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 .
Priority
This Application filed on 08/23/2022 is a 371 of PCT/NL2021/050125 filed on 02/25/2021 which has a PRO 62/982,589 filed on 02/27/2020.
DETAILED ACTION
The Office Action is in response to the Applicant's reply filed January 2, 2026 to the restriction requirement made on October 2, 2025.
Claims 1, 3-16, 18-33, 35-36, 38-41, and 43 are herein acted on the merits.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 1/2/26, is in compliance with the provisions of S7 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
Response to Arguments
Applicant's arguments over the 35 U.S.C. 112, first paragraph rejection of claims 1-16, 18-33, 35-36, 38-41, and 43 is persuasive in view of Applicant’s amendments. The rejection is herewith withdrawn.
Applicant's arguments over the 35 U.S.C. 112, first paragraph rejection of claims 1-16, 18-33, 35-36, 38-41, and 43 is persuasive. The rejection is herewith withdrawn.
Applicant's arguments over the 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph rejection of claims 1-16, 18-33, 35-36, 38-41, and 43 is not persuasive. The rejection is herewith maintained. The Examiner points out there are several revisions to the WOMAC differing in scoring methods, format, and length, and i.e. it appears WOMAC 3.1 is the latest standard. However, the claimed language is broader, rendering the indefinite.
Applicant argues, the results reported in Example 2 collectively show that once daily treatment with a topical diclofenac composition as claimed is safe and effective with less frequent dosing and less systemic exposure to diclofenac as compared to the other treatments tested (e.g., Voltaren® and twice daily administration of a composition as claimed). These beneficial therapeutic effects from a once a day treatment in accordance with the claims could not have been predicted or expected from the claims of the cited patents.
In response, the Examiner points out the claims of US 9999590 are drawn to a transdermal or transmucosal administration according to a schedule having a periodicity selected from once to four times daily dosing comprising at least 3% wt of diclofenac, C2 to C4 alkanol, polyalcohol, and monoalkyl ether of diethylene glycol; and an amount of about 3% wt-5% wt of a fatty alcohol, renders obvious a method for treating pain of osteoarthritis of a joint amenable to topical treatment, comprising topically applying once daily to an affected area of a subject in need thereof a therapeutically effective amount of a topical diclofenac composition, wherein the composition comprises: (i) at least 2.7% weight/weight of diclofenac; (ii) a C2 to C4 alkanol; (iii) a polyalcohol; (iv) a monoalkyl ether of diethylene glycol; and (v) from about 3% to about 5% weight/weight of a fatty alcohol, all based on the total weight of the topical diclofenac composition, wherein the once daily application provides a daily dose of diclofenac per joint of from about 30 mg to about 100 mg, based on diclofenac sodium.
In response, the Examiner points out the claims of US 10117829 are drawn to a transdermal or transmucosal administration according to a schedule having a periodicity selected from once to four times daily dosing comprising about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol, renders obvious a method for treating pain of osteoarthritis of a joint amenable to topical treatment, comprising topically applying once daily to an affected area of a subject in need thereof a therapeutically effective amount of a topical diclofenac composition, wherein the composition comprises: (i) at least 2.7% weight/weight of diclofenac; (ii) a C2 to C4 alkanol; (iii) a polyalcohol; (iv) a monoalkyl ether of diethylene glycol; and (v) from about 3% to about 5% weight/weight of a fatty alcohol, all based on the total weight of the topical diclofenac composition, wherein the once daily application provides a daily dose of diclofenac per joint of from about 30 mg to about 100 mg, based on diclofenac sodium.
The rejections are as below:
Claim Rejections - 35 USC § 11 2
The following is a quotation of the first paragraph of 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise and exact terms as to enable any : person skilled in the ad to which it pertains, or with which It is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 4-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. Where possible, claims are to be complete in themselves. Referring to a pain sub-score renders the claims vague and indefinite; rather Applicant should set out the description of the WOMAC assessment results. Incorporation by reference "is permitted only in exceptional circumstances where there is no practical way to define the invention in words... Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993) (citations omitted).
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 1-16, 18-33, 35-36, 38-41, and 43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of copending US 9999590.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose treatment of inflammation and pain using a transmucosal formulation comprising: at least 3% wt of diclofenac, C2 to C4 alkanol, polyalcohol, and monoalkyl ether of diethylene glycol; and an amount of about 3% wt-5% wt of a fatty alcohol.
The main difference between the instant application and the prior application is that the prior application does not claim once daily application per joint of 30 mg to about 100mg of diclofenac. (While the specification does describe application to encompass the formulation be applied once daily, or multiple times per day depending upon the condition of the patient).
However, to the skilled artisan, the claimed subject matter would have been obvious because the skilled artisan would have appreciated that certain factors would influence the dosage administration times required to effectively treat the subject for the purpose taught by the references, including, but not limited to the severity of the disease or disorder, previous treatments, the weight, general health and/or age of the subject and the presence of other diseases. The dosage administration times would thus have been expected to be variable and, in the absence of evidence to the contrary, the determination of the optimum dosage administration times to employ would have been a matter well within the purview of the skilled artisan.
Claims 1-16, 18-33, 35-36, 38-41, and 43 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims of copending US 10117829.
Although the conflicting claims are not identical, they are not patentably distinct from each other because both applications disclose treatment of inflammation and pain using a transmucosal formulation comprising: about 3% wt of diclofenac, about 45% wt of ethanol, about 20% wt of propylene glycol, about 5% wt of diethylene glycol monoethyl ether, and about 3% wt of myristyl alcohol.
The main difference between the instant application and the prior application is that the prior application does not claim once daily application per joint of 30 mg to about 100mg of diclofenac. (While the specification does describe application to encompass the formulation be applied once daily, or multiple times per day depending upon the condition of the patient).
However, to the skilled artisan, the claimed subject matter would have been obvious because the skilled artisan would have appreciated that certain factors would influence the dosage administration times required to effectively treat the subject for the purpose taught by the references, including, but not limited to the severity of the disease or disorder, previous treatments, the weight, general health and/or age of the subject and the presence of other diseases. The dosage administration times would thus have been expected to be variable and, in the absence of evidence to the contrary, the determination of the optimum dosage administration times to employ would have been a matter well within the purview of the skilled artisan.
Conclusion
No claims allowed.
The arguments are not persuasive and the rejection is made FINAL.
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 extension fee 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.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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