- Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01478 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–16 are unpatentable: claims 1–14 and 16 as anticipated by Kaiser, and claims 1–16 as obvious under the asserted grounds.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Considering argument and evidence of record, we define a person of ordinary skill in the art as a member of a multidisciplinary team consisting of at least (1) a person (“Engineer POSA”) with either (a) 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 (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualifies him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is also an Engineering POSA, or is receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily” slip op. at 33
- Expert testimonyPetitioner expert creditedPatent owner expert discountedDecided for petitioner
“work experience with catheters or similar medical devices, or (b) a Ph.D. in mechanical or biomedical engineering, or in a similar field; working with (2) a person with an M.D. or analogous degree and five or more years of work experience in interventional cardiology, hemodynamics or a similar discipline (“Clinician POSA”); or an Engineer POSA receiving assistance from a Clinician POSA; or a Clinician POSA receiving assistance from an Engineering POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. With respect to the parties’ proffered declarants, the record before us demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualifies him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is also an Engineering POSA, or is receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily” slip op. at 34
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Accordingly, we agree with Petitioner that the ’871 Patent “teaches activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at page 11 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 30–31 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 46
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“It is Patent Owner’s burden in this proceeding to overcome the presumption that Kaiser is enabled. See, e.g., Amgen, 314 F.3d at 1354–55. This requirement is not excused in IPR proceedings. See Apple Inc. v. Corephotonics, Ltd., 861 F. App’x 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). Considering all the argument and evidence of record, we find that Patent Owner has not overcome the presumption with respect to Kaiser for the reasons set forth on pages 16–19 of Petitioner’s Reply, which we adopt in full and briefly address below. With respect to enablement of Kaiser’s device, we find persuasive Dr. Day’s testimony that no substantial modification of Kaiser’s IVC embodiment would be necessary to deploy it in the SVC. See Ex. 2006, 218:6–220:13; Ex. 1002 ¶ 109 (annotated version of Kaiser’s Fig. 2 showing that the lead/catheter passes through the SVC to reach the IVC). With respect to enablement of Kaiser’s method in the SVC, Dr. Brecker’s analysis also falls short of overcoming the presumption that Kaiser is enabling. Dr. Brecker asserts, for example, that Kaiser also does not describe what pressure differential would need to be created through the use of a flow impedance device in the SVC in order to successfully perform its method using such a device in the SVC, and does not provide any exemplary pressure recordings demonstrating that its method can be successfully performed using a device in the SVC. Ex. 2005 ¶ 110. We find persuasive, however, Petitioner’s argument that Kaiser discloses representative pressure differentials, including an effective pressure differential for occluding the IVC (3 mmHg), which Dr. Brecker could not say would be ineffective for the SVC— but which a Clinician POSA could test, along with other pressure differentials to see what results they produced if the SVC were occluded. Reply 16–17 (citing Ex. 1007, 14:22, Fig. 4 (table showing exemplary hemodynamic data obtained by creating a pressure differential in the inferior vena cava); Ex. 1032, 190:23– 192:3 (Dr. Brecker’s testimony that a Clinician POSA would know how to measure the pressures such as those disclosed in Figure 4), 193:14–194:17 (at least some information could be derived from animal testing)). At least because Patent Owner has not argued (let alone demonstrated) that such testing would be undue, Patent Owner has not satisfied its burden to show non-enablement.” slip op. at 50
Patent outcomesUS 10,653,871 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,653,871 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Apr 4, 2023 · IPR2021-01477 · APJ Robert A Pollock · IPR · Final written decision
Claims 1–16 are unpatentable: claims 1 and 3–16 are anticipated by Gelfand, and claims 1–16 are also obvious over the listed combinations.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner’s contention that the hypothetical person of ordinary skill in the art may not comprise a multidisciplinary team, but may be “a member” of that same multidisciplinary team, strikes us as a distinction without a difference. See id. Thus, although we disagree with Patent Owner’s analysis, we rephrase part one of our provisionally adopted definition to reference “a member of a multidisciplinary team.”” slip op. at 31
- Expert testimonyPatent owner expert discountedDecided for patent owner
“demonstrates that Dr. Day and Dr. Garcia are individually well-qualified to opine as to the perspective of an Engineer POSA and a Clinician POSA, respectively; and collectively qualified to opine from the perspective of one of ordinary skill in the art as to all aspects of the claimed invention and relevant prior art. See, e.g., Ex. 1002 ¶¶ 3–15; Ex. 1003 (Dr. Day’s curriculum vitae); Ex. 1004 ¶¶ 4–15; Ex. 1005 (Dr. Garcia’s curriculum vitae). With respect to Patent Owner’s declarant, Dr. Brecker’s experience and credentials as an interventional cardiologist amply qualify him to speak to the perspective of one of ordinary skill in the art as a Clinician POSA. See Ex. 2005 ¶¶ 4–15, Exhibit A. But because there is no evidence that he is an Engineering POSA, or receiving assistance from an Engineering POSA, we accord less weight to his opinions as they relate to the province of an Engineer POSA. See Kyocera Senco Indus. Tools Inc. v. ITC, 22 F.4th 1369, 1377–78 (Fed. Cir. 2022) (holding that “to be qualified to offer expert testimony on issues from the vantage point of an ordinarily skilled artisan in a patent case, an expert must at minimum possess ordinary skill in the art”). C.” slip op. at 34
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“Accordingly, we agree with Petitioner that the ’871 Patent “teaches activating and adjusting restrictors based on pressure readings to achieve and then maintain target venous blood pressures.” Pet. Sup. Reply 2 (citing Ex. 1001, 15:33–36, 15:36–16:42, Fig. 11A). Implicit in the above analysis, and as expressly discussed at pages 11–12 of the Reply, which we adopt, we understand “maintaining” to refer to keeping intravascular pressure at a target level or range, which may be lower than a normal body pressure. Cf. POR 30–31 (Patent Owner’s argument that “maintaining” is limited to non-hypotensive (i.e., substantially normal) systemic pressure). In view of the above, we adopt and apply Petitioner’s proposed construction of “maintaining intravascular pressure,” to mean “maintaining pressure within blood vessels or a blood vessel.” Our construction is not limited to maintaining a physiologically normal systemic pressure, and encompasses maintaining regions of low pressure in portions of the venous system between occlusion devices, or in the vicinity of one or more occlusion devices. We need not further define the meets and bounds of this term to resolve any dispute between the parties or decide the merits of Petitioner’s challenge. D.” slip op. at 46
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“F.3d at 1354–55. This requirement is not excused in IPR proceedings. See Apple Inc. v. Corephotonics, Ltd., 861 F. App’x 443, 450 (Fed. Cir. 2021) (“[R]egardless of the forum, prior art patents and publications enjoy a presumption of enablement, and the patentee/applicant has the burden to prove nonenablement for such prior art.”). Considering all the argument and evidence of record, we find that Patent Owner has not overcome the presumption with respect to Gelfand for at least the reasons set forth on pages 12–24 of Petitioner’s Reply, which we adopt in full and briefly summarize below.” slip op. at 51
Patent outcomesUS 10,653,871 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,653,871 - Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution deniedPTAB · Mar 23, 2023 · IPR2022-01527 · APJ David Cotta · IPR · Institution
Institution was denied for claims 1, 2, 4, 5, 7, 8, 10, and 11 because the petition did not show a reasonable likelihood of success on any asserted anticipation or obviousness ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claims 1, 2, 4, 5, 7, 8, 10, and 11 of the ’554 patent.” slip op. at 2
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24 ,2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to provide” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentable
“a) Alleged express disclosure The evidence of record does not support Petitioner’s contention that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose what effect such treatment has on the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that “stimulation at IAF + 1 Hz triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 24. EEG power is, however, distinct from frequency. See e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses changing the frequency at which peak alpha power is observed.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached
“1. Claim 1 Petitioner relies on the same evidence discussed in connection with Grounds 1 and 2 to establish disclosure of the intrinsic frequency limitation. Pet. 39 (“For the reasons provided above in Grounds 1 and 2, both Klimesch and Jin disclose this element [the intrinsic frequency limitation] of claim 1. In particular, the recited movement is the natural, inherent consequence of applying a magnetic field to the human brain at or near the subject’s peak frequency in the alpha band”). We have already determined that this evidence is insufficient to support that Klimesch or Jin discloses the intrinsic frequency limitation. Accordingly, we determine that Petitioner has not established a reasonable likelihood that it will prevail in showing that the combination of Klimesch and Jin renders claim 1 obvious.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,480,554 - Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution deniedPTAB · Mar 23, 2023 · IPR2022-01550 · APJ Devon Zastrow Newman · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood that claim 39 was anticipated by Klimesch or Jin.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“review. 35 U.S.C. § 314(b) (2018); 37 C.F.R. § 42.4(a) (2019). An inter partes review may not be instituted “unless . . . the information presented in the petition . . . 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). Upon consideration of the Petition, the Preliminary Response, and the evidence of record, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 39 of the ’354 patent.” slip op. at 2
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“Claim 39 describes a device used to treat a subject by creating an electromagnetic field to “tune” the brain and affect mood, focus, and cognition of human subjects. Ex. 1001, 62:62–63:34. Briefly, claim 39 recites a device that creates an electromagnetic field using an electromagnet. A first processor “tunes” the brain by firing the magnetic field. The first or a second processor moves one of the recited frequency characteristics in the brain to a preselected different frequency. The term “moves” in claim 39 describes a function of the first or second processor, which provides the means by which the brain frequency is shifted. See MasterMine Software, Inc. v. Microsoft Corp., 874 F.3d 1307, 1312–1315 (reviewing cases applying and distinguishing reasoning in IPXL Holdings, 430 F.3d at 1383– 84. Unlike IPXL Holdings, there is no confusion here as to when infringement of this claim would occur; infringement occurs when one makes, uses, offers to sell, or sells the claimed apparatus, which is capable of use for treatment. For this reason, we find that the recitation “wherein the first processor or a second processor moves” in claim 39 does not recite a method step, but rather describes the function of the recited structure – the first or second processor – that is capable of performing the recited (a) through (e) steps. MasterMine, 874 F.3d at 1315–16 (“the claims at issue here merely claim that the system ‘possess[es] the recited structure [which is] capable of performing the recited functions.’”) (alterations in original). As a result, we agree with Patent Owner that the recitation “wherein the first processor or a second processor moves” is limiting.7 For purposes of resolving whether to institute trial, we adopt and apply the interpretations stated in the district court’s claim construction order, Ex. 2001.” slip op. at 11
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“(1) Alleged express disclosure The evidence of record does not support that Klimesch expressly discloses the intrinsic frequency limitation. Although Klimsech discloses treating subjects with rTMS at a frequency one Hz above the intrinsic frequency (IAF + 1 HZ), it does not disclose whether the treatment moves the intrinsic frequency. See generally, Ex. 1005. Petitioner asserts that stimulation at IAF + 1 Hz “triggered increased EEG output in the EEG band of that stimulation frequency (IAF to IAF + 2 Hz) directly corresponding to enhanced alpha power in that EEG band.” Pet. 27. Enhancing EEG power is, however, distinct from moving frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis plotting frequency on the x-axis and power on the y-axis). Thus, even if we were to credit Petitioner’s assertion that stimulation at IAF + 1 Hz “increased EEG output” and “enhanced alpha power,” such assertion does not support that Klimesch expressly discloses moving the frequency at which peak alpha power is observed. Petitioner also directs us to Klimesch’s disclosure that rTMS at IAF + 1 Hz resulted in “a significant increase in lower-2 and upper alpha desynchronization (ERD) during mental rotation.” Ex. 1005, 1132 (cited at Pet. 27–28). But ERD is also distinct from frequency. See, e.g., Ex. 2002, Fig. 1A (spectral analysis showing ERD as the difference in alpha power when subjects are performing a task as compared to when subjects are in a state of alert wakefulness). Thus, an increase in ERD does not support that Klimesch discloses changing the frequency at which peak alpha power is observed. As Petitioner does not direct us to any other disclosure in Klimesch that supports moving the intrinsic frequency, Petitioner is unlikely to prevail in establishing that Klimesch expressly discloses the intrinsic frequency limitation.12” slip op. at 18
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“Ex. 1001, 34:56–35:5. Although this disclosure supports that the intrinsic frequency can be shifted up or down by applying a “specific magnetic field close to the head,” it does not teach that the intrinsic frequency necessarily shifts every time a magnetic field above or below the patient’s peak alpha frequency is applied. Scaltech Inc. v. Retec/Tetra L.L.C., 178 F.3d 1378, 1384 (Fed. Cir. 1999) (“Inherency may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient to establish inherency.”). In addition, Petitioner does not direct us to disclosure in the ’354 patent supporting that stimulation at IAF + 1 Hz under the circumstances disclosed in Klimesch, will necessarily shift the intrinsic frequency. See, Ex. 1003 ¶ 20 (testimony of Dr. Silvetz identifying factors that impact how the brain responds to rTMS); Ex. 1001, 40:19–32 (describing “parameters that require optimization for rTMS,” including: “[f]requency, “[i]ntensity, “[d]uration,” and “[s]ite of stimulation”).” slip op. at 21
Claim construction§ 102 anticipationcites Phillips · GrahamPatents in suitUS 8,475,354 - Peaklogic, Inc. v. Wave Neuroscience, Inc.Institution deniedPTAB · Mar 23, 2023 · IPR2022-01526 · APJ David Cotta · IPR · Institution
The Board denied institution because the petition did not show a reasonable likelihood that claim 1 was anticipated by Klimesch or Jin, or obvious over their combination.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 314(a), inter partes review may not be instituted unless the Petition “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.” For the reasons discussed below, Petitioner has not established a reasonable likelihood of prevailing on its assertion that the challenged claims are unpatentable based on the grounds advanced here. Accordingly, we deny institution of inter partes review of claim 1 of the ’259 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“encountered in the art, the art’s 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). Petitioner contends that the person of ordinary skill in the art (“POSA”) would have had “a medical degree plus at least two years of academic and/or industry experience in the field of TMS.” Pet. 10. According to Petitioner, “[a]dditional professional and/or technical experience could substitute for education, and vice versa.” Id. Patent Owner does not challenge Petitioner’s proposed definition of the POSA for purposes of its preliminary response. See generally, Prelim. Resp. Petitioner’s definition appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’259 patent. Accordingly, for purposes of this Decision, we accept Petitioner’s proposed definition of the person of ordinary skill in the art. 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)).” slip op. at 7
- Expert testimonyPetitioner expert discountedDecided for patent owner
“Importantly, however, Dr. Silvetz does not cite anything to support his opinion that stimulation at a frequency above the peak alpha frequency moves the peak frequency. Id. Nor does Dr. Silvetz explain why such stimulation moves the peak frequency. Id. Accordingly, Dr. Silvetz’s testimony is entitled to little weight. Xerox Corp. v. Bytemark, Inc., IPR2022-00624, Paper 9 at 15 (PTAB Aug. 24, 2022) (Decision Denying Institution) (precedential) (finding that conclusory testimony that “does not cite to any additional supporting evidence or provide any technical reasoning to support [that testimony] . . . is entitled to little weight”); see also, 37 C.F.R. § 42.65(a) (“Expert testimony that does not disclose the underlying facts or data on which the opinion is based is entitled to little or no weight.”); Upjohn Co. v. Mova Pharm. Corp., 225 F.3d 1306, 1311 (Fed. Cir. 2000) (“Lack of factual support for expert opinion going to factual determinations, however, may render the testimony of little probative value in a validity determination.”) (quoting Ashland Oil, Inc. v. Delta Resins & Refractories, Inc., 776 F.2d 281, 294 (Fed. Cir. 1985)); Carella v. Starlight Archery & Pro Line Co., 804 F.2d 135, 138 (Fed. Cir. 1986) (“Although in some circumstances unsupported oral testimony can be sufficient to prove prior knowledge or use, it must be regarded with suspicion and subjected to close scrutiny.”). peak alpha frequency moves the peak frequency to a higher frequency is not specific to the conditions under which rTMS was administered in Klimesch. This is problematic because Dr. Silvetz also testifies that the brain’s response to rTMS varies depending on the conditions under which it was administered. Ex. 1003 ¶ 20 (“The brain’s natural response varies depending on factors such as: a) the location of the electromagnet; b) the frequency of stimulation; c) the duration of stimulation; d) the number of stimulation pulses administered; e) the amplitude of the pulses administered; and f) the patient’s physiology.”). In summary, given that it not accompanied by supporting evidence, does not provide any technical reasoning, and is not specific to Klimesch, we give little weight to Dr. Silvetz’s testimony in determining whether Petitioner has established a reasonable likelihood that Klimesch inherently discloses the intrinsic frequency limitation. We do not determine here that Dr. Silvetz’s testimony is incorrect, only that it is insufficiently supported by evidence and technical reasoning to be accorded substantial weight.” slip op. at 18
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached
“Although the parties have briefed construction of the terms “preselected intrinsic frequency” and “preselected Q-factor” (Pet. 13–20; Prelim. Resp. 11–16), there does not appear to be any dispute regarding the “preselected” aspect of these claim terms. Pet. 18, 20 (proposing that “preselected intrinsic frequency” and “preselected Q-factor” be construed to require “a fixed target [intrinsic frequency/Q-factor] . . . chosen before treatment”); Prelim. Resp. 16 (proposing that the Board should adopt the district court’s claim construction: “a targeted [intrinsic frequency/Q-factor] chosen before treatment”); Reply 4 (“the parties to the IPRs have agreed that, for the purposes of these IPRs, the Board should accept the claim construction as adopted by the district court”). Accordingly, we do not find it necessary to construe any claim terms in order to resolve this proceeding. See Vivid Techs. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”).” slip op. at 8
Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,446,259 - Apotex Inc. v. Regeneron Pharmaceuticals, Inc.Institution deniedPTAB · Mar 10, 2023 · IPR2022-01524 · APJ Ryan H Flax · IPR · Institution
Institution denied because Petitioner did not show a reasonable likelihood that claims 1–14 and 26–30 were unpatentable over the asserted anticipation and obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“APPLICABLE LEGAL STANDARDS “In an IPR, the petitioner has the burden from the onset to show with particularity why the patent it challenges is unpatentable.” Harmonic Inc. v. Avid Tech., Inc., 815 F.3d 1356, 1363 (Fed. Cir. 2016) (citing 35 U.S.C. § 312(a)(3) (requiring inter partes review petitions to identify “with particularity . . . the evidence that supports the grounds for the challenge to each claim”)). This burden of persuasion never shifts to Patent Owner. See Dynamic Drinkware, LLC v. Nat’l Graphics, Inc., 800 F.3d 1375, 1378 (Fed. Cir. 2015) (discussing the burden of proof in inter partes review). An inter partes review may be instituted if the information presented by Petitioner in the Petition, in view of Patent Owner’s Preliminary Response and the preliminary record, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the Petition. 35 U.S.C. § 314.” slip op. at 19
- BurdenDecided for patent owner
“As an initial matter, we find Petitioner has insufficiently addressed the issue of inherent anticipation by Dixon (or any other prior art) and has done so in a merely conclusory manner. There is no dispute that Dixon (as well as the other asserted prior art) discloses angiogenic eye disorder treatment using the same drug (aflibercept), at the same dose (2 mg), administered in the same way (intravitreal injection), and administered at the same dosing regimen (an initial, a secondary, and a tertiary dose), as required by all challenged claims. See generally Pet.; Prelim. Resp. Petitioner relies on these facts, and the results of a phase 2 clinical trial that followed a different dosing protocol (one not claimed) to establish that the results limitations of claims 1, 26, and 29 are inherent to the phase 3 clinical trials (VIEW 1 and 2) with a dosing regimen that is claimed. See Pet. 38–39. Petitioner calls the claimed results limitations mere newly discovered results of a known process. Id. (citing Montgomery, 677 F.3d at 1381). As Patent Owner identifies, it is not so simple. The evidence of the results of the VIEW 1 and 2 trials itself (found in the ’572 patent) shows that some, but not all, patients treated with the claimed dosing regimen achieved “a gain in visual acuity” as recited by claim 1, “a gain in visual acuity” that is “as effective” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 26, or “maintaining visual acuity” “as effective[ly]” “as monthly administration of 0.5 mg of ranibizumab” as recited by claim 29. See Ex. 1001, 13:5–38 (Table 1). As Patent Owner points out, the ’572 patent’s described studies 1 and 2, when following the claimed dosing regimen (2Q8), were not always effective treatments––achieving mere maintenance (as opposed to improvement or “gains”) of vision 95.1% and 95.6% (respectively) of the time. Id.; see Prelim. Resp. 34–37 (citing Ex. 1001, 13:8–27; Ex. 1014, 4, 6; Ex. 1030, 9; Ex. 2021 ¶¶ 109–111; Ex. 2022). Thus, the evidence shows that, although most would, about 4–5% of patients (or, possibly, an even higher number based on Patent Owner’s cited evidence––Ex. 1030, 9) would not see the gains in visual acuity required by claims 1 and 26 or the maintenance in visual acuity required by claim 29. It is well established that “[i]nherency . . . may not be established by probabilities or possibilities” and “[t]he mere fact that a certain thing may result from a given set of circumstances is not sufficient.” In re. Oelrich, 666 F.2d 578, 581 (CCPA 1981) (quoting Hansgirg v. Kemmer, 102 F.2d 212, 214 (CCPA 1939)). Here, the evidence shows that the claimed results limitations may typically flow from the claimed method, but not necessarily.” slip op. at 33
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed patent owner constructionDecided for patent owner
“Relating to the claim construction, the Federal Circuit found that patent at issue was “clear” that the tissue fibrosis, recited by the claim as arrested or regressed by the otherwise recited treatment, was not the same as and did not necessarily accompany the symptom of erectile disfunction (taught in and the focus of the relied-upon prior art), although the former (fibrosis) may frequently result in the latter (disfunction). Id. at 1059. The Federal Circuit held that the “arresting or regressing” clause was more than a mere statement of intended result, but was a limitation carrying patentable weight because the phrase was drafted as a part of a separate step of the method rather than of the preamble, the “arresting or regressing” language demanded efficacy, and the efficacy was linked to specific treatment minimum duration and dosage. Id. at 1060–61. The patients exhibiting these two issues were not necessarily the same. In part because the Board did not consider the arresting/regressing result limitation in its unpatentability analysis, the Federal Circuit agreed with the patent owner that the Board’s findings were insufficient. Id. at 1064, 1067. The Federal Circuit found that that prior art reference relied upon in the Board’s decision for teaching the claimed treatment, and also relied upon to link the condition of fibrosis with the symptom of erectile dysfunction, did not teach treating a population of patients suffering from erectile dysfunction only because of a fibrosis condition and, even though such patients may have had fibrosis, it was not certain; and further found that other cited prior art did not make certain a link between fibrosis and such dysfunction. Id. at 1065–66. This, the Federal Circuit found, was error. We find in agreement with Patent Owner that the results limitations of the challenged claims are limitations and must be given patentable weight for the same reasons arresting or regressing a tissue fibrosis was a limitation in Los Angeles Biomed. Similarly, here the claims are directed to expressly required results of the administration of aflibercept to patients at 2 mg at an initial dose, in at least one secondary dose 4 weeks later, and in at least one tertiary dose 8 weeks later. Therefore, we find that in claim 1, “wherein the patient achieves a gain in visual acuity within 52 weeks following the initial dose,” is a limitation. Further, in claim 26, “wherein the method is as effective in achieving a gain in visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation. And, in claim 29, “wherein the method is as effective in maintaining visual acuity as monthly administration of 0.5 mg of ranibizumab by intravitreal injection in human subjects with age-related macular degeneration at 52 weeks following the initial dose,” is a limitation.” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“A prior art reference without express reference to a claim limitation may anticipate by inherency. See In re Cruciferous Sprout Litig., 301 F.3d 1343, 1349 (Fed. Cir. 2002). “Under the principles of inherency, if the prior art necessarily functions in accordance with, or includes, the claimed limitations, it anticipates.” Id. (quoting MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999)).” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,253,572 - Penumbra, Inc. v. Rapidpulse, Inc.All claims unpatentablePTAB · Mar 10, 2023 · IPR2021-01466 · APJ Jamie T Wisz · IPR · Final written decision
Claims 1–18 are unpatentable under §103: claims 1–12, 15, 16, and 18 over Teigen and Grey; claims 13–14 over Teigen, Grey, and Yang; claim 17 over Teigen, Grey, and Matteo.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Based on our consideration of the full record, we find that, overall, Patent Owner’s definition is more specifically tailored to the claimed subject matter of the ’883 patent. We also find that, a person with a biomedical engineering degree could have the required background in fluid mechanics. See Ex. 1031, 45:21–46:7. Therefore, we find that a person of ordinary skill in the art would have a B.S. in mechanical or biomedical engineering with at least three years of experience in designing systems for minimally invasive intravascular procedures for treating occluded vessels or the equivalent and in consultation with medical professionals such as interventional neurosurgeons. Although we agree with, and have primarily adopted Patent Owner’s definition for an ordinarily skilled artisan in this proceeding, our analysis and conclusions herein would not change even under Petitioner’s definition. The parties also do not indicate that the outcome would differ based on the definition of the person of ordinary skill in the art. See Pet. 15; PO Resp. 6; Pet. Reply 1.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed petitioner constructionDecided for petitioner
“as adopted by the Board in the Institution Decision. The ’883 patent explicitly defines this term, stating: The term “forward flow” is used herein to define an amount of liquid in the lumen 662 that exits the distal end 664 in a distal direction. Forward flow is defined as greater than 6 microliters of fluid (approximately 1 mm of catheter length of ID 0.071″=5.7 μL). Ex. 1001, 36:18–23 (emphasis added). Moreover, in discussing problems with the prior art systems, the ’883 patent states that “[w]hen positive pressure exists at the distal end of the lumen, liquid from inside the lumen exits out from the distal end of the catheter in a distal direction. This is referred to as forward flow.” Id. at 2:62–65. In the ’883 patent, the patentee acted as its own lexicographer as evidenced by usage of language such as “is used herein to define,” “is defined,” and “is referred to as,” to discuss “forward flow.” We find that the definition of “forward flow” in the ’883 patent specification would provide a person of ordinary skill with “reasonable clarity, deliberateness, and precision” as to the meaning of the term. See Paulsen, 30 F.3d at 1480; see also Ex. 1030 ¶¶ 13–14; Ex. 2001 ¶¶ 53, 62. Thus, we construe the term, “forward flow,” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.”” slip op. at 14
- Disclosure Requirements (§112) › Written description (Ariad)Not entitled to earlier dateDecided for petitioner
“As discussed above, we construed “forward flow” to mean “an amount of liquid in the lumen that exits the distal end in the distal direction that is greater than 6 microliters.” Thus, for the ’011 provisional to provide support for this limitation, the provisional must demonstrate that the inventors had possession of preventing greater than 6 microliters of fluid out of the distal end of the catheter. While Patent Owner points to disclosure from the ’011 provisional application which describes “a minimal amount of momentum transfer from the fluid column to the stuck clot to unstick the clot sufficiently” and “[t]he exiting movement of fluid [being] limited to a specific volume and/or pressure and is automatically and precisely controlled” to prevent the “possibility of overshooting,” it would not convey to one of ordinary skill in the art that the inventors were in possession of a device that limited forward flow to no greater than 6 microliters of fluid. PO Resp. 33 (citing Ex. 1003 ¶¶ 16, 138). Patent Owner also contends that the ’011 provisional application provides “multiple examples of liquid flow exiting the distal end of the catheter such that no forward flow occurs, such as 1 microliter or 0.5 mm of column shift.” PO Resp. 34 (citing Ex. 1003 ¶ 91). However, the disclosure cited by Patent Owner provides ranges of liquid flow of “approximately 0.001 ml to approximately 1.0 ml, in particular, approximately 0.1 ml to approximately 0.5 ml” and exemplary length of shift distances of “approximately 0.5 mm to approximately 30 mm, in particular, approximately 0.5 mm to approximately 15 mm.” Ex. 1003 ¶ 91. There is nothing in the disclosure of the ’011 provisional application that specifically directs the person of ordinary skill to the portions of these ranges which fall within the ’883 patent’s definition of no “forward flow” (i.e., no greater than 6 microliters of fluid). In fact, the majority of the cited ranges are greater than 6 microliters, going all the way up to 1,000 microliters, such that there would be forward flow in these examples. See Ex. 1030 ¶ 29; Purdue Pharma, 230 F.3d at 1326–27 (“[O]ne cannot disclose a forest in the original application, and then later pick a tree out of the forest and say here is my invention. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”); Fujikawa v. Wattanasin, 93 F.3d 1559, 1571 (Fed. Cir. 1996).” slip op. at 21
- Novelty / Anticipation (§102) › Prior-art status of a reference › Patents / published applications (effective date, provisional support)Reference is prior artDecided for petitioner
“AIA § 102 draws a distinction between actually being entitled to a right of priority to, or the benefit of, a prior-filed application according to the definition of “effective filing date” of a claimed invention in AIA 35 U.S.C. § 100(i)(1)(B), and merely being entitled to claim a right of priority to, or the benefit of, a prior-filed application for prior-art purposes according to the use of “effectively filed” in AIA 35 U.S.C. § 102(d). See 35 U.S.C. §§ 100(i)(1)(B), 102(a)(2), 102(d)(2); MPEP § 2154.01(b). USPTO guidance also indicates that AIA § 102 prior-art reference effective-filing-date determinations differ from pre-AIA law. For example, a 2018 Memorandum to the Patent Examining Corps states, in the context of prior-art determinations, that “[t]he requirement that one of the claims in the patent [document] . . . be supported by the written description of the provisional application in compliance with pre-AIA 35 U.S.C. § 112, first paragraph (or AIA 35 U.S.C. § 112(a)), is not applicable when examining an application subject to the first inventor to file provisions of the AIA.” Robert W. Bahr, Memorandum re: Critical Reference Date Under pre-AIA 35 U.S.C. §102(e) (Apr. 5, 2018), available at http://www.uspto.gov/sites/ default/files/documents/dynamic_memo_05apr2018_0.pdf (emphasis added) (citing Dynamic Drinkware, 800 F.3d at 1381 n.2; 157 Cong. Rec. 3423 (2011) (explaining the distinction between being entitled to claim priority or benefit in AIA 35 U.S.C. § 102(d) and actually being entitled to priority or benefit under 35 U.S.C. § 119, 120, or 365)). This Memorandum further indicates: The date subject matter was “effectively filed” under AIA 35 U.S.C. § 102(d) for purposes of considering a U.S. patent, a U.S. patent application publication, or an international application publication as prior art under AIA 35 U.S.C. § 102(a)(2) is discussed in MPEP § 2154.01(b), and is not affected by Dynamic Drinkware or [Amgen v. Sanofi, 872 F.3d 1367, 1380 (Fed. Cir. 2017)] and is not being modified by this memorandum. Id. at 2. MPEP § 2154.01(b) explicitly states, as a result of the distinction discussed above, in application of the AIA version of § 102, “the question of whether a patent or published application is actually entitled to priority or benefit with respect to any of its claims is not at issue in determining the date the patent or published application was ‘effectively filed’ for prior art purposes.” MPEP § 2154.01(b) (emphases added).” slip op. at 31
Patent outcomesUS 10,531,883 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites KSR · GrahamPatents in suitUS 10,531,883 - Ricetec, Inc. v. BASF SEAll claims unpatentablePTAB · Mar 8, 2023 · PGR2021-00114 · APJ Tina E Hulse · PGR · Final written decision
Claims 1–17 are unpatentable: they lack written description support and are anticipated by Hinga; the Board also found the challenged dependent claims obvious over the listed combinations.
RulingsFinal written decision- Skill levelSkill level board ownOther
“As explained in our Institution Decision (Dec. Inst. 5–6), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 4–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“amount.” Pet. Reply 14. Patent Owner, however, argues that we erred in our construction because the Specification explicitly defines “effective amount” to mean “the amount of herbicide required to achieve at least about 65% phytotoxicity of conventional [i.e., wild, non-mutant] rice (e.g., red rice) in field applications.” PO Resp. 10 (quoting Ex. 1001, 6:34–37). Because the inventors served as their own lexicographers, Patent Owner asserts the Specification’s express definition controls. Id. at 10–11 (citing Martek Biosciences Corp. v. Nutrinova, Inc., 579 F.3d 1363, 1380 (Fed. Cir. 2009) (“When a patentee explicitly defines a claim term in the patent specification, the patentee’s definition controls.”)). Nevertheless, Patent Owner acknowledges that the “less than 10% injury” language “is indeed a limitation of the ’346 Patent claims.” Id. at 11. Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide (i.e., 14 g AI/Ha to 40 g AI/Ha of quizalofop) and cause “less than 10% injury” to the mutant rice. See Ex. 1001, claim 1.” slip op. at 10
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“Mankin would derive the herbicide range suggested by Patent Owner and Dr. Somers from the “rules of thumb,” that range is much broader than the claimed range. Claim 1 recites that the effective amount is 14 g AI/Ha–40 g AI/Ha of quizalofop, but, according to Dr. Somers’s calculations from the Assure II herbicide label, a POSITA would understand the effective amount to be 19.25–154 (or 19.25–184.8) g AI/Ha. Ex. 2036 ¶ 54; PO Resp. 38. Patent Owner does not identify anything in the specification that would allow a POSITA to “immediately discern” the specific range limitations of the claims. See General Hospital, 888 F.3d at 1372. As the Federal Circuit has stated, “one cannot disclose a forest in the original application, and then pick a tree out of the forest and say here is my invention.” Purdue Pharma, 230 F.3d at 1326. Thus, we are not persuaded that the disclosure of a broad range of effective amounts via the Assure II herbicide label coupled with Dr. Somers’s undisclosed “rules of thumb” provide written description support for the narrower range limitations of the claims. Moreover, we agree with Petitioner that Patent Owner is impermissibly working backward from the claimed ranges to determine whether Dr. Somers’s “rules of thumb” can be used to re-create the claimed range from the herbicide label. Pet. Reply 15. That is not the test for written description. Written description “requires a statement of an invention, not an invitation to go on a hunting expedition to patch together after the fact a synthetic definition of an invention.” Indivior UK Ltd. v. Dr. Reddy’s Labs. S.A., 18 F. 4th 1323, 1329 (Fed. Cir. 2021). Accordingly, we are not persuaded that Dr. Somers’s “rules of thumb” applied to the extrinsic herbicide label would be understood by a POSITA as a description in Mankin of the range limitation of the claims. Rather, as Dr. Somers concedes, his “rules of thumb” in conjunction with the herbicide label represent a starting point for a POSITA to test plants to determine what the effective amount range should be. See Ex. 2036 ¶ 53 (referring to a “dose response analysis” between 0.5x and 4x). But “a ‘mere wish or plan’ for obtaining the claimed invention is not sufficient.” See Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1351 (Fed. Cir. 2011).” slip op. at 30
- Disclosure Requirements (§112) › Enablement (Wands, Amgen full scope)EnabledNot shown unpatentable
“We are not persuaded. Given the state of the art in 2017, and the known availability of the G2096S seeds at that time, we find the ’346 patent specification enables the claims. The ’346 patent specification clearly describes the G2096S mutant ACCase rice and its use in the claimed method for treating rice. See, e.g., Ex. 1001, 2:37–45, 57:51–61. Contrary to Petitioner’s assertion, the ’346 patent specification has not omitted the G2096S herbicide tolerant rice. Rather, the ’346 patent specification expressly identifies the G2096S mutant rice that possesses the phenotype of tolerance to the effective amounts of herbicides, and describes the method for treating that mutant rice with those effective amounts. See, e.g., id. at 8:8–12; 57:51–61. Thus, we are not persuaded that we erred in relying on Hinga’s seed deposits to determine that Petitioner has failed to meet its burden to prove that the ’346 patent specification fails to enable the challenged claims. Cf. Wands, 858 F.2d at 736 (stating “[n]o deposit is necessary if the biological organisms can be obtained from readily available sources.”).” slip op. at 46
Patent outcomesUS 11,096,346 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,096,346 - Ricetec, Inc. v. BASF SEAll claims unpatentablePTAB · Mar 8, 2023 · PGR2021-00113 · APJ Tina E Hulse · PGR · Final written decision
Claims 1–15 are unpatentable: they lack written-description support, and claims 1–3, 7, and 11–15 are anticipated by Hinga or Hinga2013.
RulingsFinal written decision- Skill levelSkill level board ownDecided for petitioner
“As explained in our Institution Decision (Dec. Inst. 6–7), we do not discern a substantive difference between the parties’ respective definitions for the level of ordinary skill in the art. Although Petitioner states a POSITA must have one to two years of postdoctoral research experience and Patent Owner’s definition requires at least five years of “research experience,” Patent Owner’s definition does not indicate a specific time for that research (i.e., it could include research during or after a doctoral program). Neither party addresses or contests the other party’s definition in their post-institution papers. See generally PO Resp.; Pet. Reply; PO Sur-reply. Accordingly, we find the parties’ respective definitions to be equivalent and consistent with the level of ordinary skill in the art as reflected by the prior art in this proceeding. 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))). Moreover, we find that Dr. Shaner and Dr. Somers are both qualified to opine from the perspective of a skilled artisan as both are persons of at least ordinary skill in the art, based on either party’s definition. See Ex. 1002 ¶¶ 5–15; Ex. 2036 ¶¶ 5–11, App’x A; see also Kyocera Senco Indus. Tools Inc. v. Int’l Trade Comm’n, 22 F. 4th 1369, 1376–77 (Fed. Cir. 2022) (“To offer expert testimony from the perspective of a skilled artisan in a patent case—like for claim construction, validity, or infringement—a witness must at least have ordinary skill in the art.”).” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Lexicography (patentee as own lexicographer)Term construed patent owner constructionDecided for patent owner
“Having considered the arguments and evidence presented at trial, we agree with Patent Owner that the inventors acted as their own lexicographer to define “effective amount” and that that definition governs its meaning. Phillips, 415 F.3d 1316 (“[O]ur cases recognize that the specification may reveal a special definition given to a claim term by the patentee that differs from the meaning it would otherwise possess. In such cases, the inventor’s lexicography governs.”). We, therefore, construe the term “effective amount” to mean “the amount of an herbicide required to achieve at least about 65% phytotoxicity of conventional rice (e.g., red rice) in field applications.” As explained further below, however, whether incorporated into the construction of “effective amount” or not, the claim language itself further requires that the “effective amount” encompass a specific range of amounts of herbicide and cause “less than 10%” injury to the mutant rice. See Ex. 1001, claim 1. We determine it is unnecessary to expressly construe any other claim terms for purposes of this Decision. See Wellman, 642 F.3d at 1361.” slip op. at 11
- Disclosure Requirements (§112) › Written description (Ariad)Written description inadequateNot entitled to earlier dateUnpatentable
“labels is akin to relying on literature that clearly provides, on its face, the missing disclosure, as in Falkner. Id. On the contrary, Patent Owner’s argument makes clear that the herbicide labels, by themselves, are insufficient to describe the claimed range limitation. Specifically, because the label ranges do not align with the claimed ranges, Dr. Somers had to make additional assumptions and inferences to support Patent Owner’s written description argument. For example, to calculate the potential effective amount range of herbicides, Dr. Somers applied several different “rules of thumb,” none of which are disclosed in the Mankin specification. See Ex. 2036 ¶¶ 34, 54. According to Dr. Somers, to determine the effective amount for a plant with an unknown response to an herbicide, a POSITA “would naturally test the lowest label (1X) rate of the herbicide, along with a few rates below (starting at about half-X) and above the 1X rate (up to 4X) of the herbicide, to determine the effective dose for this ‘uncharacterized’ plant.” Id. ¶ 34. Dr. Somers refers to this as a “dose response analysis.” Id. ¶ 53. In other words, to determine what the actual effective amount of herbicides should be, Dr. Somers explains that a POSITA would have to test the plants at these “rule of thumb” amounts to determine the effective range. Id. ¶ 34. Given the additional assumptions and inferences that must be made to the herbicide labels to arrive at the range limitations, we are not persuaded that relying on the extrinsic herbicide labels for written description support is proper in this case. That said, even if we were to allow Patent Owner to rely on the herbicide labels and the “rules of thumb” for determining the effective herbicide dose, Patent Owner admits that the ranges calculated from the herbicide labels are broader than the range limitations of the claims. See PO Resp. 39. As Petitioner notes, however, the Mankin Application does not provide any guidance as to whether the effective amount range of herbicide would include a 0.5x dose, a 2x dose, or the 4x dose, such that a POSITA could immediately discern the claimed range from the herbicide label.17 Pet. Reply 16.” slip op. at 30
- Expert testimonyPatent owner expert discountedDecided for petitioner
“Dr. Somers, however, relies on the label for Fusilade II, which is a different fluazifop-P-butyl herbicide with a different range of 52.98–103.96 g AI/Ha, which—not surprisingly—aligns more closely with the claimed range of at least 56–150 g AI/Ha. Ex. 2036 ¶ 52. We note that Fusilade II does not appear to be one of the listed herbicides in Table 1, whereas Fusilade DX is. Ex. 2034 ¶ 219 (listing “Fusilade, Fusilade 2000, Fusilade DX, ICI-A 00009, ICI-A 00005, SL-236, IH-773B, TF-1169, and Fusion” as examples of synonyms and trade names for fluazifop-P-butyl). Regardless, that the dose range differs for the same herbicide calls into question the credibility of Dr. Somers’s assertion that a person of ordinary skill in the art would have been able to discern the claimed range limitation by simply looking at the EPA-approved herbicide labels (and applying his “rules of thumb”).18, 19” slip op. at 33
Patent outcomesUS 11,096,345 unpatentableClaim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites Phillips · KSR · GrahamPatents in suitUS 11,096,345 - PTAB · Feb 10, 2023 · IPR2022-01440 · APJ Erica A Franklin · IPR · Institution
The Board instituted IPR on claims 1–19 based on all asserted grounds, finding a reasonable likelihood that the petitioner would prevail on at least one challenged 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 one of the claims challenged in the petition. 35 U.S.C. § 314(a). Upon considering the parties’ arguments and evidence, we determine that Petitioner has demonstrated 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 1–19 of the ’133 patent.” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner contends that a person of ordinary skill in the art (“POSA” or “POSITA”) 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 5 Lang, WO 01/19383 A1, published Mar. 22, 2001 (Ex. 1009, “Lang”). 6 Brown et al., Nutrition Supplements and the Eye, 12 EYE 127–33 (1998) (Ex. 1014, “Brown”). degeneration, and background information. To the extent needed, the POSITA would have collaborated with others having ordinary skill in the areas pertinent to the subject matter of the ’133 Patent. Pet. 8–9 (citing Ex. 1024 ¶¶ 15–16) (citations omitted). This definition by Petitioner is uncontested on the current record. See Prelim. Resp. 7–8. Because we find Petitioner’s definition to be reasonable and consistent with the ’133 patent and the cited art, we adopt it for purposes of this Decision.” slip op. at 6
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“1. “substantially free of meso-zeaxanthin stereoisomers” Independent claims 1, 14, and 19 recite that the zeaxanthin is “present in the 3R-3R' stereoisomer form and is substantially free of meso-zeaxanthin stereoisomers.” Claims 1, 14, 19 (emphasis added). Petitioner contend that the term “substantially free of meso-zeaxanthin stereoisomers” should have its plain and ordinary meaning, and a POSA would have understood the 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. 25– 26 (emphasis removed) (citing Ex. 1024 ¶ 70; Ex. 1031, 3). The Board adopted, preliminarily, this construction by Petitioner in the Institution Decisions in the -0089 IPR and -1029 IPR. -0089 IPR, Paper 7 at 9–10; -1029 IPR, Paper 6 at 8–9. At this stage of the proceeding, we adopt Petitioner’s proposed construction as consistent with the plain and ordinary meaning of the term and the prior decisions in the -0089 IPR and -1029 IPR.” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“We begin by noting that the challenged claims do not recite that the nutritional supplements are “free of Vitamin A” or “free of all sources of Vitamin A.” Rather, independent claim 1 expressly recites that the supplement is “free of beta-carotene.” See Claim 1. Patent Owner urges us to expand the exclusion of beta-carotene to all forms of Vitamin A. That argument, however, lacks support on the current record. In particular, the support asserted by Patent Owner and its expert, Dr. Dorey, that “nutritional supplements include beta-carotene as Vitamin A equivalent,” see Prelim. Resp. 9–10 (citing Ex. 2001 ¶ 19), establishes little, on its own. Barker does not require the use of beta-carotene as its source of Vitamin A, nor does it limit the source or form of Vitamin A used. Rather, Barker discloses that several “[e]xamples of compounds having vitamin Aactivity or precursors thereof are retinol and esters thereof, such as retinyl palmitate; α- and β-carotene, β-cryptoxanthin, and lycopene.” Ex. 1011, 2:11–13. Thus, Barker discloses a number of exemplary compounds to supply Vitamin A to its nutritional supplement that are not beta-carotene. Accordingly, based on the current record, we disagree with Patent Owner’s argument that the challenged claims exclude all forms of Vitamin A and that Barker, therefore fails to anticipate those claims. Having considered the arguments and evidence at this stage in the proceeding, we are persuaded that Petitioner has shown sufficiently for institution that Barker discloses a nutritional supplement that is “free of beta-carotene.” Therefore, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing in showing that claims 1, 2, 5, and 9–12 are anticipated by Barker.” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 11,173,133
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.