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
STATUS OF THE CLAIMS: Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on December 29, 2025 is acknowledged.
Groups II-VII are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 reserved the right to file a divisional application to the non-elected subject matter.
An action on the merits on claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 (Group I of Formula Ia) is contained herein.
Claim Rejections - 35 USC § 112, first paragraph
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 1-2, 4, 10-14, 17-19, 109, 122 and 131 (including claims dependent thereon) 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are directed to a method of treating cancer. The term cancer is interpreted to include any and all forms of cancer. In light of this, it can be asserted that in spite of the vast expenditure of human and capital resources in recent years, no one drug has been found which is effective in treating all types of cancer because it is not a simple disease, nor is it even a single disease, but a complex of a multitude of different entities, each behaving in a different way. In re Hozumi, 226 USPQ 353 (ComrPats 1985).
The determination that “undue experimentation” would have been needed to make and use the claimed invention is not a single, simple factual determination. Rather, it is a conclusion reached by weighing all the above noted factual considerations. In re Wands, 858 F.2d at 737, 8 USPQ2d at 1404.
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) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims
The breadth of the instant claims is seen to encompass methods for treating cancer by administering to a patient in need of such treatment a therapeutically effective amount of compounds listed in claim 1 of Formula Ia. Thus, the claims are extremely broad.
The nature of the invention
The nature of the invention is the treatment of cancer through the use of the claimed compound and derivatives thereof. Currently, there are no known agents that treat cancers all inclusively. (See Pinedo et al. pages 1-2).
The level of predictability in the art
The treatment of cancer is highly unpredictable due to the differing forms of cancerous cells, their location, their potential for metastases, the fact that cancer therapeutics is palliative rather than curative and that cancer treatment readily harms normal tissues. (See McMahon, page 5, col. 2).
The amount of direction provided by the inventor.
The applicant has not demonstrated sufficient guidance provided in the form of administration profiles, combination ratios of the active agents or reference to the same in the prior art to provide a skilled artisan with sufficient guidance to practice the instant treatment of cancer claimed. Further, the applicant discloses that an effective amount of the compound will be administered without providing any direction other than that the compounds of the invention have a high therapeutic index and follows this with a definition readily found in a basic pharmacology textbook. It should be noted that the therapeutic index of a drug in humans is almost never known and is only determined through clinical experience.
The existence of working examples.
There is not seen in the disclosure, sufficient evidence to support Applicant’s claims of treating cancer. 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, 27 USPQ2d 1510 (CAFC). The disclosure does not demonstrate sufficient evidence to support the applicant's claim to the treatment of cancer. There are not sufficient working examples or data from references of the prior art to provide a nexus between those examples and a method of treating cancer with the claimed compound.
The level of one of ordinary skill.
The level of skill is that of one with a doctoral understanding of cancer therapeutics.
The quantity of experimentation.
A great deal of experimentation is required. In order for there to be a method of treating cancer generally, as claimed by the applicant, it would be necessary to show that a vast range of different types of cancers can be treated that have differing cell types, locations and potentials for metastases. Furthermore, direction, in the form of examples, must be shown to determine what an effective dose may be. The references submitted do not demonstrate this. Therefore, one of ordinary skill in the art would require a significant amount of experimentation in order to determine the effective dosage to treat the multitudes of different types of cancer with the claimed compound individually or in combination with other therapeutic agents.
Thus, it can be safely concluded that the instant case fails to provide an enabling disclosure for the treatment of cancer.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinsch et al. (WO2022/162471).
Applicant claims the following methods:
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305
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wherein all of the variables are defined in the claims.
This reference discloses methods for treating the disorders in Applicant claims on page 71. (See Abstract, pages 1-11 and 203-247, Tables and Examples). These methods read on the -instant claim. Since this reference teaches the exact methods, Applicant’s claims are , and anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Priem et al. (WO2014111580).
This reference discloses methods for treating the disorders in Applicant claims on paragraphs 1-21 and page 20. (See Abstract and entire documents). These methods read on the -instant claim. Since this reference teaches the exact methods, Applicant’s claims are , and anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinsch et al. (WO2015097231).
This reference discloses methods for treating the disorders in Applicant claims on pages 5 (lines 18-21), 14 (lines 24-28), and 18 (lines 2-9) and pages 31-32. (See Abstract, Compounds 3 and 5, and Tables II and III). These methods read on the -instant claim. Since this reference teaches the exact methods, Applicant’s claims are , and anticipated, and thus, rejected under 35 U.S.C. 102.
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sherris et al. (US Pub. 2007/0197567).
This reference discloses methods for treating the disorders in Applicant claims on pages 2-4 and 24-26. (See Abstract, Table 1 and following Examples/Compounds SG00580, SG00583, SC00603, SG00586, SG00610 ad SG00605). These methods read on the -instant claim. Since this reference teaches the exact methods, Applicant’s claims are , and anticipated, and thus, rejected under 35 U.S.C. 102.
Conclusion
Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are pending. Claims 1-2, 4, 10-14, 17-19, 109, 122 and 131 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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