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 .
Status of the Application
This Office Action is in response to Applicant's arguments filed on October 22, 2025. Claim(s) 1-2, 16, 18-23, 25, and 30-39 are pending and examined herein.
Response to Arguments
In view of applicant’s amendments, the new rejections are made of record in the Final Office action below as necessitated by amendment.
Any rejection from the previous Office action not set forth on record below is hereby withdrawn.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-2, 16, 18-23, 25, and 30-39 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,497,740. Although the conflicting claims are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method for treating cancer in a subject in need thereof, the method consisting of administering to the subject a therapeutically effective amount of JIB-04 or GSK-J4, wherein the JIB-04 or GSK-J4 is administered as a monotherapy, wherein the cancer is non-small cell lung cancer, and wherein the non-small cell lung cancer is resistant to a cancer therapy. The instant claims are drawn to the same methods administering to the subject a therapeutically effective amount of JIB-04 or GSK-J4 derivates as recited in claims 1, 20 and 39. JIB-04 is recited as one of the derivates in the claimed methods, therefore the two inventions overlap in scope.
Thus, the invention is deemed anticipated in light of the patented 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 1-2, 16, 18-23, 25, and 30-39 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 claim(s) contains 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.
To be enabling, the specification of the patent 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 (Fed. Cir. 1993). Explaining what is meant by "undue experimentation," the Federal Circuit has stated: The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).1 The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors: 1) the nature of the invention 2) the state of the prior art 3) the relative skill of those in the art 4) the breadth of the claims 5) predictability of the art 6) the amount of direction or guidance provided 7) the presence or absence of working examples and 8) the quantity of experimentation necessary. These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
(1), (6), (7): The nature of the invention, the amount of direction or guidance provided, the presence or absence of working examples:
The claims are drawn to a method for treating cancer in a subject in need thereof, the method consisting of administering to the subject a therapeutically effective amount of an agent that inhibits a JmjC polypeptide, wherein the agent that inhibits a JmjC polypeptide comprises a JIB-04 or GSK-J4 derivative, wherein the JIB-04 or GSK-J4 derivative is administered as a monotherapy, wherein the cancer is non-small cell lung cancer. The specification does not demonstrate the inventors were in possession of the claimed therapeutic methods in its entirety at the time of filing. The specification demonstrates the methods of treatment as described employing JIB-04 or GSK-J4, however there is no mention of any of the derivatives as recited in the claims of the instant invention. The grouping includes compounds of the claimed invention that do not share a substantial structural feature, for example EJM1/EMI01, EJM1/EMI02, EBI02, INHE02, INHE03, INHE10, INHE23, and NSC693322 possess no structural commonality with either JIB-04 or GSK-J4 to be considered a derivative. If there is said commonality, no such evidence exists in the specification to support such a notion.
Applicant has not provided sufficient written description that would enable the skilled artisan to make and/or use the invention.
Conclusion
Claims 1-2, 16, 18-23, 25, and 30-39 are not allowed.
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 extension fee 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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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Sahar Javanmard whose telephone number is (571)270-3280. The examiner can normally be reached on Monday-Friday, 9:00-5:00 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/SAHAR JAVANMARD/Primary Examiner, Art Unit 1622