DETAILED ACTION
A non-final Office action was mailed 4 November 2025 (“Office Action”).
Applicant’s reply to the Office Action was received 8 December 2025 (“Reply”).
Status of the Claims
The listing of claims filed with the Reply has been examined.
Claims 3–12, 20, and 21 are pending. Claims 1, 2, and 13–19 are canceled.
Claims 3, 7, 10, and 20 are amended.
Status of Rejections and Objections
The text of those sections of Title 35, U.S. Code and/or text providing the basis for non-statutory double patenting rejections not included in this action are set forth in the Office Action.
Unless repeated herein, any objection or rejection in the Office Action is withdrawn.
Claim Objections
Claim 3 is objected to for containing grammatical error(s). The term “in an mammal” should recite “in a mammal.”
Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 102
Claims 3–12 and 21 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Ucciferri et al., Le Infezioni in Medicina (2012), 1, 49–51 (“Ucciferri”).
Ucciferri discloses a case report in which an HIV-infected human was administered lacidipine. (Ucciferri, p. 49).
Applicant previously acknowledged that claims 3–12, 20, and 21 read on the elected species. (Reply received 20 October 2025, p.1).
Response to Arguments
Applicant’s arguments submitted with the Reply have been considered but are not persuasive. First, Applicant argues lacidipine was administered to the patient in Ucciferri for the treatment of blood pressure, as opposed to being administered for the treatment of HIV. (Remarks, p.9). Second, Applicant argues the claim requires lacidipine to be administered “in a therapeutically effective amount to treat the HIV-1 infection.” (Id.). Third, Applicant argues the claim is directed to treating HIV-1, whereas Ucciferri is silent with respect to the type of HIV. Fourth, Applicant argues that claim 20 specifies “treating the acquired immune deficiency syndrome.”
Regarding the first argument, Examiner notes the claim language, “inhibiting the initiation step of the reverse transcription of RNA of a type 1 human immunodeficiency virus (HIV-1) in an [sic] mammal infected with HIV-1,” is an intended result and does not modify the active step of administering lacidipine to a subject. Courts have held that expressions of an intended result in a method claim are not given much patentable weight. MPEP § 2111.04. Thus, regardless of why the drug was administered to the subject with HIV in Ucciferri, the active step in the claim is disclosed in the reference.
Regarding the second argument, Examiner notes that neither the instant claims nor the specification defines what dosages would qualify as “a therapeutically effective amount of a compound of formula (I) to treat the HIV-1 infection.” Moreover, Applicant does not argue the 6mg dose in Ucciferri is not a therapeutically effective amount to treat an HIV-1 infection. Accordingly, the phrase fails to distinguish the claims from Ucciferri.
Regarding the third argument, Examiner notes the HIV-1 type encompasses a majority of all HIV cases worldwide, whereas the HIV-2 type is restricted to West Africa or people with ties to that area; likely due to the relatively lower transmission rate and viral load of HIV-2. See, e.g., Sharp et al., Cold Spring Harb. Perspect. Med. (2011), 1:a006841 (22 pages), p.11. Based on the disproportionate patient populations, the silence regarding the type of HIV in Ucciferri would have been reasonably understood by one of ordinary skill in the art to mean the patient was infected with HIV-1.
Regarding the fourth argument, it is noted that AIDS is the final, most severe stage of an untreated HIV infection. Thus, treating AIDS is treating a severe HIV infection. Nevertheless, the claim language is directed to a subpopulation of the HIV patient population and Ucciferri does not indicate the subject was suffering the AIDS stage of an HIV infection. For this reason, the rejection of claim 20 is withdrawn.
Claim Rejections - 35 U.S.C. § 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. § 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Graham v. John Deere Co., 383 U.S. 1, 17 (1966); MPEP § 2141(II).
Claim 20 is rejected under 35 U.S.C. § 103 as being unpatentable over Ucciferri.
The Graham factors are addressed in turn below.
Determining the scope and contents of the prior art
Ucciferri discloses a case report in which an HIV-infected human was administered lacidipine. (Ucciferri, p. 49).
Ascertaining the differences between the prior art and the claims at issue
Ucciferri does not indicate the subject was suffering from an HIV infection at the AIDS stage of HIV infection.
Resolving the level of ordinary skill in the pertinent art
The level of one of ordinary skill may be found by inquiring into: (i) the type of problems encountered in the art; (ii) prior art solutions to those problems; (iii) the rapidity with which innovations are made; (iv) the sophistication of the technology; and (v) the education level of active workers in the field. Custom Accessories, Inc. v. Jeffrey-Allan Industries, Inc., 807 F.2d 855, 962 (Fed. Cir. 1986). All of the factors may not be present in every case, and one or more of them may predominate. Envtl. Designs, Ltd. v. Union Oil Co., 713 F.2d 693, 696 (Fed. Cir. 1983). Based on the typically high education level of workers in the pharmaceutical art and the high degree of sophistication required to solve problems encountered in the art, Examiner finds a person having ordinary skill in the art would have at least a college degree in chemistry, biology, biochemistry, pharmacology, or a related field, and several years of experience.
Considering objective evidence present in the application indicating obviousness or nonobviousness
The instant application does not include evidence of treating AIDS.
The question of obviousness
Based on the above factors, it would have been obvious for a person having ordinary skill in the art prior to the filing of the instant application to modify the method of treating the subject with HIV disclosed in Ucciferri to treat a subject with AIDS because AIDS is the final, most severe stage of an untreated HIV infection. Thus, treating AIDS is essentially treating a severe HIV infection. One of ordinary skill in the art would have been motivated to modify Ucciferri to treat a subject with AIDS because it was shown that a subject with HIV can be safely treated with lacidipine. There would have been a reasonable expectation of success at arriving at the claimed invention because the method involves a single administration step and the same drug would be administered to treat the same virus.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 C.F.R. § 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 C.F.R. § 1.17(a)) pursuant to 37 C.F.R. § 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.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jason Nolan at (571) 272-2480. The examiner can normally be reached Monday through Friday between 9:00–5:00.
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 submit an Automated Interview Request: http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam Milligan, can be reached on 571-270-7674.
/J.M.N./Patent Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623