DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Notice of New Examiner
The Examiner would like to note for the Applicant that this case has been
transferred to a new examiner for examination. Any further communications on this case may be directed to the contact information included in the conclusion of this
office action.
Election/Restrictions
Applicant’s election of the species FBXW7 1435C>T in the reply filed on January 28th, 2026 is acknowledged.
After further consideration, the species election is hereby withdrawn. All species of mutations in claim 26 will be examined, as well as all claims.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on March 23rd, 2023; May 16th, 2023; June 10th, 2024; and January 28th, 2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
Claim Summary
Claims 1-25 have been canceled. Claims 26-35 are pending. Claims 26-35 are under examination and discussed in this Office action.
Specification
The use of the terms such as AMPure and Phusion, which are trade names or marks used in commerce, has been noted in this application. All terms that are trade names or marks should be accompanied by the generic terminology; furthermore the terms should be capitalized wherever they appear or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see pages 22-23 of the instant specification). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 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, 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 negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 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. Applicant is advised of the obligation under 37 CFR 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 26-30 and 32-35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Linder (US 20050136405 A1; cited on the IDS filed March 21st, 2023), in view of McConechy (Use of mutation profiles to refine the classification of endometrial carcinomas, The Journal of Pathology, May 2012, 228, 20-30; cited on the IDS filed March 21st, 2023; attached with supplemental table) and Mirabelli-Primdahl (β-Catenin Mutations Are Specific for Colorectal Carcinomas with Microsatellite Instability but Occur in Endometrial Carcinomas Irrespective of Mutator Pathway, Cancer Research, July 1999, 59, 3346-3351), and as evidenced by GenBank (GenBank accession number NM_001904.4 [online]. GenBank, [2026] [retrieved on July 7th, 2026]. Retrieved from: https://www.ncbi.nlm.nih.gov/nuccore/NM_001904.4) and Wisconsin (Conventional Pap Test [online]. Wisconsin State Laboratory of Hygiene, [2026] [retrieved on July 7th, 2026]. Retrieved from: https://www.slh.wisc.edu/clinical/cytology/analytical-services/conventional-pap-smear/).
Regarding instant claims 26 and 32-35, Linder teaches a method comprising testing a liquid Pap specimen obtained from a human subject to detect endometrial cancer markers (Page 3, paragraph [0026]). These markers may be selected from nucleic acids (Page 3, paragraph [0026]). Linder further teaches that detection methods include those which detect mRNA, cDNA, or genomic DNA (Pages 6-7, paragraph [0062])
Linder does not teach testing for PIK3CA 323G>A, TP53 328C>T, or PIK3CA 263 G>A; or detecting the presence of the A allele at position 323 of PIK3CA gene, the T allele at position 328 of TP53 gene, or the A allele at position 263 of PIK3CA gene.
McConechy, in a reasonably pertinent field, teaches on mutations related to endometrial cancer (whole document). These include PIK3CA 323G>A (Supplemental Table 1, see rows 429 and 1047), TP53 328C>T (Supplemental Table 1, see rows 287 and 910), and PIK3CA 263 G>A (Supplemental Table 1, see rows 52, 225, 238, 270, 304, 337, 348, and several others). Each of the cited rows lists the chromosomal location and amino acid change for each of these mutations, which match the mutations as presented in Figure 11 of the Drawings. McConechy teaches that these mutations are detected using target enrichment and exon sequencing (Page 21, column 2, paragraph 2).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the markers of Linder with the mutations of McConechy. Since McConechy teaches on mutations in endometrial cancer, which is reasonably pertinent to the method of Linder, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because it amounts to simple substitution of one known element for another to obtain predictable results (see MPEP 2141(III)).
Neither reference teaches testing for CTNNB1 100G>A; or detecting the presence of the A allele at position 100 of CTNNB1 gene.
Mirabelli-Primdahl, in a reasonably pertinent field, teaches on mutations related to endometrial cancer (Page 3346, column 2, paragraph 1; Table 1). These include CTNNB1 100G>A (Table 1, case #13 under endometrial neoplasms). The cited table lists the codon and amino acid change for each of these mutations, which match the mutations as presented in Figure 11 of the Drawings. As evidenced by GenBank (see screenshot below), the coding sequence for CTNNB1 starts at position 215 of the provided transcript sequence (Page 3 of GenBank for coding sequence details; also yellow box around start codon, with “a” in position 215, below). One hundred bases away from this is position 314, which is the first base of codon 34 (Page 3 of GenBank for coding sequence details; Page 7 of GenBank for coding sequence; also red box, with first “g” 100 bases from position 215, below). Mirabelli-Primdahl teaches that this base is mutated from G>A (Table 1, case #13 under endometrial neoplasms). Therefore, Mirabelli-Primdahl teaches testing for and detecting the mutation CTNNB1 100G>A. Mirabelli-Primdahl teaches that this mutation is detected using amplification of exon 3 of CTNNB1 (Page 21, column 2, paragraph 2).
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It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the markers of Linder with the mutation of Mirabelli-Primdahl. Since Mirabelli-Primdahl teaches on mutations in endometrial cancer, which is reasonably pertinent to the method of Linder, one of ordinary skill in the art would combine the two teachings with a reasonable expectation of success. One of ordinary skill in the art would have been motivated to make this modification because it amounts to simple substitution of one known element for another to obtain predictable results (see MPEP 2141(III)).
Regarding instant claim 27, Linder, in view of McConechy, teaches the method of claim 26. McConechy further teaches wherein said human subject has an endometrial tumor (Page 21, column 2, paragraph 1).
Regarding instant claim 28, Linder, in view of McConechy, teaches the method of claim 26. Linder further teaches wherein said human subject has endometrial cancer (Page 3, paragraph [0026]).
Regarding instant claim 29, Linder, in view of McConechy, teaches the method of claim 26. Linder further teaches wherein the liquid Pap specimen is collected from the cervix (Page 3, paragraph [0026]).
Regarding instant claim 30, Linder, in view of McConechy, teaches the method of claim 26. Linder further teaches taking a cervical Pap specimen. As evidenced by Wisconsin, a conventional Pap test includes cells from the cervix, endocervix, ectocervix, vagina and vulva (whole document). Therefore, the cervical Pap specimen of Linder reasonably includes cells from the ectocervix.
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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 26-35 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11525163 B2 in view of Linder (US 20050136405 A1; cited on the IDS filed March 21st, 2023), McConechy (Use of mutation profiles to refine the classification of endometrial carcinomas, The Journal of Pathology, May 2012, 228, 20-30; cited on the IDS filed March 21st, 2023; attached with supplemental table) and Mirabelli-Primdahl (β-Catenin Mutations Are Specific for Colorectal Carcinomas with Microsatellite Instability but Occur in Endometrial Carcinomas Irrespective of Mutator Pathway, Cancer Research, July 1999, 59, 3346-3351).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the ‘163 patent and the instant application claim a method comprising: testing a liquid Pap specimen obtained from a human subject for mutations in the genes FBXW7, PIK3CA, TP53, and CTNNB1, wherein a specific mutation in FBXW7 is 1435C>T and detecting the presence of the T allele at position 1435 of FBXW7 gene (instant claim 26 and 31; reference claim 1). While the method as described in the ‘163 patent has more specific details regarding the testing, these details are reasonably a species of the genus of testing as claimed in the instant application.
The ‘163 patent and the instant application both further claim wherein said human subject has an endometrial tumor (instant claim 27, reference claims 12 and 13); wherein said human subject has an endometrial tumor (instant claim 28, reference claims 14 and 15); wherein the liquid Pap specimen is collected from the cervix (instant claim 29; reference claim 5); wherein the liquid Pap specimen comprises cells from the ectocervix (instant claim 30; reference claim 6); and wherein said one or more mutations in said CTNNB1 gene comprises 100G>A and the presence of said 100G>A mutation in said CTNNB1 gene is detected (instant claim 26 and 35, reference claims 9 and 10).
The ’163 claims do not require testing for the following mutations: PIK3CA 323G>A, TP53 328C>T, or PIK3CA 263 G>A; or detecting the presence of the A allele at position 323 of PIK3CA gene, the T allele at position 328 of TP53 gene, or the A allele at position 263 of PIK3CA gene. However, Linder, McConechy and Mirabelli-Primdahl teach the claimed limitations as discussed in the above 103 rejections, obviating these variations to the claims of the ‘163 patent. Any additional limitations of the claims of U.S. Patent No. 11525163 B2 are encompassed by the open claim language "comprising" found in the instant claims.
Conclusion
All claims are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Allison E Schloop whose telephone number is (703)756-4597. The examiner can normally be reached Monday-Friday 8:30-5 ET.
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/ALLISON E SCHLOOP/Examiner, Art Unit 1683
/Robert T. Crow/Primary Examiner, Art Unit 1683
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