`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Olflce
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria, Virginia 22313-1450
`www.mptogov
`
`15/632,497
`
`06/25/2017
`
`Wanen Foster
`
`GWLG—017US-CIP
`
`2488
`
`M1lste1n Zhang & Wu LLC
`2000 Commonwealth Avenue, Suite 400
`Newton, MASSACHUSETTS 02466-2004
`
`MARI-WELL JAMES
`
`ART UNIT
`
`1634
`
`MAIL DATE
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`01/09/2018
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`PAPER NUMBER
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 0407)
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`

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`017709 A0110” Summary
`
`Application No.
`15/632,497
`
`Examiner
`JAMES MARTINELL
`
`Applicant(s)
`Foster et al.
`
`Art Unit
`1634
`
`AIA Status
`Yes
`
`- The MAILING DA TE ofthis communication appears on the cover sheet with the correspondence address -
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 2 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
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`1)l:| Responsive to communication(s) filed on
`I:I A declaration(s)laffidavit(s) under 37 CFR 1.130(b) was/were filed on
`2a)l:| This action is FINAL.
`2b) I This action is non-final.
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`3)|:| 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.
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`4)|:| 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 Exparfe Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims"
`5)
`Claim(s)
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`1-12 is/are pending in the application.
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`5a) Of the above claim(s)
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`is/are withdrawn from consideration.
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`6) El Claim(s)
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`is/are allowed.
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`7)
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`8)
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`Claim(s) fl is/are rejected.
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`I] Claim(s) _ is/are objected to.
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`
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`are subject to restriction and/or election requirement
`9) El Claim(s)
`* If any claims have been determined allowable, you may be eligible to benefit from the Patent Prosecution Highway program at a
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`participating intellectual property office for the corresponding application. For more information, please see
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`http:llwww.uspto.govlpatents/init_events/pphlindex.jsp or send an inquiry to PPeredback@uspto.gov.
`
`Application Papers
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`10). The specification is objected to by the Examiner.
`
`11). The drawing(s) filed on 12 September 2017 is/are: a). accepted or b)|:| 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)l:| Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)-(d) or (f).
`Certified copies:
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`a)I:I All
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`b)l:l Some**
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`c)I:I None of the:
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`1.[:|
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`Certified copies of the priority documents have been received.
`
`2.l:|
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`Certified copies of the priority documents have been received in Application No.
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`3.|:| 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)).
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`** See the attached detailed Office action for a list of the certified copies not received.
`
`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`2) D Information Disclosure Statement(s) (PTOISBIOSa andfor PTOISBIOBb)
`Paper No(s)lMail Date
`U.S. Patent and Trademark Office
`
`3) |:| Interview Summary (PTO—413)
`Paper No(s)/Mail Date
`4) D Other'
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`PTOL-325 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper NoJMail Date 20180105
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`

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`Application/Control Number: 15/632,497
`Art Unit: 1634
`
`Page2
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`Notice of Pre-AIA or AIA Status
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`The present application, filed on or after March 16, 2013, is being examined under the first
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`inventor to file provisions of the AIA.
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`Color photographs and color drawings are not accepted in utility applications unless a petition
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`filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee
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`set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted
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`via EFS-Web or three sets of color drawings or color photographs, as appropriate, if not submitted via
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`EFS—Web, and, unless already present, an amendment to include the following language as the first
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`paragraph of the brief description of the drawings section of the specification:
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`The patent or application file contains at least one drawing executed in color. Copies of this
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`patent or patent application publication with color drawing(s) will be provided by the Office upon request
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`and payment of the necessary fee.
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`Color photographs will be accepted if the conditions for accepting color drawings and black and
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`white photographs have been satisfied. See 37 CFR 1.84(b)(2).
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`Applicants should clarify for the record whether they wish color drawings to appear in any patent
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`that may issue from the instant application.
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`The disclosure is objected to because of the following informalities: the Brief Description of the
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`Drawings needs to mention part E in Figure 11 (see paragraph 0023).
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`Appropriate correction is required.
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`The following is a quotation of 35 U.S.C. 112(d):
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`(cl) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent
`form shall contain a reference to a claim previously set forth and then specify a further
`limitation of the subject matter claimed. A claim in dependent form shall be construed to
`incorporate by reference all the limitations of the claim to which it refers.
`
`

`

`Application/Control Number: 15/632,497
`Art Unit: 1634
`
`Page3
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`The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
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`Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim
`in dependent form shall contain a reference to a claim previously set forth and then specify a
`further limitation of the subject matter claimed. A claim in dependent form shall be construed
`to incorporate by reference all the limitations of the claim to which it refers.
`
`Claims 8-12 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as
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`being of improper dependent form for failing to further limit the subject matter of the claim upon which it
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`depends, or for failing to include all the limitations of the claim upon which it depends. Claims 8-12 are
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`kit claims that depend from method claim 1. Applicant may cancel the claim(s), amend the claim(s) to
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`place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a
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`sufficient showing that the dependent claim(s) complies with the statutory requiremenE.
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`35 U.S.C. 101 reads as follows:
`
`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.
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`Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-
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`statutory subject matter. The claimed invention is not directed to patent eligible subject matter. Based
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`upon an analysis with respect to the claim as a whole, the instant claim(s) is/are determined to be
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`directed to a law of nature/natural principle. The rationale for this determination follows. The U.S.
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`Supreme Court has ruled that claims to methods that are considered to be no more than an expression of
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`the application of a law of nature are unpatentable subject matter under 35 U.S.C. § 101. See Mayo
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`Collaborative Services v. Prometheus Laboratories, Inc. (101 USPQ 2d 1961, Decided March 20, 2012).
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`The correlation between the expression of each of BDNF, glycodelin (progestogen-associated protein,
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`PAEP, see the instant application at paragraph 0036), and ZAG (zinc-alpha-2—glycoprotein) and biological
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`disorders is a well-understood, routine, conventional activity. For example, see Browne et al (Fertility and
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`Sterility 98 (3), 713 (September 2012)) (BDNF), Ward et al (US. Patent Application Publication
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`2008/0305967 A1) (PAEP), and Signorile et al (J. Cellular Physiol. 231: 2622 (May 2, 2016)) (ZAG). Since
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`

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`Application/Control Number: 15/632,497
`Art Unit: 1634
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`Page4
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`the expression of genes and the development of biological disorders are naturally occurring phenomena,
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`the correlation of the expression of one or more genes with a disordered or non-disorders state is no
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`more than the application of a law of nature and is deemed unpatentable subject matter under 35 U.S.C.
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`§ 101 (Mayo Collaborative Services v. Prometheus Laboratories, Inc. (101 USPQ 2d 1961). See also
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`MPEP 2106.01; Assocration fbr Molecular Pathology V. Myriad Genetics, Inc. (106 USPQ2d 1972 (Decided
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`June 13, 2013); and2014 Interim Guidance on Patent Subject Matter Eligiblfilfy (Fed. Reg. 79 (241),
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`74618, December 16, 2014).
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`The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the
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`basis for the rejections under this section made in this Office action:
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`A person shall be entitled to a patent unless —
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`(a)(1) the claimed invention was patented, described in a printed publication, or in public use,
`on sale or otherwise available to the public before the effective filing date of the claimed
`invention.
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`The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections
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`set forth in this Office action:
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`A patent for a claimed invention may not be obtained, notwithstanding that the claimed
`invention is not identically disclosed as set forth in section 102, if the differences between the
`claimed invention and the prior art are such that the claimed invention as a whole would have
`been obvious before the effective filing date of the claimed invention to a person having
`ordinary skill in the art to which the claimed invention pertains. Patentability shall not be
`negated by the manner in which the invention was made.
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`This application currently names joint inventors. In considering patentability of the claims the
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`examiner presumes that the subject matter of the various claims was commonly owned as of the
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`effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised
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`of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that
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`was not commonly owned as of the effective filing date of the later invention in order for the examiner to
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`consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against
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`the later invention.
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`

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`Application/Control Number:15/632,497
`Art Unit: 1634
`
`Page5
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`Claim 7 is rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Browne et al
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`(Fertility and Sterility 98 (3), 713 (September 2012)). Browne et al teaches the correlation between
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`endometriosis and the overexpression of BDNF. For example, see the Abstract and pages 717-718.
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`Absent evidence to the contrary, the overexpression levels in Browne et al are deemed to be embraced
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`by the claims.
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`Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Browne et al (Fertility
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`and Sterility 98 (3), 713 (September 2012)) (BDNF) in view of Ward et al (US. Patent Application
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`Publication 2008/0305967 A1) and where necessary in further in view of Signorile et al (J. Cellular
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`Physiol. 231: 2622 (May 2, 2016)). The primary reference teaches the correlation of BDNF expression
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`and endometriosis. For example, see Brown et al, the Abstract and pages 717-718. Ward et al teaches
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`the screening of subjecE for endometriosis by detecting PAEP expression (e.g., see claims 43-50).
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`It
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`would have been obvious for one of ordinary skill in the art before the effective filing date of the instant
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`application to screen for, diagnose, or monitor endometriosis by monitoring expression of both BDNF and
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`PAEP, such monitoring being taught for each gene separately by Browne et al and Ward et al in order to
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`achieve greater sensitivity and accuracy than by monitoring expression either one of the genes separately
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`for the known and expected results.
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`In the case of the optional monitoring expression of ZAG, Signorile
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`et al teaches the correlation of ZAG expression with endometriosis (e.g., see the Abstract), thus it would
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`further have been obvious for one of ordinary skill in the art before the effective filing date of the instant
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`application to monitor expression of ZAG in addition to the monitoring of BDNF and PAEP in order to
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`achieve greater sensitivity and accuracy than by monitoring expression of any one of the three genes
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`separately for the known and expected results.
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`Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Browne et al (Fertility
`
`and Sterility 98 (3), 713 (September 2012)) (BDNF) in view of Ward et al (US. Patent Application
`
`Publication 2008/0305967 A1) and where necessary in further in view of Signorile et al (J. Cellular
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`

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`Application/Control Number: 15/632,497
`Art Unit: 1634
`
`Page6
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`Physiol. 231: 2622 (May 2, 2016)) as applied to claims 1-6 above, and further in view of Ahern (The
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`Scientist 9(15), 20 (1995)). Ahern et al teaches the collection of materials needed for molecular
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`biological procedures into kit form for convenience. It would have been obvious for one of ordinary skill
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`in the art before the effective filing date of the instant application to collect the materials needed to
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`perform the gene expression assays discussed in the previous rejection into kit form for convenience as
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`taught by Ahern.
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`Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Browne et al
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`(Fertility and Sterility 98 (3), 713 (September 2012)) (BDNF) in view of Ward et al (U.S. Patent
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`Application Publication 2008/0305967 A1) and where necessary in further in view of Signorile et al (J.
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`Cellular Physiol. 231: 2622 (May 2, 2016)) and further in view of Ahern (The Scientist 9(15), 20 (1995))
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`as applied to claims 8-10 above, and further in view of applicanE’ admitted state of the prior art (e.g.,
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`instant application at paragraph 0047). Applicants acknowledge biochip technology to be old (e.g.,
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`instant application, paragraph 0047). Ahern et al teaches the collection of materials needed for
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`molecular biological procedures into kit form for convenience.
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`It would have been obvious for one of
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`ordinary skill in the art before the effective filing date of the instant application to collect the materials
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`needed to perform the gene expression assays discussed above in addition to the admittedly old biochips
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`into kit form for convenience as taught by Ahern.
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`Any inquiry concerning this communication or earlier communications from the examiner should
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`be directed to JAMES MARTINELL whose telephone number is (571) 272-0719.
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`The examiner works a flexible schedule and can be reached by phone and voice mail.
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`Alternatively, a request for a return telephone call may be e-mailed to james.martinell@uspto.gov. Since
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`e-mail communications may not be secure, it is suggested that information in such requests be limited to
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`name, phone number, and the best time to return the call.
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`If attempE to reach the examiner by telephone are unsuccessful, the examiner's supervisor,
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`Dave T. Nguyen, can be reached on (571) 272-0731.
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`

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`Application/Control Number: 15/632,497
`Art Unit: 1634
`
`Page7
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`OFFICIAL FAX NUMBER
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`The fax phone number for the organization where this application or proceeding is assigned is
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`(571) 273-8300. Any Official Communication to the USPTO should be faxed to this number.
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`Any inquiry of a general nature or relating to the status of this application or proceeding should
`be directed to (571) 272-0547.
`
`Patent applicants with problems or questions regarding electronic images that can be viewed in the Patent Application
`Information Retrieval system (PAIR) can now contact the USPTO's Patent Electronic Business Center (Patent EBC) for assistance.
`Representatives are available to answer your questions daily from 6 am to midnight (EST). The toll free number is (866) 217-9197.
`When calling please have your application serial or patent number, the type of document you are having an image problem with,
`the number of pages and the specific nature of the problem. The Patent Electronic Business Center will notify applicants of the
`resolution of the problem within 5-7 business days. Applicants can also check PAIR to confirm that the problem has been corrected.
`The USPTO's Patent Electronic Business Center is a complete service center supporting all patent business on the Internet. The
`USPTO's PAIR system provides Internet-based access to patent application status and history information. It also enables applicants
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`
`For all other customer support, please call the USPTO Call Center (UCC) at 800-786-9199.
`
`[JAMES MARTINELL/
`Primary Examiner, Art Unit 1634
`
`