DETAILED ACTION
Claims 1-17 and 19 are currently pending in the instant application. Claims 1-4 and 10-14 are rejected. Claims 6, 8, and 9 are objected. Claims 5, 7, 15-17, and 19 are withdrawn from consideration as being for non-elected subject matter.
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
Applicant’s election without traverse of Group I, claims 1-14, drawn to products of the Chemical formula 1 and the election of the species of example 40:
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in the reply filed on 14 November 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has previously determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been previously extended to the compounds of claims 6, 8 and 9 which also appear allowable over the prior art, and now further to the compound:
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which is not allowable.
Claims1-4, 6, and 8-14 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 30 March 2026 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the objection to the specification and has overcome the objection to claim 9 for minor informalities. The objection to claim 6 and 8 as being dependent upon a rejected base claim is maintained as claim 1 is rejected. Claim 9 is now also objected to as being dependent upon a rejected base claim. The amendment has overcome the 35 USC 112(b) rejection of claim 13 as the instance of “preparation” has been amended to “formulation.” The amendment has overcome the 35 USC 102(a)(1) rejection of claims 1-4, 10-12 and 14 as being anticipated by Registry No. 290303-6-41-2 as ring B has been amended to exclude C3-10 carbocyclyl.
Claim Objections
Claims 6, 8, and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 1 and its dependent claims 2-4, and 10-14 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. Specifically, claim 1 has been amended to delete C3-10 carbocyclyl from the definition of ring B. However, in the definition of ring B claim 1 also states “wherein C3-10carbocyclyl…is unsubstituted or substituted with one or more functional groups….” The inclusion of C3-10 carbocyclyl in the “wherein” clause renders the claims indefinite as it is unclear what C3-10 carbocyclyl is unsubstituted or substituted in ring B as ring B has been amended to exclude C3-10carbocyclyl.
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) 1-4 and 10-14 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent No. 6,403,580.
US Patent No. 6,403,580 discloses compounds of the formula (I):
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having an inhibitory effect on signal transduction mediated by tyrosine kinases for treating diseases, such as tumoral diseases, diseases of the lungs and respiratory tract (column 1). Column 2 provides the compound of example (1):
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which corresponds to the formula:
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. Pharmaceutical compositions are disclosed on column 7 including with other active substances, with carriers, and in forms such as tablets, powders, capsules, suspensions, etc. The compound (1) of the prior art corresponds to the instant chemical formula 1:
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, for example, wherein m is 0; R3 can be any definition (including the definitions found in instant claim 3) as m is 0; ring A1 is C6-10aryl; R1 is C1alkyl; R2 is hydrogen; L1 is -O-; n is 2; ring B is C2-9 heterocyclyl which is substituted with two C1 alkyl functional groups and one oxo group; X1 is -N(R5)(R6) wherein one of R5 and R6 is hydrogen and the other is C2-6alkenyl which is substituted with the functional group oxo.
Regarding claim 11 which has an intended use “for treating cancer or a tumor that can be treated by inhibiting binding of SOS1 to RAS family proteins and/or RAC1.” In regards to the intended use of the pharmaceutical composition claim, while these product claims include an intended use, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the prior art structure is capable of performing the intended use. Additionally, an intended use generally is not limiting when the claim body describes a structurally complete invention such that deletion of the intended use phrase does not affect the structure of the claimed invention. As is the instant case, the deletion of the intended use phrase does not affect the structure of the claimed invention as the structure is still a pharmaceutical composition. It is noted that recitation of the intended utility into a compound claim which can otherwise stand alone is not considered a further limitation of the claim. Additionally, a recitation of the intended utility does not impart patentability to a known composition. This intended use in claim 11 does not overcome the prior art rejection as the instant claim is drawn to a product and not a method.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, 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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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 15 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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