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 1-2, 4, 6-10, 13-17, 19, 21-24, 26-27, and 32-34 are pending as amended 7/27/23, and are considered herein.
Specification
The specification is objected to, for containing sequences requiring sequence identifiers.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
See also: PTO-2301
Drawings
The drawings are objected to.
Figures 10A and 10C contain sequence requiring sequence identifiers, and there are no such sequence identifiers in the drawings, nor in the brief description of the drawings. Thus, they are objected to.
See also: PTO-2301
Claim Objections
Claims 10, 13, and 19 each contain amino acid sequences requiring sequence identifiers.
Thus, Claim 10, 13, and 19 are objected to.
See also: PTO-2301
Applicant is advised that should claim 6 be found allowable, claim 33 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 33 limits the ligase of Claim 6 to OaAEP1 ligase. However, Claim 6 depends from Claim 2, which also requires the ligase to be OaAEP1 ligase. Thus, despite a distinct wording, these claims have substantially the same scope.
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 4, 8, and 13 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 4 recites “preferably [a submarkush]”. Such is not clear for its metes and bounds, as the specification fails to define the embodiments in which these members are preferable.
Claim 8 recites the linker C-terminal sequence is Xaa1GG, wherein Xaa1 is not “G or has the NG or NCL”. It is not clear if the sequence cannot contain “NG or NCL”, or if the sequence must be NG or NCL if the sequence is not G. Further, NG contains G. The scope is not clear at all.
Claim 13 recites “preferably [a submarkush]”. Such is not clear for its metes and bounds, as the specification fails to define the embodiments in which these members are preferable.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 22 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 22 is drawn to the RBC obtained by the method of Claim 1. However, such RBC is being claimed, and thus, it could be made by another method, and yet read on the claim. Therefore, the claimed scope of Claim 22 is larger than the scope of Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1 and 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Pishesha, et al. (2017) “Engineered erythrocytes covalently linked to antigenic peptides can protect against autoimmune disease”, Proceedings of the National Academy of Science, USA, 114(12): 3157-62.
Claim 1: Pishesha teaches using Sortase A to covalently attach an antigenic peptide equipped with a LPETG peptide at the C-terminus, to RBC membrane proteins with an exposed N-terminal glycine (results “Application of the Sortase Modification Strategy to Human RBCs”; Figure 6A). Further, with regard to the optional step, these RBCs were washed three times with PBS before transfusion back to the subject (SI Materials and methods “Sortagging of Kell-LPETGG, C57BL/6J Rag2-/-, BALB/c, and Human RBCs”).
Claim 22: the cells are obtained by the method (e.g., ABSTRACT).
Allowable Subject Matter
Claims 2, 6-7, 9-10, 14-17, 19, 21, 23-24, 26-27, and 23-34, are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
To wit, Applicant’s cited reference Harmand, et al. (2021) “Asparaginyl Ligase-Catalyzed One-Step Cell Surface Modification of Red Blood Cells”, ACS Chem Biology, 16(7): 1201-07 (Cited Non-Patent Literature No. 1 of the IDS of 2/16/24) is the first seen use in the Art of AEP1 ligases in the decoration of cells (It is noted that this publication is post-filing). Also, prior to the publication of Harmand, and even at the publication of Harmand, it was not known to deglycosylate cells prior to decorating the same with polypeptides. Given the number of ligases I the Art, and the choice of AEP1 ligases, and further first publication dating to after Applicant’s priority, the Examiner has concluded that the aforementioned claims, requiring such, are free of the Art of record. Additionally, the use of deglycosylating enzymes was not know in the Art of decorating cells prior to Applicant’s disclosure and it is judged that the use of the same would be hindsight.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
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