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 .
This action is in response to papers filed 3/06/2026.
Applicant’s election of species BMP2_RS1979855 in the reply filed on 8/22/2025 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 4,6-8,10,13-14,16,19-24 are pending. Claims 1-3,9,11-12,15,17-18,25-117 are cancelled.
Claims 4,6-8,16,19-24 are withdrawn as being drawn to a nonelected species.
The following rejections are maintained with response to arguments following.
This action is FINAL.
Withdrawn Rejections
The 35 USC 112b made in the previous office action is withdrawn based upon amendments to the claims.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) 1-2 is/are rejected under 35 U.S.C. 102(a) as being anticipated by Yang et al. (Oncotarget 2017 Vol 8 p. 43080-43090 cited on IDS).
With regard to Claim 10, Yang et al. teaches a method of administering treatment in patients with and without RS1979855(Tables 3-5). Yang et al. teaches use of high radiation which would include hypofractionated (p. 43087 1st column last full paragraph).
With regard to claim 2, Yang et al. teaches giving 2 Gy fraction does and therefore at about 8 fractions the dose administered would be about 20 Gy (16) (p. 43087 1s column last full paragraph).
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments. The reply asserts that Yang does not teach hypofractionated radiation (p. 2). The reply asserts that Yang does not teach an association of rs1979855 with radiation pneumonitis and therefore does not teach the claim method (p. 2). These arguments have been reviewed but have not been found persuasive. It is noted that the claims as amended do not require any correlation to hypofractionated radiation. Rather, the claims only require that a patient who is not carrying or carrying only one copy of a G nucleic at position 101 of SEQ ID No. 53 is treated with the radiation treatment. As such the claims are not limited to any particular treatment effect. Furthermore although Yang et al. does not state “hypofractionated radiation” this term is considered any radiation that has increased dosage. As Yang et al teaches high radiation can be used, the teaching of Yang et al. teaches the required steps of the claims.
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) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (Oncotarget 2017 Vol 8 p. 43080-43090 cited on IDS) in view of Yang (Radiation Oncology November 2015 Vol 93 E440-E441, Referred to as Yang2015).
Yang et al. teaches a method of administering treatment in patients with and without RS1979855(Tables 3-5). Yang et al. teaches use of high radiation which would include hypofractionated (p. 43087 1st column last full paragraph).
Yang et al. does not teach that the radiation is stereotactic body radiation therapy.
With regard to claim 14, Yang2015 teaches screening samples with rs1979855 in patients with proton beam radiation therapy (results). Proton beam is a type of SBRT radiation.
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the method of Yang et al. to further screen known radiation therapies and patient with known mutations associated with NSCLC such as the proton beam radiation therapy as taught by Yang2015. The ordinary artisan would be motivated to such administration as Yang2015 suggests such patients with rs1979855 can be treated with protein beam radiation therapy.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments The reply asserts that Yang2015 does not cure the issues with Yang et al. (p. 3). This argument has not been found persuasive based upon the response to arguments above.
Conclusion
No claims are allowed.
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 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.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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