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 .
DETAIL ACTION
This office action is a response to a 371 application filed -----4/4/2023, which is a national stage application of PCT/US2021/071692 filed 10/4/2021, which claims domestic priority to 63/087,780 filed 10/5/2020.
As filed, claims 1-10, 20-22, and 24-29 are pending; and claims 11-19, 23, and 30 are cancelled.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 9/21/2023 has been considered by the Examiner.
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 26-29 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 claim 26, the claim is dependent of claim 25 and recites the phrase, “a mutation in the Bcr-Abl tyrosine kinase gene” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” Bcr-Abl tyrosine kinase gene in claims 25 and 26. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 27, the claim is dependent of claim 26, and it failed to correct the indefiniteness issue of claim 26, which rendered the claim indefinite.
Regarding claim 28, the claim is dependent of claim 25 and recites the phrase, “ one or more mutations in the Bcr-Abl tyrosine kinase gene” wherein the word, “the”, requires antecedent basis, and it is unclear where applicant has defined “a” Bcr-Abl tyrosine kinase gene in claims 25 and 28. Without antecedent basis, the claim is rendered indefinite.
Regarding claim 29, the claim is dependent of claim 28, and it failed to correct the indefiniteness issue of claim 28, which rendered the claim indefinite.
Claim Rejections - 35 USC § 102
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, 5, 6, 9, and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chemical Abstract Registry No. 1262291-12-2, hereinafter CAS122.
Regarding claims 1, 2, 5, 6, 9, and 22, CAS122 teaches the following compound or pharmaceutical composition thereof (with unbuffered water), which meets all the limitations of these claims.
PNG
media_image1.png
216
378
media_image1.png
Greyscale
PNG
media_image2.png
86
1294
media_image2.png
Greyscale
Wherein: instant variable X is CR8; instant variable R8 is H; instant variable R2 is pyridine substituted by two R6 groups; one of R6 groups is chlorine, the other R6 group is -NR4NR5; instant variable R4 is H; instant variable R5 is cyclohexyl; instant variable R0 is -NH-R3; and instant variable R3 is ethyl.
Claims 1, 2, 5, 6, 9, 22, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 8,435,980, hereinafter Florjancic.
Regarding claims 1, 2, 5, 6, 9, 22, and 24, Florjancic, for instance, teaches the following compound or pharmaceutical composition thereof for treating acute myelocytic leukemia, which meets all the limitations of these claims.
PNG
media_image3.png
546
644
media_image3.png
Greyscale
(abstract)
PNG
media_image4.png
66
542
media_image4.png
Greyscale
(column 89, example 79)
PNG
media_image1.png
216
378
media_image1.png
Greyscale
(structure of example 79)
PNG
media_image5.png
262
632
media_image5.png
Greyscale
(column 48, lines 58-67)
PNG
media_image6.png
400
620
media_image6.png
Greyscale
(column 49, lines 54-67)
Claim Objections
Claims 1-10, 20-22, 24, and 28 are objected to because of the following informalities:
Regarding claims 1-10, 20-22, and 24, the claims recites the phrase, “mixture of any of the foregoing”.
Such expression can be clarified by reciting -- mixture of the pharmaceutically acceptable salt, solvate, hydrate, or co-crystal thereof --.
Regarding claim 28, the claim recites the phrase, “the human having refractory leukemia has one or more mutations”.
Such expression can be clarified by reciting -- the human has refractory leukemia, and the refractory leukemia has one or more mutations --.
Appropriate correction is required.
Allowable Subject Matter
Claim 25 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.
Conclusion
Claims 1, 2, 5, 6, 9, 22, 24, and 26-29 are rejected.
Claims 1-10, 20-22, 24, 25, and 28 are objected.
Claims 11-19, 23, and 30 are cancelled.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PO-CHIH CHEN whose telephone number is (571)270-7243. The examiner can normally be reached Monday - Friday 10:00 am to 6:00 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 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PO-CHIH CHEN/Primary Examiner, Art Unit 1621
Prosecution Insights