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 .
Applicant’s amendments, filed 8/12/2026, is acknowledged.
Claims 63-68 are cancelled.
Claims 1-62 and 69-74 are currently pending.
Claims 1-9 are independent claims.
Claims 2-4, 8-17, 22-27, 33, 34, 38-42, 51-53, and 72 stand withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions and/or Species.
Claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-62, 69-71, 73, and 74 are under examination directed to a method comprising administration of a CD47-SIRPα blockade agent to a subject that as previously administered a population of cells engineered to express CD47.
In view of the amendments and remarks filed on 12/04/2025, the following rejections remain.
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.
Claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74 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 claims 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, at the time the application was filed, had possession of the claimed invention. This new ground of rejection is necessitated by Applicant’s amendments.
The claims are rejected for the same reasons discussed in the Office Action mailed on 5/12/2026. Specifically, the claims encompass a genus of polypeptides with a partial structure at best and the function of “CD47 polypeptide” (claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, and 73) and a genus of agents with a partial structure at best with the function of “CD47-SIRPα blockade agent” (claims 1, 5-7, 18-21, 28-32, 35-37, 43-59, 54-63, 68-71, 73, and 74) without adequate written description support for the broadly claimed genera.
Applicant’s arguments, filed 8/12/2026, have been fully considered, but have been found to be not convincing.
Applicant has amended instant claims 1 and 5-7 to recite the anti-CD47 antibodies comprising MIAP410 or B6H12 as well as generic “SIRPα-containing fusion protein” with a partial structure at best, and asserts that the claims are fully described (Remarks pg. 12); however the claims still do not have full written description support for the broadly claimed genera of “SIRPα blockade agent” comprising the claimed genera of “SIRPα-containing fusion protein” with a partial structure at best, which the instant specification only describes two working examples of with no structure-function relationship.
As discussed in the Office Action mailed on 5/12/2026, regarding structures with the function of “CD47-SIRPα blockade agent” (claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74), neither the specification nor the prior art provide sufficient structural features between an agent’s structure (i.e., the amino acid sequence in the case of polypeptides such as antibodies or fusion polypeptides) and the function of “CD47-SIRPα blockade agent”, which includes disrupting the “don’t eat me signal” produced by CD47/SIRPα interactions. The only structure-function guidance the specification provides is to disclose individual examples of anti-CD47 antibody structures and SIRPα-Fc fusion polypeptide structures with these functions.
Claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74 do not meet the requirements of 35 U.S.C. 112(a) for written description.
To overcome the rejection, it is recommended to amend the claims to recite specific structures, defined by their amino acid sequences, that have the functions of “CD47 polypeptide” and “CD47-SIRPα blockade agent”, including specific structures of polypeptides with the function of “SIRPα-containing fusion protein”.
Claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74 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 enablement requirement. The claims contain subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. This new ground of rejection is necessitated by Applicant’s amendments.
It is apparent that the hybridoma that produce the MIAP410 and B6H12 antibodies are required to practice the claimed invention. As a required element, it must be known and readily available to the public or obtainable by a repeatable method set forth in the specification. If it is not so obtainable or available, the enablement requirements of 35 USC 112, a deposit of the hybridoma, which produces this antibody, may satisfy first paragraph. See 37 CFR 1.801-1.809.
If the deposit has been made under the terms of the Budapest Treaty, an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature, stating that the hybridoma has been deposited under the Budapest Treaty and that the hybridoma will be irrevocably and without restriction or condition released to the public upon the issuance of a patent would satisfy the deposit requirement made herein. See 37 CFR 1.808. Further, the record must be clear that the deposit will be maintained in a public depository for a period of 30 years after the date of deposit or 5 years after the last request for a sample or for the enforceable life of the patent whichever is longer. See 37 CFR 1.806. If the deposit has not been made under the Budapest treaty, then an affidavit or declaration by applicants or someone associated with the patent owner who is in a position to make such assurances, or a statement by an attorney of record over his or her signature must be made, stating that the deposit has been made at an acceptable depository and that the criteria set forth in 37 CFR 1.801-1.809, have been met.
If the deposit was made after the effective filing date of the application for a patent in the United States, a verified statement is required from a person in a position to corroborate that the hybridoma described in the specification as filed are the same as that deposited in the depository. Corroboration may take the form of a showing of a chain of custody from applicant to the depository coupled with corroboration that the deposit is identical to the biological material described in the specification and in the applicant’s possession at the time the application was filed.
Claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a method of inducing killing of cells engineered to express an exogenous CD47 polypeptide in a subject in need thereof comprising administration of the polypeptide structures (defined by their amino acid sequences) of the antibodies magrolimab, MIAP410, and B6H12, and the polypeptide structures (defined by their amino acid sequences) of the SIRPα IgG1Fc or IgG4Fc fusion polypeptides; does not reasonably provide enablement for a method comprising administration of a broadly claimed genus of agents with little to no recited structure and the function of “CD47-SIRPα blockade agent”. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims. This new ground of rejection is necessitated by Applicant’s amendments.
The claims are rejected for the same reasons discussed in the Office Action mailed on 5/12/2026. Specifically, the claims encompass a genus of polypeptides with a partial structure at best and the function of “CD47-SIRPα blockade agent” (claims 1, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74) without adequate written description support for the broadly claimed genera.
Applicant’s arguments, filed 8/12/2026, have been fully considered, but have been found to be not convincing.
Applicant argues that the currently amended claims recite the specific species with the function of “CD47-SIRPα blockade agent”. However, while the claims have been amended to recite laboratory designations of anti-CD47 antibodies and a generic “SIRPα-containing fusion protein” with a partial structure at best (claims 1, 5-7, 18-21, 28-32, 35-37, 43-49, 54-63, 68-71, 73, and 74), including a laboratory designation with an undefined structure (claim 50). Therefore, the claims are still rejected as not enabled.
To overcome this rejection, it is recommended to recite the structures of the species with the recited function of “CD47-SIRPα blockade agent”, as defined by their amino acid sequences.
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, 5-7, 18-21, 28-32, 35-37, 43-50, 54-63, 68-71, 73, and 74 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. This new ground of rejection is necessitated by Applicant’s amendments.
Claims 1, 5-7, and 50 are indefinite in the recitation of "MIAP410” and “B6H12” (claims 1 and 5-7); or “ALX148 (ALX Oncology)” (claim 50) because their characteristics are not known. The use of "MIAP410” and “B6H12” monoclonal antibodies as the sole means of identifying the claimed antibody and hybridoma renders the claim indefinite because "MIAP410” and “B6H12” are merely a laboratory designation which does not clearly define the claimed product, since different laboratories may use the same laboratory designations to define completely distinct hybridomas or cell lines. Additionally, “ALX148 (ALX Oncology)” is merely laboratory designations which does not clearly define the claimed product.
Applicant’s arguments, filed 8/12/2026, have been fully considered, but have been found to be not convincing. Applicant argues that amending instant claim 50 to add “(ALX Oncology)” renders the laboratory designation definite (Remarks pg. 13). However, the laboratory designation for the specific structure of “ALX148 (ALX Oncology)” that is disclosed in the instant specification can be changed to refer to entirely different structures even after allowance, which can alter the scope of claim 50.
Conclusion
No claim is allowed.
Applicant’s remarks, filed 8/12/2026, have obviated the previous 35 U.S.C. § 103 rejections. Specifically, the following remarks are found convincing (Remarks pg. 13-15):
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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 ALEC JON PETERS whose telephone number is (703)756-5794. The examiner can normally be reached Monday-Friday 8:30am - 6:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at (571) 272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALEC JON PETERS/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641
