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
Election/Restriction
Applicant's election without traverse of Group I (claims 1-4, 8 and 29-30) and species : 1) Sumatriptan as the specific triptan; 2) SSRI to be combined with the triptans; 3) Fragile X Syndrome (FXS) as the FMR1 mediated autism species or disease, 4) Fluvoxam as the specific SSRI, on 10/23/2025, is acknowledged.
Claims 1-4, 8 and 29-30 read on the elected invention and species.
Claims 5-7, 9, 11-20 and 22-28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention.
Status of Claims
Claims 1-9, 11-20 and 22-30 are pending in the instant application.
Claims 5-7, 9, 11-20 and 22-28 are withdrawn.
Claims 1-4, 8 and 29-30 are currently under examination.
Priority
This application 18/249,229 filed on 04/14/2023 is a 371 of PCT/EP2021/078720 filed 10/15/2021,which claims benefit to GB patent Application No. 2016493.5 filed 10/16/2020 and GB patent Application No. 2111346.9 filed 08/05/2021.
The certified copy of GB patent Application Nos. 2016493.5 and 2111346.9 are filed on 04/14/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/23/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the Examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: “the” article before treatment lacks antecedent basis and is not necessary.
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.
Claims 1, 3-4, 29 and 30 are rejected under 35 U.S.C. 112(a) first paragraph, as failing to comply with the enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to practice the invention commensurate in scope with these claims. The specification, while being enabling for a method of ameliorating symptoms of FMR1 mediated autism with certain triptan (e.g. sumatriptan) at certain treatment regimen, does not reasonably provide enablement for treating FMR1 mediated autism with any triptan or derivatives thereof. This is a scope of enablement rejection.
To be enabling, the specification must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). The determination that "undue experimentation" would have been needed to practice the claimed invention in full scope is not a single, simple factual determination.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is "undue." In In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first paragraph, have need described. They are:
(A) The breadth of the claims;
(B) The nature of the invention;
(C) The state of the prior art;
(D) The level of one of ordinary skill;
(E) The level of predictability in the art;
(F) The amount of direction provided by the inventor;
(G) The existence of working examples; and
(H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. Keeping that in mind, the Wands factors are relevant to the instant application for the following reasons:
The Breadth of The Claims/ Nature of The Invention
Instant claims are directed to a method for the treatment, management or amelioration of FMR1 mediated autism comprising, administering a therapeutically effective amount of a medicament comprising one or more triptans or derivatives thereof to an individual in need of such treatment, management or amelioration. As disclosed by instant specification (See Page 5) : the terms "treatment", "treating", “treat” and the like, refer to obtaining a desired pharmacologic and/or physiologic effect. The effect can be prophylactic in terms of completely or partially preventing a disease or symptom thereof and/or can be therapeutic in terms of a partial or complete cure for a disease and/or adverse effect attributable to the disease. "Treatment" as used herein, covers any treatment of a disease in a mammal, particularly in a human, and includes: (a) preventing the disease from occurring in a subject which can be predisposed to the disease but has not yet been diagnosed as having it; (b) inhibiting the disease, i.e., arresting or slowing its development; and (c) relieving the disease, i.e., causing regression of the disease. As such, instantly claimed scope of “treatment” is extremely broad. Instant Spec does not define instant claimed triptans or derivatives genus which might include any modified compound related to triptans. Instant claim 30 recites SSRI genus which encompass variety of active compounds having different chemical structures and different activities, etc. Instant claims do not recite route of administration, treatment regimen(dose, frequency, duration, etc.) and measurement of therapeutic effect, etc. As such, the scope of instant claims are extremely broad in contrast with instant specification which only discloses a few working example of triptans (sumatriptan, oxitriptan) ameliorating certain behavior symptoms of FMR1-mediated autism model in mice.
The State of the Prior Art and the Predictability or Lack Thereof in the Art
It is well known in the art that autism is highly heterogenous and variety of genes have been implicated as related to autism, wherein FMR1 is only one of the possible cause as discussed in Dolen (2009, Applicant’s IDS dated 10/23/2025). Gürkan (2012, Applicant’s IDS dated 10/23/2025) reviews neurobiology of autism and teaches FXS caused by full mutation of the fragile X mental retardation 1 gene (FMR1) is the most common single-gene cause of the autism with 60% percentage of ASD in FXS (See page 4) . In general, the treatment for autism including FMR1-related autism is highly unpredictable due to highly individual nature of the condition. There is no cure for the underlying pathology of FMR1-related autism and/or Fragile X syndrome (FXS). FMR1-related autism and/or Fragile X Syndrome can’t be prevented because it is caused by inherited gene dysfunction. The FDA-approved medications for treating certain symptoms of autism are risperidone and aripiprazole for treating irritability, aggression, and self-injurious or explosive behaviors. Although there are many studies (e.g. mGluR5 antagonists, D-cycloserine, etc.) on treating secondary behavioral problems in autism, treatments targeting the core symptoms of autism are relatively few and are in need of study for evidence of clinical efficacy (See Gürkan 2012, page 6-8).
More generally, the invention is directed toward medicine and is therefore physiological in nature. It is well established that “the scope of enablement varies inversely with the degree of unpredictability of the factors involved,” and physiological activity (e.g., cancer prevention) is generally considered an unpredictable factor. See In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970).
The Amount of Direction Present and Presence or Absence of Working Examples
The specification does not provide sufficient guidance/protocols for a skilled artisan to practice the claimed treatment or in its full scope. The disclosed examples are directed to evaluating two triptans ( sumatriptan, oxitriptan) on behavior symptoms of FMR1 knock-out mice model compared with wild- type mice (See Example 1). It’s noted the effectiveness of triptans (sumatriptan and oxitriptan) vary in different assays (daily living , sociability) and is not significant in comparation with control as shown in Figures 1-6, Table 1-6 and 11, which shows unpredictability of symptomatic treatment of FMR-1 related autism. No direction or examples are provided for assay of other triptans or derivatives. No direction or examples are provided for the efficacy of triptans (e.g. sumatriptan) in combination with any SSRI as recited in claim 30.
The level of one of ordinary skill in the art
The level of skill required to make and/or use the instant invention would likely require many years of professional experience conducting research in the art (e.g., medicine, pharmaceutical science, biology, biochemistry, medicinal chemistry, and/or organic chemistry, etc.) as well as an advanced educational degree (e.g., M.D. and/or Ph.D.) commensurate in level with the advanced techniques involved in the preparation and/or use of the instant invention.
The quantity of experimentation needed
An unduly extensive amount of experimentation would be required for one of ordinary skill in the art to develop protocols for different triptans and derivatives in different subjects. Different triptan derivatives have different chemical structure, different biological activity, different pharmacokinetic profile, etc. Working examples would be needed to determine the therapeutic regimen for different triptans and derivatives, respectively. The therapeutically effective amount may vary depending on many factors, e.g. the subjects being treated, the disease condition and intended result etc. Although FMR1 knock-out mice model might correlate with human study in some symptomatic treatment, the efficacy in mice model might not translate into efficacy in human due to the high unpredictable nature of FMR1 mediated autism.
Therefore, it would be a great burden for one of ordinary skill in the art to carry out undue experimentation to use the claimed invention for treating the claimed in full scope.
Conclusion
MPEP 2164.01(a) states, “A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557,1562,27 USPQ2d 1510, 1513 (Fed. Cir. 1993).” That conclusion is clearly justified here with respect to the claimed method for treatment, management or amelioration of FMR1 mediated autism with triptans or derivatives in view of the analysis above pursuant to In re Wands. In other words, one skilled in the art could not practice the claimed invention without undue experimentation.
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.
Claims 1-4, 8 and 29-30 are rejected under 35 U.S.C. 112(b), 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 1 is directed to “a method for the treatment, management or amelioration of FMR1 mediated autism comprising, administering a therapeutically effective amount of a medicament comprising one or more triptans or derivatives thereof to an individual in need of such treatment, management or amelioration”. The term “derivatives” renders the claim indefinite, since the derivatives might include any modified compound related to triptans. The Spec does not define what kind of triptans derivatives, e.g. oxide, salt, esters, etc. are included in instant claimed “derivatives”. The term “management” is vague which might refer to general maintenance, not necessarily therapeutic improvement. The limitation “amelioration” is relative and subjective term. Instant specification does not disclose quantifiable degree or to what extent by what measurement would be considered as “amelioration” of FMR1 mediated autism. There are no objective standard to determine what’s the scope of instantly claimed method for management and amelioration of FMR1-mediated autism. The lack of clarity renders the claims indefinite since the resulting claims do not clearly set forth the metes and bounds of the patent protection desired.
MPEP 2173.05(b) IV states “ A claim that requires the exercise of subjective judgment without restriction may render the claim indefinite. In re Musgrave, 431 F.2d 882, 893, 167 USPQ 280, 289 (CCPA 1970). Claim scope cannot depend solely on the unrestrained, subjective opinion of a particular individual purported to be practicing the invention. Datamize LLC v. Plumtree Software, Inc., 417 F.3d 1342, 1350, 75 USPQ2d 1801, 1807 (Fed. Cir. 2005)); see also Interval Licensing LLC v. AOL, Inc., 766 F.3d 1364, 1373, 112 USPQ2d 1188 (Fed. Cir. 2014)”.
Claims 3-4, 8 and 29-30 are rejected due to dependency from claim 1.
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-4 and 30 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hollander et al. (Neuropsychopharmacology 2000, 22, 163–167, Applicant’s IDS dated 10/23/2025, “The relationship between repetitive behaviors and growth hormone response to sumatriptan challenge in adult autistic disorder”).
Hollander teaches autism is heterogeneous disease related with variety of neurobiological biomarkers and clinical symptoms, e.g. unique behavioral dimensions: social impairment, communication difficulties and rigid, restricted interests, and repetitive behaviors (See abstract, page 163, left column). Hollander and incorporated reference teach pharmacological treatment studies support a role of 5-HT in autistic disorders (See page 163, right column; page 164, left column, para 1-4). Hollander teaches sumatriptan, originally marketed as an anti-migraine medication, is primarily a 5-HT1d receptor agonist but may also bind to 5-HT1b, and evaluate the repetitive behavior dimension response to sumatriptan in adult autistic patients (See page 164, left column; Method, Result)
Hollander teaches the severity of repetitive behaviors (as measured by the YBOCS-compulsion subscale), but not other behavioral dimensions (communication and social deficits as measured by ADI-R algorithm subscales), parallels sumatriptan-elicited growth hormone response, indicating specific component of the 5HT system (the 5HT 1d receptor) may play a role in mediating one specific behavioral component of autistic disorder (repetitive behavior) (See page 165, left column).
Regarding claim 30, Hollander and incorporated references teach serotonin reuptake inhibitors (SRI’s) (e.g. clomipramine, fluvoxamine and fluoxetine and sertraline, etc. have documented efficacy in treating both global autistic symptoms as well as symptoms of repetitive behaviors(See page 164, left column, para 1). Hollander teaches patient treated with fluvoxamine prior to sumatriptan (See Method, page 164, right column).
Hollander is silent about sumatriptan treating or ameliorating FMR1 mediated autism or the FMRI related autism is related to FXS. However, products of identical or similar composition cannot exert mutually exclusive properties when administered under the same or similar circumstances. Therefore, the functional effects would be inherent/direct result of sumatriptan based upon the fact that Hollander medicament contains the instantly claimed ingredients (sumatriptan) administered to subjects with autism as in instant application. As such, Hollander anticipates instant claimed invention.
Claims 1-4, 8 and 29 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WOOD (WO 2021081376 A1, Applicant’s IDS dated 10/23/2025).
Wood disclosed a method of treating symptoms associated with autism spectrum disorder ASD comprising administering a therapeutically effective amount of a triptan (e.g. zolmitriptan, sumatriptan, etc.) to a patient in need thereof (See abstract, [0003]-[0007], claims 1-32). Wood and incorporated reference teaches serotonin system has been implicated in the pathophysiology of autism since an abnormal blood 5-HT level was discovered as the first biomarker of the disorder and FMR1 is related with ASD (See [0028]). Wood teaches triptans have selective activity on the 5-HT1B, 5-HT1D, and 5-HTlF receptors, which belong to the serotonin (5-HT) system (See [0027]). Wood teaches reduction of the symptoms/amelioration of autism in patients with ASD by triptans can be determined by various evaluation/measurement, e.g. OSU Autism Rating Scale (OARS-5), sociability, behaviors, etc. (See [0049]-[0053], [0192], Examples 1-4, Figure 1-4).
Regarding claims 2 and 3, Wood explicitly disclosed sumatriptan (See[0005], [0030]-[0031], [0054], claim 13, 20-32).
Regarding claim 8, Wood teaches the dosing regimen and variety of dose amount of sumatriptan for treating autism comprise administering a therapeutically effective amount of sumatriptan or a pharmaceutically acceptable salt thereof from about 1mg, to 50 mg to about 100mg (See [0054]-[0066], claim 20-32)
Regarding claim 29, Wood teaches medicament/formulation of sumatriptan comprise pharmaceutical carrier/excipient (See [0026], [0039]-[0042]).
Wood is silent about FMR1 mediated autism is related to Fragile X Syndrome (FXS) as recited in instant claim 4. It’s well-known that Fragile X Syndrome (FXS) is genetic disorder associated with mutation of FMR1 as disclosed prior art and by instant specification (See page 1). A skilled artisan would know FMR1 mediated autism is related to Fragile X Syndrome (FXS). Please note the subjects diagnosed as having or suspected of having autism spectrum disorder in need thereof taught by Wood is considered to encompass subjects with FMR-1 mediated autism related to FXS in the absence of evidence to the contrary. The functional effects of treating FMR-1 related autism and Fragile X Syndrome (FXS) would be inherent/direct result of triptans based upon the fact that Wood medicament contains the instantly claimed ingredients (triptans, sumatriptan) administered to subjects with autism as in instant application.
Wood collectively teaches a method for treatment and management of autism comprising administering triptans (e.g. sumatriptan, etc.) in a subject in need thereof. As such, Wood anticipates instantly claimed invention.
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 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 non-obviousness.
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 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.
Claims 1-4, 8 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over WOOD (WO 2021081376 A1, Applicant’s IDS dated 10/23/2025), as applied to 102 rejection above, and further in view of McDougle et al. (Arch Gen Psychiatry, 1996, 53:1001–1008, doi:10.1001/archpsyc.1996.01830110037005, A double-blind, placebo controlled study of fluvoxamine in adults with autistic disorder).
The collective teaching of Wood is elaborated in preceding 102 rejection and applied as before. Wood collectively teaches a method for the treatment and management of autism comprising administering triptans (e.g. sumatriptan, etc.) to a patient in need thereof.
Regarding claim 30, Wood teaches combination of triptans with other active ingredients (e. g risperidone (See [0185]). Wood is silent about medicament of triptans further comprise an SSRI. Wood teaches autism is related with serotonin system and selective serotonin re-uptake inhibitor SSRIs are commonly used medicament treating serotonin related disease/disorder. It would be prima facie obvious to combine triptans with SSRI in treating autism spectrum disorder since both triptans and SSRI are related to serotonin system.
Further, McDougle teaches a double-blind, placebo controlled study of fluvoxamine in adults with autistic disorder (See full article). McDougle teaches fluvoxamine superior to placebo in reducing repetitive thoughts and behavior, maladaptive behavior, and aggression and in improving some aspects of social relatedness , especially language usage (See Results from page 1003-1005, Figures 1-3). McDougle concludes fluvoxamine is more effective in the treatment of symptoms of autistic disorder in adults (See page 1006, Comment/Conclusion).
"It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Jn re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980).
Combination therapy is common practice in the art of treating neurological disease/disorder. The skilled artisan would be motivated to combine triptans with SSRI because both triptans taught by Wood and fluvoxamine taught by McDougle are 5-HT inhibitor that show efficacy in treatment of autism. One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the teachings of prior art and general knowledge of treatment/management of autism. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1-4, 8 and 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over WOOD (WO 2021081376 A1, Applicant’s IDS dated 10/23/2025), as applied to 102 rejection above, and further in view of Uutela et al. (Front. Cell. Neurosci., 2014, Vol. 8 Article 150, page 1-9, https://doi.org/10.3389/fncel.2014.00150, Distinctive behavioral and cellular responses to fluoxetine in the mouse model for Fragile X syndrome).
The collective teaching of Wood is elaborated in preceding 102 rejection and applied as before. Wood collectively teaches a method for the treatment and management of autism comprising administering triptans (e.g. sumatriptan, etc.) to a patient in need thereof.
Wood is silent about FMR-1/FXS related autism and medicament of triptans further comprise an SSRI. ). The functional effects of treating FMR-1 related autism and Fragile X Syndrome (FXS) is considered as direct result of triptans based upon the fact that Wood medicament contains the instantly claimed ingredients (triptans, sumatriptan) administered to subjects with autism as in instant application.
Uutela teaches fluoxetine, a SSRI, is a therapeutic agent for treating symptoms of autism spectrum disorder (ASD), including Fragile X syndrome (See whole article). Uutela teaches Fragile X syndrome (FXS) caused by FMR1 mutation, is a well characterized form of autism spectrum disease (ASD), and treatment with fluoxetine has been shown to benefit FXS individuals with autism, social anxiety, or selective mutism (See Introduction, page 1). Uutela further teaches evaluation of behavioral and cellular effects of fluoxetine on adult Fmr1 knockout (KO) mice, a mouse model for FXS wherein fluoxetine reduced anxiety-like behavior of both wild-type and Fmr1 KO mice(See abstract, Results from page 3, Figure 1-3).
It would be obvious and logical for a skilled artisan to further explore triptans taught by Wood in patients with FMR1/FXS related autism for targeted treatment based on the combined teachings of Wood and Uutela, together with experimentation and optimization based on general knowledge of treatment for FMR-1 autism. The skilled artisan would be motivated to combine the teachings of Wood and Uutela because both triptans taught by Wood and fluoxetine taught by Uutela are 5-HT inhibitor that show efficacy in symptomatic treatment of autism. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." Jn re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980). The combined teachings of Wood and Uutela would provide an alternative targeted treatment for FMR-1/FXS mediated autism with triptans (e.g. sumatriptan), and further comprises other active medicament (e.g. SSRI).
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of treatment/management of autism. Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-4, 8 and 29-30 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13, 23-25, and 31 of copending Application No. 18/249,228 (reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a method for treatment, management or amelioration of FMR1 mediated autism, comprising, administering a therapeutically effective amount of a medicament comprising one or more one or more tryptophans or derivatives thereof to an individual in need thereof.
Reference claim 2 recites 5-hydroxytryptophan (5-HTP) (Oxitriptan) which is a triptan and considered as equivalent of instant recited sumatriptan and other triptan derivative. Reference claim 4 recite autism is related to FXS. Reference claim 9 recites dose amount of tryptophans or derivatives thereof. Reference claim 31 recites medicament further comprises SSRI.
Reference claim reciting triptan derivatives (e.g. oxitriptan) anticipates instant claim 1, and render instant claims 2-3 obvious.
The instant application shares one common inventor/applicant with the reference patent. Based on the continuing data on the record, instant application is not related to the reference patent, thus no 35 USC 121 shield exists.
Conclusion
No claim is allowed.
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/L.M./Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628