DETAILED ACTION
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 Group I and the species of FN1, POSTN, FAP, GEN1 , DNA2 and POLQ in the reply filed on 1/28/2026 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 1-3,5-6,8-10,12,16-17,21,29,31-36,38-39,41,45-46,50-51,59-62 are pending.
Claims 4,7,11,13-15,18-20,22-28,30,37,40,42-44,47-49,52-58 have been cancelled.
Claims 16-17,21,29,31-36,38-39,41,45-46,50-51,59-62 are withdrawn as being drawn to a nonelected invention.
An action on the merits for claims 1-3, 5-6, 8-10, 12 is set forth below.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. 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. See page 21
Claim Objections
Claims 1-3, 5-6, 8-10, 12 are objected to because of the following informalities: The term “DDR” should be spelled out for clarity. Claims 2-3, 5-6, 8-10, 12 are objected to as being dependent on an objected claim. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
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.
Claims 1-3, 5-6, 8-10, 12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1-3, 5-6, 8-10, 12 are indefinite over the phrase “impaired TGFBeta signaling” and “alt-EJ activation”. The terms have not been defined in the specification. It is not clear the metes and bounds of impaired as it is not clear if the claims require a particular assessment of the signal or if as set forth in the dependent claims expression changes in a gene. It is not clear the metes and bounds of the term activation as it is not clear if the claims require a particular assessment of activation, level of activation or if as set forth in the dependent claims expression changes in a gene.
Claim 2-3 are indefinite over the term “low expression”. The term “low expression” in claim 2 is a relative term which renders the claim indefinite. The term “low expression” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no comparison step it is not clear which expression would be considered “low”.
Claim 5-6 are indefinite over the term “high expression”. The term “low expression” in claim 2 is a relative term which renders the claim indefinite. The term “high expression” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. As there is no comparison step it is not clear which expression would be considered “high”.
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 1-3, 5-6, 8-10, 12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a natural correlation without significantly more. The claim(s) recite(s) a judicial exception of correlation response to DDR deficit phenotype and assessing cancer cells. This judicial exception is not integrated into a practical application because the claims require steps measuring expression (assessing competency and activation) of naturally known genes and does not provide a step to integrate the judicial exception.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims do not integrate the judicial exception to steps that are not considered routine and conventional steps.
These judicial exceptions are not integrated into a practical application because the claims only recite the natural correlation, wherein the step of obtaining and assessing does not integrate the judicial expectation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the steps are considered general and routine knowledge in the prior art as exemplified by the specification (as discussed below).
According to the 2019 Patent Eligibility Guidance an initial two step analysis is required for determining statutory eligibility.
Step 1. Is the claim directed to a process, machine, manufacture, or composition of matter? In the instant case the Step 1 requirement is satisfied as the claims are directed towards a process.
Step 2A Prong one. Does the claim recite a law of nature, a natural phenomenon or an abstract idea? Yes, a natural phenomenon
The correlation of phenotype and assessing is considered a natural correlation.
Step 2A prong two. Does the claim recite additional elements that integrate the judicial exception into a practical application? The answer is no as the steps require only routine and convention steps and does not integrate the judicial exception to a practical application.
Step 2B. Does the claim recite additional elements that are significantly more than the judicial exceptions? No as the claims do not require any elements that integrate the judicial exception.
The steps that are not considered judicial expectations are the steps of obtaining a sample and assessing. Liu et al. (Clin Cancer Res 2018 Vol 24 p. 6001 cited on IDS) teaches steps of obtaining a sample of cancer cells (p. 6003 1st column). Liu et al. teaches assessing by expression analyzing TGFB and alt-ETJ activities and therefore competency and activation (p. 6003-6004). As such Liu et al. teaches the required steps of the claims.
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.
Claim(s) 1,8-10,12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu et al. (Clin Cancer Res 2018 Vol 24 p. 6001 cited on IDS).
With regard to claim 1, Liu et al. teaches steps of obtaining a sample of cancer cells (p. 6003 1st column). Liu et al. teaches assessing by expression analyzing TGFB and alt-ETJ activities and therefore competency and activation (p. 6003-6004). As such Liu et al. teaches the required steps of the claims.
With regard to claims 8-9, Liu et al. teaches methods of performed combined statistical analysis and therefore encompasses an integrated score that would be considered a B-alt score (p. 6004 1st and 2nd columns). As the specificaoin does not define the term “B alt score” any score that combined these gene expression levels would be encompassed.
With regard to claim 10 and 12, Liu et al. teaches use of HNSCC cancer tissue and carcinoma cells (p. 6003 1st column and 6005 1st parpaghra).
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to 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 the later invention.
Claim(s) 2-3 and 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (Clin Cancer Res 2018 Vol 24 p. 6001 cited on IDS) in view of Ji et al. (US Patent Application Publication 2020/0010468 Jan 9, 2020)
Liu et al. teaches steps of obtaining a sample of cancer cells (p. 6003 1st column). Liu et al. teaches assessing by expression analyzing TGFB and alt-ETJ activities and therefore competency and activation (p. 6003-6004). As such Liu et al. teaches the required steps of the claims.
Although Liu et al. teaches measuring expression of genes associated with TGFB and alt-EJ, Liu et al. does not teach the elected genes.
With regard to claims 2-3 Jai teaches determining expression of FAP, FN1, and POSTN in cancer samples for DNA repair analysis (para 4, 524, and 530). The wherein clausa does not particular limited the step of expression. Further, as noted above it is not clear which expression levels would be considered “low” and as such any expression analysis would be encompassed.
With regard to claims 5-6 Jai teaches determine expression of DNA2, GEN1 and POLQ in cancer samples for DNA repair analysis (para 4, 524, and 530). The wherein clausa does not particular limit the step of expression. Further, as noted above it is not clear which expression levels would be considered “high” and as such any expression analysis would be encompassed.
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to screen any known genes associated with DNA repair including the genes of Jai et al. in order to determining expression of genes associated with cancer in the method of Liu et al. The ordinary artisan would be motived to screen the finite number of genes associated so that a patient phenotype based upon expression analysis of genes can be determined in the method of Liu et al.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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 at 5712723157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682
Prosecution Insights