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, 31-32, 34, 36-39, 43, 52-54 and 56-79 are pending in the present application file.
Election/Restrictions
Applicant's election with traverse of Group I (claims 1, 31 and 60-61, drawn to a compound selected from the group consisting of a kinase inhibitor of the formula (Ia)) as well as a species of present claim 60 in the reply filed on 10/17/2025 is acknowledged. The traversal is on the ground(s) that the election of species requirement depends on a reference which does not qualify as prior art. This is not found persuasive because the prior art in WO 2020/083926 A1 (Sennhenn et al.; same patent family as EP 3643713 A1; International Filing Date 10/22/2019) discloses compounds comprising the shared technical features of the chemical compounds of claim 60 (see compound C7 on page 41 in Table A and page 119 in Scheme 2 of the WO Sennhenn reference.
The requirement is still deemed proper and is therefore made FINAL.
Claims 34, 36-39, 43, 52-54, 56-59, 62-63, 73-78 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 timely traversed the restriction (election) requirement in the reply filed on 10/17/2025.
Claims 1, 31, 60-61 and 63-72 are allowable. The restriction requirement between Groups I-XI and species of compounds of claim 60 , as set forth in the Office action mailed on 06/03/2025 , has been reconsidered in view of the allowability of claims to the elected invention pursuant to MPEP § 821.04(a). The restriction requirement is hereby withdrawn as to any claim that requires all the limitations of an allowable claim. Specifically, the restriction requirement of 06/03/2025 is partially withdrawn. Claims 34, 36-39, 43, 52-54, 62-63 and 77-78, directed to a process of making or using a compound selected from the group consisting of a kinase inhibitor of present formula (Ia) no longer withdrawn from consideration because the claim(s) requires all the limitations of an allowable claim. However, claims 32, 56-59 and 73-76, directed to an intermediate of a compound of formula (Ia) or a different compound of formula (Ia) of claim 1 remain withdrawn from consideration because they do not all require all the limitations of an allowable claim.
In view of the above noted withdrawal of the restriction requirement, applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Priority
The following continuity data is acknowledged in the present application file:
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Information Disclosure Statement
The Information Disclosure Statement(s) filed 10/19/2022, 05/24/2024, 08/23/2024 and 10/17/2025 have been acknowledged by the Examiner. The submissions 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 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 34 and 36-39 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.
Present claim 34 is drawn to a method for the treatment of a disease, disorder or condition comprising administration of the compounds of present claim 1.
The specification details the diseases, disorders and conditions as compounds of the invention can sensitize cells involved with a proliferative disorder (e.g. a tumor or a cancer). See page 99, paragraph [408] and page 85, paragraph [394]. The specification also provides that further in Examples 6, 8 and 9 on pages 208-222 where compounds of the disclosure are shown to have anti-tumor activity against leukemia cell lines as well as colorectal and pancreatic adenocarcinoma cell lines.
The specification details exemplary compounds E1-E16 of the disclosure in Table A from pages 70-72. Additionally compounds B3, A8, C1-13, D1-D10 are provided in Table 1A and Table 1B on page 187-188 of the specification.
The specification further details the inhibitory activity and selectivity of the compounds of the disclosure towards SIK, ABL1, and SRC kinases in Examples 2-4 in pages 189-198. The antitumor activity is largely attributed to the inhibition of SIK family members and not the ABL1 or SRC kinases. See page 221 for paragraph [909]-[910] as well as Figures 7A-7C.
The person of skill in the art would be able to extrapolate from the exemplary compounds and data present in the specification how to treat a proliferative disorder via administration of a compound of formula (I) of the disclosure.
There are no methods provided in order to extrapolate the method for the treatment of any disease, disorder or condition, which includes diseases other than proliferative diseases or conditions.
The Applicant is reminded of the written description guidelines set out by the USPTO in MPEP 2163:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
While the genus of diseases, disorders or conditions of the present invention are described by the specification to comprise proliferative disorders (e.g. cancer), the description of treatment for proliferative diseases or conditions is not sufficiently detailed to show that the Applicant was in possession of the full scope of the claimed invention, a method for the treatment of any disease, disorder or condition, at the time of filing.
Namely, that the definitions of proliferative diseases or conditions described above, while not being indefinite, are not sufficiently detailed in order to stand on their own as being adequately described. Therefore, the “representative number of species” standard is used to determine whether the claims are adequately described.
MPEP 2163 goes on to describe what a "representative number of species" is:
What constitutes a "representative number" is an inverse function of the skill and knowledge in the art. Satisfactory disclosure of a "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features of the elements possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly. Description of a representative number of species does not require the description to be of such specificity that it would provide individual support for each species that the genus embraces. For example, in the molecular biology arts, if an applicant disclosed an amino acid sequence, it would be unnecessary to provide an explicit disclosure of nucleic acid sequences that encoded the amino acid sequence. Since the genetic code is widely known, a disclosure of an amino acid sequence would provide sufficient information such that one would accept that an applicant was in possession of the full genus of nucleic acids encoding a given amino acid sequence, but not necessarily any particular species. Cf. In re Bell, 991 F.2d 781, 785, 26 USPQ2d 1529, 1532 (Fed. Cir. 1993) and In re Baird, 16 F.3d 380, 382, 29 USPQ2d 1550, 1552 (Fed. Cir. 1994). If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112, para. 1.
The species described in the specification do not cover the entire genus such that it is a representative sample of the genus as the species are close together in structure and only describe an extremely small portion of the claimed genus.
Therefore, the claims lack written description and are properly rejected under 35 U.S.C. 112(a).
Present claims 36-39, which are dependent upon present claim 34, are similarly rejected.
Applicant may amend claim 34 to include where the proliferative disorder that is a cancer or tumor and add kinase selected from the group consisting of ABL1, mutants of ABL1, SRC, SIK1, SIK2, and SIK3 to overcome this rejection.
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.
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 43, 52 and 77-78 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.
The term “preferable” in claim 43 and the term “preferably” in claims 43 and 52 renders the claims indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Claims 77-78, which are dependent upon claim 52, are similarly indefinite and rejected.
Allowable Subject Matter
Claims 1, 31, 53-54 and 60-72 are allowed.
Closest Prior Art
The closest prior art is from Sim et al. (WO 2006/081172 A2) which teaches compounds of formula (I) and in particular formula (Ia).
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Figure 1. Formula (I) of Sim (WO 2006/081172).
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Figure 2. Formula (Ia) of Sim (WO 2006/081172)
Sim teaches a compounds of the disclosure have activity as inhibitors of BCR-ABL kinases and useful for the treatment of proliferative disorders. See page 6, paragraph [0019]-[0020] and Table 1 from pages 27-46 for exemplary compounds 1-94 of the disclosure. The closest prior art compound is example 88 on page 45.
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In this example, there is a pyridine ring between the thiazole ring and piperazine ring, as well as an amido further substituted with phenyl also connected to the thiazole ring. The present claims require a kinase inhibitor selected from the group of compounds of present formula (Ia),
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where, there is a pyrimidine ring at the Hy position (instead of pyridine between thiazole and piperidine), as well as an amido further substituted by a group NR4R5 where R5 is a thienyl group, rather than a phenyl group. There is not a teaching or motivation in the prior art to change the substitution of the prior art to correspond to the thienyl of the present invention for the same utility of providing a kinase inhibitor.
Conclusion
Claims 1, 31-32, 34, 36-39, 43, 52-54 and 56-79 are pending.
Claims 1, 31, 53-54 and 60-72 are allowed.
Claims 34, 36-39, 43, 52 and 77-78 rejected.
Claims 32, 56-59 and 73-76 are withdrawn.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUINCY A MCKOY whose telephone number is (703)756-4598. The examiner can normally be reached Monday - Thursday 8:00 - 6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeff Lundgren can be reached at 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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/QUINCY A. MCKOY/
Patent Examiner
Art Unit 1626
/KAMAL A SAEED/Primary Examiner, Art Unit 1626