DETAILED ACTION
This office action is in response to applicant’s filing dated June 1, 2026.
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 1-14 and 16-28 are pending in the instant application. Acknowledgement is made of Applicant's amendments filed June 1, 2026. Acknowledgement is made of Applicant's amendment of claims 2-5, 7, 11-14, and 19; and cancelation of claim 15.
Election/Restrictions
Applicant’s election without traverse of Group I, drawn to an aqueous topical suspension for treating or preventing an inflammatory or autoimmune disease or condition of human skin comprising 0.01 to 1% of one or more benzimidazole compounds, wherein at least some of the one or more benzimidazole compounds remain in undissolved form in the aqueous topical suspension; and 15 to 45% of an ethylene glycol based solvent; wherein the percentages are by weight of the aqueous topical suspension; and wherein the aqueous topical suspension does not include any aprotic solvents in the reply filed on June 1, 2026 is acknowledged.
Claims 14 and 16-28 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 1, 2026.
Applicant’s election without traverse of a formulation species comprising mebendazole, diethylene glycol monoethyl ether, and hydroxycellulose in the reply filed on June 1, 2026 is acknowledged.
Claim 4 and 8-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on June 1, 2026.
Claims 1-3 and 5-7 are presently under examination as they relate to the elected species: mebendazole, diethylene glycol monoethyl ether, and hydroxycellulose
Priority
The present application is a CIP of US Application No. 18/212,065 filed on June 20, 2023, which claims benefit of US Provisional Application NO 63/353,907 filed on June 21, 2022. The present application claims benefit of US Provisional Application NOs. 63/635,923 and 63/650,567 filed on April 18, 2024 and May 22, 2024, respectively.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) or under 35 U.S.C. 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed applications, US Application No. 18/212,065 and US Provisional Applications 63/353,907; 63/635,923; and 63/650,567 fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. In a review of US Application No. 18/212,065 and US Provisional Applications 63/353,907; 63/635,923; and 63/650,567, disclosure of aprotic solvents was not identified. MPEP 2173.05(i) states:
Any negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). In the instant case, the prior-filed applications do not appear to disclose aprotic solvents, thus the prior-filed applications do not provide sufficient support for the limitation “wherein the aqueous topical suspension does not include any aprotic solvents.”
The effective filing date of the instant claims is April 16, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on July 29, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner, except where marked with a strikethrough.
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Drawings
Acknowledgement is made of the drawings received on April 16, 2025. These drawings are accepted.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5, and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Jimenez et al (WO 2023/249992 A2).
Regarding claims 1 and 6, Jimenez teaches a topical composition for treating or preventing an inflammatory or autoimmune disease or condition of human skin comprising 0.25 to 20% of one or more benzimidazole compounds, the percentage by weight of the topical composition (claim 1), wherein the carrier comprises a gel (claim 3), wherein the carrier is aqueous (claim 5), wherein the one or more benzimidazole compounds comprises mebendazole (claims 6, 8 and 9), wherein the composition comprises around 15-25% of a glycol based solvent comprising an ethylene glycol based solvent (claim 9), wherein the ethylene glycol based solvent comprises diethylene glycol monoethyl ether (claim 1), wherein the topical composition comprises around 0.01 to 1% mebendazole by weight of the total composition (claim 11). Moreover, Jimenez teaches mebendazole gel formulations comprising 0.1 % mebendazole, USP, 40% diethylene glycol monoethyl ether (Transcutol P); 1 % hydroxyethylcellulose (Natrosol® 250HR); 43.9% deionized water, and dimethyl isosorbide ([0084] Table 9).
Regarding the claimed amount of benzimidazole compounds and the claimed amount of ethylene glycol based solvent, MPEP 2131.03 states:
"[W]hen, as by a recitation of ranges or otherwise, a claim covers several compositions, the claim is ‘anticipated’ if one of them is in the prior art." Titanium Metals Corp. v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (citing In re Petering, 301 F.2d 676, 682, 133 USPQ 275, 280 (CCPA 1962)).
In the instant case, an amount of 0.1% mebendazole by weight of the total composition and 40% diethylene glycol monoethyl ether (Transcutol P) falls within the instant claimed ranges of claim 1 and thus anticipates the claimed ranges of claims 1.
Regarding the limitation, wherein the aqueous topical suspension does not include any aprotic solvents, Jimenez teaches mebendazole gel formulations comprising 0.1 % mebendazole, USP, 40% diethylene glycol monoethyl ether (Transcutol P); 1 % hydroxyethylcellulose (Natrosol® 250HR); 43.9% deionized water, and dimethyl isosorbide ([0084] Table 9). The amounts of the ingredients total 100% and does not include any aprotic solvents. Thus, the composition of Jimenez reads on a composition that does not include any aprotic solvents.
Regarding claim 2, the composition taught by Jimenez comprises water and hydroxyethylcellulose, diethylene glycol monoethyl ether, and mebendazole.
Regarding claim 3, the composition taught by Jimenez is an aqueous topical suspension in a gel form.
Regarding claim 5, the composition taught by Jimenez is an aqueous topical suspension comprises 1% hydroxyethylcellulose (Natrosol® 250HR). An amount of 1% hydroxyethylcellulose (Natrosol® 250HR) by weight of the total composition falls within the instant claimed range of claim 5 and thus anticipates the claimed ranges of claim 5.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Jimenez et al (WO 2023/249992 A2) as applied to claims 1-3, 5, and 6 above.
As set forth above, Jimenez teaches a topical composition for treating or preventing an inflammatory or autoimmune disease or condition of human skin comprising 0.25 to 20% of one or more benzimidazole compounds, the percentage by weight of the topical composition (claim 1), wherein the carrier comprises a gel (claim 3), wherein the carrier is aqueous (claim 5), wherein the one or more benzimidazole compounds comprises mebendazole (claims 6, 8 and 9), wherein the composition comprises around 15-25% of a glycol based solvent comprising an ethylene glycol based solvent (claim 9), wherein the ethylene glycol based solvent comprises diethylene glycol monoethyl ether (claim 1), wherein the topical composition comprises around 0.01 to 1% mebendazole by weight of the total composition (claim 11). Moreover, Jimenez teaches an aqueous mebendazole treatment composition for topically treating or preventing an inflammatory or autoimmune disease or condition of human skin, the treatment composition comprising: around 0.01-1% of one or more benzimidazole compounds; around 5-25% of a sorbitol based solvent; and around 15-50% of a glycol based solvent comprising an ethylene glycol based solvent, or a propylene glycol based solvent, or both; and wherein the percentages are by weight (claim 22), wherein the one or more benzimidazole compounds comprises mebendazole (claim 23) and the ethylene glycol based solvent comprises diethylene glycol monoethyl ether (claim 23); wherein the composition further comprises around 0.5-3% of a viscosity modifying agent (claim 24), wherein the viscosity modifying agent is hydroxyethyl cellulose, wherein the composition is a gel (claim 26).
Regarding the claimed amounts of mebendazole, diethylene glycol monoethyl ether, and hydroxyethylcellulose of instant claim 7, MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
Taken together, all this would result in the composition of claim 7 with a reasonable expectation of success.
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.
Claim 1-3 and 5-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 7-10, 12, 16-25, and 27-50 of copending Application No. 18/212,065 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
The instant claims are directed to an aqueous topical suspension for treating or preventing an inflammatory or autoimmune disease or condition of human skin comprising 0.01 to 1% of one or more benzimidazole compounds, wherein at least some of the one or more benzimidazole compounds remain in undissolved form in the aqueous topical suspension; and 15 to 45% of an ethylene glycol based solvent; wherein the percentages are by weight of the aqueous topical suspension; and wherein the aqueous topical suspension does not include any aprotic solvents, wherein the aqueous topical suspension further comprises water and hydroxyethylcellulose, wherein the composition is in a gel form.
The copending claims are directed to an aqueous topical composition suspension for treating or preventing a disease or a condition of human skin comprising: 0.01 to 0.075% of one or more benzimidazole compounds, wherein at least some of the one or more benzimidazole compounds remain in undissolved form in the aqueous topical suspension; wherein there are no active agents in the aqueous topical composition suspension other than the one or more benzimidazole compounds; wherein percentages are by weight of the aqueous topical suspension; and wherein the aqueous topical suspension does not include any dimethyl sulfoxide and does not include any dimethylacetamide; wherein the one or more benzimidazole compounds comprises mebendazole; wherein the composition further comprises an ethylene glycol based solvent comprising diethylene glycol monoethyl ether; wherein the composition comprises around 2.5-15% of the diethylene glycol monoethyl ether; wherein the composition further comprises around 0.5-3% of a viscosity modifying agent, wherein the viscosity modifying agent comprises hydroxyethylcellulose. The amounts of the mebendazole, diethylene glycol, monoethyl ether, and hydroxyethylcellulose overlap the instantly claimed amounts.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to arrive at the instantly claimed composition from the composition of the copending claims with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 1-3 and 5-7 are rejected.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RAYNA B RODRIGUEZ whose telephone number is (571)272-7088. The examiner can normally be reached 8am-5:00pm, Monday - Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Rayna Rodriguez/ Primary Examiner, Art Unit 1628
Prosecution Insights