DETAILED ACTION
This office action is in response to the Applicant’s filing dated August 5th, 2026.
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
This application is a 371 of PCT/KR2023/000930 filed on January 19th, 2023; and claims benefit of foreign priority of KR10-2022-0095624 filed on August 1st, 2022 and KR10-2022-0009530 filed on January 21st, 2022. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Status of Claims
Claims 1-12 are pending in the instant application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on August 5th, 2026 is acknowledged.
Claims 6 and 10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on August 5th, 2026.
Applicant’s election without traverse of the compound of Example 53 shown below in the reply filed on August 5th, 2026 is acknowledged:
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Which is a compound of instantly claimed Chemical Formula (I) wherein X is N; wherein Z, Y and W are CH; wherein P is a 6 membered heteroaryl comprising one N atom, specifically pyridine; wherein Q is a 6 membered heteroaryl consisting of one N atom substituted by an NR1R2, and R1 and R2 are both H, specifically 6-amino-3-pyridine; and wherein R is C2 alkyl.
This compound was found free of prior art.
Therefore, the Examiner expanded search to encompass CAS RN 1621988-96-2 shown below:
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Which is a compound of instantly claimed Chemical Formula (I) wherein X is N; wherein Z, Y and W are CH; wherein P is a 5 membered heteroaryl comprising one O atom, specifically furan; wherein Q is a 6 membered heterocycloalkyl comprising one N atom and one O atom, specifically morpholine; and wherein R is C5 cycloalkyl, specifically cyclopentane.
This search retrieved prior art.
Therefore, the Examiner’s search will not be extended unnecessarily to additional species of genus Chemical Formula (I) in/for/during this Office Action.
Claims 1-5, 7-9 and 11-12 read on the elected species and will be examined herein for prior art purposes.
Claim Objections
Claims 2 and 5 are objected to in part 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, and to recite only the elected species.
Note that claims 2 and 5 are objected to “in part” herein insofar as they contain non-elected subject matter to which the prior art search has not yet been extended. That part which has been searched, however (consistent with the election of species requirement as previously discussed), would be allowable if the claim was amended in independent form including all the limitations of the base claim and any intervening claims, and to remove the currently non-elected subject matter.
Claim 5 is objected to because of the following informalities: The spacing between the compound numbers and compound names should be consistent. Moreover, compounds 31 and 36 have a “,” after the compound name, but should have a “;”. 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 11-12 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.
Regarding claims 11-12, the language “A use of the compound of Chemical Formula (I)” fails to clearly define the metes and bounds of the claim. Particularly, it is unclear whether the Applicant intended the instant claims to be drawn to a compound or a method of preventing or treating cancer. See MPEP § 2173.05(q).
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter.
Regarding claims 11-12, the claims do not clearly fall within at least one of the four categories of patent eligible subject matter because they are drawn to “A use of the compound of Chemical Formula (I)” as recited in claims 11-12, which is not one of the four categories of patent eligible subject matter. “One cannot claim a new use per se, because it is not among the categories of patentable inventions specified in 35 U.S.C. § 101") In re Moreton, 288 F.2d 708, 709, 129 USPQ 227, 228 (CCPA 1961). See MPEP § 2173.05(q).
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)(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 1, 3-4 and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Gucky et al (US 2015/0368248 A1).
Regarding claims 1, 3-4 and 7-9, Gucky teaches Compound BP40 shown below (page 26, Table 1, fourth compound from the bottom):
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which is a compound of General Formula I of Gucky, wherein X is N; wherein R1 is morpholin-4-yl; and wherein R2 is 3-furanyl (page 1, paragraphs [0008-0009]; page 2, paragraphs [0020, 0030 and 0036]). This is the compound of the instant claims expanded to by the Examiner. Gucky further teaches a pharmaceutical composition comprising the compound above and a pharmaceutically acceptable carrier (page 2, paragraph [0051]; page 38, Example 42, paragraphs [0229-0231]).
Regarding the use limitations of instant claims 7-9, which are directed to the use of the claimed pharmaceutical composition for the inhibition of human epidermal growth factor 2 (herein referred to as HER2) and treatment of a cancer; wherein the cancer is a selected from the group consisting of colorectal, gastric, lung, biliary tract, bladder, esophageal, melanoma, ovarian, liver, prostate, pancreatic, colon, head and neck, uterine, breast and cervical cancers; respectively, such limitations of the instant claims fail to patentably distinguish the instant claims over the cited prior art because such a limitation is an intended use of the pharmaceutical composition (i.e. an intent to use the disclosed pharmaceutical composition as treatment for breast cancer), which does not impart any physical or material characteristics to the pharmaceutical composition that is not already present in the cited prior art. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. See Pitney Bowes Inc. v. Hewlett-Packard Co., 182 F.2d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See also Rowe v. Dror, 112 F.3d 473, 378, 42 USPQ2d 1550, 1554 and MPEP § 2112.02(II). In the instant case, the claims are directed to a pharmaceutical composition and, thus, would be reasonably expected to be capable of performing the intended use as instantly claimed, absent factual evidence to the contrary and further absent any apparent structural difference between the pharmaceutical composition of the prior art and that of the instant claims.
Thus, the teachings of Gucky anticipate the compound and pharmaceutical composition of instant claims 1, 3-4 and 7-9.
Conclusion
Claims 1, 3-4, 7-9 and 11-12 are rejected.
Claims 2 and 5 are objected to.
No claim is allowed.
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/C.L.J./Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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