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 .
Election/Restrictions
Claim 1 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 23, 24, and 28, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 20 August 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim 21 has undergone amendments. Thus, Claims 1, 2, 4, 5, 6, 8, 9, 11, 12, 16, 18, 19, 20-24, and 28-30, submitted on 20 February 2026, represent all claims currently under consideration.
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.
Response to Amendment
The 35 U.S.C. § 112(b) rejection of Claim 21 is withdrawn. Applicant has amended the claim to include an “and’ prior to the final compound, obviating the issues of indefiniteness.
Response to Arguments
The 35 U.S.C. § 103 rejection of Claims 1, 4, 5, 6, 8, 9, 16, and 22 over Meyers in view of Thornber is withdrawn. Applicant argues that every compound of Meyers, which are CSF-1R inhibitors as are the compounds of the examined application, necessarily require an amino group in the ortho position relative to variable X, and thus are an essential feature for the function of these compounds. Thus, in view of the teachings of Meyers, the artisan would not remove this amino group, as all compounds of Meyers which are disclosed have this group, and Meyers does not demonstrate that removal of this group retains activity against CSF-1R. The Examiner finds this argument persuasive. There is no reasonable expectation of success that removing this amino group from the position corresponding to the position ortho to X, and replacing the pyrazine group with a pyridine group of the compounds of the examined application, would result in a compound with similar levels of activity as those demonstrated by Meyers.
The 35 U.S.C. § 103 rejection of Claims 1, 4, 5, 8, 9, 16, 20-22, 29, and 30 over Kane in view of Thornber is withdrawn. Compound 1-49 is cited by the examiner,
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. Applicant argues that for the majority of the 263 compounds disclosed by Kane, the group corresponding to variable R1 of claim 1 of the examined application is a 9-membered heteroaryl group with a 6-membered ring fused to a 5-membered ring, with the cited compound having a 6-membered aryl ring bound to a heterocyclic ring. Compound 1-49 has a c-FMS IC50- of 0.026 and a phospho c-FMS IC50 of 0.031 µM (Table 1). While these values are rather low, there are several compounds disclsoed which have an order of magnitude lower value against both, such as Example 1-4
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(0.003 µM and 0.006 µM). Thus, the compounds disclosed by Kane which are most active have two aromatic and/or heteroaromatic rings fused with one another, rather than a single aromatic and/or heteroaromatic ring. Kane further does not disclose that this central ring is pyridine, and Applicant argues that it would not have been obvious to modify these rings to from benzene to pyridine. Applicant argues that all examples disclosed by Kane have variable T101 as CH, with no indication that nitrogen functions within this ring system, and that Kane in fact teaches away from pyridine in this ring system. The Examiner finds this persuasive. The artisan would not select compound 1-49 for further modification, and if the artisan did, would not be motivated, nor have reasonable expectation of success, in replacing the benzene ring system with pyridine as Kane does not provide any indication that this modification results in an active compound.
Claim Rejections - 35 USC § 112(a)- NEW GROUNDS OF REJECTION
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 24 and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Factors to be considered in making the determination as to whether one skilled in the art would recognize that applicant was in possession of the claimed invention as a whole at the time of filing include : (a) Actual reduction to practice; (b) Disclosure of drawings of structural chemical formulas; (c) Sufficient identifying characteristics such as: (i) Complete structure, (ii) Partial structure, (iii) Physical and/or chemical properties or (iv) Functional characteristics when coupled with a known or disclosed correlation between function and structure; (d) Method of making the claimed invention; (e) Level of skill and
knowledge in the art and (f) Predictability in the art. While all of these factors are
considered, a sufficient number for a prima facie case are discussed below:
Claims 24 and 28 are directed to a method for treating a disease mediated by CSF-1R or at least in part by CSF-1R in a subject using the compounds of Claim 1, wherein the disease is an autoimmune disease, an inflammatory disease, a neurodegenerative disease, cancer, a metabolic disease, obesity, or an obesity-related disease. The specification defines autoimmune disease, inflammatory diseases, neurodegenerative diseases, cancer, metabolic disease, obesity, and obesity-related disease, as well as provides examples for these conditions which are mediated by CSF-1R. However, the specification does not define what a disease mediated at least in part by CSF-1R is, nor does it define what “at least in part” means in the context of the disease. The specification does not define what how involved CSF-1R can or must be in the disease in order for this method to be practiced. CSF-1R signaling is involved in numerous pathways throughout the body, and thus its signaling would be implicated, in some small part, in a variety of the claimed conditions. The artisan would have an understanding for CSF-1R signaling and its role in the pathogenesis of a variety of conditions, but without a description of what “at least in part” comprises, such as how this signaling can be involved at least in part with respect to its actual involvement in the pathogenesis of the disease, the artisan would have no predictability in practicing this method as claimed. Thus, there is no support in the specification which demonstrates that Applicant was in possession of the invention, as a whole, at the time of filing of the claimed invention.
Claim Rejections - 35 USC § 112(b)- NEW GROUNDS OF REJECTION
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 24 and 28 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. Claims 24 and 28 are indefinite as the specification does not define what encompasses “mediated at least in part by CSF-1R”. There is no description of what the involvement of this receptor is within the disease, and what comprises “in part”. How involved does CSF-1R have to be in this condition in order for the claimed method to be able to treat these conditions? The artisan would not know from the specification how to practice this invention due to the “at least in part” limitation, which introduces uncertainty, and therefore, indefiniteness, into the claim language.
Allowable Subject Matter
Claims 1, 2, 4, 5, 6, 8, 9, 11, 12, 16, 18, 19, 20-23, and 29-30 are allowed.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches the compounds claimed in the examined application (See STN Search Notes, Previous Office Action). The closest art comes from Kane (See IDS, 4 April 2023), who discloses CSF-1R inhibitors of similar structure of those claimed in the examined application. However, the compounds disclosed by Kane which are most active have two aromatic and/or heteroaromatic rings fused with one another, rather than a single aromatic and/or heteroaromatic ring. Kane further does not disclose that this central ring is pyridine, and provides no representative compounds wherein this ring is a pyridine. Thus, there would be no teaching, suggestion, or motivation to modify these compounds by inserting a pyridinyl ring system, and there would be no reasonable expectation of success in performing this modification as Kane does not show that this modification is amenable to maintaining CSF-1R inhibitory activity. Glazer (U.S. Patent No. 4,762,838; Patent Date: 9 August 1988) describes quinazoline derivatives as anticoccidial agents such as the compound
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which contains a benzene rather than pyridinyl group. However, similar to Kane, there is no teaching, suggestion, or motivation found to replace this benzene group with a pyridinyl group, and there is no reasonable expectation of success in replacing this group.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Claims 1, 2, 4, 5, 6, 8, 9, 11, 12, 16, 18, 19, 20-23, and 29-30 are allowed.
Claims 24 and 28 are rejected.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP MATTHEW RZECZYCKI whose telephone number is (703)756-5326. The examiner can normally be reached Monday Thru Friday 730AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P.M.R./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625