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 .
Priority
Acknowledgments are made that this application claims the priority to the following:
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Information Disclosure Statement
The information disclosure statement (IDS), dated 08/03/2023, comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609. Accordingly, they have been placed in the application file and the information therein has been considered as to the merits.
Response to Restriction
Applicant's response to restriction requirement and election of group II corresponding to claims 4-6, 12 and 27, without traverse, in the reply filed on 03/24/2026 is acknowledged.
Claims 10-11 are regrouped in group II, in light of making or amending claims 10-11 depend on claim 4. Accordingly, claims 4-6, 10-12 and 27 encompass elected group II.
The examiner also acknowledges applicants response to election of species and providing the following species:
‘(1-3)IGF-1’ as an active agent for administration, and
‘increasing cortical mass’ for condition.
It appears that the above species read claims 4 and 27.
Claims 1-3, 5-7, 10-12, 15-20 and 24-26 are withdrawn from consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The claims 4 and 27 are examined on merits in this office action.
Claim Rejection - 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
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 in order 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 4 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Sur (US2009/0099077A1) in view of Yang (Molecular Autism, 2016, 7:11, 1-14), Bon (Molecular Psychiatry, 2016, 21, 126-132), Arranz (Neurobiology of Disease, 2019, 127, 210) and Duan (Molecular Psychiatry, 2018, 23, 747-758).
Sur teaches a method of treating autism or autism spectrum disorders by administering (1-3)IGF-1 [0008, 0030-0031].
Differences between Sur and instant claims are as follows:
(i) Sur does not explicitly each a method for increasing cortical mass.
(ii) Sur is silent on a subject having a loss of function DYRK1A mutation.
With regard to (i) of above, Yang teaches in a study that ASD participants exhibited a lack of normative age-related cortical thinning and volumetric reduction [see abstract and Figures]. Cortical thinning and volumetric reduction interpreted as lowering the cortical mass. So, in the teachings of Sur, the (1-3)IGF-1 increases cortical mass, which in turn treats autism, since autism results in reduction of cortical mass as evidenced from the teachings of Yang.
Therefore, treating autism from the teachings of Sur is nothing but “a method for increasing cortical mass”.
With regard to (ii) of above, it appears that there are several art, which teaches nexus between mutant DYRK1A and autism and other neurological disorders, see the following art:
Bon teaches that disruptive de novo mutations of DYRK1A lead to a syndromic form of autism and ID [see abstract].
Arranz teaches a link between mutations in DYRK1A and autism and down syndrome [see abstract].
Duan also teaches autism-associated Dyrk1a truncation mutants impair neuronal dendritic and spine growth and interfere with postnatal cortical development [see abstract].
Based on the above established facts from the cited prior art, it appears that all the claimed elements, i.e, applicants individual components and their function, were known in the prior art, and one skilled person in the art could have combined the elements as claimed by known relationships, with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art.
The motivation to combine the art can arise from the expectation that the prior art elements will perform their expected functions to achieve their expected results when combined for their common known purpose. See MPEP 2144.07. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention by taking the advantage of the teaching of the above cited reference and to make the instantly claimed method with a reasonable expectation of success.
The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination. In re Sernaker, 702 F.2d 989, 994-95, 217 USPQ 1, 5-6 (Fed. Cir. 1983).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SUDHAKAR KATAKAM whose telephone number is (571)272-9929. The examiner can normally be reached 8:30 am to 5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melissa Fisher can be reached at 571-270-7430. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SUDHAKAR KATAKAM
Primary Examiner
Art Unit 1658
/SUDHAKAR KATAKAM/Primary Examiner, Art Unit 1658
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