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 1-21 are currently pending in the application.
Information Disclosure Statement
Receipt is acknowledged of Information Disclosure Statement (IDS), filed on 11/19/2024, which has been entered in the file.
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 1-21 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 expressions a method for treating “preventing” --------- a “tauopathy” (claim 1, lines 1-2, page 3, and all other occurrences of claims 1-21, if any) and a small molecule “peptidomimetic” (claim 1, line 3, page 3, and all other occurrences of claims 1-21, if any), which broaden the enabling disclosure because it is unclear what kind of “tauopathy” and “peptidomimetic” the Applicant is intending to encompass with these broad expressions, since any “tauopathy” [Tauopathies are a class of heterogeneous neurodegenerative diseases characterized by the neuronal and glial aggregation of abnormal tau protein, Wikipedia, (2026)] and “peptidomimetic” [Peptidomimetics are small protein-like chain designed to mimic a peptide can be grouped into four classes A-D, Wikipedia, (2026)] may fall within the broad definition of diseases / compound class. The above expressions, which are not described in such a way as to satisfy the statutory requirements within the purview of 35 U.S.C. 112 first paragraph and therefore, the specification fails to provide sufficient support to treat all the wide range of ‘tauopathy’, by administering to the subject, comprising a therapeutically effective amount of a small molecule ‘peptidomimetic’ thereof. The type or mode of action and functionality (structure / function relationship) of preventable or treatable ‘tauopathy’ 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 recitations a method for treating “preventing” --------- a “tauopathy” and “peptidomimetic”, which are 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 small molecule ‘peptidomimetic’ compound would be predicted to be able to prevent, delay or treat the progression of diverse “tauopathy”, as claimed in the instant application. Based on the unpredictable nature of the invention and state of the prior art (US 2021/0023062 A1 and WO 2019/118878-A1, 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 1-21 to treat all kinds of ‘tauopathy’, wherein the method comprising administering to the subject, a therapeutically effective amount of a small molecule ‘peptidomimetic’ thereof. Therefore, it is suggested to amend the claims within the context and scope of the claims [such as, deleting the word “preventing” and limiting with specific type of ‘tauopathy’ treated with a small molecule ‘peptidomimetic’ that actually contemplated in the specification (e.g., incorporating the limitations of claims 2 and 5 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 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. § 112 (b) or 35 U.S.C. § 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention. The expression “e.g.” (claim 18, line 4, page 5 and all other occurrences of claims 1-21, if any), renders the claim indefinite because it is unclear whether the limitation following the phrase is part of the claimed invention. See MPEP § 2173.05 (d) and therefore, it is not possible to ascertain the metes and bounds of the claimed subject matter. The use of expressions “e.g.” in the middle of the claim also may lead to confusion over the intended scope of the claim. It is suggested that the expression “e.g.” be deleted or amend the claim within the context and scope of the claim 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.
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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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