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 .
Claims 1-10, 14-18, and 21-25, submitted on 28 June 2023, represent all claims currently under consideration.
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.
Priority
This Application is a 371 of PCT/US2022/012220, filed 13 January 2022, which claims priority to provisional US 63/137,778, filed 15 January 2021.
The effective filing date is 15 January 2021.
Information Disclosure Statement
Three Information Disclosure Statements (IDSs), submitted on 28 June 2023, 18 August 2023, and 30 January 2025, are acknowledged and have been considered.
Claim Objections
Claims 10 and 18 are objected to because of the following informalities: The claims should define “OEA” and “OLDA” prior to the abbreviations being used. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: The claim contains a superfluous “or” prior to “postoperative status” and a superfluous “and” prior to irritable bowel syndrome”. Appropriate correction is required.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 art 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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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 art 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.
Claims 1-9, 14-17, and 21-25 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Factors to be considered in making the determination as to whether one skilled in the art would recognize that applicant was in possession of the claimed invention as a whole at the time of filing include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and knowledge in the art and (f) Predictability in the art. While all of these factors are considered, a sufficient number for a prima facie case are discussed below:
The claims are directed to methods to induce defecation comprising administering a TRPV1 agonist. The specification states that a TRPV1 agonist includes “without limitation, capsaicin, resiniferatoxin, nonivamide, anandamide, olvanil, palvanil, arvanil, piperine, N-oleoyldopamine, and SDZ-249665” (Page 9, Lines 4-6). Table 1 (Page 12) lists representative TRPV1 receptor agonists, and includes AM 404, anandamide, arvanil, capsaicin, GFK 1016790A, NADA, N-oleoyldopamine, olvanil, PPAHV, OEA, nonivamide, palvanil, E-capsaicin, piperine, dihydrocapsaicin, homodihydrocapsaicin, nordihydrocapsaicin, nordihydrocapsaicin, and homocapsaicin. The specification states that capsaicinoids are naturally occurring TRPV1 receptor agonists, thus there is support that applicant was in possession of this class of TRPV1 receptor agonists, as well as the specific TRPV1 receptor agonists of Table 1. However, there is no defined structure which could encompass all known TRPV1 agonists. The artisan would generally know understand what these compounds functionally do (agonize the TRPV1 receptor), but without a defined structure or classes of compounds, the artisan would have no reasonable expectation of predictability in practicing this invention as they would only know if a compound can agonize this receptor from a posteriori testing and analysis. Thus, there is no support that Applicant was in possession of the invention as a whole at the time of filing of the examined application.
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 1-9, 14-17, and 21-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The metes and bounds of “TRPV1 agonist” are undefined, and therefore indefinite. The specification states that “By “TRPV1” is meant transient receptor potential vanilloid 1 (TRPV1). Exemplary TRPV1 receptor agonists include, without limitation, capsaicin, resiniferatoxin, nonivamide, anandamide, olvanil, palvanil, arvanil, piperine, N-oleoyldopamine, and SDZ-249665” (Page 9, Lines 4-6). Table 1 (Page 12) lists representative TRPV1 receptor agonists, and includes AM 404, anandamide, arvanil, capsaicin, GFK 1016790A, NADA, N-oleoyldopamine, olvanil, PPAHV, OEA, nonivamide, palvanil, E-capsaicin, piperine, dihydrocapsaicin, homodihydrocapsaicin, nordihydrocapsaicin, nordihydrocapsaicin, and homocapsaicin. It is unclear what specifically encompasses a TRPV1 agonist, and what the metes and bounds of what a TRPV1 agonist is. There is no structure defined that would clearly define the metes and bounds of a TRPV1 agonist, rendering the claims undefined, and therefore, indefinite.
Claims 5-9, 13, and 23-25 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The claims at issue each contain “about” prior to the limitation for the length of time for onset of treatment. The specification defines about as to “refer to all such numbers, including all numbers in a range and modifies that range by extending the boundaries above and below the numerical value set forth”. It is unclear how these boundaries are extended above and below the numerical value set forth, i.e., how many minutes or seconds are these values extended? There is uncertainty with respect to how these boundaries can be extended, causing the metes and bounds of the claims to be undefined, and therefore, indefinite.
Claims 5 and 6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 5 recites the limitation "the rapid-onset" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claims 7-9 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 7-9 recite the limitation "the short duration of action" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 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 14 recites the limitation "the as-needed administering" in Line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 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. Regarding Claim 15, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 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 17 contains a parenthetical (e.g., opioids, antimuscarinics). This parenthetical renders the claim indefinite because it is unclear whether the limitation(s) within the parenthesis are part of the claimed invention. See MPEP § 2173.05(d).
Claim 17 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. It is unclear what “and/or” means in the context of the claim. For example, how can the defecation dysfunction be both idiopathic (lacking a known cause) and be caused by a condition such as spinal cord injury?
Claim Rejections - 35 USC § 102
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gardiner (US Patent 6,201,014; Patent Date: 13 March 2001).
Gardiner (See IDS, 28 June 2023) discloses a pharmaceutical composition for the treatment of irritable bowel syndrome, diarrhea, constipation, abdominal pain and/or bloating or abdominal distension, comprising a vanilloid compound and a carrier vehicle (Abstract). Example 1 provides a formulation of capsaicin (a TRPV1 agonist) (Column 7). Example 9 teaches the treatment of a human patient suffering from one or more of the following symptoms: diarrhea, constipation, abdominal pain, abdominal bloating, abdominal distension, altered stool frequency, altered stool form, altered stool passage or passage of mucus by administering a therapeutically effective amount of the pharmaceutical composition according to examples 1 through 8 either by oral or rectal administration wherein the composition is administered with enough frequency to alleviate one or more of the symptoms in said patient (Column 9, Lines 21-34). Example 8 (Column 9, Lines 1-19) provides a representative suppository formulation which contains capsaicin. Capsaicin is a TRPV1 agonist.
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 1-9, 14-17, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner (US Patent No. 6,201,014; Patent Date: 13 March 2001).
As described above, Gardiner discloses compositions and methods for the intrarectal administration of a vanilloid compound (capsaicin) for the treatment of constipation, wherein the intrarectal administration is a suppository. A further aspect of the present invention is a method of treatment of irritable bowel syndrome, diarrhea, constipation, abdominal pain and/or bloating or abdominal distension in a mammal the method comprising administering to a mammal in need thereof a therapeutically effective amount of a pharmaceutical composition comprising one or more vanilloid compounds, pharmaceutically acceptable salts, analogs, and/or derivatives thereof and a pharmaceutically acceptable vehicle selected to enable the release of the vanilloid compound in the GI tract between the stomach and the rectum of the mammal (Column 6, Lines 37-48). Example 1 provides a formulation of capsaicin (a TRPV1 agonist) (Column 7). Example 9 teaches the treatment of a human patient suffering from one or more of the following symptoms: diarrhea, constipation, abdominal pain, abdominal bloating, abdominal distension, altered stool frequency, altered stool form, altered stool passage or passage of mucus by administering a therapeutically effective amount of the pharmaceutical composition according to examples 1 through 8 either by oral or rectal administration wherein the composition is administered with enough frequency to alleviate one or more of the symptoms in said patient (Column 9, Lines 21-34). Example 8 (Column 9, Lines 1-19) provides a representative suppository formulation which contains capsaicin. These formulations lack an enteric coating, resulting in an immediate release of the capsaicin.
Regarding Claims 5, 6, and 23, Gardiner does not disclose wherein the rapid-onset is characterized by an onset time ranging from 0 sec to about 10 minutes, or 0 to 5 minutes after administration. However, it would be obvious to one of ordinary skill in the art to identify formulations which allow for this rapid onset using the formulations of Gardiner as a guide. Non-enteric coated formulations, such as those of Example 8, have no protective coating, and thus will be released immediately and have a rapid onset.
Regarding Claims 7-9 and 24, a short duration of action is not disclosed. However, it would have been obvious to modify these methods and formulations of Gardiner to have a short duration of action using the disclosed formulations as a guide. The artisan would recognize that the duration of action can be modified by altering the dose which is administered, or by formulating in a rapidly releasing formulation.
Regarding Claims 14 and 25, Gardiner does not disclose wherein the as-needed administering ranges from about 0 to about 10 minutes prior to when defecation is desired. However, it would have been obvious to one of ordinary skill in the art to utilize the disclosed formulations, and modify them, if necessary, in order to arrive at the claimed method.
Regarding Claim 15, Gardiner does not specifically disclose wherein the mammal is female with or without a neurological condition; however, it would be obvious to treat a female and the artisan would have a reasonable expectation of success as these formulations can treat a human patient in general.
Regarding Claim 16, Gardiner teaches methods and rectal formulations for the treatment of constipation, a defecation dysfunction, which comprise capsaicin, a TRPV1 agonist. It would have been obvious to one of ordinary skill in the art to administer this formulation as-needed , formulated as an immediate release dosage form, wherein the formulation is administered intrarectally, and has a paid onset and short duration of action, by using the formulations of Gardiner, and modifying these formulations to ensure that the capsaicin is released to allow for rapid onset and short duration.
Claims 1-10, 14-18, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner (US Patent No. 6,201,014; Patent Date: 13 March 2001) in view of Moore (US 2013/0197094; Publication Date: 1 August 2013).
The teachings of Gardiner are described previously and are fully incorporated into this rejection.
Gardiner fails to teach the use of nonivamide as a TRPV1 agonist.
Moore (See IDS, 28 June 2023) teaches the use of nonivamide as a TRPV1 agonist. Moore discloses the administration of an effective amount of a TRPV1 compound at or near a target site for the relief of pain (Abstract). Exemplary vanilloids for use in the invention includes nonivamide (Paragraph 0054). The localized delivery of these formulations allows for systemic side effects, such as liver transaminase elevations, hepatitis, liver failure, myopathy, constipation, etc. may be reduced or eliminated (Paragraph 0035).
Gardiner and Moore are considered analogous to the claimed invention as all are involved in the treatment of disorders and conditions using TRPV1 receptor agonists. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the compositions and methods of Gardiner, and utilize the specific TRPV1 agonist nonivamide as the vanilloid compound. The artisan would have reasonable expectation of success as the method of Gardiner requires the use of a TRPV1 agonist, and nonivamide is a known TRPV1 agonist. It would be prima facie obvious to one of ordinary skill in the art to perform this substitution as nonivamide is a known TRPV1 agonist, and thus this is a substitution of an equivalent known for the same purpose (See MPEP § 2144.06 II).
Claims 1-10, 14-18, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner (US Patent No. 6,201,014; Patent Date: 13 March 2001) in view of Westphal (US 2019/0038573; Publication Date: 7 February 2019).
The teachings of Gardiner are described previously and are fully incorporated into this rejection.
Gardiner fails to teach the use of OEA or OLDA as a TRPV1 agonist.
Westphal (See IDS, 28 June 2023) discloses compositions of ion channel activators and methods of preparation, formulation, and the medical use of these compositions, and these ion channel activators include TRPV1 channel activators (Abstract). In any embodiment of the invention, the TRPV1 channel activator is oleoylethanolamide (OEA)… N-oleoyldopamine (OLDA)… (Paragraph 0010). Indications to be treated include multiple sclerosis, cerebral palsy, stroke, motor neuron disease, spinal injury stenosis, Alzheimer’s, Parkinson’s, and spinal cord injury (Paragraph 0239, 0242). Methods of administration include enemas and rectal administration (Paragraph 0227).
Gardiner and Westphal are considered analogous to the claimed invention as all are involved in the treatment of disorders and conditions using TRPV1 receptor agonists. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the compositions and methods of Gardiner, and utilize the specific TRPV1 agonists OEA or OLDA as the vanilloid compound. The artisan would have reasonable expectation of success as the method of Gardiner requires the use of a TRPV1 agonist, and OEA and OLDA are known TRPV1 agonists. It would be prima facie obvious to one of ordinary skill in the art to perform this substitution as these compounds are known TRPV1 agonists, and thus this is a substitution of an equivalent known for the same purpose (See MPEP § 2144.06 II).
Claims 1-10, 14-18, and 21-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gardiner (US Patent No. 6,201,014; Patent Date: 13 March 2001) in view of Eyal (WO 2021/033149; Publication Date: 25 February 2021; International Filing Date: 19 August 2020).
The teachings of Gardiner are described previously and are fully incorporated into this rejection.
Gardiner fails to teach the use of OEA or OLDA as a TRPV1 agonist to induce defecation.
Eyal discloses pharmaceutical compositions comprising a carrier and a pharmaceutically effective amount of at least one modulator of an activity which is responsive to modulation by at least one selected from the group consisting of anandamide, N-oleoylethanolamine (OEA), N-palmitoylethnaolamide (PEA), and serotonin (Abstract). According to some embodiments, said at least one modulator comprises at least one TRP channel modulator. According to come embodiments, said at least one TRP channel modulator comprises at least one TRPV1 channel modulator (Paragraph 008). According to some embodiments, said symptom is selected from the group consisting of… constipation… (Paragraph 0019). According to some embodiments, the at least one modulator is selected from the group consisting of… N-oleoyldopamine (OLDA)… and N-oleoylethanolamide (OEA) (Paragraph 0022). According to an aspect of some embodiments, there is provided a method of treating a condition characterized by anandamide deficiency or a symptom thereof, comprising administering to the subject a preparation comprising a composition comprising a carrier and a pharmaceutically effective amount of at least one modulator of an activity responsive to modulation by at least one selected from the group consisting of anandamide, OEA, PEA, and serotonin (Paragraph 0031). According to an embodiment, the preparation comprises a suppository (Paragraph 00109). According to an embodiment, the preparation comprises the composition in a form suitable for topical administration such as in a cream, ointment, gel, oil, patch, or combinations thereof (Paragraph 00111).
Gardiner and Eyal are considered analogous to the claimed invention as all are involved in the treatment of disorders and conditions using TRPV1 receptor agonists. Therefore, it would have been prima facie obvious to one of ordinary skill in the art the time of the effective filing date of the instant application to modify the compositions and methods of Gardiner, and utilize the specific TRPV1 agonists OEA or OLDA as the vanilloid compound. The artisan would have reasonable expectation of success as the method of Gardiner requires the use of a TRPV1 agonist, and OEA and OLDA are known TRPV1 agonists, with Eyal disclosing their usefulness in treating conditions such as constipation. It would be prima facie obvious to one of ordinary skill in the art to perform this substitution as OEA and OLDA are known TRPV1 agonists, and thus this is a substitution of an equivalent known for the same purpose (See MPEP § 2144.06 II).
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, 14-17, and 21-25 are rejected on the ground of nonstatutory double patenting as being unpatentable over Claims 1-9 and 11-14 of U.S. Patent No. 11,458,112 (Patent Date: 4 October 2022) (‘112).
Claim 1 of ‘112 is directed to a method for inducing defecation in a mammal, comprising administering to the mammal a therapeutically effective amount of capsaicin or a pharmaceutically acceptable salt thereof as an active agent for inducing defecation, wherein the administering is rectal and capsaicin is the only active agent administered for inducing defecation. Claim 2 of ‘112 claims the method of claim 1 wherein the capsaicin is administered on an as-needed basis. Claim 3 of ‘112 claims the method of claim 1 wherein the rectal administration is selected from the group consisting of one or more of rectal suppositories, capsules, tablets powders, creams, ointments, gels, foams, solutions, emulsions, and suspensions. Claim 4 of ‘112 claims the method of claim 1 wherein the mammal is a human, a cat, or a dog. Claim 5 of ‘112 claims the method of claim 1 wherein the administering ranges from about 0 minutes to about 30 minutes prior to when the defecation is desired. Claim 6 of ‘112 claims the method of claim 5 wherein administering ranges from about 0 minutes to about 10 minutes prior to when the defecation is desired. Claim 7 of ‘112 claims a method for treating defecation dysfunction in a mammal in need of treatment, comprising administering to the mammal a therapeutically effective amount of capsaicin as an active agent for treating defecation dysfunction, wherein the administering is rectal and capsaicin is the only active agent administered for treating defecation dysfunction. Claim 8 of ‘112 claims the method of claim 7 wherein the therapeutically effective amount of capsaicin or pharmaceutically acceptable salt thereof is administered on an as-needed basis. Claim 9 of ‘112 claims the method of claim 7 wherein the defecation dysfunction is a result of one or more of spinal cord injury, traumatic brain injury, multiple sclerosis, spina bifida, degenerative brain disease, Alzheimer’s, Parkinson’s, dementia, diabetes, advanced age, idiopathic constipation, or postoperative status. Claim 11 of ‘112 claims the method of claim 7 wherein the rectal administration comprises a rectal suppository. Claim 12 of ‘112 claims the method of claim 7 wherein the mammal is a human, a cat, or a dog. Claim 13 of ‘112 claims he method of claim 7 wherein administering ranges from about 0 minutes to about 30 minutes prior to when the defecation is desired. Claim 14 of ‘112 claims the method of claim 13 wherein administering ranges from about 0 minutes to about 10 minutes prior to when the defecation is desired.
The claims are not identical but are not patentably distinct because the methods of ‘112 utilize capsaicin, which is a TRPV1 agonist, while the claims at issue require the use of a TRPV1 agonist.
Conclusion
Claims 1-10, 14-18, and 21-25 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625