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 .
DETAILED ACTION
STATUS OF THE CLAIMS: Claims 72-92 are pending in this application.
Claim Rejections - 35 USC § 112, first paragraph
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 72-92 (including claims dependent thereon and claims that relate back to the independent claims) 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.
Claim 72 is rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for specific compounds disclosed in the specification, does not reasonably provide enablement for hydrates, tautomers and solvates of those compounds and composition containing same. 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 use the invention commensurate in scope with these claims.
Claims 72-92 are rejected because the claims recite specific compounds and hydrates, tautomers and solvates of said compounds. However, the specification fails to teach the preparation or identity of hydrates, tautomers and solvates. Therefore, the specification is not adequately enabled for making and/or using hydrates, tautomers and solvates.
Identifying hydrates, tautomers and solvates requires knowledge of in vivo regeneration pathways of instant compounds and short of extensive experimentation, would be the skilled artisan would need much more data to determine prodrugs of the instant compounds and compositions.
Applicants have not provided any clear guidance that would provide hydrates, tautomers and solvates of the instant compounds that will regenerate in vivo to the instant compounds by one or more biological processes or methods for preparing prodrugs. It is not the norm that one can predict with any accuracy whether a particular ester form of an active compound will be more soluble, more easily handled in formulations or more bioavailable without art recognized data to support same. The specification provides no guidance as to what type(s) of hydrates, tautomers and solvates are suitable for the instant compounds. Generally, hydrates, tautomers and solvates themselves are not considered to be therapeutically active but only to provide the active compound in vivo.
For rejections under 35 U.S.C. 112, first paragraph, the following factors must be considered (In re Wands, 8 USPQ2d 1400, 1404 (CAFC, 1988)):
1) Nature of invention.
2) State of prior art.
3) Quantity of experimentation needed
4) Level of predictability in the art.
5) Amount of direction and guidance provided by the inventor.
6) Existence of working examples.
7) Breadth of claims.
8) Level of ordinary skill in the art.
Nature of the invention
The nature of the invention is the method comprising compounds of structural of Formula I. As stated, however, hydrates, tautomers and solvates are also intended. The nature of hydrates, tautomers and solvates is not set forth nor is the manner in which the hydrates, tautomers and solvates are to be prepared or the core compounds modified.
State of the prior art
The state of the prior art is that hydrates, tautomers and solvates are known in the pharmaceutical industry. Hydrates, tautomers and solvates in related compounds are not modified.
Quantity of experimentation needed
The quantity of experimentation needed is undue. The skilled artisan would need to regenerate in vivo the instant compounds by one or more biological processes. All of which require undue experimentation. Applicant has not postulated a metabolic pathway or mechanism, which facilitate conversion of the hydrates, tautomers and solvates into an active agent.
Level of predictability in the art
The art pertaining to the preparation and use of hydrates, tautomers and solvates is high as hydrates, tautomers and solvates are compound specific and not all hydrates, tautomers and solvates have the ability to regenerate in vivo. (See “Wolff, M.E., “Burger’s Medicinal Chemistry”, pp. 975-977, and Banker et al., “Modern Pharmaceuticals”, p. 596).
Amount of direction and guidance provided by the inventor
There is no guidance provided as all the examples in the specification are drawn to the preparation of compounds disclosed in the specification and not to hydrates and solvates. The lack of guidance to prepare any solvates and hydrates is not provided by the inventor.
Existence of working examples
As discussed above, working examples are drawn to the preparation of compounds disclosed in the specification and not to hydrates, tautomers and solvates. The lack of guidance to prepare any hydrates, tautomers and solvates is telling. There is no direction or guidance provided by Applicant to prepare hydrates, tautomers and solvates of the instant invention.
Breadth of claims
The breath of the recited compounds and compositions in the claims includes hydrates, tautomers and solvates for which there have been provided no specific examples or procedural steps to prepare hydrates, tautomers and solvates. Failure to teach how to make the instant compounds makes teaching how to use the compounds unduly difficult, if not impossible.
Level of ordinary skill in the art
The level of ordinary skill in the art is high due to the unpredictability in the chemical art.
Hence, as discussed above, to practice the claimed invention herein, a person of ordinary skill in the art would have to engage in undue experimentation to test which hydrates, tautomers and solvates can be used in the instant claim, with no assurance of success. Therefore, applicant must show that the specification teach the preparation of hydrates, tautomers and solvates, or limit the claims accordingly.
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 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 72-92 are rejected under 35 U.S.C. 103 as being unpatentable over Schafer et al. (US Pub. 2014/0343058).
Applicants claim a method for treating systemic lupus erythematosus comprising:
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Schafer teaches a similar method for treating systemic lupus erythematosus. (See Abstract, pages 1-6, pages 18-19 and Examples).
Schafer does not teach the dose of the treatment compound to be 0.45 mg or higher per day or 0.15 mg or lower per day, where the subject has a high type 1 IFN gene expression or gene signature.
It would have been obvious to one having ordinary skill in the art at the time of the invention to determine the dosage based on the 1 IFN gene expression rather than genetic polymorphism used by Schafer because measuring gene expression levels is inherent in the process of pharmacogenomic screening, which optimizes the dose based on genetic analysis. Additionally, it would have been further obvious to score the value relative to a reference level by routine experimentation in order to identify the appropriate level for the dosage based on the measurement. Therefore, one of ordinary skill in the art, confronted with an alternative method of determining a dose of a treatment compound for treating systemic lupus erythematosus would determine the dose based on the gene expression rather than genetic polymorphism used by Schafer because measuring gene expression levels is inherent in the process of pharmacogenomic screening, which optimizes the dose based on genetic analysis. See In re Payne, 203 USPQ 245(CCPA 1979).
Since Applicant’s claims are prima facie obvious in view of the teachings of this reference, Applicant’s claims are obvious, and therefore, rejected under 35 U.S.C. 103.
Allowable Subject Matter
Claims 72 and 74-92 will be allowed if: (1) claim 72 is amended to overcome the rejections under 35 USC 112, first paragraph; and (2) claim 73 is incorporated into claim 72 with the correct dependency of subsequent claims (i.e., claims 74-92). The methods in claims 72 and 74-92 were not found to be obvious nor anticipated by the prior art of record. Thus, the prior art does not teach or suggest the presently claimed methods encompassing the compounds in the manner claimed by Applicant. Therefore, these claims will be allowed if amended if claim 72 is amended to overcome the rejections under 35 USC 112, first paragraph, and if claim 73 is incorporated into claim 72 with the correct dependency of subsequent claims (i.e., claims 74-92).
Conclusion
Claims 72-92 are pending. Claims 72-92 are rejected. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL V WARD whose telephone number is (571)272-2909. The examiner can normally be reached M-F 9am to 5pm.
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/PAUL V WARD/ Primary Examiner, Art Unit 1622
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