DETAILED ACTION
Status of Application
Receipt of the response to the non-final office action, the amendments to the specification, drawings and claims as well as applicant arguments/remarks, filed 02/18/2026, is acknowledged. Amendments to the specification and drawings have been entered. The Declaration under 37 C.F.R. §1.132, filed 02/18/2026, is acknowledged and taken into consideration.
Applicant has previously elected the invention of Group I, claims 1-16, drawn to topical compositions comprising microcapsules comprising tretinoin or salt thereof, benzoyl peroxide, and a carrier or excipient.
Claims 1-29 are pending in this application. Claims 17-29 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species and inventions, there being no allowable generic or linking claim. Claims 1, 6-7, 13-14, 16 have been amended. Claims 1-16 are currently under consideration.
Any rejection or objection not reiterated in this action is withdrawn. Applicant's amendments necessitated new ground(s) of rejection presented in this office action.
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-in-part of U.S. Patent Application No. 17/327,732, filed May 23, 2021, which claims benefit of provisional U.S. Application No. 63/028,599, filed May 22,2020.
Terminal Disclaimer
The terminal disclaimer, filed 02/18/2026, disclaiming the terminal portion of any patent granted on this application, which would extend beyond the expiration date of the prior Patent Nos. 12,133,919 and 12,257,348, has been reviewed and is accepted. The terminal disclaimer has been recorded.
Information Disclosure Statement
The information disclosure statement, filed 02/18/2026, is acknowledged and has been considered. Please see the attached initialed PTO-1449.
In the present case, it is noted that the references 1-27, 29-66, 68-82 recited in said information disclosure statement are identical to references recited in the information disclosure statements, filed 01/26/2023 and 09/11/2025. To this point, it is noted that the "filing of duplicate copies of correspondence in the file of an application, patent, trademark registration file, or other proceeding should be avoided, except in situations in which the Office requires the filing of duplicate copies." 37 CFR 1.4. Applicant is requested to review previously-filed information disclosure statements to avoid duplicate entries.
Further, it is noted that the foreign language references (e.g., WO 1994/20075) listed in the information disclosure statement, for which no English translation has been provided, have not been considered. If an English abstract has been provided or available for a foreign language document then only the English abstract has been considered.
The information disclosure statement does not include Certificate Statement (MPEP 609), and/or does not have a signature of the applicant or representative that is required in accordance with CFR 1.33.
For the record, the legible copies of cited foreign patent and/or non-literature documents have been submitted in parent application 17/327,732.
Claim Objections
Claims 3, 7, 14 are objected to because of the following informalities:
It is suggested that the limitation “repeated between 3 and 50 times” recited in claim 3 should be corrected to “repeated from 3 to 50 times” for clarity.
The acronyms “CTAC” and “PDAC” recited in claim 7 should be removed, because said acronyms are not used in subsequent claims.
It is suggested that the limitation “repeated between 5 and 7 times” recited in claim 14 should be corrected to “repeated from 5 to 7 times” for clarity.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
As stated previously, claim 1 attempt to encompass topical compositions comprising (i) microcapsules comprising tretinoin or a pharmaceutically acceptable salt thereof, (ii) microcapsules comprising benzoyl peroxide, and (iii) a pharmaceutically acceptable career or excipient, and wherein said compositions are “stable at ambient conditions and/or during a treatment period of up to 12 weeks”. The claim attempts to define the subject-matter in terms of the result to be achieved, which merely amounts to a statement of the underlying problem, without providing the technical features necessary for achieving this result. To this point, it is noted that claiming a result (i.e., stability) without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation. See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Clarification is required.
Newly amended claim 1 recites the limitation “microencapsulation efficiency of tretinoin is at least 90% by weight” that is not reasonably clear. Does this limitation imply that 10 wt% of tretinoin are present in claimed composition and are not included into the claimed microcapsules? Similar is applied to claim 16. Clarification is required.
Claim 1 further recites the limitation “microcapsules comprising tretinoin or a pharmaceutically acceptable salt thereof in an amount of 0.1 % by weight of said composition” that is not reasonably clear. Does this limitation disclose the amount of said microparticles, OR tretinoin? Similar is applied to the limitation regarding microcapsules comprising benzoyl peroxide. Clarification is required.
Claim 3 (dependent on claims 1, 2) recites the limitation “the tretinoin microcapsules” that is not reasonably clear. To this point, it is noted that independent claim 1 discloses the use of “microcapsules comprising tretinoin”. This limitation recited in claim 3 was interpreted as best understood as “the microcapsule comprising tretinoin comprise a core”. Similar is applied to claim 4 regarding the limitation “the benzoyl peroxide microcapsules”. Clarification is required.
As stated previously, claims 6 and 13 discloses a preparation of a microcapsule, wherein several elements are characterized by their assumed function (e.g., surfactant, a surface adhering additive) and not by the structure essential for said composition. These claims are unclear and indefinite, because the function of a particular compound may change and/or depend on conditions. Therefore, given that the scope of the claims is not limited by claim language that does not limit a claim to a particular structure (MPEP 2111.04), one of ordinary skill in the art would not be reasonably appraised of the scope of the invention. Clarification is required.
As stated previously, claim 7 (dependent on claims 6, 1) recites the limitation “said cationic polymer”. In the present case, it is noted that claim 1 and/or claim 6 do not include or identified the role/use of “a cationic polymer ". Therefore, there is insufficient antecedent basis for this limitation in the claim. Therefore, the metes and bounds of the claim cannot be determined. Similar is applied to claim 12 (dependent on claims 6, 1) regarding the limitation “wherein the thickness of the shell”. Clarification is required.
As stated previously, claim 10 recites the limitation “weak acid comprises citric acid, lactic acid…” that is not reasonably clear. Does this limitation disclose “a weak acid” as a mixture of compounds (i.e., comprising), OR at least of the recited acids? Clarification is required.
As stated previously, claim 11 recites the limitation “average diameter of said microcapsule is less than 50 micrometers” that is not reasonably clear. In the present case, it is noted that where a claimed value (i.e., average diameter of microcapsules) varies with its method of measurement and several alternative methods of measurement are available (see Wikipedia), the value is indefinite when the claim fails to concurrently recite the method of measurement used to obtain it. Honeywell Intl. v. Intl. Trade Commn., 341 F.3d 1332, 1340 (Fed. Cir. 2003). Without knowing these parameters, the metes and bounds of the claimed subject matter are not reasonably clear. Similar is applied to claim 12. Clarification is required.
Claims 2, 5, 8-9, 14-15 are rejected as being dependent on rejected independent claim 1 and failing to cure the defect.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Arkin et al., US 2019/0015369 (cited in IDS; hereinafter referred to as Arkin), and Toledano et al., US 2013/0095185 (cited in IDS; hereinafter referred to as Toledano).
Arkin teaches stabilized topical compositions for treating a skin disease/disorder such as acne, psoriasis, rosacea by administering said compositions to a subject in need thereof (Title; Abstract; Para. 0002, 0003), wherein said compositions include:
(a) a plurality of core-shell microcapsules comprising: (i) a core in form of oil solution and/or dispersion (Para. 0065) comprising a retinoid/tretinoin (ATRA); and (ii) a shell comprising an inorganic polymer/silica polymer; and wherein (iii) retinoid/tretinoin is present in said compositions in an amount of 0.05-0.1 wt% (Para. 0017-0023, 0065-0066, 0071, 0167, 0263-0266, Examples 1, 5 as applied to claim 1); and
(b) a plurality of core-shell microcapsules comprising: (i) a core comprising benzoyl peroxide; and (ii) a shell comprising an inorganic polymer/silica polymer; and (iii) wherein benzoyl peroxide is present in said compositions in an amount of 3-6 wt% (Claims 1, 4; Para. 0017-0023 as applied to claim 1); and
(c) wherein said microcapsules are carried in an emulsion, a cream, a lotion, a paste, a gel (Abstract; Para. 0059, 0189, Examples as applied to claim 1).
Arkin teaches that said compositions comprise solid particulate benzoyl peroxide and solid particulate retinoid/tretinoin/ATRA, and the core can be in a form of a dispersion (Claims 1, 17; Abstract; Para. 0002 as applied to claims 2-4).
Arkin teaches preparation of encapsulated benzoyl peroxide (Para. 0285-0287) that include such steps: (a) mixing benzoyl peroxide with such cationic surfactant as cetrimonium chloride/CTAC, and water (Para. 0285 as applied to claims 6, 7, 13); (b) adding to (a)-mixture sodium silicate, a cationic polymer such as poly(dimethyldiallylannnonium chloride)/PDAC, a mixture of citric acid and lactic acid (i.e., weak acids), and water (Para. 0286, 0287 as applied to claims 6-10, 13, 15).
Arkin teaches that said compositions are stable at ambient conditions for 3 months (Para. 0298-0307 as applied to claim 1).
Toledano teaches stabilized topical formulations/compositions that can be applied to skin for treatment of acne, psoriasis, etc., wherein said compositions contain stabilized core-shell microcapsules, i.e., (i) microcapsules having a core comprising a retinoid/tretinoin, oil, and other additives and a shell that comprises an inorganic polymer, and a stabilizing agent; (ii) microcapsules having a core comprising benzoyl peroxide and a shell that comprises an inorganic silica polymer; and (iii) wherein said compositions can be in form of a cream, an aqueous solution, an oil, an ointment, a paste, a gel, a lotion, and a suspension (Title; Abstract; Para. 0003, 0007, 0022, 0034, 0079-0081, 0089 as applied to claim 1).
Toledano teaches that (i) retinoid/tretinoin can be present in said compositions in an amount of 0.01-0.1 wt%; and (ii) benzoyl peroxide can be present in said compositions in an amount of 1-10 wt% (Para. 0034-0037, 0044-0046 as applied to claim 1), and said compositions are stable for 3 months during the storage at room temperature 25 oC (Para. 0247 as applied to claim 1).
Toledano teaches preparation of encapsulated benzoyl peroxide (Example 1) that include: (a) mixing benzoyl peroxide with such cationic surfactant as cetrimonium chloride/CTAC, and water; (b) adding to (a)-mixture sodium silicate, a cationic polymer such as poly(dimethyldiallylannnonium chloride)/PDAC, a mixture of citric acid and lactic acid (i.e., weak acids), and water (Para. 0228-0230 as applied to claims 6-10, 13, 15).
Toledano teaches that said compositions are stable at ambient conditions for 3 months (Para. 0241-0250 as applied to claim 1).
Therefore, the examiner maintains the position that the claimed invention, as a whole, would have been prima facie obvious to one of ordinary skill in the art at the time the invention was filed, because every element of the invention has been taught by the teachings of the reference cited. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare compositions to be used for skin treatment and comprising tretinoin microcapsules and benzoyl peroxide microcapsules as taught by Toledano and Arkin. One would do so with expectation of beneficial results, because the cited prior art teaches the compositions comprising a combination of tretinoin and benzoyl peroxide that can be administered concomitantly and exhibit long term physical/chemical/microbial stability.
With regard to the concentration of tretinoin in a core (claim 5), 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.
Claims 11, 12 are rejected as being dependent on rejected claims. Further, regarding product-by-process claims 6-15 it is noted that product-by-process claims do not carry any patentable weight unless there is factual evidence to the contrary. MPEP 2113. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). As a practical matter, the Patent Office is not equipped to manufacture products by the myriad number of processes put before it and then obtain prior art products and make physical comparisons therewith. In re Brown, 459 F.2d 531, 535, 173 USPQ 685, 688 (CCPA 1972). Therefore, with the showing of the reference, the burden of establishing non-obviousness by objective evidence is shifted to the applicants. Regarding the claimed properties of the disclosed compositions such as microencapsulation efficiency (claims 1, 16), it is noted that the cited prior art teaches compositions comprising the same components. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and/or effects would also be provided.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
US 2019/0015368 (cited in IDS) – teaches a method of treatment skin conditions by topically applying to the skin a composition comprising core-shell microcapsules, wherein said microcapsules comprise in the core tretinoin or benzoyl peroxide; and a shell comprising silica polymer.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 8-10 of U.S. Patent No. 12,357,602
Although the conflicting claims are not identical, they are not patentably distinct from each other, because prior patents also claim: A topical composition comprising (i) core-shell microcapsules comprising tretinoin in the core; (ii) core-shell microcapsules comprising benzoyl peroxide in the core; and (iii) carrier/excipient. Further, cited prior patents also teach that the microencapsulation efficiency of tretinoin is at least 90%, and microencapsulation efficiency of benzoyl peroxide is at least 75%. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents.
Claims 1-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4-5, 10 of copending Application No. 19/267,732.
Although the conflicting claims are not identical, they are not patentably distinct from each other, because the subject matter claimed in the instant application is fully disclosed in the referenced copending applications and would be covered by any patent granted on that copending application since the referenced copending application and the instant application are claiming common subject matter, as follows: A composition comprising (i) microcapsules comprising a core containing solid tretinoin, and wherein said tretinoin is present in an amount of 0.01%-0.1% by weight of the composition; and (ii) microcapsules comprising solid benzoyl peroxide; wherein said benzoyl peroxide is in an amount of 3% by weight of the composition. In the present case, the instant claims are merely broader than copending application claims that include additional limitation (i.e., core comprising oil and phase changing material) and therefore are more specific. Therefore, the claimed invention is directed to the same invention or is an obvious variation of the inventions claimed in said prior patents. This is a provisional obviousness-type double patenting rejection, because the conflicting claims have not in fact been patented.
Response to Arguments
Applicant's arguments, filed 02/18/2026, have been fully considered, but they were not found to be persuasive for the reasons set forth above. New arguments and/or rejections have been added to the record to clarify the position of the examiner and/or to address newly introduced amendments. Additional examiner comments are set forth next.
In response to the applicant’s argument that the instant specification provides a clear description for the “microencapsulation efficiency”, it is noted that independent claim 1 discloses compositions comprising microcapsules with tretinoin or benzoyl peroxide in combination with carrier or excipient, wherein said compositions are stable for up to 12 weeks. To this point, it is noted that it is well known in the field that properties of multicomponent systems (i.e., compositions) depends on compounds included (e.g., components of microcapsules, carriers, excipients, etc.) as well as on concentrations and distribution of said compounds that define the network of intermolecular interactions, and thereby physical and chemical properties of the system/composition. “Claiming a result without reciting what materials produce that result is the epitome of an indefinite claim. Such a claim fails to delineate with any reasonable certainty the requirements of the formulation.” See Forest Labs., Inc. v. Teva Pharms. USA, Inc. 2017 U.S. App. LEXIS 24877. Further, it is noted that “[i]f a claim is amenable to two or more plausible constructions, applicant is required to amend the claim to more precisely define the metes and bounds of the claimed invention or the claim is indefinite under §112, ¶ 2. Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (expanded panel).” Furthermore, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims.” See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to the applicant’s argument that the cited prior art does not teach “microencapsulation efficiency of 90 wt%, it is noted that the cited prior art teaches compositions comprising the same components. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and/or 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.” See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
The Declaration under 37 C.F.R. §1.132, filed 02/18/2026, has been considered and is insufficient to overcome 103-rejection of record. First, it is noted that said declaration recites the Office Action from different application, i.e., 17/327,739. Second, in response to the applicant’s argument that examples recited in the cited prior art do not have microencapsulation efficiency as instantly claimed, it is noted that “A reference is not limited to working examples.” In re Fracalossi 215 USPQ 569 (CCPA 1982). “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). As stated above, one skilled in the art would have understood that properties of multicomponent systems depend on compounds included as well as on concentrations and 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 cited prior art teaches compositions comprising the same components. Therefore, it is expected that since the prior art is comprised of the same components, the same beneficial properties and/or effects would also be provided. The determination of suitable or effective concentration/composition (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. To this point, it is noted that the applicant shows that same compositions works better than others, but does not explain what is unexpected. Applicant is advised to clarify the claim language, the structure of the claimed compositions 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 in condition for allowance.
Conclusion
No claim is allowed at this time.
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.
Correspondence
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert A. Wax can be reached at (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/OLGA V. TCHERKASSKAYA/
Examiner, Art Unit 1615
/Robert A Wax/Supervisory Patent Examiner, Art Unit 1615
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