DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 28, 2026 has been entered.
Claims 3, 4, 10, 14-19 and 25-30 have been canceled.
Claims 35-44 have been added.
Claims 1, 6, and 7 have been amended.
Claims 1, 2, 5-9, 11-13, 20-24, and 31-44 are pending in the instant application.
Claims 13, 20-24, and 39 are withdrawn from consideration as being drawn to a nonelected inventions. See 37 CFR 1.142(b) and MPEP § 821.03, for reasons of record set forth in the restriction requirement mailed June 4, 2025.
Claims 1, 2, 5-9, 11, 12, 31-38, and 40-44 are under examination in this office action.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed. More specifically, the title does not discuss fusion proteins, broadly neutralizing anti-HIV Env antibodies, soluble CD4 domains, or even HIV itself. Submission of a new title more commensurate in scope with that which is actually claimed in the instant application is suggested.
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 (i.e., changing from AIA to pre-AIA ) 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The rejection of claims 1-7, 12, 25, and 28-32 under 35 U.S.C. 103 as being unpatentable over WO 2018/075564 in view of Chen et al. has been withdrawn in view of applicant’s claim amendments received January 28, 2026 which add additional limitations.
The rejection of claims 33 and 34 under 35 U.S.C. 103 as being unpatentable over WO 2018/075564 in view of Chen et al. as applied to claims 1-7, 12, 25, and 28-32 above, and further in view of WO 2015/048770 has been withdrawn in view of applicant’s claim amendments received January 28, 2026 which add additional limitations.
Claim Objections
The objections to claims 10 and 11 for being dependent upon a rejected independent claim but otherwise allowable has been rendered moot by the cancelation of said claims as part of the January 28, 2026 response.
Claims 1, 2, 5-9, 11, 12, 31-38, and 40-44 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(b), claims 13 and 39, directed to the process of making or using the allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104. Claims 20-24, directed to the invention(s) of a different product do not require all the limitations of an allowable product claim, and have NOT been rejoined.
Because a claimed invention previously withdrawn from consideration under 37 CFR 1.142 has been rejoined, the restriction requirement between groups I and II as set forth in the Office action mailed on June 4, 2025 is hereby withdrawn. Note that the inventions of groups III and IV as set forth in said restriction requirement have not been rejoined. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 13 and 39 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Applicant has claimed methods of treating and preventing HIV infection by administering a fusion construct combining a broadly neutralizing anti-HIV antibody based upon the prior art PGT128 clone (the CDRs of SEQ ID NOs:22-27 as well as the VH of SEQ ID NO:58 and the VL of SEQ ID NO:59 are those of PGT128 as is readily evidenced by the sequence table beginning on page 86 of the instant specification) with the soluble domain of CD4. In vitro data demonstrating anti-viral efficacy is disclosed (see particularly working examples 5, 8, and 9) no in vivo data in either a human or animal model is provided. It should be pointed out that the concept of combining soluble CD4 with broadly neutralizing antibodies that bind HIV Env as part of a fusion protein, and the use of such fusion proteins to treat HIV was known in the art as evidenced by Chen 2010 et al. and Chen 2014 et al. (both of record, see entire documents) however the genus of fusion molecules encompassed by the instant claims is reasonably narrow and appears non-obvious as presently claimed.
The instant specification sets forth a multitude of definitions on pages 4-12, yet no definitions for “treatment” or “prevention” appear to be disclosed. Given that the terms are recited as alternatives in claims 13 and 39, it reasonable to assume that the two terms are not synonymous. HIV is a viral infection, and as such it is reasonable that the patient populations intended by applicant encompass those already infected with HIV (which usually would be considered treatment) as well as those not yet infected but at risk of becoming infected (typically referred to a prophylaxis). Thus while “treatment” in the indicated claims reasonably indicates administration to a person already infected with HIV, the term “prevention” is more complicated. Specifically, does it denote efficacy, in that while “treat” indicates a measurable level of clinical efficacy, “prevent” means complete efficacy (i.e. 100%)? Alternatively the term “prevent” could relate to timing of administration, as you cannot stop something from happening (i.e. prevent) if it has already occurred (such as say HIV infection), or it could be some combination of timing and efficacy. As discussed above, there is no in vivo data disclosed to support applicant’s claims, but studies with other anti-HIV agents including broadly neutralizing antibodies indicate that while reagents can offer some clinical efficacy, especially for a short duration, such reagents often are not effective long term due to escape mutants and other means of resistance (Mahomed et al., 2025, see entire document particularly the abstract). Thus artisans would not readily accept that the instant administered reagents can “prevent” HIV infection even if they have clinical benefit when administered to patients who are at risk of contracting HIV but who are not presently infected. As such it does not seem reasonable that artisans would be able to practice the full extent of the instant claimed methods in the absence of additional unpredictable basic science research and experimentation.
Claims 1, 2, 5-9, 11, 12, 31-38, and 40-44 are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641