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 .
Claims 1-11 and 16-27 are pending as of the claim set received on June 2, 2026.
Priority
The Instant application claims priority as follows:
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Response to Election/Restriction
Applicant’s election of Group I, claims 1-7, 11 and 16-21, in the reply filed on 06/02/2026 is acknowledged. Applicant’s election of the species compound 93
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is also acknowledged.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 8-10 and 22-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 06/02/2026.
Examination
Examination will begin with the elected species. In accordance with 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 examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
The elected species of compound was searched and found unpatentable over the art as detailed below. Thus, examination was stopped and art has been applied against the claims. Therefore, the entire scope of claims 1-7, 11 and 16-21 has not yet been examined in accordance with Markush search practice. See MPEP 803.02.
Specification Objection - Title
Applicant is reminded of the proper content of the title of the invention.
The title of the invention should be brief, but technically accurate and descriptive. See 37 CFR 1.72(a) and MPEP § 606. The title of the invention should be more descriptive of what is claimed. Currently, the title does not indicate the type of compounds of the invention with their common core. A new title is required that is clearly indicative of the invention to which the claims are directed. See MPEP 606.01.
Specification Objection - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is objected to because it fails to exemplify any members or formulae illustrative of its class. Correction is required. See MPEP § 608.01(b). The examiner requests Applicant to illustrate compound species representative of what is claimed. A depiction of formula (I) or of compounds of claim 7 will obviate this objection.
Appropriate correction is required.
Claim Objections
Claims 16-21 are objected to under 37 CFR 1.75(c) as being in improper form because a multiple dependent claim should refer to other claims in the alternative only. See MPEP § 608.01(n). Accordingly, claims 16-21 have not been further treated on the merits.
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 5 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 5, structures 3, 4, 5, 6 and 7 are ambiguous structures when variables A2 and A3 are CH or N. The valence of these atoms is improper.
Claim Rejections - 35 USC § 103
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7 and 11 are rejected under 35 U.S.C. 103(a) as being unpatentable over Xia et al. (US 2020/0190091) or Li ( J. Med. Chem. 2022, 65, 5334-5354), in view of Gray (WO 2019/241715).
Applicants claim a compound of formula
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, its stereoisomers, geometric (Z) isomer and non-fluorinated compound thereof.
Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
Teachings of Xia
Xia teaches compounds of formula I
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as inhibitors of HER2, useful for the treatment of cancers, and pharmaceutical compositions with suitable carriers (at least cl. 29).
Xia further discloses representative compounds of the formula
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VII ,
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and their potency. See the biological data, starting at paragraph [0657] and claim 25. Embodiment 44 of Xia is the closest structure to applicant’s elected species.
Teachings of Li
Li teaches compounds of formula
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, and compound 13, as having great cell proliferation inhibitory activities, and much higher selectivity for HER2 than known inhibitors neratinib and pyrotinib. See at least Table 3. Compound 18 of Li is the same compound taught by Xia above, and is the closest to applicant’s elected species.
Teachings of Gray
Gray teaches compounds of formula (Ia)
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as inhibitors of HER2, useful for the treatment of cancers, and pharmaceutical compositions with suitable carriers (see whole document, claim 1, 84-89). Particularly formulae
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,
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and
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. More particularly of formula
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, and formula
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, wherein,
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The genus of Gray encompasses Embodiment 22 of Xia, which is Compound 14 of Li.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
The difference between the compounds of Xia or Li and the instantly claimed species of formula
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and stereoisomers, geometric (Z) isomer and non-fluorinated compounds thereof, is only the -O-X1 substituent, which is represented in the claimed formula (I)
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.
The claimed and prior art compounds have exactly the same core and the same use.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
The level of skill in the art is the level of the authors of the references cited above. Someone preparing these compounds would be trained in organic chemistry and would recognize these have the same structure and the same use. The problem to be solved is that of providing additional selective, potent and irreversible HER2 inhibitors for the treatment of cancers.
Xie, Li and Gray taught that the compounds discussed above are useful as HER2 inhibitors for the treatment of cancers. Particularly, Gray taught that compounds of formula
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can have the substituents R3 as depicted. Artisans interested in irreversible HER2 inhibitors for the treatment of cancers would have found the compound examples of Xie and Li above to be appropriate leads on the basis of their known biological activity. Once the artisans would have identified said compounds as suitable lead compounds, they would have been motivated to add a C1-C6 alkoxy or C1-C6 haloalkoxy group at the ortho-position of the NH-phenyl group (R3 in compounds of Gray), because Gray taught that this would provide additional triazolo-pyridin-7-yloxy-quinazolin-6-yl compounds for the same use. It would have been obvious to substitute the ortho-position with the simplest group, which is the methoxy group (-O-CH3). The ortho-position has been already substituted by a halogen in similar compounds (see at least comp. 11 in Grey). There would have been a reasonable expectation of success in view of the reference’s teachings.
Pursuant to MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, subsection II.A.4.(c) and (d).
Under the Supreme Court rationales in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007), here at least exemplary rationales (A) and (G) apply:
(A) Combining prior art elements according to known methods to yield predictable results;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Conclusion
Claims 1-7, 11 and 16-21 are rejected. No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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 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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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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