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 .
Election/Restrictions
Applicant’s election without traverse of a species of P2X3 antagonist, an additional therapeutic agent of claim 35, and a species of NK-1 antagonist from claim 36 in the reply filed on 06/29/2026 is acknowledged.
The elected species reads on claims 2-14 and 21.
Claims 15-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.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 06/29/2026.
Priority
This application is a continuation of the abandoned application 17/283,904, which is a national stage entry of PCT/IB2019/0011222, which claims priority to US provisional application 62/744,006.
The instant claims find support from the provisional application. Therefore, the effective filing date is 10/10/2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 5/16/2024, and 05/16/2024, and 09/04/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claim(s) 2-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
BUON (WO 2014117274) as evidenced by MIHO (Miho Shiratori-Hayashi et al., “Role of P2X3 Receptors in Scratching Behavior In Mouse Models”, Journal Of Allergy and Clinical Immunology”, November 17, 2018).
BUON anticipates administering the elected species (CAS #1621164-74-6
page 55, paragraph [237], example 15), depicted here
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BUON anticipates a method of treating a disorder associated with P2X3 activity in an animal in need of such treatment, wherein the method comprises administering to the animal a therapeutically effective amount of the compound above (claim 26 and Example 49 from paragraphs [261 and 262]). BUON anticipates administering to a mammal (mouse, example 49).
MIHO is relied upon for the beneficial teaching that pruritus is mediated by P2X3 receptors (figure 2, and page 1253, and title). BUON as evidenced by MIHO anticipates the method of claim 2.
The elected species anticipates claims 2-14.
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.
Claim(s) 2-14 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over BUON (WO 2014117274) as evidenced by MIHO (Miho Shiratori-Hayashi et al., “Role of P2X3 Receptors in Scratching Behavior In Mouse Models”, Journal Of Allergy and Clinical Immunology”, November 17, 2018) and in view of NAIR (Nair and Jacob, “A simple practice guide for dose conversion between animals and human”, J Basic Clin Pharm., March 2016).
Claims 2-14 are taught above.
NAIR teaches a simple practice guide for dose conversion between animals and humans and teaches to convert a mouse dose (in mg/kg) to a human equivalent dose (in mg/kg) (table 1).
While BUON uses an animal model above, it would have been obvious for an ordinary person skilled in the art to administer a compound which was tested using an animal model (mouse) to a human (NAIR table 1). Making an equivalent human dose from an animal dosage is well known in the art (NAIR). This teaches claim 21.
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 2-14 and 21 are rejected on the ground of anticipatory-type nonstatutory double patenting as being unpatentable over claims 17 and 15 of U.S. Patent No. 12,655,145 B2 as evidenced by MIHO (Miho Shiratori-Hayashi et al., “Role of P2X3 Receptors in Scratching Behavior In Mouse Models”, Journal Of Allergy and Clinical Immunology”, November 17, 2018).
The reference claims 15 and 17 anticipate instant claims 2-14 and 21. Ref Claim 15 anticipates the elected species P2X3 antagonist. Ref claim 17 anticipates a method of treating a disorder associated with P2X3 activity to a mammal.
MIHO is relied upon for the beneficial teaching that pruritus is mediated by P2X3 receptors (figure 2, and page 1253, and title).
Claims 2-14 and 21 are rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1, 8, and 16 of U.S. Patent No. US 10111883 in view of BUON (WO 2014117274) as evidenced by MIHO (Miho Shiratori-Hayashi et al., “Role of P2X3 Receptors in Scratching Behavior In Mouse Models”, Journal Of Allergy and Clinical Immunology”, November 17, 2018).
The reference claims 1 and 16 anticipate instant claims 2-14 and 21. Ref Claim 16 anticipates the elected species P2X3 antagonist. Ref claim 1 anticipates a method of avoiding loss of taste response by administering a P2X3 antagonist.
BUON also teaches administering the elected species (CAS #1621164-74-6
page 55, paragraph [237], example 15), depicted here
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BUON anticipates a method of treating a disorder associated with P2X3 activity in an animal in need of such treatment, wherein the method comprises administering to the animal a therapeutically effective amount of the compound above (claim 26 and Example 49 from paragraphs [261 and 262]). BUON anticipates administering to a mammal (mouse, example 49).
MIHO is relied upon for the beneficial teaching that pruritus is mediated by P2X3 receptors (figure 2, and page 1253, and title).
The artisan would have been motivated by BUON to use the reference claims in order to treat pruritus. BUON teaches the elected compound (also taught by the ref claims) in a method of treating P2X3 associated diseases, which pruritus is one of (MIHO).
Conclusion
No claims are allowed as currently written.
Application 18160167 was considered to be double patent art, however this application is abandoned.
Examiner notes that the elected species is also known as Camlipixant,
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN A HUTTER whose telephone number is (571)272-6323. The examiner can normally be reached M-F 7:30-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.A.H./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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