- Liquidia Technologies, Inc. v. United Therapeutics CorporationRehearing deniedPTAB · Feb 2, 2023 · IPR2021-00406 · APJ Christopher M Kaiser · IPR · Rehearing
Rehearing was denied; claims 1–8 remain unpatentable because conference distribution established Voswinckel JESC and Voswinckel JAHA as prior art.
RulingsRehearing decision- RehearingRehearing, deniedDenied
“the abuse of discretion standard. 37 C.F.R. § 42.71(c). “The burden of showing a decision should be modified lies with the party challenging the decision.” 37 C.F.R. § 42.71(d). “The request must specifically identify all matters the party believes the Board misapprehended or overlooked, and the place where each matter was previously addressed in a motion, an opposition, reply, or a sur-reply.” Id. An abuse of discretion may be found where a decision “(1) is clearly unreasonable, arbitrary, or fanciful; (2) is based on an erroneous conclusion of law; (3) rests on clearly erroneous fact findings; or (4) involves a record that contains no evidence on which the Board could rationally base its decision.” Redline Detection, LLC v. Star Envirotech, Inc., 811 F.3d 435, 442 (Fed. Cir. 2015) (quoting Abrutyn v. Giovanniello, 15 F.3d 1048, 1050–51 (Fed. Cir. 1994) (citation omitted)). D. We Overlooked Patent Owner’s Argument Patent Owner is correct that its argument that the Ghofrani and Sulica research aids were dated after May 15, 2005, appeared in the Sur-Reply. Sur-Reply 9–11. Patent Owner also is correct that we overlooked this argument in relying on these research aids as supporting that Petitioner had established that Voswinckel JESC and Voswinckel JAHA were prior art to the ’793 patent. Final Dec. 11–12; Paper 81, 2 (“the Board’s analysis did not consider whether the research aids themselves were available prior to the critical date”).” slip op. at 5
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedReference is prior artDecided for petitioner
“disseminated to the interested public, ‘public accessibility’ has been called the touch-stone in determining whether a reference constitutes a ‘printed publication.’” Jazz Pharm., Inc. v. Amneal Pharm., LLC, 895 F.3d 1347, 1356 (Fed. Cir. 2018) (quoting In re Hall, 781 F.2d 897, 898–99 (Fed. Cir. 1986)). A reference is considered publicly accessible if it was “disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it.” Id. at 1355–56 (citing In re Wyer, 655 F.2d 221, 226 (CCPA 1981)). Under at least some circumstances, a reference may be a printed publication under § 102(b) if it was “displayed to the public,” even if it “was not later indexed in any database, catalog, or library.” In re Klopfenstein, 380 F.3d 1345, 1350 (Fed. Cir. 2004). There are several factors relating to whether such a display is sufficient to constitute a printed publication, including “the length of time the display was exhibited, the expertise of the target audience, the existence (or lack thereof) of reasonable expectations that the material displayed would not be copied, and the simplicity or ease with which the material displayed could have been copied.” Id. In addition, distribution of a reference at a professional conference may, under at least some circumstances, constitute sufficient dissemination to show public accessibility. Nobel Biocare Services AG v. Instradent USA, Inc., 903 F.3d 1365, 1375–80 (Fed. Cir. 2018); Medtronic, Inc. v. Barry, 891 F.3d 1368, 1380–83 (Fed. Cir. 2018).” slip op. at 8
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)UnpatentableUnpatentable
“whether the Voswinckel JESC and Voswinckel JAHA references qualify as prior art” and in particular “whether the Voswinckel JESC and Voswinckel JAHA references were publicly accessible by way of their presentation and/or inclusion in distributed materials, such as at a conference.” Paper 81, 3. As discussed above, we find that both references were distributed sufficiently at professional conferences to be publicly accessible at the time of those conferences. By virtue of this public accessibility, both Voswinckel JESC and Voswinckel JAHA were printed publications early enough to qualify as prior art under 35 U.S.C. § 102(b). G. Asserted Obviousness over ’212 Patent, Voswinckel JESC, and Voswinckel JAHA Petitioner argues that claims 1–8 would have been obvious over the combination of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA. Pet. 30–46. As discussed above, Petitioner has shown by a preponderance of the evidence that both Voswinckel JESC or Voswinckel JAHA qualify as prior art. Accordingly, we do not disturb the obviousness analysis in the Final Written Decision, which relies on the prior-art status of Voswinckel JESC and Voswinckel JAHA. Final Dec. 12–35. slip op. at 12
§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,716,793 - Illumina, Inc. v. Ravgen, Inc.No claims unpatentablePTAB · Jan 25, 2023 · IPR2021-01271 · APJ David Cotta · IPR · Final written decision
Claims 1, 3–9, 21, 22, and 24–30 were not shown unpatentable because Illumina did not prove that glucose in the cited ACD samples necessarily impeded cell lysis.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner did not expressly contest this definition during trial, noting only that “Dr. Van Ness meets [this] definition” and “confirms [that] his opinions are the same under either party’s definition.” PO Resp. 6 (citing Ex. 2239 ¶¶ 20–25). To the extent there are minor differences in the above 14 definition and the alternative definition offered by Dr. Van Ness (Ex. 2239 ¶ 23), Dr. Van Ness’s proposal is too broad for at least the reason that it does not require the POSA have experience collecting and analyzing cell-free DNA from blood samples—subject matter relevant to the claims and applied art. Accordingly, we continue to apply Petitioner’s proposed definition here.13 In any event, the parties’ technical declarants meet or exceed either definition and there is no indication that their opinions would change depending on which definition was applied, and no argument from the parties to the contrary. Ex. 1056 ¶¶ 5–10 (overview of qualifications and experience); Ex. 2239 ¶¶ 4–7 (same).” slip op. at 14
- Claim Construction › Intrinsic evidence (Phillips canons) › Specification disavowal / 'present invention' languageDisclaimer foundTerm construed board ownDecided for patent owner
“presents is whether a claimed agent that inhibits cell lysis may be a chelator used as an anticoagulant. The Specification and prosecution history make clear that at least one anticoagulant chelator—EDTA—is excluded from satisfying the claimed agent as recited in claim 1. As discussed above, the Specification describes an example where a sample processed in a tube with only EDTA is described as processing a sample in the “absence” of an agent that inhibits cell lysis. Ex. 1001, 89:35–57 (describing, in contrast, the EDTA + formalin sample as showing an example in the “presence of inhibitors of cell lysis”). If EDTA alone could be read as meeting the “agent” limitation, that example would make no sense. Petitioner provides no persuasive argument otherwise. The prosecution history buttresses the exclusion of the anticoagulant chelator EDTA from being the claimed “agent.” For example, during prosecution of the related ’277 patent, the Examiner at one point expressly 20 identified the EDTA in the tubes of a prior art reference as satisfying the agent term, prompting applicant’s argument that the Office was “incorrect” in doing so, and further distinguishing EDTA as merely “a well-known chelator of calcium and magnesium” that is added to blood “as an anticoagulant due to its ability to chelate calcium.” Ex. 2064, 1196 (arguing “EDTA is clearly referred to as a chelator in Applicant’s specification, not as a cell lysis inhibitor”); supra Section I(E); Ex. 1001, 32:61–64 (listing EDTA and EGTA as chelators). This, in turn, convinced the Examiner to withdraw the finding that EDTA was an “agent” as claimed and move on to art that disclosed formaldehyde as meeting that claim term. Ex. 2064, 1024 (Examiner interview summary noting that “applicant pointed out [that] EDTA could not be defined as a cell lysis inhibitor but rather was simply an anticoagulant”). This colloquy during prosecution evidences a clear and unmistakable disavowal of EDTA as being the claimed “agent.” Having determined that Patent Owner disavowed EDTA as the claimed “agent,” we next consider whether the disavowal extends more broadly to other anticoagulant chelators and, specifically, to ACD. On this record, we find that it does as explained below. In distinguishing EDTA from being the “agent,” Patent Owner relied not on properties that are unique to EDTA, but on the fact that it was a “well-known chelator” used as an anticoagulant in this technical field. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was simply an anticoagulant chelator, we find that a POSA would also have understood other anticoagulant chelators as subject to Patent Owner’s disavowal.” slip op. at 20
- Novelty / Anticipation (§102) › Priority / effective filing date / continuation supportReference is prior artDecided for petitioner
“20 Before institution, Patent Owner contested the sufficiency of Petitioner’s showing on whether Landes was entitled to the priority benefit of the filing date of the Landes provisional application. We disagreed that Petitioner’s showing was insufficient. Inst. Dec. 43–47. Patent Owner did not raise any issue during trial about Landes’s prior art status and, thus, has forfeited any argument that Landes is not prior art. On this record, we determine that Landes is § 102(a) prior art based on its July 31, 2003, publication date. On this record, we do not presume the claims of the ’720 patent are entitled to any earlier priority date of other applications listed in its ancestral chain. PowerOasis, Inc. v. T-Mobile USA, Inc., 522 F.3d 1299, 1305 (Fed. Cir. 2008) (explaining that “there is simply no reason to presume that claims in a [CIP] application are entitled to the effective filing date of an earlier filed application”). That is especially true with the patent’s complex priority chain, involving several CIPs leading back to a provisional application filed 26” slip op. at 26
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureNot shown unpatentableInherency not foundNot shown unpatentable
“Altogether, considering the argument and evidence of record, Petitioner has shown, at best, that it is possible for glucose to help impede cell lysis by reason of isotonicity and providing a nutrient source. But such possibilities are not enough for Petitioner to prevail on its challenge to the claims as anticipated by Landes. In re Oelrich, 666 F.2d 578, 581 (CCPA 1981) (“Inherency, however, may not be established by probabilities or 41 possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”) (internal quotation and citation omitted); Guangdong Alison Hi-Tech, 936 F.3d at 1364 (same). Petitioner has not, on this record, met its burden to show that the glucose component of ACD in Landes’s specific method is an “agent that impedes cell lysis” in the manner claimed.” slip op. at 41
Patent outcomesUS 7,727,720 not shown unpatentableClaim construction§ 102 anticipationcites KSR · GrahamPatents in suitUS 7,727,720 - Illumina, Inc. v. Ravgen, Inc.No claims unpatentablePTAB · Jan 25, 2023 · IPR2021-01272 · APJ Timothy G Majors · IPR · Final written decision
Illumina did not prove claims 55–63, 66–69, 80–91, 94–96, 126–130, 132, and 133 unpatentable because the asserted grounds failed.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Patent Owner did not expressly contest this definition during trial, noting only that “Dr. Van Ness meets [this] definition” and “confirms his opinions are the same under either party’s definition.” PO Resp. 6 (citing Ex. 2239 ¶¶ 20–25). To the extent there are minor differences in the above definition and the alternative definition offered by Dr. Van Ness (Ex. 2239 ¶ 23), we find that Dr. Van Ness’s proposal is too broad for at least the reason that it does not require the POSA have experience collecting and analyzing cell-free DNA from blood samples—subject matter relevant to the claims and asserted art. Accordingly, we continue to apply Petitioner’s proposed definition here.14 In any event, the parties’ technical declarants meet or exceed either definition and there is no indication that their opinions would change depending on which definition was applied. Ex. 1056 ¶¶ 5–10 (overview of qualifications and experience); Ex. 2239 ¶¶ 4–7 (same).” slip op. at 17
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“that anticoagulant chelators are not the claimed “agent” and, accordingly, that “Landes’s disclosure of ACD (and its dextrose component) fails to meet the ‘agent’ limitation.” Id. at 17–19 (citing the aforementioned prosecution history). Second, even if the dextrose of ACD is not excluded from the scope of the “agent” term as a matter of claim interpretation, Patent Owner argues that Petitioner fails to provide evidence sufficient to show that dextrose in Landes’s ACD tubes and method necessarily “inhibits lysis of cells” as claimed. Id. at 19–20; 26–34 (arguing, inter alia, that a “mere possibility” of ACD’s dextrose component inhibiting lysis in Landes’s method is not enough); PO Sur-Reply 10–12 (arguing that Petitioner’s contentions about dextrose regulating “isotonicity” or providing a “nutrient source” for cells are belated and otherwise substantively flawed).23” slip op. at 32
- Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable
“warning against formaldehyde’s use and recommending other fixatives altogether. Id.; Ex. 2150 (Srinivasan), 6 (“A method to overcome the problems of formaldehyde is to use an alternative fixative that is better suited for the preservation of nucleic acids and proteins.”).33 Accordingly, Patent Owner contends that “significant evidence of negative perceptions of formaldehyde” would have dissuaded the modification of Lo proposed by Petitioner. PO Resp. 46–47; PO Sur-Reply 18–20.34 3. Analysis On the complete record developed through trial, we agree with Patent” slip op. at 56
- Obviousness (§103) › Objective indicia / secondary considerationsNot reached
“warning against formaldehyde’s use and recommending other fixatives altogether. Id.; Ex. 2150 (Srinivasan), 6 (“A method to overcome the problems of formaldehyde is to use an alternative fixative that is better suited for the preservation of nucleic acids and proteins.”).33 Accordingly, Patent Owner contends that “significant evidence of negative perceptions of formaldehyde” would have dissuaded the modification of Lo proposed by Petitioner. PO Resp. 46–47; PO Sur-Reply 18–20.34 3. Analysis On the complete record developed through trial, we agree with Patent” slip op. at 56
Patent outcomesUS 7,332,277 not shown unpatentable§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 7,332,277 - Laboratory Corporation Of America Holdings v. Ravgen, Inc.No claims unpatentablePTAB · Dec 12, 2022 · IPR2021-01026 · APJ David Cotta · IPR · Final written decision
Claims 1–9 and 21–30 were not shown unpatentable: Lee did not establish that ACD dextrose impeded cell lysis, and Sorenson/Rao lacked motivation to combine because formaldehyde was known to damage nucleic acids.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Dr. Van Ness’s proposed POSA level is too broad. Under that proposal, an individual with, for example, an undergraduate degree in microbiology and three years’ work experience studying the habitats of bacteria might qualify as a POSA. It is not clear that such a person would have sufficient, relevant experience in the detection of chromosomal abnormalities, especially through non-invasive methods for detecting fetal 10 genetic abnormalities in maternal samples, as described in the ’720 patent. See, e.g., Ex. 1001, 1:22–5:44 (Field of Invention and Background Art). Petitioner’s proposal of the POSA level is more precise because it requires familiarity with techniques for detecting cell-free DNA in biological samples, which is relevant to the prior art and the claimed technology. Petitioner’s proposal also appears to be more consistent with the cited prior art. 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). Accordingly, we adopt Petitioner’s POSA level here, but note that our other determinations on this record would not change under Patent Owner’s POSA level.12” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Prosecution history disclaimer / disavowalTerm construed board ownDisclaimer foundDecided for patent owner
“Owner relied not on properties unique to EDTA, but on the fact that it was a “well-known chelator” and anticoagulant: [T]he assertion by the Office that EDTA is a cell lysis inhibitor is simply incorrect. . . EDTA is not an “agent that inhibits cell lysis.” Rather, EDTA is a well-known chelator of calcium and magnesium. EDTA is routinely added to blood during the blood collection process as an anticoagulant due to its ability to chelate calcium. Ex. 2064, 1196. Given Patent Owner’s clear intent to exclude EDTA from the scope of the claimed “agent” on the basis that it was a chelator and an anticoagulant, we find that a POSA would have understood other chelators and anticoagulants to also be excluded from the scope of the claimed agent. Consistent with this understanding, during subsequent prosecution of the application that issued as the ’720 patent, Patent Owner argued that the Holodniy reference, which disclosed a method of detecting free nucleic acid in which blood was collected in tubes containing ACD, “fail[ed] to teach or suggest a method for detecting free nucleic acid comprising, inter alia, isolating free nucleic acid from a non-cellular fraction of a sample, wherein an agent that impedes cell lysis has been added.” Ex. 1003, 1428 (emphasis added). On the salient point here, the Examiner agreed, concluding that “Holodniy et al. teach a method of detecting free nucleic acid which comprises all of the limitations of Claim 1, except these authors do not teach that their samples comprise an agent that impedes cell lysis.” Id. at 1344 (emphasis added); see also id. at 1156 (finding that Adams et al., a reference that also collects blood in tubes containing ACD, taught “all of the limitations recited in Claim 1 except these authors do not teach adding an agent that impedes cell lysis to the sample.”). And Patent Owner argues 15 persuasively, without dispute from Petitioner, that ACD is the “only” addition to the collection tubes besides the blood sample itself. Sur-reply 4 (citing Ex. 1016, 2; Ex. 2023, 20:52–54). This supports that neither the Examiner nor the Patent Owner considered ACD as an anticoagulant chelator to be an “agent,” as that term is used in claim 1. Accordingly, we construe the phrase “agent that impedes cell lysis” to” slip op. at 15
- Strike new argumentNew argument consideredDecided for petitioner
“function to prevent cell lysis, “by: (1) interacting with and stabilizing the cell membrane; (2) maintaining osmolarity so that the cells do not rupture; and (3) providing a nutrient source.” Reply 3 (citing Ex. 1002 ¶¶ 22–23; 2001 ¶ 169; Ex. 1059 ¶ 5; Ex. 1054, 125:3–127:12; 1057, 3–4, and Ex. 1056, 7– 13, 15–19, 24). Patent Owner argues that the evidence as to how dextrose functions to prevent cell lysis should have been presented in the Petition. Sur-reply 16. On this record, we do not agree. While this evidence could have been included in the Petition, it is responsive to arguments raised in Patent Owner’s response. See PO Resp. 18–22. In any event, consideration of this evidence simply explains how and why dextrose has the capacity to impede cell lysis, and we have already found that the ’720 patent provides 25 evidence that dextrose has this capacity. Under the circumstances, it was therefore reasonable for Petitioner, in the Petition, to rely on such disclosures of the patent itself. Further, consideration of how and why dextrose impedes cell lysis largely benefits Patent Owner, by providing reasons why dextrose might not inhibit cell lysis under the specific circumstance present in Lee.” slip op. at 25
- Expert testimonyPetitioner expert discountedPatent owner expert creditedMixed
“interact with and stabilize the cell membrane. Reply 3 (citing Ex. 1002 ¶¶ 22–23). In the cited testimony, Dr. Edwards states, “it was known that carbohydrates have a role in membrane stabilization” and that dextrose “is a membrane stabilizer.” Ex. 1002 ¶¶ 22–23. This is consistent with the teaching in the ’720 patent that glucose is “[a]n agent that stabilizes cell membranes.” See e.g., Ex. 1001, 6:49–56. The evidence thus supports that dextrose can help to stabilize cell membranes. However, this evidence is tempered by evidence supporting that the “impact of carbohydrates on biological membranes is extremely complex” and that it is “extremely difficult to predict how solutes such as carbohydrates will affect biological membranes.” Ex. 2231, 60:18–61:2, 83:14–18 (Dr. Edwards testimony). This is because “there’s a finite but long – long list of variables that will impact the – the mechanism by which carbohydrate interacts with the cell membrane.” Id. at 66:20–67:7; see also id. at 66:1–15 (identifying temperature, concentration and pressure as variables that play a role in how carbohydrates interact with biological membranes); id. at 68:1–17 (identifying prior and simultaneous exposure to other substances as variables that play a role in how carbohydrates interact with biological membranes). 26 Petitioner also provides evidence that dextrose helps prevent cell lysis by “maintaining osmolarity so that cells do not rupture.” Reply 3 (citing Ex. 2001 ¶ 169; Ex. 1056, 7–13, 24; Ex. 1059 ¶ 5). We agree that the cited evidence supports that dextrose has the ability to prevent cell rupture by maintaining isotonicity. In particular, Rapoport found that erythrocytes in an acid-citrate glucose solution underwent osmotic hemolysis at a slower rate than erythrocytes in a simple citrate solution. Ex. 1056, 613. However, Patent Owner introduces evidence, which we credit, that the failure to maintain isotonicity does not necessarily cause cell lysis. Ex. 2299, 237:4– 16 (Dr. Edward’s testimony). For example, cells placed in a hypertonic solution may “shrink or kind of shrivel” rather than burst, and cells placed in a hypotonic solution may swell, but will not necessarily lyse. Id. at 245:3– 16, 246:17–247:8.” slip op. at 26
Patent outcomesUS 7,727,720 not shown unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 7,727,720 - 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 - Liquidia Technologies, Inc. v. United Therapeutics CorporationAll claims unpatentablePTAB · Jul 19, 2022 · IPR2021-00406 · APJ Christopher M Kaiser · IPR · Final written decision
Claims 1–8 are unpatentable as obvious over the ’212 patent, Voswinckel JESC, and Voswinckel JAHA; the Board did not reach the other grounds.
RulingsFinal written decision- Strike new argumentNew argument consideredDecided for petitioner
“Petitioner is permitted a “limited opportunit[y]” to present new evidence in or with its Reply, as long as that new evidence is “responsive to the prior briefing” and does not constitute “changing theories after filing [the] petition.” Hulu, LLC v. Sound View Innovations, LLC, IPR2018- 01039, Paper 29, at 14–15 (PTAB Dec. 20, 2019) (precedential). Here, both of the arguments that Patent Owner alleges are new—the argument that Voswinckel JESC and Voswinckel JAHA were presented publicly and the argument that these references were cited in other publicly available references—respond to Patent Owner’s argument in the Patent Owner Response that Voswinckel JESC and Voswinckel JAHA were not publicly accessible. PO Resp. 11–18. The argument that Voswinckel JESC was publicly presented is not a change in theory from the Petition, because Petitioner presented this argument in the Petition. Pet. 22. As to both Voswinckel JESC and Voswinckel JAHA, Petitioner’s Reply evidence showing citation to the references in other publicly accessible documents is merely additional evidence supporting Petitioner’s original theory that a person of ordinary skill in the art could have located the references. Accordingly, we find that the following arguments made by Petitioner are not untimely: (1) that Voswinckel JESC was presented publicly, (2) that Voswinckel JESC was referenced in a publicly accessible document, and (3) that Voswinckel JAHA was referenced in a publicly accessible document.” slip op. at 10
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“Voswinckel JESC and Voswinckel JAHA were publicly accessible. “[T]he presence of a ‘research aid’ can . . . establish public accessibility” of a reference if that research aid “provide[s] a skilled artisan with a sufficiently definite roadmap leading to” the reference by “provid[ing] enough details [to] determine that an interested party is reasonably certain to arrive at the destination: the potentially invalidating reference.” Blue Calypso, LLC v. Groupon, Inc., 815 F.3d 1331, 1350 (Fed. Cir. 2016). Here, Petitioner directs us to research aids for finding both Voswinckel JESC and Voswinckel JAHA: a “June 2005 Ghofrani article in the journal Herz” for the former, and “a March 2005 article authored by Roxana Sulica et al. in the Expert Review of Cardiovascular Therapy” for the latter. Reply 3, 7 (citing Ex. 1010, 298, 301; Ex. 1104, 359). The Ghofrani article cites Voswinckel JESC as providing a solution to patients experiencing “pain at the injection site” by replacing injected treprostinil for “pulmonary arterial hypertension” with “inhaled treprostinil.” Ex. 1010, 298 (citing reference 6), 301 (defining reference 6 as Voswinckel JESC). The Ghofrani article also discusses the study reported in Voswinckel JESC, summarizing both the “major reduction in pulmonary selective pressure and resistance” and the lack of “adverse effects” described in Voswinckel JESC. Id. The Sulica article cites to Voswinckel JAHA, explaining that the reference reports that “inhaled treprostinil demonstrated substantial pulmonary vasodilatory efficacy in acute administration, as well as symptomatic and functional benefit in chronic use in a small number of PAH patients.” Ex. 1104, 351, 359. Thus, both the Ghofrani article and the Sulica article provide roadmaps directing a person of ordinary skill in the art looking for successful studies discussing the use of inhaled treprostinil in pulmonary arterial hypertension straight to Voswinckel JESC or Voswinckel JAHA. Because these articles provide these roadmaps, they are “research aid[s]” that “establish [the] public accessibility” of Voswinckel JESC and Voswinckel JAHA. Blue Calypso, 815 F.3d at 1350.” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“The preponderance of the evidence supports Petitioner’s position. Patent Owner is correct that Voswinckel JESC notes that side effects could occur more frequently at higher doses than at lower doses. Ex. 1007, 7. But there is considerable evidence of record that a person of ordinary skill in the art would not have avoided increasing Voswinckel JESC’s dose due to the side effects reported in Voswinckel JESC. First, Dr. Hill testifies that “[p]otential side effects are always weighed against potential clinical benefit, and pulmonary arterial hypertension is a serious, life-threatening disease where physicians and patients are more willing to tolerate side effects . . . to obtain clinical benefit.” Ex. 1106 ¶ 74. Second, Dr. Waxman testifies that “[u]sually the headache goes away” and “there are things that can be done to help ameliorate the cough so in general we are able to get over that issue.” Ex. 1108, 101:19–102:10. Together with Voswinckel JESC’s description of potential side effects as “mild and transient,” this evidence supports a finding that a person of ordinary skill in the art would not have been deterred from pursuing the course that is supported by the evidence to which Petitioner directs us. With respect to reasonable expectation of success, Petitioner argues that a person of ordinary skill in the art would have had a reasonable expectation of success in combining the teachings of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA because Voswinckel JAHA teaches that “[t]olerability is excellent” for its short-duration, high-concentration treprostinil inhalation therapy. Pet. 33 (citing Ex. 1008, 3). Other than the argument discussed above about side effects reported in Voswinckel JESC, Patent Owner does not raise any timely counter to this argument.8 PO Resp. 10–40. The record supports Petitioner’s argument. Ex. 1008, 3. Accordingly, Petitioner has shown by a preponderance of the evidence that a person of ordinary skill in the art would have had a reason to combine the teachings of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA and that they reasonably would have expected to succeed in doing so.” slip op. at 20
- Obviousness (§103) › Objective indicia / secondary considerations › Unexpected resultsDecided for petitioner
“[U]nexpected results must establish . . . a difference between the results obtained and those of the closest prior art.” Bristol-Myers Squibb v. Teva Pharms. USA, 752 F.3d 967, 977 (Fed. Cir. 2014). Petitioner argues that the prior art over which Patent Owner argues the challenged claims showed unexpected results is not the closest prior art. Reply 24. We agree. As noted above, Patent Owner argues that the challenged claims show unexpected results over inhaled iloprost, intravenous epoprostenol, and intravenous treprostinil. PO Resp. 55–57. But the challenged claims recite inhaled treprostinil, and, as discussed above, inhaled treprostinil is taught by each of the ’212 patent, Voswinckel JESC, and Voswinckel JAHA. Ex. 1001, 18:22–44; Ex. 1006, code (57); Ex. 1007, 7; Ex. 1008, 3; Ex. 1035, 582. Patent Owner does not even allege that the results of the challenged claims are unexpected over these references.9 Accordingly, we find that the evidence of record does not establish that the challenged claims produced a result that was unexpected over the closest prior art. slip op. at 22
Patent outcomesUS 10,716,793 unpatentable§ 102 anticipation§ 103 obviousnesscites PhillipsPatents in suitUS 10,716,793 - PTAB · May 31, 2022 · IPR2022-00402 · APJ Michael A Valek · IPR · Institution
The Board instituted IPR on claims 1–30, finding a reasonable likelihood of success on the anticipation challenge and all asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Petitioner has shown that Pioneer Hi-Bred discloses examples of synthetic guide RNA and crRNA molecules having the recited modifications at their 3’ and 5’ ends. See Pet. 20–24 (referring to Table 8 of Ex. 1006). That disclosure undermines the Applicant’s arguments during prosecution that: (1) “a skilled person would not modify a CRISPR guide RNA or crRNA at the particularly claimed positions,” and (2) the reference to “‘securing or steadying the structure’ of RNA in [Zhang] relates to secondary structure” as opposed to “modifications at the claimed positions,” i.e. within five nucleotides from one or both of the ends. Ex. 1002, 783. Both of these arguments were credited by the Examiner as reasons for withdrawing the rejection over Zhang. Id. at 783–784. Thus, Petitioner has sufficiently shown that the Examiner materially erred by not recognizing the relevance of Pioneer Hi-Bred’s disclosure and in particular the crRNA examples in Table 8.” slip op. at 10
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Institution denied fintivDenied
“On the current record, we determine that the merits of Petitioner’s anticipation ground appear to be particularly strong for the independent claims and for those dependent claims where Petitioner’s arguments are similarly premised on the crRNA examples in Table 8 being anticipatory without any further modification. See infra § V.E (explaining that, on the current record, Petitioner has shown that Pioneer Hi-Bred Table 8 discloses presumptively-enabled examples that read on claims 1 and 12 as well as a number of the dependent claims). Accordingly, we find that this factor weighs strongly against exercising discretion to deny institution. G. Weighing of Fintiv Factors Considering the Fintiv factors as part of a holistic analysis of the factors discussed above, we are not persuaded that the interests of the efficiency and integrity of the system would be served by invoking our authority under 35 U.S.C. § 314(a) to deny institution of a potentially meritorious Petition. Accordingly, we do not exercise our discretion to deny institution under § 314(a).” slip op. at 18
- Skill levelSkill level board ownOther
“B. Level of Ordinary Skill in the Art Relying on the testimony of its declarant, Dr. Furneaux, Petitioner contends that a POSA “as of December 3, 2014 (the earliest possible priority date of the ’001 Patent) would have had a Ph.D. in molecular biology, biochemistry, or a related discipline.” Pet. 12 (citing Ex. 1003 ¶ 60). Patent Owner’s declarant, Dr. Marshall, applies the same definition for his analysis. Ex. 2003 ¶ 85. At this stage in the proceeding, we find this description of the level of ordinary skill in the art to be sufficiently supported by the record. Thus, for purposes of this decision, we adopt the description of a POSA noted above.” slip op. at 19
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“C. Claim Construction Neither party identifies any claim term for construction. Pet. 17; Prelim. Resp. 35. We agree that no formal claim construction is necessary at this stage of the proceeding. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (explaining that it is only necessary to “construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))).” slip op. at 21
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 10,337,001 - Streck, Inc. v. Ravgen, Inc.InstitutedPTAB · Apr 22, 2022 · IPR2021-01577 · APJ Timothy G Majors · IPR · Institution
The Board instituted inter partes review of claims 55–61, 68, 69, 80–86, 89–92, 94, 126–130, 132, and 133 on all asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Institution denied general plasticDenied
“We do not agree that General Plastic Factor 1 favors discretionary denial on this record. To be sure, Streck’s tubes feature prominently in Patent Owner’s infringement allegations against Quest, Natera, and other customers. See Exs. 2065, 2178, 2179, and 2196 (identifying, collectively, Streck’s tubes dozens of times). And, as evidenced by the filing of its own petition, Streck is also interested in seeing claims of the ’277 patent held unpatentable. But Streck is not a defendant in any action brought by Patent Owner related to the ’277 patent. Nor is there any assertion or indication that Streck’s blood collection tubes infringe the methods claimed in the ’277 patent. These facts, at minimum, distinguish this case from Valve. Valve at 9–10 (explaining that Valve and HTC were co-defendants sued at the same time in the same case, based on the same allegedly infringing devices that HTC and Valve co-developed).” slip op. at 17
- PTAB / AIA Trials › §315(b) time barNot time barredDecided for petitioner
“each case, taking account of equitable and practical considerations. CTPG 13; RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 at 7–8 (PTAB Oct. 2, 2020) (precedential) (hereafter “RPX”) (asking “whether the non-party is a clear beneficiary that has a preexisting, established relationship with the petitioner”) (quoting Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018)). Two questions are at the heart of the RPI inquiry: whether the non-party desires review of the patent and whether the petition has been filed at the non-party’s behest. RPX at 7–8; see also CTPG at 16 (explaining that a “common consideration” is “whether the non-party exercised or could have exercised control over a party’s participation in proceeding”). Privity is a more expansive concept because a privy need not be an RPI. RPX at 37; CTPG at 13.” slip op. at 59
- PTAB / AIA Trials › Real party in interest / privityRpi dispute resolved for petitionerDecided for petitioner
“each case, taking account of equitable and practical considerations. CTPG 13; RPX Corp. v. Applications in Internet Time, LLC, IPR2015-01750, Paper 128 at 7–8 (PTAB Oct. 2, 2020) (precedential) (hereafter “RPX”) (asking “whether the non-party is a clear beneficiary that has a preexisting, established relationship with the petitioner”) (quoting Applications in Internet Time, LLC v. RPX Corp., 897 F.3d 1336, 1351 (Fed. Cir. 2018)). Two questions are at the heart of the RPI inquiry: whether the non-party desires review of the patent and whether the petition has been filed at the non-party’s behest. RPX at 7–8; see also CTPG at 16 (explaining that a “common consideration” is “whether the non-party exercised or could have exercised control over a party’s participation in proceeding”). Privity is a more expansive concept because a privy need not be an RPI. RPX at 37; CTPG at 13.” slip op. at 59
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Altogether, we determine that Petitioner has met its threshold burden and established to a reasonable likelihood that at least claim 55 would have been obvious over Pertl and Granger. Petitioner cites evidence to support its assertions on the other challenged claims, none of which are separately argued by Patent Owner at this stage. Pet. 32–42. Considering Petitioner’s argument and evidence, Petitioner is reasonably likely to prevail in establishing that one or more of those additional claims are unpatentable over Pertl and Granger.” slip op. at 51
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 7,332,277 - PTAB · Apr 12, 2022 · IPR2021-01565 · APJ Robert A Pollock · IPR · Institution
The Board instituted IPR on claims 1–24, finding a reasonable likelihood that at least one challenged claim is unpatentable based on the petition’s asserted grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Legal Standards “In an [inter partes review], 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) (2012) (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).” slip op. at 22
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner proposes two highly similar and interrelated versions of a person of ordinary skill in the art. The first comprises 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”). Pet. 24–25; Ex. 1002 ¶¶ 97–98; Ex. 1004 ¶¶ 54–55. In the second, Petitioner recasts the above team as a collection of skilled artisans in complementary fields, specifically, an Engineer POSA receiving assistance from, or equivalent to that provided by, a Clinician POSA; a Clinician POSA receiving assistance from, or equivalent to that provided by, an Engineer POSA; or a single person with the qualifications of both an Engineer POSA and a Clinician POSA. Pet. 25; Ex. 1002 ¶ 99; Ex. 1004 ¶ 56. However phrased, Petitioner’s proposed definition indicates a high level of skill in the relevant art.” slip op. at 25
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Other
“Consistent with this portion of the Specification, the parties agree that maintaining systemic pressure excludes “reducing pressure like prior treatments.” See Prelim. Resp. 13, 20 (quoting Pet. 26). But because the record does not make clear how broadly one of ordinary skill in the art would have defined hypotension—let alone the conditions under which hypotension activates the renin angiotensin aldosterone system—the parties are encouraged to address how one of ordinary skill in the art would understand the range of pressure (if any)—and any permissible temporal variance—encompassed by the term “maintaining.”” slip op. at 30
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Considering the intrinsic record and the testimony of Dr. Garcia, Petitioner has the better argument on present record. For the purpose of institution, we provisionally construe “maintaining intravascular pressure,” as used in independent claims 1 and 13 to mean, “maintaining pressure within blood vessels or a blood vessel” and encompassing: 1) maintaining a systemic pressure that does not lead to hypotension; 2) maintaining an isolated region of reduced pressure between pairs of occlusion devices; and 3) maintaining a region of reduced pressure in the vicinity of an occlusion device. The parties are encouraged to submit additional argument and evidence as to the meaning of this term at trial. 2. “distal restrictor,” the catheter extends across a vein wall,” and “resistors” Patent Owner “does not take a position on the constructions of the remainder of [the terms addressed by Petitioner] for the purposes of this Preliminary Response because no issue that must be decided by the Board depends on them.” Prelim. Resp. 12. While we agree with Patent Owner that our Decision on Institution does not depend on a precise meaning of “distal restrictor,” “the catheter extends across a vein wall,” or “resistors.” Petitioner presents reasoned argument and evidence as to their meaning, which we find useful in understanding the claims as a whole, and Petitioner’s proposed definitions appear consistent with the intrinsic evidence of record. In the interest of clarity, we provisionally adopt Petitioner’s proposed definitions for these terms, and invite Patent Owner to address the meaning of any relevant claim term at trial.” slip op. at 31
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,639,460 - PTAB · Feb 9, 2022 · IPR2021-01339 · APJ David Cotta · IPR · Institution
The Board instituted inter partes review of claims 1–16, 18–26, and 28–31, finding a reasonable likelihood that Brcka anticipates some challenged claims and renders the others obvious.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Decided for petitioner
“35 U.S.C. § 314(a) and deny institution in light of the advanced stage of the parallel district court proceedings involving the ’538 patent. Prelim. Resp. 5–27; Prelim. Sur-reply 1–5. Petitioner contends that Petitioner is not a party to any of the parallel district court proceedings involving the ’538 patent, and resolution of those parallel proceedings would not resolve the dispute between Petitioner and Patent Owner with respect to the present proceeding. Pet. 10–15; Prelim. Reply 1–5. In assessing whether to exercise such discretion, the Board weighs six non-exclusive factors, known as the Fintiv factors. Apple Inc. v. Fintiv, Inc., IPR2020-00019, Paper 11 at 6 (PTAB Mar. 20, 2020) (precedential) (“Fintiv”). Recognizing that “there is some overlap among these factors” and that “[s]ome facts may be relevant to more than one factor,” the Board “takes a holistic view of whether efficiency and integrity of the system are best served by denying or instituting review.” Id.” slip op. at 7
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“are anticipated by Brcka. Pet. 30–44. We provided an overview of the prior art above. Petitioner shows, based on this preliminary record, where each of the limitations of the challenged claims is disclosed in Brcka. Id. Petitioner’s assertions are backed by the cited prior art and by the testimony of its declarant, Dr. Shanfield. Id.; see also Ex. 1003 ¶¶ 68–107. On this preliminary record, we determine that Petitioner’s arguments and evidence are sufficient for purposes of institution. We focus our discussion on Patent Owner’s arguments to provide guidance to the parties. Prelim. Resp. 38–44.” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“illustrating Brcka’s “fault detection analysis.” Pet. 32–33; see also, Ex. 1003 ¶¶ 72–73. Figure 4 is a “flow diagram demonstrating operation of a learning system and a neural network model designed in accordance with at least one embodiment of [Brcka’s] invention.” Ex. 1005 ¶ 44. In step 415 of the operation disclosed in Figure 4, “a determination is made whether maintenance has been performed or a machine failure has occurred.” Id. ¶ 44, Fig. 4. In step 440, “a determination is made whether maintenance is needed.” Id. ¶ 45; Fig. 4. Thus, Brcka determines whether a failure has occurred, accounts for this determination by assigning a “reward value” (Fig. 4, step 425), and then decides whether maintenance is needed. On this record, the analysis reflected in these steps qualifies as a “fault detection analysis.”” slip op. at 21
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Obviousness over Brcka Petitioner asserts that claims 3–5, 7, 8, 14–16, 20, 24–26, 30, and 31 would have been obvious over Brcka. Pet. 31–33. Petitioner provides documentary and testimonial evidence to back its assertions. Id.; see also Ex. 1003 ¶¶ 108–143. Patent Owner argues that claims 3–5, 7, 8, 14–16, 20, 24–26, 30, and 31 are not rendered obvious by Brcka because of the alleged shortcomings of Brcka with respect to the claims challenged as being anticipated, and because Petitioner has not asserted the knowledge of a POSA remedies these alleged shortcomings. See Prelim. Resp. 45. For the reasons discussed above, on the current record, we do not find these arguments persuasive. IV. CONCLUSION On this preliminary record, Petitioner has established a reasonable” slip op. at 26
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites KSR · GrahamPatents in suitUS 8,676,538
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.