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 .
Claims 1, 4-13, and 25-27 are examined on the merits.
Applicant’s response and amendments are acknowledged, as well as the previous interview of record.
Follow-Up Interview: A follow-up interview is suggested - once applicant has reviewed the below - to discuss and address the below, towards advancing prosecution on the merits.
Election/Restrictions – Withdrawn Based On Amendments
Claimed Invention
The present claims are drawn to a distinct method from that of related family U.S. Patent Application No. 17054740, now U.S. Patent No. 11969460. Here the cognitive decline is the result of trauma-based as opposed to professionally medical-diagnosed age-related cognitive decline.
The same peptides are employed, adropin SEQ ID NOS: 1 and 2 are the 76mer naturally occurring Adropin C polypeptide (SEQ ID NO: 1) or its fragment residues 34-76 thereof (SEQ ID NO: 2) (see Deasy et al. (U.S. Patent Publication No. 20130085105; paras 70 & 251; reciting SEQ ID NO: 2; see also as mirrored in instant specification para’s 41-43 (as recited in U.S. Patent Publication No. 20210252108):
[0070] In one aspect, any of the embodiments of this invention are practiced using fatty acid salts of ADROPIN c( Cys-His-Ser-Arg-Ser-Ala-Asp-Val-Asp-Ser-Leu-Ser-Glu-Ser-Ser-Pro-Asn-Ser- -Ser-Pro-Gly-Pro-Cys)-Pro-Glu-Lys-Ala-Pro-Pro-Pro-Gln-Lys-Pro-Ser-His-Glu-- Gly-Ser-Tyr-Leu-Leu-Gln-Pro (SEQ ID NO:13) or analogs thereof.
[0251] O) ADROPIN c( Cys-His-Ser-Arg-Ser-Ala-Asp-Val-Asp-Ser-Leu-Ser-Glu-Ser-Ser-Pro-Asn-Ser- -Ser-Pro-Gly-Pro-Cys)-Pro-Glu-Lys-Ala-Pro-Pro-Pro-Gln-Lys-Pro-Ser-His-Glu-- Gly-Ser-Tyr-Leu-Leu-Gln-Pro) (SEQ ID NO:13) is a secreted peptide that is encoded by a gene highly expressed in the liver and central nervous system that is involved in regulating energy homeostasis and lipid metabolism in response to dietary nutrient composition. ADROPIN [derived from the Latin root "aduro" (to set fire to) and "pinquis" (fats or oils)] is encoded by the "Energy Homeostasis Associated" transcript (gene symbol: Enho (previously referred to as Swir1); see WO 2007/019426 incorporated herein in its entirety; Kumar KG,@ et al., Adropin is a secreted peptide involved in energy homeostasis and lipid metabolism, 2008, submitted to Cell Metabolism, incorporated herein in its entirety).
Prior Art Made of Record But Not Relied Upon – Maintained
Based on the initial prior art search and prior art of record (but see written description rejection), the instantly claimed invention was not found reasonably taught or suggested thereby. The closest prior art is deemed general references directed to adropin:
Jacobs (U.S. Patent Publication No. 2003/0096951)
Kumar et al. (Identification of Adropinasa Secreted Factor linking Dietary Macronutrient Intake with Energy Homeostasis and Lipid Metabolism. Cell Metabolism. December 2008. Vol. 8, No.6: pages 468-481).
Claim Rejections - 35 USC § 112 – Written Description – Maintained In-Part
Modified, Necessitated by Amendment
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, 4-13, and 25-27 remain/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.
In this case, issues tied to possession (written description) are present that must be addressed on the record before a reasonable search of the full scope of the invention can be completed:
1. Effective Amount (All Claims): What constitutes an “effective amount” for treating cognitive decline based on [trauma] --concussion-- is not immediately identifiable in the description as within applicant’s possession. While an undue experimentation (scope of enablement) prong is not raised, nevertheless, there must be guidance upon which PHOSITA can grab to determine that which applicant had described/possessed versus that outside said scope.
2. Variants and Fragments of Peptide SEQ ID NOS: 1 or 2 - Traversed by Amendment.
Re: With the exception of the peptide SEQ ID NO: 1 or 2, no variants or fragments are found within applicant’s possession. The skilled artisan cannot envision the detailed chemical structure of the encompassed variants, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112.
Response to Arguments/Amendments (In-Part, 1. of 2. Above)
Applicant’s amendments and arguments have been fully considered but are not yet found persuasive. Claim 1 remains drawn to any effective amount of peptide SEQ ID NOS: 1 or 2 to achieve any/all of delaying, arresting AND/OR reducing progression of cognitive decline resulting from concussion minimum required effective amount to effectuate the desired end result (treating cognitive decline by delaying, arresting, and/or reducing progression thereof). However, possession of the scope claimed is not yet found support/reasonably supported based on the representative examples within any one or more specification concussion model tests (the test data) are not yet found to establish a that ‘any’ amount of peptide SEQ ID NOS: 1 or 2 would constitute an effective amount for achieving any/all of delaying, arresting AND/OR reducing progression of cognitive decline resulting from concussion minimum required effective amount to effectuate the desired end result (treating cognitive decline by delaying, arresting, and/or reducing progression thereof). Further, no minimal effective amount of peptide SEQ ID NOS: 1 or 2 is found in possession to achieve any/all of delaying, arresting AND/OR reducing progression of cognitive decline resulting from concussion minimum required effective amount to effectuate the desired end result (treating cognitive decline by delaying, arresting, and/or reducing progression thereof). Dependent claims 4-5 claim narrower amounts, but the test data does clearly show possession that these amounts of peptide SEQ ID NOS: 1 or 2 constituted an effective amount for achieving any/all of delaying, arresting AND/OR reducing progression of cognitive decline resulting from concussion. Further evidence and/or arguments is required to establish that PHOSITA would have been guided by the specification support (test data) that applicant was in possession of that any amount would be effective for treating (delaying, arresting, and/or reducing progression) of cognitive decline caused by concussion upon administering either peptide SEQ ID NO: 1 or 2. Therefore, the rejection is maintained in part, pending further evidence and/or arguments.
Thus, the present claim scope is not commensurate therewith. Further evidence and/or arguments is required to establish the scope that was in possession at the time of filing.
Conclusion
Applicant's amendment necessitated the modified ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lianko Garyu can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
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