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 1/5/25. Claims 1-16 are pending and considered on the merits.
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 12-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
These claims depend from claim 1, but refer to the ELENE gene. This gene is not identified in the Specification. The ELANE gene is identified as the “elastase, neutrophil expressed gene” [0012, 0023]. However ELENE is found 5 times, but it often intermixed with ELANE in the Specification [0002, 0030, 0052] and no definition is provided. This appears to be a typo for ELANE since the they are found so close together and appear to be used interchangeably. In the interest of prosecution the claims will read ELANE and ELENE as synonyms, however clarification or correction is required.
Claims 15-6 are indefinite since the preamble recites “A method for the …examination of 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. As these claims are currently written treating and examining have the same steps, while their intended results are completely different.
Claim Interpretation
The compositions of claims 1-11 have several intended uses. These include “allele-specific editing of the ELANE gene” and “for the prophylaxis or treatment or examination of congenital neutropenia/severe congenital neutropenia (CN/SCN) or cyclic neutropenia (CyN)”. These intended use does not appear to recite any structural limitations to the claim and merely states the purpose of the invention. As such, this limitation is not afforded significant patentable weight since the body of the claim fully and intrinsically sets forth all the limitations of the invention (MPEP 2111.02 II).
Therefore since compositions are defined by their components and not by their intended use any composition that contains the ingredients listed in claims will inherently meet the intended uses.
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. 4.
Baram et al. teach a composition comprising [0085-0091]:
An RNA molecule comprising a single guide RNA (sgRNA) of SEQ ID NO: 5451 which is 100% identical to the claimed SEQ ID NO: 4 as supported by the USPTO Sequence search for SEQ ID No. 4; 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.
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.
Claim(s) 1, 2, 4, 5, 6, 10, and 11 is/are 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.
Table 1 of the Specification shows SEQ ID NO: 3 is a single stranded DNA repair template. 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].
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 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.
Baram et al. teach a composition comprising [0085-0091]:
An RNA molecule comprising a single guide RNA (sgRNA) of SEQ ID NO: 5451 which is 100% identical to the claimed SEQ ID NO: 4 as supported by the USPTO Sequence search for SEQ ID No. 4; 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. 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).
Baram et al. teach a vector comprising [0085-0091, 0339, Table 3]:
An RNA molecule comprising a single guide RNA (sgRNA) of SEQ ID NO: 5451 which is 100% identical to the claimed SEQ ID NO: 4 as supported by the USPTO Sequence search for SEQ ID No. 4; 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.
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