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 1-18 are pending in the instant application.
Election/Restrictions
Applicant’s election of Group I,
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and the species of Compound 1, disclosed on page 18 of the instant specification (reproduced below),
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,
in the reply filed on July 17, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
Applicant has requested rejoinder of the non-elected invention of Group II. In accordance with
MPEP §1893.03(d) and §821.04 and In re Ochiai, 71 F.3d 1565, 37 USPQ 1127 (Fed. Cir. 1995), rejoinder of product claims with process claims commensurate in scope with the allowed product claims will occur following a finding that the product claims are allowable. Until, such time, a restriction between product claims and process claims is deemed proper. Additionally, in order to retain the right to rejoinder in accordance with the above policy, Applicant is advised that the process claims should be amended during prosecution to maintain either dependency on the product claims or to otherwise include the limitations of the product claims. Failure to do so may result in a loss of the right to rejoinder.
The requirement is still deemed proper and is therefore made FINAL.
Claims 11, 12 and 14-17 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 17, 2026.
Power of Attorney
Of note, there is not an attorney of record on file due to a lack of an official power of attorney of record. While a customer number has been provided on the Application Data Sheet (ADS) submitted
July 10, 2024, this is not the equivalent of a power of attorney or an authorization to act in a representative capacity. In order to expedite prosecution in the instant application, it is suggested that a power of attorney be filed as per MPEP §402 or MPEP §1807, or an Authorization to Act in a Representative Capacity be filed as per MPEP §403 in order for the Office to freely and openly discuss the merits of the case with the applicant's representative(s). Please refer to the MPEP or http://www.uspto.gov/patents/law/poafaqs.jsp#a if you have questions regarding the proper filing of a power of attorney. "
Priority
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of
35 U.S.C. 112(a). See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
Since the instant application claims the benefit under 35 USC § 119(e) of Provisional application 63/312,537 filed February 22, 2022, the disclosure in the provisional application was reviewed because of the possibility of intervening art. It was found that Provisional application 63/312,537 fails to provide adequate support for the entire scope of the instant claimed invention. The disclosure of the prior-filed application, Application No. 63/312,537, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) for one or more claims of this application. For instance, Provisional application 63/312,537 does not disclose the general formula as claimed in instant claim 1 or the elected species of Compound 1 as claimed in instant claim 5. Therefore, the instant claimed invention can only rely on the filing date of PCT/US2023/013588, which is February 22, 2023.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement filed on July 10, 2024. The submission is in compliance with the provisions of
37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
The definition of variables X1-X5 in independent claim 1 has been interpreted that when one or more of variables X1-X5 represents C (in some instances) or N (in some instances), the C or N can only have a hydrogen(s) attached “as chemically possible”. See page 5, line 9; page 8, line 3; and page 15, lines 21-30 of the instant specification.
Claim 13 is directed to a compound but depends improperly from a method of use claim. Prior art will be considered for claim 13 based on compounds and not a method of use.
Claim Objections
Claims 1, 2, 4-7 and 9 are objected to because of the following informalities:
in claim 1, “R =” is listed twice consecutively (line 4 of the claim);
in claim 1, the numbers in the variables X1, X2, X3, X4 and X5 should all be subscripted to be consistent with these variables use to define the 5-membered ring in the R variable substituent;
in claim 1, the 3rd line from the end of the claim, the phrase “and salts and stereoisomers thereof,” should be changed to “or a salt or a stereoisomer thereof,”;
in claim 2, the phrase “M is 0,” should be changed to “M is absent” (see page 16, line 26 of the instant specification for support);
in claim 4, the phrase “M = 0” should be changed to “M is absent” (see page 16, line 26 of the instant specification for support);
in claim 5, some of the chemical structures of the claimed compounds are not completely legible;
in claim 6, lines 1-2 of the claim, the phrase “compound is a hydrochloride salt” should be changed to “compound is in a form of a hydrochloride salt”;
in claim 7, the phrase “M = 0 or 1” should be changed to “M is absent or methyl” (see page 16, line 26 of the instant specification for support); and
in claim 9, the next to the last line of the claim, an “and” should be added before “the compound is”.
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 1-10, 13 and 18 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.
In claim 1, a dangling valence problem is raised when variables X1, X2, X3, X4 and/or X5 represent C (in some instances) and when variables X1, X2, X3, X4 and/or X5 represent N (in some instances). The metes and bounds of independent claim 1 cannot be ascertained. The claimed compounds should not have dangling valences. Claims of the “dangling valence” type in which only the portion of the structure responsible for the activity is defined in the claim are indefinite because the claims are of indeterminate in scope and generally broader than any possible supporting disclosure. Ex parte Diamond, 123 USPQ 167 (POBA 1959). Therefore, claim 1 is indefinite. This rejection can be overcome by amending claim 1 to indicate that variables X1, X2, X3, X4 and/or X5 can represent C, CH and CH2 {page 15, lines 21-30} and can represent N and NH {see page 5, line 9; and page 8, line 3, of the instant specification for support}.
Claims dependent on claim 1 which do not resolve the dangling valence problem in claim 1 are also found indefinite.
Claims 3-5 and 7-9 each lack antecedent basis from claim 1 because there is no earlier recitation in claim 1 that variables X1, X2, X3, X4 and/or X5 can represent NH when defining the R variable substituent,
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Claim 6 lacks antecedent basis from claim 5 because there is no earlier recitation in claim 5 that the compounds being claimed in claim 5 can be in the form of a salt. See claim 13 for same. Therefore, claims 6 and 13 are indefinite.
Claim 9 lacks antecedent basis from claims 7 and 8 8 because there is no earlier recitation in claim 7 or claim 8 that variable M can represent ethyl as found in the compounds claimed in claim 9. Therefore, claim 9 is indefinite.
Claim 13 is confusing because claim 13 is directed to a compound but claim 13 depends from method of use claim 12. Therefore, claim 13 is indefinite. This rejection can be overcome by changing the dependency of claim 13 to depend from a compound claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 6, 9 and 13 are rejected under
35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 6 fails to further limit claim 5 because claim 6 is broader in scope than claim 5. Claim 5 does not claim that the claimed compounds can be in the form of a salt. See claim 13 for same.
Claim 9 fails to further limit claims 7 and 8 because claim 9 is broader in scope than claims 7 and 8. Claim 7 nor does claim 8 claim that variable M can represent ethyl as found in the compounds claimed in claim 9.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-3, 9, 10, 13 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 and 6-9 of copending Application No. 19/104,877 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because copending Application No. 19/104,877 generically claims compounds which overlap with the instant claimed compounds. Further, the description in copending Application No. 19/104,877 discloses Compound 9 and Compound 10 in Scheme 3 on page 26, which compounds are embraced by the claimed genus in copending Application No. 19/104,877 and would anticipate the instant claimed invention.
One skilled in the art would thus be motivated to prepare products embraced by the copending application to arrive at the instant claimed products with the expectation of obtaining additional beneficial products which would be useful in treating pain.
The instant application shares a common inventor with copending Application No. 19/104,877. The instant application is not related to copending Application No. 19/104,877 and thus, no 35 USC 121 shield exists here. See MPEP §804.01. The instant claimed invention would have been suggested to one skilled in the art and therefore, the instant claimed invention would have been obvious to one skilled in the art.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
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 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.
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 1-10, 13 and 18 are rejected under
35 U.S.C. 102(a)(1) as being anticipated by:
Cashman et al. {U.S. Patent 8,778,958} – who disclose, for instance, Compound 19(b) in Example 48 in column 42,
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{a compound of instant general formula,
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wherein
R =
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;
X1 = O;
X2 = C;
X3 = C;
X4 = C;
X5 = C; and
M = unsaturated, unbranched, unsubstituted alkyl
chain comprising 2 carbon atoms (i.e., ethyl)};
Nagase et al. {U.S. Patent 6,277,859} – who disclose Compound 79 in columns 127-128,
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{a salt of a compound of instant general formula,
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wherein
R =
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;
X1 = O;
X2 = C;
X3 = C;
X4 = C;
X5 = C; and
M = unsaturated, unbranched, unsubstituted alkyl
chain comprising 2 carbon atoms};
Huang et al. {Journal of Medicinal Chemistry (March 24, 2022), 65(6), pages 4991-5003} – who disclose, for example, Compound 3 in Table 1 on page 4994,
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{a compound of instant general formula,
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wherein
R =
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;
X1 = N;
X2 = C;
X3 = C;
X4 = C;
X5 = N; and
M = unsaturated, unbranched, unsubstituted alkyl
chain comprising 2 carbon atoms (i.e., ethyl)}; and
Pagare et al. {Journal of Medicinal Chemistry (March 24, 2022), 65(6), pages 5095-5112} – who disclose, for example, Compound 1 in Table 1 on page 5098 and page 5103, wherein Compound 1 was prepared in its free base form as well as a hydrochloride salt thereof,
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{a compound of instant general formula,
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wherein
R =
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;
X1 = C;
X2 = C;
X3 = N;
X4 = C;
X5 = C; and
M = zero carbons (i.e., absent);
-OR-
the elected species of Compound 1 in the instant application as claimed in
instant claim 5}.
Each of the above cited prior art disclose at least one compound that is embraced by the instant claimed invention. Further, Cashman et al. (columns 27-28) disclose pharmaceutical compositions comprising his compounds together with pharmaceutically acceptable carriers and/or excipients. Therefore, each of the above cited prior art anticipates the instant claimed invention.
The elected species of Compound 1, disclosed on page 18 of the instant specification and claimed in instant claim 5, is not allowable.
Reminder to Applicant
As a reminder, Applicant should specifically point out the support in the original disclosure {i.e., page number(s) and line number(s)} for any new claims or amended claims and for any amendments made to the disclosure. Making generic statements such as “all amendments are fully supported in the originally filed disclosure or the originally filed claims” without specifying page numbers and originally filed claim numbers are insufficient. See MPEP §714.02 and MPEP §2163.06(I).
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to:
Laura L. Stockton
(571) 272-0710.
The examiner can normally be reached on Monday-Friday from 8:30 am to 6 pm, Eastern Standard Time.
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 acting supervisor,
James Alstrum-Acevedo can be reached on 571/272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/LAURA L STOCKTON/ Primary Examiner, Art Unit 1626 Work Group 1620
Technology Center 1600
July 31, 2026
Book XXIX, page 99
Prosecution Insights