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 .
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 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.
DETAILED ACTION
The amendments filed on 1/8/2026 in which no claims were amended, canceled, or newly added.
Claims 1-8, 11-12, and 15 are pending in the instant application.
Priority
This application is a 371 of PCT/US19/46709, filed on 8/15/2019 which claims priority to the provisional application 62/764864 filed on 8/16/2018.
Claim Rejections – 35 USC § 102
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.
Claims 1 and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wrobel et al. (WO2016140879).
claim 1
Regarding claim 1, Wrobel teaches that riluzole is clinically relevant to generalized anxiety disorder, social anxiety, and memory loss (pg 2, para 3). Because treating memory loss results in re-establishing a normal amount of memory that had deteriorated, this meets the limitation of “enhancing memory” relative to the baseline of the patient prior to treatment. Wrobel teaches a method of treating an anxiety disorder and memory loss in a patient in need thereof (claim 11), comprising administering to the patient a pharmaceutical composition (claim 10) comprising a therapeutically effective amount of riluzole, or a pharmaceutically acceptable salt or prodrug thereof (claim 1). Wrobel teaches riluzole has the structure below (pg 69, Scheme 7).
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Wrobel teaches that derivatives of riluzole have the structure of Formula I, below (pg 3), wherein variable R1 is defined in pgs 3-8.
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Wrobel teaches the prodrug form of riluzole comprising the structure below, wherein R23 is optionally H (claim 1).
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Wrobel teaches the prodrug form of riluzole wherein R23 is H (claim 1), thus generating the structure below (pg 208, Table 1, entry 15).
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In sum, Wrobel teaches administering the same prodrug of riluzole as instantly claimed for treating social anxiety disorder and enhancing memory.
Claim 15
Claim 15 is drawn to a kit comprising troriluzole and instructions for its use, with the intended use of “treating a disease”. Regarding the intended use, MPEP § 2111.02(II) recites:
“During examination, statements in the preamble reciting the purpose or intended use of the claimed invention must be evaluated to determine whether or not the recited purpose or intended use results in a structural difference (or, in the case of process claims, manipulative difference) between the claimed invention and the prior art. If so, the recitation serves to limit the claim. See, e.g., In re Otto, 312 F.2d 937, 938, 136 USPQ 458, 459 (CCPA 1963)…To satisfy an intended use limitation which is limiting, a prior art structure which is capable of performing the intended use as recited in the preamble meets the claim. See, e.g., In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997) (anticipation rejection affirmed based on Board’s factual finding that the reference dispenser (a spout disclosed as useful for purposes such as dispensing oil from an oil can) would be capable of dispensing popcorn in the manner set forth in appellant’s claim 1 (a dispensing top for dispensing popcorn in a specified manner)) and cases cited therein.”
In the instant case, the intended use does not provide any additional structure between the claimed invention and the prior art, and the intended use is also described in the prior art (as detailed in the 102(a)(1) rejection of claim 1).
Regarding the “instructions for its use”, MPEP § 2111.02(I)(B) recites:
“Where a product merely serves as a support for printed matter, no functional relationship exists. These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864. See MPEP § 2111.05(I)(B). Thus the instantly claimed written instructions hold no patentable weight.”
In the instant case, the printed matter does not have a functional relationship with the prodrug of the invention, thus the instantly claimed instructions hold no patentable weight. Because the kit comprises only the instructions and the prodrug, claim 15, represents a broader version of claim 1: a composition comprising the prodrug troriluzole, which is fully anticipated by Wrobel who teaches the compound below (pg 208, Table 1, entry 15).
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Claim Rejections – 35 USC § 103
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.
Claims 1-8, 11-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Wrobel et al. (WO2016140879) as applied to claims 1 and 15 above, and further in view of Williams et al. (doi: 10.1186/1477-7525-8-57), Walpole et al. (doi: 10.1186/1471-2458-12-439), Rowe et al. (US20050136104), and Matsuda et al. (WO2016085998). This rejection has been modified solely to address the amendments.
*claim 2
Regarding claim 2, Wrobel teaches a dosage of 1 mg/kg per day, wherein the dosage can be given once daily or split into two or more dosages (pg 216, para 2).
Walpole teaches the average body mass of a human in Asia is 57.7 kg (pg 3, Table 3). Thus a 57.7 kg person would consume a 57.7 mg daily dosage. Thus satisfying the limitation of the dosage being ≤400 mg/day.
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 the instant case, Wrobel’s dosages of 1 mg/kg when interpreted by the subject body weights described by Wapole, overlap with the instantly claimed dosage of 20-50 mg. Thus, this would have been considered obvious. See MPEP § 2144.05(I).
It would have been obvious to combine the teachings of Wrobel and Walpole, arriving at a method of treating anxiety using riluzole because (1) Wrobel provides the drug, the drug dosage, and its use as an anxiolytic; and (2) Walpole provides an average body mass of human in kg. One of skill in the art would have had a reasonable expectation of success because Wrobel provides a dosage range that can be modified depending on the organism being treated, and Williams provides a list of human subpopulations and their average weights from which to calculate a dosage.
*claim 3
Regarding claim 3, Wrobel does not teach a reduction of at least 10 VAS points relative to placebo.
Williams teaches using the VAS scale to measure anxiety, wherein the patient marks where on the scale they are feeling and the distance from the left edge is measured in mm, wherein the total length of the line is 100 mm in length (pg 2, col 2, para 3; Figure 1, reproduced below).
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Williams teaches that general anxiety (GA) disorder patients in the study began with an average VAS of 67.26+/-16.1 points (pg 4, col 2, para 3). Williams teaches that VAS scores declined in the treatment group to 49.16+/-23.7 points (pg 4, col 2, para 3). Williams teaches comparing the treatment group from the placebo using Cohen’s effect size estimate calculation of the VAS results, shown below (pg 4, col 1, para 2).
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Williams teaches that relative to placebo, those receiving paroxetine showed a reduction of 0.07×(standard deviation) VAS points in anxiety in week 1 (pg 5, Table 2). Williams teaches that a decrease of 10-15 points is indicative of a “minimally improved” change in VAS (pg 5, col 2, para 1).
It would have been obvious to combine the teachings of Wrobel and Williams, to use the anxiolytic formulation of riluzole and combine it with the VAS metric described by Williams in order to measure the effectiveness of the drug relative to placebo because Williams describes that a reduction of 10 VAS points is indicative of a minimal improvement in anxiety in response to an anxiolytic drug and Wrobel provides the same anxiolytic drug as instantly claimed. One of skill in the art would have had a reasonable expectation of success because Wrobel teaches that riluzole and its prodrugs are useful for treating anxiety and Williams teaches the VAS scale for anxiety is useful for determining if a given drug is effective in treating anxiety.
claim 4-6
Regarding claims 4-6, Wrobel does not teach a reduction of at least 12 VAS points, at least 14 VAS points, or 10-25 VAS points.
Williams teaches that a decrease of 10-15 points is indicative of a “minimally improved” change in VAS (pg 5, col 2, para 1). 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 the instant case, the VAS range of 10-15 points overlaps with the instantly claimed VAS ranges of ≥12, ≥14, and 10-25 VAS points. Thus is considered obvious. See MPEP § 2144.05(I).
claim 7, 8
Regarding claims 7 and 8, Wrobel does not teach a mean VAS of 49-60 points, nor a mean VAS score of 52-58 points.
Williams teaches that general anxiety (GA) disorder patients in the study began with an average VAS of 67.26+/-16.1 points (pg 4, col 2, para 3). Williams teaches that VAS scores declined in the treatment group to 49.16+/-23.7 points (pg 4, col 2, para 3). 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 the instant case, the mean VAS of 49.16+/-23.7 points overlaps with the instantly claimed VAS ranges of 49-60 points and 52-58 VAS points. Thus is considered obvious. See MPEP § 2144.05(I).
claim 11, 12
Regarding claims 11 and 12, Wrobel teaches that their invention identifies novel prodrugs of riluzole which possess enhanced stability to hepatic metabolism and are delivered into systemic circulation by oral administration, in order to treat anxiety and/or cancer (pg 3, para 3). Wrobel teaches a pharmaceutical composition of riluzole or prodrug thereof (abstract), comprising an excipient and other active ingredients (pg 213, para 1), intended for improved oral bioavailability (pg 214, para 1). Wrobel teaches the excipient may be a filler or a coating to ensure delivery of the ingredients or to improve oral bioavailability (pg 214, para 1). Wrobel teaches the composition can comprise a pharmaceutically acceptable carrier or diluent as described in Remington’s Pharmaceutical Sciences (pg 214, para 2).
Wrobel teaches administering to the patient a pharmaceutical composition (claim 10) comprising a therapeutically effective amount of riluzole, or a pharmaceutically acceptable salt or prodrug thereof (claim 1), in the form of an oral solid molded fast-dispersing dosage form, such as a sublingual tablet comprising a tablet-disintegrating agent (pg 214, para 3). Wrobel teaches the intrinsic properties of riluzole such as “a very low solubility in water, poor oral palatability, pH dependent chemical stability, and intense as well as persistent numbness or burning sensation throughout the oral cavity” make it undesirable for sublingual administration in isolation (pg 3, para 1). Similarly, the instant specification echoes these teachings that riluzole has “a very low solubility in water, poor oral palatability, pH dependent chemical stability, and intense oral numbness if administered directly to the oral mucosa” (pg 4, para 5). Hence, Wrobel teaches that other additives and adjuvants to address these concerns must be included, such as flavoring agents, solubilizers, fillers, and/or binders (pg 214, para 3).
Wrobel teaches the tablet can comprise gelatin, mannitol, (pg 215, para 2), or a flavoring agent (pg 215, para 3). Wrobel teaches tablets of the disclosed compounds can be mixed with a carrier having the necessary compression properties in suitable proportions and compacted in the shape and size desired (pg 214, para 3). Wrobel teaches compositions can comprise up to 99% of the active compound (pg 214, para 3).
Wrobel does not teach the composition of the riluzole or prodrug thereof, comprising about 50-70 weight% riluzole/riluzole prodrug, about 10-30 weight% fish gelatin, about 10-20 weight% of a filler, and 0.1-5.0 weight% of a flavorant. Wrobel does not teach the filler is mannitol.
Rowe teaches a capsule formulation designed for rapid dissolution of the shell components (abstract; para 0048). Rowe teaches the capsules are designed for pre-gastric absorption of the active ingredient, such as a medicament (pg 1, para 004). Rowe teaches the formulation comprises 29 wt% gelatin (claim 1), wherein the gelatin is fish gelatin (claim 11), Thus rendering obvious the limitation of 10-30 wt% fish gelatin. Rowe teaches the capsules comprise 19 wt% of a plasticizer (claim 2), wherein the plasticizer is mannitol (claim 5). Thus rendering obvious the filler, mannitol, in an amount of 10-20 wt%. Rowe teaches flavoring the capsules (claim 37) with 8.708 mg of peppermint oil per 1000 mg capsule (pg 8, Table 11), this corresponds to a 0.9 wt% of flavorant. Thus rendering obvious 0.1-5.0 wt% flavorant.
It would have been obvious to combine the teachings of Wrobel and Rowe, arriving at rapidly dissolving capsule or tablet comprising the quantities of ingredients instantly claimed because Wrobel teaches riluzole and prodrugs thereof can be compounded into tablets comprising gelatin, mannitol, and a flavorant, and Rowe teaches the specific quantities of those ingredients in over to arrive at a fast-dissolving capsule suitable for pre-gastric absorption of a medicament. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In the instant case, applicant has not provided any evidence of criticality, thus arriving at an optimal quantity of riluzole or prodrug thereof of 50-70 wt% in the tablet or capsule is considered a matter of routine experimentation. See MPEP § 2144.05(II)(A). Furthermore, it is clear from the teachings of Wrobel that in order to arrive at a tablet that compacts and dissolves properly, the quantity of riluzole or prodrug thereof was recognized as a result-effective variable, intended to be modified. See MPEP § 2144.05(II)(B).
claim 15
Regarding claim 15, Wrobel teaches a method of treating an anxiety disorder in a patient in need thereof (claim 11), comprising administering to the patient a pharmaceutical composition (claim 10) comprising a therapeutically effective amount of the riluzole prodrug defined by R23 being H described previously in the 102(a)(1) rejection of claim 1 above (pg 208, Table 1, entry 15; claim 1), in the form of an oral solid molded fast-dispersing dosage form, such as a sublingual tablet comprising a tablet-disintegrating agent (pg 214, para 3).
Matsuda teaches a kit comprising a composition comprising riluzole and instructions for its use (pg 22, para 0084 – pg 23, para 0088).
It would have been obvious to combine the teachings of Wrobel and Matsuda, arriving at a kit comprising riluzole or a prodrug thereof comprising written instructions for its use because Matsuda teaches that riluzole can be combined with written instructions that describe its use. One of skill in the art would have had a reasonable expectation of success because (1) Matsuda teaches that riluzole is compatible with written instructions; and (2) Wrobel teaches that riluzole and prodrugs thereof are capable of treating anxiety. Where a product merely serves as a support for printed matter, no functional relationship exists. These situations may arise where the claim as a whole is directed towards conveying a message or meaning to a human reader independent of the supporting product. Additionally, where the printed matter and product do not depend upon each other, no functional relationship exists. For example, in a kit containing a set of chemicals and a printed set of instructions for using the chemicals, the instructions are not related to that particular set of chemicals. In re Ngai, 367 F.3d at 1339, 70 USPQ2d at 1864. See MPEP § 2111.05(I)(B). Thus the instantly claimed written instructions hold no patentable weight.
Response to Arguments
Applicant’s arguments filed on 1/8/2026 have been fully considered but they are not persuasive.
102; pg 4, para 4
Applicant argues that Wrobel doesn’t teach their compounds treating social anxiety disorder and or enhancing memory. Applicant acknowledges that Wrobel teaches troriluzole but does not “focus” on troriluzole, but also teaches other compounds.
Examiner disagrees, see Wrobel pg 2, para 3, which specifically teaches treating these conditions. Regarding the second argument, this is a matter of subjective perception. There is no set limit of how many compounds can be claimed in a given patent application. One of skill in the art would have been able to identify that troriluzole as being capable of treating these conditions given the disclosure of Wrobel states that it is.
102; pg 5, para 1
Applicant argues Wrobel teaches too many diseases and that one of skill in the art would not assume troriluzole is effective for treating social anxiety or memory loss.
Wrobel teaches that all of the compounds are useful for treating all of the conditions. See MPEP § 2121(I): the prior art is presumed enabled. Absent any teaching or suggestion to suggest otherwise, one of skill in the art would presume that Wrobel’s teaching of troriluzole being effective in treating these diseases is valid.
102; pg 6, para 1
Applicant repeats the argument that Wrobel doesn’t teach their compounds treating social anxiety disorder and or enhancing memory.
See first response to the previous two arguments. Wrobel teaches the exact same drug as shown below (pg 208, Table 1, entry 15) and specifically teaches treating these conditions (pg 2, para 3).
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See MPEP § 2145: Arguments presented by applicant cannot take the place of factually supported objective evidence. See, e.g., In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984).
103; pg 7, para 1
Applicant argues improper hindsight was used to construct the rejection wherein the basis of this argument hinges on the assumption that Wrobel does not teach teaching social anxiety or enhancing memory. Applicant then later acknowledges Wrobel does treat these conditions, but argues that the list is too long, and presumes a person of skill in the art would not be able to select the diseases from the list because the examples focus on other diseases.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Furthermore, there is no requirement that the examples supplied in patent applications must encompass the same scope as the claims. Thus despite lacking a specific exemplary study on troriluzole treating social anxiety, one of skill in the art would be able to determine from the disclosure of Wrobel, that it is effective in treating social anxiety because the application states that it is.
103; pg 8, para 1
Applicant argues that a person of skill in the art would recognize that cancer is a different disease than neurological conditions. Applicant repeats the argument that there was no guidance in the reference of Wrobel provided suggesting that troriluzole could treat multiple conditions.
Because cancer can also effect the brain, it is not a given that the two conditions are separate. Arguments towards the drug having multiple uses are undermined by Wrobel teaching those same multiple uses. Thus a person of ordinary skill in the art would only need to read the disclosure of Wrobel to realize troriluzole had multiple functions. Given that disclosure, they would have had a very reasonable expectation of success. The second argument has been addressed several times above.
103; pg 8, para 5
Applicant argues Wrobel teaches a broad variety of drugs, thus one of skill in the art would not have been motivated to select troriluzole from this list. Applicant argues that there was no reason for a person to select troriluzole from the list of compounds provided by Wrobel. Applicant repeats the argument that there weren’t any example studies with troriluzole. Applicant argues no pharmacokinetic data was provided and that the experiments were performed in mice.
There are no scientific standards established for patents, thus arguments regarding a lack of pharmacokinetic data, what model organism was chosen, and exemplary studies found wanting are without merit. At issue is whether a person of ordinary skill from the art could ascertain whether or not troriluzole was effective for treating these conditions. Given the disclosure of Wrobel that troriluzole can be used to treat these conditions supplies the necessary reasonable expectation of success required.
103; pg 9, para 1
Applicant argues that Wrobel does not teach which genera of compounds are effective in treating social anxiety/memory loss.
Wrobel teaches all of them are. There is no requirement or prerequisite degree establish for the extent that the given compounds treat a given disorder, be it 1% or 100%. Because all of the compounds of Wrobel have the property of treating social anxiety/memory loss, then it is sufficient to apprise a person of skill in the art of these uses.
103; pg 9, para 3
Applicant argues Williams, Walpol, Rowe, and Matsuda are supplementary references.
Examiner agrees these references are indeed, supplementary, as no deficiency in Wrobel has been identified.
103; pg 9, para 5
Applicant argues that the previously made improper hindsight argument made in their previous correspondence was from the perspective of a person of skill in the art lacking the scientific data to justify using troriluzole to treat these conditions.
While Examiner fully understands the frustration of a disclosure lacking concrete or substantiative scientific evidence to verify a given claim. Degree of efficacy of a given treatment or thoroughness of the evidence provided is not a prerequisite for a patent. Again, see MPEP § 2121(I): the prior art is presumed enabled. Absent the evidence suggesting a given invention doesn’t work, it is presumed fully functional to an infinitesimal degree.
103; pg 10, para 2
Applicant argues that Examiner uses five references to make a 103 rejection and that no motivation is used to combine them.
As applicant stated previously, four of the five references are supplementary references not related to the core structure of the instant invention, because the reference of Wrobel teaches the remainder. There is no limit on the number of references used to formulate a rejection, and this number is not particularly high compared to other office actions. The motivation to combine these references is established in the 103 rejection above. Applicant also provided an excellent summary of these motivations:
“Williams is cited with regard to the VAS scale to measure Anxiety. Walpole is cited for the average body mass of a human. Rowe is cited as disclosing a capsule formulation designed for rapid dissolution of the shell components. Matsuda is cited as disclosing a kit including a riluzole-containing composition and instructions for its use Williams is cited with regard to the VAS scale to measure anxiety. Walpole is cited for the average body mass of a human. Rowe is cited as disclosing a capsule formulation designed for rapid dissolution of the shell components. Matsuda is cited as disclosing a kit including a riluzole-containing composition and instructions for its use.”
Conclusion
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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA ANN ESSEX whose telephone number is 571-272-1103. The examiner can normally be reached Mon - Fri 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey Stucker can be reached on 571-272-0911. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.E./
Examiner, Art Unit 1675
/JEFFREY STUCKER/Supervisory Patent Examiner, Art Unit 1675
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