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 .
DETAILED ACTION
Election/Restrictions
Applicant’s election without traverse of Group I, and a formulation comprising cyclosporine, isopropyl palmitate, benzyl alcohol, stearic acid, safflower oil, oleic acid, deionized water, phosphatidylcholine, polyglyceryl-4 laurate, and Pluronic Gel in the reply filed on 11/11/2025 is acknowledged.
Claims 6-10 and 19-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species/invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/11/2025.
Status of the Claims
Claims 1 and 3-24 are pending in this application.
Claims 6-10 and 19-24 are withdrawn from consideration as being drawn to a non-elected species/invention.
Claims 1, 3-5 and 11-18 are presently under consideration as being drawn to the elected species/invention.
Claim Objections
Claim 5 is objected to because of the following informalities: claim 5 should be rewritten as follows: “…….Pluronic Gel at a concentration of 5% to 40%. Appropriate correction is required.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 16 is drawn to the transdermal delivery formulation of claim 15, wherein the sufflower oil comprises a linoleic acid. It is well known in the art that sufflower oil comprises linoleic acid. Therefore, claim 16 fails to further limit the subject matter of claim 15. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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, 3 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzsimmons et al. (WO 2020/257538).
With respect to claims 1, 11-15 and 17-18, Fitzsimmons et al. teach a transdermal delivery formulation for transdermal delivery of a Cannabidiol for the treatment of a disease (claim 1), wherein, the transdermal delivery formulation is in an amount less than about 60 %w/w, and comprises: iii. one or more phosphatides, and iv. one or more fatty acids; and b) water in an amount less than about 50 %w/w (claim 3), wherein the formulation includes an additional active agent to treat a disease (claim 52), wherein the treatment for ulcerative colitis comprises the administration of cyclosporine (claim 61), wherein the transdermal delivery formulation comprises benzyl alcohol in an amount less than 5 %w/w of the formulation (claim 5), wherein the transdermal delivery formulation comprises lsopropyl Palmitate in an amount between about 5%-50 %w/w (claim 6), wherein the water is deionized water and/or purified water (claim 7), wherein the water is in an amount between about 7-40 %w/w of the formulation (claim 9), wherein the one or more fatty acids in an amount between about 1-35 %w/w of the transdermal delivery formulation (claim 13), wherein the one or more fatty acids comprises Linoleic Acid, Oleic Acid, Stearic Acid, sunflower oil, or a combination thereof (claim 15), and wherein the one or more phosphatides are derived from a safflower oil in an amount between about 0.5-55 %w/w of the transdermal delivery formulation (claim 21).
A prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to the claimed amount of cyclosporine, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum amount of cyclosporine by normal optimization procedures known in the pharmaceutical art.
With respect to claim 3, Fitzsimmons et al. teach that the one or more phosphatides are in an amount between about 0.5-55 %w/w of the transdermal delivery formulation (claim 10), and wherein the one or more phosphatides comprises phosphatidylcholine of the transdermal delivery formulation (claim 12).
With respect to claim 16, as discussed above under 35 U.S.C. 112(d), the claim does not further limit the subject matter of claim 15, thus it is obvious as discussed above.
Claims 1, 3-4 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzsimmons et al. (WO 2020/257538) as applied to claims 1, 3 and 11-18 above, and further in view of Yoneda et al. (US 2009/0252773).
The teachings of Fitzsimmons et al. with respect to claims 1, 3, 5, and 11-18 have been discussed above.
Fitzsimmons et al. do not teach that the transdermal delivery formulation comprises polyglyceryl-4 laurate.
Yoneda et al. teach a skin external preparation comprising an emulsion composition (claim 1), wherein “[c]ommon components that are generally used for skin external preparations may be added within limits not detrimental to the effects of the invention. Such components can be added in amounts of, for example, 0.01 to 25 parts by mass based on the total 100 parts by mass of the components (A) to (D)” (para [0055]).
Yoneda et al. also teach that the nonionic surfactant is polyglyceryl-4-laurate (para [0073]).
It would have been obvious to one of ordinary skill in the art to include polyglyceryl-4 laurate in the formulation of Fitzsimmons et al. because the formulation of Fitzsimmons et al. comprises a nonionic surfactant (paras [0059, [0065], [0069]]) and Komiya et al. (column 7, lines 22-25), and Yoneda et al. teach that the nonionic surfactant polyglyceryl-4-laurate can be used in skin external formulations.
Claims 1, 3, 5 and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Fitzsimmons et al. (WO 2020/257538) as applied to claims 1, 3 and 11-18 above, and further in view of Brunner et al. (US 2019/0083386).
The teachings of Fitzsimmons et al. with respect to claims 1, 3, 5, and 11-18 have been discussed above.
Fitzsimmons et al. do not teach that the transdermal delivery formulation comprises pluronic gel.
Brunner et al. teach topical formulations with improved penetration comprising 1-10% w/w isopropyl palmitate (paras [0027], [0029], [0041], [0117]); 0.5-20% w/w benzyl alcohol (paras [0014], [0031]); 0.25-5% w/w stearic acid (paras [0134], [0148]; claim 12); oleic acid (para [0041]); deionized water (para [0224]); phosphatidylcholine (paras [0028], [0224], [0229]; claim 10); and PLU-F127 (i.e. a mixture of water and poloxamer 407) (paras [0036], [0224]).
It would have been obvious to one of ordinary skill in the art to include PLU-F127 in the transdermal delivery formulation of Fitzsimmons et al. because Brunner et al. teach that topical formulations comprising PLU-F127 have improved penetration.
Claims 1, 3, 5, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Komiya et al. (US 5504068) in view of Brunner et al. (US 2019/0083386).
With respect to claims 1, 3, 11-15 and 17-18, Komiya et al. teach a topical preparation comprising 0.1% to 10% by weight of cyclosporin, 2% to 15% by weight of lower alcohol (i.e. isopropyl palmitate; para [0007], [0013], [0032]; claims 1 and 15; column 6, line 34); stearic acid (column 6, lines 21 and 63; Examples 12 and 14-15); safflower oil (column 7, line 16); oleic acid (column 4, line 41; column 6, line 63; column 7, line 2); and sterilized water (Examples 11-15).
Komiya et al. do not teach that the preparation further comprises benzyl alcohol.
Brunner et al. teach topical formulations with improved penetration comprising 1-10% w/w isopropyl palmitate (paras [0027], [0029], [0041], [0117]); 0.5-20% w/w benzyl alcohol (paras [0014], [0031]); 0.25-5% w/w stearic acid (paras [0134], [0148]; claim 12); oleic acid (para [0041]); deionized water (para [0224]); phosphatidylcholine (paras [0028], [0224], [0229]; claim 10); and PLU-F127 (paras [0036], [0224]).
It would have been obvious to one of ordinary skill in the art to include benzyl alcohol in the topical composition of Komiya et al. because Brunner et al. teach that topical formulations comprising benzyl alcohol have improved penetration.
Furthermore, the MPEP 2144.05 A states that “[G]enerally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here 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.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”); In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969) (Claimed elastomeric polyurethanes which fell within the broad scope of the references were held to be unpatentable thereover because, among other reasons, there was no evidence of the criticality of the claimed ranges of molecular weight or molar proportions.). For more recent cases applying this principle, see Merck & Co. Inc. v. Biocraft Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989); In re Kulling, 897 F.2d 1147, 14 USPQ2d 1056 (Fed. Cir. 1990); and In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997)”.
Since Applicant has not disclosed that the specific limitations recited in the instant claims are for any particular purpose or solve any stated problem, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum concentration of the various components by normal optimization procedures known in the pharmaceutical art.
With respect to claim 5, it is noted that PLU-F127 is a mixture of water and poloxamer 407.
With respect to claim 16, as discussed above under 35 U.S.C. 112(d), the claim does not further limit the subject matter of claim 15, thus it is obvious as discussed above.
Claims 1, 3-5, and 11-18 are rejected under 35 U.S.C. 103 as being unpatentable over Komiya et al. (US 5504068) in view of Brunner et al. (US 2019/0083386) as applied to claims 1, 3, 5, and 11-18 above, and further in view of Yoneda et al. (US 2009/0252773).
The teachings of Komiya et al. and Brunner et al. with respect to claims 1, 3, 5, and 11-18 have been discussed above.
Komiya et al. and Brunner et al. do not teach the transdermal formulation further comprises polyglyceryl-4-laurate.
Yoneda et al. teach a skin external preparation comprising an emulsion composition (claim 1), wherein “[c]ommon components that are generally used for skin external preparations may be added within limits not detrimental to the effects of the invention. Such components can be added in amounts of, for example, 0.01 to 25 parts by mass based on the total 100 parts by mass of the components (A) to (D)” (para [0055]).
Yoneda et al. also teach that the nonionic surfactant is polyglyceryl-4-laurate (para [0073]).
It would have been obvious to one of ordinary skill in the art to include polyglyceryl-4 laurate in the formulation obvious over Komiya et al. and Brunner et al. because the formulations of Komiya et al. and Brunner et al. include a nonionic surfactant (Brunner et al. (claim 7; para [0013]) and Komiya et al. (column 7, lines 22-25), and Yoneda et al. teach that the nonionic surfactant polyglyceryl-4-laurate can be used in skin external formulations.
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, 3-5 and 11-18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 5, 8, 11-12, 17-19, 26-27, 34, 36, 39, 44, 47, 49, 65, 67, 68-69 and 78 of copending Application No. 18/351192 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they relate to the same transdermal delivery formulation.
With respect to claim 1, ‘192 teaches a formulation for transdermal delivery of a medicament through the skin of a subject, the formulation comprising a therapeutically effective amount of a medicament and a penetrant portion, wherein the penetrant portion comprises: a phospholipid, a fatty acid ester formed from a low molecular weight alcohol, and a long-chain fatty acids, and, optionally, one or more of a viscosity-improving agent, a penetration enhancer, and an emulsifier (claim 1), wherein the fatty acid ester formed from a low molecular weight alcohol is selected from isopropyl palmitate, isopropyl myristate, isopropyl linoleate, isopropyl oleate, ethyl laurate, and ethyl myristate (claim 8), wherein the fatty acid ester formed from a low molecular weight alcohol is in an amount from about 5% to about 20% w/w of the formulation (claim 11), wherein the long-chain fatty acid is selected from a linoleic, oleic, stearic acid, linolenic, palmitic, arachidonic, palmitoleic, myristic, eicosenoic, benehic, euricic, and lignoceric acid or is obtained from safflower oil or almond oil (claim 12), wherein the long-chain fatty acid is in an amount from about 0.10% to about 10% w/w of the formulation (claim 17), wherein the penetrant portion comprises a penetration enhancers elected from benzyl alcohol, ethanol, propylene glycol, polyethylene glycol, limonene, menthol, borneol, and camphor (claim 27), wherein the penetration enhancer is in an amount from about 0.5% to about 5% w/w of the formulation (claim 34), wherein the penetrant portion comprises water in an amount from about 50% to about 80% w/w of the formulation (claim 47), wherein the medicament is cyclosporine (claim 65), and wherein the medicament is in an amount from about 0.001% to about 30% w/w of the formulation (claim 49).
With respect to claim 3, ‘192 teaches that the phospholipid is phosphatidylcholine (claim 2), in an amount from about 3% to about 15% w/w of the formulation (claim 5).
With respect to claim 4, ‘192 teaches that the penetrant portion comprises an emulsifier selected from polyglyceryl-4-laurate, polyglyceryl-4-oleate, span 60, cetyl alcohol, and polyglyceryl-3-oleate (claim 36).
With respect to claim 5, ‘192 teaches that the penetrant portion comprises a viscosity-improving agent which is a poloxamer selected from poloxamer 407, poloxamer 188, poloxamer 184, and poloxamer 124 (claim 19), in an amount from about 5% to about 20% w/w of the formulation (claim 26), and wherein the penetrant portion comprises water in an amount from about 50% to about 80% w/w of the formulation (claim 47).
With respect to claims 11-15 and 17-18, a prima facie case of obviousness necessarily exists when the prior art range overlaps or touches a claimed range, such as in the instant rejection (MPEP § 2144.05).
With respect to claim 16, ‘192 teaches that the safflower oil comprises a linoleic acid (claim 12).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERGIO COFFA whose telephone number is (571)270-3022. The examiner can normally be reached M-F: 6AM-4PM.
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/SERGIO COFFA Ph.D./
Primary Examiner
Art Unit 1658
/SERGIO COFFA/Primary Examiner, Art Unit 1658