DETAILED ACTION
The receipt is acknowledged of applicants’ amendment and request for RCE filed 02/19/2026.
Claims 1, 3, 4, 6, 8, 10-12 and 25-30 previously presented. Claims 3, 6, are currently canceled.
Claims 1, 4, 8, 10-12 and 25-30 are pending.
Claim 11 is previously withdrawn from further consideration with traverse pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention of Group III, there being no allowable generic or linking claim.
Claims 1, 4, 8, 10, 12 and 25-30 are subject of this office 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/19/2026 has been entered.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claims 1, 4, 8, 10, 12, 25, 27, 29 are rejected under 35 U.S.C. 103 as being unpatentable over any of WO publication 2016/164315 (IDS filed 03/13/2023, hereinafter WO ‘315) or WO publication 2018/071278 (IDS filed 03/13/2023, hereinafter WO ‘278), each WO publication in view of Colombo et al. (US 2010/0008972, previously cited on PTO 892) and further each WO publication in view of Mantelle (US 5,332,576, currently cited on PTO 892).
Applicant Claims
Claim 1 is directed to a gel composition for use as a conformable film bandage, the gel composition comprising:
a silicone containing, film-forming polymer;
an amine-rich adhesion promoter;
about 60 wt. % to about 80 wt. % of a volatile solvent;
a penetration enhancer comprising diisoproyl adipate, dipropylene glycol, ethyl oleate,
glyceryl monooleate, isopropyl palmitate, isostearic acid, lauryl lactate, methyl laurate, octisalate, octyldodecanol, oleyl alcohol, oleyl oleate, sorbitan monooleate, triacetin, or a combination thereof; and
active ingredient,
wherein a film cast from the gel composition is self-supporting on a biological substrate and can be peeled off the substrate.
Claim 10 is directed to a gel composition for use as a conformable film bandage, the gel composition comprising:
a silicone containing, film-forming polymer;
an amine-rich adhesion promoter;
about 60 wt. % to about 80 wt. % of a volatile solvent;
a penetration enhancer comprising diisoproyl adipate, dipropylene glycol, ethyl oleate,
glyceryl monooleate, isopropyl palmitate, isostearic acid, lauryl lactate, methyl laurate, octisalate, octyldodecanol, oleyl alcohol, oleyl oleate, sorbitan monooleate, triacetin, or a combination thereof; and
lidocaine.
Claim 12 is directed to a conformable film bandage comprising:
a silicone containing, film-forming polymer;
an amine-rich adhesion promoter;
about 60 wt. % to about 80 wt. % of a volatile solvent;
a penetration enhancer comprising diisoproyl adipate, dipropylene glycol, ethyl oleate,
glyceryl monooleate, isopropyl palmitate, isostearic acid, lauryl lactate, methyl laurate, octisalate, octyldodecanol, oleyl alcohol, oleyl oleate, sorbitan monooleate, triacetin, or a combination thereof; and
lidocaine.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
WO ‘315 teaches film forming gel composition useful for forming comfortable flexible gel film that is self-supporting when applied to substrate, e.g. skin. The gel composition comprises: silicone containing film forming polymer e.g. linear polydiorganosiloxane; amine-rich adhesion promoter, e.g. aminopolymer including polyethyleneimine that can be linear or branched; at least 60%, e.g. 60-80%, volatile solvent preferably isooctane and hexamethyldisiloxane (HMDS); additives that can read on penetration enhancers, and active agent that can be lidocaine for local or systemic delivery. The reference teaches additives including glycerol monolaurate, propylene glycol monolaurate, fatty acid monoesters that can read on penetration enhancers (abstract; page 2, lines 1-18; page 4, lines 35-36; page 8, line 27; page 9, lines 1-6; page 10, lines 1-16; page 19, line 25 to page 20 line 35; page 23, lines 15-36; page 26, lines 35-36; page 27, lines 1-10; page 34, lines 19-20; page 35, lines 8-11, 29; Table 1).
WO ‘278 teaches film forming gel composition useful for forming comfortable flexible gel film that is self-supporting when applied to substrate, e.g. skin. The film forming composition comprises film forming silicone polymer including polydiorganosiloxane; amine-rich adhesion promotor comprising aminopolymers including polyethyleneimine; at least 60 % volatile solvent including isooctane and HMDS; and active agent, e.g. lidocaine, for local and systemic delivery. Other solvents can be used, e.g. dipropylene glycol dimethyl ether. The solvents taught by the reference can read on penetration enhancers, e.g., dipropylene glycol dimethyl ether, which is a species of the claimed dipropylene (abstract; ¶¶ 0002, 0005, 0006, 0030, 0041, 0045, 0048, 0051-0053, 0101-0104, 0125, 0162, 0164, 0176; Table 1; claims).
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While both WO publications teach the claimed gel composition comprising silicone film-forming polymer, amine-rich adhesion promoter, volatile solvent and suggest active agent including lidocaine, and further teach other ingredients in the composition that read on penetration enhancer, however, the references do not exemplify composition comprising lidocaine and penetration enhancer as claimed by claims 1, 10 and 12, and the references do not teach these two ingredients with sufficient specificity. For completeness of record, Colombo reference is cited.
While WO ‘278 teaches dipropylene glycol dimethyl ether that reads on the broadly claimed dipropylene glycol, the reference does mot teach the claimed dipropylene glycol. For completeness of record Mantelle reference is cited.
Colombo teaches single layer film for active ingredient dermal and transdermal administration containing film forming agent, penetration enhancer and active ingredient. The film is thin and self-supporting, and easily tolerated. Lidocaine is a preferred active ingredient as evidenced by its exemplification and being claimed. Penetration enhancer includes isopropyl myristate, oleic acid and diethylene glycol monoethyl ether. The film comprises 0.1-20% active agent (abstract; ¶¶ 0016, 0019-0023, 0028, 0038-0039; examples 1 and 5; claims 1, 15).
Mantelle teaches topical gel composition that is flexible and finite to deliver local anesthetic, preferably lidocaine. The composition comprises dipropylene glycol to provide proper consistency of the composition without negatively affect the adhesion property of the composition (abstract; col.4, lines 10-15; col.5, lines 20-30, 59-61; col.6, lines 12-20, 45-50; col.7, lines 53-55; examples 12-16, 20, 21, 23).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the film taught by any of WO ‘315 or WO ‘278 that may comprises lidocaine for local or systemic delivery and ingredients that enhance penetration of active agents through the skin, and confidently use lidocaine and penetration enhancer as taught by Colombo. One would have been motivated to do so because both WO publications desired to deliver active agent locally or systemically from self-supporting film and because Colombo teaches lidocaine is suitable to be delivered dermally or transdermally from self-supporting gel single layer that is thin and well tolerated. One would reasonably expect formulating single layer self-supporting film that deliver lidocaine locally or systemically through the skin wherein the delivery is enhanced by penetration enhancers.
Further one having ordinary skill in the art would have used dipropylene glycol taught by Mantelle in the gel composition comprising lidocaine as taught by the combination of WO ‘315, WO 278, Colombo, because Mantelle teaches gel composition comprising lidocaine is flexible and finite, and preferably deliver lidocaine and because dipropylene glycol provides proper consistency of the composition without negatively affects the adhesion property of the composition.
All the limitations of claims 1, 10 and 12 are taught by the combination of any of the WO publications combined with Colombo and Mantelle.
Regarding the amount of the volatile solvent as claimed by claims 1, 10 and 12 of 60-80%, WO ‘315 teaches at least 60%, e.g. 60-80%, and WO ‘278 teaches at least 60% that overlaps with the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the penetration enhancers claimed by claims 1, 10, 12, WO ‘315 teaches glycerol monolaurate, propylene glycol monolaurate, WO ‘278 teaches dipropylene glycol dimethyl ether, which is a species of the claimed dipropylene, and Colombo teaches isopropyl myristate, oleic acid and diethylene glycol monoethyl ether. Applicants failed to show unexpected results obtained from any specific penetration enhancer versus the other. Mantelle teaches the use of lidocaine with dipropylene glycol in topical gel composition that provides proper consistency of the composition without negatively affects the adhesion property of the composition.
Regarding lidocaine claimed by claims 4, 10 and 12, it is suggested by both WO publications and taught by sufficient specificity by Colombo and Mantelle.
Regarding the amount of lidocaine claimed by claim 8 of 1-5 %, Colombo teaches 0.1-20 % that embraces the claimed amount. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP 2144.05 [R-5].
Regarding the aminopolymers claimed by claims 25, 27 and 29 as amine rich adhesion promoter, this is taught by both WO ‘315 and WO ‘278.
Regarding silicone film forming polymer comprises polydiorganosiloxane as claimed by claims 25, 27 and 29, this is taught by both WO ‘315 and WO ‘278.
Regarding volatile solvents claimed by claims 25, 27 and 29, this is taught by both WO ‘315 and WO ‘278 that both teach the claimed isooctane and PDMS.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present invention.
Claims 26, 28 and 30 are rejected under 35 U.S.C. 103 as being unpatentable over WO ‘315 or WO 278, each combined with Colombo and Mantelle as applied to claims 1, 4, 8, 10, 12, 25, 27 and 29 above, and further in view of Jonn et al. (US 2006/0211820, previously cited on PTO 892).
Applicant Claims
Claims 26, 28 and 29 recite that the aminopolymer comprises a linear, branched, or dendrimeric polyethyleneimine; and the volatile solvent comprises isooctane and hexamethyldisiloxane.
Determination of the Scope and Content of the Prior Art
(MPEP §2141.01)
The combined teachings of WO ‘315 or WO ‘278, each combined with Colombo and Mantelle are previously discussed in this office action.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
While both WO ‘315 and WO ‘278 teach aminopolymer comprises a linear, branched, or dendrimeric polyethyleneimine, and both references teach isooctane and HMDS as volatile solvents, however the references do not teach their combination as claimed by claims 26, 28 and 30.
Jonn teaches topical composition that is solidifies when applied to skin or wound to form coating or film to provide flexible waterproof breathable, non-stinging protective coating that can contain active agents to be delivered for treating the area of application. The film comprises linear or branched polydimethylsiloxane polymer and volatile solvents. The volatile solvent comprises d combination of isooctane and HMDS (abstract; ¶¶ 0004-0010, 0021-0023, 0039; examples 2 and 3).
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP §2142-2143)
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide composition for skin application comprising polydimethylsiloxane polymer, polyethyleneimine, lidocaine and non-volatile solvents that selected from solvents containing isooctane or HMDS as taught by any of WO ‘315 or WO ‘278, each combined with Colombo and Mantelle, and use combination of both isooctane and HMDS as volatile solvents as taught by Jonn. One would have been motivated to do so because Jonn preferred and exemplified their combination in a topical composition when applied to the skin or wound to form coating or film to provide flexible waterproof breathable, non-stinging protective coating that can contain active agents to be delivered for treating the area of application. One would reasonably expect formulation topical composition comprising polydimethylsiloxane polymer, polyethyleneimine, lidocaine and combination of isooctane and HMDS wherein the composition forms flexible waterproof breathable, non-stinging protective coating to skin or wound while delivering active agents for treating the area of application.
Absent any evidence to the contrary, and based upon the teachings of the prior art, there would have been a reasonable expectation of success in practicing the instantly claimed invention. Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the present 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 1, 4, 8, 10, 12 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,497,828 in view of Mantelle (US 5,332,576, currently cited on PTO 892). The issued patent and the instant application are claiming common subject matter as follows: gel composition comprising: a silicone containing film-forming polymer; an amine-rich adhesion promoter; a volatile solvent; and active ingredient. The difference between the present claims and the claims of issued patent is that the issued claims do not recite the claimed penetration enhancers. The claimed penetration enhancers are taught by Mantelle, whose teaching are discussed above. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the composition claimed by the issued claims and add dipropylene glycol taught by Mantelle to the composition claimed by the issue patent because Mantelle teaches gel composition comprising lidocaine is flexible and finite, and preferably deliver lidocaine and because dipropylene glycol provides proper consistency of the composition without negatively affects the adhesion property of the composition. One would reasonably achieves the instantly claimed composition.
Claims 1, 4, 8, 10, 12 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 11,491,255 in view of Mantelle. The issued patent and the instant application are claiming common subject matter as follows: gel composition comprising: a silicone containing film-forming polymer; an amine-rich adhesion promoter; a volatile solvent; and active ingredient. The difference between the present claims and the claims of issued patent is that the issued claims do not recite the claimed penetration enhancers. The claimed penetration enhancers are taught by Mantelle, whose teaching are discussed above. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the composition claimed by the issued claims and add dipropylene glycol taught by Mantelle to the composition claimed by the issue patent because Mantelle teaches gel composition comprising lidocaine is flexible and finite, preferably deliver lidocaine and because dipropylene glycol provides proper consistency of the composition without negatively affects the adhesion property of the composition. One would reasonably achieve the instantly claimed composition.
Claims 1, 4, 8, 10, 12 and 25-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,603,405 in view of Mantelle. The issued patent and the instant application are claiming common subject matter as follows: gel composition comprising: a silicone containing film-forming polymer; an amine-rich adhesion promoter; a volatile solvent; and active ingredient. The difference between the present claims and the claims of issued patent is that the issued claims do not recite the claimed penetration enhancers. The claimed penetration enhancers are taught by Mantelle, whose teaching are discussed above. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the composition claimed by the issued claims and add dipropylene glycol taught by Mantelle to the composition claimed by the issue patent because Mantelle teaches gel composition comprising lidocaine is flexible and finite, preferably deliver lidocaine and because dipropylene glycol provides proper consistency of the composition without negatively affects the adhesion property of the composition. One would reasonably achieve the instantly claimed composition.
Claims 1, 4, 8, 10, 12, 25-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/576,822 (reference application) in view of Mantelle. Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter claimed in the instant application is fully disclosed in view of Mantelle. The referenced copending applications claims the instantly claimed subject matter. The difference between the copending claims and the instant claims is that the copending claims do not recite penetration enhancers as instantly claimed. The claimed penetration enhancers are taught by Mantelle, whose teachings are previously discussed in this office action. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the present invention to provide the composition claimed by the copending application, and add dipropylene glycol taught by Mantelle to the claimed composition because Mantelle teaches gel composition comprising lidocaine is flexible and finite, preferably delivers lidocaine and because dipropylene glycol provides proper consistency of the composition without negatively affects the adhesion property of the composition. One would reasonably achieve the instantly claimed composition.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive.
Rejections under 35 U.S.C. § 103
WO 315, WO 278 and Colombo
Applicants argue that independent claims 1 and 10 are drawn to gel compositions for use as a conformable film bandage. Independent claim 12 is drawn to a conformable film bandage. Each of claims 1, 10, and 12 is amended to specify "about 60 wt.% to about 80 wt.% of a volatile solvent," and further that the penetration enhancer comprises "diisoproyl adipate, dipropylene glycol, ethyl oleate, glyceryl monooleate, isopropyl palmitate, isostearic acid, lauryl lactate, methyl laurate, octisalate, octyldodecanol, oleyl alcohol, oleyl oleate, sorbitan monooleate, triacetin, or a combination thereof."
In response to this argument, it is argued that all the elements of the claimed gel compositions as claimed by claims 1, 10 and 12 are taught by the combination of the cited references. Both WO ‘315 and WO ‘278 teaches at least 60% volatile solvents. Further WO ‘315 teaches 60-80% volatile solvents. Regarding the claimed penetration enhancers, WO ‘278 teaches dipropylene glycol dimethyl ether, which is a species of the claimed dipropylene, and Colombo teaches isopropyl myristate, oleic acid and diethylene glycol monoethyl ether. Applicants failed to show unexpected results obtained from any specific penetration enhancer versus the other. In any event the newly cited reference to Mantelle teaches dipropylene glycol in a topical gel composition to deliver lidocaine with the benefit of providing proper consistency of the composition without negatively affecting the adhesion property of the composition.
Applicants argue that neither WO '315 nor WO '278 provide any teaching or suggestion for the penetration enhancer species of "diisoproyl adipate, dipropylene glycol, ethyl oleate, glyceryl monooleate, isopropyl palmitate, isostearic acid, lauryl lactate, methyl laurate, octisalate, octyldodecanol, oleyl alcohol, oleyl oleate, sorbitan monooleate, triacetin, or a combination thereof" specified in amended claims 1, 10, and 12. Instead, WO '315 and WO '278 merely discuss the use of propylene glycol monolaurate as an antimicrobial/antiseptic additive, and dipropylene glycol dimethyl ether as a solvent. However, none of these compounds are specified in the amended claims. The Examiner seems to assert that the claimed penetration enhancer species of "dipropylene glycol" and the "dipropylene glycol dimethyl ether" solvent discussed in WO '278 are equivalent compounds. However, these are distinct chemical species having distinct functional properties. Dipropylene glycol is a polar diol with two reactive hydroxyl (-OH) groups, while dipropylene glycol dimethyl ether is an aprotic diether with both hydroxyl groups replaced by methoxy (-OCH) groups. As a result, dipropylene glycol is a protic, hydrogen-bonding compound, while dipropylene glycol dimethyl ether is an aprotic solvent that cannot donate hydrogen bonds. This structural distinction leads to very different interactions with skin. For example, the claimed dipropylene glycol is useful as a penetration enhancer because its free hydroxyl groups allow it to strongly interact with the barrier layers of the skin. In contrast, the dipropylene glycol dimethyl ether of WO '278 does not act as a penetration enhancer at least because it lacks the free hydroxyl groups and thus cannot meaningfully interact with the barrier layers of the skin. Therefore, contrary to the Examiner's assertion, a solvent of "dipropylene glycol dimethyl ether" does not read on any of the claimed penetration enhancer species.
This argument is moot in view of the newly cited reference Mantelle. Further, the examiner respectfully disagrees with applicant that the teaching of the references of the species of dipropylene glycol does not read on the generically claimed dipropylene glycol because the species anticipates the genus. Applicants did not show that the dipropylene glycol composition of the reference would not work as penetration enhancer.
Applicants argue that Colombo fails to cure the deficiencies of WO '315 and WO '278. Colombo merely discusses single-layer films that may optionally include substances acting as "absorption promoters and/or humectants and/or plasticisers" and provides examples that include "glycerin, ethyl alcohol, propylene glycol, polyethylene glycol having a molecular weight ranging from 400 to 6,000, sorbitol, phospholipids, soybean lecithin, phosphatidyl choline, cholesterol, cyclodextrins, isopropyl myristate, oleic acid, polysorbate 80, diethylene glycol monoethyl ether." See Colombo at [0028]. However, none of these compounds are specified in the amended claims. The penetration enhancer species included in amended claims 1, 10, and 12 are distinct chemical compounds from the "absorption promoters and/or humectants and/or plasticisers" discussed in Colombo.
This argument is moot in view of the newly cited reference to Mantelle that teaches composition comprising lidocaine and dipropylene glycol and further teaches the advantage of dipropylene glycol in a topical gel composition to deliver lidocaine with the benefit of providing proper consistency of the composition without negatively affecting the adhesion property of the composition. One having ordinary skill in the art would have combined both references. The cited references are analogous art, and all are in the field of the inventor’s endeavor and reasonably pertinent to the particular problem with which the inventor was concerned, which is administering active agent, e.g. lidocaine, to the skin from self-supporting film. Therefore, it is appropriate to be relied upon and combined as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Applicants argue that while the formulations of WO '315 and WO '278 include a volatile solvent, the formulations of Colombo do not include an organic solvent (e.g., see Colombo at [0047], let alone a volatile solvent as the primary component of the composition at "about 60 wt.% to about 80 wt.%," as specified in amended claims 1, 10, and 12. In fact, Colombo explicitly states that the presence of such organic solvents "pose considerable safety problems" and further that organic-based adhesives cause "inconveniences." See Colombo at " [0013]-[0014]. Therefore, a person of ordinary skill in the art would not have any motivation to combine the teachings of WO '315 or WO '278 that use volatile organic solvents with the distinct teachings of Colombo that do not include, and instead teach away from including, volatile organic solvents. A person of ordinary skill in the art would not have reasonably expected that combining components from the volatile solvent containing gel compositions of WO '315 or WO '278 with components from the formulations of Colombo that lack these volatile organic solvents would result in a gel composition having desirable properties.
In response to this argument, it is argued that the present claims are directed to a composition, and all the elements of the claimed composition are taught by combination of the cited references. The claimed amount of the solvent is taught by the cited references. The intended use of the individual ingredients does not impart patentability to the claimed composition. It has been held that it is obvious to combine prior art elements according to known methods to yield predictable results. A finding that the prior art included each element claimed, although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements in a single prior art reference, was held obvious by the court.
Applicants argue that if an independent claim is nonobvious under 35 U.S.C. § 103, then any claim depending therefrom is nonobvious. In re Fine, 837 F.2d 1071, 5 U.S.P.Q.2d 1596 (Fed. Cir. 1988). Thus, dependent claims 4, 8, 25, 27, and 29 are also nonobvious for at least the same reasons that claims 1, 10, and 12 are nonobvious.
In response to this argument, it is argued that all the limitations of dependent claims are taught either explicitly or implicitly by the cited references, and each dependent claim is addressed as set forth in this office action.
WO '315, WO '278, Colombo, and Jonn
Applicants argue that each of independent claims 1, 10, and 12 is nonobvious over WO '315 or WO '278 in view of Colombo. Each of dependent claims 26, 28, and 30 ultimately depends from claim 1, 10, or 12. Jonn fails to cure the deficiencies of WO '315, WO '278, and Colombo, and is only cited as allegedly teaching a volatile solvent combination of isooctane and HMDS.
In response to this argument, it is argued that Jonn, as applicants themselves noted, is relied upon for solely teaching a volatile solvent combination of isooctane and HMDS. Jonn reference satisfies the purpose for which it was applied.
The rationale to modify the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art and the reason to modify the reference may often suggest what the applicant has done.
The obviousness does not require absolute predictability of success all that is required is a reasonable expectation of success. See In re Kubin, 561 F.3d at 1360. The Court has held that "the test of obviousness is not express suggestion of the claimed invention in any or all of the references but rather what the references taken collectively would suggest to those of ordinary skill in the art presumed to be familiar with them." See In re Rosselet, 146 USPQ 183, 186 (CCPA 1965). "There is no requirement (under 35 USC 103(a)) that the prior art contain an express suggestion to combine known elements to achieve the claimed invention. Rather, the suggestion to combine may come from the prior art, as filtered through the knowledge of one skilled in the art." Motorola, Inc. v. Interdigital Tech. Corp., 43 USPQ2d 1481, 1489 (Fed. Cir.1997). An obviousness determination is not the result of a rigid formula disassociated from the consideration of the facts of a case. Indeed, the common sense of those skilled in the art demonstrates why some combinations would have been obvious where others would not. See KSR Int'l Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007) ("The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.").
The cited references show that it was well known in the art at the time of the invention to use the claimed ingredients in compositions that is delivered transdermally. It is well known that it is prima facie obvious to combine two or more ingredients each of which is taught by the prior art to be useful for the same purpose in order to form a third composition which is useful for the same purpose. The idea for combining them flows logically from their having been used individually in the prior art. ln re Pinten, 459 F.2d 1053, 173 USPQ 801 (CCPA 1972); ln re Susi, 58 CCPA 1074, 1079-80) 440 F.2d 442, 445; 169 USPQ 423, 426 (1971); In re Crockett, 47 CCPA 1018, 1020-21; 279 F.2d 274, 276-277; 126 USPQ 186, 188 (1960).
Based on the disclosure by the cited references that these substances are used in transdermal compositions to deliver active agent transdermally, an artisan of ordinary skill would have a reasonable expectation that a combination of the substances would also be useful in creating transdermal compositions to transdermally deliver lidocaine.
Therefore, the artisan would have been motivated to combine the claimed ingredients into a single composition. No patentable invention resides in combining old ingredients of known properties where the results obtained thereby are no more than the additive effect of the ingredients. See ln re Sussman, 1943 C.D. 518; In re Huellmantel 139 USPQ 496; ln re Crockett 126 USPQ 186.
Rejections under Nonstatutory Double Patenting
Applicants argue that the present claim amendments are believed to overcome these rejections. The claims of U.S. Pat. Nos. 11,497,828; 11,491,255; and 10,603,405; and of copending Application No. 18/576,822, do not teach or suggest the currently amended claims with any reasonable expectation of success.
This argument is moot in view of the combination of the references rejected under double patenting in view of Mantelle reference. It is further argued that since the present claims are still pending and are subject to amendment, the double patenting rejection will be maintained till allowable subject matter is indicated.
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/Isis A Ghali/Primary Examiner, Art Unit 1611 /I.G./
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