Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 1 of 17
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`Exhibit 3
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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 2 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 2 of 17
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`www.uspto.gov
`
`APPLICATION NO.
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`
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`
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`
`
`
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`CONF {MATION NO.
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`14/170,370
`
`01/31/2014
`
`Daniel D. Von Hoff
`
`37901—714303
`
`4637
`
`11/05/2014
`7590
`96600
`WILSON SONSINI G00DR1CH&R0SATUCARIS
`LIFE SCIENCES
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304
`
`VANNI, GEORGE STEVEN
`
`1631
`
`PAPER NUMBER
`
`
`
`
`
` NOT *ICATION DATE
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`DELIVERY MODE
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`11/05/2014
`
`ELECTRONIC
`
`Please find below and/0r attached an Office communication concerning this application or proceeding.
`
`The time period for reply, if any, is set in the attached communication.
`
`Notice of the Office communication was sent electronically on above—indicated "Notification Date" to the
`following e—mail address(es):
`PATENTDOCKET @WSGRCOM
`
`lgoff@ carisls.com
`patent @ carisls.com
`
`PTOL—90A (Rev. 04/07)
`
`

`

`
`Case 1:17—cv—12}94—MLW Dec
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 3 of 17
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`14/170,370
`VON HOFF ET AL.
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`Examiner
`Art Unit
`AIA (First Inventorto File)
`Status
`G. Steven Vanni
`No
`
`ppllc%fio§MEI-keggar/WTWaRéI17
`
`
`Office Action Summary
`
`1 631
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE g MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`In no event, however, may a reply be timely filed
`
`-
`-
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`Status
`
`1)IXI Responsive to communication(s) filed on 24 Sthember 2014.
`[I A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
`
`2b)|:| This action is non-final.
`2a)IZ| This action is FINAL.
`3)I:I An election was made by the applicant in response to a restriction requirement set forth during the interview on
`
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`; the restriction requirement and election have been incorporated into this action.
`
`4)|:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
`closed in accordance with the practice under EX parte Quay/e, 1935 CD. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)|XI Claim(s)1-_25is/are pending in the application.
`5a) Of the above claim(s)
`is/are withdrawn from consideration.
`6 III Claim 3) _ is/are allowed.
`3 1-_25 is/are rejected.
`
`3) D Interview Summary (PT0_413)
`1) D Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date.
`.
`.
`—
`4) I:I Other'
`2) E Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mai| Date 24 Segtember2014.
`US. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mai| Date 20141024
`
`is/are objected to.
`
`) )
`
`_
`
`
`are subject to restriction and/or election requirement.
`9)|:l Claim(s
`)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
`
`participating intellectual property office for the corresponding application. For more information, please see
`htt ://\va.usnto. ov/ atents/init events"
`h/index.‘s
`
`
`
`
`
`, or send an inquiry to PF"l-ifeedback{<‘busr),to.qov.
`
`Application Papers
`
`10)I:I The specification is objected to by the Examiner.
`11)|Z| The drawing(s) filed on 24 Sthember 2014 is/are: a)IXI accepted or b)I:I objected to by the Examiner.
`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
`
`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121 (d).
`
`Priority under 35 U.S.C. § 119
`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. §119(a)-(d) or (f).
`Certified copies:
`
`b)I:I Some” c)I:I None of the:
`a)I:I All
`1.I:I Certified copies of the priority documents have been received.
`2.I:I Certified copies of the priority documents have been received in Application No.
`3.|:I Copies of the certified copies of the priority documents have been received in this National Stage
`
`application from the International Bureau (PCT Rule 17.2(a)).
`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
`
`
`
`

`

`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 4 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 4 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 2
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`DETAILED ACTION
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`This application is being examined under pre-AIA first-to-invent provisions.
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`A new primary examiner has been assigned to this application.
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`This action is responsive to the communications filed 24 September 2014.
`
`Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
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`The following rejections and/or objections are either reiterated or newly applied. They constitute the
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`complete set presently being applied to the instant application.
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`Status of Claims
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`Canceled:
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`none
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`Obj ected to:
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`none
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`Pending:
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`1-25
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`Withdrawn:
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`none
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`Rejected:
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`1-25
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`Allowable:
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`none
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`Examined:
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`1-25
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`Allowed:
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`none
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`Priority
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`This application is a continuation of US. Pat. App. 13/188,350 filed 21 July 2011, which is a
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`continuation of US Pat. App. 12/579,241 filed 14 October 2009, which claims the benefit of US
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`provisional applications 61/ 105,335 filed 14 October 2008 and 61/106,921 filed 20 October 2008. This
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`application is also a continuation-in-part of US Pat. App. 11/750,721 filed on 18 May 2007, now US
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`Patent 8,700,335 which claims the benefit of US Provisional App. 60/747,645 filed 18 May 2006.
`
`Information Disclosure Statement
`
`The information disclosure statement (IDS) filed 24 September 2014 has been entered and
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`considered.
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`Drawings
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`The drawings filed 31 January 2014, as amended 24 September 2014, are accepted.
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`

`

`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 5 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 5 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 3
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`Withdrawal of Objections to the Specification
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`Because of the amendments to the specification, the previous objections to the specification are
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`withdrawn.
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`Withdrawal of Objections to the Claims
`
`Because of the amendments to the Claims, the previous objections to the Claims are withdrawn.
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`Withdrawal of Claims Rejections under 35 US C 112, 2nd paragraph (112 7p)
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`Because of the amendments to the Claims and the arguments, the previous rejections of the Claims
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`under 112 ‘][2 are withdrawn.
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`Withdrawal of Claims Rejections under 35 USC 101
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`Because of the amendments to the Claims, the previous rejections of the Claims under 101 are
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`withdrawn, however new rejections are applied below, as necessitated by amendment.
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`Withdrawal of Claims Rejections under 35 US C 102 and 103
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`Because of the amendments to the Claims, the previous rejections of the Claims under 102 and 103
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`are withdrawn, however new rejections are applied below, as necessitated by amendment.
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`Withdrawal of Double Patenting Rejections
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`Because of the amendments to the Claims, the previous double patenting rejections are
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`withdrawn.
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 6 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 6 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 4
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`Claim Rejections - 35 USC 101
`
`35 USC 101 reads:
`
`Whoever invents or discovers any new and useful process, machine, manufacture, or composition
`of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the
`conditions and requirements of this title.
`
`For each rejection below, dependent Claims are rejected similarly as not remedying the rejection,
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`unless otherwise noted.
`
`Judicial exception to 101 patentability for abstract idea -- claims 1-25 -- abstract idea implemented as
`
`mental steps or mathematical operations and not significantly more than the abstract idea
`
`The following rejection is new as necessitated amendment.
`
`The Claimed invention is directed to non-statutory subject matter because claims 1-25, each taken
`
`as a whole and considering all elements within each Claim both individually and in combination, do not
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`Claim significantly more than the recited abstract idea. Therefore the Claims are rejected as ineligible
`
`subject matter under 35 USC 101.
`
`See the opinion in Alice Corporation v. CLS Bank International (134 S. Ct. 2347, June 2014)
`
`and the USPTO memorandum "Preliminary Examination Instructions in view of the Supreme Court
`
`Decision in Alice Corporation..." (Hirshfeld, USPTO Examination Guidance and Training Materials, 35
`
`USC. 101,25 June 2014).
`
`Claim 1 is directed to the abstract idea of identifying a therapeutic agent for an individual
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`with cancer, which is claimed as a combination of mathematical steps (e. g. mathematical operations
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`and logical comparisons). The additional elements in the Claim, other than the abstract idea, amount to no
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`more than: elements for conventional data gathering steps, e.g. a "device... to assay" and a "database,"
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`(see rejections over prior art below); elements for preliminary and conventional data processing steps, e. g.
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`"code... to compare," (see rejections over prior art below); and elements for conventional and
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 7 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 7 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 5
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`insufficiently applied post-processing steps, e. g. "program to generate a report" (see rejections over the
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`prior art below). As described above, the selection of panel markers and the associated assay elements
`
`and steps are conventional. Viewed as a whole, the Claim elements do not provide limitations to
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`transform the abstract idea into a patent eligible application of the abstract idea such that the Claim
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`amounts to significantly more than the abstract idea.
`
`The dependent Claims do not remedy the above rejections.
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`The above analysis is in contrast to, for example, those Claims patentable under 101 analysis in
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`Diamond v. Die/1r (450 US 175, 187-188 and 191-192, 1981), in which a physical process is improved
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`through application of an abstract idea.
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`Claim Rejections - 35 USC 103
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`The following is a quotation of 35 USC 103(a) which forms the basis for all obviousness
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`rejections set forth in this Office action:
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`(a) A patent may not be obtained though the invention is not identically disclosed or
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`described as set forth in section 102 of this title, if the differences between the subject
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`matter sought to be patented and the prior art are such that the subject matter as a whole
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`would have been obvious at the time the invention was made to a person having ordinary
`
`skill in the art to which said subject matter pertains. Patentability shall not be negatived
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`by the manner in which the invention was made.
`
`This application currently names joint inventors. In considering patentability of the Claims under
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`35 USC 103(a), the examiner presumes that the subject matter of the various Claims was commonly
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`owned at the time any inventions covered therein were made absent any evidence to the contrary.
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`Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of
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`each Claim that was not commonly owned at the time a later invention was made in order for the examiner
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`to consider the applicability of 35 USC 103(0) and potential 35 USC 102(e), (f) or (g) prior art under 35
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`USC 103(a).
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 8 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 8 of 17
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`Application/Control Number: 14/170,370
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`Page 6
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`Art Unit: 1631
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`Claims 1-25
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`The following rejection is new as necessitated amendment.
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`Claims 1-25 are rejected under 35 USC 103(a) as unpatentable over Kallioniemi (US Pat.
`
`App. 2005/0244880 as cited in the action of 9 June 2014) in View ofM (US Pat. App.
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`2006/0019256 as cited in the action of 9 June 2014) and Sidransky ("Emerging Molecular Markers
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`Of Cancer," Nature, vol. 2, p. 210-219, 2002 as cited in the action of 9 June 2014).
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`Claim 1 is a system for generating a report identifying a therapeutic agent for an individual with
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`a cancer.
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`The recited device to assay molecular targets and determine molecular profile test values
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`(element "a") is taught by Kallioniemi as, for example, "'Comparative Genomic Hybridization' or CGH
`
`is a technique of differential labeling of test DNA and normal reference DNA" ([0021, 0139-0149] and
`
`entire document).
`
`Kallioniemi teaches analysis of multiple targets as "markers" (e.g. [0086, 0088 and 0078-0089]
`
`and entire document). While not all of the recited molecular targets are explicitly taught by Kallioniemi,
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`they are taught in similar contexts, each of which includes cancer, as follows.
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`Kallioniemi does teach EGFR and PDGFRA (FIG. 13; [0149]; and entire document).
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`Clarke teaches molecular profiles for cancer ([0004, 0007-0023, 0033-0039, 0043, 0058-0060,
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`0095, 0112-0113]; Table 4; and entire document), wherein a string search locates the following markers
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`within Tables 4-8 on pages 11-34: VHL, TOPl, MLHl, PTEN, TP53, RRMl, KIT, SPARC and TOP2A,
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`assuming TP53TG1 and/or TP53INP1 teach TP53.
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`MGMT is taught by Sidransky (e. g. p. 213, 2nd 001., last para. and entire document).
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`The recited computer database comprising a reference value for molecular targets and a listing of
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`available therapeutic agents (element "b") is taught by Kallioniemi as, for example, "tissue array
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`technology facilitates... a correlated database of biomarkers" to "asses optimal therapy" ([0086-0089 and
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 9 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 9 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`0078-0089] and entire document).
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`Page 7
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`The recited individualized molecular profile test values for specified molecular targets (element
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`"e") are taught by Kallioniemi as, for example, "testing... markers;
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`profiling... tumors..., leading to a...
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`correlated database of biomarkers;" and "optimal therapy for particular patients" ([0086, 0089 and 0078-
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`0089] and entire document).
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`Regarding the recited individual (element "e") having cancer (preamble), Kallioniemi teaches its
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`methods in the context of cancer ([0002, 0007, 0011-0013, 0102 and 0097-0106] and entire document).
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`The recited comparing test and reference values (element "e") is taught by Kallioniemi as, for
`
`example, "'Comparative Genomic Hybridization' or CGH is a technique of differential labeling of test
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`DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
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`The recited indicating a likely benefit of and identifying a therapeutic agent (element "d") is
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`taught by Kallioniemi as, for example, "asses optimal therapy" ([0089 and 0078-0089] and entire
`
`document), wherein the recited "benefit" is given a broadest reasonable interpretation to include the
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`intended result of any therapy. Also, Kallioniemi teaches "In another application, tissue arrays can be
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`used to find novel targets for gene therapy" in conjunction With the use of multiple gene and protein
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`markers ([0089 and 0078-0089] and entire document).
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`The recited identifying a therapeutic agent (element "e") is taught by Kallioniemi as, for
`
`example, "optimal therapy for particular patients" ([0089 and 0078-0089] and entire document).
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`The recited generating a listing of the molecular targets With a likely benefit along With the
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`identified agents (element "e") is taught by Kallioniemi as, for example: "output devices;" "determine
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`Which is the most promising target for developing diagnostic, prognostic, or therapeutic approaches for
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`cancer;" "array data reported;" and "provide information" ([0084, 0089 and 0105] and entire document).
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 10 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 10 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 8
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`Claims 2 and 3 specify remote and Internet-based inputting, which Clarke teaches as
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`"transmitting the information to and from laboratories... located in any part of the world... and the data
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`transmitted... using an electronic communication systems" ([0138] and entire document).
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`Claim 4 specifies electronic or paper report formats, Which Kallioniemi teaches as, for example:
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`"output devices" ([0084] and entire document).
`
`Claim 5 specifies clinical trial data, Which Kallioniemi teaches as, for example: "pilot study"
`
`and "clinical follow up information" ([0097-0106, 01 13-0126 and 0162-0168] and entire document).
`
`Claim 6 specifies nucleic acid or protein references, Which Kallioniemi teaches as, for example:
`
`"a control sample of normal DNA;" ([0016] and entire document) and "These methods are used to
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`identify molecular characteristics, such as structural changes in genes or proteins, and copy number or
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`expression alterations of genes... to identify therapeutic agents" ([0008] and entire document).
`
`Claim 7 specifies testing after drug therapy, Which Kallioniemi teaches as, for example: "test the
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`effect of drugs" ([0146] and entire document).
`
`Claim 8 specifies assessing a cell or tissue sample, Which Kallioniemi teaches as, for example:
`
`"sample tissue" ([0145] and entire document).
`
`Claim 9 specifies a test for a gene or protein, Which Kallioniemi teaches as, for example:
`
`"presence or absence of a mutation" and "effect on the regulation of all genes" ([0145 and 0146] and
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`entire document).
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 11 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 11 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 9
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`Claim 10 specifies a cancer free and normal reference, which Kallioniemi teaches as, for
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`example: "reference (normal) DNA" and "normal glands" Which are cancer free ([0145 and 0153-0159]
`
`and entire document).
`
`Claim 11 specifies an individual that failed to respond to one cancer therapeutic, Which
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`Kallioniemi teaches as, for example: "recurrences after hormonal therapy" in a prostate cancer context
`
`([0114 and 0113-0126] and entire document).
`
`Claim 12 specifies an individual that failed to respond to more than one cancer therapeutic,
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`Which Kallioniemi teaches as, for example: "resistance to particular types of drug treatment" (abstract
`
`and entire document) and "multidrug resistance" (Sidransky, title of reference 63).
`
`Claims 13-18 specify combinations of testing methods and targets. Kallioniemi teaches each of
`
`the testing methods as, for example: protein and nucleic acid testing as described in claim 6 above;
`
`immunohistochemistry testing ([0079] and entire document); in-situ hybridization ([0079] and entire
`
`document); and assessment by sequencing ([0088] and entire document). The recited targets are taught as
`
`described in claim 1. Performing the recited combinations would have been prima facie obvious to try at
`
`the time of the instant invention as substitution of one known element for another to obtain predictable
`
`results.
`
`Claim 19 adds HERZ, Which Clarke teaches as "HERC2," "HER-2" and "Her2" (e.g. [0088,
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`0161 and 0301]; p. 24, Table 6; and entire document).
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 12 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 12 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 10
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`Claim 20 specifies a combination of testing modes paired With targets. Each testing mode and
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`target is taught as described above. Performing the recited combination would have been prima facie
`
`obvious to try at the time of the instant invention as substitution of one known element for another to
`
`obtain predictable results.
`
`Claim 21 adds reporting of a likely lack of benefit, Which is a logical equivalent of reporting a
`
`likely benefit as in claim 1 in that either is made obvious by the same information. Additionally,
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`Kallioniemi teaches "susceptibility or resistance to particular types of drug treatment" (emphasis added,
`
`abstract) and "screening" ([0012]), and claim 21 is interpreted to read on the concept of screening out
`
`candidates (e.g. [0012 and 0153-0161] and entire document). Thus, claim 21 is rejected for these reasons
`
`and similarly to claim 1.
`
`Claim 22 specifies types of assay devices, at least one of Which is taught by Kallioniemi as, for
`
`example, "'Comparative Genomic Hybridization' or CGH is a technique of differential labeling of test
`
`DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
`
`Claim 23 specifies types of analyses, at least one of Which is taught by Kallioniemi as, for
`
`example, "'Comparative Genomic Hybridization' or CGH is a technique of differential labeling of test
`
`DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
`
`Claim 24 specifies types of sequence modification, at least one of Which is taught by Kallioniemi
`
`as, for example, "'Comparative Genomic Hybridization' or CGH is a technique of differential labeling of
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`test DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
`
`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 13 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 13 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 11
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`Claim 25 specifies types of biological states, at least one of which is taught by Kallioniemi as, for
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`example, "'Comparative Genomic Hybridization' or CGH is a technique of differential labeling of test
`
`DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
`
`Combining Kallioniemi, Clarke and Sidransky
`
`At the time of the instant invention, it would have been prima facie obvious for one of skill in the
`
`art to modify the methods and devices of Kallioniemi using Clarke and Sidransky. The references
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`generally teach the combining of markers in the context of identifying agents and developing therapies
`
`(for example, Kallioniemi: [0086, 0088 and 0078-0089] and entire document; Clarke: [0004, 0007-0008,
`
`0012-0014, 0017, 0033, etC.] and entire document; Sidransky: p. 210, 2nd 001., last para.; p. 217, 2nd 001.,
`
`2nd para.; and entire document). As motivation to combine, an advantage of modifying Kallioniemi
`
`using Clarke and Sidransky would have been better reliability through analysis of additional pathways
`
`relevant to cancer as well as "privacy..., speed, and uniformity of data analysis" (Clarke, [0007 and 0140]
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`and entire document), so that one of skill in the art at the time of the instant invention would have been
`
`motivated to modify Kallioniemi using the methods and targets of Clarke and Sidransky in order to
`
`achieve better reliability. One would have had a reasonable expectation of success in doing so because
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`Kallioniemi, Clarke and Sidransky are generally drawn to related cancer treatment methods, and one well-
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`versed in these methods would have understood how to and would have been motivated to apply Clarke
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`and Sidransky's techniques above to the related applications of Kallioniemi.
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`

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`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 14 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 14 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 12
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`Response to Arguments
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`Response to arguments regarding Claim Rejections - 35 USC 101
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`In view of the amendments, the previous rejections regarding matter belonging to no statutory
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`category are withdrawn.
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`However, in light of the June 2014 opinion in Alice v. CLS (Cited above) and as necessitated by
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`applicant's amendment, a new abstract idea rejection is applied above.
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`Applicant states:
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`...the Claims provide improvements to another technology or technical field, e. g., by
`improving the treatment of cancer victims.
`The device is also configured to assay the
`particular panel of molecular targets, which panel is non-conventional in the context of
`the Claimed invention...
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`(Applicant's response, p. 8). Applicant's statement has been considered but is not persuasive. Applying
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`Alice v. CLS and, particularly, Diamond v. Die/1r (450 US 175, 187-188 and 191-192, 1981),
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`"technology" is interpreted more narrowly to mean improvement to a physical process, and not simply
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`advancement of a field of technology. Furthermore, the "panel" and the associated "assay" are
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`conventional as described in the art rejections above. The panel merely provides input data for
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`performance of the abstract idea.
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`Response to arguments regarding Claim Rejections - 35 USC 102 and 103
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`Regarding claim 1, applicant states:
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`For example, Kallioniemi never appears to suggest analysis of multiple diflerent markers
`to identify treatment having likely benefit.
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`(Emphasis added, applicant's response, p. 12, 2nd para.). Applicant's statement has been considered but is
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`not persuasive. All elements of the Claimed invention are taught as described above. Kallioniemi teaches
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`analysis of multiple targets as "markers" (e.g. [0086, 0088 and 0078-0089] and entire document). The
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`recited indicating a likely benefit of and identifying a therapeutic agent (element "d") is taught by
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`

`

`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 15 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 15 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 13
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`Kallioniemi as, for example, "asses optimal therapy" ([0089 and 0078-0089] and entire document),
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`wherein the recited "benefit" is given a broadest reasonable interpretation to include the intended result of
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`any therapy. Also, Kallioniemi teaches "In another application, tissue arrays can be used to find novel
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`targets for gene therapy" in conjunction with the use of multiple gene and protein markers ([0089 and
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`0078-0089] and entire document).
`
`Regarding claim 1, applicant states:
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`Applicants disagree with the Examiner that the lengthy tables in Clarke would motivate
`one to examine the Claimed selection of molecular targets found spread throughout its
`lengthy tables.
`the members of Applicants' Claimed panel of molecular targets appear
`in Clarke in disparate contexts including various comparisons involving passaged and
`unpassaged tumorigenic or non-tumorigenic breast cells and hematopoietic stem cells.
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`Clarke provides no motivation to even consider the Claimed grouping of markers for such
`purposes.
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`Sidransky never discloses or suggests predicting efficacy of any therapeutic agent based
`on a status of MGMT.
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`(Emphasis added, applicant's response, p. 13, 2nd para. and p. 14, 2nd para.). Applicant's statements have
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`been considered but are not persuasive. Regarding the teaching and combining, from the art of record,
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`different markers in different references, sometimes from lists of many markers, there is no evidence
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`disclosed in the specification or otherwise of record that motivates the selection of the particularly recited
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`markers. The specification discloses many markers (instant specification: e. g. [0011, 0087-0089]; FIG.
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`3C, FIG. 27A, FIG. 30A, FIG. 31), some of which markers are recited in the Claims. Similarly, the art of
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`record teaches many markers. Such is the nature of array and database technologies.
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`Additionally, the references generally teach the combining of markers in the context of
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`identifying agents and developing therapies (for example, Kallioniemi: [0086, 0088 and 0078-0089] and
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`entire document; Clarke: [0004, 0007-0008, 0012-0014, 0017, 0033, etc.] and entire document;
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`Sidransky: p. 210, 2nd 001., last para.; p. 217, 2nd 001., 2nd para.; and entire document). As described
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`above, the recited indicating a likely benefit of and identifying a therapeutic agent (Claim 1, element "d")
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`are taught by Kallioniemi as, for example, "asses optimal therapy" ([0089 and 0078-0089] and entire
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`

`

`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 16 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 16 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 14
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`document), wherein the recited "benefit" is given a broadest reasonable interpretation to include the
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`intended result of any therapy.
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`Response to arguments regarding Double Patenting
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`In view of the narrowing amendments, the previous double patenting rejection is withdrawn. The
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`instant Claims now recite one set of markers, while the previously conflicting Claims recite a different set
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`of markers.
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`Citations to Art
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`In the above Citations to documents in the art, an effort has been made to specifically Cite
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`representative passages, however rejections are in reference to the entirety of each document relied upon.
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`Other passages, not specifically Cited, may apply as well.
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`Conclusion
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`Applicant's amendments necessitated the new grounds for rejection in this action. Accordingly,
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`THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of
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`time policy as set forth in 37 CFR 1.136(a).
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`A shortened statutory period for reply to this final action is set to expire THREE MONTHS from
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`the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing
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`date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shortened statutory period, then the shortened statutory period will expire on the date the advisory action
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`is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of
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`the advisory action. In no event, however, will the statutory period for reply expire later than SIX
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`MONTHS from the date of this final action.
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`

`

`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 17 of 17
`Case 1:17-cv-12194-MLW Document 24-3 Filed 01/16/18 Page 17 of 17
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`Application/Control Number: 14/170,370
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`Art Unit: 1631
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`Page 15
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`Inquiries
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`Information regarding the status and history of a patent application is accessible through the
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`USPTO’s online Patent Application Information Retrieval (PAIR) system, Private or Public:
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`/www.uspto.gov/portal-home.jsp.
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`PAIR questions may be directed to the Electronic Business Center (EBC) at (866) 217-9197 (toll-
`
`free), daily from 6 am. to midnight (EST). USPTO Customer Service Representatives and access to
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`automated information are available at (800) 786-9199 (USA/Canada) or (571) 272-1000.
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`Papers may be submitted to Technical Center 1600 by facsimile transmission via the Central Fax
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`Center at (571) 273-8300, conforming With notices in the Official Gazette: 1096 0G 30 (1 1/ 15/ 1988),
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`1156 0G 61 (11/16/1993) and 1157 0G 94 (12/28/1993). See also 37 CFR1.6(d).
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`Inquiries may be directed to the examiner, G. Steven Vanni, at: (571) 272-3855 Tu-F 9-7 (EST).
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`If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor,
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`Marjorie Moran may be reached at (571) 272-0720.
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`General inquiries may be directed to the USPTO at (571) 272-0547.
`
`/GSV/
`
`G. Steven Vanni
`Examiner, Art Unit 1631
`
`/ERIC S DEJONG/
`
`Primary Examiner, Art Unit 1631
`
`