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 .
2. The Amendment filed on August 6, 2026, has been received and entered.
Claim Disposition
3. Claims 1-11, 15-30, 32-104 and 106-110 and 112 have been cancelled. Claims 113-117 have been added. Claims 12-14, 31, 105, 111 and 113-117 are pending. Claims 12-14, 105 and 113-117 are under examination. Claims 31 and 111 are withdrawn from consideration as directed to a non-elected invention.
Information Disclosure Statement
4. The Information Disclosure Statements filed on August 6, 2026, has been considered. A copy of the PTO-1449 form is attached. Note that some references have been lined through because it does not have proper citation of the date. Note that a reference has been lined through based on an improper date citation.
Specification Objection
5. The specification is objected to for the following informalities:
The specification is objected to because the sequence notation is improper, see “SEQ ID NOs.:3”, which should be “SEQ ID NOs:3” (see page 16).
Appropriate correction is required.
Claim objection
6. Claims 12-14, 105 and 113-117 are objected to for the following informalities:
Claim 12 is objected to for the recitation of “relative to SEQ ID NO:1”, it is suggested that the language is amended to “…..PEST domain [[as]] set forth in SEQ ID NO:1, and comprises [[a sequence comprising having]] an amino acid substitution at each of positions 4 and 5 [[relative to]] of SEQ ID NO: 1.The dependent claims hereto are also included.
For clarity it is suggested that claim 105 is amended to recite “…..polypeptide [[that]] of claim 12,……having a sequence at least 90% [[80]] identical…..a and a (VL) domain having a sequence at least 90% [[80]] …..” See also claim 117 with similar language.
For clarity it is suggested that claim 113 is amended to recite “…..polypeptide [[that]] of claim 12….”.
For clarity it is suggested that claim 114 is amended to read, “The recombinant polypeptide of claim 113……position 4 [[relative to]] of SEQ ID NO:1…..alanine (A) [[substitution]] and/or the …..position 5 [[relative to]] of SEQ ID NO:1…….alanine (A) [[substitution]]”. See also claim 116 with similar language.
For clarity and precision of claim language it is suggested that claim 115 is amended to read, “The recombinant polypeptide of claim 114, wherein the recombinant polypeptide [[having] has a sequence set forth in….”.
Appropriate correction is required.
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.
7. Claims 12-14, 105 and 113-117 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AlA), 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.
The claimed invention as amended is directed to “a recombinant polypeptide comprising an antigen-binding domain that binds tau and a proteaseome-targeting human PEST domain set forth in SEQ ID NO:1 with substitutions relative to SEQ ID NO:1 (see claim 12 in its entirety). The claimed invention encompasses a large variable genus of proteins that are not defined by structure or function because claim 12 does not recite the structure of the recombinant protein just some of the parts it comprises and does not provide a specific function for the recombinant protein just what a domain of the protein does (there is no indication that the modification to the protein retains that activity either). It is noted that claim 13 recites that the recombinant polypeptide is an intrabody, however, claim 12 is not limited to any specific recombinant polypeptide. The claimed invention is not adequately described because it is overly broad. The claimed invention is not commensurate in scope with the disclosure and is overly broad because claim 14 recites that the intrabody is scFv. The polypeptide of the invention is recited as binding tau, however, encompasses a large genus of fragments with the recited at least 80% for example.
The polypeptide as claimed reads on many different types of polypeptides, based on the breath of the claims and encompasses a large genus. A large variable genus of products are encompassed in the claims as well as modifications that are not described. The specification fails to provide a representative number of species for the claimed genus to show that applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described, are representative of the entire genus.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, disclosure of drawings, or by disclosure of relevant identifying characteristics, for example, structure or other physical and/or chemical properties, by
functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), states that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the ‘written description’ inquiry, whatever is now claimed" (See page 1117). The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed" (See Vas-Cath at page 1116). The skilled artisan cannot envision the detailed chemical structure of the encompassed genus, 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).
Therefore, for all these reasons the specification lacks adequate written description, and one of skill in the art cannot reasonably conclude that the applicant had possession of the claimed invention at the time the instant application was filed.
Response to Arguments
8. Applicant’s comments have been considered in full. Withdrawn objections/rejections will not be discussed herein as applicant’s comments are moot. Note that objections and rejections remain for the reasons set forth above and herein. Applicant state that the specification has been amended and that the sequence notation objected to is representing multiple sequences. The objection made pertained to the improper sequence notation, not the plurality of sequences, thus the objection remains. Applicant traversed the rejection under 112 first paragraph by stating that claim 12 has been amended. However, the rejection remains because the claimed invention is not adequately described. The claimed invention is directed to a recombinant polypeptide with an antigen binding domain and PEST domain. Independent claim 12 recites the structure of the PEST domain with a mutation, however, there is no structure function correlation for the recombinant polypeptide. It is noted that dependent claim 115 recites the structure, however, independent claim 12 needs to stand on its own.
Conclusion
9. No claims are presently allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HOPE A ROBINSON whose telephone number is (571) 272-0957. The examiner can normally be reached 9-5pm on Monday to Friday.
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, Robert Mondesi can be reached on (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HOPE A ROBINSON/Primary Examiner, Art Unit 1652
Prosecution Insights