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 .
Priority
This application is a divisional of U.S. Application No. 17/255,349, filed December 22, 2020, which is a national phase application under 35 U.S.C. § 371 of International Application No. PCT/EP2019/068775 filed 12 July 2019, which claims priority to European Patent Application No. 18183435.9 filed 13 July 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 09/19/2024 and 05/13/2026 were filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Claims 1-5 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for some complexes comprising greater than 6 % by weight of the hypericin or the hypericin salt with respect to a total weight of the complex, does not reasonably provide enablement for all complexes comprising greater than 6 % by weight of the hypericin or the hypericin salt with respect to a total weight of the complex. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
The criteria for enablement set out in In re Wands, MPEP 2164.01(a), considers the following factors:
Breadth of the claims—Claim 1 encompasses complexes comprising greater than 6 % by weight of the hypericin or the hypericin salt with respect to a total weight of the complex. This includes complexes comprising amounts nearing 100 % by weight hypericin.
Level of skill in this art—The level of skill in the art is high.
State of the prior art—Kubin et al. (Pharmazie 63 (2008) 263-269) describes hypericin-PVP complexes comprising 0.6 % to 2.5 % by weight hypericin. See pp. 2-3 of the instant specification describing hypericin-PVP complexes in the prior art. The highest % by weight reported is 5% in WO 01/89576 A5.
Working examples—The specification (pp. 12-15) shows the production of hypericin-PVP complexes (Examples 1-2) compared to the production method of the prior art (Example 3). A precipitate is formed in Example 3 when additional hypericin is added, suggesting greater than 6 % hypericin as claimed is unexpected. Example 4 shows that a 40 % by weight hypericin complex is obtained from example 1.
Direction and Guidance—There is little additional guidance in the specification as to how high of a weight % of hypericin or hypericin salt thereof can be achieved.
Thus, while the specification has enabled some complexes comprising greater than 6 % by weight of the hypericin or the hypericin salt with respect to a total weight of the complex, does not reasonably provide enablement for all complexes comprising greater than 6 % by weight of the hypericin or the hypericin salt with respect to a total weight of the complex. Given that the prior art only teaches complexes with small weight % of hypericin up to 5% and that the methods employed by the prior art lead to precipitation at higher weight %, the prior instant claims drawn to higher % can be considered unexpected. Accordingly, a PHOSITA cannot reasonably consider higher % such as 80 % by weight hypericin to be enabled when only examples of 40 % by weight hypericin are shown.
Conclusion
Claims 1-5 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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