DETAILED ACTION
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 .
Status of the Application
Claims 55-66, 70-89, and 91-94 are pending
Claims 91-94 are withdrawn from examination as being drawn to a nonelected species.
Claims 55-66 and 70-89 are under consideration in the instant office action.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 04/28/2023, 05/26/2023, 06/02/2023, 06/16/2023, 08/21/2024, 09/05/2024, 06/23/2025 complies with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, it has been placed in the application file and the information therein has been considered as to the merits. See attached copy of the PTO-1449.
Priority
This application claims benefit of Japanese Application No. JP2018-087761 filed on 04/27/2018, PCT Application No. PCT/JP2019/018011, and U.S. Application No. 17/050,747 filed on 10/26/2020.
Election/Restrictions
Applicant's election with traverse of Group I and 6-( { 1-[ (2R)-2-amino-2-( lH-imidazol-4-yl)acetyl ]azetidin-3-yl }oxy)-3-(2-boronoethyl)-2-hydroxybenzoic acid in the reply filed on 01/13/2026 is acknowledged. The traversal is on the ground(s) that a search of all the claims would not impose a serious burden on the Office. This is not found persuasive because erythromycin is a materially different product from a compound of formula (II). The traversal is also on the grounds that the species are not patentably distinct. This is not found persuasive since the species contain functional groups for Ra1, Ra2, and Rb1 (e.g. a 4- to 20-membered non-aryl heterocycle) are not obvious variants of one another. However, since 6-( { 1-[ (2R)-2-amino-2-( lH-imidazol-4-yl)acetyl ]azetidin-3-yl }oxy)-3-(2-boronoethyl)-2-hydroxybenzoic acid appears free of the prior art, the species election is withdrawn.
The requirement is still deemed proper and is therefore made FINAL.
Claims 91-94 withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 01/13/2026.
Improper Markush Rejection
Claims 55-66 and 70-89 are rejected on the basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of compounds having the structure of Formula (11) or (1a) is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons: the species of the Markush group of compounds of instant formula I do not share a “single structural similarity” because there are no required structural features within each variable definition such that each member of the group would have at least one structural feature, which feature is essential to the activity/function of the claimed compounds, in common. This rejection applies for the Markush groups used to define each of variables R1, R2, R3, R4, L2, X. Claims 55-66 and 70-89 encompass a wide variety of chemical species which are in different recognized physical classes, and would embrace different chemical compounds that do not share any single structural similarity between the species. To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use. Each position in instant formula I encompassed by the claims is a variable (i.e., no single position in the chemical formula can be construed as being common among each member of the Markush group).
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 55-66 and 70-89 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-68 of U.S. Patent No. 11,702,431.
Although the claims at issue are not identical, they are not patentably distinct from each other because the conflicting claims both recite similar compounds of Formula 1a. U.S. Patent No. 11,702,431 recites a compound of formula (5a) or (5b).
U.S. Patent No. 11,702,431 does not recite a compound of formula (11).
It would have been obvious to one of ordinary skill in the art to formulate a compound of formula (11) or (1a), as suggested by U.S. Patent No. 11,702,431, and produce the instant invention.
One of ordinary skill in the art would have been motivated to do so since U.S. Patent No. 11,702,431 recites an overlapping genus of compounds, with a reasonable expectation of success absent evidence of criticality of the particular steps.
Conclusion
Claims 55-66 and 70-89 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW P LEE whose telephone number is (571)270-1016. The examiner can normally be reached Monday-Friday 9am-5pm.
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/ANDREW P LEE/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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