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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 03/19/2026 has been entered.
Status of Claims
Claims 1, 3-5, 8-9, and 11-17 are pending.
Priority
Instant application 17/774,981, filed 05/06/2022 claims priority as follows:
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Acknowledgment is made of applicant's claim for foreign priority based on an application filed in India on 11/06/2019. It is noted, however, that applicant has not filed a certified copy of the IN 201941044971 application as required by 37 CFR 1.55.
Information Disclosure Statement
All references from IDS(s) received 09/07/2022 have been considered unless marked with a strikethrough.
Response to Amendment/Arguments
The amendment filed 03/19/2026 has been entered. Applicant has amended claims 1, 4, 5, 8, 11-15, and 17.
Claims 5 and 11-17 were previously rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement. In view of the amendments to the claims, applicant has overcome the rejection. Therefore, the previous rejection under 112(a) is withdrawn.
Claims 14 was previously rejected under 35 U.S.C. 112(b) as indefinite. Claim 2, 6-7, and 10 have been cancelled, rendering the rejection over these claims moot. In view of the amendments to the claims, applicant has overcome the rejection. Therefore, the previous rejection under 112(b) is withdrawn.
Claims 1, 3-5, 8, 9, 11-12, and 14-17 were previously rejected under 35 U.S.C. 102(a)(1) and/or 102(a)(2) as being anticipated by ABRAHAM (WO2017216738A1). In view of the amendments to the claims, applicant has overcome the rejection. Therefore, the previous rejection under 102(a)(1) and/or 102(a)(2) over ABRAHAM is withdrawn.
Claims 1, 3-5, and 8-9 were previously rejected under 35 U.S.C. 103 as being unpatentable over ABRAHAM in view of SREEDHARALA (WO2017168433A1). In view of the amendments to the claims, applicant has overcome the rejection. Therefore, the previous rejection under 103 over ABRAHAM in view of SREEDHARALA is withdrawn.
Multiple claims were previously rejected on the grounds of nonstatutory double patenting over U.S. Patent No. US 11,110,077; or were provisionally rejected on the grounds of nonstatutory double patenting over copending Application Nos. 17/920,602, 16/481,257, 17/378,758, and 17/278,194. Application Nos. 17/920,602 and 17/278,194 were abandoned as of 02/26/2026 and 01/15/2026, rendering these rejections moot. In view of the amendment to the claims, Applicant has overcome the remaining double patenting rejections over US 11,110,077 and copending Application Nos. 16/481,257 and 17/378,758. Therefore, the previous double patenting rejections are withdrawn.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 appears to contain a typographical error. In line 3, the “,” between “w/w” and “a gelling agent” should be replaced with the word “and”. Otherwise, the claim reads as though apremilast, a gelling agent, or a combination thereof are selected. This does not make sense because the wherein clause later in the claim requires both the apremilast and gelling agent to be present in a particular ratio range. Appropriate correction is required.
Applicant is advised that should claim 11 be found allowable, claim 12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
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.
Claims 1, 3-5, 8-9, 11-12, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over DUBEY (IN 201911015370 A; published 23 October 2020).
Applicant cannot rely upon a certified copy of the foreign priority application (IN 201941044971) to overcome this rejection because said application has not been made of record in accordance with 37 CFR 1.55.
Dubey is drawn to topical apremilast compositions (page 17, ABSTRACT).
With respect to claims 1, 5, and 8, Dubey teaches low dose clear topical compositions of apremilast comprising apremilast in the range of 0.01 to 2 w/w% (page 5, [16]). The apremilast range taught by Dubey overlaps with the claimed ranges. Dubey additionally teaches the addition of a gelling agent in the range of 0.3 to 3 w/w%. The gelling agent taught by Dubey overlaps with the claimed ranges. The identities of the gelling agents taught by Dubey also read on the claims (see Table 1 of Dubey, e.g. Carbapol, which is a cross linked polyacrylic acid polymer). As stated in MPEP 2144.05, “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.”
Dubey fails to teach the recited ratio range between apremilast and the gelling agent of “1:10 to 1:100”.
However, Dubey teaches that the composition comprises 0.01 to 2 w/w% of apremilast and 0.3 to 3 w/w% of gelling agent. Dubey teaches that a gelling agent concentration ranging between 0.3 to 3 w/w% was optimal based on desired rheological properties: gelling agent less that 0.3% w/w produced low viscosity gel with high fluidity; and gelling agent more than 3% w/w produced high viscosity gel with poor extrudability (page 11, para. [35]). In other words, Dubey teaches that the gelling agent is a result effective variable.
Differences in result-effective variables will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating the value of the result-effective variable is critical. See MPEP 2144.05. In the instant case, the concentration of apremilast relative to gelling agent is considered a result-effective variable that impacts, for example, the viscosity of the gel and the amount of apremilast delivered in a unit of gel. Absent a showing of criticality, optimizing result-effective variables is deemed routine optimization.
Accordingly, claim 1 is obvious over Dubey.
With respect to claim 3, Dubey teaches apremilast gel/cream/ointment (page 6, [19]).
Accordingly, claim 3 is obvious over Dubey
With respect to claims 4 and 9, Dubey teaches multiple excipients which read on the claims. For example, Dubey teaches preservatives, surfactants (solubilizers), humectants (moisturizers), and neutralizing agents (alkalizer) in Table 1 (page 10).
Accordingly, claims 4 and 9 are obvious over Dubey.
With respect to claims 11 and 12, as noted for claim 1, Dubey teaches amounts of apremilast and gelling agent overlapping with the ranges recited in the claims. Moreover, Dubey teaches the addition of a surfactant in the range of 0.5-2% w/w, which overlaps with the range of 1-30% w/w recited for item (i) in the carrier; teaches 1-25% w/w of a humectant, which overlaps with the range of 5-40% w/w recited for item (iii) in the carrier; and teaches 0.0001-0.05% w/w of a preservative, which overlaps with the range of 0.05-5% recited for item (iv); and teaches at least one additional excipient (neutralizing agent, lipid).
Accordingly, claims 11 and 12 are obvious over Dubey.
With respect to claim 14, Dubey teaches various gelling agents including a cross linked polyacrylic acid polymer in Table 1 (e.g., Carbopol).
Accordingly, claim 14 is obvious over Dubey.
With respect to claim 15, Dubey teaches various moisturizers including propylene glycol, polyethylene glycol, butylene glycol in Table 1.
Accordingly, claim 15 is obvious over Dubey.
With respect to claim 17, Dubey teaches various excipients reading on the claim including glycerin in Table 1 or water in para. [33].
Accordingly, claim 17 is obvious over Dubey.
Claims 13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over DUBEY (IN 201911015370 A; published 23 October 2020) in view of SREEDHARALA (WO2017168433A1; published 05 Oct. 2017; cited in IDS).
The teachings of Dubey are disclosed above and at least those teachings are incorporated herein by reference. Dubey teaches low dose clear topical compositions comprising apremilast and the other elements of claim 11 as noted in the rejection above.
With respect to claim 13, Dubey fails to teach one of the solubilizers recited in the claim. However, Shreedharala, which is drawn to topical apremilast compositions, teaches adding carriers such as DMSO to topical apremilast compositions as a skin penetration enhancer (see e.g. page 5, lines 22-28).
Finding of prima facie obviousness
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham. See MPEP 2143.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR rationale (A) and/or (G), it would have been prima facie obvious to add DMSO to the topical apremilast composition taught by Dubey in view of Sreedharala’s teachings. A person having ordinary skill would have reasonably expected that adding DMSO would increase the skin penetrating properties of the apremilast.
Accordingly, claim 13 is obvious over Dubey in view of Sreedharala.
With respect to claim 16, Dubey teaches preservatives but fails to teach one of the preservatives recited in the claim. However, Shreedharala, which is drawn to topical apremilast compositions, teaches adding preservatives such as methyl paraben to topical apremilast (see e.g. page 7, lines 6-15).
Applying KSR rationale (B) and/or (G), it would have been prima facie obvious to substitute the preservative taught by Dubey with one of the preservatives, such as methyl paraben, taught by Sreedharala. A person having ordinary skill would have reasonably expected that adding methyl paraben would have functioned as a preservative in Dubey’s topical apremilast composition.
Accordingly, claim 16 is obvious over Dubey in view of Sreedharala.
Conclusion
Claims 1, 3-5, 8-9, and 11-17 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Kyle Nottingham whose telephone number is (571)270-0640. The examiner can normally be reached M-F from 10:00 am - 6:00 pm.
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/K.N./Examiner, Art Unit 1621
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