DETAILED CORRESPONDENCE
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on November 5, 2025 has been entered.
This action is in response to the papers filed November 5, 2025. Currently, claims 31-39, 41-48, 50-52 are pending. Claims 41-44, 48, have been withdrawn as drawn to non-elected subject matter.
All arguments have been thoroughly reviewed but are deemed non-persuasive for the reasons which follow.
Any objections and rejections not reiterated below are hereby withdrawn.
The 112B rejections have been withdrawn in view of the amendments to the claims.
The Improper Markush rejection has been withdrawn in view of the claims to require the plurality comprises PTPN22 and an additional gene that was found to be significantly associated in pairwise comparison.
The Written Description rejection has been withdrawn in view of the amendments to the claims and the arguments presented by Applicant in the June 5, 2026 response. Specifically, the response demonstrates PTPN22 is individually associated with the likelihood the subject will benefit from post-operative radiation therapy and each of the claimed pairwise gene combinations are also associated with the phenotype.
Priority
This application claims priority to
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Drawings
The drawings are acceptable.
Information Disclosure Statement
Applicant filed a 41 page Information Disclosure Statements (IDS) with 866 citations on April 21, 2025. The IDS has been reviewed to the extent reasonably possible.
Applicant is reminded that "burying" relevant references ina lengthy IDS is discouraged. See, e.g., Molins PLC v. Textron Inc., 48 F.3d 1172, 33USPQ2d 1823, 1831 (Fed. Cir. 1995) The court concluded that, by “burying” Wagenseil in a multitude of other references, Hirsh and Smith intentionally withheld it from the PTO because this manner of disclosure was tantamount to a failure to disclose. Citing PennYan Boats, Inc. v. Sea Lark Boats, Inc., 359 F.Supp. 948, 175 USPQ 260(S.D. Fla. 1972), aff'd, 479 F.2d 1328, 178 USPQ 577 (5th Cir.), cert.denied, 414 U.S. 874 (1973), the court stated that Hirsh's and Smith's failureto highlight Wagenseil in light of their knowledge of Whitson's actions in theforeign prosecutions violated their duty of candor to the PTO. Citing ourprecedent, Textron asserts that Smith's and Hirsh's conduct is “inexcusable,fraudulent, and cannot operate to cure Whitson's inequitable conduct.” See
Rohm & Haas Co. v. Crystal Chem. Co., 722 F.2d 1556, 220 USPQ 289(Fed.Cir. 1983), cert. denied, 469 U.S. 851 (1984) (where intentionalmaterial misrepresentations have been made, a “cure” through voluntaryefforts during prosecution must be demonstrated by clear, unequivocal, andconvincing evidence).
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 double patenting rejection is appropriate where the 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 Longi, 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); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 31-39, 45-47, 50 are rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over Claims 1-9 of U.S. Patent No. 11,414,708.
The third sentence of 35 U.S.C. 121 prohibits the use of a patent issuing on an application in which a requirement for restriction has been made, or on an application filed as a result of such a requirement, as a reference against any divisional application in a nonstatutory double patenting rejection, if the divisional application is filed before the issuance of the patent. The 35 U.S.C. 121 prohibition applies only where the Office has made a requirement for restriction. The prohibition does not apply where the divisional application was voluntarily filed by the applicant and not in response to an Office requirement for restriction. The U.S. Court of Appeals for the Federal Circuit has concluded that the protection of 35 U.S.C. 121 does not extend to all types of continuing applications, stating that “the protection afforded by section 121 to applications (or patents issued therefrom) filed as a result of a restriction requirement is limited to divisional applications.” Pfizer, Inc. v. Teva Pharmaceuticals USA, Inc., 518 F.3d 1353, 1362, 86 USPQ2d 1001, 1007-1008 (Fed. Cir. 2008). Here the instant application is a continuation, rather than a divisional of ‘933. In the event that applicant changed the status of the instant application to a divisional, this rejection would be reconsidered.
Although the conflicting claims are not identical, they are not patentable distinct from each other because Claims 31-39, 45-47, 50-52 of the instant application is generic to all that is recited in Claims 1-9 of U.S. Patent No. 11,414,708. That is, Claims 1-9 of U.S. Patent No. 11,414,708 falls entirely within the scope of Claims 31-39, 45-47, 50-52, or in other words, 31-39, 45-47, 50-52 are anticipated by Claims 1-9 of U.S. Patent No. 11,414,708. Here, Claim 1 of U.S. Patent No. 11,414,708 recites
1. A method for treating a subject having prostate cancer, comprising:
a) obtaining a post-operative radiation therapy outcome score (PORTOS) that has been calculated using a level of expression of a plurality of genes in the biological sample, wherein said plurality of genes comprises DRAM1, KRT14, PTPN22, ZMAT3, ARHGAP15, IL1B, ANLN, RPS27A, MUM1, TOP2A, GNG11, CDKN3, HCLS1, DTL, IL7R, UBA7, NEK1, CDKN2AIP, APEX2, KIF23, SULF2, PLK2, EME1, and BIN2;
b) determining whether or not the subject is likely to benefit from post-operative radiation therapy based on the PORTOS score, wherein a PORTOS greater than 0 indicates that the subject will benefit from the post-operative radiation therapy and a PORTOS less than or equal to 0 indicates that the subject will not benefit from the post-operative radiation therapy; and
c) if the PORTOS indicates that the subject will benefit from the radiation therapy, then administering the post-operative radiation therapy to the subject, and if the PORTOS does not indicate that the subject will benefit from the post-operative radiation therapy, then administering a cancer treatment other than the post-operative radiation therapy to the subject.
The instant claims and elected subject matter of analysis of one gene PTPN22 is generic to and anticipated by the issued claims.
Claims 32-39 of the instant claims are analogous to Claims 2-9 of ‘708.
Claims 45-47, 50 encompass the PTPN22 gene elected.
Response to Arguments
The Applicant argues the rejection has been overcome for the reasons argued above. This argument has been reviewed but is not convincing because the claim is directed to a plurality of genes comprising 2-23. This encompasses 24 genes as claimed in the parent Patent. Thus, for the reasons above and those already of record, the rejection is maintained.
Conclusion
No claims allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng (Winston) Shen can be reached on (571) 272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
August 7, 2026
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