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 May 30, 2026.
Restrictions/Elections.
Applicant’s election of Group III (Claims 11-21) in the reply filed on May 31, 2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a).
Applicant election of the following species:
1- Cannabidiol as the compound of formula I,
2- Dextromethorphan as the compound of formula II, and
3- Dementia as the disease to be treated,
Is also acknowledged.
Status of Claims
Cancellation of claims 6, 11, 19 and 21; amendment of claims 12-14, 18, 20; and addition of claim 21 is acknowledged.
Claims 1-5, 7-10, 12-18, 20 and 22 are currently pending and are the subject of this office action.
Claims 1-5 and 7-10 were withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on May 31, 2025.
Claims 12-18, 20 and 22 are under examination.
The following species elected by Applicant on May 31, 2025, are under examination:
1- Cannabidiol as the compound of formula I,
2- Dextromethorphan as the compound of formula II, and
3- Dementia as the disease to be treated,
Priority
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Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of the first paragraph of 35 U.S.C. 112. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application 16/712,010, fails to provide adequate support or enablement in the manner provided by the first paragraph of 35 U.S.C. 112 for one or more claims of this application. Application 16/712,010 fails to disclose the compounds of formula (I).
Accordingly, none of the examined claims (12-18, 20 and 22) are entitled to the benefit of the application 16/712,010. The priority date for all the claims is May 30, 2025.
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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
1) Claim(s) 12-18 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg (WO 2007/092329, August 2007) and Vangara et. al. (US 2015/0342902).
For claims 12-14, Berg teaches a method of treating neuropsychiatric or neurodegenerative disorders selected from the group consisting of: autism, depression, anxiety, Alzheimer Disease (AD), Multiple Sclerosis (MS) and Parkinson’s Disease (PD), comprising the administration of a composition comprising dextromethorphan (see abstract; page 5 under Summary of the invention; page 7, last 11 lines; page 50, one paragraph before last; and page 58, third paragraph).
Berg does not teach the treatment of the above neuropsychiatric or neurodegenerative disorders comprising the administration of a composition comprising cannabidiol (CBD). However, Vangara teaches a method of treating neuropsychiatric or neurodegenerative disorders selected from the group consisting of: autism, depression, anxiety, Alzheimer Disease (AD), Multiple Sclerosis (MS) and Parkinson’s Disease (PD), comprising the administration of a composition comprising CBD (see [0005]-[0007], [0020], [0143], [0147], [0148], [0154], [0160]-[0161], [0164]-[0165] and claim 21).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat autism, depression, anxiety, Alzheimer Disease (AD), Multiple Sclerosis (MS) or Parkinson’s Disease (PD), combining two compositions (dextromethorphan and CBD) each of which is taught by the prior art to be useful for the same purpose (treating autism, depression, anxiety, AD, MS and PD), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
All this would result in the practice of claims 12-14 with a reasonable expectation of success.
For claim 15, Berg teaches the presence of lubricants and binders (see page 57, first paragraph), thus, resulting in the practice of claim 15 with a reasonable expectation of success.
For claim 16, Berg teaches the presence of quinidine (see for example title and abstract), thus resulting in the practice of claim 16 with a reasonable expectation of success.
For claim 17, Berg teaches that the administration can be oral, rectal, transdermal, parenteral, etc. (see page 54, third full paragraph). For claim 17, Vangara teaches the oral administration of the compositions (see for example [0009])., thus resulting in the practice of claim 17 with a reasonable expectation of success.
The statement in claim 18: “wherein administration of cannabidiol results in increasing dextromethorphan plasma levels in a subject in need thereof” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating dementia comprising the administration of a composition comprising cannabidiol and dextromethorphan.”
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “administration of cannabidiol results in increasing dextromethorphan plasma levels in a subject in need thereof” appears to be the result of the process made obvious by the prior art: “a method for treating dementia comprising the administration of a composition comprising cannabidiol and dextromethorphan", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 18 with a reasonable expectation of success.
For claim 20, Berg teaches the administration of 60 mg dextromethorphan per day in two doses (i.e. twice a day) (see page 51, end of last paragraph).
The prior art does not state: “wherein the AUC0-12 of cannabidiol is at least 10 ng/hr/ml, about 100 ng/hr/ml, etc.”. However: “wherein the AUC0-12 of cannabidiol is at least 10 ng/hr/ml, about 100 ng/hr/ml, etc.” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the co-administration of dextromethorphan and CBD to patients suffering from neurological disorders”.
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein the AUC0-12 of cannabidiol is at least 10 ng/hr/ml, about 100 ng/hr/ml, etc.” appears to be the result of the process made obvious by the prior art: “a method for treating dementia comprising the administration of a composition comprising cannabidiol and dextromethorphan ", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
Further, the AUC0-12 of cannabidiol will depend on the amount administered, the formulation, the species being treated (human, rats, etc.), the route of administration, etc., all of which seem to be similar to the teachings of the prior art: for example: Berg teaches the administration of 60 mg dextromethorphan per day in two doses (i.e. twice a day) (see page 51, end of last paragraph) and the specification also teaches the administration of 60 mg dextromethorphan per day in two doses (see for example instant paragraph [00159]).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method of the prior art does not possess the same material, structural and functional characteristics of the method claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the AUC0-10 of CBD of the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claim 20 with a reasonable expectation of success.
2) Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berg (WO 2007/092329, August 2007) and Vangara et. al. (US 2015/0342902) as applied to claims 12-18 and 20 above, further in view of Siffert et. al. (US 2016/0143901).
Berg and Vangara teach all the limitations of claim 22, except for the neuropsychiatric symptom being agitation. However, Siffert teaches that the neuropsychiatric symptoms can be agitation and anxiety (see for example [0042], [0062] and [0066]), thus resulting in the practice of claim 22 with a reasonable expectation of success.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 12-18, 20 and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Siffert et. al. (US 2016/0143901) and Karolchyk (US 2021/0393578)
For claims 12-14, Siffert teaches a method of treating dementia comprising the administration of a composition comprising dextromethorphan (see abstract; paragraph [0007] and claim 1).
Siffert does not teach the treatment of dementia comprising the administration of a composition comprising cannabidiol (CBD). However, Karolchyk teaches a method of treating dementia comprising the administration of a composition comprising CBD (see abstract and paragraph [0008]).
Before the effective filing date of the claimed invention, it would have been prima facie obvious for a person of ordinary skill in the art to treat dementia combining two compositions (dextromethorphan and CBD) each of which is taught by the prior art to be useful for the same purpose (treating dementia), in order to form a third composition to be used for the very same purpose. The idea of combining them flows logically from their having been individually taught in the prior art (see MPEP 2144.06). In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). See also: In re Diamond, 360 F.2d 214, 53 C.C.P.A. 1172, 149 U.S.P.Q. 562 (C.C.P.A. 1966).
All this would result in the practice of claims 12-14 with a reasonable expectation of success.
For claim 15, Siffert teaches the presence of lubricants and binders (see [0144]) thus, resulting in the practice of claim 15 with a reasonable expectation of success.
For claim 16, Siffert teaches the presence of quinidine (see for example title and abstract), thus resulting in the practice of claim 16 with a reasonable expectation of success.
For claim 17, Siffert teaches that the administration can be oral, rectal, transdermal, parenteral, etc. (see [0141]), thus resulting in the practice of claim 17 with a reasonable expectation of success.
The statement in claim 18: “wherein administration of cannabidiol results in increasing dextromethorphan plasma levels in a subject in need thereof” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “a method for treating dementia comprising the administration of a composition comprising cannabidiol and dextromethorphan.”
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case “administration of cannabidiol results in increasing dextromethorphan plasma levels in a subject in need thereof” appears to be the result of the process made obvious by the prior art: “a method for treating dementia comprising the administration of a composition comprising cannabidiol and dextromethorphan", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
All this will result in the practice of claim 18 with a reasonable expectation of success.
For claim 20, Siffert teaches the administration of 30 mg dextromethorphan per day (see claim 10) in one or two doses per day (see claims 15-16),
The prior art does not state: “wherein the AUCo-12 of CBD is at least 10 ng/hr./mL, about 100 ng/hr./mL, etc.” However, “wherein the AUCo-12 of CBD is at least 10 ng/hr./mL, about 100 ng/hr./mL, etc.” does not require additional steps to be performed and simply expresses the intended result of carrying the process made obvious by the prior art: “the co-administration of dextromethorphan and CBD to patients suffering from dementia”.
MPEP 2111.04 states: “Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) “ adapted to ” or “adapted for ” clauses;
(B) “ wherein ” clauses; and
(C) “ whereby ” clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a “whereby’ clause states a condition that is material to patentability; it cannot be ignored in order to change the substance of the invention.” Id. However, the court noted (quoting Minton v. Nat ’l Ass ’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)) that a “whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.” (Emphasis added).
In the instant case: “wherein the AUCo-12 of CBC is at least 10 ng/hr./mL, about 100 ng/hr./mL, etc.” appears to be the result of the process made obvious by the prior art: “the co-administration of dextromethorphan and CBD to patients suffering from dementia", e. g. the intended result of a process step positively recited. As such, this limitation in the instantly claimed method has not been given any weight.
Further, the AUC0-12 of cannabidiol will depend on the amount administered, the formulation, the species being treated (human, rats, etc.), the route of administration, etc., all of which seem to be similar to the teachings of the prior art: for example: Siffert teaches the administration of 30 mg dextromethorphan per day (see claim 10) in one or two doses per day (see claims 15-16), and the specification also teaches the administration of 30 mg dextromethorphan per day in two doses (see for example instant paragraph [00159]).
The office does not have the facilities and resources to provide the factual evidence needed in order to establish that the method of the prior art does not possess the same material, structural and functional characteristics of the method claimed in the instant application. In the absence of evidence to the contrary, the burden is on the applicant to prove that the AUC0-10 of CBD of the claimed method is different from those taught by the prior art and to establish patentable differences. See In re Best 562F.2d 1252, 195 USPQ 430 (CCPA 1977) and Ex parte Gray 10 USPQ 2d 1922 (PTO Bd. Pat. App. & Int. 1989).
All this will result in the practice of claim 20 with a reasonable expectation of success.
For claim 22, Siffert teaches that the neuropsychiatric symptoms can be agitation and anxiety (see for example [0042], [0062] and [0066]), thus resulting in the practice of claim 22 with a reasonable expectation of success.
Response to Applicant’s arguments related to the above103 rejections
Applicant's arguments have been fully considered but are not persuasive.
Applicant argues that:
Claims 11, 19 and 21 have been canceled and claim 12 has been amended to be an independent claim. The cited references (Berg and Vangara), either alone or in combination, fail to render the pending claims obvious.
Specifically, the cited references fail to disclose or suggest:
(i) the co-administration of cannabidiol (CBD) with an NMDA receptor antagonist such as dextromethorphan;
(ii) the treatment of behavioral and psychological symptoms of dementia (BPSD) using such a combination; and
(iii) the pharmacokinetic interaction wherein CBD when administered increases dextromethorphan plasma levels.
Obviousness requires more than the mere existence of all claim elements in the prior art; there must be an apparent reason to combine the known elements in the manner claimed. See KSR International Co. v. Teleflex Inc. No such rationale is provided or supported here.
Accordingly, the pending claims 12-18, 20 and 22 are not obvious, and the rejection under § 103 is respectfully traversed.
Examiner’s response:
The above 103 rejections addressed every one of the structural/functional limitations of claims 12-18, 20 and 22.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L. Clark can be reached on 571 272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent- center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARCOS L SZNAIDMAN/ Primary Examiner, Art Unit 1628 June 15, 2026.
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