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
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/30/2026 has been entered.
The amendment filed 04/30/2026, amended claim 1 and cancelled claims 8-16, and 27, and added claim 28.
Note: pg. 7 of the specification provides support for the amendment to the definition of R in instant claim 1, and the addition of instant claim 28. See also pg. 11, Remarks.
Claims 1, 5-7, 17-18, 22-26 and 28 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Election/Restrictions
In the 06/18/2025, Office Action, Groups I-III were rejoined, and examined. Group IV, claims 19-21, were withdrawn from consideration.
The 09/17/2025 Amendment to the claims deleted Group IV, claims 19-21.
Claims 1, 5-7, 17-18, 22-26 and 28 are examined on the merits herein.
REJECTIONS WITHDRAWN
The status for each rejection and/or objection in the previous Office Action is set out below.
35 U.S.C. § 112(d)
Applicant’s amendment to claim 1 that adds “C1-C5 cycloalkyl and C1-C5 alkoxy” to the Markush group of R, is sufficient to overcome this rejection.
35 U.S.C. § 112(a)
Applicant’s deletion of claims 8-16 and 27 is sufficient to overcome this rejection.
REJECTIONS
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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, 5-7, 17, 22-26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9-10, 12-15, and 26 of copending Application No. 17/904,388 (claim set dated 08/17/2022, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘388 teaches a compound of formula B-L-B’, wherein B and B’ can be:
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, wherein Z can be -COOH, and L can be C6-C12(hetero)aryl, and wherein B and B’s are the same and the compound is a palindromic compounds, and salts thereof (claims 1-3 and 6).
‘388 additionally teaches L as:
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and
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, wherein n can be 0 (claims 9-10).
‘388 additionally claims:
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(claims 11-12),
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, and
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(claims 13-14), which meets the limitations of instant Formula (I) when Ar is Ar-I in instant claim 1 and is Ar-VII in instant claim 22, and is instant Formula (II) of instant claim 5.
Regarding instant claims 6 and 23, ‘388 claims salts of its compounds and teaches hydrochloric acid as such a salt (pg. 8, ‘388 specification), and specifically regarding claim 23, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation," MPEP 2144.05(II).
Regarding instant claims 7 and 23-26, ‘388 claims its compounds as having an IC50 of about 200µM or less to about 1µM or less (claim 15).
Regarding instant claim 17, ‘388 claims a pharmaceutical composition comprising pharmaceutical excipients (claim 17).
Regarding instant claim 28, since R represents optional substituents, even though
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does not depict R,
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meets the limitations of instant claim 28, since R is optional.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 5-7, 17, 22-26, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, and 20 of copending Application No. 18/683,412 (claim set dated 04/03/2025, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘412 claims the following compound:
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, wherein R3 can be H (claim 1).
Claims 2-3 of ‘412 claims the same aryl linker groups recited in instant claims 1, 22, and 28.
‘412 specifically claims:
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, wherein R1 and R2 can be -OR3, wherein R3 is H, and
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(claims 6, 8-9), meeting the limitations of instant claims 1, 5, and 22.
Regarding instant claims 6 and 23, ‘412 claims a hydrochloride salt and particularly a 2HCl salt (claim 8).
Regarding instant claims 7 and 24-26, ‘412 claims the compound as an inhibitor of human C-reactive protein (CRP) having an IC50 of about 20µM or less to about 1µM or less (claim 10).
Regarding instant claim 17, ‘412 claims pharmaceutical composition comprising one or more pharmaceutically acceptable excipients, diluents, or carriers (claim 20).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Allowable Subject Matter & Free of the Prior Art
Claim 18 is allowable. Claims 1, 5-7, 17, 22-26 and 28 are free of the prior art.
REASONS FOR ALLOWANCE
The following is an examiner’s statement of reasons for allowance for claim 18 and reasons why claims 1, 5-7, 17, 22-26, and 28 are free of the prior art:
The instantly claimed method is novel and non-obvious over the prior art. The instantly claimed compound is free of the prior art.
The closest prior art is US 2007/0155738 to Steeneck (published 2007, PTO-892, claim 1), which teaches the following compound:
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(pg. 809, claim 1), and species such as
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and
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(pg. 964, 971, claims 95 and 96).
The reference does not teach a palindromic compound comprising quinuclidine rings and a carboxy group attached to the methylene group following the amide group, which are the distinct features of the instantly claimed compound.
Therefore, the prior art neither anticipates nor reasonably makes obvious the claimed
invention and therefore, the claimed invention is deemed novel and unobvious over the
prior art.
Conclusion
Claims 1, 5-7, 17, 22-26 and 28 are rejected.
Claim 18 is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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, James (Jim) 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.
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/LAUREN WELLS/Examiner, Art Unit 1622
Prosecution Insights