IPR2024-00459
`Preliminary Response
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`__________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`__________________
`
`GENEOSCOPY, INC.,
`Petitioner,
`v.
`EXACT SCIENCES CORPORATION,
`Patent Owner.
`_________________
`
`Case No: IPR2024-00459
`U.S. Patent 11,634,781
`__________________
`
`PATENT OWNER’S PRELIMINARY RESPONSE
`
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`
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`Geneoscopy Exhibit 1032, Page 1
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`

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`
`
`I. 
`II. 
`
`B. 
`
`C. 
`
`2. 
`
`3. 
`
`4. 
`
`IPR2024-00459
`Preliminary Response
`
`TABLE OF CONTENTS
`
`Page
`INTRODUCTION ........................................................................................... 1 
`BACKGROUND OF THE COLOGUARD TEST AND ’781
`PATENT .......................................................................................................... 2 
`A. 
`CRC Screening Techniques Prior to the Cologuard Test ...................... 2 
`B. 
`The Invention of the ’781 Patent ........................................................... 4 
`III.  GENEOSCOPY’S PRIOR (AND FAILED) ATTEMPT TO
`INVALIDATE THE ’781 PATENT ............................................................... 5 
`IV.  PROSECUTION HISTORY ........................................................................... 8 
`A. 
`The ’607 Parent Application Issued Over Substantially Similar
`Rejections as the Petition Art and Arguments ...................................... 8 
`Similar Claims in the ’945 Application Were Recently Allowed
`Over all References Cited in the Petition ............................................ 10 
`The Petition References are the Same as, or Substantially
`Overlap with, References Considered During Examination of
`the ’335 Application that Resulted in the ’781 Patent ........................ 11 
`V.  OVERVIEW OF REFERENCES CITED IN GROUNDS ........................... 12 
`1. 
`Lenhard (Ex. 1004) – Describes Laboratory Collection
`and Comparison of gFOBT with a Specific Methylation
`Marker Tested from Frozen Samples ........................................ 12 
`Vilkin (Ex. 1005) – Limited to a Specific iFOBT Device
`Compared to gFOBT ................................................................. 14 
`Itzkowitz (Ex. 1006) – Limited to Specific DNA-Based
`Testing ....................................................................................... 15 
`Shuber (Ex. 1009) – Limited to Nucleic-Acid Based
`Testing ....................................................................................... 17 
`VI.  THE BOARD SHOULD EXERCISE DISCRETION AND DENY
`INSTITUTION UNDER § 325(d) ................................................................. 18 
`A.  Ground 1 – Lenhard in view of Itzkowitz and Vilkin is the same
`as, or cumulative of, previously cited art and arguments .................... 21 
`
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`i
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`Geneoscopy Exhibit 1032, Page 2
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`IPR2024-00459
`Preliminary Response
`
`
`
`1. 
`
`2. 
`
`B. 
`
`C. 
`
`Becton Dickinson Factors (a) and (b) - Lenhard in view
`of Itzkowitz and Vilkin is the same or substantially the
`same as previously presented art .............................................. 22 
`Becton Dickinson Factors (d) - the Petitioner’s arguments
`substantially overlap the previous reexamination
`arguments and the Examiner’s arguments ................................ 32 
`Ground IV – Shuber in combination with Vilkin is the same as,
`or cumulative of, previously cited art and arguments – Becton
`Dickinson Factors (a), (b), and (d) ...................................................... 34 
`All Grounds - Becton Dickinson Factors (c), (e), and (f) –
`Petitioner’s failure to allege “material error” weighs heavily in
`favor of denial ..................................................................................... 36 
`VII.  THE BOARD SHOULD EXERCISE DISCRETION AND DENY
`INSTITUTION UNDER § 314(a) ................................................................. 38 
`A. 
`Factor 1: “whether the same petitioner previously filed a
`petition directed to the same claims of the same patent.” ................... 41 
`Factor 2: “whether at the time of filing of the first petition the
`petitioner knew of the prior art asserted in the second petition or
`should have known of it.” ................................................................... 41 
`Factor 3: “whether at the time of filing of the second petition
`the petitioner already received the patent owner's preliminary
`response to the first petition or received the Board's decision on
`whether to institute review in the first petition.” ................................ 42 
`Factor 4: “the length of time that elapsed between the time the
`petitioner learned of the prior art asserted in the second petition
`and the filing of the second petition.” ................................................. 44 
`Factor 5: “whether the petitioner provides adequate explanation
`for the time elapsed between the filings of multiple petitions
`directed to the same claims of the same patent.” ................................ 44 
`Factor 6: the finite resources of the Board. ......................................... 44 
`Factor 7: the requirement under 35 U.S.C. § 316(a)(11) to issue
`a final determination not later than 1 year after the date on
`which the Director notices institution of review. ................................ 45 
`VIII.  CLAIM CONSTRUCTION IS NOT NECESSARY TO DENY
`INSTITUTION .............................................................................................. 46 
`
`B. 
`
`C. 
`
`D. 
`
`E. 
`
`F. 
`G. 
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`ii
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`Geneoscopy Exhibit 1032, Page 3
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`IPR2024-00459
`Preliminary Response
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`IX.  THE PETITIONER’S GROUNDS INDEPENDENTLY FAIL ON
`THE MERITS ................................................................................................ 46 
`A. 
`Level of Ordinary Skill in the Art ....................................................... 46 
`B. 
`The Lenhard, Vilkin, and Itzkowitz Combination Does Not
`Teach or Suggest the Claimed Invention ............................................ 48 
`The Shuber and Vilkin Combination Does Not Teach or
`Suggest the Claimed Invention ........................................................... 55 
`Petitioner’s Second, Third, Fifth, and Sixth Grounds Also Fail ......... 60 
`D. 
`CONCLUSION .............................................................................................. 61 
`
`C. 
`
`X. 
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`
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`iii
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`Geneoscopy Exhibit 1032, Page 4
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`
`
`TABLE OF AUTHORITIES
`
`IPR2024-00459
`Preliminary Response
`
`Page
`
`Cases
`
`Advanced Bionics, LLC v. MED-EL Elektromedizinische Geräte GmbH,
`2020 WL 740292 (P.T.A.B. Feb. 13, 2020) (precedential, designated
`March 24, 2020) .................................................................................................................19, 36
`
`Becton, Dickinson & Co. v. B. Braun Melsungen AG,
`IPR2017-01586, Paper 8 (P.T.A.B. Dec. 15, 2017).................................................................20
`
`Biocon Pharma Ltd. v. Novartis Pharmaceuticals Corp.,
`2021 WL 608300 (P.T.A.B. Feb. 16, 2021) .....................................................................19, 29
`
`Ecofasten Solar, LLC v. Unirac, Inc.,
`2022 WL 443369 (P.T.A.B. Feb. 8, 2022) ........................................................................20, 38
`
`General Plastic Indus. Co., Ltd. v. Kaisha,
`2017 WL 3917706 (P.T.A.B. Sept. 6, 2017) .........................................................40, 42, 43, 44
`
`Google LLC v. Valtrus Innovations,
`IPR2022-01197, Paper 18 (P.T.A.B. June 13, 2023) ...................................................28, 37, 38
`
`Illumina Inc. v. Ravgen, Inc.,
`IPR2021-01271, Paper 12 (P.T.A.B. Jan. 26, 2022) ................................................................39
`
`NVIDIA Corp. v. Samsung Elec. Co.,
`IPR2016–00134 (P.T.A.B. May 4, 2016) ................................................................................40
`
`Realtime Data, LLC v. Iancu,
`912 F.3d 1368 (Fed. Cir. 2019)................................................................................................46
`
`Samsung Elec. Co. Ltd. v. Rembrandt Wireless Techs., LP,
`IPR2015-00114, Paper 14 (P.T.A.B. Jan. 28, 2015) ..........................................................40, 45
`
`Samsung Elecs. Co., Ltd. v. Netlist, Inc.,
`2022 WL 22412095 (P.T.A.B. Oct. 19, 2022) .........................................................................39
`
`Toyota Motor Corp. v. Cellport Systems, Inc.,
`IPR2015-01423, Paper No. 7 (P.T.A.B. Oct. 28, 2015) ..........................................................45
`
`Vivid Techs., Inc. v. Am. Sci. & Eng’g, Inc.,
`200 F.3d 795 (Fed. Cir. 1999)..................................................................................................46
`
`In re Vivint
`14 F.4th 1342 (Fed. Cir. 2021) ................................................................................................39
`
`
`
`iv
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`Geneoscopy Exhibit 1032, Page 5
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`
`
`Statutes
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`IPR2024-00459
`Preliminary Response
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`35 U.S.C. § 103 ..............................................................................................................................35
`
`35 U.S.C. § 314 ................................................................................................................................2
`
`35 U.S.C. § 314(a) .............................................................................................................38, 39, 45
`
`35 U.S.C. § 316(a)(11) ...................................................................................................................45
`
`35 U.S.C. § 316(b) .........................................................................................................................44
`
`35 U.S.C. § 325(d) .......................................................................................2, 18, 19, 20, 30, 36, 38
`Other Authorities
`
`H.R. Rep. No. 112-98, pt.1 (2011) .................................................................................................40
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`
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`v
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`Geneoscopy Exhibit 1032, Page 6
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`IPR2024-00459
`Preliminary Response
`
`No.
`2001
`2002
`2003
`
`2004
`
`2005
`
`2006
`
`2007
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`2008
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`2009
`
`2010
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`2011
`
`2012
`
`2013
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`EXHIBIT LIST
`Exhibit
`Declaration of Vadim Backman, Ph.D.
`Curriculum vitae of Vadim Backman, Ph.D.
`Prosecution file history for application number 15/634,607,
`issued as patent number 11,845,991
`Prosecution file history for application number 17/936,335,
`issued as patent number 11,634,781
`Prosecution file history for application number 18/179,945,
`issued as patent number 11,970,746
`European Patent Application Publication No. EP1266715A1 to
`DeLuca et al. (“DeLuca”)
`Zohar Levi et al., A quantitative immunochemical faecal occult
`blood test is more efficient for detecting significant colorectal
`neoplasia than a sensitive guaiac test, 23(9) Aliment Pharmacol
`Ther., 1359, 1359–1364 (2006) (“Levi”)
`Thomas F. Imperiale et al., Multitarget Stool DNA Testing for
`Colorectal-Cancer Screening, 370(14) N. Eng. J. Med., 1287,
`1287–1297 (2014)
`Sidney J. Winawer and Ann G. Zauber, The Advanced
`Adenomas as the Primary Target of Screening, 12(1)
`Gastrointestinal Endosc. Clin. N. Am. 1, 1–9 (2002)
`Daniel C. Chung, The Genetic Basis of Colorectal Cancer:
`Insights Into Critical Pathways of Tumorigenesis, 119
`Gastroenterology 854, 854–865 (2000)
`Hermann Brenner et al., Risk of progression of advanced
`adenomas to colorectal cancer by age and sex: estimates based
`on 840 149 screening colonoscopies, 56(11) Gut 1585, 1585–
`1589 (2007)
`David L. Zack et al., Colorectal Cancer Screening Compliance
`by Medicine Residents: Perceived and Actual, 96(10) Am. J.
`Gastroenterology 3004, 3004–3008 (2001)
`Amnon Sonnenberg and Fabiola Delcò, Cost-effectiveness of a
`Single Colonoscopy in Screening for Colorectal Cancer, 162(2)
`Arch Intern Med. 163, 163–168 (2002)
`
`vi
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`Geneoscopy Exhibit 1032, Page 7
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`2014
`
`2015
`
`2016
`2017
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`2018
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`2019
`
`2020
`
`IPR2024-00459
`Preliminary Response
`
`Peter B. Cotton et al., Computed Tomographic Colonography
`(Virtual Colonoscopy): A Multicenter Comparison With
`Standard Colonoscopy for Detection of Colorectal Neoplasia,
`291(14) JAMA 1713, 1713–1719 (2004)
`Nathalie Schoofs, et al., A. PillCam colon capsule endoscopy
`compared with colonoscopy for colorectal tumor diagnosis: a
`prospective pilot study. Endoscopy 38, 971-977 (2006)
`Exact Sciences, “Cologuard™ Patient Guide” (2014)
`Exact Sciences, “FDA Approves Exact Sciences’ Cologuard®;
`First and Only Stool DNA Noninvasive Colorectal Cancer
`Screening Test,” https://investor.exactsciences.com/investor-
`relations/press-releases/press-release-details/2014/FDA-
`Approves-Exact-Sciences-Cologuard-First-and-Only-Stool-
`DNA-Noninvasive-Colorectal-Cancer-Screening-
`Test/default.aspx (August 12, 2014)
`Exact Sciences, “Get Off the Bench: Hoops Themed Campaign
`Urges Colorectal Cancer Screening,”
`https://www.exactsciences.com/newsroom/news-and-
`stories/get-off-the-bench-hoops-themed-campaign-urges-
`colorectal-cancer-screening-
`#:~:text=March%2007%2C%202024-,Get%20Off%20the%20B
`ench%3A%20Hoops%2DThemed%20Campaign%20Urges%20
`Colorectal%20Cancer,'&text=Shortly%20after%20basketball%
`20star%20Jamal,he%20got%20some%20tough%20news
`(March 07, 2024)
`Geneoscopy, “Geneoscopy Submits Premarket Approval
`Application to U.S. food and Drug Administration for its
`Noninvasive Colorectal Cancer RNA Biomarker Screening
`Test,” https://www.geneoscopy.com/geneoscopy-submits-
`premarket-approval-application-to-fda-for-its-noninvasive-
`colorectal-cancer-rna-biomarker-screening-test/ (January 24,
`2023)
`United States Department of Health and Human Services,
`“Increase the proportion of adults who get screened for
`colorectal cancer — C‑07,”
`https://health.gov/healthypeople/objectives-and-data/browse-
`objectives/cancer/increase-proportion-adults-who-get-screened-
`colorectal-cancer-c-07
`
`vii
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`Geneoscopy Exhibit 1032, Page 8
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`
`I.
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`IPR2024-00459
`Preliminary Response
`
`INTRODUCTION
`U.S. Patent No. 11,634,781 (the “’781 patent”) covers the use of Exact
`
`Sciences’ revolutionary Cologuard® colorectal cancer (“CRC”) screening kits. The
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`technology protected by the ’781 patent has given millions of people a noninvasive
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`and convenient approach to CRC screening, and has been a resounding commercial
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`success.
`
`Petitioner Geneoscopy is attempting to bring its own competing product to
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`market. Geneoscopy already failed at its first attempt to challenge the ’781 patent –
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`a 280-page ex parte reexamination request with 14 proposed rejections (2
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`anticipatory and 12 obviousness based) that applied 8 different references – which
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`resulted in the CRU confirming all claims as patentable. Geneoscopy is trying
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`again here, but this Petition is entirely duplicative of what the PTO has already
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`considered. Indeed, this Petition relies on art that is substantively the same as the
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`reexamination art as well as art raised in initial prosecution. The Petition likewise
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`raises arguments here that are substantively identical to those raised in the
`
`reexamination. Yet nowhere does the Petition explain how the art raised here is
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`any different than the art already considered, and thus fails to establish under the
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`first prong of the Becton Dickinson analysis that the art or arguments are in any
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`way different than those already considered. The Petition likewise fails the second
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`Geneoscopy Exhibit 1032, Page 9
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`prong of the Becton Dickinson test, as Petitioner fails to allege any material
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`IPR2024-00459
`Preliminary Response
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`error—even for art that was undisputedly considered during prosecution. These
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`failures warrant discretionary denial under 35 U.S.C. § 325(d).
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`Denial is also appropriate here under 35 U.S.C. § 314. Geneoscopy’s serial
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`challenges to the ’781 patent are unnecessary, waste the Board’s time, and impose
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`undue burden on the Patent Owner. And while section 314 has been applied to
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`serial IPRs, the underlying rationale applies equally here, in some respects more
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`so, considering the broader standard for claim interpretation and unlimited pages
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`available to Petitioner in the reexamination.
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`Finally, even if the Board finds discretionary denial is not appropriate, the
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`Petition should nevertheless be denied on the merits. Petitioner improperly relies
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`on hindsight to pick and choose features from multiple references, and there is no
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`teaching or reason that would have motivated a person of ordinary skill in the art to
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`choose the various, isolated elements of different references and combine them to
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`arrive at the claimed invention.
`
`II. BACKGROUND OF THE COLOGUARD TEST AND ’781 PATENT
`A. CRC Screening Techniques Prior to the Cologuard Test
`CRC is a leading cause of cancer-related deaths worldwide. Ex. 1001 at
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`1:41-43. By the ’781 patent’s priority date, colonoscopy had become the primary
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`screening test for CRC because of its high sensitivity and specificity, and because
`
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`2
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`Geneoscopy Exhibit 1032, Page 10
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`polyps can be removed during the procedure. Id. at 1:65-67. However, while both
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`IPR2024-00459
`Preliminary Response
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`sensitive and specific, colonoscopy is also “invasive, costly, has limited
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`availability and includes certain risks.” Id. at 2:1-3. There was therefore a need for
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`effective, efficient screening tests. See Ex. 2001 ¶¶31-32, 34. To be useful, any
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`such tests would need (i) to have sufficient sensitivity to detect indications of
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`cancer and precursor lesions, (ii) to have sufficient specificity to minimize false
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`positives that result in unnecessary colonoscopies, and (iii) to be both accessible to,
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`and acceptable to, patients. See id.
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`By 2009, various approaches for screening for CRC that were less invasive
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`than colonoscopy, including fecal occult blood tests (“FOBT”) and nucleic acid
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`screening tests, were also being used and further developed. See Ex. 1001 at 2:4-
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`3:40. Each of the less invasive tests had limitations, including limited sensitivity,
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`specificity, patient acceptability, or a combination of all three. See id. Those
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`working in the field sought to balance the goals of both sensitivity and specificity
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`in a test that could be made widely available. Ex. 2001 ¶¶31-32, 34. Further, those
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`working in the field recognized that precancer indications, such as adenomas,
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`should be a target of screening because detection and removal of adenomas
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`provides an opportunity to prevent CRC. Ex. 2009 at 1; Ex. 2001 ¶¶23, 31-32.
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`3
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`Geneoscopy Exhibit 1032, Page 11
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`B.
`The Invention of the ’781 Patent
`The Cologuard test using the ’781 patented technology accomplished these
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`IPR2024-00459
`Preliminary Response
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`goals. Indeed, use of the Cologuard test achieved 92.3% sensitivity and 86.6%
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`specificity. Ex. 2008 at 1. The Cologuard test revolutionized home CRC screening.
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`Under the ’781 patent’s novel and innovative approach, a fecal sample for both
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`nucleic acid and blood testing can be conveniently collected at the same time, in
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`the privacy of a patient’s own home, and shipped without freezing from virtually
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`anywhere. Ex. 2016 at 13-31. The Cologuard test using the ’781 patent’s invention
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`enables many patients to get screened for CRC, patients who would otherwise go
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`unscreened. Ex. 2001 ¶32.
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`More specifically, the invention of the ’781 patent, as embodied in the
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`Cologuard product, provides a patient-friendly, effective means of collecting and
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`processing fecal samples for screening. Under the patented method, a patient
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`collects a fecal sample by direct defecation into a convenient container in the
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`privacy of their own home, and then removes a portion of the sample to a separate
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`sealable container. Ex. 2016 at 17-21. That separate sealable container contains a
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`buffer that prevents denaturation or degradation of blood proteins. Id. at 8. The
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`patient also adds a stabilizing buffer to the remaining sample in the first container.
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`Id. at 8, 22. The containers are both sealed and shipped to a lab at room
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`temperature – they are not ever frozen. Id. at 21, 23, 30. The portion in one
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`4
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`Geneoscopy Exhibit 1032, Page 12
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`container is then tested for a blood protein and the portion in the other container is
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`Preliminary Response
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`tested for nucleic acid. Id. at 8. The Cologuard test was the first, and is still the
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`only, FDA-approved commercially available multitarget stool-based blood and
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`nucleic acid test for CRC screening. Ex. 2017. It has been used by millions since it
`
`received FDA approval in 2014. See Ex. 2018.
`
`III. GENEOSCOPY’S PRIOR (AND FAILED) ATTEMPT TO
`INVALIDATE THE ’781 PATENT
`Geneoscopy is seeking FDA approval for its own CRC screening test known
`
`as ColoSense. Ex. 2019. Geneoscopy filed a request for ex parte reexamination of
`
`the ’781 patent on May 22, 2023, less than a month after it issued. Ex. 1021.
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`Geneoscopy’s 282-page request relied upon multiple references and combinations
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`and asserted six separate bases for purported substantial new questions of
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`patentability (“SNQ”) for claim 1 alone. Id. at 2, 14. Geneoscopy also asserted at
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`least four separate bases for purported SNQs for each of the ’781 patent’s twenty
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`claims. Id. at 10-13. The proceeding confirmed the patentability of all claims of the
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`ʼ781 patent.
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`As discussed in more detail below, the art cited here is substantively the
`
`same as the art cited during the reexamination. In many cases, art cited here, such
`
`as Lenhard and Itzkowitz, are substantively no different than the reexamination
`
`prior art reference Ahlquist. Further, while Petitioner argues that it does not rely on
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`5
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`Geneoscopy Exhibit 1032, Page 13
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`any of the same references as the reexamination, Petitioner fails to inform the
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`IPR2024-00459
`Preliminary Response
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`Board that, although not named in (VI)(B) References in Grounds, Petitioner
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`nonetheless relies on a key reexamination reference in the arguments submitted.
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`The Olson reference examining fecal DNA stabilizing buffers was used in twelve
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`of the fourteen proposed reexamination rejections. See Ex. 1021 at 2. Here, the
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`Petitioner instead cites Itzkowitz, but points to Itzkowitz’s citation of Olson, then
`
`to Olson itself, to inform its discussion. See Pet. at 24-25. Indeed, there is almost
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`complete overlap in how Olson was used in the reexamination, and how it is
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`repackaged in the Petition. Compare Ex. 1021 at 97, with Pet. at 24-25.
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`Petitioner’s arguments in support of purported motivations to combine
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`likewise mirror the reexamination, where Petitioner unsuccessfully argued that
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`generalized goals of improved performance and patient convenience provided
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`adequate motivation. Those arguments are repeated here.
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`The CRU granted the request for reexamination as to all claims. Ex. 1022. In
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`doing so, the CRU agreed that consideration of the combination of Ahlquist with
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`DeLuca1 and Olson raised an SNQ as to claims 1-6 and 15. Id. at 8. The CRU
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`found that Ahlquist teaches at home collection of a fecal sample; that after
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`collection, the patient separated the sample by smearing stool onto cards; and that
`
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`1 DeLuca is not included in the dozens of references that Petitioner chose to
`submit with the Petition. See Pet. at viii-xvi.
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`6
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`Geneoscopy Exhibit 1032, Page 14
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`the patient then shipped the smeared cards and sealed bucket containing the
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`Preliminary Response
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`remaining portion of the stool sample for testing. Id. The CRU found that DeLuca
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`teaches separating a portion of a fecal sample into a sealable tube and adding a
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`buffer to the sample. Id. at 7. The CRU found that Olson discusses the use of
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`buffers to stabilize DNA in stool samples stored at room temperature. Id.
`
`The Patent Owner did not file a statement under 37 C.F.R. § 1.530. Ex. 1023
`
`at 4. Without input from the Patent Owner, the CRU confirmed patentability of all
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`twenty claims. Id. at 5. As the CRU explained, “[n]one of the references of record
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`reasonably suggest collection at home with each of the fecal portions sealed in
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`separate containers, each with a buffer therein as required by independent claim 1.”
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`Id. at 4.
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`
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`Notably, although Petitioner asserts that the arguments and combinations of
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`art in the Grounds are substantively different from the multiple SNQs presented in
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`the reexamination proceedings, Petitioner makes no attempt to explain how they
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`purportedly differ. Pet. at 10, 67. If anything, the Grounds are even weaker than the
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`failed reexamination arguments. Just like the references in the reexamination, none
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`of the references in the Grounds “reasonably suggest collection at home with each
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`of the fecal portions sealed in separate containers, each with a buffer therein as
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`required by independent claim 1.” Ex. 1023 at 4.
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`7
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`Geneoscopy Exhibit 1032, Page 15
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`IV. PROSECUTION HISTORY
`The ’781 patent issued on April 25, 2023, from Application No. 17/936,335.
`
`IPR2024-00459
`Preliminary Response
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`The ’335 application was a continuation of application No. 15/634,607 (the “’607
`
`application”), which issued as U.S. Patent No. 11,845,991 on December 19, 2023.
`
`Petitioner suggests that the ’781 patent issued without significant
`
`prosecution history. Pet. at 10. This largely ignores the history of office actions
`
`during prosecution of the ’607 parent application, in which the Patent Owner
`
`overcame rejections based on Petitioner’s primary Shuber reference and on the
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`subject matter of Petitioner’s primary Lenhard reference. Pet. at 9-10, 67. The ’781
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`patent is subject to terminal disclaimer over the ’607 application. Ex. 2004 at 157.
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`Moreover, since the Petition was filed, a notice of allowance has issued for
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`another patent application (18/179,945) in the same family. That notice of
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`allowance issued after Patent Owner reopened examination to submit the current
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`Petition arguments, expert declaration, and references to the Examiner. That
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`patent, which issued on April 30, 2024, is subject to terminal disclaimer over the
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`’781 patent. Ex. 2005 at 1, 560.
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`A. The ’607 Parent Application Issued Over Substantially Similar
`Rejections as the Petition Art and Arguments
`Petitioner acknowledges that the Shuber reference (the primary reference in
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`Grounds 4-6) was the basis of an obviousness rejection in the ’607 parent
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`8
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`application. Pet. at 67.2 It attempts to side-step this fact, however, arguing that the
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`Preliminary Response
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`rejection was based on different secondary references and arguments. Id. However,
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`the Examiner expressly cited Shuber for its discussion of stabilizing biological
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`samples, including fecal samples, with a nucleic acid stabilizing solution. Ex. 2003
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`at 358. This is the primary purpose for which Petitioner relies on Shuber here. Pet.
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`at 19-20.
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`After Patent Owner overcame the rejection over the Shuber combination, the
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`Examiner rejected the pending claims in the parent ’607 application on other
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`grounds. Ex. 2003 at 640-643. Once again, the cited art and the Examiner’s
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`reasoning substantially overlapped with Petitioner’s arguments. See id. Among
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`other references, the Examiner relied on Kutzner. Ex. 2003 at 643; Ex. 1012. In
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`particular, the Examiner asserted that Kutzner describes a “method for the
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`detection of colorectal tumors using a combination of tests – one of which looks
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`for a component of blood, and one of which is based on nucleic acid analysis, e.g.,
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`PCR.” Ex. 2003 at 643. This is the same purpose for which Petitioner now relies
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`on Lenhard. Pet. at 13.
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`2 Petitioner relies on International Patent Application Publication Number
`WO2005/113769 as “Shuber.” Ex. 1009. Petitioner acknowledges that cited
`reference US 2008/0124714 A1 (Shuber et al.) is the same reference. Pet. at 67.
`Patent Owner refers to both interchangeably herein as “Shuber.”
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`Patent Owner also overcame the rejection over the Kutzner combination.
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`After an Advisory Action from the Office (Ex. 2003 at 687), Patent Owner filed a
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`Pre-Appeal Brief Request for Review in which it explained the deficiencies in the
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`Examiner’s rejection over Wang in view of Liang, Olek, and Kutzner. Id. at 719-
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`723. The previous rejection was then withdrawn. Id. at 727. A notice of allowance
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`issued on December 2, 2022. Id. at 740-747. Prosecution of the parent application
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`continued after requests for continued examination, including to allow
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`consideration of the materials submitted in the request for reexamination of the
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`’781 patent. Id. at 884. The ’607 application issued as U.S. Patent No. 11,845,991
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`(the “’991 patent”) on December 19, 2023. Ex. 2003 at 1.
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`B.
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`Similar Claims in the ’945 Application Were Recently Allowed
`Over all References Cited in the Petition
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`Patent Owner is continuing to prosecute applications in the same family,
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`
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`including continuation application No. 18/179,945 (the “’945 application”), filed
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`on March 7, 2023. Ex. 2005 at 6. The claims of the ’945 application are similar to
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`the claims challenged here – Patent Owner in fact filed a terminal disclaimer over
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`the ’781 patent on October 6, 2023. Id. at 560. Of importance to this proceeding,
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`Patent Owner withdrew the ’945 application from issuance in order to file an IDS
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`disclosing the Petition and materials cited in support of the Petition. Id. at 27-33,
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`87-88. The ’945 application claims have been re-allowed over all of these
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`references. Id. at 17-20. The ’945 application issued as U.S. Patent 11,970,746 on
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`April 30, 2024. Id. at 1.
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`C. The Petition References are the Same as, or Substantially Overlap
`with, References Considered During Examination of the ’335
`Application that Resulted in the ’781 Patent
`The ’781 patent issued on April 25, 2023, from a continuation of the ’607
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`application. Ex. 1001. Applicant disclosed references in information disclosure
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`statements (“IDS”) during examination, and the Examiner indicated on the IDS
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`that all references were considered, except if they were lined through. Ex. 2004 at
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`140-143, 242-243, 256. Petitioner concedes that both of its primary references,
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`Shuber and Lenhard, were listed in an IDS. Pet. at 67. The numerous other listed,
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`and considered, references included Itzkowitz 2008 and Levi. Ex. 2004 at 140-143.
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`As discussed below, the Itzkowitz reference on which Petitioner relies is
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`substantially the same as the cited Itzkowitz 2008 reference. Compare Ex. 1006,
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`with Ex. 1055. Likewise, the Vilkin reference on which Petitioner relies is
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`substantially the same as the cited Levi3 reference – disclosing essentially the same
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`work by a largely overlapping group of authors. Compare Ex. 1005, with Ex. 2007.
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`3 Levi is not included in the dozens of references that Petitioner chose to
`submit with the Petition. See Pet. at viii-xvi.
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`11
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`Thus, the exact same or substantially the same references as cited in Grounds I and
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`IV were considered during prosecution of the ’781 patent.4
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`V. OVERVIEW OF REFERENCES CITED IN GROUNDS
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`None of the references in the Grounds address the CRU’s explanation for
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`confirming all claims as patentable in the reexamination. In particular, none of the
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`Grounds “reasonably suggest collection at home with each of the fecal portions
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`sealed in separate containers, each with a buffer therein as required by independent
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`claim 1.” See Ex. 1023 at 4.
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`1.
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`Lenhard (Ex. 1004) – Describes Laboratory Collection and
`Comparison of gFOBT with a Specific Methylation Marker
`Tested from Frozen Samples
`Lenhard does not describe at home collection of samples. Lenhard also does
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`not describe the separation of the fecal portions sealed in separate containers, with
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`a buffer in each container. Lenhard also does not describe processing without
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`freezing. In fact, far from describing at home collection for processing without
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`freezing, Lenhard describes that the samples “were received within 10 hours after
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`defecation at the laboratory, aliquoted, and stored at -80°C.” Ex. 1004 at 2; Ex.
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`4 Petitioner relies on the remaining two references, Derks and Kanaoka
`only for its arguments concerning the additional limitations of claims 10, 12 and
`13, Grounds II-III and V-VI. Pet. at 12. Patent Owner reserves its rights to raise
`additional arguments for other claims should the Board institute inter partes
`review.
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`12
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`Geneoscopy Exhibit 1032, P