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 .
DETAILED ACTION
Responsive to claim set of 12/29/2023
Claims pending 1,2,4-8,11,78,122-129
Claims currently under consideration 1,2,4-8,11,78,122-129
Priority
This application has a filing date of 04/27/2023 and is a 371 of
PCT/US21/57229 (aka WO/2022/094197) filed 10/29/2021
PCT/US21/57229 has
PRO 63/107,737 filed 10/30/2020
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.
(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.
Claim(s) 1,2,4-8 are rejected under 35 U.S.C. 102(a)(1 & 2) as being anticipated by Lee et al (WO 2017/037543 aka PCT/IB2016/001427) as evidenced by Lee et al (2018 Nature Communications 9, Article number: 2546 – IDS entry 4/27/2023; referred to hereafter as Lee Nature)
Lee et al teach throughout the document and especially the abstract, figures 1-2,5; pp 2-6 and example 11, ISLE (identification of clinically relevant synthetic lethality) and INCISOR (IdeNtification of ClinIcal Synthetic Rescues) techniques applied toward choosing synergistic therapeutic combinations for treating cancer. More particularly, in the passages, Lee et al::
A accesses a database storing information associated with genetic interactions to obtain a plurality of candidate synthetic lethality (SL) or synthetic rescue (SR) gene partners for a cancer therapy; B identifies, based on experimental functional screens, reference patients' omics survival data and phylogenetic profile information of each of the plurality of candidate SL or SR gene partners, a subset thereof candidate partners as predictive biomarkers for the cancer therapy, such as by obtaining molecular profiles comprising gene expression levels from somatic copy number alterations (SCNAs), phylogenetically ranking such candidate subset and filtering members based on an identification of candidate SR gene partners in which a downregulation (or upregulation) of a partner rescuer gene occurs, the ranked subset of the plurality of candidate SR gene partners, to provide well in excess of 10 filtered candidate SR gene partners; C compares the subset to a cancer inhibiting drug dataset to filter said subset; D identifies (selects), based on a transcriptomics profile (e.g. proliferation) of a tumor of a patient and the filtered subset, a cancer therapy for a patient; and/or assigns a score to each of the plurality of candidate SL or SR gene partners based on patient response data to each of the plurality of candidate SL or SR gene partners, then filters, based on the assigned scores, the plurality of candidate SL or SR gene partners to identify a subset the plurality of candidate SL or SR gene partners; and/or ranks, based on the assigned scores, the plurality of candidate SL or SR gene partners, wherein the subset of the plurality of candidate SL gene partners comprises a subset of the plurality of candidate SL gene partners with the highest assigned scores. The foregoing reads on claims 1,2,4,5,6*,7 and 8.
* While Lee et al do not explicitly teach 25 candidate SL gene partners as in claim 6, evidence provided by Lee Nature in the ISLE-based drug rescue prediction section at p 8 of the article shows ISLE generates well in excess of 25 such candidates
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 11,78,122-129 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 pre-AIA the applicant regards as the invention.
Each of claims 11 and 78 recite the limitation "the total number of SL partner genes" and “the total number of SR partner genes each in part d. There is insufficient antecedent basis for this limitation in the claim, rendering the metes and bounds uncertain.
Claims 122 and 126 are each is deemed incomplete in so far as they refer to anti-cancer therapies from Table 1, whereas in accordance with MPEP 2173.05(s), the courts have held where possible, claims are to be complete in themselves. Incorporation by reference to a specific table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). Here, it is not necessary to refer to Table 1 since it is not impractical to define the therapies in the claims themselves.
In accordance with MPEP 2173.02: If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112, second paragraph, would be appropriate. See Morton Int ’l, Inc. v. Cardinal Chem. Co., 5 F.3d 1464, 1470, 28 USPQ2d 1190, 1195 (Fed. Cir. 1993).
In so far as the metes and bounds of the offending claim(s) may not be interpreted properly for the reasons above, all such dependent claims therefrom claims 11 and 78 are rejected as being indefinite as well.
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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER M GROSS whose telephone number is (571)272-4446. The examiner can normally be reached M-F 10-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Heather Calamita can be reached on (571)272-2876. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHRISTOPHER M GROSS/Primary Examiner, Art Unit 1684