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 .
Claim Rejections - 35 USC § 112
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claim is inconsistent because “the pharmaceutically acceptable salt” lacks antecedent basis. Appropriate correction to insert the phrase “or a pharmaceutically acceptable salt” following the compound name consistent as in claim 1 overcomes this rejection.
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 1-14 and 17 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 treating rheumatoid arthritis or plaque psoriasis, does not reasonably provide enablement for treating an autoimmune disease or inflammatory disease generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The specification does not enable any physician skilled in the art of medicine to use the invention commensurate in scope with these claims. The factors to be considered in making an enablement rejection have been summarized below.
In evaluating the enablement question, several factors are to be considered. Note In re Wands, 8 USPQ2d 1400 and Ex parte Forman, 230 USPQ 546. The factors include: 1) The nature of the invention, 2) the state of the prior art, 3) the predictability or lack thereof in the art, 4) the amount of direction or guidance present, 5) the presence or absence of working examples, 6) the breadth of the claims, and 7) the quantity of experimentation needed.
1) The nature of the invention: The claims are drawn to treating an autoimmune disease or inflammatory disease generally.
2) The state of the prior art: The treatment of “autoimmune diseases” generally would be unprecedented feat. For a compound to be effective against “autoimmune diseases” generally is contrary to medical science. The “autoimmune diseases” are a process that can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. There are hundreds of such diseases, which have fundamentally different mechanisms and different underlying causes. There are both chronic and acute “autoimmune diseases,” most of which lack satisfactory treatment. The intractability of these disorders is clear evidence that the skill level in this art is low relative to the difficulty of the task. Under such circumstances, it is proper for the PTO to require evidence that such an unprecedented feat has been accomplished, In re Ferens, 163 USPQ 609. No such evidence has been presented in this case. The failure of skilled scientists to achieve a goal is substantial evidence that achieving such a goal is beyond the skill of practitioners in that art, Genentech vs Novo Nordisk, 42 USPQ2nd 1001, 1006.
Similarly, inflammation is a process that can take place in virtually any part of the body. There is a vast range of forms that it can take, causes for the problem, and biochemical pathways that mediate the inflammatory reaction. There is no common mechanism by which all, or even most, inflammations arise. Mediators include bradykinin, serotonin, C3a, C5a, histamine, leukotrienes, cytokines, and many, many others. Accordingly, treatments for inflammation are normally tailored to the particular type of inflammation present, as there is no, and there can be no “magic bullet” against inflammation generally.
3) The predictability or lack thereof in the art: Applicants have not provided any competent evidence or disclosed tests that are highly predictive for the pharmaceutical use for treating any or all condition of the instant compound. Pharmacological activity in general is a very unpredictable area. Note that in cases involving physiological activity such as the instant case, “the scope of enablement obviously varies inversely with the degree of unpredictability of the factors involved.” See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). RIP1 inhibitors are unpredictable and are still exploratory and the state of the art is of inhibiting RIP1 is unpredictable.
4) The amount of direction or guidance present and 5) the presence or absence of working examples: The specification has working examples to show treating rheumatoid arthritis and plaque psoriasis for which the claims are enabled.
6) The breadth of the claims: The instant claims embrace treating any and all autoimmune and inflammatory diseases including those yet to be related to RIP1.
7) The quantity of experimentation needed would be an undue burden to one skilled in the pharmaceutical arts since there is inadequate guidance given to the skilled artisan, regarding the pharmaceutical use, for the reasons stated above.
Thus, factors such as “sufficient working examples”, “the level of skill in the art” and “predictability”, etc. have been demonstrated to be sufficiently lacking in the instant case for the instant method claims. In view of the breadth of the claims, the chemical nature of the invention, the unpredictability of enzyme-inhibitor interactions in general, and the lack of working examples regarding the activity of the claimed compounds towards treating the variety of diseases of the instant claims, one having ordinary skill in the art would have to undergo an undue amount of experimentation to use the instantly claimed invention commensurate in scope with the claims. RIP1 inhibitors are not presently art-recognized to be efficacious for this purpose. Thus, the skilled clinicians would not know how to use them to treat an autoimmune disease or inflammatory disease generally.
Case law is clear on this point. In an unpredictable art, such as an autoimmune disease or inflammatory disease therapy, models may be used for enablement only if there is a well-established correlation between the assay and clinical efficacy.
MPEP §2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, 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. In re Wright, 999 F.2d 1557,1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here, and undue experimentation will be required to practice Applicants’ invention.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Masuda et al. (US 10,815,206). The reference teaches the compound (S)-5-benzyl-N-(7-(3-hydroxy-3- methylbut-1-yn-1-yl)-5-methyl-4-oxo-2,3,4,5-tetrahydrobenzo [b] [1,4] oxazepin-3-yl)-1H-1,2,4- triazole-3-carboxamide its corresponding pharmaceutical composition and method of using the same. (See also Zhou et al. (US 12,065,447) which teaches the same). The claims differ by requiring a dose of about 12.5 mg to about 125 mg free base equivalent of said compound. However, arriving at a certain dosage is routine in the art where a compound, composition and method of use are known. Therefore, one skilled in the art would be motivated to formulate the compound into dosage forms and arrive at the instant claims because the reference teaches that an effective amount of the compound is needed to treat the diseases.
Claims 18-20 are directed to pharmaceutical compositions comprising the compound and a polymer. However, similar to the rejection above, the reference teaches pharmaceutical compositions comprising pharmaceutically acceptable carriers. Therefore, one skilled in the art would be motivated to select any carrier, including those instantly claimed and arrive at the instant claims because the skilled artisan knows to combine the compound with carriers to formulate a pharmaceutical composition.
Thus, the difference between the prior art and the instant claims is dosage amount, and, in claims 18-20, using a polymer as a carrier. Optimization of dosage and pharmaceutical compositions is an obvious step to one skilled in the art where the active compound and use thereof have been disclosed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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August 20, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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