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 CON of PCT/CN2022/094068, filed May 20, 2022 and claims foreign priority to CN202110653809.4, filed June 11, 2021 in the People’s Republic of China.
Formal Matters
Claims 1-20 are currently pending.
Applicant’s election without traverse of Compound 7,
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in the reply filed on Sept. 26, 2025 is acknowledged.
Claims 1-2, 4-7, 9-12, and 16-20 are pending and subject to examination as they read on the elected species. Claims 3, 8, 13-14 and 16 are withdrawn. Claim 8 does not read on the elected species because claim 8 requires that all of Ra, Rb, Rc, and Rd are present but in the elected species, only Rb is present.
Claim Rejections – Withdrawn – Overcome by Amendment
The rejection of claim 20 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn.
The rejection of claim 15 under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form is withdrawn.
The rejection of claims 1-2, 4-7, 9-12, and 17-20 under 35 U.S.C. 102(a)(1) as being anticipated by Fink & Chen (US 2008/0058337 A1) is withdrawn.
The rejection of claims 1-2, 4-7, 9-12, and 15 under 35 U.S.C. 102(a)(1) as being anticipated by Ningbo Xidun Pharmaceutical Coating Technology Co Ltd (CN106432249A, Published Dec. 4, 2018) (herein “Ningbo”) is withdrawn.
Claim Rejections – 35 USC § 112(b) – New Grounds of Rejection Necessitated by Amendment
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 15 is 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.
One of ordinary skill in the art cannot determine the metes and bounds of claim 15 because claim 15 was amended to be dependent on claim 1, but neither claim 15 or claim 1 define each variable present in claim 15 (e.g. W, s, q, Y, Rw).
Appropriate correction is required.
Claim Rejections - 35 USC § 112(d) – New Grounds of Rejection Necessitated by Amendment
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.”
Claim 15 is 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 8 and 15 fail to include all the limitations of claim upon which they depends.
Claim 15 includes a structure wherein R3 is Orb (Formula (VIII), which is not allowed by claim 1 upon which it depends.
Claim Rejections - 35 USC § 102 – New Grounds of Rejection Necessitated by Amendment
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.
(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, 4-5, 7, 10, and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Breslin et al. (US 8,471,005 B2).
Claim 1 is directed towards a compound of formula (I):
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Breslin teaches a compound falling within formula (I):
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(Breslin, Specification, col. 305, lines 60-65).
This compound has the following structure:
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(drawn by examiner).
Therefore, claim 1 is anticipated.
Claims 4-5, 7, 10 and 15 read on the compound, example 20, above. Therefore, claims 4-5, 7, 10 and 15 are anticipated.
Claim 17 is directed towards a pharmaceutical composition comprising an effective amount of the compound according to claim 1. Claim 18 is directed towards the pharmaceutical composition of claim 17, further comprising a pharmaceutically acceptable carrier, adjuvant, vehicle or combination thereof.
Breslin teaches a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier, diluent, or excipient (Breslin, Specification, col.3, lines 32-35).
Therefore, claims 17-18 are anticipated.
Claim 19 is directed towards the pharmaceutical composition of claim 17, further comprising one or more therapeutic agents selected from other anti-tumor drugs. Claim 20 is directed towards the pharmaceutical composition according to claim 19, wherein the therapeutic agent is an antimitotic agent, an alkylating agent, an antimetabolic drug, a topoisomerase inhibitor, an estrogen receptor modulator, an androgen receptor modulator, a protein kinase targeting small molecule inhibitor, and a protein kinase targeting antibody drug. Breslin teaches that the composition can comprise an additional anticancer agent: “The compounds of the invention can also be combined in a pharmaceutical composition that also comprises compounds that are useful for the treatment of cancer or another ALK- or JAK2-mediated disorder.” (Breslin, Specification, col. 234, lines 37-41). Breslin also teaches that the composition can comprise two or more compounds of the invention (id., lines 39-33), and the compounds of the invention are small molecule kinase inhibitors (composition comprises an additional protein kinase small molecule inhibitor).
Therefore, claims 19-20 are anticipated.
Claims 1, 4-7, 10 and 17-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamamoto et al. (US 10,377,759 B2).
Claim 1 is directed towards a compound of formula (I):
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.
Yamamoto teaches a compound falling within formula (I):
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Yamamoto, Specification, col. 68, lines 40-45.
This compound has the following structure:
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(drawn by Examiner).
As in formula (I) of claim 1, L2 is a bond, R1 is F, R2, R4 and R5 are H, R3 is C(=O)NRcRd, RcRd are C1-alkyl, R6 is
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, L1 is N, A1 and A2 are C6-aryl-C1-alkylene, m is 1, and R’ is Br.
Therefore, claim 1 is anticipated.
Claims 4-7 and 10 read on the compound above and are therefore also anticipated.
Claim 17 is directed towards a pharmaceutical composition comprising an effective amount of the compound according to claim 1. Claim 18 is directed towards the pharmaceutical composition of claim 17, further comprising a pharmaceutically acceptable carrier, adjuvant, vehicle or combination thereof.
Yamamoto teaches a pharmaceutical composition comprising the compound and a pharmaceutically acceptable carrier (Yamamoto, Specification, col. 31, lines 34-42).
Therefore, claims 17-18 are anticipated.
Claim 19 is directed towards the pharmaceutical composition of claim 17, further comprising one or more therapeutic agents selected from other anti-tumor drugs. Claim 20 is directed towards the pharmaceutical composition according to claim 19, wherein the therapeutic agent is an antimitotic agent, an alkylating agent, an antimetabolic drug, a topoisomerase inhibitor, an estrogen receptor modulator, an androgen receptor modulator, a protein kinase targeting small molecule inhibitor, and a protein kinase targeting antibody drug.
Yamamoto teaches that the compound of their invention can be combined with another active agent in a single preparation (Yamamoto, Specification, col. 30, lines 9-12), which include “an alkylating agent, an antimetabolite, an anticancer antibiotic, a plant-derived preparation, a hormone preparation, a platinum compound, a topoisomerase inhibitor, a kinase inhibitor, an immune checkpoint inhibitor, an anti-CD20 antibody, an anti-HER2 antibody, an anti-EGFR antibody, an anti-VEGF antibody, other anticancer drugs and the like.” (Id., lines 29-37).
Therefore, claims 19-20 are anticipated.
Claims 1, 4-7, 9-10, and 17-18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Southern Medical University (CN104876935A).
Claim 1 is directed towards a compound of formula (I):
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Southern Medical University teaches compounds falling within the genus of formula (I):
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(Southern Medical University, Specification, p. 11);
4-(2-(4-cyclopropylanilino)pyrrolo[1,2-f][1,2,4]triazine-4-oxyl)-3,5-dimethylbenzocyanide (Translation, p. 3) having the structure:
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(drawn by Examiner).
As in formula (I) of claim 1, L2 is a bond, R1, R2, R4 and R5 are H, R3 is C3 cycloalkyl or C1 alkyl, R6 is
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, L1 is O, A1 is phenyl and R’ is C1-alkyl or CN.
Therefore, claim 1 is anticipated.
Claims 4-7 and 9-10 read on the compound(s) above and are therefore also anticipated.
Claim 17 is directed towards a pharmaceutical composition comprising an effective amount of the compound according to claim 1. Claim 18 is directed towards the pharmaceutical composition of claim 17, further comprising a pharmaceutically acceptable carrier, adjuvant, vehicle or combination thereof.
Southern Medical University teaches a pharmaceutical composition comprising the compound and a pharmaceutically acceptable excipient: “A pharmaceutical composition comprising 2-aminopyrrolo[1,2-f][1,2,4]triazine compounds or their pharmaceutically acceptable salts, hydrates, solvates or prodrugs. Also included are pharmaceutically acceptable excipients.” (Translation, p. 4).
Therefore, claims 17-18 are anticipated.
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 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.
Claim(s) 1-2, 4-7, 9-12, 15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Southern Medical University (CN104876935A), as applied to claims 1, 4-7, 9-10 and 17-18 above in view of McCurdy & Cohen (Bioisosterism, Drug Design Org, Feb 2007, p. 1-138).
The rejection of claims 1, 4-7, 9-10 and 17-18 above as anticipated by Southern Medical University is incorporated herein by reference. As such, these claims were also prima facie obvious at the time of filing.
Claim 2 is directed towards a compound of formula (II):
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.
As shown above, Southern Medical University teaches compounds which are virtually identical to formula (II), for example:
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(Southern Medical University, Specification, p. 11).
This compound differs from formula (II) by a single atom, O instead of NH, however, one of ordinary skill in the art would have a reasonable expectation of success to substitute O for NH because this is a well-known bioisosteric replacement that produces compounds with similar properties.
For example, McCurdy and Cohen teaches O and NH are divalent bioisosteres:
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McCurdy, p. 12.
Therefore, claim 2 was prima facie obvious at the time of filing.
Claims 11-12 and 15 also read on the compound of Southern Medical University, except that O is replaced with NH, and thus were prima facie obvious at the time of filing.
Given the above teachings, the invention as a whole was prima facie obvious at the time of filing.
Allowable Subject Matter
Claim 16 is allowable subject matter.
Conclusion
Claims 1-2, 4-7, 9-12, 15 and 17-20 are rejected. Claim 16 is allowable subject matter.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HEATHER DAHLIN whose telephone number is (571)270-0436. The examiner can normally be reached 9-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HEATHER DAHLIN/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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