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 .
Priority
The present Application was filed September 23, 2024.
Status of the Claims
In the amendment filed October 3, 2024, claims 4-5 and 7 are amended. Claims 1-7 are currently pending.
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 1 and 4-7 are indefinite:
Claims 1 and 4-7 rejected are 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 1 is indefinite for reciting a compound having an R1 group that is optionally −(CH2)qCH3, without defining “q.” Claim 1 is further indefinite for ending with the word “and” and no period. It appears that a final clause defining “q” and a period may have been accidentally deleted from the claim. Claims 4-7 are indefinite for depending directly or indirectly from claim 1 without curing this indefiniteness.
Claim 1 is further indefinite for reciting that the variable R group is selected from the group consisting of “(a) -C(O)R1, (b) -C(O)OR1, (c) -CH2OC(O)R1, (d) -CH2OC(O)OR1; OR1 and (e) -CH2OR1.” In particular, alternative (d) appears to list two alternatives, unlike alternatives (a)-(c) and (e), and it would be unclear which is intended. Furthermore, the substituent OR1, which is separated by a semicolon, is not disclosed anywhere in the specification, or in the otherwise similar claims 2-3. It thus appears that this substituent may have been added in error. Claims 4-7 are likewise indefinite for depending from claim 1 without curing this indefiniteness.
Claim 5 is further indefinite for reciting, “[a] method of treating opioid dependence, alcohol dependence, a depressive disorder, itchiness and opioid-induced constipation brought by opioid use, or congenital insensitivity to pain with anhidrosis,” because a person of ordinary skill in the art could not reasonably determine the metes and bounds of this limitation. In particular, the conjunctive “and” suggests that the method is used to simultaneously treat “opioid dependence, alcohol dependence, a depressive disorder, itchiness and opioid-induced constipation,” but it is unclear how this could be achieved. Furthermore, it is noted that the instant specification references treating one or more medical conditions, including opioid dependence, alcohol dependence, etc. (paragraphs [2331]-[2334]). It thus appears that the method may be intended to treat a condition selected from the recited group, rather than to treat all conditions at once.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 6 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Specifically, claim 6 fails to further limit the base claim from which it depends, claim 5. Claim 6 recites a list of conditions that define the “depressive disorder” of claim 5. However, the specification defines “depressive disorder” at paragraph [2340], and the definition is identical to the list of claim 6. Furthermore, this definition includes several conditions that wouldn’t ordinarily be considered depressive disorders (e.g. “hot flashes”) and so this definition from the specification is understood as Applicant’s particular definition that is controlling in the claims, including claim 5. As such, claim 6, which merely repeats Applicant’s particular definition of “depressive disorder,” does not further limit claim 5, from which it depends. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 2-3 are allowable. No species of formula (II) or formula (III) is disclosed in the art. Certain references disclose genera that overlap with presently claimed compound genera. For example, US Patent No. 8,080,661 to Wang et al. discloses derivatives of [4,5-epoxy]-morphinan of a formula (IIa)
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that encompasses instant formula (III). The prior art formulae like formula (IIa) are generally very broad, however, and no teaching of the prior art would lead one to select the substantially more focused genera of instant formulae (II) or (III). Claims 2-3 are therefore allowable.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEXANDER K SHOWALTER whose telephone number is (571)270-0610. The examiner can normally be reached M-F 9:00 am to 5:00 pm, eastern time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached on (571) 272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEXANDER K. SHOWALTER/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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