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 9/24/2025.
Applicant’s election of the species of cellular density and CD3 and CD8 cells in the reply filed on 11/5/2019 is acknowledged.
Claims 30-35 are pending. Claims 1-29 have been cancelled.
The following rejections for claims 30-35 are newly applied as necessitated by amendment. It is noted that Galon et al. used below was previously used in prosecution, however, was withdrawn based upon amendments to the claims (see 8/6/2020 final rejection). However, based upon amendments to the claims the reference was provided below as a 35 USC 103(a). As this reference could have been placed on the record for the previous set of claims this rejection has been made nonfinal.
This action is NONFINAL.
Withdrawn Rejections
The 35 USC 112b, 35 USC 112a and 35 USC 103 made in the previous office action are withdrawn based upon cancellation of the claims.
Newly Applied 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 30-35 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 30-35 are indefinite over the phrase “wherein the two or more biological markers comprise the density….”. This phrase I s unclear as the phrase encompasses the term “comprise” as such it is not clear if the claims are attempting additional markers beside the density list provided. Therefore the metes and bounds are unclear as it is not clear which markers are required by the method.
Newly Applied 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) 30-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Galon et al. (US Patent Application 2014/0363472 December 11, 2014 cited on previous PTO 892)
With regard to claim 30, Galon et al. measuring the density of CD8 and CD3 cells in the invasive margin of the tumor (Paragraphs 47-53). Galon et al. teaches that the human patient has solid cancer (para 5). Galon et al. teaches invitro measurement of a solid tumor sample (para 62). Although Galon et al. does not teach specifically that the percentile of distribution, Galon et al does teach calculating the mean density (para 62-64). Galon et al. teaches comparison to a reference group to determine survival prognosis (para 5 and 30-35). As the percentile is between 0% to 100% any survival prognosis would be encompassed. Galon et al. teaches percents of survival that includes means that are between 25 to 100% (table 11 and para 65-68). Although Galon et al does not teach administering treatment, Galon suggests such a step. Galon et al. suggests that the method of determining survival time can be used to determine the effectiveness of anticancer treatments (para 42). Galon suggests that with responders to treatment would be associated with good prognosis of survival and determining use of chemotherapy (para 42). Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date that a patient could be provided and administered anti-cancer treatment wherein there is an improved survival prognosis based upon the density of CD3 and CD8 cells in the invasive margin of a tumor sample as the treatment would reduce the tumor cells in patients responding to treatment.
With regard to claims 32-33, Galon et al. teaches that the solid cancer is colorectal cancer (para 58).
With regard to claims 34-35, Galon et al. teaches density at the lowest and highest of the region (para 18-22).
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu Cheng (Winston) Shen can be reached on 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