DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Status of the Claims
Claims 1, 6, 12, 15 – 17, 20, 22 and 30 – 41 are pending.
Claims 30 – 31 and 33 – 40 are rejected.
Claims 1, 6, 12, 15 – 17, 20, 22, 32 and 41 are withdrawn.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1, 6, 12, 15 – 17, 20, 22 and 30 – 40, in the reply filed on December 1, 2025 is acknowledged. Applicant further specifically elected the compound of Example 208, 3-[2-(4-chloro-3-fluorophenoxy)acetamido]-N-(5-ethoxypyrazin-2-yl)bicyclo[1.1.1]pentane-1-carboxamide, as presented below:
PNG
media_image1.png
476
522
media_image1.png
Greyscale
PNG
media_image2.png
110
524
media_image2.png
Greyscale
Examination: Claims 30 – 31 and 33 – 40 read upon the elected species. Applicant’s elected species is found to be free of prior art. Examination of the Markush-type claim has been extended to the scope of Formula (II), that constitutes a proper Markush group wherein:
D is a bridged bicyclic cycloalkyl (bicyclo[3.2.1] octan-l-yl);
L1 is 2-membered heteroalkylene (–O-CH2–);
R1 and R2 are each hydrogen;
A is unsubstituted phenyl, or substituted with 5 RY, wherein each RY is hydrogen; and
W is 6-membered heteroaryl (pyrimidinyl) substituted with 1 RY; wherein RY is C1 alkyl.
such that the compounds share a phenyl-CH2O-C(O)-NR1-D-C(O)-NR2-phenyl core, pursuant to Federal Register, Vol. 76, No. 27, dated February 9, 2011, page 7166 (middle column):
“Under principles of compact prosecution, the examiner should also require the applicant to elect a species or group of indistinct species for search and examination (i.e., an election of species). If the examiner does not find the species or group of indistinct species in the prior art, then the examiner should extend the search to those additional species that fall within the scope of a permissible Markush claim. In other words, the examiner should extend the search to the species that share a single structural similarity and a common use. The improper Markush claim should be examined for patentability over the prior art with respect to the elected species or group of indistinct species…within the scope of a proper Markush claim.”
Subject matter not embraced by the elected embodiment or the scope searched is therefore withdrawn from further consideration. Claims 1, 6, 12, 15 – 17, 20, 22, 32 and 41 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention/ species, there being no allowable generic or linking claim.
Priority
PNG
media_image3.png
96
364
media_image3.png
Greyscale
Information Disclosure Statement
The information disclosure statements (IDS) submitted on June 6, 2023, January 26, 2024 and December 1, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Improper Markush Group Rejection
Claims 30 – 31 and 33 – 40 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 the compound of Formula (II) 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:
Claim 30 is directed to a compound of Formula (II) as presented below:
PNG
media_image4.png
89
310
media_image4.png
Greyscale
wherein:
PNG
media_image5.png
201
818
media_image5.png
Greyscale
The structures associated with each of the variables above in the Formula (II) do not share a substantial feature to each other.
For example, in variable D, consider the following moieties having the structures as presented below (according to claim 31):
PNG
media_image6.png
136
638
media_image6.png
Greyscale
Further, in variable W, consider the following structures as presented below (according to claim 36):
PNG
media_image7.png
292
710
media_image7.png
Greyscale
Claim 39 is directed to a list of several compounds, which includes the compounds as presented below:
PNG
media_image8.png
755
563
media_image8.png
Greyscale
The compound of Formula (II) as claimed in claim 30 and the compounds as recited in claim 39 do not belong to the same art-recognized class or chemical class of compounds because there is no common core structure shared among all of the compounds that would enable them to be categorized the same. For example, in variable D, the alternatives for “bridged bicyclic cycloalkyl” and “bridged bicyclic heterocyclyl” groups can be classified as cyclohexanes (e.g., CPC class C07C17), tetrahydrothiophenes (e.g., CPC classes C07D333 and C07D495), pyrrolidines (e.g., CPC classes C07D207 and C07D487), or as selenolanes (e.g., CPC classes C07D345 and C07D517). Further, in variables A and W, the alternatives for “phenyl” and “5-6 membered heteroaryl” groups can also be classified in different CPC classes as noted above. Besides the two amide moieties (-C(O)-NR1-) and (-C(O)-NR2-), there is no shared structure amongst all of the alternatives as claimed by the variables D, A and W in the structures of Formula (II) (claim 30) and (II-a) (claim 38), and the compounds as claimed in claim 39. The compounds do not belong to the same recognized physical or chemical class or to the same art-recognized class and each compound would possess different physical and chemical properties in view of the functional and cyclic groups such that they would not be expected to have the necessary common use. Thus, the compounds of the Markush grouping cannot be considered to share a “single structural similarity” that is essential from which a common use flows.
In order 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. For example, the following is a proper Markush group of structure of Formula (II):
PNG
media_image9.png
246
161
media_image9.png
Greyscale
or a single grouping of patentably indistinct species such that the variables D, A and W are conserved across all species of Formula (II) and Formula (II-a), and all the claimed compounds in claim 39.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 30, 34 – 35, 37 and 40 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Li et al. WO2012/088365 A1 (publ. June 28, 2012; effect. filed December 22, 2010), as disclosed in the information disclosure statement filed on June 6, 2023.
Li et al. teach the compound, Benzyl 5-(2-methylpyrimidin-4-ylcarbamoyl)bicyclo[3.2.1] octan-l-ylcarbamate. See, e.g., page 42, Step 3. The compound is presented below:
PNG
media_image10.png
144
328
media_image10.png
Greyscale
.
The prior art anticipates the present claims as presented below:
Claims 30, 34 – 35 and 37, directed to a compound of Formula (II):
PNG
media_image4.png
89
310
media_image4.png
Greyscale
, wherein:
D is a bridged bicyclic cycloalkyl (bicyclo[3.2.1] octan-l-yl);
L1 is 2-membered heteroalkylene (–O-CH2–);
R1 and R2 are each hydrogen;
A is unsubstituted phenyl, or substituted with 5 RY, wherein each RY is hydrogen; and
W is 6-membered heteroaryl (pyrimidinyl) substituted with 1 RY; wherein RY is C1 alkyl.
With respect to claim 40, Li et al. teach the compound is reacted with HBr/HOAc, concentrated under reduced pressure, dissolved in aqueous HCl, and extracted with ethyl acetate. See, e.g., page 43, Step 4. Ethyl acetate is considered a pharmaceutically acceptable carrier (according to official notice). Thus, Li et al. teach a pharmaceutical acceptable composition comprising the compound and a pharmaceutically acceptable carrier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sagar Patel whose telephone number is (571)272-1317. The examiner can normally be reached Monday - Friday: 9am to 5pm EST.
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, Amy L. Clark can be reached at (571) 272-1310. 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.
/Sagar Patel/Examiner, Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626