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
Claims 105-138 are pending in the application. Claims 126-138 are rejected. Claim 110 is objected to. Claims 105-109 and 111-125 are allowed.
Information Disclosure Statement
The Examiner has considered the Information Disclosure Statement(s) filed on October 10th, 2024.
Claim Objections
In claim 110, “methyl is” should be changed to “methyl, which is”.
In claim 133, “relating” should be changed to “related”.
Claim Rejections - 35 USC § 112(b)
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 126-138 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.
Claim 126 recites the limitation "the subject in need thereof" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 126 only previously refers to “a subject” in the preamble. It is unclear if claim 126 is missing some additional qualifier that makes a subject “in need thereof” or if any subject can be considered “in need thereof”. Dependent claims 127-129 are rejected as indefinite for the same reason. It is suggested that Applicant replace “the subject in need thereof” with “a subject in need thereof”.
Claims 130 and 131 are rejected as indefinite since the claims recite “comprising administering to subject in need thereof”. The claims are missing an article before “subject” and is it therefore unclear if the claims are merely missing the word “a” or if the claims were intended to recite “the subject in need thereof” which possesses its own indefiniteness issue as discussed above relative to claim 126. It is suggested that Applicant add the word “a” before “subject in need thereof”.
Claim 132 recites the limitation "the subject in need thereof" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 132 only previously refers to “a subject” in the preamble. It is unclear if claim 132 is missing some additional qualifier that makes a subject “in need thereof” or if any subject can be considered “in need thereof”. Dependent claims 133-138 are rejected as indefinite for the same reason. It is suggested that Applicant replace “the subject in need thereof” with “a subject in need thereof”.
Allowable Subject Matter
Claims 105-109 and 111-125 are allowed.
The closest prior art appears to be WO 00/66614 A1 by Hogenkamp, which discloses compounds of the following general formula (page 3):
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Hogenkamp teach anesthesia utility in the abstract. The difference between the formula above and a closest instantly claimed compound is the instant variable R7 (found at position C-7), which is required to be one of five non-hydrogen options where one option is a methyl group. The prior art structure does not generically encompass substitution at the corresponding position and the prior art as a whole provides insufficient guidance or motivation regarding departing from the generic structure. The replacement of hydrogen with methyl on a steroid backbone does not appear to be routine or predictable. For instance, Zeng et al. (J. Med. Chem. 2005, 48, 3051-3059) teach the following compounds on page 3051:
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The authors teach compounds 1a and 2a act (abstract) at GABAA receptors and are potent anesthetics (page 3051). The prior art compounds 1d, 1e, 2d and 2e each contain a methyl group at the analogous position relative to the instant variable R7. Zeng et al., however, teach that a methyl substituent at the C-7 position corresponds to diminished activity as follows on page 3056:
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Accordingly, the Examiner finds that even if a person having ordinary skill in the art would have been motivated to depart from generic structures or disclosed species in the prior art, a person having ordinary skill in the art would either have not been motivated to modify the C-7 position and/or would have had no reasonable expectation of success in doing so.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW P COUGHLIN whose telephone number is (571)270-1311. The examiner can normally be reached Monday - Friday, 10 am - 6 pm EST.
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/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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