- Azurity Pharmaceuticals, Inc. v. Exelixis Inc.Institution deniedPTAB · Jun 4, 2025 · IPR2025-00210 · APJ Jeffrey N Fredman · IPR · Institution
The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving claims 1–3 unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Accordingly, we find that on the current record Petitioner has not shown that the combination of Brown, Kubo, and Remington would inherently result in less than 200 ppm impurity and Petitioner has not shown that it has a reasonable likelihood that it would prevail on the obviousness ground.” slip op. at 29
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportPriority date awardedReference not prior artDecided for patent owner
“Here, there is no dispute that the ’349 patent and Wilson, which issued from a patent application from which priority was claimed for the ’349 patent, share the identical disclosure of a pharmaceutical composition comprising Compound IA or IB; one or more fillers; one or more disintegrants; one or more glidants; and one or more lubricants. In this embodiment, the filler comprises microcrystalline cellulose. In this embodiment, the disintegrant comprises croscarmellose sodium. In this embodiment, the disintegrant comprises croscarmellose sodium and sodium starch glycolate. In this embodiment, the glidant comprises fumed silica. In this embodiment, the lubricant comprises stearic acid. Ex. 1001, 21:1–12; Ex. 1002, 20:51–62. There is express ipsis verbis disclosure of the elements recited in claim 1 of the ’349 patent.” slip op. at 13
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundNot shown unpatentable
“1. Reason to reduce contaminant levels We agree with Patent Owner that Petitioner identifies no teaching in the prior art providing any reason to reduce levels of 6,7-dimethoxy-quinoline-4-ol specifically. And while Brown does teach a desire to form “substantially pure” compounds, Brown focuses on “at least about 90 wt.%” of the compound, then lists specifically “about 90, about 91, about 92, about 93, about 94, about 95, about 96, about 97, about 98, about 99 and about 100% wt. %.” Ex. 1003 ¶ 97. This permits a range of concentration for contaminants from about 0 to 10%.” slip op. at 24
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“to modify Brown’s process with Kubo to eliminate the added step. See, e.g., Id. ¶ 73. But even with that combination, Dr. Dichtel states only that a “POSA would have expected there to be a decrease in the amount of 6,7- dimethoxy-quinoline-4-ol at the end of cabozantinib (L)-malate’s synthesis that was attributable to hydrolytic degradation of the 4- (nitrophenoxy)quinoline intermediate by avoiding its use in the synthesis.” Id. ¶ 78. That is not, however, the standard for inherency. It must be the necessary result, not a possible expected result. The Federal Circuit in Par explained that: Inherency, however, 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. If, however, the disclosure is sufficient to show that the natural result flowing from the operation as taught would result in the performance of the questioned function, it seems to be well settled that the disclosure should be regarded as sufficient.” slip op. at 28
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites Phillips · KSR · GrahamPatents in suitUS 11,298,349 - PTAB · Sep 25, 2023 · IPR2023-00760 · APJ Zhenyu Yang · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of prevailing on any challenged claim under the asserted anticipation or obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“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). For the reasons provided below, we determine Petitioner has not demonstrated a reasonable likelihood that it would prevail with respect to at least one claim challenged in the Petition. Accordingly, we deny institution of an inter partes review.” slip op. at 2
- Skill levelSkill level patent owner adoptedDecided for patent owner
“We agree with Patent Owner that an ordinarily skilled artisan should encompass the inventor. See Daiichi Sankyo Co., Ltd. v. Apotex, Inc., 501 F.3d 1254, 1256–57 (Fed. Cir. 2007). On this record, we also decline to include publication of academic articles as a requirement. After reviewing the record, for purposes of this Decision, we adopt Patent Owner’s definition as it is consistent with the prior art’s demonstration of the skill level at the time of the invention.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingTerm construed patent owner constructionDecided for patent owner
“In general, “a preamble is not limiting where 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.” Catalina, 289 F.3d at 808 (quotation marks omitted). But even then, “[w]hether a preamble stating the purpose and context of the invention constitutes a limitation of the claimed process is determined on the facts of each case in light of the overall form of the claim, and the invention as described in the specification and illuminated in the prosecution history.” Applied Materials, Inc. v. Advanced Semiconductor Materials Am., Inc., 98 F.3d 1563, 1572–73 (Fed. Cir. 1996). We determine that, read in view of the Specification, the preamble, even though it states an intended purpose, is limiting, because “it is necessary to give life, meaning, and vitality to the claim.” See Catalina, 289 F.3d at 808 (quotation marks omitted). The ’308 patent discloses “an adoptive cellular immunotherapy composition comprising a genetically modified helper T lymphocyte cell [i.e., CD4+ T cell] preparation that augments the genetically modified cytotoxic T lymphocyte cell [i.e., CD8+ T cell] preparation[’]s ability to mediate a cellular immune response.” Ex. 1001, 9:4–8, see also id. at 9:36–42 (disclosing that in some embodiments, an adoptive cellular immunotherapy composition “comprises an antigen-reactive chimeric antigen receptor modified naïve CD4+ T helper cell that augments the CD8+ immune response.”), 9:48–51 (the same). The ’308 patent also discloses that in some embodiments, an adoptive cellular immunotherapy composition further “comprises a chimeric antigen receptor modified tumor-specific CD8+ cytotoxic T lymphocyte cell preparation that elicits a cellular immune response.” Id. at 9:14–17, 23–26.” slip op. at 12
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“the claimed composition are surface positive for “CD62L and/or CD45RA,” and the CAR-modified CD8+ T cells are surface positive for “CD62L and/or CD45RO.” Petitioner proposes that the term “and/or” includes “embodiments having the element preceding ‘and/or,’ the element following ‘and/or,’ or both the element preceding ‘and/or’ and the element following ‘and/or’.” Pet. 20 (citing Ex. 1002 ¶ 86). Under this construction, Petitioner argues, the CD4+ T cells recited in claim 1 can be surface positive for CD62L, for CD45RA, or both. Id. (citing Ex. 1002 ¶ 87). And because CD62L+ can be either TN or TCM cells, Petitioner contends “claim 1’s CAR-modified CD4+ T cells can be either majority TCM or TN.” Id. at 17 (citing Ex. 1002 ¶¶ 62–66). For similar reasons, Petitioner argues that “claim 1’s CD8+ T cells can be majority TN, TCM, TEM, or TE.” Id. (citing Ex. 1002 ¶¶ 67–70); Id. at 20 (citing Ex. 1002 ¶¶ 87–88). At this stage, Patent Owner does not dispute Petitioner’s proposed construction or provide its own construction of “and/or.” Based on the current record, we agree with Petitioner’s proposed construction because it is supported by the claim language and the Specification of the ’308 patent.” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,987,308 - 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 - Beckman Coulter, Inc. v. Becton, Dickinson And CompanyInstitution deniedPTAB · Dec 1, 2022 · IPR2022-01122 · APJ Michael A Valek · IPR · Institution
The Board denied institution because Petitioner did not show a reasonable likelihood of proving claims 1–13 unpatentable on any asserted ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“likelihood of establishing that any of the challenged claims are unpatentable on any of the grounds in the Petition. Accordingly, institution of inter partes review is denied. V. ORDER Accordingly, it is: ORDERED that the Petition is denied, and no inter partes review is instituted” slip op. at 33
- Skill levelOther
“We are sympathetic to Patent Owner’s argument that a POSA would have had at least some experience with the optical systems used in optical analyzers. All of the claims recite an “optical analyzer” and the Specification is replete with references to optical analyzers and their operation. See, e.g., Ex. 1001, Abstr., 1:14–15, 2:3–4, 2:18–29, 3:38–57, 9:55–10:59 (claims reciting an “optical analyzer”). Moreover, Patent Owner cites other evidence that also suggests a POSA would have such experience. See Prelim. Resp. 12–13. However, on the current record, we are not convinced that the ordinary level of skill in the art would necessarily require the amount of specific experience (i.e., two years working and/or designing optical systems in optical analyzers) that Patent Owner urges. Petitioner’s declarant, Dr. Fang, testifies that two years of experience “in the field of optical imaging, with a specific focus on laser optics” would suffice. See Ex. 1002 ¶ 9. Thus, while it seems likely that a POSA would have at least some experience specific to optical analyzers, we see no reason why additional experience with laser optics more generally could not provide the balance of the two years of experience noted in the parties’ definitions. In any event, we need not resolve this issue here because we would reach the same outcome under either parties’ POSA definition.” slip op. at 8
- Expert testimonyPetitioner expert discountedDecided for patent owner
“The testimony Petitioner offers from its declarant, Dr. Fang, does not provide the missing explanation. Paragraphs 115 and 127 of Dr. Fang’s declaration, provide his opinions that “adapting a lens to focus a light beam onto a focal spot within a sample analysis region is no different from adapting a lens to focus a light beam into any region in space in other applications” and that a POSA would “understand that Lynch is generally applicable to light sources emitting collimated beams, and that such light sources were well-known in the art.” Ex. 1002 ¶¶ 115, 127. In paragraph 126, Dr. Fang testifies that a POSA would have a reasonable expectation of success in implementing the system described in Lynch.11 None of this testimony explains why a POSA would have been motivated to modify Lynch for implementation in an optical analyzer. For these reasons and based on the current record, Petitioner has not” slip op. at 25
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Whether to treat a preamble as a limitation is a determination ‘resolved only on review of the entirety of the patent to gain an understanding of what the inventors actually invented and intended to encompass by the claim.”’ In re Cruciferous Sprout Litig., 301 F.3d 1343, 1347 (Fed. Cir. 2002) (citation omitted). “In general, a preamble limits the claimed invention if it recites essential structure or steps, or if it is necessary to give live meaning and vitality to the claim.” Id. (citation and quotations omitted). This may be ascertained by review of the entirety of the patent to determine whether the preamble “discloses a fundamental characteristic of the claimed invention” as opposed to merely “stat[ing] a purpose or intended use.” Poly-Am., L.P. v. GSE Lining Tech., Inc., 383 F.3d 1303, 1310 (Fed. Cir. 2004). As Patent Owner points out, the ’197 patent is replete with references describing the invention as an optical analyzer. See Prelim. Resp. 24–25 (bullet pointing quotes from the Specification). The Specification begins by explaining that optical or “[p]article analyzers . . . are well known analytical tools that enable the characterization of particles on the basis of optical parameters such as light scatter and fluorescence.” Ex. 1001, 1:16–19. The Specification explains that “[t]he present invention” provides both “illumination optics for use in an optical analyzer” and “an optical analyzer incorporating the illumination optics of the present invention.” Ex. 1001, 2:3–4, 2:18–19. Claims 1–13, each of which recites an “optical analyzer” comprising a set of optical elements, are specifically directed to the latter. Id. at 9:55–10:59. The Specification further demonstrates that the preamble term is limiting by explaining that “the invention addresses a concern specific to” optical analyzers. See Deere & Co. v. Bush Hog, LLC, 703 F.3d 1349 1358 (Fed. Cir. 2012) (finding that the specification “demonstrates that the preamble phrase ‘rotary cutter deck’ is a limitation” because it “explains that the invention addresses a concern specific to rotary cutters”). The Specification explains that in a flow cytometer, i.e., an exemplary type of optical analyzer, “the excitation light from a laser . . . is focused onto a focal spot to illuminate the core stream (the fluid stream containing the particles to be analyzed).” Ex. 1001, 1:39–42. According to the Specification, “[a]ccurate focusing of the excitation light beam on the core stream is important,” “[o]ptimal performance is compromised if the focused light beam is not properly adjusted on the core stream,” and because the particles being analyzed are only a “few microns in size, the precision of the light beam adjustment also needs to be in the micron range.” Id. at 1:42–51; see also id. at 3:38–49 (explaining that “fine control over the focus spot” is useful in optical analyzers). The present invention addresses these concerns by providing an optical analyzer “adapted to focus an illumination beam onto a sample analysis region,” configured to obtain a “high degree of precision over the adjustment of the focal spot using less expensive lens adjusting mechanisms,” and comprising “detection optics for measuring the light emitted from the analysis region.” See id. at 2:18–23, 7:3–8. We also agree with Patent Owner that the recitation of an “optical analyzer” in the preamble informs the meaning of the phrase “a focusing lens . . . adapted to focus the light beam onto a focal spot within a sample analysis region” in the claim body. The term “sample analysis region” refers to a structural feature of the claimed “optical analyzer,” i.e., the area configured to contain the sample to be analyzed. This is confirmed by the Specification, which explains that in addition to illumination optics “[t]he optical analyzer will further comprise detection optics for measuring the light emitted from the analysis region. In a preferred embodiment, the optical analyzer is a flow cytometer, and the sample analysis region is a sample detection region in a fluid stream containing particles to be optically analyzed.” Ex. 1001, 2:21–26. In this regard, the preamble informs the meaning of “sample analysis region” by indicating that the recited “sample analysis region” is configured such that it can contain a sample and that light emitted from that region can be measured by the analyzer. See Deere, 703 F.3d at 1358 (explaining that “rotary cutter deck” in the claim preamble “informs the meaning of the ‘torsional stiffness’ limitation––the claimed structure must possess sufficient stiffness to withstand the torsional loads imposed by the operation of a rotary cutter”). By the same measure, holding that the “sample analysis region” need not be so configured would undermine the benefits the Specification indicates the recited illumination optics achieve. See Ex. 1001, 1:39–55, 2:30–48, 7:3–7 (explaining that “accurate focusing” is important because the sample to be analyzed may be very small and that the present invention obtains “precise positioning control” using less expensive components). The fact that the preamble informs the meaning of a term in the claim body, distinguishes it from “nonlimiting preamble terms” that “merely state a name or a use” by demonstrating that the optical analyzer recited in the preamble of the presently challenged claims is a “fundamental characteristic of the claimed invention.” Deere, 703 F.3d at 1358 (quoting Poly-Am., 383 F.3d at 1310).9 slip op. at 13
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 7,787,197
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