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 .
Status of the Claims
Claims 3-5, 7, 9, 11, 13-15, 20, 25-31, 33-36, 38, 39, 41, 47, and 85-92 are pending.
Domestic Benefit
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Instant application claims domestic benefit of U.S. Provisional Application No. 63/529,468, filed 07/28/2023. Therefore, the effective filing date is 07/28/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/12/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 33 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 33 teaches that the tablet comprises “300 mg of the compound of Formula Ia, or a pharmaceutically acceptable salt thereof”. However, claim 29, from claim 33 depends, requires that the tablet must comprise the sodium salt of Formula Ia. Therefore, claim 33 fails to include all the limitations of the claim upon which it depends.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Claims 3, 5, 7, 9, 11, 25, 38, 39, 41, 47, and 85 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Dvory-Sobol et al. (Lenacapavir: a first-in-class HIV-1 capsid inhibitor, Current Opinion in HIV and AIDS, 1 January 2022, Vol. 17(1), pages 15-21), cited by Applicant in the IDS.
Dvory-Sobol et al. teaches, on page 20, the Phase 2 trial of lenacapavir (instant Formulas Ia and Ib) administration which comprises an initial oral dose for induction, followed by a second oral dose for maintenance. It is taught, throughout the review, that lenacapavir is used for PrEP. A study in Figure 4 shows an initial administration of 600 mg lenacapavir, followed by 300 mg of lenacapavir 8 days later, as in instant claims 3, 5, 7, 9, 11, 25, 38, 39, 47, and 85. It is taught on page 20 that lenacapavir demonstrates prophylactic activity, and is useful in individuals who are both at risk for or have been exposed to HIV-1, as in instant claim 41.
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.
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.
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.
Claims 4, 13-15, 20, 26-29, 33-35, and 86 are rejected under 35 U.S.C. 103 as being unpatentable over Dvory-Sobol et al. (cited above), as applied to claims 3, 5, 7, 9, 11, 25, 38, 39, 41, 47, and 85 above.
Dvory-Sobol et al. teaches HIV prevention and treatment comprising administering 600 mg of lenacapavir, followed by 300 mg of lenacapavir 8 days later. See above rejection.
It is taught on page 20 that lenecapavir can be used in long-acting regimens with infrequent dosing, or alternatively for daily or weekly dosing intervals.
Dvory-Sobol et al. fails to explicitly state that the treatment is life-long or that treatment should be re-started if a dose is missed. Dvory-Sobol et al. fails to teach the sodium salt of lenacapavir.
However, it would be prima facie obvious to one of ordinary skill in the art to re-start treatment in cases where a patient misses a dose, as in instant claims 4, 14, 15, 20, 26, and 27. One would be motivated to do this in order to continue the prevention of HIV.
Additionally, it would be prima facie obvious to one of ordinary skill in the art to continue the HIV prevention method taught by Dvory-Sobol et al., as in instant claim 13, in order to prevent HIV, especially since the methods teach continued administration of maintenance doses. One of ordinary skill in the art would be motivated to continue the method taught above with maintenance methods throughout the life of a patient in order to continue the prevention of HIV.
It is common knowledge and common practice in the art to use a pharmaceutical salt of a drug in order to increase the bioavailability of said drug. As evidenced by Dhaval et al. (Pharmaceutical Salts: Comprehensive Insights From Fundamental Chemistry to FDA Approvals (2019–2023), AAPS PharmSciTech, 2025, Vol. 26(36), pages 1-29) on page 3, and by Berge et al. (Pharmaceutical Salts, Journal of Pharmaceutical Sciences, 1977, Vol. 66(1), pages 1-19) in Table 1, sodium is the most frequently used cationic counterion in pharmaceutical salts, with 62% of pharmaceutical salts containing the sodium salt.
Therefore, it would be prima facie obvious to one of ordinary skill in the art, and one would have a reasonable expectation of success, using the method taught by Dvory-Sobol et al. with the sodium salt of lenacapavir, as in instant claims 28, 29, 33-35, and 86.
Claims 30, 31, 36, and 87-92 are rejected under 35 U.S.C. 103 as being unpatentable over Dvory-Sobol et al. (cited above) in view of Graupe et al. (WO 2018035359 A1), as applied to claims 3-5, 7, 9, 11, 13-15, 20, 25-29, 33-35, 38, 39, 41, 47, 85, and 86 above.
Dvory-Sobol et al. teaches HIV prevention and treatment comprising administering 600 mg of lenacapavir, followed by 300 mg of lenacapavir 8 days later. See above rejection.
Dvory-Sobol fails to teach the inactive ingredients of the lenacapavir tablets.
However, Graupe et al. teaches, in claims 1, 2, and 9, a method of treating or preventing (including PrEP and PEP) HIV in a human comprising administering a compound of instant Formula Ia or Formula Ib. Graupe et al. teaches, in paragraph [00173], that the oral tablets may be prepared from spray-drying dispersion, as in instant claim 29. Graupe et al. teaches, in paragraphs [00172]-[00188], that the oral tablets may contain magnesium stearate, poloxamers, microcrystalline cellulose, 20% mannitol, croscarmellose sodium, and copovidone, as in instant claims 31, 36, and 87-92.
It would be prima facie obvious to use the tablets of lenacapavir taught by Graupe et al. in the method taught by Dvory-Sobol et al., since both teach methods of treating and preventing HIV comprising administering lenacapavir orally, with about the same amount of active ingredient.
Although the exact amounts of inactive ingredients are not taught in the prior art, MPEP 2144.05 II states: “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)… “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969)”.
Therefore, the optimization of inactive ingredients within a known method, where the method itself, oral tablets, and amount of active ingredients are taught in the prior art, would be considered routine optimization, and in the absence of unexpected results, would be considered prima facie obvious in view of the prior art.
Nonstatutory Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 3-5, 7, 9, 11, 13-15, 20, 25-31, 33-36, 38-39, 41, 47, and 85-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23, 25, 29-37, 39-45, 60, 87-88, 90, and 95-96 of copending Application No. 18/639,097 (refer-ence application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the ‘097 application are drawn to a method of preventing HIV infection comprising administering the same compound and substantially the same dosage amounts as required by the instant claims. Claim 1 of the ‘097 provides for administering a remedial dosage amount “if the patient misses a maintenance dosage.” This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 3-5, 7, 9, 11, 13-15, 20, 25-31, 33-36, 38-39, 41, 47, and 85-92 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 7-8, 13-14, 18-36, 38, 41-42, 44, 46-48, 50, 58, 61, 88, and 96-97 of copending Application No. 18/812,842 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for substantially the same reasons discussed above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 3-5, 7, 9, 11, 13-15, 20, 25-31, 33-36, 38, 39, 41, 47, and 85-92 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RILLA M SAMSELL whose telephone number is (703)756-5841. The examiner can normally be reached Monday-Friday, 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Murray can be reached at (571) 272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/R.M.S./Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
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