DETAILED ACTION
This action is in response to Applicant’s submission dated August 20, 2024, in which Applicant amended the specification, canceled claims 2-127, and added new claims 128-153.
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 May 20, 2024 are made of record.
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.
Claims 1, 128-147, 150, and 153 are rejected under 35 U.S.C. 112(a) because the specification, while being enabling for a compound according to Formula (A) in claim 1 limited to “Compound 1”, it does not reasonably provide enablement for a compound having the structure in claim 1 outside the scope of “Compound 1” (any of the other variables listed in claim 1).
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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 or use the invention commensurate in scope with these claims.
Undue experimentation is a conclusion reached by weighing the noted factual considerations set forth below as seen in In re Wands, 858 F.2d 731, 737, 8 USPQ2d 1400, 1404 (Fed. Cir. 1988). A conclusion of lack of enablement means that, based on the evidence regarding a fair evaluation of an appropriate combination of the factors below, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation.
These factors include:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
The breadth of the claims - The nature of the invention
The currently pending invention is drawn to compounds and a composition according to Formula (A), wherein the definitions of W, D, J, K, Ring A, Ring B, L, R, m, n, p, & X1-X5 are defined therein. Compounds according to this formula are useful for treating or preventing a disease in a subject in need thereof.
The state of the prior art
A review of the literature provided by Applicant in the Information Disclosure Statement (IDS) and the CAS structure search results suggest that the state of the prior art is more advanced for species “Compound 1” whereas no species have been described outside of “Compound 1” of Formula (A) in claim 1.
The level of predictability in the art
The synthesis of complex natural products is an integral part of modern organic chemistry, however, even the synthesis of molecules or molecular fragments containing ten carbons or less can also pose great challenges. Examination of many synthetic endeavors, large and small, reveals that formation of the carbon skeleton by carbon-carbon bond forming reactions requires the most strategic planning. The largest number of actual chemical reactions in a synthesis, however, usually involves manipulation of functional groups (Smith, M. B. Organic Synthesis, McGraw-Hill, Inc. 1994, Chapter 1). The functional group substitution of the many possibilities for Formula (A) changes the necessary starting materials for making these compounds as well as the predictability of their chemical reactivity. The functional group difference influences the bond length, electronegativity, and therefore the localization of electrons with respect to the functionality, which results in a lack of said predictability in their preparation. The art is silent with regard to the predictability of any compound as set forth by Formula (A) with respect to its preparation, isolation, and use for treatments and a change in Formula (A) would not only affect the chemical properties of the reagents for producing the desired products, but inherently also affects the desired biological properties for this class of compounds. Therefore, it is unpredictable to know, from the outlined methods in the instant specification, how to make and use all of the compounds claimed in the Formula (A).
The amount of direction provided by Applicant
The instant specification is not seen to provide adequate guidance, which would allow the skilled artisan to extrapolate from the disclosure and examples provided, to use the claimed invention commensurate in the scope with the instant claims. There is a lack of information pertaining to the synthesis of all compounds according to Formula (A) outside that of “Compound 1” of the specification. The direction provided does not adequately represent the scope of claim 1 as written. Examiner points out that all of the compounds in the schemes and as well as the synthetic procedures described in the specification provide guidance to the invention only for the synthesis of “Compound 1”.
The existence of working examples
The working examples set forth in the instant specification are directed to the compounds of the formula (A) for “Compound 1” only. There has not been provided sufficient evidence that would warrant the skilled artisan to accept the data and information provided in the working examples as correlative proof that any compound of formula (A) other than “Compound 1” would indeed be able to be synthesized and used by means of the methods outlined in the specification.
The quantity of experimentation needed to make and use the invention
In view of the information set forth supra, the instant disclosure is not seen to be sufficient to enable the preparation of any compound of Formula (A) as defined other than “Compound 1”. A person skilled in the art could not use the entire scope of the claimed invention without undue experimentation. Undue experimentation would include, for instance: the preparation of multiple synthetic outlines for each of the different definitions of W, D, J, K, Ring A, Ring B, L, R, m, n, p, & X1-X5; the preparation of the necessary starting materials required for each of the compounds according to the Formula (A), followed by attempts to prepare a desired product for each of the different functional groups, subsequently followed by isolation, characterization, and testing the various compounds to determine if indeed they had utility for the treatment of various diseases.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 151-153 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Robbins, et al, WO 2020/081450 by Nurix Therapeutics, which published on April 23, 2020 (more than a year of the priority date of July 14, 2021 for the instant application). Robbins, et al. teaches bifunctional compounds for degrading BTK via ubiquitin proteosome pathway, which include instant compounds. Specifically, the compounds with the structure:
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and
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of the reference anticipates the aforementioned claims and are called compound 14 and compound 18, respectively, in claim 151. The references compounds exhibit the same activity as the compounds of the instant claims.
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 nonobviousness.
Claims 148-153 are rejected under 35 U.S.C. 103 as being rendered obvious by Robbins, et al, WO 2020/081450 by Nurix Therapeutics, see supra.
Determining the scope and contents of the prior art.
Specifically, the compounds: and
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,
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, and
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which Applicant calls compounds 9, 16, and 17, respectively, in claim 151. The references compounds exhibit the same activity as the compounds of the instant claims.
Ascertaining the difference between the prior art and the claims at issue.
The reference differs from the claims at issue in that they are stereoisomers of one another. “Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds … a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (e.g., ortho v. para).” In re Deuel 34 USPQ2d 1210, 1214. See also MPEP 2144.09, second paragraph. Here, the former geometric isomers (cis v. trans) applies.
Resolving the level of skill in the art.
The Court has addressed this obviousness issue: “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 12 (2007). “When there is a design need or market pressure to solve a problem and there are finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, … the fact that a combination was obvious to try might show that it was obvious”. Id. at 17. That is exactly the case here. The scope of geometric isomers is a very finite list (2) and Applicant was not left to pick and choose from a generic disclosure which compound(s) should be tested.
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