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 .
Claims 1-11 filed 06 August 2024 are pending in the application.
Priority
This application is a divisional of 17/267,715 filed 02/10/2021, now US Patent No. 12,083,139, which is a 371 of PCT/US2019/046227 filed 08/12/2019 which claims the benefit of 62/717,372 filed 08/10/2018.
Claim Objections
Claim 1 is objected to because of the following informalities: In claim 1, at line 3, the recitation ‘a ND’ should be replaced by the recitation ‘the ND’. Appropriate correction is required.
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 (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.
Claim(s) 1-3 and 9-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steinmetz et al (The Journal of Neuroscience, January 24, 2018, 38(4), 1015-1029; cited in IDS filed 08/06 2024).
Steinmetz et al teaches that mice with inbred strain BTBR T+ Itpr3tj/J mice recapitulate several core behavioral deficits of autism spectrum disorder. It shows cognitive impairments, which include object recognition, and spatial learning. They also have social deficits including reduced social approach, and social interaction (page 1015, right col., last para through page 1016, left col., first para). The mice were administered IGF-2 and tested for reversal of these behaviors (Abstract; page 1016, Materials & Methods through page 1027; method as in claim 1 and subject is mice, conditions recited in claim 2-intellecutal abilities, movement, social behavior, agonist ligand as in claim 3). The amount of IGF-2 administered is 30mg/Kg (page 1016, Second para under Materials and Methods; limitations of claims 9-10).
Therefore, Steinmetz et al anticipates claims 1-3 and 9-10.
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 (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 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.
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.
Claim(s) 1-2, 4-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Steinmetz et al (The Journal of Neuroscience, January 24, 2018, 38(4), 1015-1029; cited in IDS filed 08/06 2024) in view of Jeanjean et al (Bioorganic & Medicinal Chemistry, 2006, 14, 3575-3582; cited in IDS filed 08/06 2024) and further in view of Vidal et al (Bioorganic & Medicinal Chemistry, 2002, 10, 4051-4056; cited in IDS filed 08/06 2024), Vidil et al (Eur. J. Org. Chem. 1999, 447-450) and Qiu (Secrets of the Brain, August 31, 2017, 131-136; English translation pages 1-8).
The teachings of Steinmetz et al are set forth above. The above teaching of Steinmetz shows that administration of an IGF-2 agonist alleviates deficits seen in ASD subjects.
Steinmetz does not teach treating Angelman syndrome as in claim 1, alleviating developmental milestones, speech, and epilepsy as in claim 2, the limitations of claims 4-8 and 11.
Jeanjean et al teaches that derivative 3 displayed binding to M6P/IGF2 receptor (page 3576, Scheme 1 and page 3577, Scheme 3; page 3578, Table 1). Compound 3 of Jeanjean is the same as compound L5 in claim 5. This teaching also reads on claim 4 (derivative thereof).
Vidil et al, drawn to M6P analogs, teaches that the isosteric analog 1, which is very close to the compound of formula L3 in claim 5, was found to have affinity for the M6P/IGF-2 receptor. This suggests the considerable potential of such compounds in targeting therapy (Abstract; page 448, Scheme 2, formula 1, page 448, right col., see under sub-Title: Biological activity of phosphonate analogs of M6P and page 449-Conclusion; limitations of claims 4-5).
Since Steinmetz teaches that IGF2 acts as an agonist ligand for the IGF-2 receptor and is used to reverse deficits in autism spectrum disorder, one of ordinary skill in the art would have a reasonable expectation that the compounds taught by Jeanjean and Vidil will also do the same and administer the compounds taught by Jeanjean and Vidil in the claimed method of treatment.
According to Qiu, Angelman syndrome is a type of developmental neurological disease that seriously affects the physical and mental health of adolescents like autism spectrum disorder, and the causative gene Ube3a of Angelman syndrome is also very closely related to autism (page 7, last para). In view of this teaching of Qiu and that of Steinmaetz, Jeanjean and Vidil, one of ordinary skill in the art will have a reasonable expectation that administration of an M6P agonist ligand will also treat a subject having Angelman syndrome as in claim1 and the deficits as in claim 2.
In view of Steinmaetz and using the amount of the IGF-2 administered as a starting point one of ordinary skill in the art can adjust the dosages as in claims 6 and 8. Jeanjean and Vidil teach M6P derivatives that are not conjugated to another moiety as in claim 7. Hence, administration of an M6P derivative that is not conjugated to another moiety in the claimed method is obvious. The teachings of Steinmetz, Jeanjean and Vidil also renders obvious to administer a composition consisting essentially of a M6p or a derivative thereof and IGE-2 as in claim 11.
MPEP 2141 states, "The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit. The Court quoting In re Kahn, 441 F.3d 977, 988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006), stated that "[R]ejections on obviousness cannot be sustained by mere conclusatory statements; instead, there must be some articulated reasoning with some rational underpinning to support the legal conclusion of obviousness.'" KSR, 550 U.S. at, 82 USPQ2d at 1396. Exemplary rationales that may support a conclusion of obviousness include: (A) Combining prior art elements according to known methods to yield predictable results; (B) Simple substitution of one known element for another to obtain predictable results; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) " Obvious to try " choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
According to the rationale discussed in KSR above, the rationale in (G) above is seen to be applicable here since based on the prior art teachings, IGF-2 which is an agonist ligand of IGF-2 receptor known in the art to be used as active agents for reversing the deficits of ASD, and Angelman syndrome is related to ASD. M6P derivatives are known in the art to be ligands for IGF-2 receptor. Thus, it is obvious to arrive at the instant invention in view of the combined teachings of the prior art. It is obvious to substitute the IGF-2 of Steinmetz with the M6P derivatives of Jeanjean and Vidil as active agents and also use a combination of M6P derivative and IG-2 in the claimed method.
Thus, the claimed invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the instant invention over the combined teachings of the prior art. Method improvement is the motivation.
Conclusion
Pending claims 1-11 are rejected
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/GANAPATHY KRISHNAN/Primary Examiner, Art Unit 1693