DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission, filed 11/05/2025, has been entered.
Status of Application
Receipt of the amendments to the claims and applicant arguments/remarks, filed 11/05/2025, is acknowledged.
Claims 17-34 are pending in this application. Claims 1-16 have been cancelled previously. New claim 34 has been added. No new matter was added. Claims 17-34 are currently under the consideration.
Any rejection or objection not reiterated in this action is withdrawn. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . 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.
Priority
This application is a continuation of U.S. Patent Application No. 17/595,145, filed November 10, 2021 and now issued as U.S. Patent No. 11,523,992, which is a 371 of PCT/EP2020/061872, filed April 29, 2020, which claims benefit of foreign priority to IN201941019448, filed May 15, 2019.
Terminal Disclaimer
The terminal disclaimer, filed 09/03/2024, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent No. 11,523,992 and any patent granted on pending reference application No. 15/733,083, has been reviewed and is accepted. The terminal disclaimer has been reviewed, accepted, and recorded.
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.
Claims 17-34 are rejected under 35 U.S.C. 103 as being unpatentable over Guha et al., WO 2019/096833A1 (cited in IDS; hereinafter referred to as Guha) in view of Betageri et al., WO2013/170012A2 (cited in IDS; hereinafter referred to as Betageri).
Guha teaches a process for preparing polymer-coated hard-shell capsules, wherein said capsules are coated in the pre-locked state, and wherein said coated capsules further are filed with biologically active ingredients by using filing machine with an output of 2000 capsules per hour (Abstract; Pages 5-8, 21, 51). To this point, Guha teaches that said capsules comprise a body and a cup, and the material of the body and the cap can be hydroxypropyl methyl cellulose, starch, gelatin, pullulan, etc. (Page 9 as applied to claims 17, 18).
Guha teaches that the coating layer comprises a meth(acrylate) copolymer(s), and the thickness of said coating layer may be 1-8 mg/cm2, e.g., 1-5 mg/cm2 (Pages 10, 17 as applied to claims 17, 33).
Guha teaches that the coating may include (i) (meth)acrylic polymers polymerized from of 40-60 wt% of methacrylic acid and 60-40 wt % of ethyl acrylate (Page 11 as applied to claims 19, 20); and/or (ii) (meth)acrylate copolymers that are polymerized from 5-15 wt% of methacrylic acid, 50-70 wt% of methyl acrylate, and 10-30 wt% of weight methyl methacrylate (Page 11 as applied to claim 22), because of its good elongation at break properties (Page 12).
Guha teaches that said coating layer may include 60-90 wt% of a polymer mixture and 10-40 wt % of pharmaceutical or nutraceutical excipients (Pages 19, 20 as applied to claim 27).
Guha further teaches that the coating layer may include: (i) a plasticizer such as alkyl citrates, glycerol esters, alkyl phthalate, alkyl sebacates, sucrose esters, etc. (Page 19, 23 as applied to claims 25, 26); (ii) glycerol monostearate/detacking agent (Page 19 as applied to claim 28, 29); (iii) polysorbate 80/emulsifier (Page 19 as applied to claims 30, 32).
Regarding a glass transition temperature of the claimed (meth)acrylate copolymers and/or an elongation of dried film of coating at break (claims 17, 34), it is noted that Guha teaches (meth)acrylate copolymers as instantly claimed and coating compositions comprising said copolymers in combination with plasticizers, detacking agents, and/or emulsifiers as instantly claimed, therefore, it is expected that the same beneficial properties and effects would also be provided.
Though Guha teaches that the coating may include a mixture of (meth)acrylic polymers, Guha does not specifically teach the use in coating (meth)acrylate copolymers comprising ethyl acrylate and methyl methacrylate monomeric units as disclosed in claims 23, 24.
Betageri teaches filled capsules that are coated with an enteric coating providing controlled/delayed release of active agent/fill to a target location, and specifically teaches the use in said coatings (meth)acrylate copolymers of Eudragit E, L, S, RL, RS and NE types that dissolve under different pH conditions (Para. 075, 081, 0120, 0168), identified in the instant specification as anionic and/or cationic (meth)acrylate copolymers. Betageri teaches that the Eudragit NE (i.e., copolymers of 60-80 wt% of ethyl acrylate and 40-20 wt% of methyl methacrylate) are insoluble in the gastrointestinal tract but are permeable and can be used primarily for colonic targeting (Para. 081).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use/include (meth)acrylate copolymers as taught by Betageri into the enteric coating of capsules as taught by Guha. One would do so with expectation of beneficial results, because cited prior art teaches that said approach can be used for providing desired drug/fill release profile and/or drug/fill delivery to a target location identified by pH conditions, e.g., for colonic targeting.
With regard to the concentrations as instantly claimed (claims 24, 25, 27, 31), it is noted that differences in experimental parameters such as concentration of compounds in a solution/formulation will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such parameter is critical. The prior art teaches formulations comprising the same components. The determination of suitable or effective concentration/composition can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. 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 experimentation.
Regarding the properties of the disclosed coating layers (claims 17, 34), it is noted that the cited prior art teaches coating formulations that may include components as instantly claimed. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and effects would also be provided. The fact that applicant has recognized another advantage, which would flow naturally from following the suggestion of the prior art, cannot be the basis for patentability when the differences would otherwise be obvious. Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Response to Arguments
Applicant's arguments, filed 11/05/2025, have been fully considered, but they were not found to be persuasive for the reasons set forth above. Additional examiner’s comments are set forth next.
Applicant argues that Declaration Under 37 CFR 1.132 (filed 11/05/2025) demonstrates that Examples 2, 3, 6 in Guha et al. (WO 2019/096833) do not demonstrate the elongation break as instantly claimed, e.g., (i) Example 2 in Guha et al. shows coating layer having elongation break 398% and present in the amount of 6.5 mg/cm2 that is outside of the claimed range of 1-5.8 mg/cm2; and (ii) Examples 3 and/or 6 in Guha et al. show the coating layer having the elongation break below 5%.
In response to applicant’s argument, it is noted that “A reference is not limited to working examples.” In re Fracalossi 215 USPQ 569 (CCPA 1982). “Nonpreferred embodiments can be indicative of obviousness.” Merck & Co. v. Biocraft Laboratories Inc. 10 USPQ 2d 1843 (Fed. Cir. 1989); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Kohler 177 USPQ 399 (CCPA 1973); In re Mills 176 USPQ 196 (CCPA 1972); In re Bozek 163 USPQ 545 (CCPA 1969); In re Meinhardt 157 USPQ 270 (CCPA 1968); In re Boe 148 USPQ 507 (CCPA 1976); In re Nehrenberg 126 USPQ 383. “A reference is good not only for what it teaches by direct anticipation, but also for what one of ordinary skill might reasonably infer from the teachings.” In re Opprecht 12 USPQ 2d 1235, 1236 (Fed. Cir. 1989); In re Bode 193 USPQ 12 (CCPA 1976); In re Lamberti 192 USPQ 278 (CCPA 1976); In re Bozek 163 USPQ 545, 549 (CCPA 1969); In re Preda 159 USPQ 342 (CCPA 1968); In re Van Mater 144 USPQ 421 (CCPA 1965); In re Jacoby 135 USPQ 317 (CCPA 1962); In re LeGrice 133 USPQ 365 (CCPA 1962). “It is sufficient that the references clearly suggest doing what applicants have done.” In re Gershon 152 USPQ 602 (CCPA 1967). In the present case, it is noted that Guha et al. teaches coating compositions comprising (meth)acrylate copolymers in combination with (i) plasticizers (e.g., alkyl citrates, glycerol esters, alkyl phthalate, alkyl sebacates, sucrose esters, etc.); (ii) glycerol monostearate/detacking agent; (iii) polysorbate 80/emulsifier, i.e., components/constituents as instantly claimed. Further, it is noted that the instant specification teaches that (iv) the addition of plasticizer(s) to the (meth)acrylate copolymer(s) is usually lowering the glass transition temperature of the mixture, and the elongation at break is usually increased; and (v) the required elongation at break/elasticity of the coating layer may be realized by addition of plasticizers, emulsifiers, and/or detacking agents. Therefore, it is the examiner’s position that given that Guha et al. teaches coating compositions comprising the same components (i.e., (meth)acrylate copolymers, emulsifiers, detacking agents, emulsifiers, etc.) the same beneficial properties and/or effects would also be provided. Furthermore, it is noted that one skilled in the art would have understood that properties of multicomponent systems (i.e., coating compositions) depend on compounds included as well as on concentrations and/or distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. Therefore, it is expected that different compositions might have different properties. The determination of suitable or effective compositions (i.e., for providing/controlling properties of compositions) can be and usually is determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Therefore, the applicant’s arguments were not found to be persuasive.
In response to applicant’s argument that Guha et al. teaches that “(meth)acrylate copolymer is particularly suitable, because of its good elongation at break properties, for compressing pellets to tablets”, it is noted that Guha et al. teaches a process for preparing polymer-coated hard-shell capsules, wherein said capsules are coated in the pre-locked state, and wherein a coating layer comprises a meth(acrylate) copolymer(s), and the thickness of said coating layer may be 1-8 mg/cm2. Therefore, the applicant’s arguments were not found to be persuasive.
In response to applicant’s argument regarding the nonstatutory double patenting rejection over claims 1-14 of U.S. Patent No. 11,523,992 (i.e., parent application), it is noted that the applicant has filed the terminal disclaimer (see above) to overcome a nonstatutory double patenting rejection of record. If the applicant wants to withdraw said terminal disclaimer that should be clearly stated on a record. In the present case, it is noted that claims of prior patent 11,523,992 include additional limitations (i.e., specific plasticizers, additional steps). In the present case, the conflicting claims are not patentably distinct from each other, because the instant claims are merely broader than prior patent claims that include additional limitations and therefore are more specific. As stated previously, the invention of the prior patent claims is considered to be a "species" of the "generic" invention of the instant claims. Further, it is noted that it has been held that the generic invention is "anticipated” by the “species". In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
Applicant is advised to clarify the structure of the constituents to be used in the claimed method, and clearly point out the patentable novelty, which the applicant thinks the claims present in view of the state of the art disclosed by the references cited, to place the application condition for allowance.
Conclusion
No claim is allowed at this time.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLGA V. TCHERKASSKAYA whose telephone number is (571)270-3672. The examiner can normally be reached 9 am - 6 pm, Monday - Friday.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615