DETAILED ACTION
Claims 1-20 are currently pending and are examined on the merits herein.
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 .
Application Priority
This application filed 10/10/2024 is a 371 of PCT/GB2022/050924 filed on 04/13/2022.
Information Disclosure Statement
The information disclosure statement(s) (IDS) filed on 12/19/2024 and 9/22/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS is being considered by the Examiner.
The following rejections are made:
Claim Rejections - 35 USC § 112
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 11-20 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. Since the claim does not set forth any steps involved in the method/process, it is unclear what method/process applicant is intending to encompass. A claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 11-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the claims are directed to non-statutory subject matter, because the claims lack positive recitation of any steps involved in the method of use. Further, the claims solely recite “use”, “used” or “used as” without setting forth any steps involved in the process, results in an improper definition of a process, i.e., results in a claim which is not a proper process claim under 35 U.S.C. 101. See for example Ex parte Dunki, 153 USPQ 678 (Bd.App. 1967) and Clinical Products, Ltd. v. Brenner, 255 F. Supp. 131, 149 USPQ 475 (D.D.C. 1966)
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-7 and 11-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Whalen et al. (US 20110224128 A1).
Whalen et al. teaches a method for treating a patient having muscular dystrophy, e.g., Duchenne muscular dystrophy (reads on dystrophinopathy), said method comprising administering to said patient an effective amount of a Rho kinase inhibitor: fasudil (see claim 1, Table 1, [0008 ] , and [0087]).
The fasudil is identical to the claims and will therefore inherently “inhibits the RhoA/ROCK pathway by directly inhibiting ROCK1 and/or ROCK2.”
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 8-10 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Whalen et al. (US 20110224128 A1), as applied to claims 1-7 and 11-17 above, in view of Just et al. (Therapeutic effects of Clostridium botulinum C3 exoenzyme Naunyn-Schmied Arch Pharmacol (2011) 383:247–252 DOI 10.1007/s00210-010-0589-3).
Whalen et al. is as discussed above.
Whalen et al. does not specify the use of C3 exoenzyme inhibitor.
Just et al. teaches “to prevent the detrimental effect of active Rho in the recovery of injured neuronal systems, C3 has become a promising drug to inactivate RhoA in neurons.” In addition, C3 peptide was shown to be efficacious in post-traumatic neuro-regeneration.
It would have been obvious to one of ordinary skill in the art at the time of filing to combine C3 exoenzyme inhibitor, with the fasudil of Whalen. The motivation to combine C3 exoenzyme inhibitor is because Just teaches to prevent the detrimental effect of active Rho in the recovery of injured neuronal systems, C3 has become a promising drug to inactivate RhoA in neurons. A skilled artisan would have reasonable expectation of successfully achieving similar efficacy and results.
Conclusion
No claims allowed.
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/LAYLA SOROUSH/ Primary Examiner, Art Unit 1622
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