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 January 2, 2026, has been received and entered. The substitute specification filed on January 2, 2026 has been received and entered.
Claim Disposition
3. Claims 4 and 9 have been cancelled. Claims 1-3, 5-8 and 10-16 are pending. Claims 1, 3 and 10-12 are under examination. Claims 2, 5-8 and 13-16 are withdrawn as directed to a non-elected invention.
Information Disclosure Statement
4. The Information Disclosure Statement filed on February 19, 2026, has been received and entered. The references cited on the PTO-1449 Form have been considered by the examiner and a copy is attached to the instant Office action.
Claim objection
5. Claims 1, 3 and 10-12 are objected to for the following informalities:
For clarity and precision of claim language it is suggested that claim 1 is amended to read, “A complex, comprising:
a genome editing enzyme and a cell membrane-permeable peptide (CPP), wherein the CPP has 8 to 20 amino acid residues in length, wherein the CPP is fused to the genome editing enzyme, wherein 80% or more of the amino acid residues………and wherein the genome editing enzyme and the cell membrane-permeable peptide are set forth in SEQ ID NO: X”. The dependent claims hereto are also included.
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.
6. Claims 1, 3 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) contain 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 complex comprising a fusion of a genome editing enzyme and a CPP (cell membrane permeable peptide)’. The claimed invention is not adequately defined and encompasses a large variable genus of structures encompassed in the claims with respect to the genome editing enzyme and CPP of 8 to 10 amino acids. No structure or activity per se. The claimed invention encompasses features such as amino acid residues with 80% or more histidine, signal sequence and subdomain, however no reference structure is provided. Thus no correlation is made between structure and function.
The specification discloses that the genome editing enzyme can be from the Cas family nucleases such as Cas 9, Cas 12 etc. (see page 17). It is disclosed that the CPP can be a polyhistidine. The claimed invention is not limited to a specific embodiment. An ordinary skilled worker is not informed about the claimed complex and its components. The claims are not commensurate in scope with the disclosure in the specification. The specification also discloses that mutants are encompassed in the claimed invention but the claims are limited to any specific fusion partner. It is well established in the art that a single amino acid change can be detrimental to the structure-function relationship of the protein so much so that the protein can be rendered inactive or not functional in the manner asserted.
The claimed invention does not inform an ordinary skilled worker of the metes and bounds of the claims. There is also no clear structure-function correlation provided. The claimed invention is overly broad and encompasses large variable genus of enzymes. An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. See Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir.1997). Thus, applicant has not demonstrated possession of the invention as claimed. Furthermore, the 'written description' requirement.., serves both to satisfy the inventor's obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed ....The descriptive text needed to meet these requirements varies with the nature and scope of the invention at issue, and with the scientific and technologic knowledge already in existence." Capon v. Eshhar, 418 F.3d 1349, 1357 (Fed. Cir. 2005). The purpose of the written description requirement "is to ensure that the scope of the right to exclude ... does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification." Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345-46 (Fed. Cir. 2000). The goal of the written description requirement is "to clearly convey the information that an applicant has invented the subject matter which is
claimed." In re Barker, 559 F.2d 588, 592 n.4 (CCPA 1977) "A disclosure in an application, to be complete, must contain such description and details as to enable any person skilled in the art or science to which the invention pertains to make and use the invention as of its filing date." In re Glass, 492 F.2d 1228, 1232 (CCPA 1974).
Additionally, 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 of structures, 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).
Accordingly, the claimed invention is determined as lacking adequate written description because applicant has not demonstrated possession of the entire genus encompassed in the claims which is vast with respect to the fusion protein that encompasses mutants and fragments with no asserted activity.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1, 3 and 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 and the dependent claims hereto lack clear antecedent basis for the recitation of “the amino acid residues” because the claim language prior was directed to 8 to 10 amino acids in length. In addition, the claim lacks clarity because it recites the length of the structure and that it is comprising 80% or more histidine residues but it does not provide a reference structure where this percentage can be found. The claim language is also ambiguous as it can be construed that the CPP has 8 to 10 amino acids or that the genome editing enzyme with the cel membrane permeable peptide is 8 to 10 amino acids, language needs to be clearer (see suggestions in the objections).
Based on amendments made to the claims note that new rejections have been instituted under 112,second paragraph for the reasons set forth above.
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 the rejections of record under 112, first and second paragraphs remain for the reasons stated above and herein, but have been altered to reflect amendments made to the claims.
Applicant traverses the rejection under 112, first paragraph written description and state that claim 1 has been amended to recite the length and composition of CPP. This argument is not persuasive because two proteins are involved in the fusion and no structure is provided for the fusion or the fusion partners. The recitation of the CPP being 8 to 10 amino acids in length does not provide a discrete sequence structure that is searchable and comparable. The recitation of 80% or more histidine does not provide a reference structure where this 80% can be found. A large variable genus of structures are encompassed in the claim language that applicant has not demonstrated possession of. Note the new rejections have been instituted under 112, second paragraph for the reasons set forth above based on amendments made to the claims. Applicant’s arguments are not persuasive and the amendments made are not sufficient to obviate these grounds of rejection, thus the action is made final.
Conclusion
9. No claims are presently allowable.
10. Applicant’s amendment necessitated the new/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 extension fee 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 date of this final action.
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/HOPE A ROBINSON/Primary Examiner, Art Unit 1652