DETAILED ACTION
Notice of 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 .
Election/Restrictions
Applicant’s election with traverse of Group I in the reply filed on 7/15/2026 is acknowledged. Applicant traverses on the grounds that “the examination of... Group II would not cause a serious burden” (Applicant Arguments, Page 1).
The argument is not found persuasive. The instant Application is a 371 of PCT/CN2022/139704. As discussed by MPEP 823, “[t]he analysis used to determine whether the Office may require restriction differs in national stage applications submitted under 35 U.S.C. 371”. Significantly, that analysis does not include search burden.
The requirement is still deemed proper and is therefore made FINAL.
Claims 23-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election without further specifying traverse of a single species in the reply filed on 7/15/2026 is also acknowledged.
The elected species read upon claims 1-3, 5-7, 13-15, 18-20 and 22. Claims 4, 8-12, 16-17 and 21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Expansion of Election of Species Requirement
Applicant’s elected species, a compound having the following formula:
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reads upon claims 1-3, 5-7, 13-15, 18-20 and 22.
The elected species has been searched and is deemed to be free of the prior art and non-obvious. Accordingly, the search has been expanded as called for under current Office Markush practice – a compound-by-compound search – to include a single additional species (M.P.E.P. § 803.02). That species is
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wherein, in formula (I), X1 is CR4 wherein R4 is H; X2 is CR5 wherein R5 is H; L is a bond; A is a bond; R1 is hydrogen; R2 is C1 alkyl; R3 is hydrogen; n is 0; m is 2; and R6 is hydrogen – which reads on pending claims 1-3 and 20, as well as composition claim 22. A rejection to those claims follows.
Since the search has not been expanded beyond the single additional species identified above, claims 5-7, 13-15 and 18-19, which are directed to the elected species but which do not include the single additional species, are objected to as indicated below, and have not been further examined.
Claim Objections
Claims 1, 3, 5-7, 13-15, 18-20 and 22 are objected to for the following reasons:
Claim 1 recites:
“A compound represented by formula (I), its pharmaceutically acceptable salt or isomer:
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X1 is selected from N or CR4;
X2 is selected from N or CR5...”
The claim should be amended to include a comma after (I) and to further recite “wherein:” preceding the definition of X1 as follows:
“A compound represented by formula (I), its pharmaceutically acceptable salt or isomer:
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,
wherein:
X1 is selected from N or CR4;
X2 is selected from N or CR5...”
Claims 3, 5-7, 13-15, 18 and 20 are similarly objected to.
Claim 13 is additionally objected to as reciting “The” in the penultimate line. The “T” in “The” should not be capitalized.
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.
Claims 5-6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 5 and 6 are drawn to a compound wherein X1 is selected from N or CR4 and X2 is selected from N or CR5, wherein “preferably, at least one of X1 and X2 is N”
Regarding claims 5 and 6, the phrase “preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
As such, claims 5-6 are rejected as 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 1-3, 20 and 22 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by French et al (J Med Chem 13(6):1117-1124, 1970).
Claim 1 is drawn to a compound of formula (I), which embraces the following compound species
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wherein X1 is CR4 wherein R4 is H; X2 is CR5 wherein R5 is H; L is a bond; A is a bond; R1 is hydrogen; R2 is C1 alkyl; R3 is hydrogen; n is 0; m is 2; and R6 is hydrogen – which reads on pending claims 1-3 and 20.
French et al teach the instantly claimed compound (Page 1118, Table 1, Compound 7-NH2; see also Page 1118, Column 2 and Page 1120, Scheme II, Compound XXI).
Accordingly, claims 1-3 and 20 are anticipated.
Claim 22 is drawn to a pharmaceutical formulation having CDK-9 inhibitory activity, comprising a compound according to claim 1 and any one or more pharmaceutically acceptable carriers.
French et al teach that “7-amino-1-methylisoquinoline (XXI) [was] synthesized from XIX by typical Bucherer reaction conditions” (Page 1118, Column 2) as follows (Page 1120, Scheme II):
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which would produce water, a pharmaceutically acceptable carrier, as a side-product (i.e., C10H8N-7-OH + (NH4)2SO3 → C10H8N-7-NH2 + NH4HSO3 + H2O).
As such, French et al teach a pharmaceutical formulation comprising a compound according to claim 1 and any one or more pharmaceutically acceptable carriers.
And it is necessarily the case that the compound possesses CDK-9 inhibitory activity. As stated in In re Papesch, 315 F.2d 381 (CCPA 1963), “[f]rom the standpoint of patent law, a compound and all its properties are inseparable”.
Accordingly, claim 22 is also anticipated.
Claim Objections
Claims 5-7, 13-15 and 19 are objected to as depending from a rejected base claim.
Additionally, claims 5-7, 13-15 and 18-19 are objected to as containing non-elected subject matter that has not been further searched. Since the search has not been expanded beyond the single additional species identified above, claims 5-7, 13-15 and 18-19, which are directed to the elected species but which do not include the single additional species, are objected to, and have not been further examined.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CRAIG D RICCI whose telephone number is (571) 270-5864. The examiner can normally be reached on Monday through Thursday, and every other Friday, 7:30 am - 5:00 pm ET. 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, Bethany Barham can be reached on (571) 272-6175. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CRAIG D RICCI/Primary Examiner, Art Unit 1611
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