DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Applicant should note that the examiner assigned to this case has changed.
Election/Restrictions
Applicant’s election without traverse of claims 99-116 and subsequent species election in the reply filed on 5/01/2026 is acknowledged.
Claims 117 and 118 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/01/2026.
Claims 99-116 are under consideration on the merits.
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 99-116 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.
The term “balanced” in claim 1 is a relative term which renders the claim indefinite. The term “balanced” 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. Particularly, it is unclear what elements in the claim must be “balanced” relative to each other or if “balanced” is a statement of intended use/outcome (see M.P.E.P. § 2111.02 and 2111.04). Clarification and/or correction is required.
The term “about” in claim 115 is a relative term which renders the claim indefinite. The term “about” 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. Correction is required.
In so much that claims 100-116 depend from claim 99 and do not resolve the point of confusion, these claims must be rejected with claim 99 as indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 99-103 and 105-115 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yu et al. (Nature Biotechnology (2016), 34(4), 419-423 and appended Online Methods and Supplemental Information; Reference U).
Yu teaches a balanced cell count culture composition, the composition comprising four lentivirus barcoded human lung adenocarcinoma tumor cell lines seeded at 1000 cells each and a fifth adenocarcinoma tumor cell line seeded at 0-1000 cells and cultured for a day (Fig. 2a and the paragraph spanning pages 419-420; see the 1st page of the Online Methods, subheading “Barcoding of tumor cell lines” for the tumor cell lines being human), anticipating the embodiment of equal cell numbers for the balanced composition of claim 99, the embodiment of culturing for one day to meet the functional limitations of claim 100, claims 101-103, the embodiments of equal cell numbers for claim 105, the embodiment of different adenocarcinoma cell lines for claim 106, claim 108, the embodiment of cells from cell lines for claim 110, the embodiments of an in-vitro model system and ex-vivo model system for claim 114, and the embodiment of 5,000 cells for claim 115. Yu teaches a combination of pooled 25 lung adenocarcinoma cell lines harboring EGFR mutations or EML4-ALk translocations (page 420, left column, the paragraph starting “We next treated a pool of …” and Fig. 1. Fig. 2b, and Supplemental Fig. 1), anticipating claims 107 and 109. Yu teaches further injecting 2.4 x 107 cells a pool of 24 of the lung adenocarcinoma cell lines (i.e. 1 x 106 cells from each of the 24 cell lines) subcutaneously into ten NSG (i.e. NOD-SCID-IL2Rgammanull) mice to generate one or more xenograft models (Fig. 2d, Supplemental Fig. 4-5, and the paragraph spanning pages 420-421; the 1st page of the Online Methods, subheading “In vivo PRISM” for the cell dosage), anticipating claims 111, 112, the elected embodiment of lung cancer for claim 113, and the embodiment of an in-vivo model system for claim 114.
Claims 99-110 and 114-116 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McFarland et al. (Nature Communications (Aug. 27th, 2020), 11(4296), 14 pages and appended Supplemental Information; Reference V).
McFarland teaches a balanced cell count culture composition, the composition comprising 25, 50, or 100 pooled cancer cell lines wherein each cell line is screened for viability and cultured at 200,000 cells per well in a 6-well plate for 16-20 hours prior to subsequent drug treatment (page 11, subheadings “Method of cell line pooling” and “Cell culture”; Fig. 1b), anticipating the embodiment of equal cell numbers for the balanced composition of claim 99, the embodiment of culturing for 16-20 hours to meet the functional limitations of claim 100, claims 101 and 102, the embodiments of equal cell numbers and at least 1,000 viable cells for claim 105, the embodiment of different cancer cell lines for claim 106, claim 108, the embodiment of cells from cell lines for claim 110, the embodiments of an in-vitro model system and ex-vivo model system for claim 114, the embodiment of 200,000 cells for claim 115, and at least 500 viable cells of each cell type for claim 116. In a separate embodiment, McFarland teaches the pooled cancer cell lines further comprising GPX4 knockout and then harvesting the cells 72 or 96 hours after infection (page 11, subheading “Cell culture”), anticipating claim 104. McFarland teaches the pooled cancer cells comprise activating BRAF and KRAS mutations (Fig. 3e, Supplemental Fig. 12, and the paragraph spanning pages 5-6), anticipating claim 107.
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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 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 104 is rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Yu et al. (Nature Biotechnology (2016), 34(4), 419-423 and appended Online Methods and Supplemental Information; Reference U).
The teachings of Yu are relied upon as set forth above in rejecting claims 99 and 101 as anticipated under 35 U.S.C. § 102.
Regarding claim 104, Yu does not teach a single embodiment wherein the (culture) time period is from 72 hours to 45 days. Yu further teaches screening the pooled and barcoded adenocarcinoma cells with known and putative anti-cancer agents for 5 days followed by isolation of genomic DNA from cell lysates to generate PRISM profiles ((Fig. 3, and 1st page of the Online Methods subheading “PRISM compound assays”), anticipating or reading on claim 104.
Claim 104 is a product-by-process claims. See M.P.E.P. § 2113; product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps. Furthermore, alternate grounds of rejection under both 102 and 103 is permissible given the lack of physical description of product-by-process claims and the inability of the USPTO to manufacture and compare products. See M.P.E.P. § 2113 (III). Once a product appearing to be substantially identical is found and an art rejection made, the burden shifts to the applicant to show an unobvious difference. In this case, Yu teaches a substantially identical balanced cell count composition, and only differs with respect to claim 104 towards the method step of culture time. The burden is shifted to Applicant to show that the manufacturing process steps of the product-by-process claims impart any novel and/or non-obvious structural characteristics to the claimed product as compared to the composition taught by Yu Particularly, if the product-by process limitations of claim 104 impart no structural difference then the claim is anticipated. If the product-by process limitations of claim 13 imparts a structural difference, then Applicant must clearly set forth why any structural difference between the claimed composition and the composition of [DDD] is non-obvious as Yu provides both a reasonable expectation of success and motivation to otherwise lengthen the culture in the additional embodiment directed towards screening the pooled and barcoded adenocarcinoma cells with known and putative anti-cancer agents.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the invention was filed.
Conclusion
No claims are allowed. No claims are free of the art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN C BARRON whose telephone number is (571)270-5111. The examiner can normally be reached 7:30am-3:30pm EDT/EST (M-F).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau can be reached at 571-272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Sean C. Barron/Primary Examiner, Art Unit 1653
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