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 .
Receipt is acknowledged of Applicant’s Amendment and Declaration filed on 02/24/2026.
Claims 1 and 5 are amended.
Claim 8 is canceled.
Claims 1-7, 10-12 are pending in the instant application.
Claim 12 has been previously withdrawn from consideration.
Note, rejections and objections not reiterated from previous office actions are hereby withdrawn. The following rejections or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Declaration under 37 CFR 1.132
The Declaration under 37 CFR 1.132 filed 02/24/2026 is insufficient to overcome the rejection as set forth in the last Office action because of the reasons discussed below in the Response to Argument section.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-7, 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 11,260,035 in view of KARAMI et al (On iontophoretic delivery enhancement: Ionization and mobility of lidocaine hydrochloride in propylene glycol. International Journal of Pharmaceutics 168 (1998) 85–95).
The patent recites a topical composition comprising a topical skin composition comprising: about 4% w/w lidocaine (active ingredient) or a salt thereof; about 1% w/w poloxamer 407 (nonionic surfactant); about 0.2% w/w poloxamer 188; about 0.25% w/w polyoxyl castor oil; about 0.75% w/w menthol; and about 1% w/w carbomer (viscosity enhancer), wherein w/w denotes weight by total weight of the composition.
The patent does not teach using a permeation enhancer, such as propylene glycol.
KARAMI teaches the prior art had known of using penetration enhancers, such as propylene glycol, to enhance the drug delivery of topical lidocaine drug (see abstract; pg. 86 1st col). Additional disclosures include: synergistic effect can be found with combination with other penetration enhancers, such as oleic acid and/or ethanol, and surfactants (see pg. 85-86, under Introduction), wherein all formulations containing propylene glycol produced significantly greater anesthesia compared with the formulations without propylene glycol (see pg. 86, 1st col).
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate permeation enhancers, such as propylene glycol. The person of ordinary skill in the art would have been motivated to make those modifications, because the penetration enhancer would increase the skin penetration of the lidocaine drug and produced significantly greater anesthesia compared with the formulations without propylene glycol, and reasonably would have expected success because penetration enhancers are well-known in the prior art, such as topical formulations.
Claims 1-7, 10-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over U.S. Patent No. 12,508,221.
The patent recites a topical composition comprising lidocaine or a salt thereof, one or more nonionic surfactants, one or more viscosity enhancers, a mixture of propylene glycol monolaurate and propylene glycol at a ratio of about 1:9 and ethanol (see claim 1), wherein the one or more nonionic surfactants are selected from the group consisting of poloxamer 407, poloxamer 188 and polyoxyl 35 castor oil (see claim 4), wherein the one or more viscosity enhancers are selected from the group consisting of sodium carboxymethyl cellulose and carbomer 974P (see claim 7).
The difference between instant application and the patented claims is that the patent claims include additional limitations. Thus, the invention of the patent is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”, and, therefore, the application claims are not patentably distinct from the claims of the patent and are rejected on the ground of nonstatutory obviousness-type double patenting. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993).
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.
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(s) 1-7, 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over HORN (US 2019/0262290) in view of KARAMI et al (On iontophoretic delivery enhancement: Ionization and mobility of lidocaine hydrochloride in propylene glycol. International Journal of Pharmaceutics 168 (1998) 85–95) and CARRARA et al (US 2006/0153905).
HORN teaches a composition comprised of: an active ingredient, such as lidocaine (see abstract); nonionic surfactants, such as poloxamer 407, poloxamer 188 and polyoxyl 35 castor oil (see [0057] and [0193); viscosity enhancers, such as propylene glycol, carbomers, and carboxymethyl cellulose (see [0200]); and oleic acid (see Table 8, #225), which is a permeation enhancer. Additional disclosures include: ophthalmological drug vehicles (see [0174]) and skin drug vehicles (see [0177]); menthol (see [0068]); increase drug permeation (see [0012] and [0174]). Note, propylene glycol can be both a viscosity enhancer and a permeation enhancer.
HORN does not teach using propylene glycol as a permeation enhancer; or using a specific carbomer, such as carbomer 974P.
KARAMI teaches the prior art had known of using penetration enhancers, such as propylene glycol, to enhance the drug delivery of lidocaine drug (see abstract). Additional disclosures include: synergistic effect can be found with combination with other penetration enhancers, such as oleic acid and/or ethanol, and surfactants (see pg. 85-86, under Introduction), wherein all formulations containing propylene glycol produced significantly greater anesthesia compared with the formulations without propylene glycol (see pg. 86, 1st col).
CARRARA teaches the prior art had known of carbomers, such as carbomer 974P. (see [0079]). Thus, it would have been obvious to use carbomer 974P as the carbomer viscosity enhancer taught in HORN.
It would have been obvious to the person of ordinary skill in the art at the time the invention was made to incorporate a permeation enhancer, such as propylene glycol. The person of ordinary skill in the art would have been motivated to make those modifications, because the penetration enhancer would increase the skin penetration of the lidocaine drug and produced significantly greater anesthesia compared with the formulations without propylene glycol, and reasonably would have expected success because penetration enhancers are well-known in the prior art, such as topical formulations.
Response to Arguments
Applicant argues that neither Horn nor Carrara teach any of the specifically claimed permeation enhancers. Further, Applicant has demonstrated evidence of unexpected results. Specifically, in Example 1 of the Instant Specification, Applicant has demonstrated that Formulations #6-#8, each of which are covered by the Instant Claims, provide superior penetration of lidocaine than industry standards Salonpas® Cream and Salonpas® Gel Patch and Formulation #7 further provide superior penetration of lidocaine than Aspercreme®. Further, as seen in the 132 declaration ("Nallakrishnan Declaration"), submitted herewith, Applicant has demonstrated that formulations of the Instant Invention provide superior penetration of diclofenac over the industry standard Omni Gel and Voltaren Gel. Specifically, a composition of the Instant Invention provided 1.6 times better average flux than Omni Gel and 1.2 times better average flux than Voltaren Gel. Thus, Applicant has demonstrated unexpected results that the Instantly Claimed compositions provide superior penetration of the claimed actives as compared to industry standards.
The Examiner finds this argument unpersuasive, because in order to overcome a prima facie case of obviousness, it is incumbent upon the Applicant to provide comparative test evidence that demonstrates unexpected superiority of the claimed compositions versus the closest prior art compositions, and not simply an advantage predictable from the prior art. See In re Chapman, 148 USPQ 711, 715 (CCPA, 1966). Moreover, such proffered comparisons must be commensurate in scope with the breadth of the claims. See In re Clemens, 206 USPQ 289, 296 (CCPA, 1980) and In re Coleman, 205 USPQ 1172, 1175 (CCPA 1980). In this instance, (1) Applicant’s proffered comparisons are not commensurate in the scope of the claims, wherein Applicant’s Formulation #6-8 use specific nonionic surfactants, such as poloxamer 408 and poloxamer 188, and polyoxyl 35 castor oil, and propylene glycol/monolaurate propylene glycol and other specific ingredients, (2) as discussed in the rejection, the prior art KARAMI teaches the prior art had known of using penetration enhancers, such as propylene glycol, to enhance the drug delivery of lidocaine drug (see abstract). Additional disclosures include: synergistic effect can be found with combination with other penetration enhancers, such as oleic acid and/or ethanol, and surfactants (see pg. 85-86, under Introduction), wherein all formulations containing propylene glycol produced significantly greater anesthesia compared with the formulations without propylene glycol (see pg. 86, 1st col); (3) Applicant’s claims recited other drugs and permeation enhancers.
Applicant argues that Claims 1-11 are provisionally rejected on the ground of nonstatutory double patenting as unpatentable over copending Application No. 17/469,012. The '012 application recently issued as US Patent No. 12,508,221. Applicant herewith submits a terminal disclaimer over the '221 patent. Accordingly, this rejection is moot.
The Examiner finds this argument unpersuasive, because no terminal disclaimer was filed.
Conclusion
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.
Telephonic Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAKE MINH VU whose telephone number is (571)272-8148. The examiner can normally be reached Mon-Fri 9:00am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Hartley can be reached at (571) 272-0616. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAKE M VU/Primary Examiner, Art Unit 1618
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