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
Priority
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, is acknowledged.
Status of Claims
Claims 1-19 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on 08/13/2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 10/01/2024, which has been entered in the file.
Response to Election/Restriction
In response to the restriction requirement Applicants have elected Group I (which includes claims 1-10), drawn to a method of treating a cancer in a subject, the method comprising administering to the subject in need of treatment a combination therapy comprising EZH2 inhibitor, CDK inhibitor and a therapeutic agent fulvestrant or a pharmaceutically acceptable salt thereof, without traverse, acknowledged.
Claims 11-19 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter. Therefore, the requirement for restriction is still deemed proper and made it final.
Applicants preserve their right to file a divisional on the non-elected subject matter.
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 1-10 are rejected under 35 U.S.C. § 112, 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(s), at the time the application was filed, had possession of the claimed invention. The expression a method of treating a “cancer” (claim 1, line 1, page 3, and all other occurrences of claims 1-10, if any), which broadens the enabling disclosure because it is unclear what kind of “cancer”, the Applicant is intending to encompass with this broad expression and/or how this ‘cancer’ is treated and therefore, the specification fails to provide sufficient support to treat all the wide range of cancers, by administering to the subject in need of treatment a combination therapy comprising EZH2 inhibitor, CDK inhibitor and a therapeutic agent fulvestrant or a pharmaceutically acceptable salt thereof. The type or mode of action and functionality of preventable or treatable ‘cancer’ is not defined in the claims or anywhere in the specification so as to ascertain the breadth and/or metes and bounds of the claimed subject matter.
The recitation a method of treating a “cancer”, which is not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. § 112 first paragraph because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. As stated in the MPEP 2164.01 (a), there are many factors [1) The nature of the invention, 2) The state of the prior art, 3) The level of ordinary skill in the art, 4) The level of predictability in the art, 5) The amount of direction and guidance provided by the inventor, 6) The existence of working examples, 7) The breadth of the claims, and 8) The quantity of experimentation needed to make or use the invention based on the content of the disclosure (In re Wands, 8 USPQ 2d 1400, 1404 (CAFC, 1988)] 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.” Therefore, it is not likely that a single or combination of compounds would be predicted to be able to prevent, delay or treat the progression of diverse “cancer”, as claimed in the instant application. Based on the unpredictable nature of the invention and state of the prior art and the extreme breadth of the claims, one skilled in the art could not perform the claimed methods of use without undue experimentation, see In re Armbruster 185 USPQ 152 CCPA 1975. Thus, the specification fails to provide sufficient support of the broad use of the method claims 1-10 to treat all kinds of cancers, wherein the method comprising administering to the subject in need of treatment a combination therapy comprising EZH2 inhibitor, CDK inhibitor and a therapeutic agent fulvestrant or a pharmaceutically acceptable salt thereof. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “cancer” and limiting specific type of “cancer” that actually contemplated in the specification (e.g., incorporating the limitations of claims 8-9 into claim 1) and that have enough support] in order to overcome the rejection.
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 1-10 are rejected under 35 U.S.C. § 112, 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(s), at the time the application was filed, had possession of the claimed invention. The expression “EZH2 inhibitor” [claim 1, line 3, page 3, and all other occurrences] is broad, because it is not clear what kind of ‘EZH2 inhibitor’ [a targeted drug that blocks the EZH2 enzyme to stop the cancer cells from growing, which covers a wide range of selections, such as, Valemetostat, Tazemetostat, PF-06821497, 3-deazaneplanocin A etc.] the Applicant is intending to encompass with this broad expression and therefore, any ‘EZH2 inhibitor’ may fall within the broad definition of ‘EZH2 inhibitor’ class]. The above expression, which is not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. 112 first paragraph, because the specification does not provide essential description to carry out the invention and thus lacks enablement as well. The omission of failing to describe the claimed invention renders the claims incomplete. These claims are written in functional language and therefore, broader than the enabling disclosure. Therefore, it is suggested that the expression “EZH2 inhibitor” either be limited to the specific ‘EZH2 inhibitor ’ that actually contemplated in the specification (such as, incorporating the limitations of claims 2 and 3 into claim 1) and/or to amend the claims within the context and scope of the claims in order to overcome the rejection.
Telephone Inquiry
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Golam Shameem, Ph.D. whose telephone number is (571) 272-0706. The examiner can normally be reached on Monday-Thursday from 7:30 AM - 6:00 PM. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks, Ph.D. can be reached at (571) 270-7682.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://portal.uspto.gov/external/portal. Should you have questions about access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Any inquiry of a general nature or relating to the status of this application should be directed to the Group receptionist, whose telephone number is (571) 272-1600.
/GOLAM M SHAMEEM/Primary Examiner, Art Unit 1621
