- PTAB · Dec 14, 2021 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Institution
The Board instituted review of claims 1–24 on all petition grounds, finding a reasonable likelihood of obviousness over the Swinger-based combinations in grounds 1–3.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“To institute an inter partes review, we must determine that the information presented in the Petition shows “a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a) (2018). The Supreme Court has held that a decision to institute under 35 U.S.C. § 314 may not institute on less than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018). After considering the evidence and arguments presented in the Petition, we determine that Petitioner has demonstrated a reasonable likelihood of success in proving that at least 1 claim of the ’001 patent is unpatentable. Accordingly, an inter partes review of all of the claims and all of the grounds presented in the Petition is hereby instituted.” slip op. at 2
- Skill levelSkill level board ownOther
“For purposes of this Decision, at this stage of the proceeding we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’001 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which includes a significant number of prior art references authored by PhDs, MDs, and BSs and combinations thereof. See, e.g., Ex. 1015 (we understand includes inventors that are PhDs and MDs); Ex. 1039 (we understand includes PhDs and MDs as inventors); Ex. 1040 (we understand inventor is a JD with a BS); Ex. 1041 (we understand authors are MDs); Ex. 1042 (we understand authors are PhDs, MD, and BS); Ex. 1043 (we understand authors are MDs); Ex. 1045 (we understand inventor is MD); see also Ex. 1053; Ex. 1054; 1; Ex. 2010; Ex. 2019. However, our decision to institute trial in this proceeding is not dependent upon the specific definition of ordinarily skilled artisan and would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 11
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“Petitioner does not assert that any claim term requires express construction. See Pet. 6 (stating that it “reserves the right to respond to any constructions that PO submits”). Patent Owner does not present any remarks regarding claim construction. See generally Prelim. Resp. On this record and for purposes of this Decision, we determine that no claim terms require express construction. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)). To the extent further discussion of the meaning of any claim term is” slip op. at 12
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundInstituted
“After considering both the Petition and the Preliminary Response, we determine that Petitioner’s arguments and evidence on the issues of motivation to combine and reasonable expectation of success provide a sufficient basis on which to institute trial. We recognize the merit of Patent Owner’s counterarguments, which are supported by the expert testimony of Dr. Kang. Prelim. Resp. 21–22, 27–29 (citing generally Ex. 2002). The issues identified by Patent Owner implicate genuine issues of fact more appropriately resolved at trial. 37 C.F.R. § 42.108(c). We decline to engage in weighing of the information presented at this stage of the proceeding. We will evaluate both parties’ arguments and evidence once the record is fully developed during trial.” slip op. at 29
Claim construction§ 103 obviousnessPatents in suitUS 8,709,001 - Genus PLC v. Inguran, LLCInstitutedPTAB · Dec 14, 2021 · IPR2021-01027 · APJ Ulrike W Jenks · IPR · Institution
The Board instituted IPR of claims 1–5 on all three grounds, finding a reasonable likelihood that at least one challenged claim would be anticipated or obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“determine whether to institute an inter partes review under 35 U.S.C. § 314 and 37 C.F.R. § 42.4(a)(2020). Inter partes review may not be instituted unless “the information presented in the petition filed under section 311 and any response filed under section 313 shows that there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). The Supreme Court held that a decision to institute under 35 U.S.C. § 314 may not institute on fewer than all claims challenged in the petition. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level petitioner adoptedDecided for petitioner
“Petitioner asserts 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” and “would have been well-acquainted with methods of commercial breeding of lines and breeds within a genetic nucleus for the purpose of promoting genetic progress, the use of sex-selected semen in breeding schemes, including those within the genetic nucleus, genetic evaluation of livestock for desirable and undesirable traits, and the use of genetic markers, e.g., SNPs, and various other genotype data, to guide selection strategies to 1 The relevant sections of the Leahy-Smith America Invents Act (“AIA”), Pub. L. No. 112–29, 125 Stat. 284 (Sept. 16, 2011), took effect on March 16, 2013. Because the priority application from which the ’734 patent issued was filed before that date, our citations to Title 35 are to its pre-AIA version. 2 Petitioner contends that claims 1–5 are anticipated by Dekkers, as evidenced by either Maxwell, Garner, or Kim. Pet. 26–41. Alternatively, Petitioner contends that claims 1–5 are obvious over Dekkers and either Maxwell, Garner, or Kim. Pet. 41–45. 3 In the table identifying ground III, Petitioner does not list Kim. Pet. 4. However, in the arguments provided for this ground in regard to claim 5, Petitioner includes Kim. Pet. 48. improve desirable traits and/or minimize undesirable traits.” Pet. 13 (citing Ex. 1002 ¶ 22). Patent Owner states, “[s]olely for purposes of this Preliminary Response, Patent Owner and its expert apply this portion of Petitioner’s proposal, while reserving the right to dispute it later.” Prelim. Resp. 17. On this record, we adopt Petitioner’s definition of the level of ordinary skill in the art as Patent Owner also does. We also note that the prior 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)). B. Principles of Law” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner
“would not find the additional language in Petitioner’s proposed definition accurate in describing a genetic nucleus. Prelim Resp. 21 (citing Ex. 2001 ¶ 21). Patent Owner contends “that the plain and ordinary meaning of ‘genetic nucleus’ is ‘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.’” Id. (citing Ex. 2001 ¶ 24 (“The ’734 Patent does not specify this additional requirement as part of the meaning of ‘genetic nucleus,’ nor would the additional language be accurate in describing every genetic nucleus.”). On the present record, Petitioner has the better argument. The ’734 specification describes pig breeding as pyramid with the “nucleus herd” at the top of the pyramid and commercial farms at the bottom. Ex. 1001, 9:43– 44. “A nucleus herd is typically comprised of 12 to 15 lines, although any number of lines may be represented, with each line comprising a number of desirable traits. . . . Only the offspring with the highest measured selection index are retained in the nucleus herd.” Id. at 9:47–49. The retention of offspring with the most desirable features in the nucleus herd reasonably implies that these individuals are selected to propagate the desirable trait in the nucleus heard. Accordingly, at this stage of the proceeding, we 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, wherein certain offspring of the herd are used for breeding within the herd.”” slip op. at 12
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Instituted
“the context of artificial insemination for the purpose of directing piglet production toward creating predominantly male or female offspring. Petitioner’s expert explains that the state of the art at the time the invention was made required at least an 80% or better sex sorted semen in order to be able to use the sorted semen in to skew the piglet production in a littler to be either predominantly female or male offspring. See Ex. 1002 ¶ 113. Specifically, Petitioner’s expert avers that one of ordinary skill in the art would have understood that “[f]rom a commercial pig production perspective, using semen with less than 80% sex skew (i.e., purity for X or Y chromosomes) would not be efficient or economical, and consumers (e.g., pig producers) would not purchase such poorly enriched samples.” Ex. 1002 ¶ 113. Petitioner’s expert testimony is supported by the teachings of Maxwell (Ex. 1005) and Garner (Ex. 1006), both of which are expressly cited in Dekkers as evidencing “sperm sexing technology . . . for the production of either male or female offspring for sire or dam lines.” See Ex. 1004, 396, 420, 422. In particular, Maxwell teaches that “[i]n combination with the orientating nozzle and changes in the design of the sorter electronics, this allowed significant increases in sorting rates (15 million spermatozoa per hour) to be achieved while maintaining more than 85% purity.” Ex. 1005, 81. In addition, Gardner teaches that “acceptable sperm sexing efficiency, usually at 90% accuracy.” Ex. 1006, Abstract. Based on the current record, Petitioner’s expert testimony reasonably supports the position that Dekkers application of sex sorting technology at the level of the nucleus or multiplication tiers would require at least an 80% sex sorting efficiency. Patent Owner contends that Petitioner is improperly relying on Maxwell and Garner in order to support its anticipation argument over Dekkers. Prelim. Resp. 26 (citing Callaway Golf Col. v. Acushnet Co., 576 F.3d 1331, 1346 (Fed. Cir. 2009)). On the record at the stage of the proceeding, Petitioner has made an adequate showing to supports its anticipation argument. In particular, Dekkers disclosure of using sex sorted semen to allow for the production of either male or female offspring for sire or dam lines, reasonably suggests that the sorted sperm is at a sufficient purity level to achieve the stated result. Ex. 1004, 396. Petitioner relies on the testimony of its expert to establish that at the time the invention was made one of ordinary skill in the art would have understood that 80% or better sex sorted semen is a necessary level in order to skew the sex of the litter. See Ex. 1002 ¶ 113. Here, Petitioner’s expert testimony is supported by the teachings of either Maxwell (Ex. 1005) or Garner (Ex. 1006) to establish the knowledge of one of ordinary skill in the art at the time of Dekkers publication. Accordingly, we are not persuaded by Patent Owner’s contention that Petitioner is improperly relying on Maxwell and Garner. Accordingly, having considered the arguments and evidence presented by the parties at this stage, Petitioner has made a sufficient showing that Dekkers discloses the claim limitations of element 1c.” slip op. at 25
Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · GrahamPatents in suitUS 10,542,734 - Neurocrine Biosciences, Inc. v. Spruce Bosciences, Inc.Institution deniedPTAB · Dec 10, 2021 · PGR2021-00088 · APJ John G New · PGR · Institution
The Board denied institution on all five grounds, finding the petition did not show any challenged claim was likely unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied
“Under 35 U.S.C. § 324, the Board “may not authorize a post-grant review to be instituted unless … the information presented in the petition … if such information is not rebutted would demonstrate that it is more likely than not that at least 1 of the claims challenged in the petition is unpatentable.” Upon consideration of the Petition, the Preliminary Response, and the evidence presently before us, we determine that Petitioner has failed to demonstrate that it is more likely than not that it would prevail in establishing the unpatentability of at least one challenged claim of the ’908 patent. We consequently deny institution of post-grant review.” slip op. at 2
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed board ownOther
“The Specification expressly teaches that, with respect to the clinical phase 2 trial described in Example 4, “Patients will have overnight [pharmacokinetic/pharmacodynamics] PK/PD assessments performed at baseline, which include an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose.” Ex. 1001 col. 42, ll. 12–16. This is the same quotation and clinical trial relied upon by Dr. Barnes in his Declaration, and is the only definition of a “baseline” in the ’908 patent. See Ex. 1002, 36–37. We note that placebos were evidently not employed in the phase 2 clinical study of Example 4.3 Given the sole exemplary description of “baseline” in Example 4 of the Specification, we construe the claim term reciting “reduced by at least 10% from baseline” as meaning “a reduction of at least 10% in the level of ACTH (claim 1) or 17-OHP (claim 11) compared to measurements of ACTH or 17-OHP made prior to, and/or at the beginning of, administration of the drug.”” slip op. at 8
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element)Not shown unpatentableNot shown unpatentable
“likely than not that independent claims 1 and 11 are anticipated by Grigoriadis. “For a claim to be anticipated, each claim element must be disclosed, either expressly or inherently, in a single prior art reference, and the claimed arrangement or combination of those elements must also be disclosed, either expressly or inherently, in that same prior art reference.” Therasense, Inc. v. Becton, Dickinson and Co., 593 F.3d 1325, 1332–33 (Fed. Cir. 2010). The single clinical trial taught by Example 6 of Grigoriadis does not establish a baseline value for patients against which to compare the data obtained from patients receiving 300 mg or 600 mg of the test drug, NBI- 77860 (verucerfont). See Ex. 1006 ¶¶ 90–94. Specifically, Example 6 does not establish a baseline “which include[s] an [sic] pre-dose overnight assessment and a post-dose overnight assessment for PK/PD following administration of the first dose,” as disclosed by the ’908 patent. See Ex. 1001, col. 42, ll. 12–16. We therefore conclude that Grigoriadis fails to disclose expressly the limitations of claims 1 and 11 severally reciting “wherein [the] … hormone … level in the human is reduced by at least 10 % from baseline.”” slip op. at 16
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency not foundNot shown unpatentable
“A reference may anticipate if a claim limitation that is not expressly disclosed is inherently disclosed because it “is necessarily present, or inherent, in the single anticipating reference.” Verizon Servs. Corp. v. Cox Fibernet Va., Inc., 602 F.3d 1325, 1337 (Fed. Cir. 2010); see also Agilent Techs., Inc. v. Affymetrix, Inc., 567 F.3d 1366, 1383 (Fed. Cir. 2009) (holding that the “very essence of inherency is that one of ordinary skill in the art would recognize that a reference unavoidably teaches the property in question”).” slip op. at 17
Claim construction§ 102 anticipation§ 103 obviousness§ 112 disclosurecites PhillipsPatents in suitUS 10,849,908 - Slayback Pharma LLC v. Sumitomo Dainippon Pharma Co., Ltd.All claims unpatentablePTAB · Dec 7, 2021 · IPR2020-01053 · APJ Zhenyu Yang · IPR · Final written decision
Claims 1–75 are unpatentable as obvious over Saji; the Board did not reach the Latuda Information anticipation and Latuda Information–Loebel obviousness grounds.
RulingsFinal written decision- Skill levelSkill level patent owner adoptedDecided for patent owner
“We do not discern an appreciable difference in the parties’ respective definitions of the level of ordinary skill in the art, and any perceived distinction does not impact our Decision. Indeed, as Patent Owner acknowledges, the parties’ proposed definitions of the ordinary skill level do “not differ significantly.” Id. at 25. Nevertheless, for purposes of this Decision, we adopt Patent Owner’s definition of the skill level, as it is consistent with the ’827 patent disclosures and the prior art of record, and more inclusively describes the suitable experience for one of ordinary skill in the art.” slip op. at 9
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed petitioner constructionDecided for petitioner
“On this record, we find Petitioner’s proposed constructions are supported by intrinsic and extrinsic evidence. See Pet. 18–23. We agree with Petitioner here that “a patient” or “the patient” should have its ordinary and customary meaning of “one or more patients,” as opposed to a “patient population” as Patent Owner has previously argued in a district court litigation involving another party. See id. at 19–20. Indeed, Patent Owner agrees. See Reply 19 (“There is no dispute that ‘a patient,’ as recited in the ’827 claims, refers to ‘one or more patients.’”).” slip op. at 10
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“On this record and for purposes of this Decision, we see no need to construe any other term expressly. See Wellman, Inc. v. Eastman Chem. Co., 642 F.3d 1355, 1361 (Fed. Cir. 2011) (stating that claim terms need only be construed to the extent necessary to resolve the controversy).” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundUnpatentable
“Based on Saji’s preferred dose range of 5 to 100 mg/day, which overlaps with the “from 20 to 120 mg/day” range required by each challenged independent claim, Petitioner argues that an ordinarily skilled artisan would have been “motivated to conduct dose ranging studies and would find the claimed dosing regimens.” Pet. 62; see also id. at 55 (contending that “dose ranging was a routine part of drug development” (citing Ex. 1030)). Dr. Stahl’s testimony supports Petitioner’s argument. Indeed, Dr. Stahl testifies that, although with some drugs, it can be difficult to find a safe and effective dose, or to get an effective dose into the patient, neither is the case with lurasidone. Ex. 1054, 141:3–14; see also id. at 142:2–6 (“Q. [A]re you aware of any particular difficulties with lurasidone hydrochloride and finding a safe and effective dose for schizophrenia and manic depressive psychosis? A. No.”); 135:18–25 19 (Dr. Stahl testifying that he is “not aware of anything unusual about [lurasidone’s] dose range”). Thus, we agree with Petitioner that an ordinarily skilled artisan, starting from Saji’s preferred dosing range, would have conducted routine dose ranging studies and identified the claimed dosing regimens.” slip op. at 19
Patent outcomesUS 9,815,827 unpatentableClaim construction§ 103 obviousnesscites Phillips · KSR · GrahamPatents in suitUS 9,815,827 - PTAB · Dec 6, 2021 · IPR2021-00846 · APJ Jon B Tornquist · IPR · Institution
The Board instituted inter partes review of claims 1–12 on all asserted grounds after finding a reasonable likelihood that Petitioner would show at least one challenged claim unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’356 patent. Accordingly, we institute an inter partes review of” slip op. at 2
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“A petition must “identify with particularity the grounds for institution and evidence supporting such grounds,” including “the prior art relied upon and evidence that it qualifies as such.” Hulu, Paper 29 at 13 (citing 35 U.S.C. § 312(a)). The Petition identifies the grounds for institution and the evidence supporting such grounds, and presents evidence that Weikert qualifies as prior art under 35 U.S.C. § 102(b). Pet. 5–6, 27. For example, Petitioner and Dr. Lubatschowski assert that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists,” and that Weikert was included in the 2005 edition of” slip op. at 11
- Obviousness (§103) › Motivation to combine / reasonable expectation of success › Teaching awayTeaching away not foundDecided for petitioner
“We are not persuaded, on this record, that this disclosure rises to the level of a teaching away. First, Weikert does not address the specific laser system disclosed in Blumenkranz, which is already designed to successfully treat eyes with cataracts, and Patent Owner and Dr. Kang do not persuasively explain why Weikert’s concerns would apply to a non-excimer laser surgery system that is already designed to treat “eyes with cataracts.” See Ex. 1017 ¶ 8; Ex. 2002 ¶ 62; see also Ex. 2002 ¶ 57 (Dr. Kang asserting that the PRK and LASIK excimer laser systems disclosed in Weikert are unrelated to the claimed relaxation incision made during cataract surgery). Second, Weikert suggests that eyes with cataracts “could reduce the efficacy and safety of laser treatment” and that refractive keratotomy “can be an effective” option, but does not indicate that laser surgery is never, or is generally not, suitable for treating astigmatism in eyes with cataracts. Ex. 1019, 227 (emphasis added). As such, we are left with a disputed issue of material fact that is best resolved on a complete trial record.” slip op. at 17
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundInstituted
“The evidence set forth by Patent Owner presents significant issues of fact to be addressed at trial. On the one hand, it is evident that modifying cataract surgical systems for use on the cornea, or providing a system that is capable of performing both corneal and lens surgery, was extremely difficult. Ex. 2006, 5:33–36, 25:27–31; Ex. 2007, 8:32–39, 15:53–58; Ex. 2009, 1209–11. On the other hand, Blumenkranz specifically asserts that its system is useful for not only cataract surgery, but also surgery on other areas of the eye, including the sclera, and Dr. Lubatschowski testifies that the system of Blumenkranz is “well-suited to perform . . . anterior incisions to permit access to the inner eye chamber.” Ex. 1017 ¶ 71; Ex. 1001 ¶¶ 107–108. Such evidence facially supports Petitioner’s case for obviousness. Thus, considering this evidence as a whole, we are left with a material issue of fact as to the capabilities of the Blumenkranz system that is best resolved on a complete trial record, and after reviewing the cross-examination testimony of the parties’ declarants.” slip op. at 20
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,376,356 - PTAB · Dec 6, 2021 · IPR2021-00849 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on claims 1–14, finding a reasonable likelihood that the claims would be unpatentable on the asserted obviousness grounds.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’548 patent. Accordingly, we institute an inter partes review of claims 1–14 of the ’548 patent. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level board ownDecided for patent owner
“For purposes of this Decision, we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosures of the ’548 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the appropriate level of ordinary skill in the art may be reflected in “the prior art itself”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which demonstrates individuals having a broad array of scientific degrees that collaborate as a team. We note, however, that our decision to institute trial in this proceeding would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 8
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededDecided for patent owner
“Both parties provide a construction of the term “cataract incision.” Pet. 7–9; Prelim. Resp. 17–18. Upon review of the parties’ arguments and supporting evidence, we determine that no claim terms require construction for purposes of this Decision. See Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999) (“[O]nly those terms need be construed that are in controversy, and only to the extent necessary to resolve the controversy.”)).” slip op. at 9
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityReference is prior artPrinted publication establishedDecided for petitioner
“and evidence supporting such grounds,” including “the prior art relied upon and evidence that it qualifies as such.” Hulu, Paper 29 at 13 (citing 35 U.S.C. § 312(a)). The Petition identifies the grounds for institution and the evidence supporting such grounds, and presents evidence that Weikert qualifies as prior art under 35 U.S.C. § 102(b). Pet. 5–6, 28–29. For example, Petitioner and Dr. Lubatschowski assert that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists,” and that Weikert was included in the 2005 edition of CATARACT AND REFRACTIVE SURGERY as Chapter 14: Refractive Keratotomy: Does it Have a Future Role in Refractive Surgery? Ex. 1001 ¶ 73. Although minimal, given the type of document involved, and in the absence of any reason to question Petitioner’s and Dr. Lubatschowski’s assertions, Petitioner’s evidence is sufficient to present a reasonable likelihood that Weikert is prior art to the ’548 patent under 35 U.S.C. § 102(b).” slip op. at 11
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 10,709,548 - PTAB · Nov 18, 2021 · IPR2021-00841 · APJ Ryan H Flax · IPR · Institution
The Board instituted IPR of claims 1–15 on all six asserted obviousness grounds, finding a reasonable likelihood of success on at least one ground.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“institute trial in an inter partes review. We may institute an inter partes review if the information presented in the petition filed under 35 U.S.C. § 311, and any preliminary response filed under § 313, shows that there is a reasonable likelihood that Petitioner would prevail with respect to at least one of the claims challenged in the petition. 35 U.S.C. § 314. After reviewing the parties’ submissions, we conclude Petitioner demonstrates a reasonable likelihood it would prevail in showing that claims of the ’648 patent are unpatentable under the presented grounds. Therefore, we institute inter partes review of all challenged claims (1–15) under the grounds raised in the Petition, pursuant to 35 U.S.C. § 314. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018); see also Guidance on the Impact of SAS on AIA Trial Proceedings (April 26, 2018) (available at https://www.uspto.gov/patents-application-process/patent-trial-and-appeal-board/trials/guidance-impact-sas-aia-trial) (“Guidance”).” slip op. at 2
- Skill levelSkill level petitioner adoptedOther
“For purposes of this Decision, at this stage of the proceeding we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’648 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as also including a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers, and that these people may collaborate. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (“the prior art itself [may] reflect[] an appropriate level” as evidence of the ordinary level of skill in the art) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which includes a significant number of prior art references authored by PhDs, MDs, and BSs and combinations thereof. See, e.g., Ex. 1030 (we understand includes inventors that are PhDs and MDs); Ex. 1039 (we understand includes PhDs and MDs as inventors); Ex. 1040 (we understand inventor is a JD with a BS); Ex. 1041 (we understand authors are MDs); Ex. 1042 (we understand authors are PhDs, MD, and BS); Ex. 1043 (we understand authors are MDs); Ex. 1045 (we understand inventor is MD); Ex. 1046 (we understand the inventor is an MD); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019.” slip op. at 24
- Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther
“CLAIM CONSTRUCTION “[W]e need only construe terms ‘that are in controversy, and only to the extent necessary to resolve the controversy.’” Nidec Motor Corp. v. Zhongshan Broad Ocean Motor Co., 868 F.3d 1013, 1017 (Fed. Cir. 2017) (quoting Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc., 200 F.3d 795, 803 (Fed. Cir. 1999)). Petitioner asserts that, although dependent claim 12 is indefinite, its language, “to determine one or more axial locations of the anterior capsule of the lens; and or more anterior capsule axial locations,” should be construed to mean “to determine one or more axial locations of the anterior capsule of the lens (i.e., one or more anterior capsule axial locations).” Pet. 7–8; see also Ex. 1030, 18:46–50 (claim 12). Petitioner’s position is that, as it reads in the ’648 patent, claim 12’s language is “a nonsense phrase,” rendering it indefinite, but that for the purposes of this proceeding it may be understood by the definition set forth above. Pet. 7–8. Patent Owner does not ask that any claim language be expressly construed. See generally Prelim. Resp. Claim 12 depends from independent claim 1 and is but one of fifteen challenged claims. Ex. 1030, 17:30–18:61. It is not necessary for us to consider the Petition’s specific challenges to claim 12 to render our decision” slip op. at 25
- Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner
“At this stage of the proceeding, we find Petitioner has sufficiently explained how and why the cited prior art would have been combined, why the ordinarily skilled artisan would have had a reasonable expectation of success in doing so, and that such a combination teaches or suggests the limitations or steps of claims 1–5 and 12–15. We address Patent Owner’s preliminary arguments below. Patent Owner addresses Petitioner’s Grounds 1–3 together; each is based on a combination of Swinger, Baikoff, and Li. Prelim. Resp. 10–31 (citing, inter alia, Ex. 1001 (Izatt) ¶¶ 46–49, 143, 149, 159; Ex. 1030, 2:5– 13, 11:19–26, 17:38–45; Ex. 1039 (Swinger), 17:50–54, 19:23–28, 23:28– 31, 34:30–35:3, 35:18–36:17; Ex. 1041 (Baikoff), 1843–45, 1847, 1849, Fig. 10; Ex. 1043 (Hoppeler); Ex. 1044 (Li); Ex. 1046 (L’Esperance); Ex. 2002 (Kang) ¶¶ 32–39, 46–52, 55–57, 60; Ex. 2004 (Walter) ¶¶ 16–17; Ex. 2006, 286, 296–98).15 Patent Owner addresses the claims in this way as a set, presenting the same arguments for all claims, and addresses the dependent claims as not unpatentable because the additionally cited prior art (Hoppeler and L’Esperance) do not remedy the argued shortcomings regarding Swinger, Baikoff, and Li. Id. Patent Owner argues that the ordinarily skilled artisan would not have combined these references because Swinger requires a surgeon’s direct visualization for cataract surgery, foreclosing using OCT, and because Baikoff and Li teach that OCT is limited to the eye’s anterior chamber, which makes it impossible to obtain satisfactory imaging (e.g., of lens portions behind the iris’s shadow). Id. at 15–18. Patent Owner argues that Swinger’s use of direct visualization and Baikoff’s acknowledgement of an inability to OCT-image the lens where shadowed by the iris teaches away from using OCT in cataract surgery and the combination of the references. Id. at 15–19. Patent Owner argues that the prior art combination does not disclose a device that “generate[s] image data for the patient’s crystalline lens,” or “process[ing] the image data to determine an anterior capsule incision scanning pattern for scanning a focal zone of the laser beam for performing an anterior capsule incision,” as recited by claim 1. Id. at 21–30. Patent Owner also argues that Petitioner took positions before the Office contrary to those it now asserts, specifically that in 2010 OCT imaging could 15 Patent Owner cites this evidence by shorthand names, e.g., “Swinger” and “Kang.” Although Patent Owner is free to cite evidence by any manner it desires, it is more useful to the Board if citations reference exhibit numbers, which facilitates review of the record.” slip op. at 29
Claim construction§ 103 obviousnesscites KSR · GrahamPatents in suitUS 9,474,648 - PTAB · Nov 12, 2021 · IPR2021-00845 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on claims 1–17 and 20–26 on all asserted grounds, finding a reasonable likelihood that at least one challenged claim would be shown obvious.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’024 patent. Accordingly, we institute an inter partes review of claims 1–17 and 20–26 of the ’024 patent. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level board ownDecided for patent owner
“For purposes of this Decision, we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosures of the ’024 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the appropriate level of ordinary skill in the art may be reflected in “the prior art itself”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which demonstrates individuals having a broad array of scientific degrees that collaborate as a team. We note, however, that our decision to institute trial in this proceeding would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“On this record, we agree with Patent Owner that the disputed preamble phrase is limiting. “[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.” Catalina Mkt’g Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808–09 (Fed. Cir. 2002). Here, the Examiner expressly allowed the claims in view of the Examiner’s Amendment changing “[a] method” to “[a] cataract surgery method,” thereby transforming this portion of the preamble into a limitation. Ex. 1009, 14, 16, 19; see Catalina Mkt’g, 289 F.3d. at 808. system may be able to make additional types of incisions, we understand the current method steps to require a laser surgery system that is capable of creating the type of “cataract incision” discussed repeatedly in the ’024 patent, the Petition, the Preliminary Response, and Drs. Lubatschowski’s and Hatch’s declarations, i.e., the type of incisions traditionally used in the art when performing cataract surgery to allow for the insertion of slender surgical instruments. Ex. 1007, 3:10–13 (noting that the invention enables “the formation of very small and geometrically precise opening(s) and incision(s) in precise locations in and around the cornea and limbus”), 10:19–21, 11:7–10, Figs. 5A–B; Pet. 12 (noting that cataract incisions have been applied as part of cataract surgeries since the late 1800s), 29 (referencing the small cataract incisions discussed in Weikert); Prelim. Resp. 7–8 (asserting that a “cataract incision” is “a small incision” made in the cornea, limbus, or sclera, to provide access for “slender surgical instruments . . . to be inserted through a small opening in the cornea”); Ex. 1001 ¶¶ 23, 61 (Dr. Lubatschowski describing cataract incisions and noting that he “will apply the prior art as if the incision must be specifically for cataract surgery”); Ex. 2004 ¶¶ 16, 18 (Dr. Hatch asserting that the “cataract incisions” of the ’024 patent are small and made with the goal of minimizing refractive changes). In view of the foregoing, for purposes of this Decision, we construe the preamble phrase “[a] cataract surgery method” recited in independent claims 1, 8, 12, and 22 to be limiting and to require, inter alia, a method step of creating a cataract incision of the type commonly used in cataract surgery to allow for insertion of slender surgical instruments into the eye cavity.” slip op. at 12
- Novelty / Anticipation (§102) › Prior-art status of a reference › Printed publication / public accessibilityPrinted publication establishedDecided for petitioner
“A petition must “identify with particularity the grounds for institution and evidence supporting such grounds,” including “the prior art relied upon and evidence that it qualifies as such.” Hulu, Paper 29 at 13 (citing 35 U.S.C. § 312(a)). The Petition identifies the grounds for institution and the evidence supporting such grounds, and presents evidence that Weikert qualifies as prior art under 35 U.S.C. § 102(b). Pet. 5, 26–27. For example, Petitioner and Dr. Lubatschowski assert that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists,” and that Weikert was included in the 2005 edition of CATARACT AND REFRACTIVE SURGERY as Chapter 14: Refractive Keratotomy: Does it Have a Future Role in Refractive Surgery? Ex. 1001 ¶ 73. Although minimal, given the type of document involved, and in the absence of any reason to question Petitioner’s and Dr. Lubatschowski’s assertions, Petitioner’s evidence is sufficient to present a reasonable likelihood that Weikert is prior art to the ’024 patent under 35 U.S.C. § 102(b). In addition, Hulu contemplates additional evidence being admitted in a reply to a patent owner preliminary response, as long as that evidence is responsive to the prior briefing. Hulu, Paper 29 at 14. In this case, Petitioner’s evidence submitted in its Reply is responsive to arguments made in the Preliminary Response, and confirms what was asserted in the Petition CATARACT AND REFRACTIVE SURGERY and the document bears a copyright date of 2005 (or, as asserted by Dr. Lubatschowski, is a “2005 edition”). Ex. 1060, 5, 12; Pet. 5, 26–27; Ex. 1001 ¶ 73. In addition, this evidence indicates that CATARACT AND REFRACTIVE SURGERY was published by “Springer,” which is a well-known publishing company, and is the type of document that would be expected to be made publically accessible. See Ex. 1001 ¶ 73 (asserting that CATARACT AND REFRACTIVE SURGERY “is a quarterly review series comprising chapters written by well-known specialists”); Ex. 1019, 220, 224, 227, 228, 230, 232 (providing a “Summary for the Clinician” at the end of several sub-chapters); Ex. 1060, 4–5. In the absence of evidence or argument suggesting that Weikert was not publically available, at this stage of the proceeding, we find the information presented in the Petition, as confirmed by the Reply evidence submitted by Petitioner, demonstrates a reasonable likelihood that Weikert is prior art to the ’024 patent.” slip op. at 15
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,233,024 - PTAB · Nov 12, 2021 · IPR2021-00843 · APJ Jon B Tornquist · IPR · Institution
The Board instituted IPR on all grounds for claims 1–17, finding a reasonable likelihood that at least one challenged claim would be shown unpatentable.
RulingsInstitution decision- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“review. 35 U.S.C. § 314; 37 C.F.R. § 42.4(a). The standard for institution is set forth in 35 U.S.C. § 314(a), which provides that an inter partes review may not be instituted “unless the Director determines . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” After considering the parties’ arguments and evidence, and for the reasons set forth below, we determine that Petitioner has demonstrated a reasonable likelihood of prevailing with respect to at least one challenged claim of the ’023 patent. Accordingly, we institute an inter partes review of claims 1–17 of the ’023 patent. See SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1359–60 (2018).” slip op. at 2
- Skill levelSkill level board ownDecided for petitioner
“For purposes of this Decision, we generally accept Petitioner’s proposed definition of the person of ordinary skill in the art (or ordinarily skilled artisan), which appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosures of the ’023 patent; however, we also agree with Patent Owner that such a definition should be flexible enough to include a person with a lesser academic degree and having experience working in the field, such as an engineer with clinical experience in ophthalmic surgery, as well as a medical doctor, such as an ophthalmic surgeon with experience working with medical optics and lasers. See Okajima v. Bourdeau, 261 F.3d 1350, 1355 (Fed. Cir. 2001) (noting that the appropriate level of ordinary skill in the art may be reflected in “the prior art itself”) (quoting Litton Indus. Prods., Inc. v. Solid State Sys. Corp., 755 F.2d 158, 163 (Fed. Cir. 1985)). Such an expanded definition of the person of ordinary skill in the art, including aspects of both parties’ definitions, is appropriate based on our review of the record, which demonstrates individuals having a broad array of scientific degrees that collaborate as a team. We note, however, that our decision to institute trial in this proceeding would not change were we to adopt Patent Owner’s proposed definition.” slip op. at 8
- Claim Construction › Intrinsic evidence (Phillips canons) › Preamble limiting or notPreamble limitingDecided for patent owner
“On this record, we agree with Patent Owner that the disputed preamble phrase is limiting. “[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.” Catalina Mkt’g Int’l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 808–09 (Fed. Cir. 2002). Here, the Examiner expressly allowed the claims in view of the Examiner’s Amendment changing “scanning system” to “cataract surgery scanning system,” thereby transforming this portion of the preamble into a limitation. Ex. 1006, 13, 15, 18; see Catalina Mkt’g, 289 F.3d. at 808. Furthermore, contrary to Petitioner’s arguments, the record appears to suggest that there are structural differences between the optical systems of cataract surgery systems on the one hand and corneal surgery systems on the other. See Ex. 2006, 5:30–36; Ex. 2009, 1209–10. Thus, on this record, we are not persuaded that the language added by the Examiner represents merely an intended use for the disclosed system. In view of the foregoing, for purposes of this Decision, we construe the preamble phrase “cataract surgery scanning system” recited in independent claims 1, 8, and 12 to be limiting.” slip op. at 10
- Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner
“The ’023 patent explains that a “cataract incision” is an incision created “to allow access for the lens removal instrumentation.” Ex. 1004, 10:17–19. The potential ambiguity in the claim comes, as Petitioner notes, from the fact that the cataract incision of claim 1 “only partially extend[s] through the target tissue,” which would not appear to provide immediate “access to an eye chamber of the patient’s eye.” Pet. 10; Ex. 1004, 10:19– 23, 14:15–21. Although somewhat ambiguous on its face, the prosecution history provides guidance as to how this claim phrase is to be interpreted. Phillips, 415 F.3d at 1317 (“Like the specification, the prosecution history provides evidence of how the PTO and the inventor understood the patent.”). During prosecution, the Applicants explained that the invention allows “straight cataract incisions [to be] made at the correct location,” and that partially penetrating cataract incisions are advantageous because they allow the laser delivery system to be located in an “unsterile field,” with the final penetrating incision to be made “by a physician after a patient has been moved to a sterile field.” Ex. 1006, 52–53. The Applicants then explained that despite the fact that partially penetrating cataract incisions do not fully for the lens removal instruments,” as that term is used in the ’023 patent. Id. at 52 (noting the purpose of “partially penetrating cataract incisions” is “to allow access for lens removal instruments”), 55 (“In short, none of the cited art teaches . . . to deliver the first treatment pattern to the target tissue to form partially penetrating cataract incisions – i.e. incisions that allow access for the lens removal instruments.”). The Examiner agreed with this reasoning. Id. at 15 (agreeing that the prior art did not teach or suggest partially penetrating cataract incisions that provide “access to the eye chamber of the patient’s eye”). Given these disclosures, we agree with Patent Owner that “provides access to an eye chamber of the patient’s eye” in claim 1 means that the partial incision is a starting incision, made in the appropriate shape and location, that allows complete access for lens removal instrumentation when completed, for example, by the surgeon. In view of the foregoing, we construe the claim phrase “cataract incision therein that provides access to an eye chamber of the patient’s eye, the incision . . . only partially extending through the target tissue” to require “a partially penetrating cataract incision that, when completed by the” slip op. at 12
Claim construction§ 102 anticipation§ 103 obviousnessPatents in suitUS 9,233,023 - PTAB · Nov 10, 2021 · IPR2021-00880 · APJ John G New · IPR · Institution
The Board instituted inter partes review on all challenged claims and grounds, finding a reasonable likelihood that claims 1 and 9–12 are anticipated by Dixon or Heier 2009.
RulingsInstitution decision- PTAB / AIA Trials › Discretionary denial › §325(d) same art / argumentsInstitution denied 325dDenied
“Becton-Dickinson factors (a), (b), and (d) have been satisfied. The evidence of record shows that the Dixon reference before the Examiner consisted of merely the first page of Dixon. See Ex. 1087. The single page of Dixon that 8 Thomas Reuters Integrity, VEGF Trap-Eye Final Phase II Results in Age-Related Macular Degeneration Presented at 2008 Retina Society Meeting, (Sep. 28, 2008). Ex. 2007. was before the Examiner provides no disclosure of the claimed dosing regimen. It would consequently have been impossible for the Examiner to analyze the limitations of the challenged claims in view of the complete teachings of Dixon under these circumstances. We consequently find that the disclosure of Dixon that form the basis of Petitioner’s Grounds I and IV (of which Dixon is the sole reference) were not before the Examiner as prior art during examination (because the relevant disclosures were missing or omitted), and that there could therefore be no overlap between the arguments made during examination and the manner in which Petitioner relies on the prior art or Patent Owner distinguishes the prior art.” slip op. at 12
- PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)InstitutedInstituted
“c. Analysis We conclude that Petitioner has established a reasonable likelihood of success in prevailing at trial on Grounds 1 and 2, and that Patent Owner’s arguments are insufficient, based upon the current record, to overcome that likelihood of success. Petitioner’s claim chart maps out the correspondence between the limitations of claim 1 and the disclosures of Dixon and Heier 2009 in a manner that persuasively demonstrates that the disclosures of both references disclose all of the limitations. Patent Owner does not dispute Petitioner’s showing that the references anticipate, with three exceptions. We address each of those arguments in turn.” slip op. at 30
- Novelty / Anticipation (§102) › Anticipation standard (single reference, every element) › Inherent disclosureInherency foundInstituted
“Ex. 1006, 4 (emphasis added). Dixon thus expressly discloses that patients were treated on a “p.r.n. basis” (i.e., an “as needed basis”) for additional doses, and details the criteria by which the physical symptoms were assessed to determine whether another dose was warranted. It is true that Dixon does not expressly state that it is a physician who performs this assessment of the patient in question. But we find that a person of ordinary skill in the art, as defined by Petitioner, would understand that the preforming of diagnostic procedures and analysis, and the prescription of the appropriate medication, would necessarily need to be performed by a physician or other qualified medical professional licensed by 12 Patent Owner also argues that, contra Petitioner’s assertion, this limitation is a positive limitation of the claim that should be afforded patentable weight. See Prelim. Resp. 20–24. For the purposes of this Decision, we accept Patent Owner’s contention that the limitation reciting “assessed by a physician or other qualified medical professional” is entitled to patentable weight. As we explain, however, Patent Owner’s argument that this limitation is not disclosed by the cited prior art is unpersuasive. the state. That is, almost by definition, the practice of medicine, and is certainly well known in this art. See In re Graves, 69 F.3d 1147, 1152 (Fed. Cir. 1995) (holding that the teachings of a reference may be taken in combination with knowledge of the skilled artisan to put the artisan in possession of the claimed invention within 35 U.S.C. § 102 even though the patent does not specifically disclose certain features); see also Continental Can, 948 F.2d at 1269 (holding that anticipation requirement that every element of a claim appears in a single reference accommodates situations where the common knowledge of “technologists” is not recorded in a reference, i.e., where technical facts are known to those in the field of the invention). We therefore find that a person of ordinary skill in the art, as defined by Petitioner, would understand that only a licensed physician could competently perform the procedures disclosed by Dixon in the quoted passage.” slip op. at 31
- Skill levelSkill level petitioner adoptedDecided for petitioner
“equivalent, or less education but considerable professional experience in the medical, biotechnological, or pharmaceutical field), with practical academic or medical experience in (1) developing treatments for angiogenic eye disorders (such as AMD), including through the use of VEGF antagonists, or (2) treating of angiogenic eye disorders (such as age-related macular degeneration (“AMD”)), including through the use of VEGF antagonists. Pet. 25 (citing Ex.1002 ¶¶ 26–28). Patent Owner does not expressly contest this definition of a person of ordinary skill in the art in its Preliminary Response, although Patent Owner contends that such a skilled artisan could not necessarily perform the limitation of claim 1 reciting “based on visual and/or anatomical outcomes as assessed by a physician or other qualified medical professional.” See, e.g., Prelim. Resp. 28. We address Patent Owner’s contentions with respect to this limitation in our analysis below. For the purposes of this decision, because we find Petitioner’s definition to be consistent with the level of skill in the art (see, e.g., Exs. 1006, 1020), and in the absence of a different proposed definition of the level of skill in the art by Patent Owner, we consequently adopt Petitioner’s definition.” slip op. at 8
§ 102 anticipation§ 103 obviousnessDiscretionary denialcites PhillipsPatents in suitUS 9,669,069
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.