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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404
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, is acknowledged.
Status of Claims
Claims 1-20 are currently pending in the application.
Receipt is acknowledged of amendment / response filed on 05/05/2026 and that has been entered.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 02/21/2025, 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 1-11] drawn to a method of treating cancer-associated thrombosis and cancer in a patient in need of treatment thereof, the method comprising administering to the patient a therapeutically effective amount of an extracellular thiol isomerase inhibitor compound, without traverse, is acknowledged.
Claims 12-20 are withdrawn from further consideration pursuant to 37 C.F.R. 1.142 (b) as being drawn to a non-elected subject matter.
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 1-11 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 --------- “cancer” (claim 1, line 1, page 1, and all other occurrences of claims 1-11, 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 patient a therapeutically effective amount of an extracellular thiol isomerase inhibitor compound thereof. The type or mode of action and functionality (structure / function relationship) of preventable or treatable ‘cancer’ is not defined in the claims or anywhere in the specification so as to ascertain the scope and breadth of the claimed subject matter.
The recitation a method of treating “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 compound 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 (WO 99/25338; WO 99/32082, IDS) 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 1-11 to treat all kinds of cancers, wherein the method comprising administering to the patient a therapeutically effective amount of an extracellular thiol isomerase inhibitor compound and 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 claim 10 into claim 1) and that have enough support] in order to overcome the rejection.
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1-11 are rejected under the judicially created doctrine of obviousness-type double patenting, as being unpatentable over claims 1-11 of US 11,872,210 (US ‘210) and if allowed, would improperly extend the “right to exclude” already granted in the patent. Although the conflicting claims are not identical, they are not patentably distinct from each other because both sets of claims are drawn to the same art recognized subject matter. A reference anticipating one set of claim will render the other obvious and it would have been obvious to a person having ordinary skill in the art to which the claimed invention pertains, before the effective filing date of the claimed invention, since US ‘210 patent teaches the generic thiol isomerases inhibitors and the method of uses thereof (e.g., for treating thrombosis or a thrombotic disease), which are similar to the instantly claimed inventions. The subject matter claimed in the instant application is fully disclosed and covered in US ‘210 patent. Therefore, the disclosure of US ‘210 patent that teaches all the essential elements, components and /or reagents [including administering to a patient a therapeutically effective amount of an extracellular thiol isomerase inhibitor compound, wherein the extracellular thiol isomerase inhibitor compound is zafirlukast for the treatment of thrombosis or a thrombotic disease etc. see US ‘210, column 16, claim 1], which would easily place Applicant’s invention in possession of the public before the effective filing date of the claimed invention. Therefore, in the instant case, one skilled in the pharmaceutical / chemical art would be motivated to prepare a similar treatment protocol for treating cancer-associated thrombosis and cancer in a patient in need of treatment thereof in view of the known teaching of the art. The claimed compositions and their method of uses are so closely related functionally and methodically to the homologous and /or analogous compositions of the reference as to be functionally and methodically obvious, therefore in the absence of any un-obviousness or unexpected properties. Moreover, any other differences are but obvious chemical or pharmaceutical modifications, which would be apparent to one skilled in the chemical art that can use similar treatment protocol would expect to have the same or essentially the same results and therefore, is obvious, absent evidence to the contrary.
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
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