Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 1 of 18
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`Exhibit 4
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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 2 of 18
`UNITED STA IBS p A IBNT AND TRADEMARK OFFICE
`
`UNITED STA TES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria., Virginia 22313-1450
`www.uspto.gov
`
`APPLICATION NO.
`
`FILING DATE
`
`FIRST NAMED INVENTOR
`
`ATTORNEY DOCKET NO.
`
`CONFIRMATION NO.
`
`14/170,450
`
`01/31/2014
`
`Daniel D. Von Hoff
`
`37901-714.304
`
`5232
`
`10/23/2014
`7590
`96600
`WILSON SONSINI GOODRICH & ROSA TI/ CARIS
`LIFE SCIENCES
`650 PAGE MILL ROAD
`PALO ALTO, CA 94304
`
`EXAMINER
`
`VANNI, GEORGE STEVEN
`
`ART UNIT
`
`PAPER NUMBER
`
`1631
`
`NOTIFICATION DATE
`
`DELIVERY MODE
`
`10/23/2014
`
`ELECTRONIC
`
`Please find below and/or 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):
`PA IBNTDOCKET@WSGR.COM
`lgoff@carisls.com
`patent@carisls.com
`
`PTOL-90A (Rev. 04/07)
`
`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 3 of 18
`Applicant(s)
`Application No.
`VON HOFF ET AL.
`14/170,450
`
`Office Action Summary
`
`AIA (First Inventor to File)
`Status
`No
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address -(cid:173)
`Period for Reply
`
`Examiner
`G. Steven Vanni
`
`Art Unit
`1631
`
`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE ;J. MONTHS FROM THE MAILING DATE OF
`THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a). In no event, however, may a reply be timely filed
`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).
`
`Status
`1 )~ Responsive to communication(s) filed on 19 September 2014.
`0 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on __ .
`2a)~ This action is FINAL.
`2b)0 This action is non-final.
`3)0 An election was made by the applicant in response to a restriction requirement set forth during the interview on
`__ ; the restriction requirement and election have been incorporated into this action.
`4)0 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 Quayle, 1935 C.D. 11, 453 O.G. 213.
`
`Disposition of Claims*
`5)~ Claim(s) 1-16 is/are pending in the application.
`5a) Of the above claim(s) __ is/are withdrawn from consideration.
`6)0 Claim(s) __ is/are allowed.
`7)~ Claim(s) 1-16 is/are rejected.
`8)0 Claim(s) __ is/are objected to.
`9)0 Claim(s) __ are subject to restriction and/or election requirement.
`* 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
`http:ilwww.uspto.gov/patents/init events/pph/index.isp or send an inquiry to PPHfeedback(wuspto.aov.
`
`Application Papers
`10)0 The specification is objected to by the Examiner.
`11 )~ The drawing(s) filed on 19 September 2014 is/are: a)~ accepted or b)O 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)0 Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
`a)O All b)O Some** c)O None of the:
`Certified copies of the priority documents have been received.
`1.0
`Certified copies of the priority documents have been received in Application No. __ .
`2.0
`Copies of the certified copies of the priority documents have been received in this National Stage
`3.0
`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)
`1) ~ Notice of References Cited (PT0-892)
`
`2) ~ Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date 19 September 2014.
`
`3) 0 Interview Summary (PT0-413)
`Paper No(s)/Mail Date. __ .
`4) 0 Other: __ .
`
`U.S. Patent and Trademark Office
`PTOL-326 (Rev. 11-13)
`
`Office Action Summary
`
`Part of Paper No./Mail Date 20141019
`
`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 4 of 18
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`Application/Control Number: 14/170,450
`
`Art Unit: 1631
`
`Page 2
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`DETAILED ACTION
`
`This application is being examined under pre-AIA first-to-invent provisions.
`
`This action is responsive to the communications filed 19 September 2014.
`
`Applicant's amendments and arguments have been considered. Withdrawal of previous
`
`objections and/or rejections is discussed in the Response to Arguments below. The objections and/or
`
`rejections herein constitute the complete set presently applied.
`
`Canceled:
`
`none
`
`Pending:
`
`1-16
`
`Withdrawn: none
`
`Examined:
`
`1-16
`
`Status of Claims
`
`Priority
`
`Objected to:
`
`none
`
`Rejected:
`
`1-16
`
`Allowable:
`
`none
`
`Allowed:
`
`none
`
`This application is a continuation of US. Pat. App. 13/188,350 filed 21 July 2011, which is a
`
`continuation of US Pat. App. 12/579,241 filed 14 October 2009, which claims the benefit of US
`
`provisional applications 61/105,335 filed 14 October 2008 and 61/106,921 filed 20 October 2008. This
`
`application is also a continuation-in-part of US Pat. App. 11/750,721 filed on 18 May 2007, now US
`
`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 19 September 2014 has been entered and
`
`considered.
`
`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 5 of 18
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`Application/Control Number: 14/170,450
`
`Art Unit: 1631
`
`Drawings
`
`Page 3
`
`The drawings filed 31 January 2014, as amended 19 September 2014, are accepted.
`
`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,
`
`unless otherwise noted.
`
`Judicial exception to 101 patentability for abstract idea -- claims 1-16 -- abstract idea implemented as
`
`mental steps or mathematical operations and not significantly more than the abstract idea
`
`The following rejection is maintained with substantive changes necessitated by the amendments.
`
`The claimed invention is directed to non-statutory subject matter because claims 1-16, each taken
`
`as a whole and considering all elements within each claim both individually and in combination, do not
`
`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. 234 7, 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 U.S.C. 101,
`
`25 June 2014).
`
`Claim 1 is directed to the abstract idea of identifying a therapeutic agent for an individual
`
`with ovarian cancer, which is claimed as a combination of mathematical steps (e.g. mathematical
`
`operations and logical comparisons). The additional elements in the claim, other than the abstract idea,
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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 6 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 4
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`amount to no more than: elements for conventional data gathering steps, e.g. a "device ... to assay" and a
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`"database," (see rejections over prior art below); elements for preliminary and conventional data
`
`processing steps, e.g. "code ... to compare," (see rejections over prior art below); and elements for
`
`conventional and insufficiently applied post-processing steps, e.g. "program to generate a report" (see
`
`rejections over the 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 transform the abstract idea into a patent eligible application of the abstract idea such that the
`
`claim amounts to significantly more than the abstract idea.
`
`The dependent claims do not remedy the above rejections.
`
`The above analysis is in contrast to, for example, those claims patentable under 101 analysis in
`
`Diamond v. Diehr (450 US 175, 187-188 and 191-192, 1981), in which a physical process is improved
`
`through application of an abstract idea.
`
`Claim Rejections - 35 USC 103
`
`The following is a quotation of 35 USC 103(a) which forms the basis for all obviousness
`
`rejections set forth in this Office action:
`
`(a) A patent may not be obtained though the invention is not identically disclosed or
`described as set forth in section 102 of this title, if the differences between the subject
`matter sought to be patented and the prior art are such that the subject matter as a whole
`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
`by the manner in which the invention was made.
`
`This application currently names joint inventors. In considering patentability of the claims under
`
`35 USC 103(a), the examiner presumes that the subject matter of the various claims was commonly
`
`owned at the time any inventions covered therein were made absent any evidence to the contrary.
`
`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 7 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 5
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`Applicant is advised of the obligation under 37 CPR 1.56 to point out the inventor and invention dates of
`
`each claim that was not commonly owned at the time a later invention was made in order for the examiner
`
`to consider the applicability of 35 USC 103( c) and potential 35 USC 102( e ), (f) or (g) prior art under 35
`
`USC 103(a).
`
`Claims 1-16
`
`The following rejection is new as necessitated by the amendments.
`
`Claims 1-16 are rejected under 35 USC 103(a) as unpatentable over Kallioniemi (US Pat.
`
`App. 2005/0244880 as cited in the action of 23 July 2014) in view of Clarke (US Pat. App.
`
`2006/0019256 as cited in the action of 23 July 2014), Eck (US Pat. App. 2005/0222163 as cited on the
`
`attached form 892), Lukashova ("Ependymoma gene expression profiles associated with
`
`histological subtype, proliferation, and patient survival," Acta Neuropathol, vol.113, p. 325-337,
`
`2007 as cited on the attached form 892), Randall ("cDNA Microarray Analysis of Gene Expression
`
`in Ovarian Cancer Cells After Treatment with Carboplatin and Paclitaxel," Cancer Genomics and
`
`Proteomics, vol. 3, p. 289-294, 2006 as cited in the action of 23 July 2014) and Mu (US Pat. App.
`
`2005/0026194 as cited in the action of 23 July 2014).
`
`Claim 1 is a system for generating a report identifying a therapeutic agent for an individual with
`
`a ovarian cancer.
`
`The recited device to assay molecular targets and determine molecular profile test values
`
`(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 the recited molecular targets are not explicitly taught by Kallioniemi, they
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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 8 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 6
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`are taught in similar contexts, each of which includes ovarian cancer, as follows.
`
`Clarke teaches molecular profiles for cancer ([0004, 0007-0023, 0033-0039, 0043, 0058-0060,
`
`0095, 0112-0113]; Table 4; and entire document), wherein a string search locates the following markers
`
`within Tables 4-8 on pages 11-34: KDR and PTEN.
`
`Eck teaches molecular pathways in cancer and pathways involving the following proteins and
`
`their genes: HSP90, VEGF, SRC, FLT-3, and BRCAI (Eck: e.g. [0009-0010, 0032, 0071]; and entire
`
`document).
`
`Lukashova teaches molecular profiles for cancer and the following genes: TOP2A, FLTI and
`
`VEGF (Lukashova: p. 331, 2nd col.; Fig. 6; p 334, 1st col.; and entire document).
`
`The recited computer database comprising a reference value for molecular targets and a listing of
`
`available therapeutic agents (element "b") is taught by Kallioniemi as, for example, "tissue array
`
`technology facilitates ... a correlated database of biomarkers" to "asses optimal therapy" ([0086-0089 and
`
`0078-0089] and entire document).
`
`The recited individualized molecular profile test values for specified molecular targets (element
`
`"c") are taught by Kallioniemi as, for example, "testing ... markers;" "profiling ... tumors ... , leading to a ...
`
`correlated database of biomarkers;" and "optimal therapy for particular patients" ([0086, 0089 and 0078-
`
`0089] and entire document).
`
`Regarding the recited individual (element "c") having ovarian cancer (preamble), Kallioniemi
`
`teaches its methods in the context of ovarian cancer ([0102 and 0097-0106] and entire document).
`
`The recited comparing test and reference values (element "c") 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).
`
`The recited indicating a likely benefit of and identifying a therapeutic agent (element "d") is
`
`taught by Kallioniemi as, for example, "asses optimal therapy" ([0089 and 0078-0089] and entire
`
`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 9 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 7
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`document), wherein the recited "benefit" is given a broadest reasonable interpretation to include the
`
`intended result of any therapy. Also, Kallioniemi teaches "In another application, tissue arrays can be
`
`used to find novel targets for gene therapy" ([0089 and 0078-0089] and entire document).
`
`The recited identifying a therapeutic agent (element "d") is taught by Kallioniemi as, for
`
`example, "optimal therapy for particular patients" ([0089 and 0078-0089] and entire document).
`
`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).
`
`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
`
`transmitted ... using an electronic communication systems" ([0138] and entire document).
`
`Claim 4 specifies electronic or paper report formats, which Kallioniemi teaches as, for example:
`
`"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, 0113-0126 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
`
`identify molecular characteristics, such as structural changes in genes or proteins, and copy number or
`
`expression alterations of genes ... to identify therapeutic agents" ([0008] and entire document).
`
`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 10 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 8
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`Claim 7 specifies testing after drug therapy, which Kallioniemi teaches as, for example: "test the
`
`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
`
`entire document).
`
`Claim 10 specifies a cancer free and normal reference, which Kallioniemi teaches as, for
`
`example: "reference (normal) DNA" and "normal glands" which are cancer free ([0145 and 0153-0159]
`
`and entire document).
`
`Claim 11 specifies additional targets, at least one of which is taught by Clarke as molecular
`
`profiles for cancer ([0110-0112, 0013, 0050] and Table 4 and entire document), wherein a string search
`
`locates at least one of the recited markers within Tables 4-8 on pages 11-34 ( e.g. recited "CD52,"
`
`synonymous with Clarke's "CDW52").
`
`RRM2B is taught by Randall (Table III and entire document), and SSTR5 is taught by Mu
`
`([0090] and entire document).
`
`Claim 12 adds reporting of a likely lack of benefit, which is a logical equivalent of reporting a
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`likely benefit as in claim 1. Additionally, Kallioniemi teaches "susceptibility or resistance to particular
`
`types of drug treatment" (abstract) and "screening" ([0012]), and claim 12 is interpreted to read on the
`
`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 11 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 9
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`concept of screening out candidates (e.g. [0012 and 0153-0161] and entire document). Thus, claim 12 is
`
`rejected for these reasons and similarly to claim 1.
`
`Claim 13 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 14 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 15 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
`
`test DNA and normal reference DNA" ([0021, 0139-0149] and entire document).
`
`Claim 16 specifies types of biological states, 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).
`
`Combining Kallioniemi, Clarke, Eck, Lukashova, Randall and Mu
`
`At the time of the instant invention, it would have been primafacie obvious for one of skill in the
`
`art to modify the methods and devices of Kallioniemi using Clarke. As motivation to combine, an
`
`advantage of modifying Kallioniemi using Clarke would have been better "privacy ... , speed, and
`
`uniformity of data analysis" (Clarke, [0140] and entire document), so that one of skill in the art at the time
`
`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 12 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 1 O
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`of the instant invention would have been motivated to modify Kallioniemi using the networked methods
`
`of Clarke in order to achieve better privacy, speed and uniformity of data analysis. One would have had a
`
`reasonable expectation of success in doing so because Kallioniemi and Clarke are generally drawn to
`
`related cancer treatment methods, and one well-versed in these methods would have understood how to
`
`and would have been motivated to apply Clarke's techniques above to the related applications of
`
`Kallioniemi.
`
`At the time of the instant invention, it would have been primafacie obvious for one of skill in the
`
`art to modify the methods and devices of Kallioniemi using the targets of Clarke, Eck, Lukashova,
`
`Randall and Mu. As motivation to combine, an advantage of modifying Kallioniemi using Clarke, Eck,
`
`Lukashova, Randall and Mu would have been better reliability through analysis of additional pathways
`
`known to be relevant to cancer (Clarke, [0007] 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 targets of
`
`Clarke, Eck, Lukashova, Randall and Mu in order to achieve better reliability. One would have had a
`
`reasonable expectation of success in doing so because Kallioniemi, Clarke, Eck, Lukashova, Randall and
`
`Mu are generally drawn to related cancer treatment methods, and one well-versed in these methods would
`
`have understood how to and would have been motivated to apply the techniques of Clarke, Eck,
`
`Lukashova, Randall and Mu above to the related applications of Kallioniemi.
`
`Nonstatutory Double Patenting
`
`The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in
`
`public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise
`
`extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple
`
`assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the
`
`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 13 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 11
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`conflicting claims are not identical, but at least one examined application claim is not patentably distinct
`
`from the reference claim(s) because the examined application claim is either anticipated by, or would
`
`have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226
`
`(Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Langi, 759 F.2d
`
`887,225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937,214 USPQ 761 (CCPA 1982); In
`
`re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ
`
`644 (CCPA 1969).
`
`A timely filed terminal disclaimer in compliance with 37 CPR 1.32l(c) or 1.32l(d) may be used
`
`to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided
`
`the conflicting application or patent either is shown to be commonly owned with this application, or
`
`claims an invention made as a result of activities undertaken within the scope of a joint research
`
`agreement.
`
`A registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer
`
`signed by the assignee must fully comply with 37 CPR 3.73(b).
`
`In the case of double patenting rejections versus claims of pending applications, as opposed to
`
`claims of an issued patent, the rejections are provisional rejections because the conflicting claims have not
`
`in fact been patented.
`
`Versus App.13/942,539
`
`Instant claims 1-16 are provisionally rejected on the ground of nonstatutory obviousness-type
`
`double patenting as being unpatentable over conflicting claim 18 of application 13/942,539 (3 October
`
`2013 version). Although the conflicting claim is not identical, it is not patentably distinct from the instant
`
`claims either because the instant claims recite similar or broader limitations as the conflicting claim or
`
`because the instant claims recite obvious limitations.
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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 14 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 12
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`For example, instant claim 1 recites similar limitations to those of conflicting claim 18, including
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`specifying the possibility of ovarian cancer, but with two exceptions. First, instant claim 1 is narrower
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`with respect to reciting additional markers, however these limitations are obvious as described above.
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`Second, instant claim 1 is narrower with respect to computer implementation and a database, however
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`these limitations are obvious as described above.
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`With regard to each of the instant dependent claims 2-16, all narrowing limitations of instant
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`claims 2-16 are obvious as described above.
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`Response to arguments regarding Objections to the Specification
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`Response to Arguments
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`In view of the amendments, the previous objections to the specification are withdrawn.
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`Response to arguments regarding Claim Objections
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`In view of the amendments, the previous objections to the claims are withdrawn.
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`Response to arguments regarding Claim Rejections - 35 USC 112, 2nd paragraph (112 <J[2)
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`In view of the amendments, the previous 112 <]{2 rejections are withdrawn.
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`Response to arguments regarding Claim Rejections - 35 USC 101 -- Matter belonging to no statutory
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`category
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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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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 15 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 13
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`Response to arguments regarding Claim Rejections - 35 USC 101 --Abstract idea
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`Applicant states:
`... 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. 7). Applicant's statement has been considered but is not persuasive. Applying
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`Alice v. CLS (cited above) and, particularly, Diamond v. Diehr (450 US 175, 187-188 and 191-192,
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`1981), "technology" is interpreted more narrowly to mean improvement to a physical process, and not
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`simply advancement of a field of technology. Furthermore, while the "panel" and the associated "assay"
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`are 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:
`For example, Kallioniemi never appears to suggest analysis of multiple different markers
`to identify treatment having likely benefit.
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`In summary, the primary reference Kallioniemi fails to suggest the invention, for at least
`the reason that the reference does not disclose or suggest all elements for which it is
`cited. The secondary reference Clarke fails to supply the missing elements of the primary
`reference. Moreover, Clarke only presents the claimed markers in laundry lists of
`irrelevant micro array data without guideposts that would lead one to the claimed
`invention. Thus, the combined references fail to disclose or even hint at Applicants'
`claimed invention. Accordingly, Applicants respectfully request that the Examiner
`withdraw this rejection to claim 1.
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`(Emphasis added, applicant's response, p. 10 and 14 ). Applicant's statements have been considered but
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`are not persuasive. All elements of the claimed invention are taught as described above.
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`Regarding "multiple different markers," the term "markers" (plural) and their analysis appear
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`repeatedly throughout Kallioniemi (e.g. [0086, 0088 and 0078-0089] and entire document), as described
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`above. Also as described above, for example, Kallioniemi teaches "In another application, tissue arrays
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`

`

`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 16 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 14
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`can be used to find novel targets for gene therapy" in conjunction with the use of multiple gene and
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`protein markers (e.g. [0089 and 0078-0089] and entire document).
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`Regarding the teaching and combining, from the art of record, different markers in different
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`references, sometimes from lists of many markers, there is no evidence disclosed in the specification or
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`otherwise of record that motivates the selection of the particularly recited markers in claims 1 and 11.
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`The specification discloses many markers (instant specification: e.g. [0011, 0087-0089]; FIG. 3C, FIG.
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`27A, FIG. 30A, FIG. 31), some of which markers are recited in claims 1 and 11. Similarly, the art of
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`record teaches many markers. Such is the nature of array and database technologies. Additionally, the
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`references generally teach the combining of markers in the context of identifying agents and developing
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`therapies (for example, Kallioniemi: [0086, 0088 and 0078-0089] and entire document; Clarke: [0004,
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`0007-0008, 0012-0014, 0017, etc.] and entire document). As described above, the recited indicating a
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`likely benefit of and identifying a therapeutic agent (claim 1, element "d") are taught by Kallioniemi as,
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`for example, "asses optimal therapy" ([0089 and 0078-0089] and entire document), wherein the recited
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`"benefit" is given a broadest reasonable interpretation to include the intended result of any therapy.
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`The above discussion applies equally to claim 11.
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`Applicant's remaining arguments depend on the above unpersuasive arguments.
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`Response to arguments regarding Double Patenting
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`In view of the amendments, the previous 112 <]{2 rejections are withdrawn regarding applications
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`14/170,370; 12/658,770 (now pat. 8,768,629); 13/188,350 and 14/070,357. In each instance, the instant
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`claims now recite one set of markers, while the conflicting claims recite a different set of markers. The
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`rejection of application 13/942,539 is maintained because the conflicting markers are included among the
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`instant markers, all of which are obvious as described above.
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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 17 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Page 15
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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 presented in this action.
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`Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the
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`extension of time policy as set forth in 37 CPR 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 CPR 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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`

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`Case 1:17-cv-12194-MLW Document 24-4 Filed 01/16/18 Page 18 of 18
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`Application/Control Number: 14/170,450
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`Art Unit: 1631
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`Inquiries
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`Page 16
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`Information regarding the status and history of a patent application is accessible through the
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`US PTO' 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 question