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 .
Election/Restrictions
Applicant’s election of TP53 species in the reply filed on 12/1/2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 181-192 are under examination with respect to TP53.
Claim Rejections - 35 USC § 101
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.
Claims 181-192 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea and a law of nature without significantly more.
Claim 181 recite a method for screening for head and neck cancer or precancer and detecting mutations in two or more genomic regions of TP53. This encompasses a law of nature/natural phenomenon and an abstract idea. The abstract idea is a mental process of screening for head and neck cancer or precancer, this encompasses evaluating data and critical thinking wherein one mentally reads information or report and screens for head and neck cancer or precancer. The step of detecting mutations with the recitation of a method for screening head and neck cancer or precancer is law of nature, the relationship is a natural phenomenon that exists apart from any human action. This type of correlation is a consequence of a natural process.
Thes judicial exception is not integrated into a practical application because the claims do not recite additional steps or elements that integrate the recited judicial exceptions into a practical application. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps in addition to the judicial exception are data gathering steps recited at a high level of generality employing techniques that were well-established, routine and conventional at the time of the invention. For example, the claims do not practically apply the judicial exception by including one or more additional elements that the courts have stated integrate the exception into a practical application:
An additional element reflects an improvement in the functioning of a computer, or an improvement to other technology or technical field;
An additional element that applies or uses a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition;
An additional element implements a judicial exception with, or uses a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim;
An additional element effects a transformation or reduction of a particular article to a different state or thing; and
An additional element applies or uses the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception.
While claim 181 recites obtaining nucleic acids from a sample and detecting mutations in two or more genomic regions in TP53, the claims generically recites any method for detecting mutations in TP53. Additionally detecting mutations in TP53 in two or more genomic regions were well known routine and conventional in the art taught by Ginkel (Oncotarget, 2016, vol 7, pp 61575-61586) and De Leng (PLOS one, 2016, e0149405, pp 1-18).
Claims 182 recite exonic regions of DNA. These claims only limit the judicial exceptions. However, it was routine in the art to determine exonic regions of TP53 as taught by Ginkel (Oncotarget, 2016, vol 7, pp 61575-61586) and De Leng (PLOS one, 2016, e0149405, pp 1-18).
Claims 183-184 and 192,further limit the sample, this is a field of use limitation which does not amount to significantly more.
Claims 185-189 further limit the detection step to include next generation sequencing and enriching target sequence. These steps were well known, routine and conventional in the art as taught by Ginkel (Oncotarget, 2016, vol 7, pp 61575-61586) and De Leng (PLOS one, 2016, e0149405, pp 1-18).
Claim 190 further limit the head or neck cancer or precancer which further limits the judicial exception and does not amount to significantly more.
Claim 191 further limits the detecting step and recites absence of mutation is indicative of a benign oral lesion which is an additional judicial exception reciting a natural correlation and thus is a law of nature.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 181-190 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ginkel (Oncotarget, 2016, vol 7, pp 61575-61586) as evidence by De Leng (PLOS one, 2016, e0149405, pp 1-18).
Ginkel teaches obtaining samples from subjects with head and neck cancer (see patient and tumor characteristics, pg. 61576). Ginkel teaches obtaining nucleic acids from the sample and sequencing by next generation sequencings (see mutational analysis). Ginkel teaches mutations were detected in TP53 by next generation sequencing (claim 183-186) (see fig 1). Ginkel teaches sequencings TP53 exons (see molecular analysis, last para pg. 61584 and S6-8) (claim 182). Ginkel teaches targeted next generation sequencing (see abstract and molecular analysis). Ginkel teaches oral cavity tumor sites (oral lesions, oral potentially malignant disorders) (see table 1) (claim 190)
While Ginkel does not specifically teaches enriching for target nucleic acid prior to sequencing, Ginkel teaches targeted NGS was performed as previously described by De Leng. De Leng teaches targeted next generation comprises enrichment of target nucleic acid prior to sequencing. De Leng teaches amplification of samples (conditions to allow hybridization of a primer) followed by barcoded adapter (DNA hybridization of probe to nucleic acid). De Leng teaches the library, PCR and enrichment were performed and followed by sequencing nucleic acids (see Next Generation sequencing). Therefore the method of Ginkel teaches enrichment step encompasses PCR and probe hybridization prior to sequencing (detecting) the mutations (claims 187-189)
Claims 181-185, 187-188, 190-192 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vogelstein (US20180171413 A1).
Vogelstein teaches a method for assaying for tumor DNA in saliva from head and neck squamous cell carcinoma in a patient (claim 192). Vogelstein teaches samples from oral cavity cancer comprising HNSCC (see ex 4 and table 1) (oral potentially malignant disorder, oral cavity SCC) (claim 190). Vogelstein teaches extracting DNA from cells (See para 31) (claim 183-184). Vogelstein teaches performing whole exomic sequences for mutations (see para 33). Vogelstein further teaches multiplex PCR and massively parallel sequencing for mutations in TP53 (see para 38, fig 5). Vogelstein teaches most commonly mutated gene was TP53. Vogelstein teaches enrichment of the target sequence by performing PCR and sequencing for mutation detection (see para 33) (claim 187-188). Vogelstein teaches no mutations were identified after surgery of five patients whose tumors did not recur (absence of mutation indicative of benign oral lesion) (para 25) (claim 191).
Claims 181-185, 187-188, 190-192 are rejected under 35 U.S.C. 102(a)(1) and 35 USC 102(a)(2) as being anticipated by Vogelstein (US20220220563 A1).
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Vogelstein teaches a method for assaying for tumor DNA in saliva from head and neck squamous cell carcinoma in a patient (claim 192). Vogelstein teaches samples from oral cavity cancer comprising HNSCC (see ex 4 and table 1) (oral potentially malignant disorder, oral cavity SCC) (claim 190). Vogelstein teaches extracting DNA from cells (See para 31) (claim 183-184). Vogelstein teaches performing whole exomic sequences for mutations (see para 33). Vogelstein further teaches multiplex PCR and massively parallel sequencing for mutations in TP53 (see para 38, fig 5). Vogelstein teaches most commonly mutated gene was TP53. Vogelstein teaches enrichment of the target sequence by performing PCR and sequencing for mutation detection (see para 33) (claim 187-188). Vogelstein teaches no mutations were identified after surgery of five patients whose tumors did not recur (absence of mutation indicative of benign oral lesion) (para 25) (claim 191).
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 181-192 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-9, 12, 18-20 of U.S. Patent No. 12275996 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because ‘996 anticipates the instant claims. The claims recite assaying a sample to detect the presence of two more genomic mutations in TP53 and the claims achieve the same stated objected detecting the presence of HNSCC. While claim ‘996 includes additional steps, as the practice of ‘996 results in performing the activities set forth in the instant claims, ‘996 anticipates the instant claims and are not patentably distinct from the instant claims. ‘996 includes dependent claims that are analogous to the instant dependent claims – reciting the same preferred cancer types, amplification/sequencing, subjects such that instant claims 181-192 are not patentably distinct from ‘996 claims.
Claims 181-192 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5-11, 13-19 of U.S. Patent No. 11268153B2 Although the claims at issue are not identical, they are not patentably distinct from each other because ‘153 anticipates the instant claims. The claims recite assaying a sample to detect the presence of two more genomic mutations in TP53 and the claims achieve the same stated objected detecting the presence of HNSCC. While claim ‘153 includes additional steps, as the practice of ‘153 results in performing the activities set forth in the instant claims, ‘153 anticipates the instant claims and are not patentably distinct from the instant claims. ‘153 includes dependent claims that are analogous to the instant dependent claims – reciting the same preferred cancer types, amplification/sequencing, subjects such that instant claims 181-192 are not patentably distinct from ‘153 claims.
Conclusion
No claims are allowed.
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/SARAE L BAUSCH/Primary Examiner, Art Unit 1699