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 .
The amendments and remarks filed 2/19/26 are acknowledged. Claims 1, 4, 10, 15, 20, 25, 31, 43, and 48-49 have been amended. Claims 61-67 have been added. Claims 2, 3, 6-9, 11-14, 16-19, 21-24, 26, 28-30, 32-42, 45-47, and 50-60 have been canceled. Claims 1, 4, 5, 10, 15, 20, 25, 27, 31, 43-44, 48-49, 61-67 are pending and under examination.
Withdrawn Rejections
The rejection of claims 1, 4, 5, 9-11, 15, 17-21, 25, 27, 31, 43, 44, and 47-49 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112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement, is withdrawn in light of Applicant’s amendment thereto. See paragraph 4, page 2 of the previous Office action.
The rejection of claims 9-11, 15, and 31 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention, is withdrawn in light of Applicant’s amendment thereto. The cancelation of claims 9 and 11 renders the rejection moot. See paragraph 6, page 13 of the previous Office action.
The rejection of claims 1, 4, 5, 9-11, 15, and 27 under 35 U.S.C. 103 as being unpatentable over Villiger et al. (WO 2019/060629 A1, published March 28, 2019) in view of Yim et al. (Exosome engineering for efficient intracellular delivery of soluble proteins using optically reversible protein-protein interaction module. Nat Commun 7, 12277 (2016)), is withdrawn in light of Applicant’s statement that Villager is not prior art to the captioned application under 35 U.S.C. § 102(b)(2)(C) because the subject matter of the claimed invention and Villager were owned by the same person, i.e., CODIAK BIOSCIENCES, INC. or subject to an obligation of assignment to CODIAK BIOSCIENCES, INC., not later than the effective filing date of the captioned application.
New Rejections Necessitated by Applicant’s Amendments
Claim Rejections - 35 USC § 112
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.
Claims 1, 4, 5, 10, 15, 20, 25, 27, 31, 43-44, 48-49, 61-67 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.
Claims 1 and 43 recites “(ii) the full-length or N-terminus amino acid sequence of brain acid soluble protein 1 (BASP1)”. This limitation is indefinite because it is unclear what portion of BASP1 is encompassed by the N-terminus amino acid sequence. For instance, does not N-terminus sequence encompass amino acids 1-20 or 1-50. Therefore, the claim scope is ambiguous and one of skill in the art would not be apprised of the metes and bounds of the claims. Dependent claims 4, 5, 10, 15, 20, 25, 27, 31, 44, 48, 49, and 61-67 do not remedy the deficiency of claims 1 and 43, and thus, are included in the rejection.
Claim 4 recites an exogenous sequence. The limitation is indefinite because it is unclear if the exogenous sequence is one of the scaffold protein sequences recited in claim 1, or some other sequence. Therefore, the scope of the claim is ambiguous and one of skill in the art would not be apprised of the metes and bounds of the claim. Clarification and/or correction is required.
Claim 64 recites wherein the exogenous sequence encodes a therapeutic peptide. This limitation is indefinite because claim 27 states that the exogenous sequence encodes the scaffold protein. It is unclear if the exogenous sequence in claim 27 encodes both the scaffold protein and the therapeutic peptide, or if distinct sequences encode the scaffold protein and therapeutic peptide. Dependent claim 65 does not cure the deficiency of claim 64, and thus, is included in the rejection. Clarification and/or correction is required.
Claim 66 recites wherein the exogenous sequence encodes a targeting moiety. This limitation is indefinite because claim 27 states that the exogenous sequence encodes the scaffold protein. It is unclear if the exogenous sequence in claim 27 encodes both the scaffold protein and the targeting moiety, or if distinct sequences encode the scaffold protein and targeting moiety. Dependent claim 67 does not cure the deficiency of claim 66, and thus, is included in the rejection. Clarification and/or correction is required.
Claim Status
No claims are allowed.
Conclusion
Applicant's amendment necessitated the new 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 SANDRA CARTER whose telephone number is (571)272-2932. The examiner can normally be reached 8:00-5:00 pm.
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/SANDRA CARTER/Examiner, Art Unit 1674
/VANESSA L. FORD/Supervisory Patent Examiner, Art Unit 1674
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