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
This is a response to Applicant’s communication filed on June 29, 2026. Application No. 18/694,362, March 21, 2024, is a 371 of PCT/US2022/044437, filed September 22, 2022, and claims the benefit of U.S. Provisional application No. 63/247,727, filed September 23, 2021. Claims 1-26 are pending.
Election/Restrictions
Applicants’ elections without traverse of the invention of Group I and the compound species of Compound No. I-118, in the reply filed on July 29, 2026, are acknowledged. Claims 21-26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. The elections were made without traverse in the reply filed on July 29, 2026.
Please note that as the claims are presently construed, the elected species depicted as follows:
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does not read on the claimed Markush formula, formula I-a of claim 1, depicted as follows:
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In order for the elected species to read on formula I-a (above), two of R4, R5, or R6 would have to join together to form a cyclobutyl ring on the carbon atom to which they are attached. As presently construed, this is not included in the definition of R4-6.
Nonetheless, in order to advance prosecution, the species election requirement is withdrawn. The claims are examined accordingly.
Claim Rejections - 35 USC § 112(b)
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.
Claims 7, 13 and 14 are rejected under 35 U.S.C. 112(b), as being indefinite. Claims 14 and 15 improperly refer to “Table 1A,” “Table 1B” and “Table 1C” elsewhere in the specification to give meaning to the specific compounds encompassed by the claims. See Ex Parte Fressola 27 USPQ2d 1608, for the proposition that:
“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 in utility applications 1 that define the invention entirely by reference to the specification and/or drawings, so-called “omnibus” or “formal” claims, while perhaps once accepted in American patent practice, are properly rejected under Section 112 Para. 2 as failing to particularly point out and distinctly claim the invention. See MPEP Section 706.03(h) (5th ed., rev. 14, Nov. 1992); Landis, Mechanics of Patent Claim Drafting, Section 2 (1974). This analysis is limited to claims in utility applications. Plant patent claims are defined “in formal terms to the plant shown and described.” Claims in design patents are recited in formal terms to the ornamental design “as shown” or, where there is a properly included special description of the design, the ornamental design “as shown and described.” MPEP Section 1503.01…….The general rule is that the claims should be self-contained; that is, they should not expressly rely upon the description or drawing to give them meaning. . . . The terms “substantially as described” and the like, once much used in claims (GLASCOCK 1943 Section 5640) are now rarely seen. The Office disregards them in interpreting claims. . . . Claims consisting only in a reference to the disclosure, as “The features of novelty herein disclosed,” are not allowed except in design cases.…..A claim which refers to the specification defeats the purpose of a claim.”
In this case, the specification should not be referenced when the specific compounds can be clearly described in the claims by either name or structural representation. Appropriate correction is required.
Claim Rejections - 35 USC § 102(a)(1)
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 1-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Molfino et al., US2012/0010179 A1. Molfino discloses the following β1/β2 adrenergic agonists.
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(Molfino et al., citing the CAS Abstract for the compounds depicted above.) These compounds read on compounds of formula I-a, wherein formula I-a, Ring A and Ring B are fused partially saturated 6 membered heterocyclyl/heteroaryl (containing a nitrogen and an oxygen heteroatom) with a benzo ring; R1 is -OH, n is 2; R2 and R3 are hydrogen; R4-6 are substituted aliphatic or phenylC0-3alkyl.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 59 and 65-69 of copending Application No. 17/620,065, (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘065 application encompass a similar compound intended to be encompassed (i.e., the elected species) of the claimed invention. The ‘065 application claims the following compound:
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(See amended claim 59 of the ‘065 application.) This compound differs from the elected species only by the halogen of R1 of Formula I-a of the present invention. As noted above in the response to the election/species requirement, the elected species presently does not read on the Markush formula I-a of the present invention. However, it is presumed Applicant intended for the elected species to read on the claims. Accordingly, the above compound of the ‘065 application would also read in the presently claimed invention.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. A Notice of Allowance was mailed on July 28, 2026, in the ‘065 application.
Conclusion
No claims are allowed
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIMOTHY R ROZOF whose telephone number is (571)270-5992. The examiner can normally be reached Monday - Friday, 9:00 a.m. -5:00 p.m..
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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/TIMOTHY R ROZOF/ Primary Examiner, Art Unit 1625
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