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 .
DETAILED ACTION
Claims 1, 5, 6, 8, 9, 12, 15, 51, 54-58, 61 and 68 are pending in the application. Claims 1, 5, 6, 8, 9, 12, 15, 51, 54-56, 58, 61 and 68 are rejected. Claim 57 is objected to.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 6th, 2026 has been entered.
Response to Amendment / Argument
Objections and rejections made in the previous Office Action have been overcome by Applicant's amendments to the claims or specification.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(a)-(d) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(a)-(d) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. EP20171965.5, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
The foreign priority document fails to support the option of “A” in instant claim 1 to be “substituted C1-C13 heteroaryl”. This limitation is rejected as indefinite; however, at least one interpretation would be that “A” is required to be substituted by a non-hydrogen substituent besides R13 and R14. The foreign priority discloses the following option for variable R6 in claim 1 (page 417):
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The foreign priority document provides the following definition for “A” in claim 1 (page 417):
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In a narrowed embodiment, the foreign priority document discloses the following option for R6 (claim 2, page 419):
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The foreign priority document provides the following definition for “A” in claim 2 (page 420):
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The foreign priority document therefore points to two embodiments, i.e. (1) where ring “A” is generally open to substitution and (2) where ring “A” is substituted by R13 and R14 but apparently not open to further substitution. Instant claim 1, however, provides for ring A to be substituted by R13 and R14 and (under one interpretation) requires that ring A be further substituted. Claims which change the scope relative to the originally filed claims may lack written description, see In re Ruschig, 371 F.2d 990, 154 USPQ 118 (CCPA) 1967) which supports that the original disclosure of a large genus did not support a later filed claim to a previously unnamed single species. Furthermore, Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir.2000) notes that with respect to In re Ruschig, that “Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say “here is my invention”. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”
In this situation, the blazemarks in the foreign priority document only suggest substitution of ring A by variables R13 and R14 when ring A is not further substituted as opposed to the instant claim 1 that recites ring A is a substituted heteroaryl and substituted by R13 and R14.
Since the difference above affects the scope of instant claims 1, 5, 6, 8, 9, 12, 15, 51, 58, 61 and 68, these claims are not afforded the filing date of the EP20171965.5 application.
Claim Objections
The preamble of claim 57 should be amended to replace “formula” with “chemical name” or amended to otherwise avoid the use of “formula” such as by reciting “A compound selected from:”.
The text “[page 25 limes 22-25]” in the definition of R10 in claim 1 should be deleted.
Claim Rejections - 35 USC § 112
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.
Claims 1, 5, 6, 8, 9, 12, 15, 51, 58, 61 and 68 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
Claim 1 has been amended to recite the following structural option for R6:
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along with the option for “A” to be “substituted C1-C13-heteroaryl”. This limitation is rejected as indefinite; however, at least one interpretation would be that “A” is required to be substituted by a non-hydrogen substituent besides R13 and R14.
The original application discloses the following option for variable R6 in claim 1 (page 13):
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The original application provides the following definition for “A” in claim 1 (page 415):
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In a narrowed embodiment, the original application discloses the following option for R6 (page 17):
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The original application provides the following definition for “A” in claim 2 (page 18):
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The original application therefore points to two embodiments, i.e. (1) where ring “A” is generally open to substitution and (2) where ring “A” is substituted by R13 and R14 but apparently not open to further substitution. Instant claim 1, however, provides for ring A to be substituted by R13 and R14 and (under one interpretation) requires that ring A be further substituted. Claims which change the scope relative to the originally filed claims may lack written description, see In re Ruschig, 371 F.2d 990, 154 USPQ 118 (CCPA) 1967) which supports that the original disclosure of a large genus did not support a later filed claim to a previously unnamed single species. Furthermore, Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326, 56 USPQ2d 1481, 1486 (Fed. Cir.2000) notes that with respect to In re Ruschig, that “Ruschig makes clear that one cannot disclose a forest in the original application, and then later pick a tree out of the forest and say “here is my invention”. In order to satisfy the written description requirement, the blaze marks directing the skilled artisan to that tree must be in the originally filed disclosure.”
In this situation, the blazemarks in the original application only suggest substitution of ring A by variables R13 and R14 when ring A is not further substituted as opposed to the instant claim 1 that recites ring A is a substituted heteroaryl and substituted by R13 and R14.
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 1, 5, 6, 8, 9, 12, 15, 51, 54, 55, 56, 58, 61 and 68 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.
Claims 1, 5, 6, 8, 9, 12, 15, 51, 54, 55, 56, 58, 61 and 68 are rejected as indefinite since the fourth line of claim 1 provides a definition for a variable “X” that is not required by any position of formula (II). Dependent claims 5, 6, 8, 9, 12, 15, 51, 54, 55, 56, 58, 61 and 68 are rejected as indefinite for the same reason since they do not correct the issue.
Claims 1, 5, 6, 8, 9, 12, 15, 51, 58, 61 and 68 are rejected as indefinite based on the option for R6 to be the following group:
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together with the definition of A as follows:
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Claim 1 further recites R13 and R14 can be the following options:
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Claim 1 recites that A can be “substituted C1-C13 heteroaryl”. In this situation, there would appear to be two interpretations: (1) when ring A is heteroaryl, at least one of R13 and R14 is not hydrogen or (2) when ring A is heteroaryl, there is one non-hydrogen substituent on the ring besides R13 and R14. Dependent claims 5, 6, 8, 9, 12, 15, 51, 58, 61 and 68 are rejected as indefinite for the same reason since they do not clarify the issue.
Claim 58 is rejected as indefinite since it contains numerous references to “formula (I)” where claim 1 has been amended to only recite “formula (II)”. Accordingly, references to “formula (I)” are considered to lack antecedent basis.
Claim Rejections - 35 USC § 112(d)
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 56 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. Claim 56 provides an option for R1 and R2 to form a ring, which is no longer recited in parent claim 55. 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.
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)(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.
Claim(s) 1, 5, 6, 8, 9, 12, 15, 51 and 61 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by International Application Publication No. WO 2021/249896 A1 by Cheng et al., which claims priority to PCT/CN2020/095147, filed June 9th, 2020.
The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
The prior art teaches the compound 2-[4-[8-[3-methyl-4-(piperazine-1-carbonyl)anilino]imidazo[1,2-a]pyrazin-3-yl]-3-(trifluoromethyl)pyrazol-1-yl] acetonitrile on page 135, which has the following structure (support can be found on page 135 of the priority document):
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The compound is embraced by instant formula (I) where R1 and R2 are together to form a C4 heterocyclic ring (piperazin-1-yl), one of R3 and R9 is hydrogen and the other is C1 alkyl, R4 and R8 are hydrogen, R5 is halo C1 alkyl (-CF3), R6 is C1 alkyl substituted by cyano, R7 is hydrogen. These definitions are embraced by instant claims 1, 5, 6, 8, 9, 12, 15 and 51. Regarding instant claim 61, the prior art teaches an aqueous work-up with water, which is a therapeutically inert carrier.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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