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 the Claims
Claims 1-20 are pending. Claims 10-15 are withdrawn. Claims 1-9 and 16-20 are rejected.
Information Disclosure Statement
The Information Disclosure Statement (IDS) from 10/9/2024 was considered by the Examiner.
Election/Restrictions
Applicant’s election without traverse of Group I and the species of sulconazole in the reply filed on 3/16/2026 is acknowledged.
Claims 1-9 and 16-20 embrace Applicant’s elected species and are therefore under examination. The elected species is not allowable. Additional subject matter was discovered incidental to the search of the elected species and is presented below in the interest of compact prosecution.
Claims 10-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 112
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.
Claim 7 is 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 depends from claim 6, wherein claim 6 already describes a time of azole administration. Claim 7 describes an additional time of azole administration and it is unclear if claim 7 was intended to be a second administration. Examiner recommends that claim 7 depend from claim 5 instead of claim 6 to provide clarity on one time point administration of the azole.
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.
Claim(s) 1, 2, 3, 8, 9, 16, 17, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerbe (US20180050034).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Gerbe teaches a method of treating Crohn’s disease (fibrotic disease or disorder) by topically administering agents, which includes an imidazole (see claims 1 and 3). An example of the imidazole taught was sulconazole (azole derivative) (see para. [0078]) and any therapeutic agent taught in the prior art can be administered in an amount ranging from about 0.1 ug/kg to about 1 mg/kg (see para. [0112]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art teaches a variety of imidazoles, without a single embodiment of administering sulconazole.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-3 and 16, it would have been obvious to a PHOSITA to arrive at the instant claims because the prior art list of imidazoles:
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has a finite number of choices (14), wherein sulconazole would have been obvious to try for a Crohn’s patient. A skilled artisan would have been motivated to explore treatment efficacy with sulconazole with a reasonable expectation of success in a Crohn’s patient. Additionally, instant claim 1 is drawn to treating a subject “at risk of developing fibrosis”, wherein the entire population of subjects would be included.
Regarding instant claims 8 and 17, it would have been obvious to a PHOSITA to either administer the azole derivative (sulconazole) systemically or locally, as the prior art teaches a topical administration. A skilled artisan would have been motivated to explore various modes of administration to find the most successful treatment method with a reasonable expectation of success.
Regarding instant claims 9 and 19, the prior art amount administration range encompasses that of the instant claims. “In the case where the claimed ranges ’overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). It would have been obvious to a skilled artisan to explore the effective amount of azole derivative by optimizing a previously known range.
Claim(s) 4, 5, 6, 7, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gerbe (US20180050034), as applied to claim 1, 2, 3, 8, 9, 16, 17, and 18 above, and further in view of Gustavsson et al. (Aliment Pharmacol Ther, 2012, 36: 151-158).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Gerbe fails to teach treatment to a subject who has a history of intestinal strictures or performing a surgical intervention or endoscopic dilation.
Gustavsson teaches “Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn’s disease” (see title). See the following from top left column on p. 152:
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. Regarding the outcome of endoscopic dilation in all patients from Gustavsson’s study: “Technical success was achieved in 689/776 dilations (89%)” (see right column, p. 154, top paragraph).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art fails to disclose the administration of sulconazole AND a surgical intervention or endoscopic dilation. Additional dependent claims will be addressed below.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 4, intestinal strictures are a common symptom of Crohn’s disease. It would have been obvious to a PHOSITA to explore successful Crohn’s treatment methods on a patient who has the common predicament of intestinal strictures with a reasonable expectation of success. Regarding instant claims 5 and 19, endoscopic dilation was known to be a successful treatment for Crohn’s patients. Regarding performing an endoscopic dilation AND administering sulconazole, both were known to be useful in treating Crohn’s disease. Absent a showing of unexpected results, one of ordinary skill in the art would be motivated to combine both of the therapeutic agents which are taught for the same purpose in order to treat said diseases. In re Susi, 58 CCPA 440 169 USPQ 423, 426 (1971); In re Crokett, 47 CCPA 126 USPQ 186,188 (1960). In the instant case, one of the “therapeutic agents” can be substituted for the procedure of endoscopic dilation and follow a similar fact pattern, wherein both the endoscopic dilation and the sulconazole were useful in treating Crohn’s. Regarding claims 6, 7, and 20, a skilled artisan would have been motivated to explore the most effective time of azole derivative administration by a result of routine experimentation, 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.
Claims 1-9 and 16-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-17 and 20-23 of copending Application No. 18880412 in view of Gerbe (US20180050034), and further in view of Gustavsson et al. (Aliment Pharmacol Ther, 2012, 36: 151-158).
The copending application teaches a method for treating fibrosis or intestinal restructuring in a gastrointestinal tract of a subject by administering sulconazole nanocrystals (see claims 1 and 10). The fibrosis may be associated with Crohn’s disease (see claims 15 and 16). The sulconazole formulation may be injected in a proximity of a stricture site after a surgical or endoscopic procedure (see claim 14).
Gerbe teaches a method of treating Crohn’s disease (fibrotic disease or disorder) by topically administering agents, which includes an imidazole (see claims 1 and 3). An example of the imidazole taught was sulconazole (azole derivative) (see para. [0078]) and any therapeutic agent taught in the prior art can be administered in an amount ranging from about 0.1 ug/kg to about 1 mg/kg (see para. [0112]). Gerbe fails to teach treatment to a subject who has a history of intestinal strictures or performing a surgical intervention or endoscopic dilation.
Gustavsson teaches “Endoscopic dilation is an efficacious and safe treatment of intestinal strictures in Crohn’s disease” (see title). See the following from top left column on p. 152:
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. Regarding the outcome of endoscopic dilation in all patients from Gustavsson’s study: “Technical success was achieved in 689/776 dilations (89%)” (see right column, p. 154, top paragraph).
Regarding instant claims 1-3 and 16, it would have been obvious to a PHOSITA to arrive at the instant claims because the prior art (Gerbe) list of imidazoles:
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has a finite number of choices (14), wherein sulconazole would have been obvious to try for a Crohn’s patient. A skilled artisan would have been motivated to explore treatment efficacy with sulconazole with a reasonable expectation of success in a Crohn’s patient. Additionally, instant claim 1 is drawn to treating a subject “at risk of developing fibrosis”, wherein the entire population of subjects would be included.
Regarding instant claims 8 and 17, it would have been obvious to a PHOSITA to either administer the azole derivative (sulconazole) systemically or locally, as the prior art (Gerbe) teaches a topical administration. A skilled artisan would have been motivated to explore various modes of administration to find the most successful treatment method with a reasonable expectation of success.
Regarding instant claims 9 and 19, the prior art (Gerbe) amount administration range encompasses that of the instant claims. “In the case where the claimed ranges ’overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” MPEP 2144.05(I). It would have been obvious to a skilled artisan to explore the effective amount of azole derivative by optimizing a previously known range.
Regarding instant claim 4, intestinal strictures are a common symptom of Crohn’s disease (Gustavsson). It would have been obvious to a PHOSITA to explore successful Crohn’s treatment methods on a patient who has the common predicament of intestinal strictures with a reasonable expectation of success. Regarding instant claims 5 and 19, endoscopic dilation was known to be a successful treatment for Crohn’s patients (Gustavsson). Regarding performing an endoscopic dilation AND administering sulconazole, both were known to be useful in treating Crohn’s disease. Absent a showing of unexpected results, one of ordinary skill in the art would be motivated to combine both of the therapeutic agents which are taught for the same purpose in order to treat said diseases. In re Susi, 58 CCPA 440 169 USPQ 423, 426 (1971); In re Crokett, 47 CCPA 126 USPQ 186,188 (1960). In the instant case, one of the “therapeutic agents” can be substituted for the procedure of endoscopic dilation and follow a similar fact pattern, wherein both the endoscopic dilation and the sulconazole were useful in treating Crohn’s. Regarding claims 6, 7, and 20, a skilled artisan would have been motivated to explore the most effective time of azole derivative administration by a result of routine experimentation, with a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy 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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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
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