DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Current Status of 18/730,769
3. This Office Action is responsive to the amended claims of 13 August 2024.
4. Claims 1-10 have been examined on the merits. Claims 1-5 are original. Claims 6-10 are currently amended.
Priority
5. This application is a 371 of PCT/CN2023/072313, filed 01/16/2023, which claims a foreign priority of CHINA 202210072234.1, filed 01/21/2022 and CHINA 202210080325.X, filed 01/24/2022.
6. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
7. The effective filing date is 01/16/2023. 2
Information Disclosure Statement
8. The information disclosure statements (IDS) submitted on 7/20/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
9. Claims 2-9 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2-9 are not further limiting, because “crystal form A” is effectively the name of the form in instant claim 1. Claims 2-9 are just further characterizations, but “crystal form A” includes all the XRPD, TGA, DSC, etc. and dependent claims don’t further limit the independent claim or “crystal form A”.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
10. Claim 10 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In the instant claim 10, the phrases “ An application of” and “in preparation of” are used to describe using the crystal form A of the compound for treatment of lung cancer, pancreatic cancer or rectal cancer, without providing action step(s).
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.
11. Claim 10 is rejected under 35 U.S.C. 101 because:
The claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because instant claim 10 cites “An application of”, which is equivalent of “use of”, that doesn’t fall within at least one of the four patentable categories of subject matter. MPEP2173.05(q)(I). In addition, the phrase “in a preparation of” could mean if it’s a method of making a pharmaceutical, a product with an intended use, or if it is intending to be a method of treatment.
Claim Rejections - 35 USC § 102/103
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.
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.
Claim(s) 1-10 are rejected under 35 U.S.C. 102(a)(2)/103 as being anticipated by/obvious over WU (WO2022017519A1, effectively filed 07/23/2021, pub. 01/27/2022. WIPO translation attached. Referenced from the original document).
WU teaches a series of quinazoline compounds and pharmaceutically acceptable salts thereof for the treatment of lung cancer, pancreatic cancer and/or rectal cancer (lines 3-4, p 9; claim 10). Compound of formula(I) is exemplified as Compound 8 (p 37). Wu further teaches that the absolute configuration can be confirmed by conventional technical means in the art. For example, single crystal X-ray diffraction method (SXRD) uses a Bruker D8 venture diffraction meter to collect diffraction intensity data from cultured single crystals, using CuKα radiation as the light source. The scanning method is φ/scan. After collecting relevant data, the crystal structure is further analyzed using the direct method (Shelxs97) to confirm the absolute configuration (lines 3-6, p 13). It is noted that compound 8 is described as a crystal and we don't have the facilities to test whether it is the same as crystal form A of the instant claim 1.
Thus, claims 1-10 are anticipated by or obvious over WU with claims 6-9 of the DSC and TGA data being the inherent properties of crystal form A of compound of formula (I).
Conclusion
11. No claims are presently allowable as written.
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/B.T./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625
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