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
The preliminary amendment filed 05/07/2025, amended claims 1, 12-13, 20, 21, 26, 29, 38-39, 41, cancelled claims 2-11, 14-19, 22-25, 27-28, 30-37, 40, 42-56, and added claims 57-65.
Claims 1, 12-13, 20-21, 26, 29, 38-39, 41, and 57-65 are pending and examined on the merits herein.
Priority
This application claims the following priority:
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Drawings
The drawings are objected to because the top half of Figure 2 is blurry and illegible. These drawings should be replaced with a legible copy. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
-The preamble of claim 1, recites “formula (I).” However, the formula is recited as “(Ia).” As such, either the preamble or the formula should be amended to both recite “formula (I)” and “(I)” or “formula (Ia)” and “(Ia).”
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1, 12-13, 20-21, 26, 29, 38-39, 41, 57-59, and 63-64 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.
-In claim 1, last 4 lines and claim 26, line 5, the variable “R” is defined. However, instant Formula (Ia) does not recite a variable “R.” As such, it is not clear if “R” and its definition are superfluous or if the Formula (Ia) is missing a variable.
-In claim 38, line 5, “-ORb” is recited. However, claim 38 does not define Rb. As such, the metes and bounds of group “-ORb” are unclear.
All other claims not specifically recited are rejected for depending from an indefinite claim and failing to cure the deficiency.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 26, 38, 39, 41, 62, and 63 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,376,254 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘254 claims a compound of instant formula (Ia), wherein R2 is -CF2, R3 is CH3, R4 and R5 are variables R1 and R2 of ‘294, and R6 is H (claim 1).
‘254 exemplifies a compound wherein R2 is -CF2, R3 is CH3, R4 is H, R5 is -CH2-substituted phenyl, and R6 is H (claims 7, 9), wherein the phenyl is substituted with cycloalkyl, a heterocycle, alkyl, hydroxyalkyl, halo, alkoxy (claim 9).
Claims 1, 12, 13, 20-21, 26, 29, 38, 39, 41, 57-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-12, 14-15, 18-30 of U.S. Patent No. 10,239,887 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘887 claims:
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(claim 15), a compound of instant formula (Ia), wherein R2 is -CH3, R3 is CH3, R4 is H, R5 is -CH2-substituted phenyl, and R6 is H, wherein the phenyl is substituted with halo and alkoxy (claim 9).
Claims 1, 12, 13, 20-21, 26, 29, 38, 39, 41, 57-65 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-22 of U.S. Patent No. 11,142,532 (PTO-892).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘532 claims:
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(claims 15, 10), a compound of instant formula (Ia), wherein R2 is -CH3, R3 is CH3, R4 is H, R5 is -CH2-substituted phenyl, and R6 is H, wherein the phenyl is substituted with halo and alkoxy. ‘532 claims additional species of instant formula (Ia) in claims 9-22.
Claims 1, 12-13, 20-21, 26, 29, 38-39, 41, 57-58, and 60-65 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-26 of copending Application No. 19/596,608 (claim set dated 06/12/2026, reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other.
‘608 claims:
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(claim 1).
‘608 specifically claims species such as:
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(claim 26), which meets the limitations of instant formula (Ia) when R2 is -CH3, R3 is CH3, R4 is H, R5 is -CH2-substituted heteroaryl, and R6 is H, wherein the heteroaryl is substituted with alkoxy.
Regarding claims 57-58, and 63-65,
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differs in that it does not teach a phenyl ring at the pyridine ring position.
‘608 claims it Cy position, which is the instant Y of formula (Ia) and instant A of formula (Ii) as a 1,4 heteroarylene or a 1,4-phenylene that is substituted or unsubstituted (claim 1).
‘608 claims that its Cy can be substituted with halogen, alkyl, cycloalkyl, OH, alkoxy, and more (claim 1).
Thus, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date to substitute the pyridine ring of
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with a phenyl ring because ‘608 claims that its Cy position can be either a heteroarylene, such as pyridine, or a phenyl ring.
As such, an ordinary skilled artisan would have been motivated to make such a substitution, to predictably arrive at a structurally and functionally similar compound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Free of the prior art
The closest prior art is Aziz (Discovery of Potent Antiproliferative Agents Targeting EGFR Tyrosine Kinase Based on the Pyrido[3’,2’:4,5]thieno[3,2-d]pyrimidin-4-amine Scaffold, published 2015, PTO-892), which teaches:
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(pg. 1016), wherein compound 6a, 7a, and 8a of Aziz meet the limitations of instant formula (Ia) when instant R2 is H, R3 is H, R4 is H, R5 is -CH2-phenyl, substituted with halo (pg. 1016).
The reference does not teach a pyridazine ring at the pyridine ring position, which is a distinct features of the instantly claimed compound.
Moreover, the prior art does not provide motivation to substitute the pyridine ring with a pyridazine ring at this position.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN WELLS whose telephone number is (571)272-7316. The examiner can normally be reached M-F 7:00-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James (Jim) Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LAUREN WELLS/Primary Examiner, Art Unit 1622
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