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 .
Withdrawn Rejections:
Applicant's amendments and arguments filed on 06/04/2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Any rejection and/or objection not specifically addressed below is herein withdrawn.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set of rejections and/or objections presently being applied to the instant application.
The application is examined in view of citric acid and citrate salt as specific buffer; sodium lauryl sulfate as specific surfactant; formulation without granule as specific formulation and tablet as solid dosage form. Claims 47, 49, 52-53, 59-61 and 69 read on the elected species and are under examination. Claims 1, 3-12, 14-20 and 68 do not read on the elected species and are withdrawn from consideration.
Claims 1, 3-12, 14-20, 47, 49, 52-53, 59-61, 63-65 and 68-69 are pending; claims 47, 49, 52-53, 59-61 and 69 are under examination.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/042026 is being considered by the examiner.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 47, 49, 52-53, 59-61 and 69 are rejected under 35 U.S.C. 103 as being unpatentable over Perovitch et al. (US5629022) in view of Kandula (US20220233629), Duarte-Vazquez et al. (US20120021048) and Amedio (US20200069592).
Determination of the scope and content of the prior art
(MPEP 2141.01)
Perovitch et al. teaches a therapeutical composition for internal use, particularly to be administered by mouth, in galenical presentation, and containing at least one active principle in solid form adsorbed on a substrate, the active product being distributed therein as finely dispersed microparticles. (abstract). The invention also relates to a medicinal specialty in galenical presentation and constituted in particular by a pastille, granule, pill, tablet or the like, adapted to be sucked by the user and for sublingual administration, characterized in that it comprises at least one active product in microdispersed form within a substrate, such microdispersion having been obtained in accordance with the method specified hereinabove. And more particularly, the specialty comprises an active product microdispersed within a substrate and included in the spongy or cellular structure thereof in the form of microcrystals, the size of the microcrystals generally being less than 10 microns. In accordance with an embodiment of the specialty according to the above characteristics, the active product is constituted by aspirin reconstituted in the form of microcrystals with a support constituted by sorbitol. And more particularly, the medicinal specialty described above and based on microdispersed aspirin comprises an acidifying agent such as citric acid or equivalent acidifying agent. The composition of each tablet is based on a percentage of aspirin in the form of microcrystals included between 10 and 200 milligrams on a substrate such as sorbitol whose weight is included between 100 and 2500 milligrams (column 4, line 10-35). This aspirin solution is preferably distributed over a support of sorbitol type or any other water-soluble substrate and usable in the formulation of tablets to be sucked via mixers conventionally used in pharmacy. The aspirin thus reconstituted in microdispersed form within the sorbitol substrate is, after sifting, mixed with any product, medicinal or not, intended to improve the therapeutical efficiency, the taste or presentation and also facilitating the technical methods of manufacture. After homogenization, the mixture constituted by particles or granules of sorbitol internally containing the micro crystals of aspirin, themselves adhering to the walls of the sorbitol thanks to the presence of the PEG serving as binding agent, is then subjected to compression by the conventional apparatus in order to obtain the pastilles, tablets, granules or pills (column 5, line 1 to 50). According to another characteristic, one proceeds, before the final phase of forming tablets and in the formulation of the latter, with the incorporation of an acidifying agent such as citric acid. This agent, during administration, makes it possible slightly to acidify the salivary dissolution medium by establishing it between pH 3 and 4.5; this acid medium protects the aspirin from a hydrolyzing attack, increases its speed of dissolution in the saliva and facilitates its contact and passage through the mucous membranes (column 6, line 20-35). The tablet disintegrates upon contact with the saliva in the buccal cavity (column 6, line 50-55). In one formulation, the aspirin table composition comprises lubricant, and aspartame as sweetener (column 7, line 20-50).
Kandula teaches pharmaceutical formulation in the form of tablet ([0140]). Examples of buffers useful in the compositions of the present disclosure include citric acid or salt or derivative thereof, benzoic acid or salt or derivative thereof, sorbic acid or salt or derivative thereof, succinic acid or salt or derivative thereof, a bicarbonate salt of alkali earth metal, amino acids, an acid salt of an amino acid, an alkali salt of an amino acid and mixtures thereof. However, any other buffer(s), as known to or appreciated by a person skilled in the art can also be used to serve its/their intended purpose as laid down in embodiments of the present disclosure. In an embodiment, the buffer is citric acid or salt or derivative thereof. In an embodiment, the composition includes a combination of citric acid and trisodium citrate dihydrate as a buffer ([0145]).
Duarte-Vazquez et al. teaches Thus, in certain embodiments, the compositions of the invention may be formulated into forms for oral administration, including solid dosage forms or liquid dosage forms. In alternative embodiments, the compositions of the invention may be formulated into forms for direct administration to the mucosa, including the buccal mucosa (i.e., buccal administration) or oral mucosa under the tongue (i.e., sublingual administration). Solid dosage forms for oral administration include capsules, tablets, pills, powders, particles and granules. In such solid dosage forms, the compositions of the invention are mixed with at least one pharmaceutically acceptable excipient or carrier such as (a) fillers or extenders such as starches, lactose, sucrose, glucose, mannitol, dicalcium phosphate and microcrystalline cellulose; (b) binders such as sodium carboxymethylcellulose, alginates, gelatin, polyvinylpyrrolidone, and acacia; (c) disintegrating agents such as agar-agar, calcium carbonate, potato or tapioca starch, alginic acid, certain silicates, sodium carboxymethyl cellulose, pregelatinized starch and sodium starch glycolate; (d) lubricants such as calcium stearate, magnesium stearate, stearic acid, solid polyethylene glycols, sodium lauryl sulfate, and mixtures thereof; and/or (e) glidants such as talc, silicon dioxide and starch. In the case of capsules, tablets and pills, the dosage form may also comprise buffering agents. Solid compositions of a similar type may also be employed as fillers in soft and hard filled gelatin capsules using such excipients as lactose or milk sugar as well as high molecular weight polyethylene glycols, oils and the like. ([0057]).
Amedio teaches Provided in one aspect is an oral disintegrating tablet comprising an Hsp90 inhibitor, a filler or binder, optionally mannitol (e.g., Pearlitol 300DC), sucrose, silicified microcrystalline cellulose (e.g., prosolv HD90), or lactose, a disintegrant, optionally crospovidone (e.g., polyplasdone XL), L-HPC, Pharmaburst, PanExcea, or F-Melt, a lubricant, optionally Pruv or Lubripharm, and/or a glidant, optionally fumed silica, and/or a dispersion agent, optionally calcium silicate ([0029]). Glidants are compounds that are added to solid forms such as powders and granulations to improve their flowability. They may accomplish this by reducing particle friction and adhesion. They may be used in combination with lubricants. Examples of glidants include but are not limited to magnesium carbonate, magnesium stearate, fumed silica (e.g., colloidal silicon dioxide) (for example at about 0.25-3% concentration), starch, and talc (for example at about 5% concentration) ([0262]).
Ascertainment of the difference between the prior art and the claims
(MPEP 2141.02)
The difference between the instant application and Perovitch et al. is that Perovitch et al. do not expressly teach citric acid / citrate salt; and sodium lauryl sulfate and fumed silica. This deficiency in Perovitch et al. is cured by the teachings of Kandula, Duarte-Vazquez et al. and Amedio.
Finding of prima facie obviousness
Rational and Motivation (MPEP 2142-2143)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Perovitch et al., as suggested by Kandula, Duarte-Vazquez et al. and Amedio, and produce the instant invention.
One of ordinary skill in the art would have been motivated to replace citric acid / trisodium citrate for citric acid as buffer because this is simple substitution of one known buffer (pH adjuster) for another to obtain predictable results. Under guidance from Kandula teaching citric acid / trisodium citrate as alternative to citric acid as buffer, it is obvious for one of ordinary skill in the art to replace citric acid / trisodium citrate for citric acid as buffer and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to choose sodium lauryl sulfate as lubricate in the tablet because sodium lauryl sulfate is a known lubricant as suggested by Duarte-Vazquez et al. Under guidance from Perovitch et al. teaching lubricant in tablet comprising aspirin, it is obvious for one of ordinary skill in the art to choose sodium lauryl sulfate as lubricate in the tablet and produce instant claimed invention with reasonable expectation of success.
One of ordinary skill in the art would have been motivated to include fumed silica in the tablet because fumed silica is a suitable ingredient in tablet. MPEP 2144.07. Under guidance from Amedio teaching glidants fumed silica for improving their flowability during process to make tablet, since it is advantage to do so, it is obvious for one of ordinary skill in the art to include fumed silica in the tablet and produce instant claimed invention with reasonable expectation of success.
Regarding the limitation of formulation without granule, granule is only alternative to particle, not required.
Regarding tripotassium citrate monohydrate, tripotassium citrate monohydrate is obvious variant of trisodium citrate dihydrate, Furthermore, tripotassium citrate monohydrate is a common citrate salt (elected species), as long as prior art teaches the elected species citrate salt, each different citrate is obvious from each other.
Regarding claim 47, 52-53, 59 and 68 prior art teaches pharmaceutical formulation in the form of tablet for sublingual administration comprising aspirin microcrystal particle less than 10um (micronized) at amount of 10-200mg, citric acid/ tripotassium citrate monohydrateas buffer, lubricant sodium lauryl sulfate (which is also surfactant), sweetener aspartame and fumed silica. Since when the tablet dissolve in salvia (about neutral pH in mouth), the buffer makes pH from 3-4.5. Prior art is silent about the amount of citric acid, citrate salt and sodium lauryl sulfate, it is within skill of one artisan in the art to adjust and optimize those amounts to have 0.82mg citric acid anhydrous, 0.24 mg tri-potassium citrate monohydrate and 3.65 mg sodium lauryl sulfate to produce instant claimed invention with reasonable expectation of success. MPEP 2144.05. Especially in the absence of showing criticality of claimed range.
Regarding claim 60, Perovitch et al., teaches orally disintegrating tablet.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Argument:
Applicants argue that the amendment of claim 2 into claim 1 and claim 48 into claim 47.
In response to this argument: this is not persuasive. After amendment, claim 1 directs towards formation comprising granule, which does not read on the elected specific formulation without granule, thus, claim 1 is withdrawn from consideration. Claims 48-49 are taught by Amedio teaching glidants fumed silica for improving their flowability during process to make tablet, since it is advantage to do so, it is obvious for one of ordinary skill in the art to include fumed silica in the tablet and produce instant claimed invention with reasonable expectation of success in the previous 103 rejection, and the correct 103 rejection is reformatted to address this amendment. Therefore, the 103 rejection is still proper.
MPEP 2141 III states: “The proper analysis is whether the claimed invention would have been obvious to one of ordinary skill in the art after consideration of all the facts.” Respectfully, after weighing all the evidence, the Examiner has reached a determination that the instant claims are not patentable in view of the preponderance of evidence and consideration of all the facts which is more convincing than the evidence which has been offered in opposition to it.
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 47, 49, 52-53, 59-61 and 69 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of copending Application No. 19471300 (reference application) in view of Perovitch et al. (US5629022). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches aspirin tablet comprising aspirin, citric acid /citrate salt, sodium lauryl sulfate, fumed silica (claim 27), in view of Perovitch et al. teaching aspirin at 10mg-200mg, and it is within skill of one artisan in the art to optimize the amount of citric acid / citrate salt and sodium lauryl sulfate to have claimed amount through routing experimentation. MPEP 2144.05. Thus, it is obvious for one of ordinary skill in the art to produce applicant’s claimed invention with reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANFENG SONG. Ph.D. whose telephone number is (571)270-1978. The examiner can normally be reached M-F 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian-Yong 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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/JIANFENG SONG/Primary Examiner, Art Unit 1613
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