• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01115 · APJ Susan L C Mitchell · IPR · Institution

  The Board denied institution on all grounds because Petitioner did not show a reasonable likelihood of proving the challenged claims obvious, including the claimed tagging efficiency.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claim 1. Pet. 18–19. Petitioner asserts that a “POSA [person of ordinary skill in the art] would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. at 19 (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s construction. Prelim. Resp. 32–33. that it is unnecessary to expressly construe any claim terms for purposes of rendering 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))).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “40–60% tagging efficiency, Petitioner fails to sufficiently explain why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer the adaptor.” Ex. 1009 ¶ 38.” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,801,063
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 30, 2022 · IPR2022-01116 · APJ Tina E Hulse · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that the claims were obvious over the asserted prior art.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’858 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience.” slip op. at 6

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner sets forth a proposed construction for “a number of double- stranded cfDNA molecules that map to the mappable base position,” recited in claims 22 and 24. Pet. 19. Petitioner asserts that a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample.” Id. (citing Ex. 1002 ¶¶ 133– 136). Patent Owner does not dispute Petitioner’s constructions. Prelim. Resp. 24. that it is unnecessary to expressly construe any claim terms for purposes of rendering 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))).” slip op. at 7

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot shown unpatentableMotivation not foundNot shown unpatentable

    “40–60% tagging efficiency, Petitioner fails to explain sufficiently why a person of ordinary skill in the art would have expected Meyer’s tagging efficiency to apply to Schmitt’s DCS method when used with Narayan’s sequencing of cfDNA. For example, Petitioner fails to address the differences between Meyer’s adapters and Schmitt’s adapters and how those differences affect the tagging efficiency. Meyer’s barcodes comprise “single self-hybridized palindromic oligonucleotides, carrying an Srf I restriction site in the middle (GCCCGGGC), a sequence tag at the 3’ end and the reverse complementary tag sequence at the 5’ end.” Ex. 1005, Fig. 1. Schmitt, on the other hand, teaches a “hybrid method” of tagging that uses a combination of the sheared ends of the DNA fragments and a “shorter n-mer tag (such as 1 or 2 or 3 or 4 or more degenerate or semi-degenerate bases) in the adaptor.” Ex. 1009 ¶ 38. Moreover, as Patent Owner notes, Petitioner is silent as to how the references’ different starting sample sizes affect tagging efficiency. Prelim. Resp. 37–38. According to the KAPA data sheet submitted by Petitioner, “[t]he proportion of fragmented DNA that is successfully converted to adapter-ligated molecules decreases as input is reduced.” Ex. 1015, 4. The KAPA data sheet states that “[w]hen starting library construction (end repair) with >100 ng fragmented DNA, 15–40% of input DNA is typically recovered as adapter-ligated molecules, whereas the recovery typically ranges from 0.5 to 15% for libraries constructed from 100 pg–100 ng DNA.”” slip op. at 14

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 10,889,858
• Twinstrand Biosciences, Inc. v. Guardant Health, Inc.Institution denied
  PTAB · Dec 13, 2022 · IPR2022-01152 · APJ Michael A Valek · IPR · Institution

  The Board denied institution on all challenged claims because Petitioner did not show a reasonable likelihood that Narayan and Schmitt taught or suggested the claimed use of unpaired reads.

  RulingsInstitution decision

  • PTAB / AIA Trials › Institution threshold (reasonable likelihood / more likely than not)Institution denied meritsInstitution denied

    “inter partes review may not be instituted “unless . . . there is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition.” 35 U.S.C. § 314(a). Upon considering the argument and evidence presented by the parties, we determine that Petitioner has not established a reasonable likelihood that it would prevail in showing the unpatentability of at least one claim challenged in the Petition. Accordingly, we decline to institute an inter partes review of any claim of the ’221 patent on any ground.” slip op. at 2

  • Skill levelSkill level petitioner adoptedDecided for petitioner

    “(i) a Ph.D. in molecular biology, genetics, bioinformatics, or a related field, and have at least about two years of experience in the use and development of sequencing technologies; or (ii) a Master’s degree in one of the same fields with at least about five years of the same experience. Pet. 19 (citing Ex. 1002 ¶¶ 27–30). Patent Owner does not offer a proposed definition of the level of ordinary skill in the art at this stage of the proceeding. On this record, we adopt Petitioner’s uncontested definition of the level of ordinary skill in the art. We further note that the prior art itself is sufficient to demonstrate 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))).” slip op. at 7

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededNot reached

    “Regarding the phrase “a number of double-stranded cfDNA molecules that map to the mappable base position” in claims 6 and 18, Petitioner contends a “POSA would understand that the number of double-stranded cfDNA molecules that map to the mappable base position will vary, depending on the number of haploid genome equivalents (HGEs) in the sample” and generally be equal to the amount of HGEs. Pet. 20, (citing Ex. 1002 ¶¶ 133–136). Patent Owner does not dispute Petitioner’s understanding, but contends no construction is necessary at this stage. See Prelim. Resp. 30 We agree with Patent Owner that it is unnecessary to expressly construe any claim terms for purposes of rendering 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))).” slip op. at 8

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successNot reached

    “The Petition frames Ground 1 as the combination of Schmitt’s DCS with Narayan’s cfDNA. See Pet. 33–36. It relies on Schmitt’s “methods of error correction for NGS by generating duplex consensus sequences (i.e., reducing or tracking redundancy in sequence reads)” as Petitioner’s alleged motivation for that combination. Id. at 33–34; see also id. at 37 (arguing that a POSA would have had a reasonable expectation of success because “the prior art expressly taught that DCS could enhance accuracy when sequencing cfDNA”) (internal quotations omitted). According to Schmitt, the error correction and improved accuracy of DCS results from grouping reads into paired families in order to “capitalize[] on the redundant information stored in double-stranded DNA, thus overcoming technical limitations of prior methods utilizing data from only one of the two strands.” Ex. 1083, 47 (Abstract); see also id. ¶¶ 7, 43. Thus, Petitioner’s theory of unpatentability is inextricably tied to DSC’s use of paired reads, as opposed to unpaired reads, to generate consensus sequences. To the extent Petitioner contends that the collapsing of reads into SSCSs prior to the formation of Schmitt’s double-stranded consensus sequences discloses the use of unpaired reads, such a theory is not sufficiently supported on the current record. The portions of Schmitt the Petition relies on for element 1(e) describe the use of paired families to generate a double-stranded consensus sequence. See Pet. 31–33 (citing Ex. 1083 ¶¶ 13, 60, 68, Fig. 3). For example, Petitioner points to the” slip op. at 16

  Claim construction§ 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 11,118,221
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Dec 12, 2022 · IPR2021-00862 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–24 were not shown unpatentable because Petitioner failed to establish the proposed prior-art combinations and the required motivation to combine with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 9–10. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” 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 [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[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 necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCT-guided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “computer system” of the claims and all of its programmed surgical functionality, particularly, using a computer system to construct an anterior capsulotomy cutting region based on the image data. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention.” slip op. at 25

  • Obviousness (§103) › Motivation to combine / reasonable expectation of success › HindsightMotivation not foundNot shown unpatentableNot shown unpatentable

    “The evidence of record demonstrates, however, that modifying an existing corneal surgery system to image and perform surgery on the lens was not the simple task asserted by Petitioner. For example, in a patent application filed in November 2009, Petitioner asserted that due to the different depth ranges for the laser’s focus, “laser systems designed for corneal procedures do not offer solution[s] for the considerable challenges of performing surgery on the lens of the eye.” Ex. 2007, 4:65–67, 5:30–36, code (22). Similarly, in a different patent filed in December 2008, Petitioner outlined the various challenges in developing laser surgery systems for creating incisions in the lens, including the difficulty in focusing a laser beam that propagates through regions of the eye with different optical properties and different curvatures. Ex. 2014, 15:51–16:18, code (22). This patent then states: Because of all the described hard challenges, corneal surgical laser systems are qualitatively simpler than lens surgical lasers. This is well supported by the fact that even though corneal surgical systems were suggested about 40 years ago, none have been adapted successfully for lens surgery to date. Id. at 16:13–18. During prosecution of another patent filed in 2008, and in responses to office actions filed in 2012 and 2013, Petitioner argued that a corneal OCT system “simply will not work” on the lens and that it would not have been obvious to modify such an OCT system to image the lens. Ex. 2015, 898, 1591, 1788. This was because OCT systems designed to image the lens would be required to deliver and scan an imaging beam “to a depth ten times bigger and a depth range ten times bigger” than an OCT system designed to image the cornea. Id. at 1591. According to Petitioner, “it is not obvious” to modify an OCT imaging system to achieve a depth and scanning range that is ten times larger than that disclosed in the art. Id. at 898 (“Increasing a system’s performance by an order of magnitude cannot be regarded as obvious.”), 1590–1591. Petitioner’s arguments presented in its own patents and during their” slip op. at 39

  Patent outcomesUS 8,709,001 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,709,001
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Dec 12, 2022 · IPR2021-00858 · APJ Sheridan K Snedden · IPR · Final written decision

  Claims 1–19 were not shown unpatentable because Petitioner failed to establish that the asserted prior-art combinations would have been made with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “The parties present compelling argument and evidence that one of ordinary skill in the art would include those with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 26; PO Resp. 8–9. The evidence of record also demonstrates that few individuals actually had such comprehensive experience. Rather, teams of individuals with different expertise and various academic degrees (Ph.D.s, B.S.s, and M.D.s) would work together to design laser surgery systems intended to make incisions in the lens of the eye. See, e.g., Ex. 1041 (several authors are M.D.s); Ex. 1042 (the authors’ degrees include Ph.D.s, an M.D., and a B.S.); see also Ex. 1053; Ex. 1054; Ex. 1055; Ex. 2010; Ex. 2019. Thus, we find that the person of ordinary skill in the art would have been either an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as nuclear engineering, having experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., five years of experience for a Ph.D. or more to compensate for lesser degrees), and that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” 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. 7 (stating that it “reserves the right to respond to any constructions that [Patent Owner] submits”). Patent Owner does not present any remarks regarding claim construction. See generally PO Resp. On this record, we determine that no claim terms require express construction because it is not essential to our conclusions on patentability. See Nidec Motor., 868 F.3d at 1017 (quoting Vivid Techs., 200 F.3d at 803 (“[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 necessary to our decision, we provide that discussion below in our analysis of the asserted grounds of unpatentability.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “Having considered the parties’ positions and evidence of record, summarized above, we find that the evidence of record does not support a conclusion that it would have been simple, straightforward, or otherwise routine to convert Swinger’s manual HeNe aiming system and Swinger’s surgeon-identification-of-target-tissue step to a computer-controlled, OCTguided laser system. Even assuming that a person of ordinary skill in the art would have combined the teachings of Swinger and Baikoff to achieve a laser surgical system incorporating an OCT imaging system, that combination still would not have achieved the required “control system” of the claims and all of its programmed surgical functionality. Petitioner relies on the ability of a person of ordinary skill in the art to configure Swinger’s computer control unit with the missing functionality, thus necessitating an electronic conversion of the steps performed by a surgeon using Swinger’s direct visualization method using a HeNe aiming beam to manually identify a surgical treatment region for laser surgery. Ex. 1039, 34:52–57; Ex. 2088 ¶¶ 55–59, 66. That conversion, however, involves the incorporation of OCT imaging technology as the basis for a computer-controlled system to plan and then implement the planned cataract surgery, two technological leaps that the record fails to show were known or suggested. In particular, the evidence of record does not support a conclusion that OCT was a well-known system used routinely, if at all, in the identification of treatment regions in the lens or lens capsule for cataract surgery, and further does not support a conclusion that a computer-controlled system to plan and to implement a planned cataract surgery in the lens was commonplace or even considered before the invention. We recognize that Petitioner directs us to the testimony of Dr. Izatt who opines that a person of ordinary skill in the art would have found it obvious to, for example, use a controller to determine the claimed scanning pattern. Ex. 1001 ¶ 159; Pet. 32–33; Reply 3–5; see also Ex. 1123 ¶ 31 (“Once the anterior capsule is identified, it is a relatively simple process to determine the location to place the capsulotomy.”). Here, however, we agree with Patent Owner that the Petition and supporting testimony fails to provide the requisite reasoned analysis with sufficient evidence to support Petitioner’s position on obviousness. In particular, absent some evidentiary support beyond Dr. Izatt’s and Dr. Tipperman’s bare opinions that it would have been obvious to program a controller to bridge the gap between the functionality disclosed in Swinger and the required functionality of the challenged claims, we are unwilling to accept this line of reasoning. PO Resp. 27; Sur-Reply 4–7; Ex. 1001 ¶ 159; see also DSS, 885 F.3d at 1374 (Fed. Cir. 2018) (A skilled artisan’s “common sense” or “common knowledge” can potentially “fill in a missing limitation only when ‘the limitation in question was unusually simple and the technology particularly straightforward.’” (emphasis omitted)).” slip op. at 25

  • Strike new argumentNew argument disregardedDecided for patent owner

    “Inter partes review must proceed in accordance with the Petition and the arguments set forth therein. SAS Inst., Inc. v. Iancu, 138 S. Ct. 1348, 1356 (2018). “It is of the utmost importance that petitioners in the IPR proceedings adhere to the requirement that the initial petition identify ‘with particularity’ the ‘evidence that supports the ground for the challenge to each claim.’” Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1369 (Fed. Cir. 2016). Arguments made in a different document, such as an expert’s declaration, may not be incorporated-by-reference in the Petition. 37 C.F.R. § 42.6(a)(3); see also General Access Solutions, Ltd. v. Sprint Spectrum L.P., 811 F. App’x 654, 658 (Fed. Cir. 2020) (noting that the Board did not abuse its discretion in enforcing its rules under 37 C.F.R. § 42.6(a)(3)) (non-precedential)).” slip op. at 35

  Patent outcomesUS 8,425,497 not shown unpatentable
  Claim construction§ 103 obviousness
  Patents in suitUS 8,425,497
• Genus PLC v. Inguran, LLCAll claims unpatentable
  PTAB · 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 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites Phillips · Graham
  Patents in suitUS 10,542,734
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCSome claims unpatentable
  PTAB · Dec 6, 2022 · IPR2021-00856 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–15 are unpatentable over the asserted §103 grounds; claims 17–23 were not shown unpatentable.

  RulingsFinal written decision

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successUnpatentableNot shown unpatentableMixed

    “persuasive and credit Dr. Kang’s testimony that Freedman’s ablating laser is incompatible with laser surgery on the lens or lens capsule during cataract surgery. Ex. 2087 ¶¶ 49–51, 79–82. This is because the ablating laser cannot pass through the cornea to reach the lens without destroying the cornea in the process. Id. ¶¶ 79, 82. In contrast, lasers used to cut internal tissues of the eye use laser photodisruption. Id. ¶ 80. Accordingly, we find that one of ordinary skill in the art would not have used Freedman’s system to perform surgery on the lens or lens capsule, as asserted by Petitioner.” slip op. at 76

  • Obviousness (§103) › Objective indicia / secondary considerations › NexusObjective indicia no nexusDecided for petitioner

    “exhibit provides no context or rationale for the award and, as discussed above, the Catalys product is composed of many components and systems not specifically covered by the challenged claims. Ex. 2043, 3. Patent Owner points also to a report dated June 28, 2012, as evidencing that this award was for the specific features of the Catalys product claimed, but this evidence lacks any identification of the author and the portion identifying features of the product appears to merely be listing features thereof rather identifying than any reason for the award. Ex. 2040. Additionally, the evidence of praise cited by Patent Owner is not specific to the subject matter of claim 1 (and its dependent claims) of the ’724 patent, but general praise for the FLACS system and laser-guided femtosecond laser procedures. See Ex. 2035; Ex. 2037; Ex. 2044; Ex. 2051. For these reasons, we are not persuaded by Patent Owner’s arguments or evidence on industry praise.” slip op. at 51

  Patent outcomesUS 8,500,724 mixed
  § 103 obviousnesscites Phillips · KSR · Graham
  Patents in suitUS 8,500,724
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCNo claims unpatentable
  PTAB · Dec 2, 2022 · IPR2021-00853 · APJ Ryan H Flax · IPR · Final written decision

  Claims 1–3, 5, 6, 8, 12, and 13 were not proven unpatentable because the asserted combinations lacked a persuasive basis for achieving the claimed system with a reasonable expectation of success.

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for patent owner

    “Petitioner’s proposed definition of the person of ordinary skill in the art appears to be consistent with the level of skill in the art reflected in the prior art of record and the disclosure of the ’725 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 here, based on our review of the record. Thus, we find that the person of ordinary skill in the art would have been someone with a PhD, MS, or BS degree in physics, biomedical engineering, or a related science such as nuclear engineering, having more or less experience in research, manufacturing, or designing medical optics or medical lasers (e.g., 5 years for a PhD or more to compensate for lesser degrees), or an ophthalmic surgeon, but that such persons would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties and is appropriate in view of the record.” slip op. at 17

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)Term construed petitioner constructionDecided for petitioner

    “Patent Owner does not ask that this claim language be expressly construed or contest Petitioner’s proposed interpretation. See Resp. 11–15. Although it is not necessary for our final decision in this proceeding to construe this claim language because it is not essential to our conclusions on patentability, as it is uncontested, we adopt as our own Petitioner’s proposed construction of “imaging device configured to acquire point by point image data from locations distributed throughout a volume of a crystalline lens.”” slip op. at 19

  • Claim Construction › Intrinsic evidence (Phillips canons) › Plain and ordinary meaning to a POSITATerm construed patent owner constructionDecided for patent owner

    “Turning to the disputed term “automatically” in this context, we agree with Patent Owner that the plain meaning of the term “automatically” is that the “control system” can, on its own and without human intervention, perform the subsequently recited step. Resp. 11–15; see also Pet. 10 (Petitioner agreeing this is the plain meaning). This is supported by the Specification, which states, inter alia, that “the entire system is controlled by the controller CPU” and describes alternative embodiments where (1) the system is fully in control and where (2) user input identifies targets. Ex. 1027, 12:23–25, 13:25–44, Figs. 14, 15. However, we also agree with Petitioner that just because the claimed “control system” is configured/programmed to perform (i.e., capable of performing) some tasks “automatically” (i.e., entirely on its own), this does not mean user input (e.g., from a surgeon) must be altogether excluded. Pet. 10–11. In fact, user input must be possible and is within the scope of the independent claim. “By definition, an independent claim is broader than a claim that depends from it, so if a dependent claim reads on a particular embodiment of the claimed invention, the corresponding independent claim must cover that embodiment as well.” Littelfuse, Inc. v. Mersen USA EP Corp., 29 F.4th 1376, 1380 (Fed. Cir. 2022). Here claim 2, requiring automatic target identification, and claim 5, requiring user input on target identification, each depends from claim 1 and illuminates its scope, which must be broad enough to encompass both. Thus, although requiring (in claim 1) that a “control system” can perform certain recited functions, and that some are performed (according to claim 2) “automatically,” that same “control system” must also be capable of allowing a user input on the locations of targets for laser treatment (according to claim 5). Such optional user input required by dependent claim 5 is described in the Specification, which includes embodiments where a surgeon can adjust the size, location, and shape of the treatment pattern, can determine the optimal cutting contours in patients, and can provide “user input” to define targets or adjust computer-defined parameters as necessary. Ex. 1027, 10:55–45; 10:67–11:2, 13:25–55, 13:63–14:2. Regardless, the configuration of independent claim 1’s “control system,” which must be programmed to and capable of performing its own recited steps/functions, is not diminished by the requirements of either dependent claim. Multilayer Stretch Cling Film Holdings, Inc. v. Berry Plastics Corporation, 831 F.3d 1350, 1360 (Fed. Cir. 2016) (“[T]he language of a dependent claim cannot change the scope of an independent claim whose meaning is clear on its face.”).” slip op. at 22

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation not foundReasonable expectation not foundNot shown unpatentable

    “generally. “The presence or absence of a reasonable expectation of success is . . . a question of fact,” and this “requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.” Intelligent Bio-Sys., 821 F.3d at 1366–67. Based on the record, we conclude that, even if it would have been potentially advantageous to in some way incorporate the use of Baikoff’s and Li’s OCT imaging and measuring into Swinger’s system and method for cataract surgery (for example, to replace the use of ultrasound imaging with OCT), we agree with Patent Owner that, other than the (ultimately) conclusory testimony of its witness Dr. Izatt (see, e.g., Ex. 1001 ¶¶ 110, 144, 151, 161, 163–165, 168), there is no persuasive evidence that the person of ordinary skill in the art would have combined these references with the result being a control system configured to (automatically or not in practice) image cataractous eye tissue, identify the targets therein (capsule and lens) to be cut with a laser, and then operate that laser to actually make those cuts based in some part on that imaging. See Resp. 15–34. We credit Dr. Kang’s testimony that, as of the invention, the person of ordinary skill in the art would not have relieved the surgeon of responsibility for identifying cutting regions for laser capsulotomy and cataract surgery (as taught by Swinger), and relegated such task to a computer, which subsequently performs the procedure. Ex. 2087 ¶¶ 36–38, 42, 46, 62–66; see also Ex. 2088 ¶¶ 56–59, 68–71 (Dr. Walter testifying similarly). Dr. Kang takes issue with Petitioner’s positions that Baikoff and Li teach or suggest such reliance on a computer because, according to Dr. Kang, neither Baikoff nor Li (and indisputably not Swinger) teaches using a computer to identify laser cutting regions or to control laser surgery, and, in fact, they suggest reliance on a surgeon to interpret their OCT images to plan a subsequent surgery. See, e.g., Ex. 2087 ¶¶ 36–38, 42, 46, 62–66. We further credit Dr. Kang’s testimony that Petitioner fails to adequately explain, even were the ordinarily skilled artisan intent on combining Baikoff’s and Li’s OCT imaging systems with Swinger’s cataract surgery system, how it would have been accomplished to overcome the “substantial challenges” and achieve the claimed invention. See id. ¶¶ 63– 66; see also Resp. 27–28 (addressing Petitioner’s lack of explanation as to how to implement the combination).19 We agree that, beyond merely suggesting plugging one system into another, Petitioner does not explain how the person of ordinary skill in the art would have programmed Swinger’s computer control system to use Baikoff’s and Li’s OCT imaging systems and tissue recognition and measurement algorithms to determine capsulotomy cutting regions and then implement the planned cutting with a laser, even from a rudimentary perspective. See Pet. 35–40. Indeed, Petitioner concedes:” slip op. at 50

  Patent outcomesUS 9,125,725 not shown unpatentable
  Claim construction§ 103 obviousnesscites Alice · Phillips · KSR · Graham
  Patents in suitUS 9,125,725
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCAll claims unpatentable
  PTAB · Dec 1, 2022 · IPR2021-00849 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 1–14 are unpatentable under § 103 over the Swinger-based grounds; the Board did not reach the Blumenkranz-based grounds.

  RulingsFinal written decision

  • Skill levelSkill level board ownOther

    “Both parties present compelling evidence that those of skill in the art would include individuals with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 26; PO Resp. 10. The evidence of record also demonstrates that few individuals actually had such experience. Rather, teams of individuals with different expertise and various academic degrees would work together to design laser surgery systems intended to make incisions in the lens of the eye. Accordingly, we find that the person of ordinary skill in the art would have been an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as optical engineering, with experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., Ph.D. or five or more years to compensate for lesser degrees). Such individuals would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 10

  • Expert testimonyPetitioner expert creditedDecided for petitioner

    “device to obtain “a qualitatively novel and previously unachievable quantitative description of the eye in respect of diagnostics and therapeutics” and providing this information as a data record to introduce the optimal ablation pattern to a patient’s eye. Ex. 1020 ¶¶ 38–39, 46. As Patent Owner notes, Benedikt does not describe the laser system that obtains the “data record” and introduces the optimal ablation pattern to a patient’s eye. PO Resp. 48. Benedikt also does not expressly state that a controller generates the incision pattern, as opposed to the incision pattern being generated by a surgeon or technician. Id. at 49. That said, Benedikt discloses using programs and data to generate the optimal ablation pattern and to automate laser surgery. Ex. 1020 ¶¶ 39, 46. When viewed as a whole, we credit the testimony of Dr. Lubatschowski that one of ordinary its data record to a controller that is programmed to generate optimal incision patterns for the cornea of a patient’s eye. Ex. 1001 ¶¶ 472–473 (citing Ex. 1020 ¶¶ 36, 39, 42); Pet. 56. In view of the foregoing, we find persuasive Petitioner’s argument that the combination of Swinger, Weikert, Benedikt, and Kurtz teaches or suggests a controller programmed to use OCT signals (in addition to signals from a profilometer) to determine an incision pattern for the cornea of a patient’s eye, as recited in independent claim 1.” slip op. at 24

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Both parties provide a construction for the term “cataract incision.” Pet. 7–9; PO Resp. 12–13. Upon review of the parties’ arguments and supporting evidence, and in view of the fact that neither party contests that Weikert discloses a cataract incision under either party’s proposed construction of that term, we determine that no claim terms require express construction for purposes of this Final Written 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 11

  • 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, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential) (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” slip op. at 12

  Patent outcomesUS 10,709,548 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,709,548
• Alcon Inc. / Alcon Vision, LLC et al. v. Amo Development, LLCAll claims unpatentable
  PTAB · Dec 1, 2022 · IPR2021-00846 · APJ Jon B Tornquist · IPR · Final written decision

  Claims 1–12 are unpatentable as obvious over Swinger, Weikert, and Benedikt (claims 1–8), and with L’Esperance added (claims 9–12).

  RulingsFinal written decision

  • Skill levelSkill level board ownDecided for petitioner

    “Both parties present compelling evidence that those of skill in the art would include individuals with experience in ophthalmology, as well as in the research, manufacture, and design of medical optics or medical lasers. Pet. 25; PO Resp. 8. The evidence of record also demonstrates that few individuals actually had such experience. Rather, teams of individuals with design laser surgery systems intended to make incisions in the lens of the eye. Accordingly, we find that the person of ordinary skill in the art would have been an ophthalmic surgeon or someone with a Ph.D., M.S., or B.S. degree in physics, biomedical engineering, or a related science such as optical engineering, with experience in researching, manufacturing, or designing medical optics or medical lasers (e.g., Ph.D. or five or more years to compensate for lesser degrees). Such individuals would have worked in collaboration with one another to fill any necessary gaps in knowledge (e.g., the engineer would consult the medical doctor on clinical issues or physiology and the medical doctor would consult the engineer on technical issues). This definition marries the two proposed by the parties.” slip op. at 10

  • Claim Construction › Threshold & procedure › Whether a term needs construction (O2 Micro)No construction neededOther

    “Petitioner provides constructions for the terms “cataract incision” and “a delivery system for delivering the laser beam to the target tissue to form a cataract incision.” Pet. 7–9. Patent Owner provides a construction for the term “cataract incision.” PO Resp. 10–11. Upon review of the parties’ arguments and supporting evidence, including the fact that neither party disputes that Weikert expressly discloses cataract incisions under either parties’ interpretation of that term, we determine that no claim terms require express construction for purposes of this Final Written 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 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, LLC v. Sound View Innovations, LLC, IPR2018-01039, Paper 29 at 13 (PTAB Dec. 20, 2019) (precedential) (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, 27–28. 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; Pet. 5–6, 27–28.” slip op. at 13

  • Obviousness (§103) › Motivation to combine / reasonable expectation of successMotivation foundReasonable expectation foundDecided for petitioner

    “Benedikt describes its combined topometer/OCT imaging device as providing a “previously unattainable comprehensive topometerical/topographical illustration of the cornea” and discloses using this comprehensive data to automate corneal laser surgery. Ex. 1020 ¶¶ 39, 46; Pet. 55–56. In contrast to the comprehensive illustration of the cornea provided by Benedikt’s system, Petitioner demonstrates that HeNe beams are limited to visualizing the surface of eye tissue at a single point. Ex. 1070 ¶¶ 32–34; Pet. Reply 23; Ex. 1073, 254:2–14; Ex. 1001 ¶¶ 29–31. As Petitioner proposes to use the system of Swinger to make incisions in the cornea, which Benedikt’s system can image comprehensively, we find persuasive Petitioner’s argument that one of ordinary skill in the art would have found it beneficial to implement Benedikt’s imaging device to aid Swinger’s corneal surgery procedure(s). (2)” slip op. at 25

  Patent outcomesUS 10,376,356 unpatentable
  Claim construction§ 102 anticipation§ 103 obviousnesscites KSR · Graham
  Patents in suitUS 10,376,356

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.