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 .
Priority
Acknowledgment is made of applicant’s claim for priority. The certified copy has been filed in parent Application No. 63/534,180, filed on 8/23/2023.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/04/2024 is being considered by the examiner.
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 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.
Claim(s) 1-2, 7-8, 13-14, 18, 19-31, 47-48, 61, 88, 96 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Segal-Maurer (Segal-Maurer et al., Capsid Inhibition with Lenacapavir in Multidrug-Resistant HIV-1 Infection, n engl j med 386;19 nejm.org May 12, 2022).
The reference Segal-Maurer teaches “In this phase 3 trial, we enrolled patients with multidrug-resistant HIV-1 infection in two cohorts, according to the change in the plasma HIV-1 RNA level between the screening and cohort-selection visits. In cohort 1, patients were first randomly assigned in a 2:1 ratio to receive oral lenacapavir or placebo in addition to their failing therapy for 14 days; during the maintenance period, starting on day 15, patients in the lenacapavir group received subcutaneous lenacapavir once every 6 months, and those in the placebo group received oral lenacapavir, followed by subcutaneous lenacapavir; both groups also received optimized background therapy. In cohort 2, all the patients received open-label oral lenacapavir with optimized background therapy on days 1 through 14; subcutaneous lenacapavir was then administered once every 6 months starting on day 15. The primary end point was the percentage of patients in cohort 1 who had a decrease of at least 0.5 log10 copies per milliliter in the viral load by day 15; a key secondary end point was a viral load of less than 50 copies per milliliter at week 26”(abstract) and “Cohort 1 was designed to include the first 36 patients who had a decrease of less than 0.5 log10 copies per milliliter (i.e., stable viremia confirming lack of response to the failing therapy) between the screening and cohort-selection visits and an HIV-1 RNA level of 400 copies or more per milliliter. These patients began a functional monotherapy period after having undergone randomization in a 2:1 ratio to receive either oral lenacapavir (600 mg on days 1 and 2 and 300 mg on day 8) or matching placebo in a directly observed fashion while continuing their failing therapy. The investigators, patients, and trial personnel were unaware of randomized assignments during the functional monotherapy period. In the maintenance period, starting on day 15, patients in the lenacapavir group received subcutaneous lenacapavir (927 mg as two 1.5-ml injections in the abdomen), which was subset quaintly administered by a health care professional once every 6 months, plus optimized back ground therapy. Those in the placebo group received oral lenacapavir (600 mg on days 15 and 16 and 300 mg on day 22), followed by subcutaneous lenacapavir plus optimized background therapy”(page 1794).
Additionally, the reference teaches “In a combined analysis of cohorts 1 and 2, all 72 patients received oral lenacapavir and at least one dose of subcutaneous lenacapavir, and 70 received the second dose of subcutaneous lenacapavir at week 26”(page 1800) and “The patients in cohort 1 had undergone previous treatment with a median of nine antiretroviral medications and had a median overall susceptibility score for the failing regimens of 0.8. (The drug susceptibility score to an individual antiretroviral medication was determined according to a proprietary algorithm, with 1.0 indicating full susceptibility, 0.5 partial susceptibility, and 0 no susceptibility; the overall susceptibility score was a sum of individual susceptibility scores.) Resistance to all four major classes of antiretroviral medications was reported in 47% of the patients. Many of the patients had exhausted both the integrase (54%) and protease inhibitor (42%) classes owing to resistance, whereas others had resistance to agents that have recently been ap proved for heavily treatment-experienced adults (ibalizumab in 11 of 33 patients [33%] and fostemsavir in 10 of 33 [30%]). Of the 36 trial patients, 6 (17%) had no fully active agents in their optimized background therapy. The characteristics of the patients in cohort 2 were similar to those in cohort 1”(page 1797).
Wherein 927mg /2= 463.5 mg and 463.5/1.5mL=309mg/mL.
As defined by the instant specification the compound of Formula Ib may also be referred to as lenacapavir.
Since the wherein, clause in claim 1 is optional (The following limitations are optional: “if the patient misses a maintenance dosage” or “if the patient misses the oral administration”(see all claims) because the patient may not miss a dose. These contingent limitations appear not to be required, so it is the examiner’s impression that they do not necessarily implicate that any particular step must be performed) this anticipates claims 1-2 , 7-8, 13-14, 18, 24-31, 47-48, 61, 88, 96. Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. Thus claims 19-23 are anticipated.
Claim(s) 1-2, 7, 8, 13-14, 18-33, 36, 38, 42, 44, 46-48, 61, 88, 96-97 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AHFS (Lenacapavir Sodium, AM J HEALTH-SYST PHARM | VOLUME 80 | NUMBER 8 | April 15, 2023).
The reference AHFS teaches:
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This anticipates claims 1-2, 7, 8, 13-14, 18-33, 36, 38, 42, 47-48, 61, 96-97.
The reference AHFS teaches:
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This anticipates claims 44 and 46.
The reference AHFS teaches “In a study of lenacapavir in combination with representatives from the major classes of anti-retroviral agents (INSTIs, NNRTIs, NRTIs, and PIs), no antagonism of anti-viral activity was observed”(page 475). This anticipates claim 88.
Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. Thus claims 19-23 are anticipated
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Graupe (Graupe et al., US 20180051005 A1, 2018-02-22).
Graupe discloses the compounds of Formula Ia and Formula Ib and their use in methods of treating or preventing HIV infection. See, e.g., para. 0077-84 and 0091-96. They are administered in a dosing regimen “for a desired period of time or duration, such as at least about one day, at least about one week, at least about one month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 6 months, or at least about 12 months or longer. In one variation, the compound is administered on a daily or intermittent schedule. In one variation, the compound is administered on a monthly schedule. In one variation, the compound is administered every two months. In one variation, the compound is administered every three months. In one variation, the compound is administered every four months. In one variation, the compound is administered every five months. In one variation, the compound is administered every 6 months” and so forth (para. 0315-16).
Since the wherein, clause in claim 1 optional (The following limitations are optional: “if the patient misses a maintenance dosage” or “if the patient misses the oral administration”(see all claims) because the patient may not miss a dose. These contingent limitations appear not to be required, so it is the examiner’s impression that they do not necessarily implicate that any particular step must be performed) and the first dosage and the second dosage may be the same amount as no limitation is given on the dosage amount in claim 1. This anticipates claim 1.
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.
Claim(s) 1-2, 7-8, 13-14, 18-36, 38, 42, 44, 46-48, 50, 58, 61, 88 and 96-97 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graupe (Graupe et al., US 20180051005 A1, 2018-02-22).
Graupe discloses the compounds of Formula Ia and Formula Ib and their use in methods of treating or preventing HIV infection. See, e.g., para. 0077-84 and 0091-96. They are administered in a dosing regimen “for a desired period of time or duration, such as at least about one day, at least about one week, at least about one month, at least about 2 months, at least about 3 months, at least about 4 months, at least about 6 months, or at least about 12 months or longer. In one variation, the compound is administered on a daily or intermittent schedule. In one variation, the compound is administered on a monthly schedule. In one variation, the compound is administered every two months. In one variation, the compound is administered every three months. In one variation, the compound is administered every four months. In one variation, the compound is administered every five months. In one variation, the compound is administered every 6 months” and so forth (para. 0315-16).
Since the wherein, clause in claim 1 is optional (The following limitations are optional: “if the patient misses a maintenance dosage” or “if the patient misses the oral administration”(see all claims) because the patient may not miss a dose. These contingent limitations appear not to be required, so it is the examiner’s impression that they do not necessarily implicate that any particular step must be performed) and the first dosage and the second dosage may be the same amount as no limitation is given on the dosage amount in claim 1. Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. This helps to teach claims 19-23.This helps to teach claims 1, 24-31, 47 and 96.
Graupe discloses “In some embodiments, the pharmaceutically acceptable salt of the compound of formula (Ia), (Ib), (IIa), and/or (IIb) is the sodium salt” [0105]. This helps to teach claim 32 and 96.
Graupe discloses “The pharmaceutical composition of claim 34, further comprising one, two, three, or four additional therapeutic agents”(reference claim 35). This helps to teach claim 88.
Graupe discloses “In some embodiments, the compounds disclosed herein are used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1”[0158]. This helps to teach claim 50.
Graupe discloses “ In certain embodiments, a compound of Formula (Ia), (Ib), (IIa), and/or (IIb), or a pharmaceutically acceptable salt thereof, is formulated as a tablet, which may optionally contain one or more other compounds useful for treating HIV“[0179] and “ In some embodiments, the current disclosure relates to a pharmaceutical composition comprising a compound of formula (Ia), (Ib), (IIa), and/or (IIb), or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable excipient. In certain embodiments, the pharmaceutical composition is a parenteral (e.g., injectable) form. In certain embodiments, the pharmaceutical composition is suitable for oral administration”[0088]. This helps to teach claims 38 and 48.
Graupe discloses “In certain embodiments, a compound disclosed herein (e.g. a compound of Formula (Ia) or (Ib)), or a pharmaceutically acceptable salt thereof, is combined with one or more additional therapeutic agents in a unitary dosage form for simultaneous administration to a subject. In certain embodiments, such a unitary dosage form can be administered by any route appropriate to the condition to be treated. Suitable routes include oral, rectal, nasal, topical (including buccal and sublingual), transdermal, vaginal and parenteral (including subcutaneous, intramuscular, intravenous, intradermal, intrathecal and epidural), and the like. In certain embodiments, the compounds disclosed can be dosed parenterally. In certain embodiments, the unitary dosage form can be dosed intravenous, subcutaneous, or intramuscular. In certain embodiments, the unitary dosage form is orally bioavailable and can be dosed orally. In certain embodiments, the unitary dosage form can be a solid dosage form for oral administration”[0147] and “The pharmaceutical compositions of the present disclosure may be in the form of a sterile injectable preparation, such as a sterile injectable aqueous or oleaginous suspension. This suspension may be formulated according to the known art using those suitable dispersing or wetting agents and suspending agents which have been mentioned herein. The sterile injectable preparation may also be a sterile injectable solution or suspension in a non-toxic parenterally acceptable diluent or solvent, such as a solution in 1,3-butane-diol or prepared as a lyophilized powder. Among the acceptable vehicles and solvents that may be employed are water, Ringer's solution and isotonic sodium chlorides solution . In addition, sterile fixed oils may conventionally be employed as a solvent or suspending medium. For this purpose any bland fixed oil may be employed including synthetic mono- or diglycerides. In addition, fatty acids such as oleic acid may likewise be used in the preparation of injectables”[0248]. This helps to teach claim 33.
The reference also teaches “ A compound as disclosed herein (e.g., any compound of formula (Ia) or (Ib)) may be combined with one or more additional therapeutic agents in any dosage amount of the compound of formula (Ia) or (Ib) (e.g., from 1 mg to 1000 mg of compound)”[0226]. As indicated by claim 18 depending on claim 14 subcutaneously administering 927 mg must be equivalent to about 309 mg/mL. Thus it would be a matter of routine optimization to identify the concentration 927mg should be administered in. In situations like this, where claimed dosage amounts “‘overlap or lie inside ranges disclosed by the prior art,’ a prima facie case of obviousness exists.” See MPEP 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). Generally, differences in such parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicat-ing the dosage amounts are critical. Where 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 experimen-tation.” See MPEP 2144.05(II)(A) (optimization within prior art conditions or through routine experimentation). The examiner is not aware of any evidence indicating they are critical. This helps to teach claims 7, 13-14, 18-23, 26-31, 36, 42.
Graupe discloses “Tablets may be uncoated or may be coated by known techniques including microencapsulation to delay disintegration and adsorption in the gastrointestinal tract and thereby provide a sustained action over a longer period. For example, a time delay material such as glyceryl monostearate or glyceryl distearate alone or with a wax may be employed”[0244]. This helps to teach claim 44. About 4% is an indefinite amount of weight gain. There would be implicitly a small amount of weight gain from coating the tablet. Through routine optimization this is likely “about” 4% as generally a coating is not the major weight of the tablet. This helps to teach claim 46.
Graupe discloses “Also of interest in the area of HIV therapies and treatments is extending the pharmacokinetic property of regimens provided to patients. While current regimens for treating HIV have progressed enough that patients no longer have to take multiple pills multiple times a day, patients today still are required to take a pill every day for the foreseeable span of their life. Thus, it would be beneficial to have HIV therapies that require patients take medication less than once a day (e.g. once every couple of days, once a week, once every other week, once a month, and so forth). It is implicit that treatment should continue as long as there is a medical need and that figuring out the optimal time periods, e.g., “first period” and “second period” referred to in claim 1, as well as the time periods referred to in claims 8, 13-14, 24-28, 30-31 and 58, would have been a matter of routine experimentation. For example, the disclosure of “once every couple of days” (para. 0075), would have suggested the time period of “two days” referred to in claim 2.
Graupe also discloses compositions of “about 5% to 20% water” (para. 0268); using PEG 300 as an excipient (para. 0256), including an example composition having “45% PEG 300” (para. 0397); and a drug concentrations of 200 mg/mL (para. 0429-30), i.e., about 20% active ingredient, which suggests compositions within the meaning of claims 33-35.
With respect to the claimed oral dosage amounts, Graupe discloses that “[t]he amount of active ingredient … may vary depending upon the intended treatment subject and the particular mode of administration,” for example, “a dosage form for oral administration to humans may contain approximately 1 to 1000 mg of active material” (para. 0272). The oral dosage amounts recited in claims 7, 13, 14, 18-23, 29-31, 42 fall within the range disclosed in the reference. In situations like this, where claimed dosage amounts “‘overlap or lie inside ranges disclosed by the prior art,’ a prima facie case of obviousness exists.” See MPEP 2144.05(I) (overlapping, approaching, and similar ranges, amounts, and proportions). Generally, differences in such parameters will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicat-ing the dosage amounts are critical. Where 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 experimen-tation.” See MPEP 2144.05(II)(A) (optimization within prior art conditions or through routine experimentation). The examiner is not aware of any evidence indicating they are critical, so the examiner concludes that the oral dosage amounts referred to in the claims are prima facie obvious over the general teachings of Graupe.
Graupe is silent regarding whether the subject is treatment naïve or heavily pretreated, but it is a reasonable inference that the patient referred to in claim 61 is within the meaning of the “subject” discussed in the reference (para. 0091-102). For example, the reference mentions treatment naïve animals (para. 0399-400), which implicates the existence of corresponding treat-ment-experienced subjects. This helps to teach claim 61.
The reference Graupe does not specifically claim the methods of all claims, but instead requires picking and choosing and routine optimization of the variables in the reference.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention to have modified Graupe to get the methods of the instant claims because all the elements of the claims are provided within Graupe and one would be motivated to optimize those elements for the best treatment of HIV. One would have a reasonable expectation of success because all the necessary limitations are provided. It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
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 1-2, 32-33, 38, 41-42, 44, 46-48, 50, 58, 61, 88, 96-97 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11944611 B2. Although the claims at issue are not identical, they are not patentably distinct from each other. The claims of the patent ‘611 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.
The patent claims:
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The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above.
Claims 1-2, 32-33, 38, 41-42, 44, 46-48, 50, 58, 61, 88, 96-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3-5, 7, 9, 11, 13-15, 20, 25-31, 33-36, 38-39, 41, 47, and 85-92 of copending Application No. 18/785,641 (refer-ence application). Although the claims at issue are not identical, they are not patentably distinct from each other. The claims (submitted on November 12, 2024) of the ‘641 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 4 of the ‘641 provides for administering a remedial dosage amount “if the patient misses a maintenance dosage.”
The reference application claims:
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688
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721
679
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61
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The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-8, 13-14, 18-36, 38, 41-42, 44, 46-48, 50, 58, 61, 88, and 96-97 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 (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. 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.
The reference application claims:
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The difference between dosages and time table are a question of routine optimization as discussed in the 103 rejection above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. Thus claims 19-23 are anticipated
The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above.
Claims 1-2, 32-33, 38, 41-42, 44, 46-48, 50, 58, 61, 88, 96-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 11, 13-14, 30-37, 70-71, 75-76, 79, 87, 109-110 of copending Application No. 19/314,157 (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. The claims of the ‘157 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.
The reference application claims:
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The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-8, 13-14, 18-36, 38, 41-42, 44, 46-48, 50, 58, 61, 88, and 96-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-77 of copending Application No. 19/706,064 (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. The claims of the ‘064 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.
The reference application claims:
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550
674
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282
677
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media_image43.png
455
654
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Greyscale
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media_image44.png
282
653
media_image44.png
Greyscale
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media_image45.png
573
667
media_image45.png
Greyscale
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media_image46.png
157
727
media_image46.png
Greyscale
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media_image47.png
439
674
media_image47.png
Greyscale
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media_image48.png
407
679
media_image48.png
Greyscale
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media_image49.png
388
642
media_image49.png
Greyscale
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media_image50.png
325
639
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Greyscale
Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. Thus claims 19-23 are anticipated The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-2, 7-8, 13-14, 18-36, 38, 41-42, 44, 46-48, 50, 58, 61, 88, and 96-97 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-65 of copending Application No. 19/706,386 (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. The claims of the ‘386 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.
The reference application claims:
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547
665
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185
633
media_image52.png
Greyscale
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media_image53.png
452
678
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Greyscale
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media_image54.png
536
661
media_image54.png
Greyscale
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media_image55.png
176
637
media_image55.png
Greyscale
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media_image56.png
611
699
media_image56.png
Greyscale
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342
640
media_image57.png
Greyscale
Claims 19-23 are contingent on an optional scenario and thus the art applies because it teaches steps I and II. Thus claims 19-23 are anticipated. The main differences between the reference patent and the instant application are dosages and time tables and these are a question of routine optimization as discussed in the 103 rejection above. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-2, 7-8, 13-14, 18-36, 38, 41-42, 44, 46-48, 50, 58, 61, 88, 96-97 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALISON AZAR HASTINGS whose telephone number is (703)756-4584. The examiner can normally be reached Mon-Thurs 7:30am-5pm EST Friday 7:30-4pm EST (every other Friday off).
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/A.A.H./ Examiner, Art Unit 1627
/Kortney L. Klinkel/ Supervisory Patent Examiner, Art Unit 1627
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