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 communications entered 9MAR2026
Claims Pending 2-6,8-17,19,27,31-39
Claims Under Consideration 2-6,8-17,19,27,31-39
Priority
This application has a filing date of 02/28/2023 and is a 371 of
PCT/US21/48741 09/01/2021
PCT/US21/48741 has PRO 63/111,238 11/09/2020
PCT/US21/48741 has PRO 63/073,365 09/01/2020
Withdrawn Objection(s) and/or Rejection(s)
The rejection of claims 3,4,6,9,11,13-16 under 35 U.S.C. 102(a)(2) as being anticipated by Kenny et al (US AppPub 20210128642 – IDS entry 10/10/2024) is hereby withdrawn in view of Applicant’s amendments
The rejection of claims 3,4,6,9,11,13-16,19 and 5,8,17 under 35 U.S.C. 103 as being unpatentable over Kenny et al (US AppPub 20210128642 – IDS entry 10/10/2024) in view of Blainey et al (US AppPub 20200392479 – IDS entry 10/10/2024) is hereby withdrawn in view of Applicant’s amendments.
The rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over Kenny et al (US AppPub 20210128642 – IDS entry 10/10/2024) in view of Blainey et al (US AppPub 20200392479 – IDS entry 10/10/2024) is hereby withdrawn as cumulative.
The rejection of claims 2,10,12,18,29 under the second paragraph of 35USC112 is hereby withdrawn in view of Applicant’s amendments.
The rejection of claims 3-6,9-17 on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1,3-6,7-17 of U.S. Patent No. 12241062 (IDS entry 4/4/2025) in view of Tagliatela et al (US AppPub 20200397917) is hereby withdrawn in view of Applicant’s amendments.
Maintained & Updated 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)(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.
Claims 19 and 37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kenny et al (US AppPub 20210128642 – IDS entry 10/10/2024; of record).
Kenny et al teach throughout the document and especially paragraphs 0085-0095,0101,0149-0163,0185-0214,0234, particularly 0213 plus paragraphs 0172,0174 (a) infecting or transfecting mammalian cells with replication competent vectors such as human AAV2 harboring barcodes to generate cell libraries, thus, (a) make cells including: (1) a nucleic acid sequence comprising a barcode (e.g. a unique molecular identifiers, UMIs) positioned between two functional AAV2 ITR sequences, wherein the nucleic acid sequence is integrated into such mammalian genome positioned between a pair of cis-acting integration sequences, that is at an integration locus inherently having transposase recognition sites (since transposons such as Tn5 are not sequence specific, as they recognize any DNA sequence), (2) gRNAs that induce perturbations via Cas-9, (3) a marker gene and (4) polynucleotide sequences encoding AAV2 capsid; and then (b) with (1) fused to (2)-(4) detect insertion(s) of such UMIs therein the cells. The foregoing reads on claim 19 and 37.
***
Please note that the above rejection has been updated from the original version to more clearly address applicants’ newly amended and/or added claims.
Response to Arguments
The remarks accompanying the present response argue not all elements are taught.
Applicant’s arguments have been fully considered but they are not deemed persuasive for the following reasons.
More particularly, the third paragraph at page 12 of the current remarks contends Kenny does not teach a barcode in-between two functional AAV ITRs that are, in turn, situated between cis-acting integration sequences like claim 19 (and child patent 12410062)
In this vein, the following is noted. First, claim 2 (now indicated as allowable) and ‘062 are both directed to methods with a detecting step that is given more patentable weight than the composition subject matter of claims 19 & 37, directed to cells. Such detection constitutes intended use of the claimed cells, whereas the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Second, as mentioned in the previous action and reiterated again in the rejection above, under the circumstance that recited cis-acting sequences are transposase recognition sites (as explicitly set forth in dependent claim 37), a transposon like Tn5 has no sequence specificity, thus cis-acting sequences represent any DNA segment. Third, concerning functional AAV ITRs, Kenny et al teaches replication competent vectors. Thus, in summary and in contrast with Applicant’s argument, Kenny et al indeed teaches a mammalian cell population with unique molecular identifier barcodes, two functional AAV ITRs and cis-acting sequences as claimed.
New 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.
Claim 27 and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Recchia et al (2004 Molecular Therapy 10:660-70)
Like claim 27, Recchia et al teach throughout the document and especially pp 661-2 including figure 1, vectors such as AR1-CMVRepTS with expression cassettes that have a pair of cis-acting integration sequences*, wherein the pair of cis-acting integration sequences is flanked by a sequence including: (i) a barcode (e.g. SV40 promoter and/or deltaLNGFR) positioned between two functional adeno-associated viral (AAV) ITR sequences - in so far as any nucleotide sequence can serve as a barcode; (ii) a GFP selection marker, and (iii) one or more library variants, wherein the at least one library variant comprises at least one engineered sequence that comprises at least one gene, at least one ORF, at least one or at least one non-coding nucleic acid, or a combination and/or a plurality
thereof (e.g. AR1-TKRepTS, etc.).
* the cis-acting integration sequences are adenovirus ITRs, however once again since transposons such as Tn5 are not sequence specific, that is they recognize any DNA segment, they also read on claim 38
Maintained & Updated Double Patenting Rejections
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory obviousness-type double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 19,27,37 and 38 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1,3-6,7-18 at least of U.S. Patent No. 12241062 (IDS entry 4/4/2025) in view of Tagliatela et al (US AppPub 20200397917; of record).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the method of transfecting and perturbing mammalian cells with barcoded AAV vectors in said ‘062 claims produces the very cells set forth in present claims 19 and 37 (e.g. when drawn to viral repeat sequences derived from lentivirus) and utilizes the very DNA set forth in claim 27 and 38.
Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify embodiments of ‘062 that fall outside the scope of the present application to select a specifically disclosed embodiment that falls within the scope of the present application because each set of claims concern cells and compositions with similar physiochemical properties and accordingly biological activity. And, one of ordinary skill in the art would have been motivated to make such a modification because such modifications are disclosed as “preferred” since the dependent claims of ‘062 “teach toward” Applicant’s presently claimed subject matter, especially in view of Tagliatela et al, who teach transfecting mammalian cells with recombinant AAV and/or lentiviruses for the benefit of producing vehicles for gene therapy as well as AAVs with selection markers (cf paragraphs 0003, 0245-0294,0069).
New 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 31-34,39 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.
Claim 31 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential structural cooperative relationships of elements, such omission amounting to a gap between the necessary structural connections or alternatively, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted structural cooperative relationships or omitted steps which render the metes and bounds uncertain are as follows.
Claim 31 is drawn to a method comprising a (single) step of... yet the body of the claims includes two steps (a) providing... and (b) detecting... Whether the claim encompasses all processes with either one of steps (a) or (b) or rather processes with both (a) and (b) is not clear.
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 dependent claims therefrom claim 31 are rejected as being indefinite as well.
Allowable Subject Matter
Claims 2-6,8-17,35,36 are allowed.
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.
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 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
16JUN2026
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