetic organic chemistry, and nucleic acid chemistry, including the development of oligonucleotide therapeutics, diagnostics, or building blocks.” Both parties acknowledge that the level of skill in the art is very high. See, e.g., Resp. 17; Reply 2. We find that, to achieve a level of ordinary skill in the art, a person with the requisite educational background would require 2–3 years of experience for one possessing a doctorate in the relevant field, or 3–5 years for one with a lesser degree (to compensate for the additional educational experience gained by achieving a doctorate) in the specific techniques recited by Patent Owner. We reject the terminal clause “pursuant to P(III) chemistry” proposed by Patent Owner as redundant in that a person engaged for a number of years in “the development and syntheses of nucleosides, nucleotides, and nucleic acids” including SPOS, would likely have an operant knowledge of P(III) chemistry. Consequently we adopt the following definition of a person of ordinary skill in the art: “A person of ordinary skill in the art having a Ph.D. (or equivalent degree) in organic or medicinal chemistry, and 2 to 3 years of post-graduate work experience in the development and syntheses of nucleosides, nucleotides, and nucleic acids, including, but not limited to, the syntheses of oligonucleotides through solid phase oligonucleotide synthesis (‘SPOS’)” and, alternatively, “a person of ordinary skill in the art would have a Bachelor’s or Master’s degree in organic or medicinal chemistry who had at least 5 years of extensive work experience in these fields.”” slip op. at 12
- Expert testimonyPetitioner expert creditedDecided for petitioner
“As for Dr. Baran, we are not persuaded by Patent Owner’s argument that Dr. Baran is not sufficiently experienced or qualified to opine with respect to the claimed subject matter. A review of Dr. Baran’s extensive curriculum vitae (Ex. 1003, 79–137), indicates that he is deeply experienced and extensively published in the field of oligonucleotide synthesis. Patent Owner’s argument that Dr. Baran is principally experienced in P(V) techniques presupposes that experience in that technique indicates an ignorance of P(III) methodologies. We do not find this position consistent with the breadth of Dr. Baran’s C.V. We will weigh Dr. Baran’s testimony, and that of Dr. Hrdlicka, against the cumulative weight of the evidence of record in this inter partes review in assessing the credibility and probative value of their respective testimonies.” slip op. at 13
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction needed
“Both parties agree that the terms of the challenged claims should be given the ordinary and customary meaning of such terms as understood by one of ordinary skill in the art and the prosecution history pertaining to the patent. Pet. 17; PO Resp. 15 (both citing 37 C.F.R. § 42.100). Accordingly we see no need for explicitly construing any of the terms of the challenged claims beyond that standard.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“Furthermore, both Petitioner and Patent Owner agree that clear errors exist in the wording of challenged claims 3–5. Both parties agree that a person of ordinary skill in the art would have recognized that the limitation reciting “where M is selected from the group consisting of succinyl, oxalyl, and hydroquinolynyl” should properly read “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl.” Pet. 18–20; PO Resp. 15. Both parties further agree that the language of claim 5 mistakenly omits the italicized portions of the limitation reciting “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy,” as is expressly recited in claims 3 and 4. Pet. 21–22 (citing Ex. 1003 ¶ 158); PO Resp. 15. We agree with both parties’ reasoning with respect to these errors, and we construe the claims as reciting the corrected language, such that claims 3–5 read, in relevant part “where M is selected from the group consisting of ethyl, oxalyl, and hydroquinolynyl” and claim 5 additionally reads “NH is capable of being attached to a solid support with a spacer selected from the group consisting of C1–C20 alkyl, ethyloxyglycol, and a combination of alkyl and ethyleneglycoxy.” See Fitbit, Inc. v. Valencell, Inc., 964 F.3d 1112, 1119–20 (Fed. Cir. 2020) (holding that the Board erred in not correcting a “conspicuous” and undisputed error in claim).” slip op. at 8
Patent outcomesUS 9,884,885 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,884,885 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00511 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable: claims 1–3 and 6 based on Govier anticipation and Govier-Williams obviousness; claims 4, 5, 7, and 8 based on obviousness over Govier-Mumford and Govier-Williams-Mumford.
RulingsFinal written decision- BurdenFwd all claims unpatentableUnpatentable
“We conclude that Petitioner has proven by a preponderance of the evidence that the challenged claims are unpatentable.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for a formal degree and vice versa.” Pet. 10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “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 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Govier describes a study in which patients with overactive bladders were given “percutaneous electrical stimulations via a 34 gauge needle placed near the tibial nerve 3 finger breadths above the ankle.” Ex. 1005, 1193. Specifically, “[a] 34 gauge, solid stainless steel needle was advanced through the skin” and “the needle was advanced approximately 3 to 4 cm. posterior to the tibia and, if advanced further, would traverse anterior to the fibula.” Id. at 1194. Govier further explains that “[a]n electrocardiogram ground pad was placed over the medial aspect of the calcaneus” and “[a] stimulator was then connected to the needle and the ipsilateral ground pad.” Id. This arrangement is depicted in Govier’s Figure 3, which is reproduced below.” slip op. at 6
Patent outcomesUS 9,387,338 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,387,338 - Cala Health, Inc. v. Emkinetics Inc.All claims unpatentablePTAB · Jul 1, 2024 · IPR2023-00508 · APJ Jason W Melvin · IPR · Final written decision
Claims 1–8 are unpatentable as anticipated by Govier and obvious over Govier and Williams; the Board did not reach the additional grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“II. ANALYSIS A. LEVEL OF ORDINARY SKILL IN THE ART Petitioner contends that a person of ordinary skill in the art “would have had an undergraduate degree in the field of biomedical engineering, or a related engineering discipline, and at least two years of experience in the design and/or analysis of biomedical devices” and that “[a]dditional work experience could serve as a substitute for an engineering degree.” Pet. 9–10 (citing Ex. 1002 ¶ 23). Petitioner’s proposed level of ordinary skill in the art appears to be consistent with the challenged patent and prior art, and we adopt it here.” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“B. CLAIM CONSTRUCTION Petitioner argues that “no claim terms require express construction to resolve the challenges in this Petition.” Pet. 10. We agree and do not expressly construe any terms. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (noting that “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 6
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“We have reviewed Petitioner’s contentions and evidence and conclude that they prove anticipation of the challenged claims by Govier for the reasons given by Petitioner. Pet. 19–55.” slip op. at 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableUnpatentable
“For claim 1, Petitioner asserts that, if Govier does not disclose applying an electrode patch to the outer surface of the skin, skilled artisans would have had reason to substitute Williams’s known electrode patch for Govier’s ground pad as a simple substitution of one known structure for another performing the same function—“creating a current path along the tibial nerve”—and yielding the same results—“ability to stimulate the tibial nerve to treat overactive bladder.” Id. at 21–24. Petitioner contends also that, if Govier does not disclose a controller including a pulse generator, skilled artisans would have had reason “to substitute Williams’s pulse generator for Govier’s stimulator.” Id. at 27–29. Petitioner reasons that skilled artisans would have found it obvious to try Williams’s pulse generator because of its similarities with Govier’s stimulator—“each create current pulses between 1–10 mA.” Id. at 28. Petitioner reasons further that using Williams’s pulse generator would have been a simple substitution. Id.” slip op. at 9
Patent outcomesUS 9,757,584 unpatentableClaim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,757,584 - Guardant Health, Inc. v. University Of WashingtonAll claims unpatentablePTAB · Jan 11, 2024 · IPR2022-01158 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–28 are unpatentable because Eltoukhy anticipates them; the Board found they were not entitled to a priority date before Eltoukhy’s publication.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of ordinary skill in the art, various factors 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). Furthermore, the prior art itself can reflect the appropriate level of ordinary skill in the art. Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001). Here, Petitioner asserts that an ordinarily skilled artisan “would typically have an advanced degree, such as a Ph.D., with research experience in genomics, molecular biology, bioinformatics, or a related field, or could have less education but significant professional experience in one or more of these fields.” Pet. 8–9 (citing Ex. 1002 ¶ 38). Patent Owner states that for the purposes of this proceeding, it does not dispute Petitioner’s definition of the skill level. PO Resp. 2 (citing Ex. 2023 ¶¶ 21, 22). After reviewing the record, we adopt Petitioner’s definition as it is consistent with the prior art’s demonstration of the level of ordinary skill in the art at the time of the invention.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionOther
“1. “Sequence Reads” Petitioner argues that, for purposes of this Decision, no claim term needs specific construction beyond its plain and ordinary meaning. Pet. 10–11. Petitioner, however, seeks to provide context for understanding the scope of the term “sequence reads.” Specifically, Petitioner contends that “sequence reads” are produced by sequencing at least some of the tagged strands, whereas “consensus sequences” are generated by collapsing sequence reads. Id. at 11 (citing Ex. 1001, 4:45–47, 20:50–22:25, 23:29–57, 24:46–48, claim 1, claim 6). In the Decision to Institute, we agreed with Petitioner that “[t]he claims of the ’951 patent as well as the specification make clear that a ‘sequence read’ is different and distinct from a ‘consensus sequence.’” DI 7 (quoting Pet. 11). Patent Owner does not dispute Petitioner’s assertion. PO Resp. 12. Based on the complete record, we see no reason to change our determination of the scope of the term “sequence reads.”” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed board ownDecided for petitioner
“We disagree with Patent Owner’s proposed construction of the terms “paired sequence reads” and “unpaired sequence reads.” Even though the ’951 patent Specification discloses grouping sequence reads “sharing a unique set of SMI tags” into paired families,4 “[t]he written description part of the specification itself does not delimit the right to exclude. That is the function and purpose of claims.” Phillips, 415 F.3d at 1312 (“[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.”). Here, claim 1 explicitly defines the terms “paired sequence reads” and “unpaired sequence reads.” Indeed, in the context of paired versus unpaired sequence reads, claim 1 specifies that the complementarity is related to the “original parent polynucleotide molecule,” and not the duplex tags. For example, claim 1 recites that “each unpaired read represents a first tagged strand having no second differently tagged complementary strand derived from an original parent polynucleotide molecule represented among said sequence reads in said set of sequence reads.” Ex. 1001, 37:50–55 (emphasis added). Thus, the plain claim language contradicts Patent Owner’s argument” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateDecided for petitioner
“Claim 1 defines the terms “paired sequence reads” and “unpaired sequence reads” based on the complementarity of the target sequence strands derived from the “original parent polynucleotide molecule.” Ex. 1001, 37:46–55. As explained above, we reject Patent Owner’s contention that a sequence read is considered unpaired solely based on the complementarity of the SMI tags. See supra Section II.C.2. Due to the “errors introduced during sample preparation and sequencing” (Ex. 1029 ¶ 5), there are four outcomes when determining the complementarity of the sequence reads of two strands of SMI-linked target sequence: (1) the first SMI tag and the first strand target sequence are complementary to the second SMI tag and the second strand target sequence, respectively; (2) the first SMI tag is complementary to the second SMI tag but the first strand target sequence is not complementary to the second strand target sequence; (3) the first SMI tag is not complementary to the second SMI tag but the first strand target sequence is complementary to the second strand target sequence; and (4) the first SMI tag is not complementary to the second SMI tag, and the first strand target sequence is not complementary to the second strand target sequence. It is undisputed that Schmitt groups sequence reads into paired families based on the SMI tags, and Schmitt only considers sequences in which “information from both DNA strands was in perfect agreement.” Ex. 1029 ¶¶ 14, 96; PO Resp. 18. Thus, among the four outcomes, only scenario (1), in which both the SMI tags and the target sequences are complementary, represents a “paired sequence read,” which claim 1 defines as corresponding to “sequence reads generated from a first tagged strand and a second differently tagged complementary strand derived from an original parent polynucleotide molecule.” Ex. 1001, 37:46–50. Contrary to Patent Owner’s argument (see PO Resp. 26), in Schmitt,” slip op. at 18
Patent outcomesUS 10,752,951 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,752,951 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00566 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Owner and its experts proposed claim construction of “effectively treating” as meaning “noninferior,” “statistically noninferior,” or “comparable.” Pet. Reply 4. Petitioner asserts that Patent Owner, and its expert, Dr. Do, advance the proposed construction of “effectively treating, ” with no explanation for what that means, or how it comports with the challenged dependent claims that recite visual acuity limitations ranging from losing less than 15 letters to gaining more than 15 letters. Id. at 4–5.” slip op. at 32
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00533 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the other grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Id. at 18. The similar language of the challenged claims of the ’601 patent, and our reasoning in the related -00881 Decision, compel the same conclusion here, i.e., that the preamble is limiting upon the claims.” slip op. at 43
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
Patent outcomesUS 10,888,601 unpatentableClaim construction§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2022-01226 · APJ John G New · IPR · Final written decision
Claims 1–9, 34–39, 41–43, and 45 are unpatentable as anticipated by Dixon; the Board did not reach the remaining grounds.
RulingsFinal written decision- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“inter partes review are anticipated by Dixon and therefore unpatentable (Ground 1). Because we reach this conclusion, we do not reach Petitioner’s contentions that the claims are obvious on the basis of Ground 5. Nor does our analysis rely upon, or cite to, Exhibit 1058. We consequently dismiss as moot Patent Owner’s motion to exclude Exhibit 1058.” slip op. at 24
- ExcludeMotion to exclude, grantedMotion to exclude, deniedMixed
“challenged claims are thus anticipated, we do not reach the additional Grounds 2–7 proposed in the Petition. Furthermore, Petitioner’s Motion to Exclude Evidence is granted-in-part, denied-in-part and dismissed-in-part. Patent Owner’s Motion to Exclude Evidence is denied-in-part and dismissed-in-part.” slip op. at 92
Patent outcomesUS 10,888,601 unpatentable§ 102 anticipationcites PhillipsPatents in suitUS 10,888,601 - Mylan Pharmaceuticals Inc. v. Regeneron Pharmaceuticals, Inc.All claims unpatentablePTAB · Jan 9, 2024 · IPR2023-00532 · APJ John G New · IPR · Final written decision
Claims 1, 3–11, 13, 14, 16–24, and 26 are unpatentable as anticipated by Dixon; the Board did not reach Grounds 2–6.
RulingsFinal written decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. As an initial matter, we are not persuaded by Patent Owner’s reliance on Sanofi and Eli Lilly. See PO Resp. 9. In Sanofi, a non-precedential decision, the Federal Circuit held that the preamble to the claims at issue, reciting “[a] method of increasing survival comprising administering to a patient in need thereof” was limiting upon the claims, in conformance with the court’s prior decisions in Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1333 (Fed. Cir. 2003) and Rapoport v. Dement, 254 F.3d 1053 (Fed. Cir. 2001). Sanofi, 757 F. App’x at 992–93. Furthermore, the court held that, because the preamble was limiting, and recited a “method of increasing survival” the proposed claims would now clearly require “increasing survival.” Id. at 994. The preamble to claim 1 of the ’681 patent, however, recites no such “increase” with respect to efficacy, but merely recites “A method for treating an angiogenic eye disorder in a patient,” and the remainder of the claim requires no specific efficacy requirement. Nor does Eli Lilly support Patent Owner’s position. In Eli Lilly, the court upheld the Board’s conclusion that the preamble reciting “a method for treating headache in an individual” was limiting upon the claims. Eli Lilly, 8 F.4th at 1343. However, it noted, in upholding the Board’s conclusion, the Board also “found that while the claims encompass a clinical result, they do not require such a result.” Id. (emphasis added). We also find that the similar language of the preamble to challenged claim 1 of the ’681 patent, although encompassing clinical efficacy, does not require it, let alone a “high degree of efficacy.”” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“the preamble’s recitation of a “method for treating” requires a high level of efficacy. In the -00881 Decision, the Board rejected Patent Owner’s similar argument because it required improperly importing limitations into the claims. See Ex. 3001, 22. Specifically, the Board found that: [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 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. We find that, as in Eli Lilly, although the claims “encompass a clinical result, they do not require such a result.” Eli Lilly, 8 F.4th at 1343. We consequently reject” slip op. at 35
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“The terms “initial dose,” “secondary doses,” and “tertiary doses,” refer to the temporal sequence of administration of the VEGF antagonist Thus, the “initial dose” is the dose which is administered at the beginning of the treatment regimen (also referred to as the “baseline dose”) ; the “secondary doses” are the doses which are administered after the initial dose; and the “tertiary doses” are the doses which are administered after the secondary doses. The initial, secondary, and tertiary doses may all contain the same amount of dosing regimens, but will generally differ from one another in terms of frequency of administration. Ex. 1001, col. 3 ll. 34–44. Petitioner also notes that the Specification further explains that “the immediately preceding dose” means “in a sequence of multiple administrations, the dose of VEGF antagonist which is administered to a patient prior to the administration of the very next dose in the sequence with no intervening doses.” Pet. 24 (citing Ex. 1001, col. 3, ll. 54–59; Ex. 1002 ¶¶ 44–45). We adopt Petitioner’s proposed 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 that 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.” slip op. at 37
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“As Petitioner states, Patent Owner relies upon these Exhibits as objective secondary evidence of non-obviousness. See, e.g., PO Resp. 65– 69. However, and as we explain below, because we find that the challenged claims are anticipated by Dixon, we do not reach Patent Owner’s arguments that the claims are non-obvious (Grounds 4–6) or its contentions regarding secondary considerations of non-obviousness. See Cohesive Techs., Inc. v. Waters Corp., 543 F.3d 1351, 1364 (Fed. Cir. 2008) (holding that “secondary considerations are not an element of a claim of anticipation”). Consequently, we dismiss Petitioner’s motion to dismiss the Financial Documents as moot.” slip op. at 10
Patent outcomesUS 10,130,681 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,130,681
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