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
Acknowledgement is made of the Applicant’s claim of foreign priority to application MX/A/2023/011800 filed 5 October 2023.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1 and 3-7) in the reply filed on 4 August 2026 is acknowledged. Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of the Claims
Claims 1 and 3-15 are pending.
Claims 8-15 are withdrawn.
Claims 1 and 3-7 are rejected.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites, “…a diluent, a diluent…” which appears to be a typographical error. Appropriate correction is required.
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.
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 1 and 3-7 are rejected under 35 U.S.C. 103 as being unpatentable over Nutalapati et al. (US 2021/0275531).
Nutalapati teaches an oral formulation comprising a PDE5 inhibitor and an additional active agent, wherein the additional active reduces a side-effect associated with PDE5 inhibitors [0040]. The PDE5 inhibitor can be sildenafil [0059], which is known to cause headaches and dyspepsia [0047]. To counter the headache side effects, an NSAID such as acetaminophen (10-1300 mg), celecoxib (25-600 mg), or a combination thereof is included in the formulation [0061-0066]. The formulation may be in the form of a tablet [0085]. Furthermore, antacids such as sodium bicarbonate may be included wherein it is taught that alternative antiacids can be used in a range of from 50-800 mg [0073-0074]. The oral dosage form can comprise an excipient in 5-95 wt% [0093]. Fillers such as microcrystalline cellulose [0094], binders such as polyvinylpyrrolidone [0095], controlled release agents such as HPMC [0096], disintegrants such as croscarmellose sodium [0098], lubricants such as sodium lauryl sulfate and magnesium stearate [0099], and glidants such as colloidal silica [0100] may be included. The tablet can comprise a coating wherein the coating may comprise enteric polymer such as HPMC [0102-0104]. The tablet may be an orally disintegrating tablet including an effervescent disintegration agent [0106] such as sodium bicarbonate in 5-50 wt% [0110, 0112]. When making an orally dissolving strip, water may be used as a solvent in preparation [0126, 0169]. In one particular example, silicon dioxide and magnesium stearate are both used in 5 mg [0161]. In another, PVP is used in 5 mg, MCC in 50 mg, croscarmellose sodium in 6 mg, and magnesium stearate in 1 mg [0157].
Nutalapati does not teach the claimed composition in a single embodiment.
It would have been prima facie obvious to prepare an oral tablet dosage form comprising PDE5 inhibitors along with acetaminophen and celecoxib to counter the headache side effects, along with various excipients and common formulation agents. 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 at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. Consistent with this reasoning, it would have been obvious to have selected various combinations of excipients from within Nutalapati, to arrive at compositions “yielding no more than one would expect from such an arrangement.” The resulting tablet comprises PDE5 inhibitor, acetaminophen (10-1300 mg), celecoxib (25-600 mg), antacid and effervescent agents such as sodium bicarbonate (50-800 mg OR 5-50 wt%), filler such as microcrystalline cellulose, binders such as polyvinylpyrrolidone, disintegrants such as croscarmellose sodium, lubricants such as sodium lauryl sulfate and magnesium stearate, and glidants such as colloidal silica wherein the overall amount of total excipients ranges from 5-95 wt%. The tablet would have also comprised a coating comprising HPMC and can further include water in the formulation if a dissolvable formulation is being prepared.
The ranges for active agents are obvious based on the prior art teachings. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976). MPEP 2144.05 (I). Regarding the amount of each excipient, the total amount of combined agents can be included in from 5-95 wt%. For a theoretical 500 mg tablet, this range includes masses of from 25-475 mg and for a theoretical 1000 mg tablet, the range is from 50-950 mg for each excipient. Based on the overall allowable amounts of excipients and the examples provided, and in lieu of evidence of an unexpected result or critical range, it would have been obvious to include the agents in any amounts up to 950 mg (assuming a 1000 mg tablet) such as the values recited in instant claims 6-7. As a result, instant claims 1 and 3-7 are obvious in view of the prior art.
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 and 3-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/906,706 in view of Nutalapati et al. (US 2021/0275531).
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘706 composition comprises celecoxib in a pharmaceutical composition however the instant claims further require the inclusion of acetaminophen. Nutalapati teaches that acetaminophen is an alternative NSAID to celecoxib and can be used in combinations thereof [0061-0062]. ‘706 also recites wherein the formulation is a tablet that can comprise excipient such as a surfactant (sodium lauryl sulfate), binders (polyvidone), diluents (MCC), disintegrants (croscarmellose), lubricants (magnesium stearate), alkaline agents (sodium bicarbonate), and water. Nutalapati teaches that glidants such as colloidal silica can further be included in tablet formulations [0100]. Nutalapati further teaches that enteric coatings, which can comprise HPMC, are useful on tablet formulations for targeted release in the GI tract [0102, 0104]. The ‘706 claims further recite amounts of each agent (claim 14) and Nutalapati teaches all excipients can be used in 5-95 wt% of the overall composition. Therefore it would have been obvious to select an enteric HPMC coating for the tablet of ‘706 and further include colloidal silica as a glidant wherein the tablet comprises various actives including celecoxib and acetaminophen. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07). The amounts of each agent are adjustable based on the broad ranges in the prior art and the reference points in the ‘706 claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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