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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/28/2026 has been entered.
Response to Amendment
Regarding the Office action mailed 10/14/2025:
The rejections under 35 USC 112(b) are withdrawn in view of the amendments to the claims.
The rejection of claims 1, 3-9, 16 and 17 under 35 USC 102(a)(1) over Chen is withdrawn in view of the amendment, and moot with respect to claim 12 which was cancelled. The rejection is maintained for claims 20, 21, and 23-25.
The rejection of claim 41 under 35 USC 103 over Chen in view of Hew is maintained.
These rejections are reiterated below. Applicant’s arguments will be addressed following the rejections.
Claim Objections
Claim 1 is objected to because of the following informalities: in part (e), line 3, the language “target polynucleotide in from a donor polynucleotide” should be corrected to “target polynucleotide in
Claim 4 is objected to because of the following informalities: in line 2, the language “or Cas protein thereof nuclease” should be corrected to “or Cas protein thereof
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(s) 20, 21 and 23-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen (The CRISPR journal. 2019 Dec 1;2(6):376-94, previously cited).
Regarding claims 20, 21, 23 and 24, Chen disclosed a vector (and a cell/cell population containing such vector) encoding Himar-dCas9; see, e.g., page 379, last paragraph: “Himar-dCas9…expressed in MG1655 E. coli from tet-inducible expression vector[] pHdCas9…”. See also Table 1 details for pHdCas9: “Himar-dCas9 on tet-inducible promoter”. Note that an E. coli cell also qualifies as “an organism”.
Regarding claim 25, Chen disclosed a lipofection reagent for transfecting mammalian cells comprising Lipofectamine 2000 and pHdCase9-mammalian expression plasmid (page 385, first column, last paragraph). Lipofectamine 2000 falls within the broadest reasonable definition of a “pharmaceutically acceptable carrier”.
Note that claim 20 requires a vector “encoding any one or more of components (a)-(h) of claim 1”. Chen’s vector encodes Himar-dCas9, which constitutes component (c), or alternatively component (d), of claim 1. In addition, the disclosure of Chen meets alternative (a) of claim 21. Note that claim 23 requires a cell comprising a “vector system comprising one or more polynucleotides encoding one or more components” of the system of claim 1. For the reasons mentioned above, Chen meets this requirement. By the same token, Chen meets claim 24, which only requires an organism comprising a “vector system comprising one or more polynucleotides encoding one or more components” of the system of claim 1. Likewise, claim 25 only requires a pharmaceutical formulation comprising a “vector system comprising one or more polynucleotides encoding one or more components” of the system of claim 1.
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(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chen (The CRISPR journal. 2019 Dec 1;2(6):376-94, previously cited) in view of Hew (Synthetic Biology 2019, 4(1): ysz018, public availability date 2 July 2019; IDS reference).
The disclosure of Chen has been discussed. Chen did not disclose or suggest use of such system as a therapy or treatment, and so did not suggest administering the system to “a subject in need thereof”.
In the same field of endeavor, Hew disclosed a similar system, except that dCas9 was fused to the piggyBac transposase; see Figure 1. Hew specifically suggested such an approach for therapies. See abstract: “Safer and more efficient methods for directing therapeutic genes to specific sequences could increase the repertoire of treatable conditions…These vectors expand the utility of the piggyBac system for applications in targeted gene addition for biomedical research and gene therapy.” See also page 10, sentence spanning two columns: “A strictly site-specific, RNA-guided transposase would have important applications including transgenic animal generation, modification of cell lines for research and diagnostics or delivery of therapeutic cargo to a designated location in the genome.”
It would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the application to adapt Chen’s system to deliver a therapeutic target nucleic acid, and administer it to “a subject in need thereof”, since Hew suggested this use for gRNA-mediated transposition.
Note that claim 41 only requires administering a “vector system comprising one or more polynucleotides encoding one or more components” of the system of claim 1.
Response to Arguments
Applicant's arguments filed 01/28/2026 have been fully considered but they are not persuasive. As noted in the rejection above, the claims for which the rejections are maintained do not require all of the components of the system of claim 1.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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, GARY BENZION can be reached at 571-272-0782. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
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