DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
2. Applicant’s election of species of compound Ia and schizophrenia in the reply filed on September 2, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
3. Examination followed guidelines provided by MPEP 803.02. The elected species of compound Ia and schizophrenia was found to be obvious over the prior art. Therefore, the Markush claims were rejected and claims to nonelected species were withdrawn from further consideration. The search and examination was extended to the elected species and further to the nonelected species shown below.
4. Claims 2 and 5 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected subject matter. Election was made without traverse in the reply filed on September 2, 2025.
Status of Claims
5. Claims 1-5 are pending. Claims 2 and 5 do not read on the elected species and are withdrawn. Claims 1, 3 and 4 read on the elected species and are under examination. Claims 1 and 4 are independent.
Priority
6. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
7. The information disclosure statement (IDS) submitted on October 23, 2024 was in compliance with the provisions of 37 CFR 1.97 and 37 CFR 1.98. The IDS was considered. A signed copy of form 1449 is enclosed herewith.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(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.
8. Claims 1, 3 and 4 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the treatment of an intellectual disorder, does not reasonably provide enablement for prophylaxis of an intellectual developmental disorder. The specification does not enable any person 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 standard for determining whether the specification meets the enablement
requirement was cast in the Supreme Court decision of Mineral Separation v. Hyde, 242
ITS, 261,270 (1918) which postured the question: is the experimentation needed to
practice the invention undue or unreasonable? That standard is still the one to be
applied, at re Wands, 858 F.2d 731, 737, 8USPQ2s 1400, 1404 (Fed. Cir. 1988). MPEP 2184. 01(a) slates “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.” The factors are applied below to the instant claims.
The breadth of the claims and nature of invention
The claims are drawn to methods of treating and preventing an intellectual developmental disorder. The specification defines treatment as including prophylaxis.
The state of the prior art, level of ordinary skill, level of predictability, amount of guidance provided
The state of the art and present specification recognizes disorders in the genus claimed can be treated (non-prophylactic). See for example animal model of ASD (autism spectrum disorder) in the present specification. See for example reference of Li et al. (attached herewith) which provides disclosure of the present utility in the treatment of various diseases.
Neither the state of the art nor the present specification recognizes that intellectual developmental disorders can be prevented by the administration of pharmaceutical agents including MGLU2/3 antagonists. See also for example references of Alzheimers, Autism, Schizophrenia (attached herewith). In the state of the art, these disorders are not known to be preventable. Reducing the risk involves lifestyle choices, and not the administration of pharmaceutical agents.
The quantity of experimentation needed to make or use the invention
In the absence of working examples/direction, enablement rests on the existence of an
art recognized predictable correlation between the disclosed activity and the claimed
method. Evidence suggests that this requirement is not met for the instant case. The
amount of experimentation is undue. The experimentation required is to find methods for preventing the claimed diseases by animal and other models. Moreover, the results will have to indicate that the diseases can be preventable with agents of the claims. It is therefore determined that the instant disclosure does not enable one of ordinary skill to practice the scope of the claimed invention.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
9. Claims 1 and 3 rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The claims state that C is optionally substituted wherein the substituents are selected from the group consisting of (i)-(xi). However, the groups that directly follow this statement are labeled xii-xxii. Therefore, the claims recite groups which are not defined, and define groups which are not necessary to the Markush formula. Appropriate correction is required. For the purpose of examination, the claimed genus was interpreted to contain the substituents as defined in the specification pages 7-8.
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.
10. Claim(s) 1, 3 and 4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20130085278 as evidenced by Depression. The reference has a first publication date of April 4, 2013 which antedates the present claims having an effective filing date of April 20, 2015 and priority claim to foreign application dated April 23, 2014.
The reference teaches the compound of
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and methods of using the compound for the treatment of depression and other CNS disorders. The compound is Applicant’s elected species. The specification defines intellectual disabilities and intellectual developmental disorders as conditions characterized by significant limitations in intellectual functioning like reasoning, learning, problem solving, and deficit in adaptive behaviors such as communication, self care, home living, social skills, self direction, leisure and work and learning. Depression is characterized by various of these limitations (see Pratt et al.), eg. impairment in social and occupational functioning and poor health.
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.
11. Claim(s) 1, 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 7,238,808 in view of Stone.
Determining the scope and contents of the prior art
The reference teaches the compound of
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(column 13, first compound, elected species) for the treatment of disorders that include psychosis, schizophrenia (elected species), Alzheimer’s disease, cognitive disorders and memory deficits.
Stone teaches that glutamatergic antipsychotic drugs are a new dawn in the treatment of schizophrenia. The reference teaches that currently available antipsychotic drugs have significant limitations and are sometimes potentially life threatening. Stone teaches that drugs targeting glutamate transmission have considerable promise in the treatment of schizophrenia because they treat those who fail to respond to conventional therapy with antipsychotic drugs, are efficacious, and low side effects, eg. page 11, page 14, and entire reference. Stone particularly discusses LY2140023 which is a mGlu 2/3 receptor antagonist.
Ascertaining the differences between the prior art and the claims at issue
The reference of Stone suggests the use of MGLU2/3 antagonist in the treatment of schizophrenia. The primary reference does not teach the use of the claimed compound for schizophrenia. However, the primary reference also suggests that the compound be used in the treatment of schizophrenia as a preferred embodiment which lists a few diseases including schizophrenia.
Resolving the level of ordinary skill in the pertinent art - considering objective evidence present in the application indicating obviousness
One of ordinary skill in the art has the teaching and suggestion in the reference to practice a method of treating schizophrenia using the claimed compound. The motivation is to practice a method which is efficacious and mild for side effects. The motivation is also to find alternative methods of treating schizophrenia without antipsychotic medication, or to treat patients that do not respond to conventional treatment using antipsychotic medication. The skilled artisan has a reasonable expectation of success in practicing the claimed invention. For this reason, the present claims are found to be prima facie obvious over the prior art.
Conclusion
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/SUN JAE YOO/Primary Examiner, Art Unit 1621