- 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 - PTAB · Jul 15, 2024 · IPR2023-00611 · APJ Georgianna W Braden · IPR · Adverse judgment
The Board granted Patent Owner’s request for adverse judgment after it disclaimed all challenged claims, terminating the proceeding and entering judgment against Patent Owner.
RulingsAdverse judgment- Adverse judgmentAdverse judgmentGranted
“Under 35 U.S.C. § 42.73(b), a party may request judgment against itself at any time during a proceeding. Also, under 37 C.F.R. § 42.73(b)(2), actions construed as a request for entry of adverse judgment include disclaimer of a claim such that the party has no remaining claim in the trial. Here, Patent Owner has not only disclaimed all of the challenged claims of the ’224 patent, such that no claim remains in this proceeding, but also expressly requests entry of adverse judgment. Therefore, under § 42.73(b), adverse judgment is appropriate. Accordingly, we grant Patent Owner’s requests and enter adverse judgment against Patent Owner pursuant to § 42.73(b), thus terminating this proceeding and cancelling the portion of the July 16, 2024 hearing that was allotted to this proceeding and the ’224 patent.” slip op. at 2
NonePatents in suitUS 10,197,224 - PTAB · Jun 24, 2024 · IPR2024-00313 · APJ Tawen Chang · IPR · Institution
The Board instituted review of claims 1–54 on all three obviousness grounds, finding a reasonable likelihood that at least one challenged claim is unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Real party in interest / privityNot reached
“Under our precedent, where there is no time bar or estoppel implication with respect to alleged unnamed real parties-in-interest, the Board need not address, for the purposes of institution, whether such parties should be so named. SharkNinja Operating LLC v. iRobot Corp., IPR2020- 00734, Paper 11, 18–20 (PTAB Oct. 6, 2020) (precedential) (“SharkNinja”). In this case, Patent Owner has not alleged that either Lin BioScience or Belite Bio is barred or estopped from this proceeding. Patent Owner suggests that “Belite Bio’s status as a publicly traded company with a vested interest in the outcome of this Petition, and the Petition’s failure to disclose Belite Bio as a [real party-in-interest,] raise concerns about its motivations.” Prelim. Resp. 75. However, Patent Owner has not pointed to any evidence tending to show beyond speculation that Petitioner purposefully omitted these parties to gain an unfair advantage. SharkNinja at 19. Accordingly, on this record, we will not consider whether Lin BioScience and Belite Bio must be named as real parties-in-interest and” slip op. at 3
- Skill levelSkill level petitioner adoptedDecided for petitioner
“would have had an advanced degree (e.g., Ph.D., M.D., M.S., or equivalent), in chemistry, biochemistry, pharmaceutical science, medicine, or a related field. This individual may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration. Moreover, skilled artisans would have had practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect, including the patents and publications discussed herein.” slip op. at 27
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“First, the Federal Circuit “has not hesitated to hold preambles limiting when they state an intended purpose for methods of using a compound.” Eli Lilly & Co. v. Teva Pharms. Int’l GmbH, 8 F.4th 1331, 1342 (Fed. Cir. 2021). And where, as here, the claims are directed to methods of using a compound for a specific purpose (i.e., treating a macular degeneration), and the method comprises a single step of administering that compound in an 30 effective amount, the Federal Circuit “[has] generally construed statements of intended purpose in such method claims as limiting.” Id. at 1340. Moreover, “[w]hen limitations in the body of the claim rely upon and derive antecedent basis from the preamble, then the preamble may act as a necessary component of the claimed invention.” Eaton Corp. v. Rockwell Int’l Corp., 323 F.3d 1332, 1339 (Fed. Cir. 2003); see also Eli Lilly & Co., 8 F.4th at 1341. In this case, claim 28 recites “[a] method of treating a macular degeneration, comprising administering an effective amount of a substituted C20-D1-3-retionoid to a patient in need thereof.” The preamble of “treating a macular degeneration” is necessary to understand the patients to whom the substituted C20-D1-3-retionoid should be administered; thus, it limits the claim. See Eli Lilly & Co., 8 F.4th at 1341–42 (citing Jansen v. Rexall Sundown, Inc., 342 F.3d 1329, 1332–33 (Fed. Cir. 2003)); Rapoport v. Dement, 254 F.3d 1053, 1059 (Fed. Cir. 2001) (holding the preamble to be limiting in a claim directed to “[a] method for treatment of sleep apneas comprising administration of a therapeutically effective amount of a [recited] compound . . . to a patient in need of such treatment,” because otherwise “the phrase ‘to a patient in need of such treatment’ would not have a proper antecedent basis”). Thus, we construe the preamble of claim 28 as limiting and give patentable weight to the phrase “method of treating a macular degeneration.” To the extent either party disagrees with our construction, the parties are welcome to further address this issue at trial.” slip op. at 30
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“The Petition points to Mata’s express suggestion of “‘[p]harmacologic inhibition of one or more steps in the A2E synthetic pathway’ as ‘an effective treatment strategy for other macular degenerations associated with lipofuscin accumulation.’” Pet. 31 (quoting Ex. 1010, 7159) (alteration in original). The Petition, again relying on Dr. Guengerich’s testimony, further explains Mata taught that deprotonation at C-20 of retinal — involving cleavage of a carbon-hydrogen bond — was “a pre-requisite for undesirable A2E formation,” and that a skilled artisan “would have recognized that this deprotonation likely was a rate-limiting step in A2E formation” such that slowing the deprotonation “would slow A2E formation,” i.e., lower the production of a toxic reaction product. Id. at 41 (citing Ex. 1002 ¶¶ 259– 260). Moreover, although the evidence of record may suggest that, at least as of 1999, “there are no drugs on the market that contain deuterium in the molecule,” Ex. 1046, 85, left col., Petitioner has also provided evidence, for instance in the form of Dr. Calman’s testimony, that “there was significant interest in making deuterated versions of known therapeutics in order to slow rates of undesirable reactions.” Ex. 1004 ¶ 96; see also Pet. 15 (stating that “it was known before 2007 to . . . use deuterium to slow undesirable reaction”) (citing Ex. 1002 ¶ 123; Ex. 1004 ¶¶ 96–102). 18 Kushner et al., Pharmacological Uses and Perspectives of Heavy Water and Deuterated Compounds, 77 CANADIAN J. PHYSIOLOGY & PHARMACOLOGY 79 (1999) (Ex. 1046, “Kushner”). 37 Finally, we note that claim 1, at least, is not directed to a method of treating any particular disease, but only a method of retarding the accumulation of particular compounds (i.e., lipofuscin pigments). We are persuaded, at least at this stage of the proceeding and based on the present record, that Petitioner has shown sufficiently that a skilled artisan would have had a reason to use C20-deuterated vitamin-A in the manner suggested in the Petition, with a reasonable expectation of success, based on alleged similarities between the use of deuterated compounds in the claimed method and use of such compounds to, e.g., lower production of toxic metabolites.” slip op. at 37
Claim construction§ 103 obviousnessDiscretionary denialcites Phillips · KSR · Graham - PTAB · Jun 24, 2024 · IPR2024-00312 · APJ Tina E Hulse · IPR · Institution
The Board instituted review of claims 1–28 on all 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 Petition, 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 the challenged claims of the ’432 Patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“of the invention (“POSA”) would have had “an advanced degree (e.g., Ph.D., M.D., M.S., or equivalent), in chemistry, biochemistry, pharmaceutical science, medicine, or a related field.” Pet. 7. Petitioner further contends that that POSA “may have worked in consultation with a team including, e.g., a practicing physician who diagnoses and treats macular degeneration” and would have had “practical knowledge about biological studies, pharmaceutical formulation, and the deuterium isotope effect.” Id. (citing Ex. 1002 ¶¶ 47–50; Ex. 1004 ¶¶ 38–40). 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” slip op. at 6
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“construction standard that would be used to construe claims in a civil action under 35 U.S.C. § 282(b). See 37 C.F.R. § 100(b). Under that standard, claim terms “are generally given their ordinary and customary meaning” as understood by a person of ordinary skill in the art at the time of the invention. Phillips v. AWH Corp., 415 F.3d 1303, 1312–13 (Fed. Cir. 2005) (en banc). Petitioner states that no construction is necessary for purposes of this decision. Petitioner also notes that the Specification confirms that the claim term “pharmaceutically acceptable carrier” “encompasses a wide variety of conventional carriers, including water, saline solution, corn oil, and starch.” Pet. 22 (citing Ex. 1001, 15:9–27; Ex. 1002 ¶¶ 26–30; Ex. 1004 ¶ 27). At this stage of the proceeding, we agree with Petitioner that no construction of any claim terms is necessary for purposes of our 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 7
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“Petitioner asserts that a POSA would have had a reason to combine Bergen and Furr with a reasonable expectation of success. Pet. 31–32. Specifically, Petitioner argues that a POSA would have understood by September 2007 that making use of Bergen’s deuterated compounds for biological studies would have involved formulation in a pharmaceutically acceptable carrier, as corroborated by Furr’s success in doing so. Id. (citing Ex. 1002 ¶¶ 225–226). Moreover, Petitioner asserts that a POSA would have had a reasonable expectation of success in making a pharmaceutical composition comprising the claimed C20-D3-retinol acetate and a pharmaceutically acceptable carrier because Bergen had already synthesized the retinoid and Furr had already formulated deuterated vitamin A retinoids in a pharmaceutical composition comprising a pharmaceutically acceptable carrier. Pet. 36–37 (citing Ex. 1002 ¶ 235). Accordingly, at this stage of the proceeding, having considered the arguments and evidence set forth in the Petition, we find Petitioner has shown a reasonable likelihood of prevailing on its assertion that Claims 1–4 would have been obvious in light of the combination of Bergen and Furr. See Pet. 24–26, 30–38; Ex. 1006, Abstract, 15–19; Ex. 1007, Abstract, 714; Ex. 1002 ¶¶ 191–216, 223–238; Ex. 1004 ¶¶ 127–144.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,486,432 - PTAB · Apr 1, 2024 · IPR2023-01431 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR on claims 1–28 and all asserted grounds, finding a reasonable likelihood of success on at least one challenged claim.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“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). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute an inter partes review of all challenged claims based on all grounds raised in the Petition. See 37 C.F.R. § 42.108(a) (“When instituting . . . review, the Board will authorize the review to proceed on all of the challenged claims and on all grounds of unpatentability asserted for each claim.”); PGS Geophysical AS v. Iancu, 891 F.3d 1354, 1359–60 (Fed. Cir. 2018) (interpreting the relevant statutory provisions to require “a simple yes or no institution choice respecting a petition, embracing all challenges included in the petition”).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Level of Ordinary Skill in the Art In determining the level of skill in the art, we consider the “type of problems encountered in the art, [the] prior art solutions to those problems, [the] rapidity with which innovations are made, [the] sophistication of the technology, and [the] educational level of active workers in the field.” Custom Accessories, Inc. v. Jeffrey-Allan Indus. Inc., 807 F.2d 955, 962 (Fed. Cir. 1986); Orthopedic Equip. Co. v. United States, 702 F.2d 1005, 1011 (Fed. Cir. 1983). Petitioner asserts that a person of ordinary skill in the art would have had “(1) a degree in Mechanical Engineering or equivalent technical background and (2) at least two years experience designing or implanting spinal implants with threaded connections. More education could substitute for less experience, and vice versa.” Pet. 6–7 (citing Ex. 1003 ¶¶ 36–42). Patent Owner does not dispute Petitioner’s definition of the person of ordinary skill. See generally Prelim. Resp. Because Petitioner’s proposed definition is unopposed and appears consistent with the Specification and art of record, we apply it here.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionNo construction neededDecided for petitioner
“We disagree with Patent Owner’s allegation because Petitioner sufficiently explains the plain meaning of the terms. See Pet. 8–16. On this record, and for purposes of this Decision, we adopt Petitioner’s proposed constructions of these terms and apply them to our analysis below. 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 other claim term.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“concave and convex surface. The leading surface in claim 1 only needs to have a curvate surface. Based on the current record, Petitioner has provided a sufficient rationale why one of ordinary skill in the art would have arrived at a structure containing a leading face that has a curvate surface based on the combination of the ’477 Publication and Boschert. Specifically, Petitioner contends that because the closure is intended to be used in a surgical environment the ordinary artisan would have been motivated to eliminate any sharp edges that could pierce a surgeon’s glove. Pet. 23 (citing Ex. 1003 ¶¶ 202–204); see also Ex. 1003 ¶ 64 (“By truncating a thread start a POSA was able to avoid very thin portions of the tapered thread, which are sharp and could cut a surgeon’s glove, could be easily damaged, and could lead to cross threading.”). Petitioner’s declarant, Dr. McMillin, asserts that “a POSA would have had an expectation of success with this combination, at least because multi-start threads and curvate[10] leading faces, and techniques for manufacturing them, were well known in the art.” Pet. 22; see Ex. 1003 ¶ 232 (citing ¶¶ 48–79 of the McMillin declaration). In addition, Petitioner asserts that “a 10 The ’641 patent recites that “[e]ach of the start structures . . . includes a leading face having at least one radius of curvature. In one embodiment, the at least on one curvate surface is both concave and convex.” Ex. 1001, 7:51–55. We interpret “curvate” leading face to be either a concave or convex structure unless the language of the claim specifies that the structure contains both, such as for example recited in claims 9–13 and 26. Id. at 13:24–42, 16:1–3. combination of familiar elements using known methods would yield predictable and successful results.” Pet. 23 (citing Ex. 1003 ¶ 204). Specifically, Petitioner contends that the “benefits of double-lead threads, including balancing insertion forces and increasing insertion speed” were known. Pet. 22–23 (citing Ex. 1003 ¶¶ 202–204). The use of truncated thread starts was also known for further easing thread insertion, reducing thread deformation, and reducing sharp edges. Pet. 23 (citing Ex. 1003 ¶¶ 202–204).” slip op. at 42
Claim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,548,641 - PTAB · Jan 16, 2024 · IPR2023-01064 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR on claims 1–50 under all petition grounds, finding a reasonable likelihood of unpatentability, including anticipation by COLCOT protocol for claims 27, 29–36, and 39.
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 arguments and evidence presented in the parties’ briefs, 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 1–50 of the ’063 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“For these reasons, we determine that all the references that Petitioner asserts in the Petition (i.e., Bouabdallaoui, COLCOT protocol, Nidorf, ESC guidelines, and COLCRYS) are the same or substantially the same art that were previously presented to the Office. Accordingly, we determine that the first part of the Advanced Bionics framework is satisfied. Part 2: Whether the Petitioner Demonstrates Material Error Next, we consider “whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” Advanced Bionics, 8. Patent Owner argues that “[t]he Examiner also did not make any material error in evaluating the prior art, or even determining the closest prior art.” Prelim. Resp. 9. Patent Owner contends that “Examiner did not err in evaluating the COLCOT Protocol as neither version of the protocol discloses key limitations of the claims that eventually issued, including the claim limitation that early intervention with colchicine reduces the risk of stroke.” Id. at 11–12. During prosecution, Examiner identified Hennessy as being the closest prior art. See Ex. 1002, 348–349, 399. Hennessy describes treating a patient population that has had a recent myocardial infarction (MI). The patient population described in Hennessy received 0.5 mg of colchicine once a day and describes the population as adults 18 years or older that have had a MI event within the prior 7 days. See Ex. 1028, 2 (“[a]dult (>18 years old) patients were eligible for enrolment if they had sustained a type 1 acute MI (by the 3rd universal definition[]) within the prior 7 days.”). Hennessy teaches that the “[r]eadmission rates [for their patient population] were significantly lower in the colchicine treated patients but [recognizes that] the numbers are small.” Ex. 1028, 6. This comports with the “Low Dose Colchicine (LoDoCo) study, treatment with 0.5 mg colchicine per day in addition to standard treatment in patients with stable [coronary heart disease] CHD significantly reduced the risk of developing an acute coronary syndrome, an out of hospital cardiac arrest or non-cardioembolic stroke.” Ex. 1028, 7. In the notice of allowability, Examiner asserts that the closest prior art also appears to be [Hennessy (Ex. 1028)] American Heart Journal (September 2019), Vol. 215, pp. 62-69, outlined above. The reference does not teach, show, suggest or make obvious the instant method of reducing the risk of a stroke in a patient having had a myocardial infarction by the administration of daily low dose colchicine within about 30 days of the myocardial infarction.” slip op. at 23
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble not limitingDecided for petitioner
“If the body of the claim sets out the complete invention, and the preamble is not necessary to give “life, meaning and vitality” to the claim, “then the preamble is of no significance to claim construction because it cannot be said to constitute or explain a claim limitation.” Pitney Bowes, Inc. v. Hewlett–Packard Co., 182 F.3d 1298, 1305 (Fed.Cir.1999). Here, the body of claim 27 recites “initiating the administration of colchicine at a daily low dose to the patient within about 30 days of an MI.” Ex. 1001, 42:34–36. The claim body, therefore, identifies the patient population that is to be treated with the low dose colchicine and the time frame in which to initiate treatment. The preamble, therefore, does not narrow the patient population nor change the way colchicine is administered – all that is required by the claim is that colchicine is administered to patients that have suffered a MI within a particular time period after the MI event. The step of the method is preformed the same way whether or not the patient experiences a reduction in the risk of stroke. See, e.g., In re Hirao, 535 F.2d 67, 70 (CCPA 1976) (“the preamble merely recites the purpose of the process; the remainder of the claim . . . does not depend on the preamble for completeness, and the process steps are able to stand alone.”); see Pet. 23 (“‘reducing the risk of a stroke’ does ‘not result in a manipulative difference in the steps of the claim’ and is [therefore] non-limiting.” (citing Bristol-Myers, 246 F.3d at 1375–76; Ex. 1049 ¶¶ 104–108)). We agree with Petitioner that Examiner’s claim interpretation is in error. Here, the body of claim 27 defines a structurally complete invention by identifying the target population as any patient that has had a myocardial infarction (MI) and the onset of treatment using 0.5 mg colchicine within a 30-day time window. See Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (“[W]here a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation.”); IMS Tech., Inc. v. Haas Automation, Inc., 206 F.3d 1422, 1434 (Fed. Cir. 2000) (“If the preamble adds no limitations to those in the body of the claim, the preamble is not itself a claim limitation and is irrelevant to proper construction of the claim.”). The recitation of “reducing the risk of a stroke” in the preamble, therefore, does not result in a difference in the way colchicine is administered to the identified patient population. See Pet. 23. We have reviewed the parties’ contentions, and determine at this stage of the proceedings that Petitioner has provided a requisite showing that the body of claim 27 describes a structurally complete invention. The preamble of claim 27, therefore, is not limiting because it simply expresses the intended result of the positively recited method step within the body of the claim. See Pet. 23.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“The dispute between the parties is directed to the third wherein clause “wherein the patient is at a lower risk of a cardiovascular event, relative to a patient not being administered colchicine.” This third wherein clause simply asks for a comparison between patients receiving colchicine with a similar situated patient population not receiving the colchicine treatment. “An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.” See Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003). Although “[s]uch statements often . . . appear in the claim’s preamble,” a statement of intended use or purpose can appear elsewhere in a claim. In re Stencel, 828 F.2d 751, 754 (Fed. Cir. 1987). We have reviewed the parties’ contentions, and determine at this stage of the proceedings that Petitioner has provided a requisite showing that this third clause merely describes the benefit of the administration of colchicine to the identified patient population. We are not persuaded by Patent Owner’s contention that this clause is material to how the method is performed. This “wherein clause,” therefore, merely defines the result of the positively recited method steps. See Pet. 23; see, e.g., Minton, 336 F.3d at 1381 (a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.”).” slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSRPatents in suitUS 11,400,063 - Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00050 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 17, 19, 20, and 22–29 on all petitioned grounds, finding a reasonable likelihood of success and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“II. STANDARD OF REVIEW A party requesting rehearing has the burden to show a decision should be modified by specifically identifying all matters the party believes were misapprehended or overlooked, and the place where each matter was 1 US 7,888,328 B2, issued Feb. 15, 2011 (Ex. 1029, “Bodor”). 2 Rice et al., Cladribine and progressive MS: Clinical and MRI outcomes of a multicenter controlled trial, NEUROLOGY, 54(5):1145–1155 (2000) (Ex. 1008, “Rice”). addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315–16 (Fed. Cir. 2000).” slip op. at 2
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Having reconsidered the record before us, we are persuaded that Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating relapsing-remitting multiple sclerosis or early secondary progressive multiple sclerosis by administering cladribine to a patient in the same claimed total amounts for both induction and the maintenance period to support Petitioner’s challenge to claim 17.” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDecided for petitioner
“Having considered the record, we agree with Petitioner that the Office erred in its evaluation of the cited art (now asserted) as required by Advanced Bionics. Advanced Bionics cautions that “[i]f reasonable minds can disagree regarding the purported treatment of the art or arguments, it cannot be said that the Office erred in a manner material to patentability.” Paper 6, 9. Here, both Examiner and Patent Owner interpret Bodor to disclose administering the same dose of cladribine in both the induction and maintenance phase. Claim 17 encompasses administering the same dose of cladribine – 1.7 mg/kg – in both the induction and maintenance phase. By interpreting claim 17 as requiring a maintenance dose that is lower than the induction dose, we agree with Petitioner that Examiner misapprehended the scope of claim 17. We, therefore, decline to exercise our discretion to deny institution under § 325(d).” slip op. at 12
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“the claims. “All that is required is that the total dose reach a stated level in each period, and Bodor discloses a total dose within that range for what a person of ordinary skill in the art would understand to be an average patient.” Req. Reh’g 14 (emphasis omitted) (citing Pet. 42–50). Dr. Greenberg testifies that Bodor’s total dosage of cladribine ranges from 100–140 mg in the two-month treatment period. Ex. 1005 ¶ 104. The issue, as presented by Petitioner, is that the ’903 patent claims simply use a different way of reciting a total dose of cladribine administered during the treatment phase when compared to the methods and dosage taught by Bodor. We agree with Petitioner that the method and cladribine dosage in the ’903 patent claims overlap with the method and dosage taught by Bodor. To determine the total amount of cladribine administered as claimed in the ’903 patent requires knowledge of the weight of the patient. In the Petition, Petitioner relied on a patient weighing 70 kilograms (≈ 154 pounds) to be an acceptable average human weight as understood in the medical community. Pet. 32 (citing Ex. 1005 ¶ 105). Patients, however, come in all shapes and sizes as recognized in the ’903 patent disclosure and further supported by Dr. Greenberg’s testimony and referenced exhibit. See Ex. 1001, 3:8 (“patients of about 52 and about 75 kilos); see also Ex. 1005 ¶ 106 (“the average weight of individuals in the United States is higher than the global average, with an overall average weight (men and women combined) of roughly 177 lbs in 2002.”); Ex. 1030 (“the average weight for men aged 20-74 years rose dramatically from 166.3 pounds in 1960 to 191 pounds in 2002, while the average weight for women the same age increased from 140.2 pounds in 1960 to 164.3 pounds in 2002.”). To arrive at the average weight of 177 pounds means that there are patients in the population that are above and below that average. See generally Ex. 1030.” slip op. at 6
§ 103 obviousnessDiscretionary denialPatents in suitUS 8,377,903 - Twi Pharmaceuticals, Inc. v. Merck Serono SARehearing grantedPTAB · Dec 20, 2023 · IPR2023-00049 · APJ Ulrike W Jenks · IPR · Rehearing
The Board granted rehearing and instituted IPR on claims 36, 38, 39, and 41–48 on all petition grounds, finding a reasonable likelihood of unpatentability and declining § 325(d) denial.
RulingsRehearing decision- RehearingRehearing, grantedGranted
“addressed previously in a motion, opposition, or a reply. 37 C.F.R. § 42.71(d). When rehearing a decision on institution, we review the decision for an abuse of discretion. 37 C.F.R. § 42.71(c). An abuse of discretion may arise if a decision is based on an erroneous interpretation of law, if a factual finding is not supported by substantial evidence, or if the decision represents an unreasonable judgment in weighing relevant factors. Star Fruits S.N.C. v. United States, 393 F.3d 1277, 1281 (Fed. Cir. 2005); Arnold P’ship v. Dudas, 362 F.3d 1338, 1340 (Fed. Cir. 2004); In re Gartside, 203 F.3d 1305, 1315– 16 (Fed. Cir. 2000).” slip op. at 3
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Petitioner has met its burden under 37 C.F.R. §§ 42.71(c) and (d) and presented sufficient evidence to support a reasonable likelihood that Bodor either alone or in combination with Rice renders obvious the method of treating multiple sclerosis by administering cladribine to a patient in the same claimed total amount for both the induction period and maintenance period to support Petitioner’s challenge to claim 36.” slip op. at 4
- Obviousness (§103) › Motivation to combine / reasonable expectation of successInstituted
“To summarize, Bodor teaches two treatment regimens for treating multiple sclerosis with a cladribine-cyclodextrin complex. 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex . . . would be administered [orally] once per day for a period of five to seven days in the first month, repeated for another period of five to seven days in the second month, followed by ten months of no treatment. Alternatively the patient would be treated with 10 mg of cladribine in the instant complex cladribine-cyclodextrin complex in the instant dosage form once per day for a period of five to seven days per month for a total of six months, followed by eighteen months of no treatment. Ex. 1029, 13:20–30. Petitioner acknowledges that Bodor does not explicitly suggest applying the same regimen again after a cladribine-free period but finds that repeating the treatment protocol is reasonably inferred. Pet. 33 (citing Ex. 1005 ¶¶ 109, 111–113), see id. at 48 (citing Ex. 1005 ¶¶ 168–170); Ex. 1029, 18:45–19:3, 20:1–20 (Examples 4 and 5 each describing that treatment days are separated by cladribine-free days); Ex. 1003 at 389; Ex. 1004 at 141. Bodor also teaches that the dosing regimen can be tailored to suit the needs of the patient. Specifically, Bodor teaches that “one of skill will appreciate that the therapeutically effective amount of cladribine administered . . . may be lowered or increased by fine tuning and/or by administering cladribine . . . with another active ingredient.” Ex. 1029, 13:31–35, see also id. 13:37–40 (“Therapeutically effective amounts may be easily determined . . . empirically by starting at relatively low amounts and by step-wise increasing with concurrent evaluation of beneficial effect.”). Based on these disclosures, we agree with Petitioner that it would be reasonable to infer from Bodor’s teachings in conjunction with the knowledge of the ordinary artisan that the cladribine dosing protocol in Bodor is repeated. Pet. 33; see also Ex. 1005 ¶¶ 109–123, 119 (“common practice in the industry when prescribing a second round of an” slip op. at 4
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDecided for petitioner
“(1) [determining] whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of [the] first part of the framework is satisfied, [determining] whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.” slip op. at 9
§ 103 obviousnessDiscretionary denialPatents in suitUS 7,713,947 - PTAB · Dec 1, 2023 · PGR2021-00088 · APJ John G New · PGR · Remand
The Board instituted PGR on claims 1–25 on all five grounds, finding the threshold met based on likely anticipation, obviousness, and lack of written-description support.
RulingsRemand decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” In conformance with the Director’s Decision, and for the reasons we explain herein, we institute post-grant review of the ’908 patent.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for petitioner
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001, col.42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 10
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art would typically possess a medical degree or a Ph.D. in a field related to endocrinology, and would have knowledge of hormone regulation and disorders, as well as knowledge of the treatment regimens employed to treat such disorders. Pet. 60 (citing Ex. 1005 ¶ 34). Petitioner argues that such a person of ordinary skill would also have at least three years of experience conducting research concerning endocrine disorders, including CAH or other adrenal disorders. Id. Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response. For the purposes of this Decision, because we find Petitioner’s definition to be consistent with the demonstrable level of skill in the art (see, e.g., Exs. 1009, 1025, 2003, 2004,” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“A claim is unpatentable as anticipated under 35 U.S.C. § 102 only when “every element and limitation of the claim was previously described in a single prior art reference, either expressly or inherently, so as to place a person of ordinary skill in possession of the invention.” Sanofi-Synthelabo v. Apotex, Inc., 550 F.3d 1075, 1082 (Fed. Cir. 2008). A reference may inherently anticipate if a claim limitation that is not expressly disclosed “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010). Thus, the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question.” Agilent Technologies, Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (emphasis added).” slip op. at 23
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosureDiscretionary denialcites PhillipsPatents in suitUS 10,849,908 - PTAB · Oct 24, 2023 · IPR2023-00875 · APJ Zhenyu Yang · IPR · Institution
The Board instituted inter partes review of claims 1 and 2 on all asserted grounds, finding a reasonable likelihood that the ’696 patent anticipates each claim.
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) (2018). For the reasons provided below, we determine Petitioner has satisfied the threshold requirement set forth in 35 U.S.C. § 314(a). Accordingly, we institute inter partes review of all challenged claims based on all grounds raised in the Petition.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“II. ANALYSIS Claim Construction In an inter partes review, we construe a claim term “using the same claim construction standard that would be used to construe the claim in a civil action under 35 U.S.C. [§] 282(b).” 37 C.F.R. § 42.100(b) (2020). Under that standard, the words of a claim “are generally given their ordinary and customary meaning,” which is “the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention,” slip op. at 4
- Skill levelSkill level petitioner adoptedDecided for petitioner
“the ’707 patent, an ordinarily skilled artisan would have had a Ph.D. (or equivalent degree) in organic or medicinal chemistry, and two to three years of post-graduate work experience in medicinal chemistry, synthetic organic chemistry, and nucleic acid chemistry, including the development of oligonucleotide therapeutics, diagnostics, or building blocks. Pet. 16 (citing Ex. 1003 ¶ 20). Alternatively, Petitioner proposes that an individual holding a Bachelor’s or Master’s degree in organic chemistry or medicinal chemistry, who had extensive work experience in these fields, and who had gained a thorough understanding of the development of nucleic acid-based materials, would also have qualified as an ordinarily skilled artisan. Id. For purposes of this Decision, we adopt Petitioner’s definition of the level of ordinary skill because it is consistent with the prior art’s demonstration of the level of ordinary skill at the relevant time. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (holding that “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)).” slip op. at 5
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“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”). Claim 1 is directed to a genus of compounds. Petitioner asserts that the ’696 patent discloses a species of claim 1 in Example 3 as 2´-Trifluoroacetamido-3´-O-(4,4´-dimethoxytrityl)-2´-deoxyuridine-5´-O- (N,N´-diisopropyl)-β-cyanoethyl-phosphoramidite. Pet. 21–29 (citing Ex. 1003 ¶¶ 74–88). Petitioner provides the following comparison:” slip op. at 6
Claim construction§ 102 anticipationcites PhillipsPatents in suitUS 8,309,707
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.