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 .
Priority
Instant application 18/294,513 filed on 02/01/2024 claims benefit as follow:
CONTINUING DATA:
PNG
media_image1.png
36
352
media_image1.png
Greyscale
Status of the Application
Claims 1, 2, 7, 8, 9, 12, 14, 17, 19, 24, 31, 34, 35, 36, 37, 38, 41, 45, 48 and 51 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/03/2026, 01/15/2026, 07/02/2025, 06/11/2026 and 06/26/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election, without traverse, of Group I in the reply filed on 06/03/2026 is acknowledged.
Regarding species election, Applicant’s election, without traverse, of
PNG
media_image2.png
130
205
media_image2.png
Greyscale
in the reply filed on 06/03/2026 is acknowledged.
Claims 37, 38, 41, 45, 48 and 51 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/03/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Improper Markush Grouping Rejection
Claims 1, 2, 7, 8, 9, 12, 14, 17, 19, 24, 31 and 36 re 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 according to formula I 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 chemical compounds of the recited formula (I) are not regarded as being of similar nature because: a significant structural element is not shared by all the alternatives. For the purposes of providing an example, the instant independent claim 1 recites a formula (I) wherein W2, W4, W4, W6 may be N or C(R )) and W7 may be N, N+, O- or C(R7)), thus, the claim encompasses a wide variety compounds bearing structurally different 6 membered moieties such as: phenyl, pyridine, pyrimidine, triazine etc. These 6 membered heterocyclic skeletons are separately classified such as pyridines are classified in CPC C07D 213/+; pyrimidines are classified in CPC C07D 239/+; and triazines are classified in C07D 251/+.
Further, the instant claims encompass compounds bearing a wide variety of
PNG
media_image3.png
76
63
media_image3.png
Greyscale
moieties, for example:
PNG
media_image4.png
108
128
media_image4.png
Greyscale
PNG
media_image5.png
124
79
media_image5.png
Greyscale
PNG
media_image6.png
137
277
media_image6.png
Greyscale
PNG
media_image7.png
162
108
media_image7.png
Greyscale
PNG
media_image8.png
240
580
media_image8.png
Greyscale
It should be noted that the above moieties are structurally very diverse, and encompass, for example, cycloalkyls and lactams. Lactams are classified in CPC C07D 201/+, and cycloalkyls are classified in C07C 2601/+.
In summary, the compounds of formula (I) are structurally too diverse to the extent that there is no one recognized class to which the compounds can be assigned.
Further, there is no one common structural feature essential to the activity/function of the claimed compounds. In view of the testing data, there is no data correlation to vast recited structural scope and function. For example, it should be noted that no compounds bearing a ring wherein each of W5, W4 and W2 is nitrogen (triazine ring) have been prepared and tested (see instant specification, paragraph [0865], Table 1).
In addition, the provided data show that not all the alternative substituents lead to similar activity as LPAR1 antagonists.
The change in
PNG
media_image9.png
76
64
media_image9.png
Greyscale
leads to significant difference in activity. For example,
Compound 107 - IC50 grater or equal to 1000 nM
Compound 113 has - IC50 less than 10 nM
PNG
media_image10.png
110
223
media_image10.png
Greyscale
PNG
media_image11.png
142
202
media_image11.png
Greyscale
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.
Conclusion
Claims 1, 2, 7, 8, 9, 12, 14, 17, 19, 24, 31 and 36 are rejected.
Claims 37, 38, 41, 45, 48 and 51 are withdrawn.
Claims 34 and 35 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 pm.
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, Clinton A Brooks can be reached at (571)270-7682. 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.
/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
Prosecution Insights