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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3/4/2026 has been entered.
The office acknowledges Applicants filing of the amendments, arguments and IDS dated 3/4/2026. Claims 1-12 has been cancelled. Claims 13-25 are pending and are examined based on the merits herein. Applicants arguments have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. Arguments, which are directed to withdrawn rejections, are thus rendered moot. The arguments in regards to the reiterated rejections/references from the previous office action are addressed below. Applicants amendments and further consideration necessitated the new rejections presented in this action. The action is made non-final.
The information disclosure statement(s) (IDS) filed on 3/4/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Applicants Arguments
103 rejection: Baert et al.
Applicants argue Baert does not teach or suggest, inter alia, a method of treating a pediatric subject infected with an HIV virus comprising administering to the subject: 15 mg or less of a non-nucleoside reverse transcriptase inhibitor that is rilpivirine, or an equivalent amount of a pharmaceutically acceptable salt of rilpivirine, once daily, wherein the subject is >2 to <12 years; wherein the subject weighs 11 kg to <25 kg; and is antiretroviral naive, as claimed in independent claim 13.
In response, Applicants arguments have been fully considered. Baert is explicit in teaching that rilpivirine and its composition is suitable for infants and children infected with HIV. The reference teach suitable daily dose is in the range of 0.1 mg to 3 mg, or 0.2 to 1.0 mg per kg of body weight and once daily administration. It is noted that children are generally defined as individuals from birth through 18 years of age. Accordingly the subject of Baert includes >2 and <12 years. Baert’s teach HIV subjects in general and it includes antiretroviral naïve. The body weight of HIV infected children as taught by Fontana, for example, 6-7 years is 20-22 kg and the weight of an HIV infected subject in general depends on malnutrition, HIV symptoms etc. From the prior art teachings a person skilled in the art would have found it obvious and motivated to arrive at administering 15 mg of rilpivirine to HIV infected subjects as claimed (0.75 mg/kg to 20 Kg subject would equate to 15 mg) with a reasonable expected of success in treating HIV in children.
Applicants argue that Baert suggests that the reconstituted TMC278 (rilpivirine) powder monotherapy may be applied after initial treatment with a combination of HIV drugs, in particular, with any of the HAART combinations (See, e.g., Baert, p. 13, lines 4-7). Absent the required suggestion or motivation, the Examiner fails to establish a prima facie obviousness case.
In response, Baert teachings is to one of the embodiments of the prior art’s invention, p 13, lines 4-7 (see below).
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Applicants' arguments focusing on disclosed examples or specific teachings in cited references are not probative. Question under 35 U.S.C. 103 is not merely what reference expressly teach, but what they would have suggested to one of ordinary skill in the art at the time the invention was made; all disclosures of prior art, including unpreferred embodiments, must considered. In re Lamberti and Konort (CCPA), 192 USPQ 278. “The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
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"[A] reference is not limited to the disclosure of specific working examples." In re Mills, 470 F.2d 649, 651 (CCPA 1972). "Patents [and publications] are part of the literature of the art and are relevant for all they contain." In re Young, 927 F.2d 588, 591 (Fed. Cir. 1991). All the disclosures in a reference must be evaluated, including nonpreferred embodiments, and a reference is not limited to the disclosure of specific working examples.
In regards to Applicants arguments that there is no motivation or suggestion, it is noted that Baert is explicit in teaching the rilpivirine composition for HIV infected infants and children. A person skilled in the art would have been motivated to administer rilpivirine to the claimed subjects with a reasonable expectation of success and to treat HIV in children.
(ii) ODP rejection:
Applicant has requested that the double patenting rejection be held in abeyance until an allowable claim is identified in the present application with regard to the allegedly overlapping subject matter, at which time, Applicant will consider whether to file a terminal disclaimer.
In response, Applicants have not made any arguments in regards to the rejection and hence it is maintained and provided below.
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.
Claim(s) 13-25 are rejected under 35 U.S.C. 103 as being unpatentable over Patankar et al. (WO 2018077815), Baert et al. (WO 2008110619) and Fontana et al. (Am J Clin Nutr 1999;69:1282–6).
Patankar teach dispersible compositions comprising rilpivirine or a pharmaceutically acceptable acid addition salt thereof as an active ingredient for use in in the treatment of HIV infection and their dispersibility properties lend themselves to be useful in particular amongst the pediatric or geriatric population (Abstract, claims). The reference teaches a pharmaceutical composition containing a certain HIV (Human Immunodeficiency Virus) agent, in particular E-4-[[4-[[4-(2-cyanoethenyl)- 2,6-dimethylphenyl]amino]-2-pyrimidinyl]amino]-benzonitrile or a pharmaceutically acceptable acid addition salt thereof, in particular the hydrochloric acid salt, as active ingredient (p 1, para 1).
Patankar teach that the total composition weight of the dispersible compositions e.g. the total tablet weight, may be about 100 mg. The active ingredient present may range from 1 to 25 mg, such as from 1 mg to 5 mg, e.g. about 2.5 mg base equivalent (2.75 mg of the corresponding HC1 salt) or e.g. about 5 mg base equivalent (5.5 mg of the corresponding HC1 salt). In this manner a pediatric (or geriatric) formulation may be provided which is dispersible and which provides for dosage flexibility for the intended population, e.g. the pediatric population, e.g. children ranging between 0 and 12 years p 18, lines 34-38, p 19, lines 1-3). The unit preferably contains from 2 to 5 mg of rilpivirine base equivalent, preferably 2.5 mg rilpivirine base equivalent, i.e. 2.75 mg of rilpivirine HC1 or 5 mg rilpivirine base equivalent, i.e. 5.5 mg of rilpivirine HCl (p 20, lines 1-6). The present compositions can be used alone or in combination with other therapeutic agents, such as anti-virals, antibiotics, immunomodulators or vaccines for the treatment of viral, e.g. HIV, infections (see p 21, lines 6-9). Patankar teach nucleotide-like reverse transcriptase inhibitors, e.g. tenofovir can be added in combination to rilpivirine in the therapy (See p 22, line 23).
Baert et al. teach a rilpivirine (NNRTI TMC278) pharmaceutical composition suitable for infants and children infected with HIV (Abstract, page 1, line 31 to page 2, line 27). The composition may be in liquid form with concentration of rilpivirine 1 mg per 0.5 ml, which is sufficient for treatment of HIV, alone or in combination with other known anti-HIV agents; the quantity of water that is added is in the range of about 0.5 ml water per mg TMC278 to about 5 ml, or of about 0.5 ml water per mg TMC278 to about 2 ml, or of about 0.5 ml water per mg TMC278 to about 1 ml, e.g. about 0.6 ml/mg TMC278. (p 12, lines 8 to 33). Infants and children constitute a growing group of HIV infected patients. It is taught that pediatric anti-HIV medication poses particular challenges in that the dose regimens vary to a large extent due to variations in age and body weight (babies - children). Especially in the first year after birth, an infant undergoes rapid changes and body weight increases spectacularly; because of these rapid changes at young age, dosing of a drug needs to be adjusted frequently and dosage forms need to offer flexibility in dosing (See p 2, lines 4-9). Suitable daily dose is in the range of 0.1 mg to 3 mg, or 0.2 to 1.0 mg per kg of body weight (See, page 13, lines 28-38). The powder for reconstitution of TMC278 is preferably administered once daily (See p 13, line 9) .Baert teaches a supersaturated solution form comprising TMC278 or a pharmaceutically acceptable addition salt thereof (See claims 5-6). Baert is explicit in teaching that the treatment of Human Immunodeficiency Virus (HIV) infection, known as cause of the acquired immunodeficiency syndrome (AIDS), remains a major medical challenge. The reference teaches that HIV is able to evade immunological pressure, to adapt to a variety of cell types and growth conditions, and to develop resistance against currently available drug therapies; the latter include nucleoside reverse transcriptase inhibitors (NRTIs), non-nucleoside reverse transcriptase inhibitors (NNRTIs), nucleotide reverse transcriptase inhibitors (See p 1, lines 8-14).
Fontana teach malnutrition is a frequent finding in HIV-infected children and
wasting syndrome is among the criteria for including these children in clinical category C (severely symptomatic) (See p 1282, col. 1, para 1). Further taught is the average weight of HIV infected children with mean ages of 6.9 y and 7.7 y for children in CDC clinical category is 24.1+/-7.0 (A), 19.8+/-9.1 (B), 20.2+/-6.6 (C) and for all 22.1+/-9.0 (See Table 2; A–C, mildly, moderately, and severely symptomatic, respectively).
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to administer rilpivirine to pediatric antiretroviral naïve subjects for e.g. children, age 7 years, body weight is 22 kg, i.e. with body weight of <25kg to treat HIV from the teachings of Patankar and Baert. As to the amount, for e.g. if 0.1 mg/kg is administered to a child of 7 years infected with HIV, with an average weight of 20-22 Kg, it will be 2 mg to 2.2 mg which is less than 15 mg as claimed. The prior art teaches pharmaceutically acceptable dosage forms comprising rilpivirine pharmaceutical salt (HCl salt). As to the subject being antiretroviral naïve, Patankar and Baert teaches the use of rilpivirine to pediatric subjects that includes antiretroviral naïve subjects. As to the limitations in regards to the viral load in claim 13, it is noted that administration of the same agent, herein rilpivirine or its salt in an amount of 2.2 mg (which is less than 15 mg) once daily to the same set of subjects (pediatric subjects, e.g. 7 years, weighing 22 kg, antiretroviral naïve) would exhibit the same pharmacological effects of viral load of less than or equal to 50 copies of HIV particles per ml of blood plasma after at least 24 weeks or 48 weeks of the once daily administration as claimed. A person of ordinary skill in the art would have been motivated to administer rilpivirine to the claimed subjects with a reasonable expectation of success and to derive therapeutic benefits. Thus claims 13, 16, 17, 22, 24 are addressed.
As to claims 14, 18, Baert teach suitable daily dose is in the range of 0.1 mg to 3 mg, or 0.2 to 1.0 mg per kg of body weight. Thus it is within the skill of an artisan, e.g. physician to routinely optimize the dosage amount based on age, conditions etc. For e.g. for a 7 year old HIV subject weighing 20 kg can be administered 15 mg with 0.75 mg/kg or 12. 5 mg with 0.625 mg dose of rilpivirine. The optimization of a result effective parameter, e.g., effective amount of a therapeutic agent according to patients' conditions, such as age, body weight, is considered within the skill of the artisan. See, In re Aller, 220 F.2d 454,456, l 05 USPQ 233, 235 (CCPA 1955) and In re Stepan, 868 F3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017).
As to claims 15, 19, a skilled artisan would have found it obvious to administer several dosage units for e.g. 6 tablets or capsules in total for 15 mg (2.5 mg each) to the patient, for e.g. a child weighing 20 kg (0.75 mg/kg).
As to claim 20, Fontana teach that HIV-infected subjects (7 year old, CDC clinical category B, about 19 kg). As to claim 21, from the teachings of Patankar a person skilled in the art would have found it obvious to administer hydrochloride salt of rilpivirine to the pediatric subject to treat HIV.
As to claim 23, a skilled artisan would have found it obvious to further administer tenofovir (known to treat HIV as taught by Patankar) to the pediatric HIV subjects in combination with rilpivirine to provide more complete viral suppression effects, synergistic or additive benefits. The further employment of other known anti-HIV drag would have been obvious as it is prima facie obvious to combine two compositions each of which is taught in the prior art to be useful for same purpose in order to form third composition that is to be used for the very same purpose; idea of combining them flows logically from their having been individually taught in prior art; thus, the claimed invention which is a combination of two known anti-HIV drugs sets forth prima facie obvious subject matter. See In re Kerkhoven, 205 USPQ 1069.
As to claim 25, the reference teach treating HIV and HIV-1 is a type of HIV infection and hence a skilled artisan would have found it obvious to administer rilpivirine
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 13-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 13-20 of co-pending Application No. 18/408900 (‘900 reference application) in view of Patankar et al. (WO2018077815), Baert et al. (WO 2008110619).
The instant claims are directed to method of treating a pediatric subject infected with an HIV virus comprising administering to the subject: 15 mg or less of a non- nucleoside reverse transcriptase inhibitor that is rilpivirine, or an equivalent amount of a pharmaceutically acceptable salt of rilpivirine, once daily; wherein the subject weighs 11 kg to <25 kg; wherein the subject is >2 and <12 years, subject is antiretroviral naïve and wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV virus particles per mL of blood plasma (50c/mL) after at least 24 weeks of the once-daily administration of the rilpivirine, or equivalent amount of the pharmaceutically acceptable salt of rilpivirine (claim 13). The dependent claims 14-16, 18-20 are limited to 15 mg of rilpivirine or its HCl salt, six tablets/capsules (2.5 mg each), subject weights, 12.5 mg of the agent. The dependent claims are limited to e.g. rilpivirine hydrochloride; further comprising administering to the pediatric subject dolutegravir, tenofovir, a pharmaceutically acceptable salt of tenofovir, a tenofovirprodrug, a pharmaceutically acceptable salt of a tenofovir prodrug, emtricitabine, or a combination thereof; wherein the pediatric subject exhibits a viral load of less than or equal to 50 copies of HIV virus particles per mL of blood plasma (5Oc/mL) prior to the once-daily administration of the pharmaceutically acceptable salt of rilpivirine; wherein the virus is HIV-1; rilpivirine administered as single unit or multiple single unit dosage forms; viral load after at least 48 weeks is less than or equal to 50 copies of HIV-1 virus particles.
‘900 reference claims are directed to a method of treating a pediatric subject aged >2 to <12 years infected with an HIV virus comprising administering to the subject: a pharmaceutically acceptable salt of rilpivirine in an amount that is equivalent to 12.5 mg of rilpivirine, once daily; wherein the subject weighs 11, 12, 13, 14, 15, 16, 17, 18, or 19 kg; is treatment experienced; and was administered a first anti-retroviral regimen that has been discontinued; wherein the pharmaceutically acceptable salt of rilpivirine is administered as multiple tablets or capsules, each tablet or capsule containing an amount of the pharmaceutically acceptable salt of rilpivirine that is equivalent to 2.5 mg of rilpivirine; and wherein the subject exhibits a viral load of less than or equal to 50 copies of HIV virus particles per mL of blood plasma (<50c/mL) after at least 24 weeks of the once-daily administration of the pharmaceutically acceptable salt of rilpivirine. The dependent claims are limited to salt, rilpivirine hydrochloride; further comprising administering to the pediatric subject dolutegravir, tenofovir, a pharmaceutically acceptable salt of tenofovir, a tenofovir prodrug, a pharmaceutically acceptable salt of a tenofovir prodrug, emtricitabine, or a combination thereof; wherein the pediatric subject exhibits a viral load of less than or equal to 50 copies of HIV virus particles per mL of blood plasma (50c/mL) prior to the once-daily administration of the pharmaceutically acceptable salt of rilpivirine; wherein the virus is HIV-1; wherein the pediatric subject exhibits a viral load of less than or equal to 50 copies of HIV-1 virus particles per mL of blood plasma (<=55c/mL) after at least 48 weeks of once daily administration of the pharmaceutically acceptable salt of rilpivirine; the age of the subject is 11 years old.
The reference claim do not teach the use of rilpivirine in the treatment of HIV in antiretroviral naïve subjects.
Patankar and Baert teachings as discussed above. From the prior art it would have been obvious to a skilled artisan that an effective amount of rilpivirine and/or its HCl salt is used in a method of treating HIV in any subject and that includes antiretroviral naïve subjects. A person of ordinary skill in the art would have found it obvious from the reference claims and the prior art teachings to administer less than 15 mg, e.g. 12.5 mg rilpivirine and/or its HCl salt once daily in antiretroviral naïve pediatric subjects aged >=2 to <=12 years, and weighing 11-19 kg. As to the limitations in claims 13 and 22 regarding the viral load, administration of the same agent, herein rilpivirine to the same set of subjects (>2 and <12 years, 11-19 kg) and with the optimized dose based on the age for e.g. 12.5 mg would exhibit the pharmacological effects of viral load of less than or equal to 50 copies of HIV particles per ml of blood plasma after at least 24 weeks of the once daily administration as claimed. Thus claims 13, 17, 18, 20, 21, 22, 24-25 would have been obvious over the reference claims and the prior art. The reference claims and Patankar is explicit in teaching rilpivirine hydrochloride salt and its use in the method of treating HIV.
As to claim 14, from Baert’s teachings, if the dosage amount is 1 mg/kg and for a pediatric subject weighing 15 kg, 15 mg would be administered once daily for treating HIV.
As to claims 15, 19, Patankar teach unit dosage forms, e.g. tablets, 2.5 mg each unit containing a predetermined quantity of active ingredient calculated to produce the desired therapeutic effect in association with the required pharmaceutical carrier. It is within the skill of an artisan to formulate the dosage forms with the desired amount of the active agent, herein e.g. rilpivirine. As to the amount, a skilled artisan would have found it obvious to administer 6 tablets in total for 15 mg or 5 tablets, 12.5 mg (2.5 mg each) to the pediatric HIV patient.
As to claims 16, 20, the reference claims teach subjects weighing 11kg to 19 kg. It would have been obvious to a skilled artisan at the time of administration to consider the pediatric subjects weight for dosage determination to obtain therapeutic benefits in the treatment of HIV and it is within the skill of an artisan.
As to claim 23, Patankar teach additional antiretroviral compounds can be added in combination, e.g. tenofovir. A skilled artisan would have found it obvious to further administer tenofovir (known to treat HIV as taught by the prior art above) for example to the pediatric HIV subjects in combination with rilpivirine to provide more complete viral suppression effects, synergistic or additive benefits. The further employment of other known anti-HIV drag would have been obvious as it is prima facie obvious to combine two compositions each of which is taught in the prior art to be useful for same purpose in order to form third composition that is to be used for the very same purpose; idea of combining them flows logically from their having been individually taught in prior art; thus, the claimed invention which is a combination of two known anti-HIV drugs sets forth prima facie obvious subject matter. See In re Kerkhoven, 205 USPQ 1069.
Conclusion
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/Umamaheswari Ramachandran/Primary Examiner, Art Unit 1627
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