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
This Office Action is in response to the Applicant’s reply received 5/11/26. Claims 1-16 are pending and considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102 rejections are withdrawn:
Claim(s) 1-3, 5-7, and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 4;
The following 35 U.S.C § 103 (a) rejections are withdrawn:
Claim(s) 9 were rejected under 35 U.S.C. 103 as being unpatentable over Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 4 as applied to claims 1-3, 5-8, and 10-16 above, and further in view of Wang et al. (Molecular Therapy: Methods & Clinical Development, 2020).
Claim(s) 1-3, 5-8, and 10-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 4.
The following 35 U.S.C. 112 rejections are withdrawn:
Claims 12-14 were 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;
Claims 15-16 were indefinite since the preamble recites “A method for the … examination of congenital neutropenia/severe congenital neutropenia (CN/SCN) or cyclic neutropenia (CyN)”. However no steps are provided as to the target of examination, the goal of the examination, or how the results of the examination are assessed. These are fundamental questions for an assay which distinguish it from a treatment or preventative care.
The Applicant’s amendments cancelling SEQ ID No 4, correcting ‘ELENE’, and removing ‘examination’ necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Observations For this Case
It is noted that SEQ ID NOs: 1 and 4 are identical. The same is true of SEQ ID NOs: 2 and 5.
Previous Rejections
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) 1, 2, 4, 5, 6, 10, and 11 remain rejected under 35 U.S.C. 102(a)(2) as being anticipated by Izhar et al. (US 2023/0122086, WIPO filing date of June 4th, 2021).
Izhar et al. teach a composition comprising:
An single stranded DNA molecule of SEQ ID 174 with is a 100% match for Applicant’s SEQ ID NO: 3 as supported by in light of support USPTO Sequence Search for SEQ ID NO. 3 [0024-0026]; and
A OMNI-79 CRISPER Nuclease.
Nucleic acids encoding i) and ii) can be incorporated into an AAV vector for transfection to a cell [0025, 0376]. This composition comprises a pharmaceutically acceptable carrier [0272].
Table 5 teach SEQ ID NO. 147 appears to be a construct with a gRNA molecule targeting g35 packaged into an AAV with a vector encoding the OMNI-79 crisper nuclease [0402-0403]. Since these claims are to a nucleic acid molecule. The limitations “for an allele-specific edition of the ELANE gene” or “which is a repair template” are not afforded significant patentable weight since the do not further limit the structure of the composition, in particular the nucleic acid.
Therefore the invention as a whole is anticipated by the reference.
Response to Applicant Arguments
The Applicant argues that SEQ ID NO: 174 is a 443 nt genomic ELANE sequence and not a single-stranded DNA repair template and is not 315 nt in length. This argument is not entirely in scope with the claims. Parent claim 1 limits a nucleic acid molecule comprising SEQ ID NO. 3. This allows for an interpretation of larger nucleic acid molecules with additional nt. The limitation of “single-stranded DNA repair template” does not appear in claim 6. Claim 6 only limits that the nucleic acid is a repair template, but does not link it to a particular DNA editing system. Nor does it provide the structural limitations which would modify SEQ ID NO: 174 as a repair template. Considering the broadest definition of “repair template” is a “homologous piece of DNA” as supported by Redman (see text in Fig. 1), then the gRNA vector disclosed in Table 5 appears to read on this limitation.
New Rejections Necessitated by Amendment
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) 1-3, 5-7, and 10-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 1, 2, and 5.
Baram et al. teach a composition comprising [0085-0091]:
An RNA molecule comprising a single guide RNA (sgRNA) comprising one of the following SEQ ID NOs:
SEQ ID NOs: 5451, 5478, or 5492 which have a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 1; or
SEQ ID NO: 26563 which has a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 2;
SEQ ID NO: 26563, 26588, or 26602 which have a 100% match to the claimed SEQ ID NO: 5 as supported by the USPTO Sequence search for SEQ ID No. 5; or
and
A CRISPR nuclease or sequence encoding a CRISPR nuclease.
The CRISPR nuclease includes CAS9 [0314]. The composition comprises a pharmaceutical acceptable carrier [0021]. The composition can be delivered as viral vector [0339].
Baram et al. teach that the composition is provided as a kit to administer as a treatment or prophylaxis to a living subject with severe congenital neutropenia (SCN) or cyclic neutropenia (CyN) by editing the mutant ELANE allele [0077-0079, 203-205]. Baram et al. teach this composition is configured to edit the ELANE in HSPC cells [0309].
Therefore the invention as a whole is anticipated by the reference.
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.
Claim(s) 1-3, 5-8, and 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 1, 2, and 5.
Baram et al. teach a composition comprising [0085-0091]:
An RNA molecule comprising a single guide RNA (sgRNA) comprising one of the following SEQ ID NOs:
SEQ ID NOs: 5451, 5478, or 5492 which have a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 1; or
SEQ ID NO: 26563 which has a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 2;
SEQ ID NO: 26563, 26588, or 26602 which have a 100% match to the claimed SEQ ID NO: 5 as supported by the USPTO Sequence search for SEQ ID No. 5; or
and
A CRISPR nuclease or sequence encoding a CRISPR nuclease.
The CRISPR nuclease includes CAS9 [0314]. The composition comprises a pharmaceutical acceptable carrier [0021].
Baram et al. teach that the composition is provided as a kit to administer as a treatment or prophylaxis to a living subject with severe congenital neutropenia (SCN) or cyclic neutropenia (CyN) by editing the mutant ELANE allele [0077-0079, 203-205]. Baram et al. teach this composition is configured to edit the ELANE in HSPC cells [0309].
Baram et al. does not expressly teach using SaCas9, however this is one of options of CAS nucleases listed suitable for their invention [0314], therefore it would be obvious for one of ordinary skill in the art to use this specific nuclease with the teachings of Baram et al.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Baram et al. (US 2021/0130804, published May 6th, 2021) in light of support USPTO Sequence Search for SEQ ID NO. 1, 2, and 5 as applied to claims 1-3, 5-8, and 10-16 above, and further in view of Wang et al. (Molecular Therapy: Methods & Clinical Development, 2020).
Baram et al. teach a vector comprising [0085-0091, 0339, Table 3]:
An RNA molecule comprising a single guide RNA (sgRNA) comprising one of the following SEQ ID NOs:
SEQ ID NOs: 5451, 5478, or 5492 which have a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 1; or
SEQ ID NO: 26563 which has a 100% match to the claimed SEQ ID NO: 1 as supported by the USPTO Sequence search for SEQ ID No. 2;
SEQ ID NO: 26563, 26588, or 26602 which have a 100% match to the claimed SEQ ID NO: 5 as supported by the USPTO Sequence search for SEQ ID No. 5; or
and
A CRISPR nuclease or sequence encoding a CRISPR nuclease.
However Baram et al. only teaches T7 promoter and not CAG promoter. However this would be obvious in view of Wang et al. who teach CRISPR/Cas gene editing systems may also use a CAG promotor (Wang, pg. 391, col 2 and Fig. 1A). Therefore it would be obvious to substitute the T7 promotor of Baram et al. with a CAG promoter since Wang et al. teach this is also a suitable promoter for CRISPR/Cas systems (MPEP 2144.06 II).
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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