DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Applicant’s amendment filed January 30, 2026 is acknowledged.
Claims 3-7, 9-11, 13-16, 19-21, 23-25, 28-31, and 34-72 are canceled.
Claims 1, 2, 8, 12, 17, 18, 22, 26, 27, 32, 33, and 73 are pending and currently under consideration.
Claim 1 is an independent claim.
In view of the applicant’s amendment filed January 30, 2026, the previous rejections under U.S.C. 112(b) and 112(d) and the objections as set forth in the Office Action mailed July 31, 2025 have been withdrawn the following objections and rejections are set forth.
The terminal disclaimer filed on January 30, 2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of U.S. Patent No. 12,516,128 (matured from Application No. 17/611,054) has been reviewed and is accepted. The terminal disclaimer has been recorded.
In view of the filing of this terminal disclaimer, the previous nonstatutory double patenting rejection to the claims in Application No. 17/611,054, now Patent No. 12,516,128, as set forth in the Office Action mailed July 31, 2025 has been withdrawn.
Interview Summary
The Examiner called the Applicant’s Representative, Benjamin Atkins, on March 23, 2026 to reiterate that a terminal disclaimer to U.S. Patent No. 12,415,860 needs to be filed in order to put the instant Application in condition for allowance. The Applicant’s Representative said the Applicant would consider the Examiner’s proposal. No agreement was reached.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP § 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 2, 8, 12, 17, 18, 22, 26, 27, 32, 33, and 73 stand rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,415,860 (the ‘860 Patent, matured from Application No. 17/055,096). Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claims are anticipated by claims of the ‘096 Application.
The instant claims are drawn to a conditionally active protein comprising: (A) a dual binding moiety, the dual binding moiety comprising (i) a single domain antibody comprising complementarity determining regions (CDRs) and non-CDR loops, wherein the non-CDR loops comprise AB, C"D, EF, and CC' loops, and (ii) a cleavable linker, wherein the cleavable linker comprises a protease cleavage site; and (B) a target antigen binding domain selected from a single domain antibody and a single chain Fv (scFv), wherein the target antigen binding domain is linked to the dual binding moiety by the cleavable linker, wherein the dual binding moiety is capable of an interaction with the target antigen binding domain by specific binding, wherein upon the interaction between the dual binding moiety and the target antigen binding domain, the dual binding moiety is capable of masking the target antigen binding domain from binding its target, wherein upon cleavage of the cleavable linker, the dual binding moiety is capable of unmasking the target antigen binding domain, and wherein the CC' loop comprises a binding site specific for the target antigen binding domain.
The claims in the ‘096 Application are drawn to a conditionally active binding protein comprising (a) a binding moiety (M) which comprises a non-CDR loop, wherein the binding moiety (M) comprises a serum albumin binding domain and the non-CDR loop comprises a binding site specific for a CD3
ε
domain, and wherein the binding moiety further comprises complementarity determining regions (CDRs), (b) a cleavable linker (L), (c) a first target antigen binding domain (T1) comprising an immunoglobulin molecule that binds to CD3
ε
, and (d) a second target antigen binding domain (T2), wherein the binding moiety (M) is capable of masking the binding of the first target antigen binding domain (T1) to CD3
ε
its target.
It is noted that in construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. See MPEP 804 II.B.1.
Furthermore, the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim in nonstatutory double patenting. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. See MPEP 804 II.B.1.
This applies to the instant case where the claims in the ‘860 Patent are drawn to a genus of conditionally active binding proteins comprising a binding moiety which comprises a non-CDR loop comprising a binding site specific for a CD3
ε
domain which encompasses disclosed species that only comprise a binding site specific for a CD3
ε
domain in the CC’ non-CDR loop.
The species disclosed in the ‘860 Patent that fall within the scope of the claims include ProTriTACs having the amino acid sequences of SEQ ID NOs: 43, 46, and 786-790 (e.g. see the “Sequence Table” on pages 64, 65, and 135-137 of the specification of the ‘096 Application). These ProTriTACs comprise a single domain antibody and a CD3
ε
masking sequence specifically in the CC’ non-CDR loop.
To demonstrate this, a partial alignment of SEQ ID NO: 906 (EpCAM H90 TriTAC C2854) and SEQ ID NO: 908 (EpCAM H90 ProTriTAC (NCLV) C2302) was done to illustrate that the CD3
ε
masking sequence is specifically inserted into the CC’ loop; and a partial alignment of SEQ ID NO: 908 (EpCAM H90 ProTriTAC (NCLV) C2302) and SEQ ID NO: 786 (Exemplary EGFR ProTriTAC) was done to show that the region where the masking sequence is inserted is identical between the two amino acid sequences. It is noted that EpCAM H90 ProTriTAC (NCLV) C2302 (SEQ ID NO: 908) does not fall within the scope of the genus of conditionally active binding proteins as claimed because it does not have a cleavable linker, but it is useful to show the masking sequence’s site of insertion. See alignment below.
NO: 908 1 EVQLVESGGGLVQPGNSLRLSCAASGFTFSKFGMSWVRQGGGGGLDGNEEPGGLEWVSSI 60
||||||||||||||||||||||||||||||||||||||| | ||||||||
NO: 906 1 EVQLVESGGGLVQPGNSLRLSCAASGFTFSKFGMSWVRQAPG---------KGLEWVSSI 51
NO: 908 1 EVQLVESGGGLVQPGNSLRLSCAASGFTFSKFGMSWVRQGGGGGLDGNEEPGGLEWVSSI 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
NO: 786 1 EVQLVESGGGLVQPGNSLRLSCAASGFTFSKFGMSWVRQGGGGGLDGNEEPGGLEWVSSI 60
The ‘860 Patent teach also disclose that a portion of the human CD3
ε
sequence was grafted into the CC' loop of the non-CDR loops within the binding moiety, along with glycine residues to further extend the CC' loop (e.g. see Example 13 on page 53, [00176]). Figure 29 (copied below) illustrates three different variants comprising 10, 12, or 16 (CC10, CC12, and CC16, respectively) amino acid extensions to the CC' loop. For the variants, the portion of human CD3
ε
sequence grafted into the CC' loop, to replace the wild type sequence of APGKG was QDGNEE (SEQ ID NO. 801) for CC10, QDGNEEMGG (SEQ ID No. 802) for CC12, or QDGNEEMGG (SEQ ID No. 803) for CC16, in addition to 4, 3, or 7 glycine residues, respectively, to extend the CC’ loop (e.g. see Example 13 on page 53, [00176]).
PNG
media_image1.png
427
646
media_image1.png
Greyscale
Figure 29 of the ‘096 Application
It is further noted that, where a species disclosed but not claimed in a parent case as filed and first acted upon by the examiner, are voluntarily presented in a different application having at least one common (joint) inventor or a common assignee (i.e., no requirement for election pertaining to said species was made by the Office) there should be close investigation to determine whether a double patenting rejection would be appropriate. See MPEP 806.04(h).
This applies to the instant case where, as noted above, the Applicant has disclosed best, and even only, candidate species of conditionally active proteins in the ‘860 Patent that comprise a binding site specific for a CD3
ε
domain only in the CC’ non-CDR loop. Thus, while these disclosed species comprising a binding site specific for a CD3
ε
domain only in the CC’ non-CDR loop are not explicitly claimed in the ‘860 Patent, these are the only species that fall within the scope of the ‘860 Patent’s claimed genus of conditionally active proteins and would therefore anticipate the instant claims.
Thus, the claims in the ‘096 Application would anticipate the instant claims.
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
The Applicant argues that the present claims are patentably distinct from the cited claims of the '860 Patent. The Applicant asserts that, in particular, the claims of the '860 Patent are silent regarding the CC' loop, much less that the CC' loop comprises a binding site specific for the target antigen binding domain as required by the present claims. The Applicant argues that, therefore, the claims of the '860 Patent would not anticipate the present claims.
The Applicant further argues that the Office has not asserted that the contents of the specification of the '860 Patent are needed to understand the meaning of a term in the claims.
This is not found persuasive for the following reasons:
Contrary to the Applicants arguments that the present claims are patentably distinct from the cited claims of the '860 Patent and that the claims in the '860 Patent would not anticipate the present claims; note that the Applicant has disclosed best, and even only, candidate species of conditionally active proteins in the ‘860 Patent that comprise a binding site specific for a CD3ε domain only in the CC’ non-CDR loop. Thus, while these disclosed species comprising a binding site specific for a CD3ε domain only in the CC’ non-CDR loop are not explicitly claimed in the ‘860 Patent, these are the only species that fall within the scope of the ‘860 Patent’s claimed genus of conditionally active proteins and would therefore anticipate the instant claims.
This is because the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim in nonstatutory double patenting. Furthermore, if the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. See MPEP 804 II.B.1.
This applies to the instant case where the claims in the ‘860 Patent are drawn to a genus of conditionally active binding proteins comprising a binding moiety which comprises a non-CDR loop comprising a binding site specific for a CD3ε domain which encompasses disclosed species that only comprise a binding site specific for a CD3ε domain in the CC’ non-CDR loop.
Regarding the Applicant’s argument that the claims of the '860 Patent are silent regarding the CC' loop, much less that the CC' loop comprises a binding site specific for the target antigen binding domain as required by the present claims; it is noted that where a species disclosed but not claimed in a parent case as filed and first acted upon by the examiner, are voluntarily presented in a different application having at least one common (joint) inventor or a common assignee (i.e., no requirement for election pertaining to said species was made by the Office) there should be close investigation to determine whether a double patenting rejection would be appropriate. See MPEP 806.04(h).
This applies to the instant case where, as noted above, the Applicant has disclosed best, and even only, candidate species of conditionally active proteins in the ‘860 Patent that comprise a binding site specific for a CD3ε domain only in the CC’ non-CDR loop. Thus, while these disclosed species comprising a binding site specific for a CD3ε domain only in the CC’ non-CDR loop are not explicitly claimed in the ‘860 Patent, these are the only species that fall within the scope of the ‘860 Patent’s claimed genus of conditionally active proteins and would therefore anticipate the instant claims.
Regarding the Applicant’s argument that the Office has not asserted that the contents of the specification of the '860 Patent are needed to understand the meaning of a term in the claims; it is noted that in order to understand the term “non-CDR loop” from the ‘860 Patent the disclosure must be considered. In considering the disclosure, it was found that they only non-CDR loop that was used for inserting a binding site specific for a CD3ε domain was the CC’ loop (e.g. see ProTriTACs having the amino acid sequences of SEQ ID NOs: 43, 46, and 786-790, Example 13, and Figure 29). Therefore, the Applicant has disclosed that the CC’ loop is the best, and really only, candidate CC’ loop for inserting a binding site specific for a CD3ε domain.
As stated above, where a species disclosed but not claimed in a parent case as filed and first acted upon by the examiner, are voluntarily presented in a different application having at least one common (joint) inventor or a common assignee (i.e., no requirement for election pertaining to said species was made by the Office) there should be close investigation to determine whether a double patenting rejection would be appropriate. See MPEP 806.04(h).
Therefore, while the disclosed species comprising a binding site specific for a CD3ε domain only in the CC’ non-CDR loop are not explicitly claimed in the ‘860 Patent, these are the only species that fall within the scope of the ‘860 Patent’s claimed genus of conditionally active proteins and would therefore anticipate the instant claims.
As such, the applicant’s argument has not been found persuasive.
Claims 1, 2, 8, 12, 17, 18, 22, 26, 27, 32, 33, and 73 stand provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims of the following copending Applications for similar reasons for the nonstatutory double patenting to the ‘096 Application. Although the claims at issue are not identical, they are not patentably distinct from each other because instant application claims are anticipated by claims of the following copending Applications.
The instant claims are drawn to a conditionally active protein comprising: (A) a dual binding moiety, the dual binding moiety comprising (i) a single domain antibody comprising complementarity determining regions (CDRs) and non-CDR loops, wherein the non-CDR loops comprise AB, C"D, EF, and CC' loops, and (ii) a cleavable linker, wherein the cleavable linker comprises a protease cleavage site; and (B) a target antigen binding domain selected from a single domain antibody and a single chain Fv (scFv), wherein the target antigen binding domain is linked to the dual binding moiety by the cleavable linker, wherein the dual binding moiety is capable of an interaction with the target antigen binding domain by specific binding, wherein upon the interaction between the dual binding moiety and the target antigen binding domain, the dual binding moiety is capable of masking the target antigen binding domain from binding its target, wherein upon cleavage of the cleavable linker, the dual binding moiety is capable of unmasking the target antigen binding domain, and wherein the CC' loop comprises a binding site specific for the target antigen binding domain.
Claims 1-13, 15, 18, 20, 26, 28, and 51 of copending Application No. 18/252,007 are drawn to methods of treating a cancer, the method comprising: administering to a subject in need thereof a conditionally active EpCAM binding protein comprising (a) an anti-EpCAM domain; (b) an anti-CD3 domain; and (c) an anti-albumin domain that comprises a masking sequence to mask the binding of the anti-EpCAM domain to its target.
The ’007 Application’s specification defines a "ProTriTAC," or an "EpCAM targeting protrispecific protein," as used herein refers to a trispecific binding protein that is conditionally activated, and comprises (i) a cleavable linker (e.g., comprising an amino acid sequence as set forth in SEQ ID NOS: 425-471 and SEQ ID NOS: 503-507)), (ii) a binding moiety that is specific for a bulk serum protein and also comprises a masking moiety (e.g., comprising an amino acid sequence as set forth in SEQ IDNOS: 380-424) which prohibits the binding of a first target antigen binding domain or a second target antigen binding domain to its target, wherein at least one of the first target antigen binding domain and the second target antigen binding domain comprises an EpCAM binding protein as described herein (e.g. see page 92, [00282]).
The EpCAM ProTriTACs disclosed by the ‘007 Application and encompassed by the claims comprise the amino acid sequences of SEQ ID NOs: 498-501.
Claims 54-74 of copending Application No. 18/635,533 are drawn to a conditionally active binding protein comprising: a binding moiety (M) which comprises a non-CDR loop, a cleavable linker (L), and a first target antigen binding domain (T1) linking the binding moiety (M) with the first target antigen binding domain (T1),wherein the binding moiety is capable of masking the binding of the first target antigen binding domain (Ti) to its target, wherein the cleavable linker comprises a protease cleavage site.
The species of conditionally active binding proteins encompassed by the claims of the ‘533 Application include SEQ ID NOs: 43, 46, 786-790, 999-1010, 1013-1074, and 1122-1124 (e.g. see pages 90-93, 157-160, 164-182, and 189-219 of the “SEQUENCE TABLE” of the specification).
Claims 39, 40, 47, 67, 70, 87, 98, 103, 104, 142, 143, 149, and 151-153 of copending Application No. 19/137,399 are drawn to a conditionally active ITGB6 binding protein comprising a binding moiety (M) which comprises a non-CDR loop, a cleavable linker (L), a first target antigen binding domain (T1), and a second target antigen binding domain (T2), wherein at least one of the first target antigen binding domain (T1) and the second target antigen binding domain (T2) comprises an ITGB6 binding domain, wherein the non-CDR loop is capable of binding to the ITGB6 binding domain or the second target antigen binding domain, and wherein the binding moiety is capable of masking the binding of the ITGB6 binding domain or the second target antigen binding domain to its target; a method for the treatment or amelioration of a proliferative disease, or a tumorous disease, comprising the administration of the conditionally active ITGB6 binding protein; pharmaceutical composition comprising the conditionally active ITGB6 binding protein; a process of producing the conditionally active ITGB6 binding protein; a method for treating or ameliorating a proliferative disease, or a tumorous disease, comprising administering the conditionally active ITGB6 binding protein; a ITGB6 targeting conditionally active multispecific protein; a process for the production of the ITGB6 targeting conditionally active multispecific protein; and the method for the treatment or amelioration of a proliferative disease, or a tumorous disease, comprising the administration of an of ITGB6 targeting conditionally active multispecific protein.
The species of conditionally active ITGB6 binding proteins encompassed by the claims of the ‘399 Application include SEQ ID NOs: 353-357 and 710 (e.g. see pages 135, 136, and 153 of the “SEQUENCE TABLE” of the specification).
Claims 39, 40, 47, 67, 70, 87, 98, 103, 104, 142, 143, 149, and 151-153 of copending Application No. 19/145,076 are drawn to a conditionally active NECTIN4 binding protein comprising a binding moiety (M) which comprises a non-CDR loop, a cleavable linker (L), a first target antigen binding domain (T1), and a second target antigen binding domain (T2), wherein at least one of the first target antigen binding domain (T1) and the second target antigen binding domain (T2) comprises an NECTIN4 binding domain, wherein the non-CDR loop is capable of binding to the NECTIN4 binding domain or the second target antigen binding domain, and wherein the binding moiety is capable of masking the binding of the NECTIN4 binding domain or the second target antigen binding domain to its target; a method for the treatment or amelioration of a proliferative disease, or a tumorous disease, comprising the administration of the conditionally active NECTIN4 binding protein; pharmaceutical composition comprising the conditionally active NECTIN4 binding protein; a process of producing the conditionally active NECTIN4 binding protein; a method for treating or ameliorating a proliferative disease, or a tumorous disease, comprising administering the conditionally active NECTIN4 binding protein; a NECTIN4 targeting conditionally active multispecific protein; a process for the production of the NECTIN4 targeting conditionally active multispecific protein; and the method for the treatment or amelioration of a proliferative disease, or a tumorous disease, comprising the administration of an of NECTIN4 targeting conditionally active multispecific protein.
The species of conditionally active NECTIN4 binding proteins encompassed by the claims of the ‘076 Application include SEQ ID NOs: 330-347 (e.g. see pages 135, 136, and 153 of the “SEQUENCE TABLE” of the specification).
Claims 1-64 of copending Application No. 19/259,785 are drawn to a binding moiety comprising a non-CDR loop and a cleavable linker, wherein the moiety is capable of masking the binding of a binding molecule to its target, wherein the binding molecule comprises an immunoglobulin molecule or a non-immunoglobulin molecule; a conditionally active binding protein comprising a binding moiety (M) which comprises a non-CDR loop, a cleavable linker (L), a first target antigen binding domain (T1), and a second target antigen binding domain (T2), wherein the first target antigen binding domain (T1) comprises an immunoglobulin molecule, wherein the non-CDR loop is capable of binding to the first target antigen binding domain, and wherein the binding moiety is capable of masking the binding of the first target antigen binding domain to its target; and a conditionally active binding protein, comprising a binding moiety linked to a target antigen binding domain via a non-CDR loop within the binding moiety, wherein the binding moiety is further linked to a half-life extension domain and comprises a cleavable linker, wherein the target antigen binding domain comprises an immunoglobulin molecule, wherein the binding protein has an extended half-life prior to its activation by cleavage of the linker, and wherein upon activation the binding moiety and the half-life extension domain are separated from the target antigen binding domain, and wherein the binding protein, in its activated state, does not have an extended half-life.
The species encompassed by the claims of the ‘785 Application include SEQ ID NOs: 46 and 786-790 (e.g. see pages 65, 66, and 138-140 of the “SEQUENCE TABLE” of the specification).
Claims 24-48, 70, 73, 76-87, 90-155 copending Application No. 19/291,091 (filed after (08/05/2025) the mailing of the Office Action from 07/31/2025) are drawn to an EpCAM binding domain, wherein the EpCAM binding domain is part of a conditionally activatable chimeric antigen receptor (a ProCAR), wherein the ProCAR further comprises a binding moiety comprising a non-CDR loop and a cleavable linker; methods for the treatment or amelioration of a proliferative disease; a conditionally active chimeric antigen receptor (ProCAR); a conditionally active EpCAM binding protein; pharmaceutical compositions; process for the production of a conditionally active chimeric antigen receptor; a process for the production of a conditionally active EpCAM binding protein; cells comprising the ProCAR; method comprising transfecting a cell; methods of increasing a therapeutic index of an EpCAM binding domain; an EpCAM targeting conditionally active multispecific protein; and a process for the production of EpCAM targeting conditionally active multispecific protein.
The species encompassed by the claims of the ‘091 Application include SEQ ID NOs: 498-501 and 576-578.
It is noted that in construing the claims of the reference patent or application, a determination is made as to whether a portion of the specification, including the drawings and claims, is directed to subject matter that is within the scope of a reference claim. For example, assume that the claim in a reference patent is directed to a genus of compounds, and the application being examined is directed to a species within the reference patent genus. If the reference patent discloses several species within the scope of the reference genus claim, that portion of the disclosure should be analyzed to properly construe the reference patent claim and determine whether it anticipates or renders obvious the claim in the application being examined. Because that portion of the disclosure of the reference patent is an embodiment of the reference patent claim, it may be helpful in determining the full scope and obvious variations of the reference patent claim. See MPEP 804 II.B.1.
Furthermore, the portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim in nonstatutory double patenting. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. See MPEP 804 II.B.1.
This applies to the instant case where the claims in the above copending Applications are drawn to a genus of conditionally active binding proteins comprising a binding moiety which comprises a non-CDR loop comprising a binding site specific for a CD3ε domain which encompasses disclosed species that only comprise a binding site specific for a CD3ε domain in the CC’ non-CDR loop.
It is further noted that, where a species disclosed but not claimed in a parent case as filed and first acted upon by the examiner, are voluntarily presented in a different application having at least one common (joint) inventor or a common assignee (i.e., no requirement for election pertaining to said species was made by the Office) there should be close investigation to determine whether a double patenting rejection would be appropriate. See MPEP 806.04(h).
This applies to the instant case where, as noted above, the Applicant has disclosed best, or even only, candidate species of conditionally active proteins in the above copending Applications that comprise a binding site specific for a CD3ε domain only in the CC’ non-CDR loop. Thus, while these disclosed species comprising a binding site specific for a CD3ε domain only in the CC’ non-CDR loop are not explicitly claimed in the ‘860 Patent, these are the only species that fall within the scope of the above copending Applications’ claimed genus of conditionally active proteins and would therefore anticipate the instant claims.
Thus, the claims in the above copending Applications would anticipate the instant claims.
These are provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Applicant's arguments filed January 30, 2026 have been fully considered but they are not persuasive.
The Applicant argues that the provisional nonstatutory double patenting rejection is the only remaining rejection in the present application following the amendment and remarks presented in this Reply and therefore, the provisional nonstatutory double patenting rejections should be withdrawn.
This is not found persuasive because the NSDP rejection to the claims in the ‘860 Patent have been maintained for the reasons outlined above.
As such, the applicant’s argument has not been found persuasive.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 Grace H. Lunde whose telephone number is (703)756-1851. The examiner can normally be reached Monday - Thursday 6:00 a.m. - 3:00 p.m. (EST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached on (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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/GRACE H LUNDE/Examiner, Art Unit 1641
/MISOOK YU/Supervisory Patent Examiner, Art Unit 1641