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 .
Priority
Instant application 18/578,240 filed on 01/10/2024 claims benefit as follows:
CONTINUING DATA:
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Status of the Application
Claims 2-16, 24, 33 and 50-54 are pending.
Information Disclosure Statement
IDS documents have not been provided.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 07/23/2026 is acknowledged.
Claims 52-54 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/23/2026.
Regarding species election, Applicant’s election without traverse of compound 375 in the reply filed on 07/23/2026 is acknowledged.
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Claims 13-16, 24 and 33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/23/2026.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. Id. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. Id. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final. Id.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Species Election
A careful review of the prior art has indicated that elected species is free of the prior art. A claim directed to the elected species in independent form would be free of prior art.
The examiner has moved onto alternative species embodied within the general formula recited in the instant claim 2, and subsequent examination is based on this species expansion.
The whole scope of claim 2 has not been searched.
Claim Objections
Claim 13 is withdrawn. However, it should be noted that a preamble is missing from claim 13.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 2-3, 5-12 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HUANG (CN-111620854-A, publication date 2020-09-04; please note that machine translation has been provided with the previous office action: Google Patents, printed 02/18/2026)
HUANG teaches heterocyclic compounds for treatments of EGFR-mediated diseases, including cancers (see the machine translation, page 51, last paragraph). For example, HUANG discloses and claims the following compound (see claim 8, machine translation, page 16, second row):
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The above compound disclosed by HUANG falls under instant Formula (I):
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wherein: X is C1 alkoxy (methoxy), Y and Y’ are each H, Het represents is 9 atom heteroaromatic bicyclic group comprising one N, Het is substituted with one C1 alkyl, Z is NR6, R6 is C1 alkyl, R1 is H, R2 is H, R3 is -C(O)-R11 wherein R11 is C2 haloalkyl, R7, R8, R9 and R10 are each H, n is 1, and R4 and R5 are each C1 alkyl.
Regarding instant claim 5, it should be noted that the above compound bears Het (the first structure recited in the instant claim)
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wherein X’ is absent and R14 is methyl.
Further, regarding instant claims 11 and 12, it should be noted that the above compound falls under the formula (IA) and (IB).
Regarding instant claim 50, HUANG teaches “The present invention also provides a pharmaceutical composition comprising the above-mentioned compound represented by formula I or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier” (see page 52, second paragraph, machine translation).
Claims 2-3 and 5-12 rejected under 35 U.S.C. 102(a)(1) as being anticipated by BUTTERWORTH (US-20130053409-A1).
BUTTERWORTH teaches compounds of Formula (II)
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For example, BUTTERWORTH teaches the following compound (see page 62, pare [0700]).
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The above compound disclosed by BUTTERWORTH falls under instant Formula (I):
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wherein: X is C1 alkoxy (methoxy), Y and Y’ are each H, Het represents is 9 atom heteroaromatic bicyclic group comprising one N, Z is NR6, R6 is C1 alkyl, R1 is H, R2 is H, R3 is -H, R7, R8, R9 and R10 are each H, n is 1, and R4 and R5 are each C1 alkyl.
Regarding instant claim 5, it should be noted that the above compound bears (Het is the first structure recited in instant claim 5)
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wherein X’ is absent and R14 is H.
Further, regarding instant claim 11 and 12, it should be noted that the above compound falls under the formula (IA) and (IB).
Claims 2-12 and 50 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sato (Sato, et al., ACS Med. Chem. Lett. 11 June 2020; 11 (6): 1137–1144; Published April 8, 2020).
Sato teaches EGSF inhibitors (see abstract):
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Sato teaches compound 19 (see Table 2):
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that falls under instant Formula (I):
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wherein: X is C1 alkoxy (methoxy), Y is CF3 and Y’ is H, Het represents is 9 atom heteroaromatic bicyclic group comprising one N, Z is NR6, R6 is C1 alkyl, R1 is H, R2 is H, R3 is -C(O)R11, R11 is haloalkyl, R7, R8, R9 and R10 are each H, n is 1, and R4 and R5 are each C1 alkyl.
Regarding instant claim 5, it should be noted that the above compound bears (Het, the first structure recited in the instant claim)
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wherein X’ is absent and R14 is H.
Further, regarding instant claim 11 and 12, it should be noted that the above compound falls under the formula (IA) and (IB).
Regarding claim 50, it should be noted that Sato teaches that compound 19 shows antiproliferative properties (see Table 2):
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Further, Sato teaches compound 19 is soluble in DMSO (see supporting information, page 47):
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Therefore, one of ordinary skill in the art would at once envisage a pharmaceutical composition comprising compound 19 and DMSO. DMSO is pharmaceutically acceptable excipient.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 2-12, 50 and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Sato (Sato, et al., ACS Med. Chem. Lett. 11 June 2020; 11 (6): 1137–1144; Published April 8, 2020 as applied to claims 2-12 and 50 above, and further in view of BUTTERWORTH (US-20130053409-A1).
Sato teaches compound 19 (see Table 2):
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that falls under instant Formula (I):
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wherein: X is C1 alkoxy (methoxy), Y is CF3 and Y’ is H, Het represents is 9 atom heteroaromatic bicyclic group comprising one N, Z is NR6, R6 is C1 alkyl, R1 is H, R2 is H, R3 is -C(O)R11, R11 is haloalkyl, R7, R8, R9 and R10 are each H, n is 1, and R4 and R5 are each C1 alkyl.
Regarding instant claim 5, it should be noted that the above compound bears Het (the first structure recited in the instant claim)
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wherein X’ is absent and R14 is H.
Further, regarding instant claim 11 and 12, it should be noted that the above compound falls under the formula (IA) and (IB).
Regarding claim 50, it should be noted that Sato teaches that compound 19 shows antiproliferative properties (see Table 2):
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Further, Sato teaches compound 19 is soluble in DMSO (see supporting information, page 47):
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Therefore, one of ordinary skill in art would at once envisage a pharmaceutical composition comprising compound 19 and DMSO. DMSO is pharmaceutically acceptable excipient.
Regarding instant claim 51, Sato does not teach a pharmaceutical composition comprising an additional therapeutic agent.
BUTTERWORTH teaches EGFR inhibitors of Formula (I):
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Further, BUTTERWORTH teaches compounds of Formula (I) in combinations with additional anti-tumor agent (see para. [0298]):
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Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine compound 19 of Sato and additional anti-tumor agent with a reasonable expectation of success. One of ordinary skill would expect additive effect.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IZABELA SCHMIDT whose telephone number is (703)756-4787. The examiner can normally be reached Monday - Friday from 9 am to 5 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, Clinton A Brooks can be reached at (571)270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GEORGE W KOSTURKO/Primary Examiner, Art Unit 1621
/I.S./Examiner, Art Unit 1621
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