DETAILED ACTION
Claims 70-100 are currently pending in the instant application. Claims 70, 72-84, and 86-100 are rejected. Claims 71 and 85 are objected.
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 and the species of compound 134:
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in the reply filed on 7 November 2025 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable over the prior art. Therefore, the search and examination has been extended to the entirety of the elected Group I, which now includes claim 89 which has been amended to be a method claim.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract contains the legal phraseology “said”. Correction is required. See MPEP § 608.01(b).
Claim Objections
Claims 71 and 85 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 70, 72-84, and 86-100 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 inhibiting KIF18A and treating a disease or condition mediated by KIF18A which is KIF18a sensitive cancer, is not enabled for the treatment of any disease or condition mediated by KIF18A or any cancer.
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:
The above factors, regarding the present invention, are summarized as follows:
Breadth of the Claim – The claims are drawn to a method of inhibiting KIF18A, treating a disease or condition mediated by KIF18A or treating cancer with the formula (I). 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 KIF18A, treating a disease or condition mediated by KIF18A or treating cancer with a compound of the formula (I).
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 of formula (I) against any and all cancers and any and all diseases mediated by KIF18A. 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 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 of formula (I) against any and all cancers.
Amount of Direction/Guidance Provided and Existence/Absence of Working Examples – The specification provides a list of cancers on page 144, no other types of diseases or conditions are provided. Table 9, starting page 321 provides biochemical assay data for inhibition of KIF18A, see page 319. Cell viability data for KIF18a sensitive cell lines is provided on page 320 and table 11, page 316. In vitro data for KIF18A-sensitive cancer cells are found on page 328 and Table 12. However, the disclosure does not provide support for treating any and all cancers or any other disease or disorder related to KIF18A inhibition. 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 disclosures KIF18A sensitive cancer would benefit from the pharmacological activities of a compound of formula (I) 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 formula (I), 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.
Claims 74 and 88 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.
Regarding claims 74 and 88 the phrase "including sarcomas" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention as applicant is claiming tumors of mesenchymal also. See MPEP § 2173.05(d). Additionally, the claims include “other tumors comprising retinoblastoma.” It is unclear what the “tumors comprising retinoblastoma” are “other” to or as opposed to what other tumors.
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.
Claims 74 and 88 are 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. Specifically, in further limiting “cancer”, claims 74 and 88 provide that the “cancer” is “other cancer-related disorders that are a consequence3 of cancer presence or progression”. Cancer-related disorders are not a type of cancer. Therefore, claims 74 and 88 fail to further limit “cancer” from the claims upon which they depend. 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 19 February 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600