DETAILED ACTION
This action is in response to Applicant’s submission dated February 28, 2023, in which Applicant amended the specification and claims 1-6.
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 .
Information Disclosure Statement
The references contained in the IDS dated February 28, 2023 are made of record.
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.
Claims 1-7 are rejected under 35 U.S.C. 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention. Claims 1-7 provides for the use “of a sesquiterpene lactone compound … for the treatment of optic neuritis”, but, since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or non-obviousness.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over CN 111494366 A.
Determining the scope and contents of the prior art.
CN 111494366 A teaches that dimethylaminomicheliolide (DMAMCL) can reduce the levels of inflammatory cytokines such as IL-6 and TNF-α and inhibit the activity of NF-κB, and can further inhibit an LPS-induced neuroinflammatory response in microglial cells and mouse models by means of inhibiting the activity of NF-κB (see specification, paragraphs [0012] and [0070]). The chemical structural formula of DMAMCL as shown in figure 1A is the sesquiterpene lactone compound in the present application.
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities.
An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties.
In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See also In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2dI 1897 (Fed. Cir. 1991)(discussed in MPEP § 2144) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. See also MPEP § 2144.08, paragraph II.A.4.(c).
Ascertaining the difference between the prior art and the claims at issue.
CN 111494366 A while being the closest prior art, does not teach; however, the subject matter of the instant claims. The difference between instant claim 1 the reference lies in that claim 1 sets forth the use of a sesquiterpene lactone compound in the preparation of a drug for treating optic neuritis, whereas CN 111494366 teaches the use of said compound in the treatment of neuroinflammation. On the basis that CN 111494366 teaches that DMAMCL can reduce the levels of inflammatory cytokines such as IL-6 and TNF-α and can be used to treat neuroinflammation; however, a person skilled in the art would have been motivated to use the compound DMAMCL in the treatment of specific inflammations associated with the optic nerve and prepare the same into a pharmaceutical form.
On the basis of the disclosure of CN 111494366 A, it would also have been conceivable to a person skilled in the art to use the compound in the treatment of specific neuromyelitis optica, and the effect thereof can also be reasonably expected. CN 111494366 A also teaches that DMAMCL is equivalent to “a michelolide derivative” and a pharmaceutically acceptable adjuvant are prepared into a pharmaceutical agent, which is a liquid agent, a gas agent, a solid dosage form or semi-solid agent, or an injection, a granule and an oral liquid (see specification, paragraphs [0007] and [0011]).
Resolving the level of skill in the art.
It would have been obvious at the time the invention was made to use the disclosure of CN 111494366 A to arrive at the present invention as instantly claimed. Since Applicant’s claims are prima facie obvious in view of the teachings of CN 111494366 A, Applicant’s claims are rejected under 35 U.S.C. § 103.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to ERICH A LEESER whose telephone number is (571) 272-9932. The Examiner can normally be reached Monday through Friday from 10-6 PST, M-F. PST.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Mr. James Alstrum-Acevedo can be reached at (571) 272-5548. The fax number for the organization where this application is assigned is 571-273-8300.
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/ERICH A LEESER/Primary Examiner, Art Unit 1622
United States Patent and Trademark Office
Tel. No.: (571) 272-9932