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 .
According to a preliminary amendment filed on July 9, 2024, the applicants have amended claims 2-19, 21-22 and 24-28.
Claims 1-28 are pending in the application.
Claim Rejections - 35 USC § 112
4. 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 16-28 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. The following eight different factors (see Ex parte Foreman, 230 USPQ at 547; Wands, In re, 858.F. 2d 731, 8 USPQ 2d 1400, Fed. Cir. 1988) must be considered in order for the specification to be enabling for what is being claimed:
Quantity of experimentation necessary, the amount of direction or guidance provided, presence or absence of working examples, the nature of the invention, the state of the prior art, the relative skill of those in the art, the predictability or unpredictability and the breadth of claims. In the instant case, the specification is not enabling based on atleast four of the above mentioned eight different factors such as quantity of experimentation necessary, the amount of direction or guidance provided, presence of working examples, state of the prior art, unpredictability and the breadth of claims.
There is no teaching in the instant specification or prior art for any specific mechanism of action (such as specific enzyme inhibition, specific receptor agonism/antagonism etc.) of the instant composition or closely related composition. There are no working examples present showing efficacy of the instant composition in animal models of any specific disease condition including all known inflammatory diseases, neurodegenerative diseases, bacterial diseases, viral diseases and autoimmune diseases. Therefore, in absence of such teachings, guidance, prior art and working examples, it would require undue experimentation to demonstrate efficacy of instant composition in animal models of all known inflammatory diseases, neurodegenerative diseases, bacterial diseases, viral diseases and autoimmune diseases in the art and hence their utility for treating but not preventing these disease conditions.
Regarding prevention, it is well known in the art that there are multiple mechanisms involved in the etiology of any disease condition. Therefore, correcting only one of these several mechanisms will not completely cure (prevent) that specific disease condition.
7. 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.
Claims 2-9 and 11-28 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
In claims 2-9, 11-15 and 20-25, the term - - characterized in that - - - is vague since its actual intent is not clear. The applicants are suggested to use the term - - - wherein - - -.
Claims 16-28 are directed to use of composition. However, it is not clear who is being treated or administered the composition? and furthermore, the steps of administration are also missing.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter: The instant composition of claim 1 and a process for preparing it is allowable over the prior art since it is neither disclosed nor obvious over the prior art. In the prior art, Geffard (US 2009/0318384 A1, cited on applicant’s form 1449) discloses compositions for dose 1 and dose 2 (see paragraphs 0083 and 0084 on page 3 as well as claims 6-17) which are related to the instant composition. However, the compositions of Geffard differ from the instant composition by lacking all the instant 15 ingredients. Furthermore, there is no teaching, suggestion or motivation in the prior art to modify the composition of Geffard to prepare the instant composition.
Claim 10 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARANJIT AULAKH whose telephone number is (571)272-0678. The examiner can normally be reached Monday-Friday 7:00-3:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARANJIT AULAKH/ Primary Examiner, Art Unit 1621
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