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 .
Status of Claims
Claims 1 and 4-14 are pending in the application as of the response filed 01/20/2026. Claims 2-3 are cancelled. Claims 1 and 4-14 are examined herein.
The 35 U.S.C. § 102 rejections of previous record over Isowaki and Okada are withdrawn in consideration of the claim amendments.
The 35 U.S.C. § 103 rejections of previous record are withdrawn in consideration of the claim amendments.
In view of the pending claims new 35 U.S.C. § 103 rejections are made, necessitated by the amendments.
The nonstatutory double patenting rejection of record is maintained and updated to reflect claim amendments in the instant and co-pending application. Please note that a typographical error in the co-pending application number is corrected from 18/269,484 to 18/269,474.
Priority
This application is a 371 of PCT/JP2021/047943 filed 12/23/2021 and claims foreign priority to JAPAN 2020-215228 filed 12/24/2020.
Applicant’s submission of a certified English translation of JAPAN 2020-215228 in the response filed on 01/20/2026 is acknowledged. The foreign application has 35 U.S.C. § 112(a) support for the subject matter of instant claims 1 and 4-14. Accordingly, the effective filing date of instant claims 1 and 4-14 is 12/24/2020.
Information Disclosure Statement
The information disclosure statements submitted on 01/20/2026 and 10/28/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim interpretation
Instant claims 1 and 4-14 have been interpreted as intended use claims drawn to a product, i.e., a pharmaceutical composition.
According to MPEP 2111.02(II), “The claim preamble must be read in the context of the entire claim. The determination of whether preamble recitations are structural limitations or mere statements of purpose or use "can be resolved only on review of the entirety of the [record] to gain an understanding of what the inventors actually invented and intended to encompass by the claim" as drafted without importing "‘extraneous’ limitations from the specification." Corning Glass Works, 868 F.2d at 1257, 9 USPQ2d at 1966. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020) (The court found that the preamble in one patent’s claim is limiting but is not in a related patent); Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997) ("where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation"); Kropa v. Robie, 187 F.2d at 152, 88 USPQ2d at 480-81 (preamble is not a limitation where claim is directed to a product and the preamble merely recites a property inherent in an old product defined by the remainder of the claim); STX LLC. v. Brine, 211 F.3d 588, 591, 54 USPQ2d 1347, 1350 (Fed. Cir. 2000) (holding that the preamble phrase "which provides improved playing and handling characteristics" in a claim drawn to a head for a lacrosse stick was not a claim limitation).
Therefore, the limitations following the preamble drawn to the intended use of the product - a pharmaceutical composition – “for transdermal administration” (as in claim 1 and claim 12); “for ophthalmic use” (as in claim 8); “for transdermal administration, wherein the transdermal administration is the administration to eyelid skin” (as in claim 9); “for treating allergic conjunctivitis” (as in claim 10); “for administration to a patient once daily” (as in claim 11); have not been not given patentable weight. (Nevertheless, it is noted that where the prior art teaches these limitations, it is cited as discussed below).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Isowaki et al. (US 2009/0143359 A1, publication date 04 June 2009, hereinafter Isowaki, in the IDS) in view of Park et al. (US 6,136,850 A, date of patent 24 October 2000, hereinafter Park, of previous record).
Regarding instant claims 1 and 8, Isowaki teaches an ophthalmic preparation for percutaneous absorption comprising epinastine or a salt thereof as an active ingredient, for preventing or treating allergic eye disease in a mammalian subject (Title; Abstract; Para. [0019]; Claim 11). Isowaki teaches the percutaneously absorptive preparation can include a stabilizer/antioxidant (Para. [0037]). Isowaki teaches exemplary stabilizers and/or antioxidants to include sodium bisulfite (i.e., sodium hydrogen sulfite), sodium sulfite, L-cysteine, thioglycerol (i.e., a sulfur-based antioxidant) (Para. [0059]; Para. [0061]).
Isowaki do not teach wherein the sulfur-based antioxidant is 2-mercaptobenzimidazole.
Park is in the field of ophthalmic compositions (Col. 2, Lns. 60-64). Park teaches ophthalmically acceptable antioxidants for use in the compositions to include thiol components (Col. 4, Lns. 7-12). Park teaches exemplary thiol components to include glutathione (GSH), … 1-thioglycerol, … 2-mercaptobenzimidazole, … (Col. 4, Lns. 13-31).
As stated in MPEP 2144.06 (II), “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”. In the instant case, the sodium bisulfite (i.e., sodium hydrogen sulfite), sodium sulfite, L-cysteine, thioglycerol of Isowaki and 2-mercaptobenzimidazole of Park, are ophthalmically acceptable antioxidants considered equivalents in the art.
Therefore, a person of ordinary skill in the art would have been motivated to substitute the sulfur-based antioxidants taught by Isowaki with the 2-mercaptobenzimidazole taught by Park, to arrive at the instant pharmaceutical composition, with a reasonable and predictable expectation of success. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use.
Regarding instant claims 4-7 and 9-11, Isowaki in view of Park render the pharmaceutical composition of the instant claim 1, prima facie obvious. Isowaki teaches the ophthalmic preparation may be applied to the skin surface including the surface of an eyelid of the subject (Abstract; Para. [0019]; Claim 11) (as in instant claim 9). Isowaki teaches the allergic eye diseases treated to include allergic conjunctivitis (Para. [0032]) (as in instant claim 10). Isowaki teaches an administration schedule of once a day of the percutaneously absorptive preparation (Para. [0093]) (as in instant claim 11). Isowaki teaches the epinastine or a salt thereof at a concentration of 0.1 to 40% by weight in the percutaneous preparation maintains a therapeutically effective amount of epinastine or a salt thereof for preventing or treating an allergic eye disease (Para. [0084]) (this overlaps and partially anticipates the claimed 0.01 to 5% w/w range as in instant claim 4). Isowaki teaches the percutaneously absorptive preparation in various dosage forms that include an ointment preparation, gel preparation and cream preparation (Para. [0035]) (as in instant claims 5-6). Isowaki teaches the cream preparation can be prepared by mixing oil phase with aqueous phase comprising epinastine or a salt thereof to give pre-emulsified mixture, emulsifying the mixture using homomixer, and subjecting the obtained emulsion to degasification, filtration and cooling (Para. [0081], this indicates forming a water-in-oil emulsion of epinastine) (as in instant claim 7). Therefore, the combined teachings Isowaki and Park render of the limitations of instant claims 4-7 and 9-11 prima facie obvious.
Regarding instant claims 12-13, Isowaki in view of Park render the pharmaceutical composition of the instant claim 1, prima facie obvious. Isowaki teaches the percutaneously absorptive preparation can include a solvent, oil (Para. [0037]). Isowaki teaches oil bases such as VaselineTM, paraffin, vegetable oil, lard, wax (Para. [0042]), volatile and involatile oils -higher alcohols such as cetyl alcohol and isostearyl alcohol; fatty acids such as isostearic acid and oleic acid; polyalcohols such as glycerol, sorbitol, ethylene glycol, propylene glycol and polyethylene glycol; and esters such as myristyl myristate, hexyl laurate, decyl oleate, isopropyl myristate and glyceryl monostearate (Para. [0045]). Isowaki teaches solvents to include purified water, methanol, ethanol, 1-propanol, lower alcohol, ethyl acetate, diethyl ether, tert-butyl methyl ether, pyrrolidone, acetic acid, acetonitrile, N,N-dimethylformamide, acetone, methyl ethyl ketone, methyl isobutyl ketone, tetrahydrofuran, chloroform, toluene and xylene (Para. [0044]). Therefore, the combined teachings Isowaki and Park render of the limitations of instant claims 12-13 drawn to further excipients, prima facie obvious.
Regarding instant claim 14, Isowaki in view of Park render the pharmaceutical composition of the instant claim 12, prima facie obvious.
Isowaki do not explicitly teach wherein the pharmaceutical composition is free of paraben.
Isowaki mentions in the background section that many eye drops contain a preservative and the use of such eye drops over a prolonged period, could result in the preservative causing adverse side effects such as irritation (Para. [0003]).
Therefore, a person of ordinary skill in the art would have been motivated to formulate a composition devoid of preservatives, such as paraben, to eliminate the adverse effects of irritation, thereby improving patient compliance.
Claims 1 and 4-14 are rejected under 35 U.S.C. 103 as being unpatentable over Okada et al. (US 2004/0247686 A1, publication date 09 December 2004, hereinafter Okada, in the IDS) in view of Park et al. (US 6,136,850 A, date of patent 24 October 2000, hereinafter Park, of previous record).
Regarding instant claim 1, Okada teaches pharmaceutical compositions for the treatment of skin disease which comprises an antihistaminic-effective amount of epinastine or a pharmaceutically acceptable salt thereof as a pharmacologically active compound and at least one compound selected from the group consisting of one or more sulfur containing amino acid(s) or peptide(s) as biologically active donor of a -S- or -SH group, at least one vitamin of the B group, at least one vitamin having antioxidant properties and an antiphlogistic compound (Abstract; Para. [0029]). Okada teaches examples of sulfur containing amino acid(s) or peptide(s) to include cysteine, methionine, and glutathione (which act as antioxidants) (Para. [0038]).
Okada do not teach the sulfur-based antioxidant 2-mercaptobenzimidazole.
Park is in the field of ophthalmic compositions (Col. 2, Lns. 60-64). Park teaches ophthalmically acceptable antioxidants for use in the compositions to include vitamins and thiol components (Col. 4, Lns. 7-12). Park teaches exemplary thiol components to include glutathione (GSH), … 1-thioglycerol, … 2-mercaptobenzimidazole, … (Col. 4, Lns. 13-31).
As stated in MPEP 2144.06 (II), “An express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982)”. In the instant case, sulfur containing amino acid(s) or peptide(s) to include cysteine, methionine, and glutathione and/or the vitamins of Okada and 2-mercaptobenzimidazole of Park, are ophthalmically acceptable antioxidants considered equivalents in the art.
Therefore, a person of ordinary skill in the art would have been motivated to substitute the antioxidants taught by Okada with the 2-mercaptobenzimidazole taught by Park, to arrive at the instant pharmaceutical composition, with a reasonable and predictable expectation of success.
Regarding instant claims 4-8 and 11-14, Okada in view of Park render the pharmaceutical composition of the instant claim 1, prima facie obvious. Okada teaches the pharmaceutical compositions can be in the form of gels, creams, ointments, etc. (Para. [0143]) (as in instant claims 5-6). Okada teaches an exemplary cream formulation that comprises epinastine hydrochloride and L-cysteine (Paras. [0165]-[0166]). Creams are inherently emulsions.
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Okada teaches epinastine has been primarily used to treat allergic reaction of
the eyes (Para. [0030]) (i.e., is capable of ophthalmic use as in instant claim 8). The composition of Okada comprises an oil ingredient (as in instant claim 12), medium chain fatty acid triglyceride (as defined in Para. [0056] of the instant specification) and a solvent, say propylene glycol and purified water (as defined in Para. [0066] of the instant specification) (as in instant claim 13). Moreover, the cream formulation of Okada does not list paraben and thus, satisfies the limitations of instant claim 14. Okada teaches the dose of epinastine hydrochloride for topical application is between 1 and 50 mg per 1 g of the composition (this is equivalent to 0.1 to 5% w/w) (as in claim 4). Okada teaches the compositions comprising epinastine may be administered once daily (Para. [0102]; Para. [0140]) (as in instant claim 11).
Regarding the limitation drawn to a water-in oil emulsion as in instant claim 7, it would have been prima facie obvious to one of ordinary skill in the art to have formulated a desired type of emulsion, say, water-in-oil emulsion by employing a suitable emulsifying agent to ensure the oil phase is the continuous external phase and the aqueous phase is the dispersed internal phase, with a reasonable expectation of success. Doing so would have been well within the skill of one of ordinary skill in the pharmaceutical arts, through routine experimentation.
Therefore, the combined teachings Okada and Park render of the limitations of instant claims 4-8 and 11-14 prima facie obvious.
Further, the modified composition of Okada in view of Park is capable of performing the intended use limitations of instant claims 9-10 (see claim interpretation section above).
Response to Arguments
Applicants argue on pages 8-10 of the response dated 01/20/2026 that “Isowaki does not teach or suggest the use of 2-mercaptobenzimidazole as a stabilizer/antioxidant … Isowaki neither discloses, nor suggests that the addition of stabilizers/antioxidants in the preparation can inhibit the generation and increase of the related substances of epinastine under long-term storage to stabilize epinastine or a salt thereof in the preparation for a long time. Thus, Isowaki neither teaches, nor suggests the claimed pharmaceutical composition for transdermal administration comprising epinastine or a salt thereof and 2-mercaptobenzimidazole with the effect of stabilizing epinastine or a salt thereof in the pharmaceutical composition for a long time”. Applicants argue “Okada neither teaches, nor suggests that the sulfur containing amino acids or peptides, such as L-cysteine, have antioxidant properties. Okada merely teaches that a vitamin is used as an antioxidant. Thus, Okada neither teaches, nor suggests the claimed pharmaceutical composition for transdermal administration comprising epinastine or a salt thereof and 2-mercaptobenzimidazole with the effect of stabilizing epinastine or a salt thereof in the pharmaceutical composition for a long time”. Applicants argue “However, Park neither teaches, nor suggests using the thiol components, such as 2-mercaptobenzimidazole, in a composition for transdermal administration, much less achieving long-term stabilization of epinastine or a salt thereof in a pharmaceutical composition comprising epinastine or a salt thereof, as an active ingredient, by the addition of a thiol component.” Applicants argue “Furthermore, Park discloses that preferably, the ophthalmically acceptable thiol component is selected from the group consisting of GSH, GSSG, (cf. Col. 4 lines 35-42). Thus, a person skilled in the art would not have been motivated to focus on 2-mercaptobenzimidazole from among the various thiol components in view of Park.”
Applicant's arguments have been fully considered but they are not persuasive.
Firstly, Applicants are reminded that the rejection is based on an obviousness rationale and not anticipation. No single reference is expected to teach all of the claimed limitations.
According to MPEP 2145 (IV), “One cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., Inc., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Where a rejection of a claim is based on two or more references, a reply that is limited to what a subset of the applied references teaches or fails to teach, or that fails to address the combined teaching of the applied references may be considered to be an argument that attacks the reference(s) individually”. As clearly outlined in the 103 rejections above, both Isowaki and Okada teach formulations of epinastine for ophthalmic use that comprises an ophthalmically acceptable sulfur containing antioxidant/stabilizer. Park teaches ophthalmically acceptable antioxidants for use in the compositions that include thiol components, such as, 2-mercaptobenzimidazole. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. Thus, substituting the sulfur-based antioxidants of Isowaki/Okada with 2-mercaptobenzimidazole (2-MBI) taught by Park, in ocular formulations would be considered to have a predictable expectation of success by a person of ordinary skill in the art, as 2-MBI is a known antioxidant and functional sulfur compound with similar chemical properties to other common pharmaceutical sulfur antioxidants.
According to MPEP 2144.07, “The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945)”.
Therefore, the combined teachings of the prior art, Isowaki, Okada and Park, render the pharmaceutical composition of the instant claims prima facie obvious.
Secondly, according to MPEP 2123 (II), “Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004)”. See also MPEP 2143.01(I). In the instant case, while Park may preferably teach the ophthalmically acceptable thiol component to be selected from the group consisting of GSH, GSSG, it does not in any way discredit use of 2-mercaptobenzimidazole (also listed by Park as an ophthalmically acceptable thiol antioxidant) for use as an antioxidant. As noted by Applicants (page 9 of the remarks dated 01/20/2026), Park teaches the thiol components can be used within the eye without causing eye irritation or discomfort. Thus, one of ordinary skill in the art would be motivated to use 2-mercaptobenzimidazole in an ocular formulation.
Furthermore, regarding Applicant’s contention that Okada does not teach that the sulfur containing amino acids or peptides, such as L-cysteine, have antioxidant properties - a compound and all its properties are inseparable. The sulfur containing amino acids or peptides, such as cysteine, methionine, and glutathione, by virtue of their inherent property, function as antioxidants.
Finally, regarding Applicant’s contention that the prior art does not teach the claimed pharmaceutical composition comprising epinastine or a salt thereof and 2-mercaptobenzimidazole with the effect of stabilizing epinastine or a salt thereof in the pharmaceutical composition for a long time, the examiner notes that the prior art does not have to suggest solving the same problem that which the inventor was trying to solve. In determining obviousness, neither the particular motivation to make the instant invention nor the problem the inventor is solving controls. In the instant case, the sulfur-based antioxidants, sodium bisulfite (i.e., sodium hydrogen sulfite), sodium sulfite, L-cysteine, thioglycerol of Isowaki OR sulfur containing amino acids or peptides - cysteine, methionine, and glutathione of Okada and the thiol components - glutathione (GSH), GSSG, 1-thioglycerol, 2-mercaptobenzimidazole of Park, are recognized in the art as antioxidants for use in ophthalmic preparations. Therefore, substituting one sulfur-based antioxidant with the other, to arrive at the instant claims is prima facie obvious.
Thus, the rejections of record over Isowaki, Okada and Park are maintained.
Applicants are encouraged to present a clear and convincing evidence of unexpected results to overcome the 103 rejections.
Double Patenting – Maintained and updated
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 and 4-14 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-15 and 17-19 of co-pending Application No 18/269,474 in view of Isowaki et al. (US 2009/0143359 A1, publication date 04 June 2009, hereinafter Isowaki, in the IDS) and Park et al. (US 6,136,850 A, date of patent 24 October 2000, hereinafter Park, of previous record).
Although the claims at issue are not identical, both sets of claims are drawn to a pharmaceutical composition comprising epinastine or a salt thereof.
The instant claims are drawn to a pharmaceutical composition for transdermal administration comprising epinastine or a salt thereof and a sulfur-based antioxidant, wherein the sulfur-based antioxidant is 2-mercaptobenzimidazole.
The claims of the reference ‘474 application are drawn to a pharmaceutical composition for application to eyelid skin for treating allergic conjunctivitis, comprising epinastine or a salt thereof in a concentration of 0.05 to 1% (w/w) as an active ingredient, wherein the pharmaceutical composition is administered to a patient once daily.
Claim 1 of the reference application anticipates administration of the composition to eyelid skin as in instant claim 9. Claim 1 of the reference application anticipates a once daily administration schedule as in instant claim 11. Claim 1 of the reference application anticipates treating allergic conjunctivitis as in instant claim 10. Claims 6-8 of the reference application anticipates the dosage form as in instant claims 5-7. Claims 13-15 of the reference application anticipates the excipients of the pharmaceutical composition as in instant claims 12-13. Claim 17 of the reference application anticipates a composition devoid of paraben as in instant claim 14.
The reference application does not teach a sulfur-based antioxidant, 2-mercaptobenzimidazole, as in the instant pharmaceutical composition.
Isowaki teaches an ophthalmic preparation for percutaneous absorption comprising epinastine or a salt thereof as an active ingredient, for preventing or treating allergic eye disease in a mammalian subject (Title; Abstract; Para. [0019]; Claim 11). Isowaki teaches the percutaneously absorptive preparation can include a stabilizer/antioxidant (Para. [0037]). Isowaki teaches exemplary stabilizers and/or antioxidants to include sodium bisulfite (i.e., sodium hydrogen sulfite), sodium sulfite, L-cysteine, thioglycerol (Para. [0059]; Para. [0061]). Park teaches ophthalmically acceptable antioxidants for use in the compositions to include thiol components (Col. 4, Lns. 7-12), specifically 2-mercaptobenzimidazole (Col. 4, Lns. 13-31).
Therefore, a person of ordinary skill in the art would have been motivated to formulate a pharmaceutical composition comprising epinastine or a salt thereof and a sulfur-based antioxidant, in view of the teachings of the reference application, Isowaki and Park.
The concentration of epinastine or a salt thereof of the reference application (0.05 to 1% w/w) falls within the instantly claimed concentration range of epinastine or a salt thereof (0.01 to 5% w/w) of instant claim 4.
According to MPEP 2144.05(II)(A), "[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). Therefore, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the optimal dosage of epinastine or a salt thereof.
Therefore, instant claims 1 and 4-14 and claims 1, 6-15, and 17-19 of co-pending Application No 18/269,474 are not patentably distinct.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1 and 4-14 are rejected.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached on 9:00-5:30pm EDT.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627