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 .
Claims 1, 4-6, 15, 19, 23, 25, 26, 29, 39, 40, 42, 43, 45, 49 and 50 are pending in this application.
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, 4-6, 15, 19, 23, 25, 26, 29, 39, 40, 42, 43, 45, 49 and 50 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 compounds and pharmaceutically acceptable salt forms, does not reasonably provide enablement for solvates. Solvates are pseudo polymorphs because they contain at least two types of compounds in the unit cell. When the unit cell contains the compound and water, we have a hydrate and if the unit cell contains the compound and a solvent, we have a solvate. 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 the invention commensurate in scope with these claims. The claims are drawn to compounds, pharmaceutically acceptable salts and solvates thereof. But the numerous examples presented all failed to produce a solvate. The type of solvent as well as the packing order of the solvate are neither set forth nor described in the specification. 35 U.S.C. 112(a) requires that an invention be described “in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same.” As was stated in Morton International Inc. v. Cardinal Chemical Co., 28 USPQ2d 1190 “The specification purports to teach, with over fifty examples, the preparation of the claimed compounds with the required connectivity. However, the district court found that even with the aid of sophisticated analytical instrumentation and the use of model systems which attempt to provide the compounds claimed, … there is no evidence that such compounds exist”. Hence, applicants must show that solvates can be made, or limit the claims accordingly.
Claims 1, 4-6, 15, 19, 23, 25, 26, 29, 39, 40, 42, 43, 45, 49 and 50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It is the Wands factors, which are used to evaluate the enablement question. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); 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.
The nature of the invention in the instant case, has claims which embrace compounds. The scope of “prodrug” is not adequately enabled. Applicants provide no guidance as how the compounds are made more active in vivo. The choice of a “prodrug” will vary from drug to drug. Therefore, more than minimal routine experimentation would be required to determine which prodrug will be suitable for the instant invention.
The instant compounds of formula (I) wherein the prodrugs are not described in the disclosure in such a way the one of ordinary skill in the art would know how to prepare the various compounds suggested by claims 1, 4-6, 15, 19, 23, 25, 26, 29, 39, 40, 42, 43, 45, 49 and 50. In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reactions, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention.
Claims 49 and 50 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. In evaluating the enablement question, several factors are to be considered. In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988); 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.
The nature of the instant invention has claims, which embrace substituted benzazepine compounds.
HOW TO USE: Claims 49 and 50 are drawn to the method of treating a disease, which is associated with Receptor-interacting protein-1 (RIP1) kinase activity. Any evidence presented must be commensurate in scope with the claims and must clearly demonstrate the effectiveness of the claimed compounds. 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 scope of claims 49 and 50 includes diseases and/or conditions not even known at this time, which may be associated with Receptor-interacting protein-1 (RIP1) kinase activity. While the treatment of psoriasis and ulcerative colitis has been linked with Receptor-interacting protein-1 (RIP1) kinase the art does not recognize use of such inhibitors as broad-based drugs for treating all disorders instantly embraced.
In view of the lack of direction provided in the specification regarding starting materials, the lack of working examples, and the general unpredictability of chemical reaction, it would take an undue amount of experimentation for one skilled in the art to make the claimed compounds and therefore practice the invention. To be enabling, the specification of a patent must teach those skilled in the art how to make and use the scope of the claimed invention without undue experimentation. The applicants are not entitled to preempt the efforts of others.
The test for determining compliance with 35 U.S.C. § 112, is whether the applicants have clearly defined their invention.
Where the utility is unusual or difficult to treat or speculative, the examiner has authority to require evidence that tests relied upon are reasonably predictive of in vivo efficacy by those skilled in the art. See In re Ruskin, 148 USPQ 221; Ex parte Jovanovics, 211 USPQ 907; MPEP 2164.05(a).
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 42 USPQ2d 1001.
As stated in the MPEP, 2164.08 "[t]he Federal Circuit has repeatedly held that the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 27 USPQ2d 1510, 1513 (Fed. Cir. 1993). Nevertheless, not everything necessary to practice the invention need be disclosed. In fact, what is well known is best omitted. In re Buchner, 929 F.2d 660, 661, 18 USPQ2d 1331, 1332 (Fed. Cir. 1991). All that is necessary is that one skilled in the art be able to practice the claimed invention, given the level of knowledge and skill in the art. Further the scope of enablement must only bear a reasonable correlation to the scope of the claims. See, e.g., In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). As concerns the breadth of a claim relevant to enablement, the only relevant concern should be whether the scope of enablement provided to one skilled in the art by the disclosure is commensurate with the scope of protection sought by the claims. In re Moore, 439 F.2d 1232, 1236, 169 USPQ 236, 239 (CCPA 1971). See also Plant Genetic Sys., N.V. V. DeKalb Genetics Corp., 315 F.3d 1335, 1339, 65 USPQ2d 1452, 1455 (Fed. Cir. 2003) (alleged pioneer status of invention irrelevant to enablement determination."
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 4-6, 15, 19, 23, 25, 26, 29, 39, 40, 42, 43, 45, 49 and 50 are 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 following reasons apply:
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the substitution on R1a, R1b, and R1c where hydrogen, halogen, -CN, -N3, -NO2, -OH, -SF5 and -SCF3 are “each …optionally and independently substituted with one to eight R5.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the definition of R4c where there is no R⁴c in Formula (I).
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the substitution on R5 where halogen, -CN, -OH, -SF5 and -SCF3 are “each of which is optionally substituted with one to eight R5c.
Claim 1 and claims dependent thereon are vague and indefinite in that it is not known what is meant by the substitution on R7 where hydrogen, halogen -CN, -N3, -NO2, -SF5 and -SCF3 are “each of which is optionally and independently substituted with one to eight R8.
Claim 15 recites the limitation "Br, Cl" in the definition of W4. There is insufficient antecedent basis for this limitation in the claim.
Claim 23 is vague and indefinite in that it is not known what is meant by the substitution on R1a where hydrogen is substituted “each of which is optionally substituted with halogen and -CN.
Claim 23 is vague and indefinite in that it is not known what is meant by “or (b) chloro, fluoro, methyl, ethyl, difluoromethyl, fluoromethyl, cyano, or hydroxyl”.
Claim 25 recites the limitation "f-fluoropyrimidin-2-ylsulfanyl" in the definition of R1a, R1b, and R1c. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 is vague and indefinite in that it is not known what is meant by the second occurrence of C1-8 haloalkyl in the definition of R5.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDA L COLEMAN whose telephone number is (571)272-0665. The examiner can normally be reached Mon-Fri 10-6 (flex).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached on 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDA L COLEMAN/Primary Examiner, Art Unit 1624
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