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 II, corresponding to claims 2-3 and 11-13, in the reply filed on 03/17/2026 is acknowledged.
Claims 1, 4-9, and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/17/2026.
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 2-3 and 11-13 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.
Clam 2 requires, inter alia, a myeloid-specific promoter “comprising at least 90% of a nucleic acid sequence as shown in SEQ ID NO: 1 or SEQ ID NO: 2.” It is unclear if the claim requires a sequence having at least 90% identity to SEQ ID NO: 1 or SEQ ID NO: 2, or at least 90% of the nucleic acids of SEQ ID NO: 1 or SEQ ID NO: 2, e.g., the first 700 nucleic acids of SEQ ID NO: 1. It is also unclear if “a nucleic acid” means the entire length of SEQ ID NO: 1 or SEQ ID NO: 2, at least the entire length of SEQ ID NO: 1 or SEQ ID NO: 2, or subsequences thereof. It is unclear if “as shown in” requires SEQ ID NO: 1 or SEQ ID NO: 2, or if those sequences serve as examples, consensus sequences, etc.
Regarding claim 13, it is unclear if the recitation of “the CYBB gene comprises a nucleic acid sequence as shown in SEQ ID NO: 3” requires at least SEQ ID NO: 3 or just a subsequence of SEQ ID NO: 3. It is unclear if “as shown in” requires SEQ ID NO: 3, or if that sequence serves as an example, consensus sequence, etc.
The dependent claims do not add additional clarity and, therefore, are also indefinite.
For purposes of compact prosecution and applying prior art, claim 2 was interpreted herein to require a myeloid-specific promoter comprising a nucleic acid sequence that is least 90% identical to the nucleic acid sequence of SEQ ID NO: 1 or SEQ ID NO: 2. Claim 13 was interpreted herein to require a CYBB gene comprising the nucleic acid sequence of SEQ ID NO: 3.
It is noted any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejections and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC §§ 102/103
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.
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.
Claims 2-3 and 11 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Siler et al. (US 2022/0409667, hereinafter “Siler”).
Siler discloses a recombinant expression vector, i.e., a lentiviral expression vector, comprising the myeloid-specific promoter miR223 (SEQ ID NO: 1), which has 100% sequence identity to instant SEQ ID NO: 1 (see alignment below), and a CYBB gene encoding a functional gp91phox protein, wherein miR223 initiates expression of CYBB (Abstract; ¶¶ 0002, 0015, 0019). Siler discloses that the vector is useful for the treatment of chronic granulomatous disease (CGD) (Abstract; ¶ 0001).
As such, Siler discloses each and every element of the claimed invention.
In the alternative, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ product they exemplify. As such, the claimed product is within the scope of Siler, and thus Siler renders the claimed product prima facie obvious. The rationale to support this conclusion of obviousness is that Siler provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
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Accordingly, Siler anticipates the claimed invention or, in the alternative, renders the claimed method prima facie obvious.
Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Siler as applied to claims 2-3 and 11 above, and further in view of CN 109971787A (IDS-FOR, published 07/05/2019, US 2022/0177919 cited herein as English equivalent, hereinafter “CN787”).
As discussed above, claims 2-3 and 11 were anticipated or, in the alternative render prima facie obvious by Siler. The reference does not explicitly teach a specific CYBB gene sequence, such as SEQ ID NO: 3, or a pTFY lentiviral vector backbone.
However, CN787 teaches a lentiviral vector for treating CGD comprising a CYBB gene (SEQ ID NO: 3) having 100% identity (see alignment below) to instant SEQ ID NO: 3, inserted into a pTYF lentiviral backbone (Abstract; ¶¶ 0001-0002; 0018-0019; 0071).
One of ordinary skill in the art would have been motivated to advantageously select a CYBB gene sequence with a known utility for treating CGD for use in the vector taught by Siler with a reasonable expectation of success. Likewise, one of ordinary skill in the art would have been free to substitute the lentiviral backbone taught by Siler for the pTYF lentiviral backbone taught by CN787 with a reasonable expectation of since both have demonstrated utility for treating CGD. See KSR rationale: (A) combining prior art elements according to known methods to yield predictable results; and (B) simple substitution of one known element for another to obtain predictable results.
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Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art at the time of filing especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS J VISONE whose telephone number is (571)270-0684. The examiner can normally be reached Monday-Thursday, 8:30 AM to 6:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Yvonne Eyler can be reached at (571) 272-1200. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
