DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s amendment and response, submitted December 10, 2025, has been reviewed by the examiner and entered of record in the file.
3. Claims 1, 2, and 6 are amended, and claims 4 and 5 are canceled. Claim 6 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected invention, without traverse, there being no allowable generic or linking claim.
4. Claims 1-3 are under examination and are the subject of this office action.
Information Disclosure Statement
5. The information disclosure statement (IDS) submitted on December 10, 2025, is in compliance with the provisions of 37 CFR 1.97 and has been considered by the examiner. Please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Previous Claim Rejections - 35 USC § 112(a)
6. Claims 1-3 were rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as lacking enablement for treating any “FXS-related developmental disorder” OR for preventing autism spectrum disorder, FXS, or any FXS-related developmental disorder, comprising administering a pharmaceutical composition comprising lisuride or any metabolite or salt thereof.
7. In view of Applicant’s amendment to limit claim 1 to the treatment of autism spectrum disorder, comprising administering a pharmaceutical composition comprising lisuride or a pharmaceutically acceptable salt thereof to a subject in need thereof, the previous rejection under 35 USC 112(a) is overcome and is withdrawn.
Previous Claim Rejections - 35 USC § 103
8. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
9. Claims 1-3 remain rejected under 35 U.S.C. 103 as being unpatentable over Sebree and Siegel, WO 2007/117687 A2, as evidenced by Lord et al., Nat. Rev. Dis. Primers (2022).
Claim 1 is directed to a method of treating autism spectrum disorder comprising administering a pharmaceutical composition comprising lisuride or a pharmaceutically acceptable salt thereof to a subject in need thereof, (more specifically, lisuride:
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(claim 2)), and
wherein the autism spectrum disorder is accompanied by one or more symptoms selected from hyperactivity or social deficit (claim 3).
10. Sebree discloses a method of treating a dopamine associated state in a subject, in particular naming autism in a subgenus of eleven dopamine associated states (Claim 2), comprising administering to said subject an implant comprising a dopamine modulating compound (as a class of drugs), specifically naming the dopamine agonist lisuride in a subgenus of seventeen particular suitable dopamine agonists (Claim 5). Sebree teaches pharmaceutically acceptable salts, esters, prodrugs, and metabolites of the dopamine agonists (page 3, lines 19-20). Sebree teaches wherein the implant comprises the dopamine agonist and a polymer that is biocompatible to the human body (i.e., comprises a pharmaceutical composition comprised of the polymer and the dopamine agonist), i.e., “[i]n one embodiment, the implant is comprised of a polymer that is biocompatible. The term "biocompatible" includes polymers which are not toxic to the human body, are not carcinogenic, and do not significantly induce inflammation in body tissues,” (page 6, lines 14-16).
11. While Sebree does not exemplify a single disclosed method of treating autism in a subject in need thereof comprising administering a composition comprising lisuride to said subject, Claim 5 of Sebree embraces a method of treating autism comprising administering a dopamine agonist that is lisuride. Thus, in this case, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter. 1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described' as that term is used in 35 U.S.C. § 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982).
12. Sebree teaches that the dopamine associated state to be treated is autism (page 2, lines 33-37). And, it is clear as evidenced by Lord et al. that autism is characterized by impairments in social communication (i.e., social deficits) and often accompanied by hyperactivity disorders:
“[m]anifestations of autism include impairments in social communication and interaction, sensory anomalies, repetitive behaviours and varying levels of intellectual disability (BOX 1). Together with these core symptoms, co-occurring psychiatric or neurological disorders are common in people with autism, of which hyperactivity and attention disorders (such as attention-deficit/hyperactivity disorder (ADHD)), anxiety, depression and epilepsy are fairly prevalent.
[emphasis added], (see page 2, third paragraph).
13. As such, one skilled in the art before the effective filing date of the claimed invention would have been motivated to administer the known dopamine agonist lisuride, specifically taught as particularly suitable by Sebree, and would have had a reasonable expectation of success in treating an autistic subject in need thereof.
14. Regarding the comprehensive of the genus of “dopamine associated states” disclosed by Sebree, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQad 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
15. Additionally, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed...." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004).
As such, claims 1-3 are prima facie obvious.
Response to Arguments
16. Applicant traverse the obviousness rejection of claims 1-3 over Sebree as evidenced by Lord et al., and argues the following points:
(i) Applicant argues that the instantly claimed method of using lisuride for treating autism spectrum disorder was experimentally confirmed in an autism animal model, demonstrated in Figures 4-7 and Examples 2 and 3 of paragraphs [0062]-[0071] of the instant Specification (referencing US 2023/0024384). Applicant contends that this discovery was both (1) not disclosed or suggested in Sebree as evidenced by Lord, and (2) surprising based on the literature available prior to the priority date of January 8, 2021, of Applicant's specification.
Applicant alleges that Sebree fails to disclose or suggest that lisuride can treat autism spectrum disorder, but instead discloses lisuride as a dopamine agonist, (referring to Sebree at claims 5, 28, and 49, each of which characterize lisuride as a dopamine agonist; see also page 3, lines 21 (identifying lisuride as a dopamine agonist)). Applicant argues that while Sebree states a relationship between autism and a "dopamine associated state," there is no disclosure or data in Sebree showing or even suggesting that lisuride, as a dopamine agonist, treats autism.
17. Applicant's arguments have been fully considered but they are not persuasive. Regarding Applicant’s argument that Sebree fails to disclose or suggest that lisuride can treat autism spectrum disorder, Sebree teaches and recites in Claim 1: “[a] method for treating a subject for a dopamine associated state, wherein said dopamine associated state is autism (Claim 2), comprising administering to said subject a biodegradable implant, wherein said implant comprises an effective amount of a dopamine modulating compound (wherein said dopamine modulating compound is a dopamine agonist (Claim 4) and wherein said dopamine agonist is lisuride (Claim 5), such that said subject is treated for said dopamine associated state.” As such, the fact that Sebree teaches lisuride as a dopamine agonist does not negate the fact that Sebree motivates one skilled in the art to select lisuride from a small genus of dopamine modulators for administration to a subject for the treatment of a dopamine associated state in said subject, specifically naming autism as the dopamine associated state.
(ii) Applicant alleges that objective third party data confirms that dopamine agonists were believed to induce repetitive or compulsive behavior, both of which are known symptoms of autism spectrum disorder (instant Specification at paragraph [0005]). Applicant references Schepisi et al., Psychopharmacology (2015), (Exhibit A), arguing that Schepisi et al. “confirm that dopamine agonists can cause autism spectrum disorder symptoms.”
Applicant references Hellings et al., (2017) (Exhibit B), for an alleged teaching of dopamine antagonists treating autism spectrum disorder symptoms.
Applicant references Paval, Dev Neurosci (2017) (Exhibit C), as “another example of objective third party data confirming that dopamine antagonists were believed to treat symptoms of autism spectrum disorder prior to the priority date of Applicant's claimed invention.”
Applicant argues that apomorphine, which is described as a dopamine agonist in Sebree (see claims 5, 28, and 49), was used by Applicant as a drug to cause autism symptoms (instant specification at Figure 5 and Example 3).
Applicant submits that a person having ordinary skill in the art, in view of Sebree, would not have a reasonable basis to conclude that lisuride could be used to treat autism spectrum disorder; rather, such a person would expect the opposite effect: lisuride would cause symptoms associated with autism spectrum disorder.
18. Applicant's arguments have been fully considered but they are not persuasive. While Schepisi et al. demonstrate that the dopamine agonist pramipexole (PPX) produces an exaggerated increase in contrafreeloading (CFL) for water, a repetitive and highly inflexible behavior that models core aspects of compulsive disorders, such as OCD, (see Abstract), Schepisi et al. fail to teach or suggest that PPX, or any dopamine agonist, causes autism spectrum disorder.
Regarding the references Hellings and Paval, the fact that each reference teaches the use of dopamine antagonists for the treatment of autism spectrum disorder symptoms does not negate the fact that Sebree suggests lisuride for the treatment of autism.
Sebree teaches a subgenus of 11 “dopamine associated state[s],” specifically naming the dopamine associated state of autism within said small subgenus of dopamine associated states, such that one skilled in the art would have immediately envisaged selecting lisuride for the treatment of autism spectrum disorder. And, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." 27 F.3d at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). In this case, Sebree teaches and recites a method for treating a dopamine associated state in a subject, specifically naming autism (Claim 2), comprising administering to said subject a biodegradable implant comprising an effective amount of a dopamine modulating compound, in particular a dopamine agonist (Claim 4), and specifically naming lisuride in small genus of dopamine agonists (Claim 5).
And, a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.").
For the sake of argument, even if it was agreed that Sebree taught away from administering lisuride for the treatment of autism spectrum disorder, “[e]ven if a reference discloses an inoperative device, it is prior art for all that it teaches,” (Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547 (Fed. Cir. 1989)). Therefore, “a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103” (Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569 (Fed. Cir. 1991)). Thus, Sebree’s suggestion of treating a dopamine associated state in a subject, specifically naming autism, comprising administering a dopamine modulating compound including lisuride to said subject, constitutes prior art.
Previous Claim Objections
19. Claim 2 objected to because the compound structure of lisuride depicted as “Formula 1” is blurry and some of the lines are difficult to distinguish.
Conclusion
20. In conclusion, claims 1-3 and 6 are present in the application. Claim 6 is currently withdrawn from consideration as directed to a nonelected invention. Claims 1-3 are rejected. No claim is presently allowable.
21. THIS ACTION IS MADE FINAL. 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.
22. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy L Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628