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 .
Claim 14 has been cancelled. Claims 1-5, 13, 15, and 16 have undergone amendments. Claims 18-23 are newly added. Thus, Claims 1-8, 11-13, and 15-23, submitted on 1 September 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 Arguments
The objections to Claims 1-3 are each withdrawn. Applicant has corrected the informalities.
The 35 U.S.C. § 112(a) rejection of Claims 13-17 is withdrawn. Applicant has amended Claim 13 to recite that the cancer has mutated EGFR or HER2, which is enabled by the specification.
Each of the 35 U.S.C. § 112(b) rejections of the prior office action are withdrawn. Applicant has amended the claims to correct the indefiniteness issues cited in the prior office action.
The 35 U.S.C. § 103 rejections of Claim 5 over Ryu and Liu are each withdrawn. Applicant has amended the claims to remove the compounds which are obvious variants of Ryu and Liu, with the remaining compounds requiring substituent groups which are not taught or suggested by either reference.
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.
Claim 2 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. Claim 2 has the limitation of “C1-4 alkyl including one or more heteroatoms selected from the group consisting of N, O, and S” in the definition for variables Rc1 and Rc2. The use of “including” raises issues of indefiniteness because it is unclear if the limitations following are merely exemplary or are required limitations of the claim. The Examiner suggests replacing “including” with “optionally substituted with” or similar to overcome this rejection.
Please delete all occurrences of “include”, “includes”, “including”, etc from the claims to render moot this rejection.
Claim Rejections - 35 USC § 102- NEW GROUNDS OF REJECTION
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.
Claims 1-2, 7, 8, 13, and 15-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Liu (US 2018/0369242; Publication Date: 27 December 2018).
Liu discloses EGFR and ALK dual inhibitor compounds (Abstract). One specific compound disclosed is
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(Paragraph 0157). This compound has variable A as C(O), variable R1 as chlorine, variable R2 as -NRb1Rb2 with variables Rb1 and Rb2 coming together to form a heterocycloalkyl substituted with methyl, variable R3 as
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with variables X, Y, and Z each as hydrogen, variable R4 as tert-butyl, and variables R5, R6, and R7 each as hydrogen. The compounds are useful for the treatment of cancers which have mutant EGFR, including cancers which are claimed in the examined application (Paragraph 0092). The inventors demonstrate utility in the treatment of lung cancer cells which had mutations which are claimed in the examined application (Paragraph 0281). In other aspects, the present invention provides a pharmaceutical composition comprising a therapeutically effective dose of the compound of the invention and a pharmaceutically acceptable carrier, and optionally other therapeutic agents (Paragraph 0088).
Claim Rejections - 35 USC § 103- NEW GROUNDS OF REJECTION
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-4, 7, 8, and 11-13, and 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Liu (US 2018/0369242; Publication Date: 27 December 2018).
The teachings of Liu are previously described and are fully incorporated into this rejection.
Liu does not disclose that variable R4 is C1-3 alkyl, the combination with another anticancer agent, or that the formulation is a health functional food.
It would be obvious to one of ordinary skill in the art to modify the compound
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by replacing the tert-butyl group with a C1-C3 alkyl as the artisan would not expect this replacement to significantly alter the properties of the resulting compound due to the close chemical structure (See MPEP § 2144.09 I). This compound is an inhibitor of mutant EGFR, and the artisan would not expect substituting tert-butyl for a smaller alkyl chain to significantly alter the inhibitory capacity of this compound.
Regarding Claims 11 and 17, it would be obvious to combine the compound of Liu with a second anticancer agent as it is prima facie obvious combination of equivalents known for the same purpose (See MPEP § 2144.06 I). "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Regarding Claim 12, Liu does not disclose that the pharmaceutical composition is in the form of a health functional food. However, Liu discloses that the compositions are suitable for oral administration (Paragraph 0089). Thus, it would be obvious to formulate this composition in the form of a health functional food as this is a form of composition suitable for oral administration, and would result in greater patient compliance if administered in a more palatable form.
Allowable Subject Matter
Claims 5 and 18-23 are allowed.
Claim 6 is 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.
The following is an examiner’s statement of reasons for allowance: There is no prior art which teaches or suggests the specific compounds of Claims 5 and 18-23 (See STN Search, Search Notes). The closest prior art comes from Liu (US 2018/0369242; Publication Date: 27 December 2018). Liu discloses EGFR inhibitors of similar structure to those claimed in the examined application. However, the specific compounds of Claims 5 and 18-23 have moieties such as
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or other fused ring systems, which are not taught, suggested, or is there a motivation provided, by Liu, nor is there any reasonable expectation that modifying the compounds of Liu by incorporating these fused ring systems would result in a compound which retains its activity. Ryu (US 2022/0227781; Publication Date: 21 July 2021) discloses an example 17
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which differs from claimed compounds 83-90 by having -S(O)2Me in the analogous variable A location, with the claimed compounds having additional methyl or halogen groups substituted throughout the compound. However, there is no teaching or suggestion found in Ryu to remove this group and replace it with C(O), nor is there any reasonable expectation from Ryu or Liu that this moiety can be substituted into this compound and result in a compound which performs similarly since Liu only provides one example of an EGFR inhibitor with this moiety, with this example differing structurally in significant ways from the compound of Ryu. Liu discloses a synthesis scheme similar to that which is claimed, but their claimed method requires multiple steps, utilizing different intermediates than what is claimed in the examined application
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(See Paragraph 0104)
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 1-4, 7, 8, and 11-13, and 15-17 are rejected.
Claims 5 and 18-23 are allowed.
Claim 6 is 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.
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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/P.M.R./ Examiner, Art Unit 1625
/JOHN S KENYON/ Primary Patent Examiner, Art Unit 1625
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