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Withdrawn rejections
Rejection of claims 56-60 under 35 USC 112(b) is withdrawn in view of amendments filed on 1/12/26
New rejection
Claim Rejections - 35 USC § 112
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 41-50, 54-57, and 59-61 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 41 has been amended on 1/12/26 to add the limitation “an emulsified component consisting of”. There are two interpretations of this limitation:
The topical composition comprises only one emulsifier which is cross-linked homopolymer based on acrylic acid.
The topical composition can comprise more than one emulsifier, but one component of the emulsifier consists of cross-linked homopolymer based on acrylic acid.
Maintained rejections
Rejection of claims 41-61 under 35 USC 103 over Dow et al is maintained. Reply to applicants’ remarks follows the repeated text of the rejection of record. Claims 51-53 and 58 have been canceled in the amendment filed on 1/12/26. The text of the rejection has been modified to reflect the changes in the amendment.
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.
Claim interpretation
Claim 41 has been amended the recite “an emulsifier component consisting of a cross-linked homopolymer based on acrylic acid”. Since Dow’s recitation of Carbomer homopolymer type A is interpreted as meeting the new limitation. Carbomer homopolymer type A represents an emulsifier component consisting of a cross-linked homopolymer based on acrylic acid.
Claims 41-50, 54-57, and 59-61 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dow et al (US 2016/0367570 A1).
Scope of prior art
Dow et al teach topical compositions and their utility in a method of treating psoriasis. Regarding compositions Dow et al teach halobetasol propionate and tazarotine as active ingredients and state that in addition to active ingredients the composition comprises one or more dermatologically acceptable ingredients such as liquid oils, waxes, viscosity modifying agents, etc (paragraph [0039] provides full list of types of excipients that can be present). Regarding emulsifying agents, Dow et al teach “A surfactant or emulsifier is included, if desired or required” and teach sorbitan monooliate as well as copolymers of acrylic acid and acrylate esters (pemulen) as suitable emulsifying agents (paragraphs [0042] and [0043]).
In Table 3, paragraph [0054], Dow et al teach an example of their emulsion composition comprising:
Hapobetasol propionate
Diethyl Sebacate – 2.97wt%
Sorbitan monooleate – 0.1wt%
Carbomer homopolymer type A – 0.6wt%
Carbomer copolymer type B (Pemulen) – 0.4wt%
Water
The composition is adjusted to pH 5.5.
Ascertaining the difference
Current claims are directed to a method of delivering an agent to a subject. While Dow teaches a topical composition and describes its utility in treatment of psoriasis, no example where composition described in Table 3 is applied to a subject is presented.
Current claim 56 is directed to the claimed composition comprising an anionic surfactant
Current claim 57 is directed to the claimed composition comprising a cationic surfactant
Claims 58 and 61 are directed to a composition where the composition does not comprise a second emulsifier and specifically does not comprise Carbomer copolymer type B.
Obviousness
With regards to applying the composition of Dow to a subject, a skilled artisan would have found it obvious to utilize the composition of Dow in a method for which it is intended. Dow describes topical treatment of psoriasis and one would have found it obvious to topically administer the composition to a subject in need of treatment for psoriasis. In administering the limitations directed to “a method of delivering an agent to a subject in need” is met.
Claims 58 and 61:
One skilled in the art prior to the earliest effective filing date of the instant application would have found it obvious to modify the composition of Dow and arrive at the instantly claimed composition which can then be administered to a subject with psoriasis.
At issue is whether it would have been obvious for one skilled in the art to exclude carbomer copolymer type B from the composition in paragraph [0054] of Dow. Dow teaches that one or more emulsifying agent can be present in a composition. Sorbitan monooleate which is included in the Dow composition is an emulsifying agent. One would have found it obvious to exclude carbomer copolymer type B with an expectation that the resulting composition would be suitable for treatment of psoriasis. The resulting composition would have the required active components and additional excipients within the scope of Dow’s disclosure.
This rejection can be overcome by a showing of unexpected results. Examiner has considered the results presented in the instant specification. Example 2, Table 2 on page 27 of the specification (paragraphs [0091] – [0093]) presents data comparing stability of formulations A through D have different carbomers of mixtures thereof present. This example represents comparative analysis of the instantly claimed composition and composition of Dow. Formulations B and D represent instant composition, Formulation A represents formulation of Dow. In paragraph [0093] specification states that all of the compositions were found to be stable. This finding supports the argument presented in this rejection. Composition with and without carbomer copolymer type B are equivalent.
Claims 56 and 57:
Daw teaches surfactant in the composition and exemplifies sorbitan monooleate, a non-ionic surfactant. However, in paragraph [0042], Dow teaches that while non-ionic surfactant is preferred, cationic and anionic surfactants are also within the scope of the described composition and can be used. A skilled artisan would have found it obvious to use an alternative disclosed embodiment such as an anionic or a cationic surfactant because they are disclosed by Dow as suitable excipients in the composition.
Reply to applicant’s remarks
Applicant’s remarks filed on 1/12/26 have been considered. Applicants argue that the amendment limits the claims to a single emulsifier present in the composition. However, the claims are not limited to a single emulsifier for the reasons set forth in the 35 USC 112(b) rejection above. Additionally, claim 61 specifically excludes cross-linked copolymer of acrylic acid and acrylic acid esters. The fact that applicants are including a claim that excludes additional emulsifier, further supports examiner’s position that the independent claim is not limited to only one.
Even if claims were interpreted as requiring a single emulsifier, the teachings of Daw still render the claims obvious. Daw teaches that one or more emulsifier may be present in the composition. Presence of carbomer copolymer type B in the composition of Dow is optional. The compositions without are therefore within the scope of the invention.
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 41-50, 54-57, and 59-61 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,364,198. Although the claims at issue are not identical, they are not patentably distinct from each other. Claims of the ‘198 patent are directed to a topical composition. The claimed composition is the same as the composition used in the currently claimed method. Since the sole disclosed utility of the composition claimed in the ‘198 patent is for delivering an active agent, it would have been obvious for a skilled artisan to deliver an active agent by administering to a subject the composition of the ‘198 patent.
Claims 41-50, 56, 59 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 20-21 of U.S. Patent No. 10,653,656. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘656 patent is directed to a composition comprising:
An active agent, water (claim 1)
Carbomer copolymer type B (claim 3)
Carbomer homopolymer type A (claim 6)
Mineral oil (claim 5)
Claim 20 of ‘656 includes all of the above components in a single claim in the instantly claimed amounts. Claim 21 is directed to a method comprising administering the composition.
Claims 41-50, 54-57, 59 and 60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 15, 16 and 17 of U.S. Patent No. 11,648,256. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘256 patent is directed to a composition comprising (claim 16):
Active agent
Liquid oil component
Purified water
Carbomer copolymer type B
Carbomer homopolymer type A
Claim 17 teaches addition of a pH adjusting agent.
Claim 15 teaches addition of surfactant. It would be obvious to add non-ionic, cationic or anionic surfactant.
While claims of the ‘256 patent to not recite the relative amount of components in the composition, a skilled artisan would have found it necessary to consult the specification in order to know how much of each component to include in the composition. Table 4 of the specification recites the currently claimed amounts.
Lastly, while claim 16 is directed to a composition, not a method of delivering an agent, it would have been obvious to for one skilled in the art to administer the composition topically to a subject in need of treatment for psoriasis. Claim 16 recites treatment of psoriasis as the intended use of the composition.
Claims 41-50, 54-57, 59 and 60are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 15 of U.S. Patent No. 11,679,115. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘115 patent is directed to the composition that is within the scope of the currently claimed composition. Claim 15 is directed to a method of treating psoriasis by administering the composition of claim 1.
Claims 41-50, 54-57, 59 and 60are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 11,679,116. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of the ‘116 patent is directed to the composition that is within the scope of the currently claimed composition. Claim 2 is directed to a method of treating psoriasis by administering the composition of claim 1.
Conclusion
Claims 41-50, 54-57, and 59-61 are pending
Claims 41-50, 54-57, and 59-61 are rejected
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 YEVGENY VALENROD whose telephone number is (571)272-9049. The examiner can normally be reached Mon-Fri 9am-5pm.
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/YEVGENY VALENROD/Primary Examiner, Art Unit 1628