DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
The election filed on 1/05/2026 in response to the Restriction Requirement of 11/13/2026. Applicants elected, with traverse, Group 1, claims 1-20 and 31, drawn to a compound having the formula (I’) and the following compound as the species:
PNG
media_image1.png
84
232
media_image1.png
Greyscale
. The traversal is on the grounds that the patent office has not established that it would pose an undue burden to examine the full scope. Applicants further point to 37 CFR 1.141, according to which an applicant is entitled to consideration of claims to additional species which are written in independent form or otherwise include all of the limitations of an allowed generic claim.
These arguments have been considered, but are not found persuasive.
Regarding Applicants arguments pertaining to search burden, the examiner recognizes that while search burden is a factor in determining a restriction requirement it is not the only one. As set forth in the Restriction Requirement, the Examiner found that the product as claimed can be used in a material different process such as being used as a reference material or as an in in vitro screening tool as claimed in claim 31. As such, the Restriction Requirement is maintained.
Claims 1-20, 22-23, 26-29 and 31 are currently pending.
Claims 22-23 and 26-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 1/05/2026.
The elected species appears to read on the following claims: 1-2, 6, 10, 13, 15, 18-20 and 31.
A search of the prior art did not identify any publications which anticipate or render obvious the elected species. The examiner has expanded the search to encompass the compounds of claim 19 and a subgenus of the elected species, specifically that recited in claim 10, having the following formula
PNG
media_image2.png
135
390
media_image2.png
Greyscale
which were also found to be free of the prior art. Accordingly, the examiner has moved onto the next species which reads on the genus of claim 1.
Claims 1-2, 6, 12-14, 20 and 31 read on next species as set forth below in the 102 rejections and are under consideration.
Claims 10 and 19 are objected to, but would be allowable if rewritten in independent form.
Claims 3-5, 7-9, 11 and 15-18 are withdrawn from consideration as not reading on the next species.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements filed on 10/20/2023 and 10/25/2023 are acknowledged and have been considered except where lined through.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Interpretation
The claims are being interpreted in the following manner for prior art purposes.
All variables recited in the claims are being interpreted as being unsubstituted unless the claims specifically recites that they are “optionally substituted”.
The dotted line in claim 1 pertaining to the 5 membered ring is not defined, but is being interpreted as meaning that the bond can be either a single bond or a double bond. In view of this, the examiner is interpreting the exemplified nitrogen as always having a double bond either to Q or to the bridged carbon since the exemplified nitrogen does not have a variable and must have three bonds such as
PNG
media_image3.png
122
237
media_image3.png
Greyscale
or
PNG
media_image4.png
131
249
media_image4.png
Greyscale
. Similar analysis would be for the bridge carbon, as well as, Z when C since these do not include a “4th” bond.
Heterocycloalkyl and cycloalkyl are not defined by the specification. In view of the examples of R3 variables within the specification and claims (for example, Claim 13), the examiner is interpreting these to include only saturated ring systems.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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.
Claim 13 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 13, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 1-2, 6, 13-14 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Revesz, Laszlo (WO01/30778A1, 2001-05-03).
Revesz, Laszlo teach a compound having the formula
PNG
media_image5.png
74
146
media_image5.png
Greyscale
which reads on the instant claims wherein X’ is CH, W is CH, Q is C, E is NRa (Ra=H), Z is C, RB is the Phenyl where R1 is a halo, R0 and R2 are H and RA is an unsubstituted piperazine (Y is a bond, m is 0) (page 44, (c)). Note: While the prior art does not specifically teach that the compound is an analytical reference or an in vitro screening tool, it is noted that these appear to be intended uses of the compounds, wherein the claims do not contain any other “ingredients” or structural limitations which make it difference from the compound of the prior art.
Claim(s) 1-2, 12, 20 and 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gobbi et al. (WO2014/187762A1, 2014-11-27)).
Gobbi et al. teach compounds of the general formula (I)
PNG
media_image6.png
216
260
media_image6.png
Greyscale
which are useful as imaging tools (abstract). Specifically, Gobbi et al. teach numerous specific compounds including, but not limited to,
PNG
media_image7.png
66
164
media_image7.png
Greyscale
,
PNG
media_image8.png
55
159
media_image8.png
Greyscale
and
PNG
media_image9.png
63
150
media_image9.png
Greyscale
which reads on the instant claims wherein X’ is CH, W is CH, Q is C, E is CRa (Ra=H), Z is N, RB is the Phenyl where R1 is a halo, R0 and R2 are H and RA is a 4 or 6 membered heterocycle containing one heteroatom (Y is a bond, m is 0) (see Table of compounds starting on page 19). Moreover, the WO document teaches a pharmaceutical composition comprising the compound of Formula I and a pharmaceutically acceptable carrier (see claim 12 of the WO). Note: While the prior art does not specifically teach that the compound is an analytical reference or an in vitro screening tool, it is noted that these appear to be intended uses of the compounds, wherein the claims do not contain any other “ingredients” or structural limitations which make it difference from the compound of the prior art.
In order to expedite prosecution, the Examiner would like to point out the following rejections that could be made once the claims are under consideration.
Claim Rejections - 35 USC § 112
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
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 3-5, 7 and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the structure:
PNG
media_image10.png
144
393
media_image10.png
Greyscale
. However, it is unclear whether there should be a double bond between the two nitrogen’s since typically nitrogen has three bonds or whether the bond placements should be more consistent with the compounds claimed in claim 19, for example,
PNG
media_image11.png
78
271
media_image11.png
Greyscale
Claims 3-5 depend from claim 1 and limit the 5 membered bridged heterocyclic ring to be an aromatic ring with the representation of solid closed ring
PNG
media_image12.png
96
277
media_image12.png
Greyscale
. The claims further recite that the Q, E and Z can be either N or C. However, considering the rules for aromaticity, there are only a few structures that could be encompassed. Mainly, the following structures can be encompassed:
PNG
media_image13.png
135
246
media_image13.png
Greyscale
,
PNG
media_image14.png
110
249
media_image14.png
Greyscale
,
PNG
media_image15.png
106
239
media_image15.png
Greyscale
or
PNG
media_image16.png
110
247
media_image16.png
Greyscale
, wherein the last compound cannot occur because the nitrogen of the 5 membered ring has to be a double bond (see claim interpretation above). As such, all the different variations are not possible and still achieve aromaticity.
Regarding claim 18, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). NOTE: While claim 26 and 29 has been withdrawn from consideration, considering potential rejoinder of the method claims once the product claims have been found allowable, the examiner suggests correcting claims 26 or 29 which also recites “including” or “preferably”.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. 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.
BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/ Primary Examiner, Art Unit 1626