DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
This application, filed 6 June, 2023, is a CON of 17/186,583, 16/808,120, 16/413,381, 15/913,750, 15/406,344, 14/679,887, and 11/669,547, which claims the benefit of U.S. provisional application 60/764,811, filed 3 February, 2006.
Information Disclosure Statement
Three information disclosure statements (IDS) submitted on 6 June, 2023, 28 August, 2023, and 6 August, 2024, are acknowledged and have been considered.
Status of the Application
Receipt is acknowledged of Applicant’s claimed invention, filed 6 June, 2023, in the matter of Application N° 18/206,218. Said documents have been entered on the record.
No additions, amendments, or cancellations have been made to the originally-filed claims. The issue of new matter is moot.
Thus, Claims 1-31 represent all claims currently under consideration.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of pre-AIA 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) the invention was known or used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for a patent.
Claim 31 is rejected under pre-AIA 35 U.S.C. 102(a) as being anticipated by Dahl, Menning, and Oliyai (US 2004/0224917 A1, cited in the IDS), hereinafter Dahl.
Regarding Claim 31, Dahl teaches a patient pack comprising a separate or co-formulated pill, tablet, caplet, or capsule of 300 mg of tenofovir disoproxil fumarate and 200 mg of emtricitabine (‘917, Pg. 19, Claims 42-45.)
As such, Claim 31 is anticipated by Dahl.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-30 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Dahl, Menning, and Oliyai (US 2004/0224917 A1, cited in the IDS), hereinafter Dahl.
Regarding Claims 1-11, 14-15, and 17-30, Dahl (2004) teaches combinations of antiviral compounds, including tenofovir disoproxil fumarate and emtricitabine, in methods for inhibition of HIV, which comprises administering a therapeutically effective amount (’917, Pg. 1, Para 007 and 0010), which includes all prodrugs of tenofovir and emtricitabine (’917, Pg. 6, Para 0059), for a periodic, e.g. daily, dose (’917, Pg. 8, Para 0077), for oral administration to humans (’917, Pg. 9, Para 0087.) Dahl further discloses that Viread (tenofovir disoproxil fumarate) has been approved by the FDA for the treatment and prophylaxis of HIV infection as a 300 mg oral tablet, to include HIV-1 infection (’917, Pg. 4, Para 0043) and Emtriva (emtricitabine) has been approved by the FDA for the treatment of HIV as a 200 mg oral tablet, wherein a once-a-day dose of 200 mg of emtricitabine reduced the viral load by an average of 99 percent (’917, Pg. 9, Para 0090.)
Each of the independent Claims 1, 11, and 20, merely restate this regimen in different words – as a method of “prohibiting infection”, as a “pre-exposure prophylactic method”, or as a method comprising the routine steps of confirming negative status and then administering the daily dose.
Regarding Claims 12-13, and 16, Dahl teaches preferably, a two-part combination is administered as a single oral dosage form, e.g., a single tablet of tenofovir disoproxil fumarate and emtricitabine (’917, Pg. 7, Para 0072.)
As Dahl teaches oral administration of the same combination of compounds for HIV prophylaxis, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer at least some of the dose before first exposure, since prophylactic regimens inherently require administration prior to pathogen exposure to achieve prevention. One of ordinary skill in the art would have been further motivated to confirm suitability of subjects by routine serological and/or PCR Assay testing to exclude pre-existing infection, and to optimize and monitor efficacy through routine pharmacokinetic evaluation of parameters such as AUC, since these constitute standard steps in initiating and evaluating prophylaxis. There would have been a reasonable expectation of success, as the known administration of tenofovir disoproxil fumarate and emtricitabine at prophylactic doses inherently results in measurable AUC values and clinical protection when given to uninfected subjects prior to exposure, and such protection would have been expected to apply across all known transmission routes (e.g., parenteral (needle), sexual transmission, etc.) since the mechanism of prophylaxis is maintenance of therapeutic plasma levels, which is independent of how the virus enters the body. It would have been further prima facie obvious to vary the duration of daily dosing depending on the anticipated exposure risk window, whether over several days, several months, or through a period involving multiple potential exposures, as such adjustments reflect routine clinical practice to ensure prophylactic coverage during the time in which exposure may occur, with a reasonable expectation of success since prophylaxis is effective so long as therapeutic levels are maintained.
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 1-30 rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-18 of U.S. Patent No. 9,044,509, Claims 1-17 of U.S. Patent No. 9,579,333, Claims 1-19 of U.S. Patent No. 9,937,191, and Claims 1-19 of U.S. Patent No. 10,335,423, in view of Dahl (US 2004/0224917 A1, cited above and in the IDS).
Dahl teaches oral administration of the same combination of compounds for HIV prophylaxis, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to administer at least some of the dose before first exposure, since prophylactic regimens inherently require administration prior to pathogen exposure to achieve prevention. One of ordinary skill in the art would have been further motivated to confirm suitability of subjects by routine serological and/or PCR Assay testing to exclude pre-existing infection, and to optimize and monitor efficacy through routine pharmacokinetic evaluation of parameters such as AUC, since these constitute standard steps in initiating and evaluating prophylaxis. There would have been a reasonable expectation of success, as the known administration of tenofovir disoproxil fumarate and emtricitabine at prophylactic doses inherently results in measurable AUC values and clinical protection when given to uninfected subjects prior to exposure, and such protection would have been expected to apply across all known transmission routes (e.g., parenteral (needle), sexual transmission, etc.) since the mechanism of prophylaxis is maintenance of therapeutic plasma levels, which is independent of how the virus enters the body. It would have been further prima facie obvious to vary the duration of daily dosing depending on the anticipated exposure risk window, whether over several days, several months, or through a period involving multiple potential exposures, as such adjustments reflect routine clinical practice to ensure prophylactic coverage during the time in which exposure may occur, with a reasonable expectation of success since prophylaxis is effective so long as therapeutic levels are maintained.
Claims 1-31 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-22 of copending Application No. 18/199,776, and Claims 1-31 of copending Application No. 18/235,285.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and referenced patent application each teach oral administration of the same combination of tenofovir disoproxil fumarate and emtricitabine (and their prodrugs) for HIV prophylaxis when given to uninfected subjects prior to exposure, and such protection would have been expected to apply across all known transmission routes, administered orally in a daily dose to humans prior to pathogen exposure to achieve prevention, with routine testing used to identity the subjects and optimize and monitor efficacy throughout.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Donna M. Nestor whose telephone number is (703)756-5316. The examiner can normally be reached generally (w/flex): 5:30a-5p EST M-Th.
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/D.M.N./ Examiner, Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627