Detailed Office 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 .
Status of the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 09 December, 2025. Claims 1, 2, 5-11, 16-19, 37, 38, 40, 52, and 54 are pending in the instant application. Claims 40 and 54 stand withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention.
35 U.S.C. § 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.
(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 previous rejection of claims 1, 2, 5-11, 37, 38, and 52 under 35 U.S.C. § 102(a)(1) and (a)(2) as being clearly anticipated by Weinberger and Notton (WO 2014/151771 A1, published 25 September, 2014; hereinafter referred to as “Weinberger and Notton (2014)”), is hereby withdrawn in response to Applicant’s amendment and arguments.
35 U.S.C. § 112(a)
The following is a quotation of 35 U.S.C. § 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Written Description
The previous rejection of claim 18 under 35 U.S.C. § 112(a), as failing to comply with the written description requirement, is hereby withdrawn in response to Applicant’s arguments.
Claim Objections
Claim 5 is objected to because of the following informalities: “h1gher” should read “higher.” Appropriate correction is required.
35 U.S.C. § 112(b)
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.
Claims 1, 2, 5-11, 16-19, 37, 38, and 52 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Claim 1 is directed toward an interfering, conditionally replicating, and conditionally mobilizing recombinant human immunodeficiency virus (HIV) construct, wherein said construct comprises a series of cis-acting elements and modifications in the genome. This recitation is confusing because the precise salient characteristics of the construct and its coding potential are not readily manifest. The preamble appears to be directed toward properties of a defective-interfering particle (DIP), as opposed to a nucleic acid construct. Amendment of the claim language to reference a proviral HIV-1 construct that encodes a defective-interfering viral particle (DIP), wherein said DIP displays conditional replication (e.g., produces transduction-competent VLPs upon rescue (complementation in trans)), interferes with HIV-1 production (e.g., as evidenced by reduced HIV titers in single-round infections), and mobilizes in the presence of replication-competent HIV (by stealing WT packaging proteins), wherein said construct contains the recited modifications set forth in the claims (e.g., cis-acting elements; alteration in Pol, Tat, Vpr, Nef, and Vif; alteration in Rev, Vpu, and Env; and a deletion of nt. 3159-4780). Applicant’s representative is invited to contact the Examiner to discuss suggested allowable claim amendments.
The claim is also confusing for referencing cis-acting elements corresponding to A3 and A7. It is not readily manifest which specific HIV-1 cis-acting elements are encompassed by the claim language. If these are referencing specific splice acceptors (SA) in the viral genome, this should be clearly stated in the claims.
The reference to HIV is also vague and indefinite. The term HIV could potentially encompass human immunodeficiency virus type 1 (HIV-1), 2 (HIV-2), or both 1 and 2. However, HIV-1 and -2 are genotypically and phenotypically distinct (Franchini and Bosch, 1989). These viruses display different pathogenicities and geographical distributions. Moreover, these viruses only display 52%, 54%, and 35% amino acid sequence identity in Gag, Pol, and Env, respectively. The specification discloses HIV-1 proviral constructs. Amendment of the claim language to recite human immunodeficiency virus type 1 (HIV-1) would be acceptable.
Claim 2 is vague and indefinite for referencing the cis-acting elements D4, A4 and A5. If these reference specific splice donors (SD) or splice acceptors (SA) in the HIV-1 viral genome, the claims should be amended appropriately.
Claim 6 references the cell-to-cell transmissibility of the construct. This would appear to actually reference a property of the DIP encoded by the proviral construct of claim 1. Amendment of the claim language to reference the DIP produced from the construct would be acceptable.
Claim 7 references the reproductive ratio of the construct in the presence of HIV-1. This also appears to actually reference a property of the DIP encoded by the proviral construct of claim 1. Amendment of the claim language to reference the reproductive ratio of the DIP produced from the construct would be acceptable.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 21 March, 2026
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