UNITED STATES PATENT AND TRADEMARK OFFICE
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`
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`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`PO. Box 1450
`Alexandria, Virginia 2231371450
`www.uspto.gov
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`15/632,497
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`06/26/2017
`
`Warren Foster
`
`GWLG-Ol7US-CIP
`
`2488
`
`7590
`-
`889-93
`M11ste1n Zhang & Wu LLC
`2000 Commonwealth Avenue, Suite 400
`Newton, MA 02466-2004
`
`09/24/2018
`
`MARTINELL' JAMES
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`ART UNIT
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`1634
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`MAE DATE
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`09/24/201 8
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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. 04/07)
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`

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`Off/09 A0170” Summary
`
`Application No.
`15/632,497
`Examiner
`JAM ES MARTINELL
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`Applicant(s)
`Foster et al.
`Art Unit
`1634
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`AIA Status
`Yes
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`- The MAILING DA TE of this communication appears on the cover sheet wit/7 the correspondence address -
`Period for Reply
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`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). In no event, however, may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`|f 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).
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`Status
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`1). Responsive to communication(s) filed on 06 June 2018.
`[:1 A declaration(s)/affidavit(s) under 37 CFR 1.130(b) was/were filed on
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`2a). This action is FINAL.
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`2b) C] 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 Expat/7e Quay/e, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims*
`5)
`Claim(s)
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`1—17 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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`E] Claim(s)
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`is/are allowed.
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`Claim(s) fl is/are rejected.
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`[:1 Claim(s) _ is/are objected to.
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`) ) ) )
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`6 7
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`8
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`
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`are subject to restriction and/or election requirement
`[j Claim(s)
`9
`* If any claims have been determined aflowabte. 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://www.uspto.gov/patents/init events/pph/index.jsp or send an inquiry to PPeredback@uspto.gov.
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`Application Papers
`10)[:] The specification is objected to by the Examiner.
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`11). The drawing(s) filed on 12 September 2017 is/are: a). accepted or b)D 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).
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`Priority under 35 U.S.C. § 119
`12)[:] 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)D Some”
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`C)D None of the:
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`1.[:]
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`Certified copies of the priority documents have been received.
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`2.[:]
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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.
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`Attachment(s)
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`1)
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`Notice of References Cited (PTO-892)
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`2) E] Information Disclosure Statement(s) (PTO/SB/08a and/or PTO/SB/08b)
`Paper No(s)/Mail Date_
`U.S. Patent and Trademark Office
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`3) C] Interview Summary (PTO-413)
`Paper No(s)/Mail Date
`4) CI Other-
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`PTOL-326 (Rev. 11-13)
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`Office Action Summary
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`Part of Paper No./Mai| Date 20180923
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`

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`Application/Control Number: 15/632,497
`Alt Unit: 1634
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`Page 2
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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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`The text of those sections of Title 35, U.S. Code not included in this action can be found in a
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`prior Office action.
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`The following is a quotation of 35 U.S.C. 112(b):
`(b) CONCLUSION.—The specification shall conclude with one or more claims palticularly
`pointing out and distinctly claiming the subject matter which the inventor or a joint inventor
`regards as the invention.
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`The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph:
`The specification shall conclude with one or more claims particularly pointing out and
`distinctly claiming the subject matter which the applicant regards as his invention.
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`Claim 4 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as
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`being indefinite for failing to palticularly point out and distinctly claim the subject matter which the
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`inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The claim is
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`incomplete.
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`(a) The recitation of “the circulating level of BDNF" is incomplete because there is no
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`antecedent basis for the phrase using the definite anticle “the”.
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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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`Application/Control Number: 15/632,497
`Alt Unit: 1634
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`Page 3
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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 (Feltility 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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`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; Association for Molecular Pathology v. Myriad Genetics, Inc. (106 USPQ2d 1972 (Decided
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`June 13, 2013); and 2014 Interim Guidance on Patent Subject Matter Eligib/lity (Fed. Reg. 79 (241),
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`74618, December 16, 2014). This rejection is repeated for reasons already of record (e.g., Office action
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`mailed January 9, 2018, page 5). Applicants’ assertions (response filed June 6, 2018, pages 8-10) are
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`not persuasive for reasons already of record.
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`The analysis of the instant claims (see the flowchalt “Subject Matter Eligibility Test for Products
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`and Processes" in MPEP 2106 III) is as follows:
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`I.
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`Step 1, the instant claims are to a process = YES.
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`II.
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`Step 2A, the instant claims are directed to a Natural Phenomenon = YES.
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`III.
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`Step 2B, the instant claims recite additional elements that amount to significantly more
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`than the Judicial Exception = NO.
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`IV.
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`Thus, the instant claims are not drawn to patent eligible subject matter under 35 U.S.C.
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`§1o1.
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`Claims 1, 2, 5-7, 13, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen
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`et al (US. Patent Application Publication 2006/0014166 A1). Cohen et al discloses glycodelin and CA-125
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`to be markers for endometriosis.
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`For example, see paragraphs 0011-0014 and funther teach the use of
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`Application/Control Number: 15/632,497
`Alt Unit: 1634
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`Page 4
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`antibodies to determine levels of endometriosis markers in bodily fluids. For example, see paragraphs
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`0016, 0022, and 0045-0048. Applicants acknowledge various treatments for endometriosis to be well-
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`understood, routine, and conventional (e.g., see the instant application at paragraph 0051). It would
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`have been obvious for one of ordinary skill in the at before the effective filing date of the instant
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`application to monitor expression of glycodelin and CA-125 in patients with or suspected of having
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`endometriosis and to use antibodies for the detection of gene expression in the manner of Cohen et al for
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`the known and expected results and to use the acknowledged well-understood, routine, and conventional
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`treatment methods for patients with endometriosis.
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`Claims 3, 14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al
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`(U.S. Patent Application Publication 2006/0014166 A1) as applied to claims 1, 2, 5-7, 13, and 15 above,
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`and further in view of Signorile et al (J. Cellular Physiol. 231: 2622 (May 2, 2016)). Signorile et al
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`teaches the correlation of ZAG expression with endometriosis (e.g., see the Abstract).
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`It would have
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`been obvious for one of ordinary skill in the at before the effective filing date of the instant application to
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`monitor expression of glycodelin and CA-125 in patients with or suspected of having endometriosis and to
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`use antibodies for the detection of gene expression in the manner of Cohen et al for the known and
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`expected results and to use the acknowledged well-understood, routine, and conventional treatment
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`methods for patients with endometriosis. It would funther have been obvious for one of ordinary skill in
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`the at before the effective filing date of the instant application to monitor expression of ZAG in addition
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`to the monitoring of glycodelin and CA-125 as taught by Cohen et al in order to achieve greater
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`sensitivity and accuracy than by monitoring expression of any one of the three genes separately for the
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`known and expected results.
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`Claims 4 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (U.S.
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`Patent Application Publication 2006/0014166 A1) as applied to claims 1, 2, 5-7, 13, and 15 above, and
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`further in view of either one of Browne et al (Fertility and Sterility 98 (3), 713 (September 2012)) (BDNF)
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`or Ward et al (U.S. Patent Application Publication 2008/0305967 A1). Browne et al teaches the
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`Application/Control Number: 15/632,497
`Alt Unit: 1634
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`Page 5
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`correlation of BDNF expression and endometriosis. For example, see Brown et al, the Abstract and pages
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`717-718. Ward et al teaches the screening of subjects for endometriosis by detecting PAEP (i.e. BDNF)
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`expression (e.g., see claims 43-50).
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`It would have been obvious for one of ordinary skill in the at before
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`the effective filing date of the instant application to monitor expression of glycodelin and CA-125 in
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`patients with or suspected of having endometriosis and to use antibodies for the detection of gene
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`expression in the manner of Cohen et al for the known and expected results and to use the
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`acknowledged well-understood, routine, and conventional treatment methods for patients with
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`endometriosis. It would funther have been obvious for one of ordinary skill in the at before the effective
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`filing date of the instant application to monitor expression of BDNF (i.e. PAEP), disclosed to be associated
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`with endometriosis in addition to the monitoring of glycodelin and CA-125 as taught by Cohen et al in
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`order to achieve greater sensitivity and accuracy than by monitoring expression of any one of the three
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`genes separately for the known and expected results.
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`Claims 8-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cohen et al (US.
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`Patent Application Publication 2006/0014166 A1) in view of either one of Browne et al (Feltility and
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`Sterility 98 (3), 713 (September 2012)) (BDNF) or Ward et al (US. Patent Application Publication
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`2008/0305967 A1), in view of Signorile et al (J. Cellular Physiol. 231: 2622 (May 2, 2016)), and further in
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`view of Ahern (The Scientist 9 (15), 20 (1995)). Browne et al 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 subjects for endometriosis by detecting PAEP (i.e. BDNF) expression (e.g., see claims
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`43-50). Signorile et al teaches the correlation of ZAG expression with endometriosis (e.g., see the
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`Abstract). Ahern teaches the collection of materials needed for molecular biological procedures into kit
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`form for convenience. It would have been obvious for one of ordinary skill in the at before the effective
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`filing date of the instant application to monitor expression of glycodelin and CA-125 in patients with or
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`suspected of having endometriosis and to use antibodies for the detection of gene expression in the
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`manner of Cohen et al for the known and expected results and to use the acknowledged well-understood,
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`routine, and conventional treatment methods for patients with endometriosis. It would funther have been
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`Application/Control Number: 15/632,497
`Alt Unit: 1634
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`Page 6
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`obvious for one of ordinary skill in the at before the effective filing date of the instant application to
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`monitor expression of BDNF (i.e. PAEP), disclosed to be associated with endometriosis and ZAG disclosed
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`by Signorile et al to be associated with endometriosis in addition to the monitoring of glycodelin and CA-
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`125 as taught by Cohen et al in order to achieve greater sensitivity and accuracy than by monitoring
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`expression of any one of the three genes separately for the known and expected results. It would funther
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`have been obvious for one of ordinary skill in the at before the effective filing date of the instant
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`application to collect the materials needed to perform the gene expression assays discussed above in
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`addition to the admittedly old biochips into kit form for convenience as taught by Ahern.
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`Applicant's amendment necessitated the new ground(s) of rejection presented in this Office
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`action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of
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`the extension of time policy as set forth in 37 CFR 1.136(a).
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`A shontened 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.
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`In the event a first reply is filed within TWO MONTHS of the mailing date
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`of this final action and the advisory action is not mailed until after the end of the THREE-MONTH
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`shontened statutory period, then the shontened statutory period will expire on the date the advisory
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`action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing
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`date of the advisory action.
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`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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`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 'amesmartineli mus to. ov. 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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`