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 .
Election/Restrictions
Applicant’s election without traverse of Group IV and certain species in the reply filed on 6/4/2026 is acknowledged.
Claims 1, 9, 21, 26, 27, 29, 32-34, 42, 46, 47, 51, 52, 54, 55 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6/4/2026.
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) 32, 37-39, 45 is/are rejected under 35 U.S.C. 102(a)(1)as being anticipated by Del Campo et al (US 2011/0262406).
Del Campo et al disclose cells, and methods of making such, comprising a target sequence altered with oligonucleotides comprising more than one mismatch. See Fig. 4 and ¶’s [0015] – [0029]. ). The deletion of 32-residue portion (i.e. 32) of CCR5 is taught by del Campo et al in Fig. 2 and ¶’s [0025], [0113]-[0116] and [0130]. The cells may be stem cells from human HIV patients (¶[0124]) which may be hematopoietic stem cells that express CD34 (¶[0125], [0028]). The change may be in one allele (¶[0096]).
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 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.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 35-39, 45, is/are rejected under 35 U.S.C. 103 as being unpatentable over Del Campo et al (US 2011/0262406) in view of Landau et al (US 6,057,102, of record).
The teachings of del Campo et al are as above and applied as before. Del Campo et al do not teach the specific SEQ ID NO: 4.
Landau et al teaches the 32 mutation in human CCR5 has the sequence of instant SEQ ID NO: 4 (SEQ ID NO: 1 of Landau et al, col. 6, lines 55-57).
The claimed methods are essentially disclosed by del Campo et al with the exception of the SEQ ID NO: 4 limitation. The ordinary skilled artisan, seeking a method to prepare 32 CCR5 cells, would have been motivated to use the sequence of Landau et al with the methods of del Campo et al because Landau et al teaches SEQ ID NO: 1 to be the sequence deleted in human CCR5 that provides inhibition of viral replication. It would have been obvious for the skilled artisan to do this because of the known benefit of generating 32 CCR5 human cells for therapy as taught by del Campo et al. Given the teachings of the cited references and the level of skill of the ordinary skilled artisan at the time of applicants’ invention, it must be considered, absent evidence to the contrary, that the ordinary skilled artisan would have had a reasonable expectation of success in practicing the claimed invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Burkhart whose telephone number is (571)272-2915. The examiner can normally be reached M-F 8-5.
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/MICHAEL D BURKHART/Primary Examiner, Art Unit 1638
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