Prosecution Insights
Last updated: April 19, 2026
Application No. 17/827,958

NOVEL COMPOSITIONS, COMBINATIONS, AND METHODS THEREOF

Non-Final OA §102§103§112
Filed
May 30, 2022
Examiner
SZNAIDMAN, MARCOS L
Art Unit
1628
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Exciva GmbH
OA Round
1 (Non-Final)
37%
Grant Probability
At Risk
1-2
OA Rounds
3y 3m
To Grant
53%
With Interview

Examiner Intelligence

Grants only 37% of cases
37%
Career Allow Rate
461 granted / 1253 resolved
-23.2% vs TC avg
Strong +16% interview lift
Without
With
+16.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
56 currently pending
Career history
1309
Total Applications
across all art units

Statute-Specific Performance

§101
1.8%
-38.2% vs TC avg
§103
38.8%
-1.2% vs TC avg
§102
17.2%
-22.8% vs TC avg
§112
26.7%
-13.3% vs TC avg
Black line = Tech Center average estimate • Based on career data from 1253 resolved cases

Office Action

§102 §103 §112
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 September 13 , 2025. 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 Claims 1-21 are currently pending and are the subject of this office action. Claims 1-10 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim.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 11-21 are under examination. Priority 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 16/712,010fails to disclose the compounds of formula (I). Accordingly, none of the examined claims (11-21) are entitled to the benefit of the application 16/712,010. The priority date for all the claims is May 30, 2025. 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. 1) Claims 11-21 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. Claims 11-21 recite: “Treating a neuropsychiatric or neurodegenerative disease or disorder, or brain injury, comprising behavioral and psychological symptoms of dementia (BPSD), in a patient in need thereof” The specification does not disclose which neuropsychiatric or neurodegenerative diseases or disorders comprise behavioral and psychological symptoms of dementia (BPSD). As such it is not known which type of diseases are being treated. The metes and bounds of the claims are not clearly defined. 2) Claim 18 is 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 18 recites: “further comprising increasing dextromethorphan plasma levels in a subject in need thereof,”. It is not clear if Applicant tries to claim an increase in the dextromethorphan dose (in order to increase dextromethorphan plasma levels) or if the plasma increase is a consequence of co-administering dextromethorphan with CBD. The metes and bounds of the claims are not clearly defined. Claim Rejections - 35 USC § 112 The following is a quotation of the first paragraph of 35 U.S.C. 112(a): (a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention. The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112: The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention. Claim 11 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection . Claim 11 recites a large genus of compounds of Formula I or Formula II, metabolites thereof, derivatives thereof and prodrugs thereof. M.P.E.P. #2163 states: “An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention….one must define a compound by ‘whatever characteristics sufficiently distinguish it’. A lack of adequate written description issue also arises if the knowledge and level of skill in the art would not permit one skilled in the art to immediately envisage the product claimed from the disclosed process”. M.P.E.P. 2163 II-A-3-a ii) states: “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i) (C), above). See Eli Lilly , 119 F.3d at 1568, 43 USPQ2d at 1406. A “representative number of species” means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure “indicates that the patentee has invented species sufficient to constitute the gen[us].” See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615; Noelle v.Lederman , 355 F.3d 1343, 1350, 69 USPQ2d 1508, 1514 (Fed. Cir. 2004) (Fed. Cir. 2004)(“[A] patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there may be unpredictability in the results obtained from species other than those specifically enumerated.”). “A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed.” In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir.2004)(Claims directed to PTFE dental floss with a friction-enhancing coating were not supported by a disclosure of a microcrystalline wax coating where there was no evidence in the disclosure or anywhere else in the record showing applicant conveyed that any other coating was suitable for a PTFE dental floss.)”. The specification does not describe nor disclose any metabolite , derivative or pro-drug of the compounds of Formula I and II. The prior art also does not describe nor disclose any metabolite , derivative or pro-drug of the compounds of Formula I and II. Even though the terms “ metabolite , derivative or pro-drug ” are well known in the chemical art, when it comes to specific “ metabolite , derivative or pro-drug of a specific compounds like Formula I or II , the skilled in the art will not be able to recognize, without any guidance from the specification and the prior art, if a specific compound qualifies or not as a metabolite , derivative or pro-drug of Formula I or II . The terms metabolite , derivative or pro-drug correspond in some undefined way to specifically instantly disclosed chemicals. None of these meet the written description provision of USC 112, first paragraph, due to lack of chemical structural information for what they are since chemical structures are highly variant and encompass a myriad of possibilities. The skilled artisan cannot envision the detailed chemical structure encompassed by metabolite , derivative or pro-drug of compounds of Formula I or II. Given the broad scope of the subject claimed matter, Applicant has not provided sufficient written description that would allow the skilled artisan to recognize that Applicant was in possession of the claimed structures encompassed by metabolite , derivative or pro-drug of compounds of Formula I or II. 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. 1) Claim(s) 11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Berg (WO 2007/092329, August 2007) . For claim 11, 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). 2) Claim(s) 11 is/are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Siffert et. al. (US 2016/0143901). For claim 11 , Siffert teaches a method of treating dementia comprising the administration of a composition comprising dextromethorphan (see abstract; paragraph [0007] and claim 1 ). 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. 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) 11-21 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 claim s 11-14, 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 11-14 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. For claim 18, Berg teaches that some individuals are extensive metabolizers of dextromethorphan (see page 10, third full paragraph). Quinidine increases the concentration of dextromethorphan in plasma (see page 10, last paragraph; page 16, first paragraph; page 18, last two paragraphs through page 19, first paragraph, page 44, first full paragraph through end of page 46) , thus resulting in the practice of claim 18 with a reasonable expectation of success. For claim 19, 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) , which anticipates the structural limitations of claim 19 (0.1 mg to about 1000 mg, once or twice a day). The statement: “ resulting in an AUCo-12 of dextromethorphan that is greater than the AUCo-12 of dextromethorphan that would be achieved by administering the same amount of dextromethorphan without a compound of Formula I ” 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 (a compound of formula I) 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 : “ resulting in an AUCo-12 of dextromethorphan that is greater than the AUCo-12 of dextromethorphan that would be achieved by administering the same amount of dextromethorphan without a compound of Formula I ” appears to be the result of the process made obvious by the prior art: “ the co-administration of dextromethorphan and CBD (a compound of formula I) to patients suffering from neurological disorders ", 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 19 with a reasonable expectation of success. For claim 20, the statement: “ wherein the AUCo-12 of a compound of Formula I 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 (a compound of formula I) 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 AUCo-12 of a compound of Formula I 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 (a compound of formula I) to patients suffering from neurological disorders ", 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 20 with a reasonable expectation of success. For claim 21, Berg teaches that the administration can be oral, rectal, transdermal, parenteral, etc. (see page 54, third full paragraph). For claim 21 , Vangara teaches the oral administration of the compositions (see for example [0009])., thus resulting in the practice of claim 21 with a reasonable expectation of success. 2) Claim(s) 11-21 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 11-14 , 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 11-14 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. For claim 18, Siffert teaches that some individuals are extensive metabolizers of dextromethorphan (see [0080]-[0081], [0085] and [0125] ). Quinidine increases the concentration of dextromethorphan in plasma (see [0080]-[0081], [0085] and [0125]) , thus resulting in the practice of claim 18 with a reasonable expectation of success. For claim 19, Berg teaches the administration of 3 0 mg dextromethorphan per day (see claim 10) in one or two doses per day (see claims 15-16 ), which anticipates the structural limitations of claim 19 (0.1 mg to about 1000 mg, once or twice a day). The statement: “ resulting in an AUCo-12 of dextromethorphan that is greater than the AUCo-12 of dextromethorphan that would be achieved by administering the same amount of dextromethorphan without a compound of Formula I ” 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 (a compound of formula I) 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 : “ resulting in an AUCo-12 of dextromethorphan that is greater than the AUCo-12 of dextromethorphan that would be achieved by administering the same amount of dextromethorphan without a compound of Formula I ” appears to be the result of the process made obvious by the prior art: “ the co-administration of dextromethorphan and CBD (a compound of formula I) 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. All this will result in the practice of claim 19 with a reasonable expectation of success. For claim 20, the statement: “ wherein the AUCo-12 of a compound of Formula I 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 (a compound of formula I) 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 a compound of Formula I 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 (a compound of formula I) 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. All this will result in the practice of claim 20 with a reasonable expectation of success. For claim 21, Siffert teaches that the administration can be oral, rectal, transdermal, parenteral, etc. (see [0141]), thus resulting in the practice of claim 21 with a reasonable expectation of success. Conclusion No claims are allowed. 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 May 7, 2025
Read full office action

Prosecution Timeline

May 30, 2022
Application Filed
Feb 18, 2025
Response after Non-Final Action
May 31, 2025
Response after Non-Final Action
Sep 13, 2025
Response after Non-Final Action
Mar 22, 2026
Non-Final Rejection — §102, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
37%
Grant Probability
53%
With Interview (+16.1%)
3y 3m
Median Time to Grant
Low
PTA Risk
Based on 1253 resolved cases by this examiner. Grant probability derived from career allow rate.

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Free tier: 3 strategy analyses per month