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 .
DETAILED ACTION
Claims 1-16 are pending in the present application file.
Election/Restrictions
Applicant’s election of Invention II (claims 4 and 6; directed to compound of formula (II), or composition thereof) and a species of present formula (II) without traverse in the reply filed June 23, 2026 is acknowledged.
As per MPEP 803.02, the examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species of present formula (I) appears free of the prior art. Therefore, according to MPEP 803.02: should the elected species be found allowable, the examination of the Markush-type claim will be extended. If the examination is extended and a non-elected species found not allowable, the Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. The examination of the Markush-type claims has been extended to include the species cited below under 35 U.S.C. 102, which are not allowable.
As a non-elected species has been found not allowable, the Markush-type claims have been rejected and claims to the nonelected invention held withdrawn from further consideration. Claims 4 and 6 have been examined to the extent that they embrace and are readable on the elected embodiment and the above identified nonelected species. Since the nonelected species has been found not allowable, subject matter not embraced by the elected embodiment or the above identified nonelected species is therefore withdrawn from further consideration.
Claims 1-3, 5, 7-16 do not read on the presently searched and examined subject matter. Therefore, claims 1-3, 5, 7-16 are withdrawn from consideration by the Examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 6/25/2026 have been acknowledged by the Examiner. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the Examiner.
Specification
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
In chemical patent abstracts for compounds or compositions, the general nature of the compound or composition should be given as well as its use, e.g., “The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics.” Exemplification of a species could be illustrative of members of the class. For processes, the type of reaction, reagents and process conditions should be stated, generally illustrated by a single example unless variations are necessary.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the general nature of the compound or composition should be given and for using phrases which can be implied ("the present disclosure related", "the present disclosure also relates", etc.). A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 4 is objected to because of the following informalities:
In lines 5 and 8 of claim 4, “halogens (F, Cl, Br, I)” should read “halogen”.
In line 3 of claim 4, “a stereoisomers thereof, a prodrug thereof, or a pharmaceutically acceptable salts thereof” should read “or a stereoisomer thereof, a prodrug thereof, or a pharmaceutically acceptable salt thereof” and the entire phrase should be moved to the end of the claim following “m or n is an integer from 0 to 4”.
Appropriate correction is required.
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.
Claims 4 and 6 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 terms “esterified, etherified or protected hydroxy” and “esterified, amidified or salified carboxy” in claim 4 are relative terms which render the claim indefinite. The terms “esterified, etherified or protected hydroxy” and “esterified, amidified or salified carboxy” are not defined by the claim, 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 metes and bounds of substituents for R1 and R2 for a compound of formula (II), and consequently the scope of the compounds encompassed by the present claims is unclear.
Claim 6, which is dependent upon present claim 4, does not clarify the indefinite subject matter, and is similarly rejected.
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 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Swanson (Swanson, Devin M., et al. "Identification and biological evaluation of 4-(3-trifluoromethylpyridin-2-yl) piperazine-1-carboxylic acid (5-trifluoromethylpyridin-2-yl) amide, a high affinity TRPV1 (VR1) vanilloid receptor antagonist." Journal of medicinal chemistry 48.6 (2005): 1857-1872.).
Swanson discloses screening compounds of pyridinylpiperazine ureas to identify TRPV1 vanilloid receptor ligands (see abstract).
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Swanson discloses specific compound example 23 which corresponds to a compound of present formula (II) wherein R1 is trifluoromethyl, R2 is trifluoromethyl, Y is NH, W is N, m is 1 and n is 1 (see pg. 1858, rc, second figure; see pg. 1867, lc for synthesis of compound 23). In the preparation of compound 23, Swanson discloses where purification with a mixture of ethyl acetate and hexanes is employed to provide the desired compound. The composition comprising compound 23 and ethyl acetate is encompassed by present claim 6 as ethyl acetate is a pharmaceutically acceptable carrier.
Claims 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2812990-12-6 (which entered STN 8/26/2022).
CAS Registry No. 2812990-12-6 is drawn to N-(4-Methoxyphenyl)-5-phenyl-2,5-diazabicyclo[2.2.1]heptane-2-carboxamide which has the following structure:
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CAS Registry No. 2812990-12-6 which corresponds to a compound of present formula (II) wherein R2 is alkoxy, Y is NH, W is CH, m is 1 and n is 0.
Regarding present claim 6, which is drawn to a pharmaceutical composition comprising a compound of the formula II and further comprising a pharmaceutically acceptable carrier, the CAS Registry No. 2812990-12-6 entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out 'the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable carrier.
Claims 4 and 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No. 2397471-86-0 (which entered STN 12/31/2019).
CAS Registry No. 2397471-86-0 is drawn to 2-(4-Hydroxy-2-methylphenyl)-1-[(1S,4S)-5-phenyl-2,5-diazabicyclo[2.2.1]hept-2-yl]ethenone which has the following structure:
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CAS Registry No. 2397471-86-0 which corresponds to a compound of present formula (II) wherein R2 is both alkyl and hydroxy, Y is NH, W is CH, m is 2 and n is 0.
Regarding present claim 6, which is drawn to a pharmaceutical composition comprising a compound of the formula II and further comprising a pharmaceutically acceptable carrier, the CAS Registry No. 2397471-86-0 entry includes predicted properties including mass and molar solubilities at varying pH values. MPEP 2131.02 states:
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out 'the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015)
In this situation, a person having ordinary skill in the art in viewing the properties of the Registry entry would at once envisage a composition with the compound and water, which is a pharmaceutically acceptable carrier.
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 4 and 6 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of copending Application No. 19/420,072 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because they are directed to the same subject matter.
Claim 1 of the ‘072 application discloses several compounds in claims 1 and 2 which are encompassed by the present claims. See for example compound 2as, compound 2c and compound 2i. Compound 2as of claims 1 and 2 of the ‘072 application corresponds to a compound of present formula (II) wherein R1 is alkoxy, R2 is halogen, Y is NH, W is CH, m is 2 and n is 1. Compound 2c of claims 1 and 2 of the ‘072 application corresponds to a compound of present formula (II) wherein R1 is alkoxy, R2 is halogen, Y is CH, W is CH, m is 2 and n is 1. Compound 2i of claims 1 and 2 of the ‘072 application corresponds to a compound of present formula (II) wherein R1 is alkoxy, Y is O, W is CH, m is 0 and n is 1. See present claim 4.
Claim 3 of the ‘072 application discloses the pharmaceutical composition of claim 2 of the ‘072 application, further comprising at least one pharmaceutically acceptable carrier. See present claim 6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 4 and 6 are rejected.
Claims 1-3, 5, 7-16 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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, Jeffrey Murray can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/QUINCY A. MCKOY/
Patent Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626
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