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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 20th 2026 has been entered.
DETAILED ACTION
Status of the Claims
Claims 28-34, 36, and 46-51 are pending and are examined on their merits.
35 U.S.C. § 103 Rejections Overcome by Argument
Applicant’s arguments in the response filed on April 20th 2026 are acknowledged. Applicant argues that any combination of Park, Manzoni, Bear, and Hagerman that suggests the treatment of fragile X syndrome with mGlur5 positive allosteric modulators (PAMs), and especially the compounds from Park, is only speculative in nature, and that the actual success of such PAMs in the treatment of fragile X syndrome is unexpected. Applicant’s arguments are found persuasive. As the treatment of fragile X syndrome with such mGluR5 PAMs is not found in the art, the success of applicant’s treatment is unexpected, and sufficient to overcome all current 103 rejections over Park, Manzoni, Bear, and Hagerman. Said 103 rejections are thereby withdrawn.
Nonstatutory Double Patenting Rejections
As the nonstatutory double patenting rejections in the final rejection filed on November 18th 2025 relied on the same arguments as the 103 rejections, the rejections are withdrawn for the same reasons.
New Grounds of Rejection - 35 USC § 112(a)
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 28 and its dependent claims 29-34, 36, and 46-51 are 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.
Claim 28 recites “a method for alleviation or treatment of developmental disorder in a subject, comprising: administering to the subject a therapeutically effective amount of an imidazopyrimidine or imidazotriazine compound of Chemical Formula 1…”
The claim encompasses alleviation or treatment of the entire genus of “developmental disorders,” a term that is not defined in the specification, but is commonly understood as an umbrella term encompassing chronic conditions that emerge during early life and affect physical, mental, or behavioral development. Applicant has disclosed many diseases included under this umbrella term, including:
“pervasive developmental disorder, autism, autistic spectrum disorder, fragile X syndrome, a developmental disorder caused by fragile X syndrome, a developmental disorder exhibiting symptoms similar to those of fragile X syndrome, Angelman syndrome, a developmental disorder caused by Angelman syndrome, a developmental disorder exhibiting symptoms similar to those of Angelman syndrome, Rett syndrome, a developmental disorder caused by Rett syndrome, a developmental disorder exhibiting symptoms similar to those of Rett syndrome, fragile X-associated tremor/ataxia syndrome (FXTAS), Asperger's syndrome, a developmental disorder caused by Asperger's syndrome, a developmental disorder exhibiting symptoms similar to those of Asperger's syndrome, childhood disintegrative disorder, a developmental disorder caused by childhood disintegrative disorder, a developmental disorder exhibiting symptoms similar to those of childhood disintegrative disorder, Landau-Kleffner syndrome, a developmental disorder caused by Landau-Kleffner syndrome, a developmental disorder exhibiting symptoms similar to those of Landau-Kleffner syndrome, Prader-Willi syndrome, a developmental disorder caused by Prader-Willi syndrome, a developmental disorder exhibiting symptoms similar to those of Prader-Willi syndrome, 22q11.2 deletion syndrome, a developmental disorder caused by 22q11.2 deletion syndrome, a developmental disorder exhibiting symptoms similar to those of 22q11.2 deletion syndrome, tardive dyskinesia, a developmental disorder caused by tardive dyskinesia, a developmental disorder exhibiting symptoms similar to those of tardive dyskinesia, seizure disorder, a developmental disorder caused by seizure disorder, a developmental disorder exhibiting symptoms similar to those of seizure disorder, Williams syndrome, a developmental disorder caused by Williams syndrome, and a developmental disorder exhibiting symptoms similar to those of Williams syndrome.”
[Specification, Paragraph [0247]]
The specification provides no data or examples demonstrating efficacy for the overwhelming majority of these disorders. The included experimental disclosure is a study limited to the treatment of Fmr1 knockout mice (relevant to fragile X syndrome) with a compound of Formula 1.
There is zero disclosure of:
Activity against Angelman syndrome, Rett syndrome, Asperger’s syndrome, or any of the other non-fragile X syndrome developmental disorders
Activity in any animal model other than the Fmr1 knockout mice that would demonstrate relevance towards the broader genus of disorders
A common mechanism that would predict efficacy across the broad spectrum of described neurodevelopmental conditions.
The single example tied to fragile X syndrome does not provide adequate support for the broad genus of disorders described by the umbrella term of “developmental disorders.” One of ordinary skill in the art would thereby not recognize applicant as having possession of the method of treating “developmental disorders” broadly as described, but only fragile X syndrome and other disorders mediated by Fmr1 knockout.
(Note that claim 31 is not directed only towards the treatment of fragile X syndrome, but also includes “a developmental disorder exhibiting symptoms similar to those of fragile X syndrome.”)
New Grounds of Rejection - 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.
Claims 28-34 and 46-51 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Park (WO 2016/137260 published on September 1st 2016).
Claim 28 is directed towards the treatment or alleviation of developmental disorder comprising administration of 0.1-500 mg/kg of a compound of Chemical Formula 1:
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,
with two such compounds being:
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(see claims 46, 50, 51)
and
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(see claims 46, 47, 48, 49).
Park teaches administration of 0.1-500 mg/kg (Park, pg. 22, paragraph [479]) of each of the two above compounds (Park, claim 13, pg. 136, 6-(4-fluorophenyl)-2-[(5-fluoro-2-pyridyl)oxymethyl)imidazo[l,2-a]pyrimidine) (Park, claim 9, pg. 119, 6-(4-fluorophenyl)-2-phenoxymethylimidazo[1,2-a]pyrimidine), as well as the treatment of schizophrenia with the compounds (Park, claims 19-20, pg. 141).
As schizophrenia is recognized in the art as a developmental disorder1, Park is anticipatory of claim 28, as well as claims 46-51, directed to treatment with the above compounds.
Claims 29-31 further limit the disorder in the method of claim 28 to “a developmental disorder exhibiting symptoms similar to those of fragile X syndrome. As shown below, there exists significant symptomatic overlap between the two conditions:
Schizophrenia symptoms2
Fragile X syndrome symptoms3
Hallucinations
Low IQ
Disorganized Speech
Language Processing Issues
Emotional Dysregulation
Depression, Anxiety
Behavioral Dysregulation
Behavioral Dysregulation
Delusions
Seizures
As shown above, the two conditions exhibit significant symptomatic overlap in the presence of emotional dysregulation, language processing, and behavioral dysregulation. Subsequently, one of ordinary skill in the art would recognize schizophrenia as “a developmental disorder exhibiting symptoms similar to those of fragile X syndrome,” and Park is thereby anticipatory of claims 29-31.
Claim 32 is directed towards the method of claim 28, wherein the method is for alleviating or treating symptoms of the developmental disorder. As the treatment of schizophrenia would necessarily entail the treatment of its symptoms, Park is anticipatory of claim 32.
Claim 33 is directed towards the method of claim 32 wherein the symptoms are selected from a group containing socio-behavioral disorder. As such behavioral dysregulation is recognized as a symptom of schizophrenia (see the above 102 rejection for claims 29-31), Park is anticipatory of claim 33.
Claim 34 requires that the subject receiving administration in the method of claim 28 is a mammal. Park teaches administration to a human (Park, pg. 23, paragraph [482]), anticipating claim 34.
New Grounds of Rejection - 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.
Claim 36 is rejected under 35 U.S.C. 103 as being unpatentable over Park in view of Cleveland Clinic (Cleveland Clinic, Schizophrenia, Diagnosis and Treatment, Wayback Machine Archived July 23rd 2019, Accessed July 20th 2026).
Claim 36 is directed towards the method of claim 28 wherein the subject additionally receives administration from a group of drugs including antipsychotics. For the teachings of Park as they relate to claim 28 (and the administration of a compound of Formula 1 for the treatment of schizophrenia), see the above 102 rejection for claim 28. Regarding the administration of an antipsychotic in addition to a compound of Formula 1, antipsychotics are known in the art as the most commonly prescribed drugs for the treatment of schizophrenia (Cleveland Clinic, pg. 2). As both the compound of Formula 1 and antipsychotics are known in the art for the treatment of schizophrenia, one of ordinary skill in the art would have a reasonable expectation of success in using them together. See MPEP § 2144.06(I):
"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." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted) (Claims to a process of preparing a spray-dried detergent by mixing together two conventional spray-dried detergents were held to be prima facie obvious.). See also In re Crockett, 279 F.2d 274, 126 USPQ 186 (CCPA 1960) (Claims directed to a method and material for treating cast iron using a mixture comprising calcium carbide and magnesium oxide were held unpatentable over prior art disclosures that the aforementioned components individually promote the formation of a nodular structure in cast iron.); Ex parte Quadranti, 25 USPQ2d 1071 (Bd. Pat. App. & Inter. 1992) (mixture of two known herbicides held prima facie obvious); and In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).
The combination treatment described in claim 36, and consequently claim 36 itself, are thereby prima facie obvious.
New Grounds of Rejection – Nonstatutory 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 28-34, and 46-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,100,057. Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘057 patent teaches the treatment of schizophrenia (‘057 Patent, claim 1) via administration of a therapeutically effective amount4 of compounds equivalent to those of the instant application. For example, the two compounds discussed above,
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[‘057 Patent, claim 18, 6-(4-fluorophenyl)-2-[(5-fluoro-2-pyridyl)oxymethyl)imidazo[l,2-a]pyrimidine]
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[‘057 Patent, claim 11, 6-(4-fluorophenyl)-2-phenoxymethylimidazo[1,2-a]pyrimidine]
Claim 36 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,100,057 in view of Cleveland Clinic (Cleveland Clinic, Schizophrenia, Diagnosis and Treatment, Wayback Machine Archived July 23rd 2019, Accessed July 20th 2026).
Claim 36 is directed towards the method of claim 28 wherein the subject additionally receives administration from a group of drugs including antipsychotics. Antipsychotics are known in the art as the most commonly prescribed drugs for the treatment of schizophrenia (Cleveland Clinic, pg. 2). As both the compound of Formula 1 and antipsychotics are known in the art for the treatment of schizophrenia, one of ordinary skill in the art would have a reasonable expectation of success in using them together. See MPEP § 2144.06(I).
Claims 28-34, 36, and 46-51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 28-29, 34-36, 49-54 of copending Application No. 17/770,686 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application teaches the treatment of cognitive disorders including learning deficit disorder via administration of compounds equivalent to those of the instant application.
The reference application further teaches identical patient populations (reference application, claim 34), identical dosages (reference application, claim 35), and administration alongside a stimulant (reference application, claim 36).
As learning deficit disorder would necessarily involve developmental delays and learning disability, the symptoms would be considered “similar to those of fragile X syndrome,” and would address the disorders of claims 29-33.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/ANTHONY JOSEPH SEITZ/Examiner, Art Unit 1629
1 For evidentiary support, see Gupta (Gupta et al., What is schizophrenia: A neurodevelopmental or neurodegenerative disorder or a combination of both? A critical analysis. Indian J Psychiatry. 2010 Jan;52(1):21-7)
2 See Cleveland Clinic: (Cleveland Clinic, Schizophrenia, Wayback Machine Archived April 25th 2019, Accessed July 20th 2026)
3 See Cleveland Clinic: (Cleveland Clinic, Fragile X Syndrome (FXS), Updated February 7th 2024, Accessed July 20th 2026)
4 The therapeutically effective amount of the compound is disclosed as being 0.1-500 mg/kg (‘057 Patent, col. 19)
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