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 .
Election/Restriction
The response filed on 12/5/25 to the restriction requirement of 10/7/25 has been received. With traverse, Applicant has elected the following species: (1) CD20 as the target of the first functional binding fragment in the bispecific recombinant protein, (2) CD47 as the target of the second functional binding fragment in the bispecific recombinant protein, (3) the A chain of the bispecific recombinant protein comprising SEQ ID NO:1 and the B chain of the bispecific recombinant protein comprising SEQ ID NO:2, (i) the elected species binds to antigens CD20 and CD47, (ii) the elected species targets cells expressing both CD20 and CD47, (iii) the first functional binding fragment comprise the heavy chain variable region and light chain variable region of Ofatumumab and the second functional binding domain fragment comprises the extracellular D1 domain of human SIRPa with a mutation of N80A, and (iv) no receptor is involved in the elected species. The traverse is based on the argument that search and examination of the entire application can be made without serious burden. Applicants further point to MPEP 803. Applicant further indicates the technical solution as claimed should not be limited to specific combination of targets because of benefits of constructs encompassed by the claims. The amendments to the claims and the arguments found in the Reply of 12/3/25 have been carefully considered, but are not deemed persuasive. In regards to the citation of MPEP 803 and argument that search and examination of the entire application can be made without serious burden, these arguments have been considered but are not found persuasive as such arguments do not apply when restriction is required under 35 USC 121 and 372, as in the instantly filed application. Thus, when the Office considers international applications as an International Searching Authority, as an International Preliminary Examining Authority, and during the national stage as a Designated or Elected Office under 35 U.S.C. 371, PCT Rule 13.1 and 13.2 will be followed when considering unity of invention of claims without regard to the practice in national applications filed under 35 U.S.C. 111. However, due the complexity of prior art searching of bispecific antibodies, a serious burden would be required to examine the application without a species requirement. In regards to the indication that the technical solution as claimed should not be limited to specific combination of targets because of benefits of constructs encompassed by the claims, the claims are not limited to specific embodiments with particular benefit of constructs encompassed by the claims discussed in the Reply of 12/5/25 because evidence has not been provided that the broad claims are limited to constructs exhibiting such benefits. Further, the examiner maintains the species do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, the species lack the same or corresponding special technical features for the following reasons: The products of each species represent separate and distinct products which are made by materially different methods, and are used in materially different methods which have different modes of operation, different functions and different effects. The methods of each species differ at least in objectives, method steps, reagents, response variables, and/or criteria for success such that one species could not be interchanged with the other.
Claims 1, 2, 4, 6, 9, 10, 12, 14-16, and 20-27 are pending.
Claims 1, 10, 15, and 16 are withdrawn from further consideration by the examiner under 37 CFR 1.142(b) as being drawn to a non-elected invention.
Claims 1, 2, 4, 6, 9, 10, 12, 14-16, and 20-27 are currently under consideration.
Claim Objections
Claim 1 is objected to because of an apparent typographical error. Claim 1 recites “…wherein a C-terminus in the antigen-binding fragment is….” A C-terminus would not be described as “in” an antigen-binding fragment; rather, a C-terminus would be described as being “of” an antigen binding fragment. In order to expedite prosecution, the following amendment is suggested to obviate this objection: “…wherein a C-terminus of the antigen-binding fragment is….” proper correction is required.
Claim 1 is objected to because of an apparent typographical error. Claim 1 recites: “…wherein the structures of chain A and chain B is selected from the group consisting of:…” The term “is” is incorrect because “structures” is a plural word. Further, the group lists combinations of chains. Therefore, the following amendment is suggested to obviate this objection: “…wherein chain A and chain B of the bispecific recombination protein are selected from the group consisting of:…” Proper correction is required.
Claim 9 is objected to because of an apparent typographical issue. A term, such as “wherein”, appears to be missing before “n is a natural number;….” Proper correction is required.
Claim 27 is objected to because of an apparent typographical error. Before the “wherein” clause, claim 27 contains a comma directly followed by a semicolon. Following a comma directly by a semicolon is not common in English and it appears the comma should be deleted.
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, 2, 4, 6, 9, 10, 12, 14-16, and 20-27 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, 2, 4, 6, 9, 10, 12, 14-16, and 20-27 are rejected because claim 1 recites “…the first functional binding fragment targeting an antigen of interest of the bispecific recombinant protein comprises…,” “…via a linker to the second functional binding fragment having a function of immunoregulation or a function of metabolic regulation or a function of endocrine regulation…,” “…optionally the CH2 further…,” and ”…and the domains in (i)-(iv).” There is a lack of antecedent basis for “the first functional binding fragment targeting an antigen of interest of the bispecific recombinant protein,” “the second functional binding fragment having a function of immunoregulation or a function of metabolic regulation or a function of endocrine regulation,” “the CH2,” and “the domains in (i)-(iv)” in the claims.
Claims 2, 4, 6, 9, 10, 12, 14-16, 20-25, and 27 are rejected because it is unclear how, or if, limitations following instance of the terms “preferably” or “more preferably” in claims 2, 4, 6, 9, 10, 15, 16, 21, 22, 25, and 27 limit the invention.
Claim 9 recites “…, wherein, the linker sequence comprises….” There is insufficient antecedent basis for “the linker sequence” in the claim.
Claim 16 recites “…the Fc region of chain A binds to the Fc region of the chain B by….” There is insufficient antecedent basis for “the Fc region of chain A” and “the Fc region of the chain B” in the claim.
Claim 25 is rejected for reciting “A method for preparing the bispecific recombinant protein of claim 24, the host cell is cultured….” It is not clear which bispecific recombinant protein claim 25 is referring, as claim 24 does not recite a “bispecific recombinant protein.” Rather, claim 24 recites a “host cell” transformed with an expression vector of claim 23 and the expression vector of claim 23 is described by claim 22 as encoding a bispecific recombinant protein of claim 1. Therefore, the method of claim 25 does not distinctly point-out what is being claimed. In an effort to expedite prosecution, the following amendment to claim 25 is suggested to obviate this rejection: “A method for preparing a bispecific recombinant protein comprising culturing the host cell of claim 24 under a condition….”
Claim 27 recites “…preferably, the tumor is…the autoimmune disease is…the infectious disease is….” There is insufficient antecedent basis for “the tumor,” “the autoimmune disease,” and “the infectious disease” in the claim.
Conclusion
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/SEAN E AEDER/ Primary Examiner, Art Unit 1642