DETAILED ACTION
Claims 1-15 are currently pending in the instant application. Claims 1-5 and 7 are allowed. Claims 14-15 are objected. Claims 6 and 8-13 are rejected.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-5 and 7 and the election of the grouping of patentably indistinct species:
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in the reply filed on 4 November 2025 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable, Therefore, the search has been extended to claims 1-5 and 7 in their entirety which appear allowable.
Claims 1-5 and 7 are directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 6 and 8-15 directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 12 September 2025 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are 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 Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable.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.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 16 March 2026 have been fully considered and entered into the instant application. Applicant’s amendment has overcome the 35 USC 112(a) rejection of claims 1-5 and 7, has overcome the 35 USC 112(d) rejection of claims 2-5, has overcome the 35 USC 102(a)(1) rejection of claims 1-5 and 7 as being anticipated by Patent No. 3,134,672, and has overcome the 35 USC 102(a)(1) rejection of claims 5 and 7 as being anticipated by William et al. J. Med. Chem. 2011, 54, 13, 4638-4658.
Claim Objections
Claims 14 and 15 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 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 8 and 9 is 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. Specifically, claim is drawn to a method for inhibiting on kinase or a plurality of kinases by administering the compound according to claim 1. However, as seen in the specification, page 20, paragraph [0076], the only written description for the present invention is the kinases selected from those mentioned in paragraph [0076] which states that the kinase “is” selected from the listed kinases. Additionally, while claim 9 provides the kinases as listed in paragraph [0076], the inclusion of “or functional equivalents thereof” lacks written description as “functional equivalents” of the listed kinases are not defined, exemplified, or any requirements for what function or how much function is required to be equivalent is not present in the originally filed specification.
Claims 6 and 10-12 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 treatment of the specific proliferative diseases provided in claims 13-15 does not reasonably provide enablement for the treatment of any disease (instant claim 6), any disease caused by, associated with or accompanied by disruption of cell proliferation and/or angiogenesis (instant claim 10) any proliferative disease (claim 11) and any cancer (claim 12). The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
As a general rule, enablement must be commensurate in scope with the claim language. The Federal Circuit has repeatedly held that “the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation.” In re Wright, 999 F.2d 1557, 1561, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). See MPEP § 2164.08. That some experimentation may be required is not fatal; the issue is whether the amount of experimentation required is “undue.” In re Vaeck, 947 F.2d 488, 495, 20 USPQ2d 1438, 1444 (Fed. Cir. 1991).
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
Breadth of the Claim – The claims are drawn to a method of treatment of any disease (instant claim 6), any disease caused by, associated with or accompanied by disruption of cell proliferation and/or angiogenesis (instant claim 10) any proliferative disease (claim 11) and any cancer (claim 12) with the compound according to claim 1. Accordingly, the claims are drawn to treating a broad scope of diseases and disorders and cancers.
Nature of the Invention – The nature of the invention pertains to a method of inhibiting specific kinases as seen in instant claim 9 for the treatment of diseases with the compound of claim 1.
State of the Prior Art and Predictability in the Art – Even in view of the seemingly high level of skill in the art, there is no absolute predictability when determining the physiological effects of a compound according to claim 1 against any and all diseases and any and all cancers. It is well established that “the scope of enablement [] varies inversely with the degree of unpredictability of the factors involved,” and physiological activity is generally considered to be an unpredictable factor. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). Lipinski et al. (Trends in Cancer, 2016, 49-63) even teach “[g]enomic aberrations differ between cancers of the same histological type, to the extent that no two tumors are thought to show an identical somatic genetic aberration profile.” See e.g., page 49. Therefore, a skilled artisan would reasonably expect the efficacy of treatment methods to vary when considering the diverse causes and symptoms associated with any and all diseases and cancers.
Relative Skill of Those in the Art – The artisan making and using applicant’s pharmaceutical compound would be a synthetic chemist and/or a health practitioner, possessing a commensurate degree level and/or skill in the art, as well as several years of professional experience. The level of skill in the art is high; however, due to the unpredictability in the pharmaceutical art and the wide scope of cancers, it is difficult to assess the potential pharmacological activity of a compound according to claim 1 against any and all diseases and cancers.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides a list of specific cancers and other specific proliferative diseases on pages 20-21. In vitro data is provides for certain cancel cell types and IC50 values on pages 42-46. However, the disclosure does not provide support for treating any and all diseases and cancers. There is no actual evidence of the effectiveness in treating the full scope claimed. Ex parte Stevens, 16 USPQ2d 1379.Quantity of Experimentation Necessary – The quantity of experimentation needed to use the invention based on the content of the disclosure is undue. One of skill in the art would need to determine which specific cancer or disease or disorder not embraced by the instant disclosed specific cancers and specific proliferative disorders would benefit from the pharmacological activities of a compound of claim 1 by administering said compound to a subject. Using the full scope of the instant claim is made further burdensome when one considers that even human testing “limited to one compound and two types of cancer” was not “commensurate with the broad scope of utility asserted and claimed.” In re Buting, 57 CCPA 777, 418 F.2d 540, 163 USPQ 689. The claimed invention would require a person having ordinary skill to invest an indefinite amount of experimentation clearly beyond what can be considered as routine.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). The test of enablement is not whether any experimentation is necessary, but whether, if experimentation is necessary, it is undue. In re Angstadt, 537 F.2d 498, 504, 190 USPQ 214, 219 (CCPA 1976). In view of the Wands factors and In re Fisher (CCPA 1970) discussed above, a person of skill in the art would have to engage in undue experimentation to test which cancers or other diseases or disorders can be treated by a compound of claim 1 with no assurance of success.
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 8 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. Specifically, claim 8 recites the limitation “with another medicament or a plurality of medicaments” in reference to treating with a compound according to claim 1 or a pharmaceutical composition comprising the compound according to claim 1. There is insufficient antecedent basis for this limitation in the claim as there is no “medicament” to indicate the use of the term “another” as the method utilizes a compound or a pharmaceutical composition. It is suggested that the word “another” be deleted and replaced with “a.”
Claim 9 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. Specifically, claim 9 defines specific kinases according to claim 8 and includes “or functional equivalents thereof.” The phrase “functional equivalents” is only found on page 20 paragraph [0076] of the specification and there is no definition provided in the instant specification. Therefore, claim 9 is considered indefinite as it is unclear what is considered functionally equivalent to the stated kinases as there is no definition provided and it is unclear exactly what function and what degree of function is required to be considered functionally equivalent.
Claim 13 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. Regarding claim 13, the use of parenthesis, such as in “myeloproliferative diseases (chronic idiopathic myelofibrosis, polycythemia vera, essential thrombocythemia, and chronic myelogenous leukemia)” renders the claim indefinite because it is unclear whether the limitation(s) in parenthesis are part of the claimed invention limitation, or just exemplary. It is suggested that the diseases listed in the parenthesis along with the parenthesis be deleted from claim 13.
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.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 9 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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