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 .
Status of the Claims
Claims 1, 3-7, and 10-12 are currently pending.
Claims 1, 3-7, and 10-12 are amended.
Claims 2 and 8-9 are cancelled.
Claims 1, 3-7, and 10-12 have been considered on the merits.
Withdrawn Objections/Rejections
The claim objections made onto claims 4-6 and 10-12 are withdrawn in light of the amendments submitted on 11/17/2025.
The 35 U.S.C. 112b rejections made onto claims 1, 3-7, and 10-12 are withdrawn in light of the amendments submitted on 11/17/2025.
The 35 U.S.C. 103 rejection made onto claims 1, 3-7, and 10-12 is withdrawn in light of the arguments presented on 11/17/2025.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claim 3 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
Claims 1, 3-7, and 10-12 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.
Claims 1, 3, 6, 7, and 12 recite the limitation of a sequence which comprises 95% identity of any of SEQ ID NOs: 3-7. The specification describes “SEQ ID NO: 3 (dGAE97, human/mouse, 97 amino acids)” (pg. 5, last line), “SEQ ID NO: 4 (dGAE95 or ‘dGAE’, human/mouse, 95 amino acids)” (pg. 6, lines 13-15), “SEQ ID NO: 5 (dGA, human/mouse, 94 amino acids)” (pg. 6, lines 25-27), “SEQ ID NO: 6 (dGAE73, human/mouse, 73 amino acids)” (pg. 6, lines 38-40), and “SEQ ID NO: 7 (residues 308 to 378 of 2N4R, human/mouse, 71 amino acids)”(pg. 7, lines 6-9). However the specification fails to demonstrate adequate written description for any sequence which comprises at least 95% identity to any of SEQ ID NOs: 3-7. The concept of any amino acid which comprises at least 95% identity thereto, as recited in claims 1, 3, 6, 7, and 12, lacks written description other than amino acid sequences that are 100% identical to SEQ ID NO: 4-7, which are explicitly taught in the specification. The art at the time and since the time of filling taught sequences encoding fragments of tau that have varying homologies; however it is unclear which amino acids of the 95 present in SEQ ID NO: 4 could be omitted and/or substituted and still result in a protein with the same structural and functional characteristics of SEQ ID NOs: 3-7. The specification and art at the time of filing do not teach variants of SEQ ID NOs: 3-7 encoding fragments of tau protein that maintained the structure and function when replacing or deleting any amino acids of SEQ ID NOs: 3-7 resulting in a 95% identity thereto. Accordingly, the concept lacks written description other than SEQ ID NOs: 4-7.
There is no evidence on the record of a relationship between the structures of the amino acid sequences coding for tau fragments and the sequence set forth by SEQ ID NOs: 3-7 that would provide any reliable information about the structure of DNA molecules within the genus of variants. The claimed invention as a whole is not adequately described if the claims require essential or critical elements that are not adequately described in the specification and that is not conventional in the art as of applicants effective filing date. Possession may be shown by actual reduction to practice, clear depiction of the invention in a detailed drawing, or by describing the invention with sufficient relevant identifying characteristics such that a person skilled in the art would recognize that the inventor had possession of the claimed invention. Pfaff v. Wells Electronics, Inc., 48 USPQ2d 1641,1646 (1998).
With the exception of the sequence referred to above, the skilled artisan cannot envision the detailed chemical structure of the encompassed polynucleotides or polypeptides, and therefore conception is not achieved until reduction to practice has occurred regardless of the complexity or simplicity of the method of isolation. The skilled artisan cannot envision the detailed chemical structure of the encompassed nucleic acid molecules 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 nucleic acid 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.
One cannot describe what one has not conceived. See Fiddes v. Baird, 30 USPQ2d 1481 at 1483. In Fiddes, claims directed to mammalian FGF' s were found to be unpatentable due to lack of written
description for that broad class. The specification provided only the bovine sequence. In view of the above considerations one of skill in the art would not recognize that applicant was in possession of the necessary common features or attributes possessed by any member of the genus of the SEQ ID NOs: 3-7 tau protein fragment or the corresponding variants and portions encompassed by the claims. Therefore, only the tau protein fragments encoded by SEQ ID NO: 4-7, but not the full breadth of the claims meet the written description provision of 35 U.S.C. §112, first paragraph. University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that “to fulfill the written description requirement, a patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude “the inventor invented the claimed invention”.
Response to Arguments
Applicant's arguments filed 11/17/2025, specifically regarding the rejections made under 35 U.S.C. 112(a), have been fully considered but they are found not persuasive.
Applicant argues, (Remarks, pgs. 6-7) in reference to the rejection of the claims for lacking adequate written description, that they are not claiming a protein with the same structural and functional characteristics of SEQ ID NO: 4 rather they are claiming a method and a system for screening. Additionally, Applicant states that the structural and functional characteristics of SEQ ID NO: 4 are not required for the practicing of the method and system for screening and “in fact, the screening method and system can be used to determine which fragments of Tau have the same structural and functional characteristics as SEQ ID NO: 4 in inhibiting cytotoxicity to internalization or in disrupting interaction”. Applicant also states that because the method is a screening method it does not require a specific agent or a specific fragment of Tau.
In response, it appears that Applicants’ arguments support that the method and system for screening are enabled through the disclosure of SEQ ID NO: 4 alone, however this does not equate to adequate written description. There is no evidence on the record of a relationship between the structures of the amino acid sequences coding for Tau fragments and the sequence set forth by SEQ ID NOs: 3-7 that would provide any reliable information about the structure of DNA molecules within the genus of variants. Additionally, Applicant states “in fact, the screening method and system can be used to determine which fragments of Tau have the same structural and functional characteristics as SEQ ID NO: 4 in inhibiting cytotoxicity to internalization or in disrupting interaction” and “since applicant has provided the amino acid sequence of SEQ ID NOs 3-7, the skilled artisan would immediately envision the entirety of this genus, which could be in Applicant’s claimed method used to determine which fragments of Tau may have the same structural and functional characteristics of SEQ ID NO: 4”. This appears to imply that one of ordinary skill would both simultaneously envision the “entirety of this genus” as well as employ the method and system for screening to discover additional members of the genus which have the same structural and functional characteristics of SEQ ID NO: 4, which is contradictory to adequate written description. Therefore, the only sequences which have adequate written description are sequences with 100% identity to SEQ ID NOs: 3-7 and the arguments are not found persuasive.
Applicant's arguments filed 11/17/2025, specifically regarding the rejections made under 35 U.S.C. 103, have been fully considered and found persuasive. Applicant argues (Remarks, pg. 8-10) that Al-Hilaly does not provide an active step of culturing a neuronal cell with the Tau fragment nor does it teach an active step of screening for agents for inhibition. Al-Hilaly teaches a model system for studying core domain assembly and states that the model system could serve to screen for inhibitors of Tau aggregation, however the system employs brain tissue blocks which have been fixed in paraformaldehyde and thus do not include living neuronal cells. Therefore, the 35 U.S.C. 103 rejection of claims 1, 3-7, and 10-12 has been withdrawn.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 CONSTANTINA E STAVROU whose telephone number is (571)272-9899. The examiner can normally be reached M-F 8:00-5:00.
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CONSTANTINA E. STAVROU
Examiner
Art Unit 1632
/ANOOP K SINGH/Primary Examiner, Art Unit 1632