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 19-38 are currently pending in the application. Claims 1-18 were canceled.
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 19-38 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 Bruton’s tyrosine kinase “BTK inhibitor” (claim 19, line 2, page 4, and all other occurrences, if any) is broad because it is not clear what kind of ‘BTK inhibitor’ [such as, First generation (ibrutinib), Second generation (acalabrutinib and Zanubrutinib) and Third generation (pirtobrutinib) etc.] the Applicant is intending to encompass with this broad expression [since, there are several different BTK inhibitors approved by the Food and Drug Administration (FDA) and uses for these medications may differ and any ‘BTK inhibitor’ may fall within the broad definition of ‘BTK 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 ‘BTK inhibitor’ either be limited to the specific ‘BTK inhibitor’ that actually contemplated in the specification (such as, incorporating the limitations of claim 29 into claim 19) 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
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