- Amphastar Pharmaceuticals, Inc. v. Aegis Therapeutics, LLCSome claims unpatentablePTAB · Feb 9, 2023 · IPR2021-01324 · APJ Cynthia M Hardman · IPR · Final written decision
Claims 1, 2, and 7–17 are unpatentable under §102 or §103; claims 3–6 and 18–20 were not shown unpatentable.
RulingsFinal written decision- Expert testimonyPetitioner expert discountedDecided for patent owner
“in Table 1 and the formulations of Potta claim 21 (i.e., ‘from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof’), because such formulations would elicit the desired biological or medicinal response.” Ex. 1002 ¶ 272. Dr. Weinstein provides an essentially identical opinion. Ex. 1003 ¶ 286. Neither declarant supports their opinion with any explanation as to why the Potta formulations would provide the claimed plasma epinephrine concentration or elicit a biological or medicinal response. Accordingly, we do not credit these opinions, and determine that Petitioner has not met its burden to establish that Potta inherently anticipates claim 3. See n re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1368 (Fed. Cir. 2004) (“[T]he Board is entitled to weigh the declarations and conclude that the lack of factual corroboration warrants discounting the opinions expressed in the declarations.”).” slip op. at 29
- ExcludeMotion to exclude, deniedDenied
“As the moving party, Petitioner bears the burden of establishing that it is entitled to the requested relief. 37 C.F.R. § 42.20(c). Having considered the arguments and evidence of record, we determine that Petitioner has not met its burden of proof. We agree with Patent Owner that “[n]o bright line rule prohibits the consideration of post-priority date evidence,” and that such evidence is permissible in certain contexts. Opp. 2–3. On this record we do not find that there is sufficient cause to exclude the challenged exhibits, because any consideration by the Board of these exhibits has taken into account their alleged post-priority date status. Thus, we do not find that maintaining the exhibits in this proceeding results in any unfair prejudice to Petitioner, or that the exhibits have confused the issues before us. Accordingly, we deny Petitioner’s motion to exclude.” slip op. at 73
- Skill levelOther
“II. ANALYSIS A. Level of Ordinary Skill in the Art We consider the grounds of unpatentability in view of the” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableNot shown unpatentableMixed
“For the above reasons, on the full trial record we determine that” slip op. at 26
Patent outcomesUS 10,682,414 mixed§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 10,682,414 - Applied Materials, Inc. v. Ocean Semiconductor LLCAll claims unpatentablePTAB · Feb 7, 2023 · IPR2021-01339 · APJ David Cotta · IPR · Final written decision
Claims 1–16, 18–26, and 28–31 are unpatentable: claims 1, 2, 6, 9–13, 18, 19, 21–23, 28, and 29 are anticipated by Brcka; the remaining challenged claims are obvious over Brcka.
RulingsFinal written decision- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner’s proposal is generally consistent with the level of skill reflected in the specification and the cited prior art. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) 6 Patent Owner does not present objective indicia of nonobviousness in this case. See generally, PO Resp. 9 (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). And we agree with Patent Owner that “additional education can compensate for less work experience and vice versa.” Accordingly, we adopt Petitioner’s proposed definition of the POSA level with the additional clarification proposed by Patent Owner.” slip op. at 9
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not identify any claim terms that require construction. Pet. 18. Patent Owner does not dispute Petitioner’s assertion that no claim terms require construction. PO Resp. 16–17. We do not find it necessary to construe the claims in order to resolve this case. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co. Ltd., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (“[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy’” (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999))); Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy’”).” slip op. at 10
- Expert testimonyPetitioner expert creditedDecided for petitioner
“The implicit premise of Patent Owner’s argument is that Brcka discloses only failures and thus does not disclose “fault detection.” However, we credit the testimony of Dr. Shanfield that “[g]enerally you always need a fault to have a failure occur. So when there is a failure, a fault has occurred.” Ex. 2003, 74:6–11; see also Ex. 1003 ¶ 37 (“A fault is an abnormal tool condition, such as when a parameter strays beyond its acceptable boundary. Faults may lead to failure, which is the ‘termination of the ability of an item to perform a required function.’”) (internal citation omitted), 81 (“Machine failure, though, means that a fault condition existed requiring termination of the machine function upon the wafer.”). Thus, Brcka’s disclosure of analyzing machine failures is also, necessarily, a disclosure of a analyzing a fault. Accordingly, we find that Petitioner has established, by a preponderance of the evidence, that Brcka discloses “performing in a computer a fault detection analysis relating to processing of a workpiece.”” slip op. at 20
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“Petitioner cites to the embodiment depicted in Brcka’s Figure 4 as 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. If either of these things has happened, “a new reward value is calculated.” Id. 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.” We recognize that Brcka’s fault detection analysis is used in a method that includes a predictive component. But, we do not find anything in the language of claim 1 that precludes performing the fault detection analysis as part of a predictive model. Indeed, the claim language requires only “performing . . . a fault detection analysis.” Moreover, the “fault detection” itself (i.e., Brcka’s step 415), as opposed to the analysis of the detected fault, is backward-looking, not predictive; it determines “whether . . . a machine failure has occurred.” Id. ¶ 44 (emphasis added).” slip op. at 16
Patent outcomesUS 8,676,538 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites KSR · GrahamPatents in suitUS 8,676,538 - 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 - PTAB · Jan 11, 2023 · IPR2022-01225 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and grounds, finding a reasonable likelihood that claim 1 is anticipated by Dixon because the exclusion criteria likely lack patentable weight.
RulingsInstitution decision- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“Decision. See Ex. 3001, 12–23. In the -00881 Decision, challenged claim 1 of US 9,254,338 B2 (the “’338 patent”) recited preamble language identical to that recited in claim 1 of the ’681 patent, viz., “a method for treating an angiogenic eye disorder in a patient.” See Ex. 1001 col. 21, ll. 40–41; Ex. 3001, 7. The Board found that this preamble was limiting upon the remainder of the claim. Ex. 3001, 18. Specifically, the Board found that: Here, the claims are directed to methods of administering, i.e., using, a VEGF antagonist for an intended purpose of “treating an angiogenic eye disorder in a patient.” The Specification repeatedly characterizes the method as one for treating angiogenic eye disorders in patients. Apart from the preamble, the independent claims do not elsewhere recite or indicate any other use for the method steps comprising the administration of a VEGF antagonist. Thus, we determine that the preamble sets forth the essence of the invention—treating an angiogenic eye disorder in a patient. Additionally, we find that the preamble provides antecedent basis for claim terms “the patient” recited in the body of each independent claim, and “angiogenic eye disorders” recited in dependent claims 6, 7, 18, and 20. Indeed, without the preamble, it would be unclear to whom the doses of VEGF are administered. Thus, … in view of the evidence of record, namely, the claim language and the written description of the ’338 patent, we find that the preambles of method claims 1 and 14 are limiting insofar as they require “treating an angiogenic eye disorder in a patient.” Id. at 17–18 (citations omitted). We adopt this same reasoning here and find, for the purposes of this Decision, that the preamble of claim 1 reciting “[a] method for treating an angiogenic eye disorder in a patient” is limiting upon the claims.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITAPlain and ordinary meaningDecided for petitioner
“[W]hen the Specification explains that “[t]he amount of VEGF antagonist administered to the patient in each dose is, in most cases, a therapeutically effective amount,” and discloses that “a therapeutically effective amount can be from about 0.05 mg to about 5 mg,” we find that a POSA would have understood that any dosage amount within that range administered according to the invention may, in some cases, result in a detectable improvement in “one or more symptoms or indicia of an angiogenic eye disorder,” or be one that “inhibits, prevents, lessens or delays the progression of an angiogenic eye disorder,” or it may not. In either event, the VEGF antagonist would have been administered for the purpose of treating the eye disorder. In other words, the method of treating the patient with the eye disorder is performed upon administration of the VEGF antagonist to the patient for the purpose of achieving an improvement or beneficial effect in the eye disorder, regardless whether the dosage amount administered actually achieves that intended result. Id. at 21–22 (citation omitted). Furthermore, the Board found that: Patent Owner’s proposes that the claims require not only achieving a therapeutically effective result, but more specifically, achieving a “high level of efficacy that was noninferior to the standard of care by the time the patent was filed in 2011.” In the Sur-reply, Patent Owner describes a “highly effective treatment for angiogenic eye disorders” as “one that is on par to Lucentis or off-label Avastin and can produce visual acuity gains, not just slow vision losses.” The Specification refers to “a high level of efficacy” in one instance, i.e., in the “Background” section. The Specification does not describe there, or elsewhere that “treating,” in the context of the claims or in the art, requires achieving a “high level of efficacy” or providing results “on par to Lucentis or off-label Avastin.” Id. at 22 (citations omitted). We adopt the same reasoning here, and find that, for the purposes of this Decision, the evidence of record and the Specification support construing the preamble’s recitation of a “method for treating a patient with an angiogenic eye disorder” as meaning administering a compound, i.e., the recited VEGF antagonist, to such patient for the purpose of improving or providing a beneficial effect in their angiogenic eye disorder, but does not require a “high level of efficacy,” as proposed by Patent Owner. See Ex. 3001, 22.” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“construction of the claim terms “initial dose,” “secondary dose,” and “tertiary dose.” Petitioner proposes adoption of the definitions expressly set forth in the Specification of the ’681 patent, viz., that the initial dose is the dose “administered at the beginning of the treatment regimen,” and is followed by the secondary doses “secondary doses” are “administered after the initial dose,” and the tertiary doses are “administered after the secondary doses” and may be distinguished from the secondary doses “in terms of frequency of administration.” Ex. 1001 col. 3, ll. 36–44. We do not find persuasive Patent Owner’s argument that the definition of these terms require a high, or otherwise defined, degree of efficacy. As we stated in the -00881 Decision: Based on those express definitions in the Specification, we do not find cause to construe the terms differently. In particular, we do not find that the Specification requires the “tertiary doses” to maintain any efficacy gain achieved after the initial and secondary doses, or that the term suggests any specific level of efficacy. The Specification unequivocally states that “[t]he terms ‘initial dose,’ ‘secondary doses,’ and ‘tertiary doses,’ refer to the temporal sequence of administration of the VEGF antagonist.” Ex. 3001, 25 (emphasis added). We see no need or reason to upend this construction now and, for the purposes of this Decision, we adopt Petitioner’s proposed definition of the claim terms “initial dose,” “secondary doses,” and “tertiary doses” as the express definition provided by the ’681 Specification.” slip op. at 13
- Obviousness (§103) › Graham factors (scope of art, differences, level of skill)Instituted
“Claim(s) 35 U.S.C. § Reference(s)/Basis Challenged 4 1, 3–11, 13, 14, 103 Dixon alone or in view of 16–24, 26 Papadopoulos5 and/or Wiegand6 5 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Rosenfeld-20067, and if necessary, Papadopoulos patent and/or Wiegand 6 1, 3–11, 13, 14, 103 Dixon in combination 16–24, 26 with Heimann-2007, and if necessary, Papadopoulos and/or Wiegand” slip op. at 5
Claim construction§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 10,130,681 - PTAB · Jan 11, 2023 · IPR2022-01226 · APJ John G New · IPR · Institution
The Board instituted IPR on all challenged claims and all petition grounds, finding a reasonable likelihood that claim 34 is anticipated by Dixon.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“Under 35 U.S.C. § 314, the Board “may not authorize an inter partes review to be instituted unless … the information presented in the petition … and any response … 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.” Upon consideration of the Petition, Preliminary Response, Reply, Sur-Reply, and the evidence of record, we determine that the evidence presented demonstrates a reasonable likelihood that Petitioner would prevail in establishing the unpatentability of at least one challenged claim of the ’601 patent.” slip op. at 2
- PTAB / AIA Trials › Discretionary denial › General Plastic (serial petitions)Denied
“General Plastic, Paper 19 at 9–10. The purpose of the analysis thus established in General Plastic is to deny a Petitioner successive attacks on the claims of a single patent, and profiting from those prior attempts by altering a petition’s strategy in response to Patent Owner’s and the Board’s responses.” slip op. at 21
- PTAB / AIA Trials › Discretionary denial › Fintiv (parallel litigation)Denied
“an Interim Procedure for Discretionary Denials in AIA Postgrant Proceedings with Parallel District Court Litigation, available at: https://www.uspto.gov/sites/default/files/documents/interim_proc_discretion ary_denials_aia_parallel_district_court_litigation_memo_20220621_.pdf (last visited December 22, 2022) (the “Interim Procedure”). The Interim Procedure explains that “to benefit the patent system and the public good, the PTAB will not rely on the Fintiv factors to discretionarily deny institution in view of parallel district court litigation where a petition presents compelling evidence of unpatentability.” Interim Proc. 2. Specifically, the Interim Procedure states that: Where the information presented at the institution stage is merely sufficient to meet the statutory institution threshold, the PTAB has the authority, where warranted, to exercise discretion to deny institution in view of the other Fintiv factors. In contrast, where the PTAB determines that the information presented at the institution stage presents a compelling unpatentability challenge, that determination alone demonstrates that the PTAB should not discretionarily deny institution under Fintiv.” slip op. at 24
- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsDenied
“In performing an analysis under § 325(d): [T]he Board uses the following two-part framework: (1) whether the same or substantially the same art previously was presented to the Office or whether the same or substantially the same arguments previously were presented to the Office; and (2) if either condition of first part of the framework is satisfied, whether the petitioner has demonstrated that the Office erred in a manner material to the patentability of challenged claims.… If, after review of [Becton, Dickinson] factors (a), (b), and (d), it is determined that the same or substantially the same art or arguments previously were presented to the Office, then factors (c), (e), and (f) relate to whether the petitioner has demonstrated a material error by the Office. Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH, IPR2019-01469, Paper 6 at 8 (PTAB Feb. 13, 2020) (precedential). Consequently, we first turn to an analysis of Becton, Dickinson factors (a), (b), and (d) under this framework to determine whether the same or substantially the same art previously was presented to the Office or whether” slip op. at 26
Claim construction§ 102 anticipationDiscretionary denialcites PhillipsPatents in suitUS 10,888,601 - Abiomed, Inc. v. White Swell Medical Ltd.All claims unpatentablePTAB · Jan 6, 2023 · PGR2021-00107 · APJ Robert A Pollock · PGR · Final written decision
The Board canceled claim 3, found substitute claim 22 unpatentable as anticipated by Gille503, Gille501, and Mohl996, and granted the motion to amend in part.
RulingsFinal written decision- PTAB / AIA Trials › Motions to amend / substitute claimsMotion to amend granted in partGranted in part
“claims.” 35 U.S.C. § 326(d)(1)(B); see 37 C.F.R. § 42.221(a)(3) (“A motion to amend may cancel a challenged claim or propose a reasonable number of substitute claims.”). Patent Owner proposes the same number of substitute claims as the original challenged claims that are canceled, i.e., a one-to-one substitution of claim 3 with proposed substitute claim 22. MTA 1. “There is a rebuttable presumption that a reasonable number of substitute claims per challenged claim is one (1) substitute claim.” Lectrosonics, Paper 15 at 4. Petitioner does not argue otherwise.” slip op. at 28
- Skill levelSkill level petitioner adoptedDecided for petitioner
“In our Institution Decision we provisionally adopted Petitioner’s proposed definition of a person of ordinary skill in the relevant art (sometimes referred to herein as a “POSA”) as having “an M.D. or 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 would have “a Ph.D. in mechanical or biomedical engineering, or in a similar field.” DI 10 (citing Pet. 15; Ex. 1002 ¶ 72). This definition is uncontested and we continue to apply it here. See MTA 4–5. D.” slip op. at 32
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“Patent Owner’s contention that we should read “baseline blood pressure measurement” as limited to a single measurement determined prior to, or at the beginning of a procedure, nothing in claim 22 prohibits the device from recalculating a baseline blood pressure measurement, or comparing current blood pressure to the updated baseline. Proposed substitute claim 22 is not a method claim, but is directed to a device that is agnostic as to when a “baseline blood pressure measurement” is determined, as well as its source. Thus, even if the flow diagrams shown in Figure 11A and 11B of the ’069 Patent do not contain instructions to update the baseline pressures acquired in steps 302 and 354, respectively, this is not forbidden by proposed substitute claim 22 as written, and Patent Owner does not persuade us that such a limitation should be imported into the meaning of “baseline blood pressure measurement.”” slip op. at 34
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)UnpatentableUnpatentable
“For the reasons discussed above, we do not read the exemplary embodiments described in paragraph 14 of Gille503 as representative of the reference as a whole. Rather, we find more persuasive Dr. Day’s testimony that Gille503 satisfies Element 22[h] because one of ordinary skill in the art would have understood that “comparisons performed by the feedback loop would detect a change in blood pressure either when current sensed blood pressure ceases to equal the target blood pressure, or when current sensed blood pressure begins to equal target blood pressure after previously not equaling the target pressure.” Ex. 1014 ¶ 114; see generally, id. ¶¶ 111–119. Dr. Leschinsky also opines that the analysis in our Preliminary Guidance fails to satisfy the requirements of claim 22 because “the control module must specifically perform a comparison between a baseline measurement and another measurement.” Ex. 2006 ¶ 69 (emphasis added). We find it self-evident that this function is carried out by a control module, and agree with Petitioner and its expert that one of ordinary skill would understand Gille503 to describe a feedback loop comprising a control module “controlling balloon inflation based on sensor data to achieve a ‘target’ pressure.” Opp. MTA 13; Ex. 1014 ¶¶ 120–125. In view of the above, we find that one of ordinary skill in the art would understand Gille503 to disclose the “in a vein” and “comparing” limitations of the proposed substitute claim (elements 22[c]/[e] and 22[h], respectively). We have also considered Petitioner’s arguments and evidence with respect to the uncontested limitations. Considering the record as a whole, Petitioner has shown by a preponderance of the evidence that claim 22 is unpatentable as anticipated by Gille503. F.” slip op. at 45
Patent outcomesUS 10,926,069 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 10,926,069 - 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 - Genus PLC v. Inguran, LLCAll claims unpatentablePTAB · Dec 8, 2022 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Final written decision
Claims 1–5 are unpatentable as obvious over Dekkers, Maxwell, Garner, and Kim; the Board did not reach the alternative obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“Patent Owner agrees with Petitioner’s first portion of the definition, specifically, that a person of ordinary skill in the art would have had at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine.” PO Resp. 16. Patent Owner, however, objects to the inclusion of the second portion of Petitioner’s definition because it is “improperly injecting a purported knowledge of the claimed invention into the definition of a” person of ordinary skill in the art. Id. at 17 (citing Arendi S.A.R.L. v. Apple Inc., 832 F.3d 1355, 1362 (Fed. Cir. 2016); In re Sang Su Lee, 277 F.3d 1338, 1345 (Fed. Cir. 2002)); Sur-reply 2–4. Petitioner responds, that its proposed definition reflects the level of skill in the art as supported by the various cited prior art. Pet. Reply. 5. Having considered the arguments and evidence, we agree with Patent Owner that Petitioner’s definition of one of ordinary skill in the art unnecessarily recites specific knowledge, whereas the art itself demonstrates the level of skill in the art at the time of the invention. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (explaining that specific findings regarding ordinary skill level are not required “where the prior art itself reflects an appropriate level and a need for testimony is not shown”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Accordingly, we agree with Patent Owner and determine that one of ordinary skill in the art is a person having at least “an undergraduate or graduate degree in genetics, genomics, and/or animal breeding, along with several years of relevant applied research and/or industry work experience in the same fields, including in swine” and this definition is reasonably consistent with the ’734 patent and the prior art of record.” slip op. at 7
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownDecided for patent owner
“Having considered the record as a whole, we determine that Petitioner’s position with respect to the interpretation of “genetic nucleus” is reasonably supported within the record. At oral argument, however, Petitioner acknowledged that omitting the language “wherein certain offspring of the herd are used for breeding within the herd” from the claim construction would not change whether the challenged claims read on the applied references. See Tr. 14:6–16:28. Because the additional language proposed by Petitioner is unnecessary in order to resolve the disputed issues in this case, we do not adopt it here. We, therefore, construe “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy of herds in a commercial herd breeding structure. 2. Remaining Claim Terms We find that it is unnecessary to expressly construe any remaining claim terms for purposes of this Decision. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (“[C]laim terms need only be construed ‘to the extent necessary to resolve the controversy.’”) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). D. Ground 1A: Anticipation of Claims 1–5 by Dekkers, as evidenced by either Maxwell or Garner (claims 1–4), or Kim (claim 5)” slip op. at 13
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“We agree with Patent Owner that in an anticipation challenge under 35 U.S.C. § 102, Petitioner cannot rely upon specific disclosures in Maxwell or Gardner based on the generic reference to these publications cited Dekkers. Merely citing Maxwell or Gardner in association with sorting sperm as discussed in Dekkers is not incorporation by reference with any level of particularity. See PO Resp. 29 (citing Callaway Golf Co. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009) (To incorporate matter by reference, “a host document must contain language clearly identifying the subject matter which is incorporated and where it is to be found; a mere reference to another application, or patent, or publication is not an incorporation of anything therein.” (internal quote and citations omitted, emphasis in original)); see also Cook Biotech Inc. v. Acell, Inc., 460 F.3d 1365, 1376 (Fed. Cir. 2006) (“To incorporate material by reference, the host document must identify with detailed particularity what specific material it incorporates and clearly indicate where that material is found in the various documents.”). The disclosure in Dekkers relied on by Petitioner recites: “The technique involves the separation of spermatozoa carrying either X or Y chromosomes (Maxwell et al., 2004; Garner, 2006).” Ex. 1004, 396. We note that Maxwell and Garner are review articles discussing the state of sperm sexting technology generally. See Ex. 1005; Ex. 1006. We agree with Patent Owner that the generic citation to these review articles as set out in Dekkers is not an incorporation by reference of any specific detail from these articles. Unlike the disclosures at issue in Callaway and Cook, Dekkers does not use language such as “reference is made to” (Callaway, 576 F.3d at 1346) or “the disclosure of which is expressly incorporated herein by reference” (Cook, 460 F.3d at 1376) in conjunction with identifying a particular portion of the cited reference that our reviewing court has held to be sufficient to indicate to one of skill in the art that the referenced material is fully incorporated in the host document. Because Dekkers does not incorporate by reference the level of sorting accuracy as required by the claims – at least 80% – the preponderance of evidence of record does not support Petitioner’s position the Dekkers anticipates claims 1–5 of the ’734 patent.” slip op. at 19
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“We find that Petitioner has the better position. Here, Patent Owner is identifying the scope of the invention as the commercial tier at the bottom of the pig production pyramid. However, the scope of the claimed invention is directed to the substantially smaller herd sitting at the top of the commercial pig breeding pyramid. As explained in Teva, “[t]he reasonable-expectationof-success analysis must be tied to the scope of the claimed invention. See Allergan, Inc. v. Apotex Inc., 754 F.3d 952, 966 (Fed. Cir. 2014) (“[F]ailure to consider the appropriate scope of the ... claimed invention in evaluating the reasonable expectation of success ... constitutes a legal error ....”); see also Intelligent Bio-Sys., Inc., 821 F.3d at 1367.” Teva, 18 F.4th at 1381. Above, we construed “genetic nucleus” as an animal herd comprising one or more lines and positioned at the top of a multi-level pyramidal hierarchy in a commercial herd breeding structure. See above II.C.1. The herd at the top of the pyramid comprises far fewer animals than the multiplication and production tiers. See Ex. 1097 ¶¶ 65 (“the relatively smaller herd size of the genetic nucleus (e.g., hundreds or thousands as compared to millions at the production level) makes the use of sexed semen far easier than in vastly larger multiplier and production herds”), 84; Ex. 1096, 36:21–37:4; Ex. 2004, 39:6–22 (millions of animals at the production level). Petitioner contends that sperm sorting combined with lowdose insemination would have been practical for the much smaller herds found at the genetic nucleus. Pet. Reply 21. Both Maxwell and Garner reasonably suggest that deep-uterine insemination (DIU) allows for the use of sex sorted boar sperm. See Ex. 1005, 88; Ex. 1006, 952. Patent Owner admits that the use of sex-selected semen in the laboratory environment works. See PO Resp. 39. Even if the genetic nucleus (i.e. nuclear herd) comprises in excess of 100 or even 1000 animals it is not clear why using artificial insemination in conjunction with sex-selection would not work at the level of the genetic nucleus as argued by Patent Owner. See PO Resp. 39 (“sexed semen has not been implemented outside of a research setting”). Absolute predictability is not necessary to reach an obviousness determination; only a reasonable expectation of success is needed. Pharma Stem Therpeutic, Inc. v. ViaCell, Inc., 491 F.3d 1342, 1360 (2007); In re Kubin, 561 F.3d 1351, 1360 (Fed. Cir. 2009); In re O’Farrell, 853 F.2d 894, 903–904 (Fed. Cir. 1988) (“Obviousness does not require absolute predictability of success . . . . For obviousness under § 103, all that is required is a reasonable expectation of success.”). In particular, Dekkers teaches that sorted sperm can be used for artificial insemination. Specifically, acknowledging that “new developments in sperm sexing technology allow for the production of either male or female offspring for sire or dam lines, and this can be very useful for the nucleus and multiplication tiers.” Ex. 1004, 396; Ex. 1002 ¶ 48; see also Ex. 1055, 80 (“The main application by pig producers is for the use of sex-sorting technology in nucleus herds, particularly for producing female lines.”). Here, the evidence supports Petitioner’s contentions that given the” slip op. at 32
Patent outcomesUS 10,542,734 unpatentableClaim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,542,734
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.