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 .
Priority
The instant application, filed 08/24/2023, claims domestic priority to U.S. provisional application no. 63/401,327, filed 08/26/2022.
Claim Status
Claims 1-20 are pending in the instant application.
Information Disclosure Statement
The Information Disclosure Statement filed on 01/10/2024 is acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the information disclosure statement is considered.
Restriction/Election
Applicant’s election without traverse of Group I (claims 1-11) in the reply filed 03/09/2026 is acknowledged. The election of the following specific species is also acknowledged:
Species A: Applicant elects “one or more of visceral pain” (see claim 2)
Species B: Applicant elects “acute pain” as the type of pain (see claim 3
Species C: Applicant elects “transient exacerbation” (see claim 4)
Species D: Applicant elects “interstitial cystitis/bladder pain syndrome, IC/BPS” (see claims 6, 8, 10)
Species E: Applicant elects “suprapubic or pelvic pain related to and relieved by voiding” (see instant claim 11)
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species do not make a contribution over the prior art of record.
Status of Claims
Claims 1-20 are pending in the instant application. Claims 12-20 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 1-11 read on an elected invention and species and are therefore under consideration in the instant application.
Drawings
The drawings filed on 08/24/2023 are found to be in compliance with 37 CFR §§1.121 and 1.84, and are hereby accepted.
Claim Rejections - 35 U.S.C. § 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.
Claims 1 and 3-10 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 1 and 3-10 of the instant application claim a method of treating pain or symptoms associated with UCPPS, comprising administering to a subject in need thereof the compound of Formula (I).
It is unclear what “pain associated with UCPPS” or “symptoms associated with UCPPS” refers to and how to determine if a particular pain or symptom is associated with UCPPS. The term “pain/symptoms associated with UCPPS” in claims 1-6 is a relative term which renders the claim indefinite. The term “pain/symptoms associated with UCPPS” is not defined by the claims, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification does not define how to determine if a particular pain is associated with UCPPS. Thus it is unclear what would be considered associated with UCPPS by a person of ordinary skill in the art. There are a large number of types of pain/symptoms that could be considered to be associated with UCPPS. These types of pain/symptoms can range from bloating pain, to fatigue, mood change, to nocturia, to inability to function socially, according to Hatchett et al. (Health Psychol. Volume, 14, Issue 6, pages 741–750, published September 1, 2010). Moreover, there are types of pain/symptoms that could result from UCPPS that do not directly have UCPPS at the center of the syndrome, for instance, bloating pain or social withdrawal. The claims, as written, do not distinctly claim the pain/symptoms to which UCPPS is associated, or how the association is made—whether it be UCPPS itself or pain which develops as a result of side effects resulting from UCPPS. Thus an ordinary skilled artisan cannot ascertain the metes and bounds of the claimed invention and thus the claims are properly rejected as being indefinite.
Claim Rejections - 35 U.S.C. § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-11 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Santos et al (Pharmacology, British Pharmacological Society Meeting Poster, published September 7, 2021, cited on Applicant IDS filed 01/10/2024), hereinafter Santos.
Santos teaches the administration of ATB-352 (the compound of Formula (I)) to treat interstitial cystitis/bladder pain syndrome (IC/BPS)— a clinical entity defining urologic chronic pelvic pain syndrome as recited (see instant claims 1, 6-8, and 10). Santos reports the resulting reduction of mechanical allodynia and visceral pain (see instant claim 2) following oral administration of ATB-352. The disclosure teaches the treatment of pain during the acute phase of cyclophosphamide-induced cystitis, with pain assessment occurring within 21 to 24 hours after induction (see instants claim 3-5, see Figures 1 and 2 of Santos), corresponding to a model of time-limited bladder inflammation and pain, i.e. acute pain that is a transient exacerbation less than 3 days from pain onset. Santos further teaches treating impaired bladder contractile function, i.e. a symptom of UCPPS (see instant claim 9). Finally, Santos teaches the treatment of the symptom recited as “suprapubic or pelvic pain related to and relieved by voiding”. This clinical description identifies the characteristic visceral bladder pain of IC/BPS, pain that is generated by bladder filling and relieved by emptying. The descriptor identifies an inherent characteristic of visceral bladder pain, that is the central matter of the disclosure by Santos. As such, it does not impose a functional limitation that the prior art does not already meet.
The teachings as outlined above are herein applied to the claims individually, and the claims stand rejected.
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 1-11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 and 13 of U.S. Patent No. US 8,541,398 B2 in view of Santos (see earlier citation). Although the claims at issue are not identical, they are not patentably distinct from each other because the patented application teaches ATB-352, i.e. Formula (I). This disclosure combined with the teachings of Santos, who discloses the use of ATB-352 in treating IC/BPS would lead a person of ordinary skill in the art to use ATB-352 in the treatment of UCPPS. Santos teaches acute visceral pain which persists 20-24 hours and pelvic pain related to voiding (see Figure 1). A person of ordinary skill in the art would have found it obvious to use ATB-352 to treat UCBPPS, because Santos outlines this very treatment in their disclosure.
Correspondence
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sophia P. Hirakis whose telephone number is +1 (571) 272-0118. The examiner can normally be reached within the hours of 5:00 am to 5:00pm EST, Monday through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Adam C. Milligan can be reached on +1 (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is +1 (571) 273-8300.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/KARA R. MCMILLIAN/Primary Examiner, Art Unit 1623
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