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 .
Detailed Action
The election with traverse filed April 2, 2026, is acknowledged and has been entered. Applicant has elected Group I. Applicant has elected the species of antigen of GPR56.
The amendment filed April 2, 2026, is acknowledged and has been entered. Claims 1-2, 5, 7, 10-11, 38 and 53 have been amended. Claims 57-58 have been newly added.
The traversal is on the basis that claim 1 has been amended and that as currently amended the Groups now share unity of invention.
In response, unity of invention practice does not require that unity of invention be reevaluated after each amendment, such that the current amendment is immaterial to the restriction requirement mailed December 5, 2025. It is further noted that restriction requirement stated that “[w]here applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder, so if all the product claims become allowable rejoinder will then be considered, but as no claims are currently allowable the reconsideration would be premature.
Therefore, the requirement is still deemed proper and is made FINAL.
Claims 1-2, 5, 7-8, 10-11, 30, 37-38 and 49-58 are pending. Claims 30, 37, 49, 51-52 and 55-56, are withdrawn from further consideration, as being drawn to non-elected invention or species of invention. Claims 1-2, 5, 7-8, 10-11, 38, 50, 53-54 and 57-58 are under consideration.
Information Disclosure Statement
The information disclosure statement has been considered.
Specification
The disclosure is objected to because of the following informalities:
Throughout the specification, SEQ ID NO:5 and SEQ ID NO:13 are used to describe a CDR2 of an antibody and both are a skipped sequence in the sequence listing. The sequence listing and CRF were entered under ST26 where sequence identifiers corresponding to 3 amino acids or less are shown as skipped sequences. Applicant is required to amend the specification of all the sequence identifiers corresponding to a skipped sequence with the specific sequences.
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 38, 50 and 53-54 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.
SEQ ID NO:13 is a skipped sequence in the sequence listing and CRF. The sequence listing and CRF was entered under ST26 where sequences that are 3 amino acids or less are listed as skipped sequences. Accordingly, these claims that recite SEQ ID NO:13 or depend from such a claim fail to particularly point out and distinctly claim the subject matter because it is unclear what CDR sequence is being claimed.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-2, 5, 7-8 and 57-58 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furch et al (EP 3087974 A1, 2016, IDS).
With respect to claims 1-2, Furch et al disclose antibody conjugate comprising an antibody and a nanoparticle conjugated to the antibody (see entire document, e.g., abstract), wherein the antibody targets a cell-surface protein that is expressed on hematopoietic stem cells (HSCs) (see entire document, e.g., ¶ [0049]), wherein the nanoparticle comprises a gene editing payload that comprises a nuclease or a nucleic acid encoding the nuclease (see entire document, e.g., abstract),, and wherein the nanoparticle comprises poly(lactic-co-glycolic acid) (PLGA) (see entire document, e.g., ¶ [0024] and [0045] and claims 1-11).
With respect to claims 5, 7-8 and 58, Furch et al disclose that the nuclease is TALEN or CRISPR Cas9 with a guide RNA (see entire document, e.g., ¶ [0021] and [0037] and claim 2).
With respect to claim 57, Furch et al disclose coating the nanoparticle with PEG (see entire document, e.g., ¶ [0046].
Accordingly, the reference anticipates the claimed invention.
Claims 1-2, 5, 7-8 and 57-58 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by US 2018/0223260 A1 (Aprikyan et al).
With respect to claims 1-2 Aprikyan et al disclose antibody conjugate comprising an antibody and a nanoparticle conjugated to the antibody (see entire document, e.g., abstract and ¶ [0129], [0262] and [0334]-[0357]), wherein the antibody targets a cell-surface protein that is expressed on hematopoietic stem cells (HSCs) (see entire document, e.g., ¶ [0029] and [0371]), wherein the nanoparticle comprises a gene editing payload that comprises a nuclease or a nucleic acid encoding the nuclease (see entire document, e.g., ¶ [0078]), and wherein the nanoparticle comprises poly(lactic-co-glycolic acid) (PLGA) (see entire document, e.g., ¶ [0180]-[0182]).
With respect to claims 5, 7-8 and 58, Aprikyan et al disclose that the nuclease is CRISPR Cas9 with a guide RNA (see entire document, e.g., ¶ [0085]).
With respect to claim 57, Aprikyan et al disclose the nanoparticle having a diameter of 200 nm (see entire document, e.g., ¶ [0352].
Accordingly, the reference anticipates the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-2, 5, 7-8, 10-11 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over Furch et al (EP 3087974 A1, 2016, IDS) and Tokoro et al (Exp. Hema. 59:51-59, 2018, IDS).
Furch et al disclose that which is set forth in the above 102.
Furch et al do not disclose GPR56 as a hematopoietic stem cell antigen.
Tokoro et al disclose GPR56 as a hematopoietic stem cell (HSC) antigen that marks long-term repopulating HSCs and an antibody that binds GPR56 (see abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to use the GPR56 antibody of Tokoro et al on the antibody conjugates of Furch et al because such an antibody is a known antibody that targets HSCs and because it has the advantage of targeting long-term repopulating HSCs. In this case, using the GPR56 antibody of Tokoro et al on the antibody conjugates of Furch et al would be seen as combining prior art elements according to known methods to yield predictable results.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
Claims 1-2, 5, 7-8, 10-11 and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over US 2018/0223260 A1 (Aprikyan et al) and Tokoro et al (Exp. Hema. 59:51-59, 2018, IDS).
Aprikyan et al disclose that which is set forth in the above 102.
Aprikyan et al do not disclose GPR56 as a hematopoietic stem cell antigen.
Tokoro et al disclose GPR56 as a hematopoietic stem cell (HSC) antigen that marks long-term repopulating HSCs and an antibody that binds GPR56 (see abstract).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art at the time the claimed invention was made to use the GPR56 antibody of Tokoro et al on the antibody conjugates of Aprikyan et al because such an antibody is a known antibody that targets HSCs and because it has the advantage of targeting long-term repopulating HSCs. In this case, using the GPR56 antibody of Tokoro et al on the antibody conjugates of Aprikyan et al would be seen as combining prior art elements according to known methods to yield predictable results.
Accordingly, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the reference, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The examiner can normally be reached on Monday through Friday.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Julie Wu can be reached on (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
June 24, 2026
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