DETAILED ACTION
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 .
This is a Final Office Action.
Claims 8, 15 and 21-30 are pending and under consideration. Claims 26-30 are new claims.
Specification
The objection to the disclosure because of the formula (II) may not be correct based on the synthesis, is withdrawn based on the amendments.
The objection to the disclosure because the use of trademarks, is withdrawn based on the amendments.
The substitute specification filed July 24, 2026, has been entered because it does conform to 37 CFR 1.125(b) and (c). The amendments submitted were to correct formula (II) based on the species embraced by formula (II). The amendments also identified trademarks cited in the disclosure. This is not new matter.
Claim Objections
Claims 25 and 30 are 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.
Claim Rejections - 35 USC § 112
The rejection of claims 1-7, 9-12, 16, 17, 19, 20 and 22-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “… optionally substituted with one or more alkyl or aryl group substituent selected from the group consisting of halo, cyano…” in claims 1, 2, 9, 16 and 19,. is withdrawn based on the amendments.
The rejection of claims 1-7, 9-12, 16, 17, 19, 20 and 22-25 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for the phrase, “… wherein two alkyl or aryl group substituents together form alkylene or substituted alkylene…” in claims 1, 2, 9, 16 and 19, is withdrawn based on the amendments.
The rejection of claim 15 under 35 U.S.C. 112, 4th paragraph, as being of improper dependent form because the species in claim 15 are not embraced by claim 1 due to the double bond missing in formula (II), is withdrawn based on the amendments.
The rejection of claims 1, 9-14 and 22-25 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), first paragraph, as failing to comply with the written description requirement the species of formula (II), is withdrawn based on the amendments.
The following is a quotation 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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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 23, 24, 28 and 29 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This is a written description rejection.
The analysis for adequate written description considers the following:
(a) Actual reduction to practice;
(b) Disclosure of drawings or structural chemical formulas;
(c) Sufficient relevant identifying characteristics, such as (i) complete/partial structure, (ii) physical and/or chemical properties, and (iii) functional characteristics when coupled with known or disclosed correlation with structure; and
(d) Representative number of samples.
A lack of adequate written description issue arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process. See, e.g., Fujikawa v. Wattanasin, 93 F.3d 1559, 1571,39 USPQ2d 1895, 1905 (Fed. Cir. 1996) (a "laundry list" disclosure of every possible moiety does not constitute a written description of every species in a genus because it would not "reasonably lead" those skilled in the art to any particular species); In re Ruschig, 379 F.2d 990, 995, 154 USPQ 118, 123 (CCPA 1967).
An applicant may also show that an invention is complete by disclosure of sufficiently detailed, relevant identifying characteristics which provide evidence that applicant was in possession of the claimed invention, i.e., complete or partial structure, other physical and/or chemical properties, functional characteristics when coupled with a known or disclosed correlation between function and structure, or some combination of such characteristics.
In particular, the specification as original filed fails to provide sufficient written basis for the scope of the compounds of formulas (I-III), which demonstrates possession as a kinase inhibitor. The mere fact that Applicant may have discovered several specific compounds of formulas (I-III) is not sufficient to claim the entire genus of compounds or kinases. Moreover, the specification is specific to 1,2,3- or 1,2,4-triazoles of formula s(I-III). Also, the claims should identify which compounds of formulas (I-III) inhibit which kinases.
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, reduction to drawings, 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 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]."
The rejection is made under 35 USC 112 (a), as written description is lacking.
Claims 23, 24, 28 and 29 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the inhibition of specific kinases for the compounds found in claims 8, 15 and 21, does not reasonably provide enablement for the inhibition of kinases generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
There are vast numbers of kinases. The largest area is protein kinases. The scope was provided previously and is incorporated here.
“The factors to be considered [in making an enablement rejection] have been summarized as the quantity of experimentation necessary, the amount of direction or guidance presented, the presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in that art, the predictability or unpredictability of the art and the breadth of the claims”. In re Rainer, 146 USPQ 218 (1965); In re Colianni, 195 USPQ 150, Ex parte Formal, 230 USPQ 546.
a) Determining if any particular claimed compounds would be active against every protein or lipid kinase enzyme would require synthesis of the substrate and subjecting it to testing against hundreds of different enzymes in this family. Applicants' provide an assay for only four of the hundreds of enzymes. Considering the large number of compounds to be made this is a large quantity of experimentation, d) The nature of the invention is inhibition of protein and lipid kinase enzymes with Applicants' compounds. This involves physiological activity. The nature of the invention requires an understanding of the structures of hundreds of different enzymes, the binding activity of small ligands to those enzymes, and the ability of those compounds to inhibit every one of the different enzymes. In view of the unpredictability of enzyme binding activity and claimed divergent substituents with varied polarity, size, and polarizability, the skilled enzymologist would indeed question the inclusion of such diverse enzymes, commensurate in scope with these claims. Also see the MPEP § 2164.03 for enablement requirements in the structure sensitive arts of pharmacology and medicinal chemistry, f) The artisan using Applicants invention with the claimed compounds would be an enzymologist with a PhD degree and several years of experience. He would be unaware of how to predict a priori how a change from one enzyme to another would affect biological activity. In view of the divergent compounds with varied basicity, steric hindrance, and polarizability, the skilled enzymologist would indeed question the inclusion of such compounds and enzymes, commensurate in scope with these claims, g) Physiological activity, is well-known to be unpredictable, In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970) (contrasting mechanical and electrical elements with chemical reactions and physiological activity). See also In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993); In re Vaeck, 947 F.2d 488, 496, 20 USPQ2d 1438, 1445 (Fed. Cir. 1991). h) The breadth of the claims includes the compounds in claims 8, 15 and 21 and the hundreds of different kinase enzymes. Thus, the scope is very broad.
Both 112(a) rejections above are addressed here.
Applicant states, “The Examiner also rejected claims 1-7, 9-14, 16-20, and 22-25 under 35 U.S.C. §112(a) as failing to comply with written description requirements, as the Examiner asserts that the specification as original filed fails to provide sufficient written basis for the description for the scope of the compounds of formulas (I-III) which demonstrate possession as a kinase inhibitor. Without acquiescing to the Examiner's rejection or the Examiner's contentions in support of this rejection, without prejudice or disclaimer of subject matter, and solely to advance prosecution, claims 2-7, 9-14, and 16-20 have been cancelled. Claims 8, 15, and 21 have been amended to independent form as discussed herein above and claims 22-24 ultimately depend on amended claim 8.
Furthermore, claim 25 has been amended to recite inhibiting cyclin dependent kinases. Figure 16 of the specification demonstrates a compound derivative of Formula I binding to CDK2 at an activity related binding site. The specification need not separately exemplify inhibition of every cyclin-dependent kinase where the art recognizes substantial structural and functional similarity among members of the CDK family. A person of skill in the art would understand that kinase inhibitors frequently exhibit activity across multiple members of a kinase family due to the structural homology of their ATP-binding domains. Accordingly, where a compound has been demonstrated to inhibit CDK2 via the competition of an activity-based probe like KY-26, a person of ordinary skill in the art would reasonably expect that compound to exhibit inhibitory activity against one or more additional CDKs, and confirmation of such activity would require no more than routine experimentation. A person of skill in the art would understand that displacement of an activity-based probe from a kinase reflects binding of the test compound to the functional kinase binding site. As such, disclosure of compounds that outcompete the probe provides a recognized indicator of kinase inhibitory activity and demonstrates that the inventors possessed compounds exhibiting the claimed inhibitory function. Thus, the disclosure reasonably conveys possession of the broader inventive concept and enables its practice across the claimed scope.”
This is not persuasive for claims 23, 24, 28 and 29. The claims are still drawn to kinases generally and therefore, the rejection is maintained.
Claim Rejections - 35 USC § 102
The rejection of claim(s) 1-8 and 22-25 under 35 U.S.C. 102(a)(1) as being anticipated by McCloud et al. (Analytical Chemistry, 2021, 93, 11946-11955), is withdrawn based on the 1.130 declaration received by the Office on July 24, 2026.
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUSANNA MOORE whose telephone number is (571)272-9046. The examiner can normally be reached Monday - Friday, 10:00 am to 7:00 pm.
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/SUSANNA MOORE/Primary Examiner, Art Unit 1624
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