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 office action is in response to applicant’s reply filed on July 24, 2026.
Restrictions/Elections.
Applicant’s election without traverse of Group I (Claims 1-10) in the reply filed on July 24, 2026, is acknowledged.
Applicant election of the following species:
PNG
media_image1.png
140
374
media_image1.png
Greyscale
Is also acknowledged.
Since the above species was found free of prior art, the examination was expanded to the following species:
3-fluoro-N-(6-methyl-2-pyridinyl)-5-(3-pyridinyl)-hydrobromide
PNG
media_image2.png
188
304
media_image2.png
Greyscale
Status of Claims
Claims 1-10 and 12-22 are currently pending and are the subject of this office action.
Claims 12-22 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 March 4, 2013.
Due to Applicant’s election of compound:
PNG
media_image1.png
140
374
media_image1.png
Greyscale
as the species corresponding to the formula of claim 1, the examination of the instant claims is restricted to the following CORE structure:
PNG
media_image3.png
182
404
media_image3.png
Greyscale
All other structures within the claims are not being examined, since they are not considered part of the elected invention, as such it is suggested that Applicant amends the claims accordingly in order to remove all non-elected inventions (see Improper Markush Group rejection below).
The following species, corresponding to CORE structure of the above formula (see above) are under examination:
1)
PNG
media_image1.png
140
374
media_image1.png
Greyscale
elected by Applicant, which is free of prior art, and
2)
PNG
media_image2.png
188
304
media_image2.png
Greyscale
expanded by the Examiner.
Compound 1) is encompassed by claims 1-10.
Compound 2) is encompassed by claims 1-9.
The combined set of claims that read on one or both species and, consequently, are presently under examination are: 1 -10.
Priority
PNG
media_image4.png
66
384
media_image4.png
Greyscale
Claim Rejections – Improper Markush Group.
Claims 1-10 are rejected under Improper Markush Group.
The improper Markush Group Rejection is based on a judicially approved doctrine when the claim contains an improper grouping of alternatively useable species. A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
In the instant case, claim 1 recites the following general structure:
PNG
media_image5.png
148
154
media_image5.png
Greyscale
wherein A can be:
PNG
media_image6.png
126
164
media_image6.png
Greyscale
wherein X1 through X5 can be CH, CR1 or N, and X6 through X9 can be CH, CR1, S, O, NR1 or N, and
wherein B can be:
PNG
media_image7.png
82
186
media_image7.png
Greyscale
wherein X10 through X14 can be CH, CR1 or N and X15 through X18 can be CH, CR1, S, O, NR1 or N.
This will result in thousands of different CORE structures, each one classified in a different group/subgroup.
These CORE structures 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 and will have completely different structural and biological properties.
These compounds lack unity of invention since they do not share a common utility and/or they do not share a substantial structural feature essential to that utility: In re Harnisch, 631 F.2d 716, 206 USPQ 300(CCPA 1980); and Ex parte Hozumi, 3 USPQ2d 1059 (Bd. Pat. App. & Int. 1984).
In order to overcome this rejection, Applicant should amend the above claims according to the CORE structure:
PNG
media_image3.png
182
404
media_image3.png
Greyscale
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kulkarni et. al. (J. Med. Chem (2009) 52: 3563-3575).
For claims 1-9, Kulkarni teaches the following compound:
3-fluoro-N-(6-methyl-2-pyridinyl)-5-(3-pyridinyl)-hydrobromide
PNG
media_image2.png
188
304
media_image2.png
Greyscale
(See compound 37 on page 3565),
wherein:
X2 is N,
X1 = X3 = X4 = X5 = CH,
R = F,
X10 = N, and
X11 = X12 = X13 = X14 = CH.
Conclusion
No claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571)270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 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, Amy L. Clark can be reached on 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.
/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
July 27, 2026.
Prosecution Insights