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 .
Election/Restrictions
Applicant's election with traverse of Group II in the reply filed on 11/5/25 is acknowledged. The traversal is on the ground(s) that there is no lack of unity. This is not found persuasive because the amended claims contain the same special inventive concept as amended.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1, 4-5, 13-16 & (new claim) 21 read on the elected invention. The claim are examined only as they read on the elected invention, i.e. “administering CST1 protein” as SEQ ID No 1.
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, 4-5, 13-16, and 21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification does not reasonably provide enablement for treating a liver immune disorder. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to enable the invention commensurate in scope with these claims.
Applicant claims a liver immune disorder by administering CST1 protein. The claimed invention cannot be considered to be enabled given the limited showing in the specification. In re Wands, 8 USPQ2d, 1400 (CAFC 1988) stated that the factors to be considered in determining whether a disclosure would require undue experimentation include the quantity of experimentation necessary, the amount of direction or guidance presented, the 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 of the art and the breadth of the claims.
First there is no clear reduction to practice of the claimed invention as no disclosed embodiment appear to have actually treated “a liver immune disorder” in the indicated patients. Applicant has induced acute liver failure in rats (page 33) by administering D-GalN but does not show and actual results where the administration of a CST1 protein actually demonstrates any treatment. Applicant’s assertion that “a liver immune disorder” can be treated in the claimed manner is not enabled by the specification as filed. "Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable .... Tossing out the mere germ of an idea does not constitute enabling disclosure." Genentech Inc. v. Novo Nordisk A/S , 108 F.3d 1361, 1366, 42 USPQ2d 1001, 1005 (Fed. Cir. 1997).
Applicant does not define “a liver immune disorder” in the specification other than to indicate that “acute liver failure” is “a liver immune disorder.” It would seem unconventional to definite acute liver failure particularly D-GalN-induced acute liver failure in a rat and the plain meaning of “a liver immune disorder” would encompass a
much broader spectrum of disorders as suggested at least by Grunebaum “Liver-associated immune abnormalities” so it is apparent that the scope of treating “a liver immune disorder” is not enabled by the instant specification especially in that applicant may intend the scope of this limitation to include liver disorders not conventionally labelled as “immune disorders.”
It has even been suggested in the art that the CST1 (also known as cystatin) may be a causative agent in some liver disorders as Markwardt et al (Hepatology Vol 66 No 4 pp1232-1241) discloses that the presence of cystatin is associated with liver cirrhosis and acute-on-chronic liver failure therefore making it very unpredictable to determine what liver disorders (immune related or otherwise) could actually be treated by administering the CST1 protein.
In re Fisher, 427 F.2d 833, 166 USPQ 18 (CCPA 1970), held that "Inventor should be allowed to dominate future patentable inventions of others where those inventions were based in some way on his teachings, since such improvements while unobvious from his teachings, are still within his contribution, since improvement was made possible by his work; however, he must not be permitted to achieve this dominance by claims which are insufficiently supported and, hence, not in compliance with first paragraph of 35 U.S.C. 112; that paragraph requires that scope of claims must bear a reasonable correlation to scope of enablement provided by specification to persons of ordinary skill in the art; in cases involving predictable factors, such as mechanical or electrical elements, a single embodiment provides broad enablement in the sense that, once imagined, other embodiments can be made without difficulty and their performance characteristics predicted by resort to known scientific law; in cases involving unpredictable factors, such as most chemical reactions and physiological activity, scope of enablement varies inversely with degree of unpredictability of factors involved."
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/BLAINE LANKFORD/Primary Examiner, Art Unit 1657