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
Status of Claims
Receipt of Remarks/Amendments filed on 09/07/2026 are acknowledged. Claim 7 is cancelled. Claims 1, 5, 8, 12, and 15 are amended. Claims 1-6, 8-18 are presented for examination on the merits for patentability.
Rejection(s) not reiterated from the previous Office Action are hereby withdrawn. The following rejections are either reiterated or newly applied. They constitute the complete set of rejections presently being applied to the instant application.
Modified Rejection As Necessitated by the Amendment Filed 09/07/2026
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 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.
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(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-6, 8, 10-11, and 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over Petrovic et al. (International Journal of Pharmaceutics 428 (2012) 57– 67), hereinafter Petrovic, in view of Desai et al. (Indian Drugs 50(03) March 2013), hereinafter Desai.
Petrovic relates the study of artificial intelligence methods for optimization of drug release from matrix tablets, wherein models used are polyethylene oxide polymer and glyceryl palmitostearate for hydrophilic and lipid matrix tablets, and model drugs were diclofenac sodium and caffeine (Abstract).
Regarding Claims 1-5, 8, and 10, Petrovic teaches the lipid matrix tablet to comprise glyceryl palmitostearate (Precirol®), caffeine, mannitol, and magnesium stearate (p. 58, materials and methods). Matrix tablets were prepared by mixing and compression (p. 58, materials and methods). Precirol® reads on the non-polymeric carrier, and Petrovic expressly teaches Precirol® between 10-20% and caffeine at 30% of each formulation P1-P12 (Table 2). Magnesium acid reads on the stearic acid derivative in Claim 5.
PNG
media_image1.png
272
620
media_image1.png
Greyscale
The release data for P11 and P12, which contain 12.5% and 17.5% Precirol® are shown in Fig. 8. The graph for P12 shows about 30% of caffeine is released in the first 1h, followed by about 75% to over 90% of caffeine release in 4-8 hour. No data is shown for 8-12 hours. However, the plateau indicates release of over 90% beyond 8h. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to expect close/similar result for Precirol® at about 20% with reasonable expectation of success.
Regarding the feature of melt granulation, Petrovic teaches that lipid matrix tablets are usually produced by melt granulation or extrusion (p. 57, last paragraph). However, Petrovic does not expressly teach its formulation as melt granulated.
Desai is in the field of melt granulation and teaches the technique as a size enlargement process in which the addition of a binder that melts or softens at relatively low temperatures of about 60 ˚C is used to achieve agglomeration of solid particles in the formulation (Abstract). Desai relates that the technique is useful for preparing sustained released dosage forms and fast release melt granules and is one of the most widely applied techniques in pharmaceutical manufacturing (Abstract). Desai teaches that active compound is embedded in a carrier comprising one or more “meltable” binder substances and other functional excipients, and gave the typical melting ranges of binders inter alia glyceryl palmitostearate, making it compatible with Petrovic (Table II; p. 6, R. Col., Binders section).
PNG
media_image2.png
410
410
media_image2.png
Greyscale
Desai teaches many advantages including fewer processing steps, which makes it less time consuming, uniform dispersion of particle, sustained, modified and targeted release capabilities, and production of a wide range of dosage forms (pp. 5-6, Advantages section). Desai further teaches that melt granulation is an anhydrous process, which avoids potential hydrolytic degradation pathways, and how tablets can be prepared without a compression process by cutting an extruded rod to the desired dimension (p. 8, L. Col., last paragraph). Desai teaches that during melt granulation, the solid fine particles are bound together into agglomerates in the presence of a molten binding liquid, and a gradual change in size and shape takes place (p. 9, L. Col., last paragraph). Desai teaches the modes of melt agglomeration and the wide scope of dosage forms manufactured by the technology (Fig. 1, Conclusion).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to use melt granulation process in the preparation of caffeine tablets of Petrovic, which provides many advantages as described supra. One would take guidance from the melting temperature range provided by Desai for glyceryl palmitostearate and stearic acid as temperature to obtain the molten form, and modify accordingly. Typically, the melting points of meltable binders range from 50 to 80 °C (p. 9, R. Col., 3rd paragraph).The temperature taught by Desai overlaps with the temperature range in Claim 8 and renders the feature obvious. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. See MPEP 2144.05.
As such, Petrovic in view of Desai has also taught all the features in Claim 8.
Regarding Claim 6, because Petrovic teaches mannitol, the sweetener feature is obvious (p. 58, materials and methods).
Regarding Claim 10, Petrovic teaches tablets (p. 58, materials and methods).
Regarding Claim 11, Petrovic relates that excipients frequently used for lipid matrices formulations include carnauba and bees wax, glyceryl monostearate, cetyl and cetostearyl alcohol, stearic acid, etc. (p. 57, last paragraph). The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Regarding Claim 15, Petrovic does not teach coating or more than one layer or phase.
Regarding Claims 16- 18, Petrovic teaches microcrystalline cellulose (MCC) and mannitol as directly compressible diluents, which were used for the diclofenac and caffeine tablets, respectively. Therefore, it would also have been prima facie obvious to one of ordinary skill in the art before the effective filing date to substitute mannitol with MCC as diluent in the tablet comprising the caffeine. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Claims 9 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Petrovic in view of Desai, as applied to Claims 1 and 8 above, and in further view of Acharya (Of record; in IDS), hereinafter Acharya.
Petrovic is silent on the particle size.
Desai teaches that during melt granulation, the solid fine particles are bound together into agglomerates in the presence of a molten binding liquid, and a gradual change in size and shape takes place (p. 9, L. Col., last paragraph).
Acharya is in the field of caffeine formulation, and teaches a formulation comprising a particulate system comprising caffeine (Claim 1). Acharya teaches pulsed release formulation, and in certain cases, the formulation also has continuous release of caffeine over 2 to 8 hours interval, which encompasses the prolonged release limitation (p. 14).
Acharya recognizes preparing particulate system by different methods, inter alia melt granulation (p. 13). The particle size of the particulate system is in the range of 100 to 1500 micron, preferably in the range of 300 to 750 micron (p. 13). The range overlaps with the range of Petrovic and that of instant Claims 9 and 13-14. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05. Furthermore, particle size is an experimental parameter considered to be a result-effect variable that is within the skill of the ordinary artisan to modify and is commonly carried out in the art as part of routine optimization in formulations; the prior art is evidence to this. It would have been obvious to make a caffeine formulation having granules of particle size within that taught by Acharya and Petrovic before the effective filing date because the ordinary skilled artisan knew that such claimed size would work for continuous release of caffeine. The references are in the same field of endeavor and they provide a reasonable expectation of success.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Petrovic, in view of Desai and in further view of Muzikova et al. (Of record), hereinafter Muzikova.
Petrovic does not teach glyceryl behenate.
Muzikova teaches that lipophilic matrix systems are cheap, easy to prepare and chemically inert; they contain various fat alcohols, waxes and fats, e.g., cetyl alcohol, glyceryl dibehenate, and carnauba wax (p. 91, 1st paragraph). Muzikova discloses the compressibility of tableting materials with different types of binders and various concentrations of glyceryl behenate (C – Compritol 888 ATO) (pp. 91-92). Muzikova teaches that addition of glyceryl dibehenate exerts different impacts on the strength of tablets, with increasing concentration to 20 % increases the strength (Fig. 1; p. 94, last paragraph to p. 95). Muzikova teaches that the release rate of the active substance decreases with increasing content of glyceryl dibehenate (Abstract; p. 97).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to combine the teachings of Muzikova to that of Petrovic and use glyceryl behenate as carrier, replacing the glyceryl palmitostearate of Petrovic to optimize the prolonged release of the actives. The rationale to support a conclusion that the claim would have been obvious is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art. See MPEP 2143.
Response to Remarks:
Applicant traverses the 103 rejection over Nart in view of Barlow, arguing that the arts do not teach the amended claim of caffeine being the sole API, but rather teaches two highly soluble compounds.
Applicant’s arguments have been considered but are not persuasive. The new ground of rejection necessitated by the amendment does not rely on Nart or Barlow for any teaching or matter specifically challenged in the argument
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sagalowicz et al. (WO 2016/096468 A1) discloses an edible composition having a lipid continuous phase and self-assembled structures comprising oil, phospholipids, caffeine and water, providing controlled release caffeine in edible capsule form (Abstract.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JANICE Y SILVERMAN whose telephone number is (571)272-2038. The examiner can normally be reached M-F, 10-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached on (571) 270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/J.Y.S./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
