17430703DETAILED 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
Claims 1-11 submitted 2024 February 2 are examined on the merits.
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 5-11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification is enabling for alleviating colorectal cancer with a composition comprising (E)-N-hydroxy-3-[1-(phenylsulfonyl)indolin-5-yl)-acrylamide and anti-[PD-1 or PD-L1]-antibody and non-enabling for preventing colorectal cancer with a composition comprising (E)-N-hydroxy-3-[1-(phenylsulfonyl)indolin-5-yl)-acrylamide and anti-[PD-1 or PD-L1]-antibody. 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/or use the invention commensurate in scope with these claims.
The factors to be considered in determining whether a disclosure meets the enablement requirements of 35 U.S.C. 112, first paragraph, have been described in In re Wands, 858 F.2d 731, 8 USPQ2d 1400 (Fed. Cir., 1988). The court in Wands states, “Enablement is not precluded by the necessity for some experimentation, such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is ‘undue’, not ‘experimentation’” (Wands, 8 USPQ2sd 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. “Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations” (Wands, 8 USPQ2d 1404). Among these factors are: (1) the nature of the invention; (2) the breadth of the claims; (3) the state of the prior art; (4) the predictability or unpredictability of the art; (5) the relative skill of those in the art; (6) the amount of direction or guidance presented; (7) the presence or absence of working examples; and (8) the quantity of experimentation necessary.
Consideration of the relevant factors sufficient to establish a prima facie case for lack of enablement is set forth herein below:
The nature of the invention and (2) the breadth of the claims:
The claims are drawn to treating colorectal cancer with a pharmaceutical kit comprising (E)-N-hydroxy-3-[1-(phenylsulfonyl)indolin-5-yl)-acrylamide and anti-[PD-1 or PD-L1]-antibody. The definition of treatment includes both alleviation and prevention (pages 8-9, paragraph [0032]. Thus, the claims taken together with the specification imply a composition comprising (E)-N-hydroxy-3-[1-(phenylsulfonyl)indolin-5-yl)-acrylamide and anti-[PD-1 or PD-L1]-antibody alleviate or prevent colorectal cancer.
The state of the prior art and (4) the predictability or unpredictability of the art:
KANTH (British Medical Journal, 2021, 374: n1855, 1-15) describes that prevention of colin cancer requires more research (page 10, column 2, paragraph 2o to page 11, column 1, paragraph 1).
The relative skill of those in the art:
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in colon cancer prevention).
The amount of direction or guidance presented and the presence or absence of working examples:
The specification has provided guidance for amelioration of colorectal cancer (page 23, paragraph [0074] to page 28, paragraph [0092]).
The specification does not provide guidance for the prevention of colon cancer.
The quantity of experimentation necessary:
Considering the state of the art as discussed by the references above, particularly with regards to prevention of colorectal cancer and the high unpredictability in the art as evidenced therein, and the lack of guidance provided in the specification, one of ordinary skill in the art would be burdened with undue experimentation to practice the invention commensurate in the scope of the claims.
Allowable Subject Matter
Claims 1-4 are allowed and 5-11 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: LIN (WO 2017/074317, published 2017 May 4) describes a composition of (E)-N-hydroxy-3-[1-(phenylsulfonyl)indolin-5-yl)-acrylamide and an antibody (page 9, paragraph [0036]; page 10, paragraph [0042]). None of the antibodies are anti-[PD-1 or PD-L1].
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699