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
This office action is in response to applicant’s reply filed on August 25, 2025.
Status of Claims
Amendment of claims 1 and 4-10 is acknowledged.
Claims 1-20 are currently pending and are the subject of this office action.
Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on April 10, 2025.
Claims 1-10 are under examination as they relate to the following species:
Dehydronorketamine, and
Schizophrenia.
Priority
The present application is a 371 of PCT/US2020/058212 filed on 10/30/2020 and claims priority to provisional application 62928401 filed on 10/31/2029.
Rejections and/or Objections and Response to Arguments
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated (Maintained Rejections and/or Objections) or newly applied (New Rejections and/or Objections, Necessitated by Amendment or New Rejections and/or Objections not Necessitated by Amendment). They constitute the complete set presently being applied to the instant application.
Responses to Applicant’s arguments have been addressed immediately after the corresponding rejections, or in the section: Withdrawn Rejections and/or Objections, if the rejection was withdrawn.
Claim Rejections - 35 USC § 112 (Modified Rejection Necessitated by Amendment.)
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 1-10 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.
Claims 1-10 recite:
“A method of treating an alcohol use disorder or a medical condition that develops from or is secondary to the alcohol use disorder”.
According to the specification (paragraph [0038]):
“Alcohol use disorder or a related condition thereof” refers to a chronic disease characterized by uncontrolled drinking and preoccupation with alcohol. It may include, but is not limited to, alcoholism, alcohol abuse, a drug or alcohol addiction, and an anxiety disorder, each of which can develop or lead to any one of schizophrenia, Alzheimer’s disease, Parkinson’s disorder, other dementia-related illnesses, Type II diabetes, and autoimmune diseases.”
First, since the “alcohol use disorder or a medical condition that develops from or is secondary to the alcohol use disorder” are not limited to the above list, then, what else is encompassed by “alcohol use disorders or related conditions” that is not listed above?
Second, if alcohol use disorder can cause or develop into a medical condition (that develops from or is secondary to alcohol use disorder), wherein the medical condition is for example schizophrenia, how is schizophrenia NOT related to “alcohol use disorder” different from schizophrenia that develops from “alcohol use disorder”? In other words, will the skilled in the art be able to differentiate one from the other? Apparently, based on the specification and the prior art, there is no differentiation between schizophrenic patients based on the origin of the disease, as such, for prior art search, and unless Applicant can prove it otherwise, schizophrenia that develops from “alcohol use disorder” will be considered the same as any other type of schizophrenia, regardless of what caused the disease.
The metes and bounds of the claims are not clearly defined.
2) Claims 4-5 recite: the method of claim 1, “wherein the subject is diagnosed or at risk of having an alcohol use disorder or at risk of having an alcohol disorder or a medical condition secondary to the alcohol disorder”.
Claim 4 depends on claim 1, which requires the subject “to be treated for an alcohol use disorder or a medical condition secondary to the alcohol disorder”, which implies that the subject as already been diagnosed with “alcohol use disorder” or “a medical condition secondary to the alcohol disorder”. So, if the subject has already been diagnosed with “alcohol use disorder” or “a medical condition secondary to the alcohol disorder” in claim 1, how is it that the same subject is being again diagnosed with “alcohol use disorder” or “a medical condition secondary to the alcohol disorder” in dependent claim 4? More specifically, claim 5 requires that “the subject is diagnosed with or at an increased risk of developing schizophrenia as a consequence of the alcohol use disorder”. If claim 1 already requires the subject to be treated against schizophrenia (which means that the subject has already been diagnosed with schizophrenia), then, how can dependent claim 5 require the same subject to be further diagnosed with schizophrenia, or being at risk of having schizophrenia (which means that the subject does not yet suffer from schizophrenia).?
Claim Rejections - 35 USC § 103 (Modified Rejection Necessitated by Amendment).
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.
CLAIM INTERPRETATION:
1- schizophrenia (a medical condition that develops from or is secondary to the alcohol use disorder) is considered the same regardless of whether it originates from “alcohol use disorder” or not (see above 112(b) rejection, and
2- The subjects of the instant claims suffer from schizophrenia but not necessarily have an alcohol drinking problem while suffering from schizophrenia. In fact, claim 8, further limits claim 1, wherein the subject has been identified as one that had experienced binge drinking, which means claim 1 encompasses subjects that had not been identified as binge drinking.
Claim(s) 1-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wainer et. al. (US 2014/0296241, cited in previous office action).
For claims 1-3, Wainer teaches a method of treating schizophrenia (a medical condition that develops from or is secondary to the alcohol use disorder thereof elected by Applicant) comprising the administration of a composition comprising Dehydronorketamine (see claims 26 and 27).
Wainer does not teach the exact ranges of therapeutically effective doses as instantly claimed. However, Wainer teaches doses between 0.5 mg and 7 g (see paragraph [0119]), which overlaps with the instantly claimed ranges.
MPEP 2144.05 states: In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Even a slight overlap in range establishes a prima facie case of obviousness. In re Peterson, 65 USPQ2d 1379, 1382 (Fed. Cir. 2003).
"A prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003). >See also In re Harris, 409 F.3d 1339, 74 USPQ2d 1951 (Fed. Cir. 2005).
Moreover, the determination of known effective amounts of known active agents to be administered to treat the same disease is considered well in the competence level of an ordinary skilled artisan in pharmaceutical science, involving merely routine skill in the art. It has been held that it is within the skill in the art to select optimal parameters, such as amounts of ingredients, in a composition in order to achieve a beneficial effect. As Wainer et al. teach that a range of dosages of Dehydronorketamine is used to treat schizophrenia generally, the dosage is considered a result effective variable. Thus, it would also have been obvious to have chosen a dosage from among those known to be effective in methods of treating schizophrenia.
Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art. See In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
A prima facie case of obviousness may be established even though a prior art reference does not disclose any particular range, but teaches that the claimed parameters are known to affect results or properties
In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980) (“Discovery of an optimum value of a result effective variable…is ordinarily within the skill of the art.”).
All this will result in the practice of claims 1-3 with a reasonable expectation of success.
For claims 4-5, Wainer, does not explicitly teach that the subject suffering from schizophrenia was diagnosed with schizophrenia. However, it is implicit that when a subject is being treated against schizophrenia, the subject was already diagnosed having schizophrenia, thus resulting in the practice of claims 4-5 with a reasonable expectation of success.
For claim 6, Wainer is silent regarding the age of the patient. However, there is nothing in Weiner’s teachings that limits the treatment to schizophrenic patients of a certain age, so it will be obvious to treat schizophrenia comprising the administration of a composition comprising Dehydronorketamine to schizophrenic patients of any age including those between 9 and 25 years old, thus resulting in the practice of claim 6 with a reasonable expectation of success.
For claim 7, Wainer does not teach the exact ranges of therapeutically effective doses as instantly claimed. However, Wainer teaches doses between 0.5 mg and 7 g (see paragraph [0119]), which are very close to the instantly claimed range (0.01 mg to about 0.1 mg).
MPEP 2144.05 states: “A prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Court held as proper a rejection of a claim directed to an alloy of “having 0.8% nickel, 0.3% molybdenum, up to 0.1% iron, balance titanium” as obvious over a reference disclosing alloys of 0.75% nickel, 0.25% molybdenum, balance titanium and 0.94% nickel, 0.31% molybdenum, balance titanium.).”
All this will result in the practice of claim 7 with a reasonable expectation of success.
For claim 8, Weiner is silent regarding the patient suffering from schizophrenia further experiencing binge drinking. However, there is nothing in Weiner’s teaching that limits the treatment to schizophrenic patients that have experienced binge drinking, so it will be obvious to treat schizophrenia comprising the administration of a composition comprising Dehydronorketamine to schizophrenic patients with any other condition, including binge drinking, thus resulting in the practice of claim 8 with a reasonable expectation of success.
For claims 9-10, Weiner is silent regarding administering a therapeutically effective amount of Dehydronorketamine prior to, during, after, within four hours prior to or subsequent to alcohol consumption. However, there is nothing in Weiner’s teaching that limits the treatment to schizophrenic patients that engage or engaged in drinking alcohol, as such, it will be obvious to treat schizophrenia comprising the administration of a composition comprising Dehydronorketamine to schizophrenic patients that have been or will be drinking alcohol, thus resulting in the practice of claims 8-10 with a reasonable expectation of success.
Response to Applicant’s arguments
Since a new rejection was issued (see above), it is the Examiner’s belief that most of the arguments presented by Applicant are no longer applicable or have been considered/answered in the rejection itself.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCOS L SZNAIDMAN whose telephone number is (571) 270-3498. The examiner can normally be reached Flexing M-F 7 AM-7 PM.
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/MARCOS L SZNAIDMAN/
Primary Examiner, Art Unit 1628
August 27, 2025.