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 6/3/26 in response to the Office Action of 3/6/26 are acknowledged and have been entered.
Claims 29-33 have been added by Applicant.
Claims 2, 9, 10, 12, 14-16, 20-27, and 29-33 are pending.
Claims 2, 9, 10, 15, 16, 21, 22, and 25-27 have been amended by Applicant.
Claims 2, 9, 10, 12, 14-16, 20-27, and 29-33 are currently under examination.
All species encompassed by claim 2 have been rejoined.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The following Office Action contains NEW GROUNDS of rejections Necessitated by Amendments.
Election/Restriction
In the Reply of 6/3/26, Applicant again requests withdrawal of the lack of unity because the claimed subject matter constitutes a single unitary invention without separate independent inventions.
The amendments to the claims and the arguments found in the Reply of 6/3/26 have been carefully considered. Due to applicant’s amendments better clarifying the claims, all species encompassed by the pending claims have been rejoined as they now all appear to constitute a single unitary invention without separate independent inventions. It is further noted that, while rejoined claims are newly rejected in this Office Action, this Office action is properly made Final. As noted at MPEP 706.07(a): “If rejoinder occurs after a first Office action on the merits and if any of the rejoined claims are unpatentable (e.g., a rejection under 35 U.S.C. 112(a) is made), the next Office action may be made final if the rejection of the rejoined claims was necessitated by applicant’s amendment, or based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p).” In the instant situation, rejection of rejoined claimed was necessitated by applicant amending the claims to better clarify the claimed subject matter.
Objections and Rejections Withdrawn
All previous objections and rejections are withdrawn.
Claim Objections
Claim 10 is objected to because of apparent typographical issues. It appears the comma after “ligand” on the third line of the claim should be a semicolon. On the fourth line of the claim, it appears (i) “is cytokine” should be replaced by “is a cytokine” and (ii) “the immune checkpoint ligand” should be replaced by “an immune checkpoint ligand.” On the fifth line of the claim, it appears “thereof; the second” should be replaced by “thereof; or the second”. Proper correction is required.
Claim 29 is objected to before of apparent typographical issues. It appears the comma after “IL-15RaSUSHI” and “amino” at line 8 of the claim should be a semicolon. Proper correction is required
New Rejection Necessitated by Amendments
Claim Rejections - 35 USC § 112
Claims 2, 9, 10, 12, 14-16, 20-27, and 29-33 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 2, 9, 10, 12, 14-16, 20-27, and 29-33 are rejected because claim 2 recites (at lines 6-7 on page 3 of the Reply) “…the CH1 domain…in (i)-(iv) are connected via….” There is insufficient antecedent basis for “the CH1 domain” in “(iv)” in the claims. The structure of “(iv)” does not comprise a CH1 domain. Therefore, the metes-and-bounds of the claims are unclear.
Claim 9 recites “The bispecific recombinant protein of claim 2, wherein the linker comprises the amino acid sequence selected from….wherein n is a natural number from 0 to 5.” Claim 2 recites at least four linkers. It is unclear which linker of claim 2 is “the linker” of claim 8. There is insufficient antecedent basis for “the linker” in the claim. Further, the metes-and-bounds of the claim are unclear because it is unclear which amino acid sequence of the Markush group is “the” amino acid sequence. Further, it is unclear what is meant by a linker that comprises a recited sequence that does not exist (when “n” is 0). In an effort to expedite prosecution, the following amendment to claim is suggested to obviate this rejection: “The bispecific recombinant protein of claim 2, wherein a linker of the bispecific recombinant protein comprises an amino acid sequence …. wherein n is a natural number from 1 to 5.”
Claims 29-30 are rejected because claim 29 recites (at line 10 of the claim) “…respectively, or a mutant of the second function binding fragment mentioned above; or….” It is unclear, as to what, is alternatively (“or”) a mutant of the second function binding fragment mentioned above. Further, is unclear which second function binding fragment is “the” second function binding fragment “mentioned above”. There is insufficient antecedent basis for “the second function binding fragment mentioned above” in the claims.
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.
Claims 22-25 are 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 the claims depend, or for failing to include all the limitations of the claim upon which it depends. Claim 22 reciting the recombinant protein of claim 2 is encoded by DNA on the same or different strands does not further limit the subject matter of claim 2 and claim 22 does not require the product of claim 22 to comprise the bispecific recombinant protein of claim 2. 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. In an effort to expedite prosecution, the following amendments to claims 22-23 are suggested to obviate this rejection:
Claim 22) One or more nucleic acid molecules encoding the bispecific recombinant protein of claim 2, wherein the one or more nucleic acid molecules comprise: a nucleic acid molecule encoding the first functional binding fragment and the second functional binding fragment in a same DNA strand, or nucleic acid molecules encoding the first functional binding fragment and a nucleic acid encoding the second functional binding fragment in different DNA strands.
Claim 23) An expression vector comprising the one or more nucleic acid molecules of claim 22.
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.
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/SEAN E AEDER/Primary Examiner, Art Unit 1642
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