Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s election of species filed 9-11-25, all without traverse, is acknowledged.
Applicant elects:
(i) the species of a bifunctional molecule which is “a heterodimeric αβ polypeptide pair,” and
(ii) the species of an immune effector polypeptide which is “an antibody which specifically binds to an antigen presented by a T-cell," and
(iii) the sub-species of immune effector polypeptide which is “an antibody which specifically binds to an antigen presented by a T-cell" which is “UCHT-1.”
Claims 1-17 are pending.
Claims 1-4, 6-8, 10, 14-17 are under examination as they read on the elected species of a bifunctional molecule which is “a heterodimeric αβ polypeptide pair,” the elected species of an immune effector polypeptide which is “an antibody which specifically binds to an antigen presented by a T-cell," and the elected sub-species of immune effector polypeptide which is “an antibody which specifically binds to an antigen presented by a T-cell" which is “UCHT-1.”
Claims 5, 9 and 11-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 9-11-25.
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, 6, 8 and 10 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.
Claim 1 is directed to (emphasis added):
“A bifunctional molecule comprising
a polypeptide binding partner specific for a given pMHC epitope,
and an immune effector polypeptide,
the N-terminus of the polypeptide binding partner being linked to the C-terminus of the immune effector polypeptide,
PROVIDED THAT the polypeptide binding partner is not a T-cell receptor (TCR) comprising the alpha (α) chain SEQ ID No: 7 and the beta (β) chain SEQ ID No: 9.”
Dependent claim 2 specifies with respect to claim 1:
“the polypeptide binding partner is a heterodimeric αβ TCR polypeptide pair, or a single chain αβ TCR (scTCR) polypeptide,” which would imply to the skilled artisan that the language of claim 1 referring to “a polypeptide binding partner” is not limited to a single polypeptide chain but instead encompasses in its breadth, e.g., polypeptide binding partner’s comprising two or more polypeptide chains as is true for “a heterodimeric αβ TCRT polypeptide pair” as recited in claim 2.
Given that “a polypeptide binding partner” is not limited to a single polypeptide chain but instead encompasses in its breadth, e.g., polypeptide binding partner’s comprising two or more polypeptide chains, the skilled artisan would understand that “…an immune effector polypeptide, the N-terminus of the polypeptide binding partner being linked to the C-terminus of the immune effector polypeptide…” as recited in claim 1 given its broadest reasonable interpretation consistent with the teachings of the instant specification and the knowledge in the prior art, could also refer to an immune effector polypeptide comprising two or more polypeptide chains, so long as said polypeptide chains are bound to one another, e.g., via a disulfide bond, and so long as at least one of said two or more polypeptide chains is joined via its C-terminus to the polypeptide binding partner.
Dependent claim 10 is drawn to:
“A bifunctional molecule comprising
a polypeptide binding partner specific for a given pMHC epitope,
and an immune effector polypeptide,
the N-terminus of the polypeptide binding partner being linked to the C-terminus of the immune effector polypeptide,
PROVIDED THAT ….
wherein the immune effector polypeptide is an antibody which specifically binds to an antigen presented by a T-cell,
wherein the antibody is an anti-CD3 antibody,
wherein the antibody is UCHT-1.”
Given all set forth above, one interpretation of the meaning of claim 10 is that it should be understood to be drawn to a bifunctional molecule comprising the conventional, four chain antibody known in the prior art as “UCHT-1” joined to the “polypeptide binding partner” as recited in claim 1.
However, the ordinarily skilled artisan looking to the specification will not find a description or definition of the meaning of the phrase “the antibody is UCHT-1.”
Moreover, nowhere does the specification graphically show (in the figures) or explicitly describe in words a bifunctional molecule having a conventional, four chain antibody, such as the UCHT1 antibody, joined to a polypeptide binding partner specific for a given pMHC epitope.
That said, while the specification does not restrict, e.g., a CD3-binding, “immune effector polypeptide” to any particular structure, the specification does use the phrase “anti-CD3 antibody” synonymously with “anti-CD3 scFv.”
For example, see:
page 8, lines 4-5 versus in paragraph 0042-0046;
page 15, paragraph 0072 versus in paragraph 0073; and
at page 19, paragraph 0087 versus in paragraph 0088).
Thus, the meaning of claim 10, and by the principal of claim differentiation claims 8, 6 and 1, would be unclear to the skilled artisan in that the skilled artisan would not understand if these claims encompass in their breadth a bifunctional molecule comprising the conventional, four chain antibody known in the prior art as the UCHT-1 antibody joined to the “polypeptide binding partner,” or if claim 10 should be understood to be limited to a bifunctional molecule comprising the “anti-CD3 UCHT-1 scFv antibody” as taught throughout the specification (see, e.g., at page 8, lines 4-5 versus in paragraph 0042-0046; at page 15, paragraph 0072 versus in paragraph 0073; at page 19, paragraph 0087 versus in paragraph 0088), including as illustrated in Figures 3-7, 16 and 17.
In the absence of clarity as to the metes and bounds of the instant claims, the skilled artisan cannot know for certain which bifunctional molecules are encompassed in their breadth versus those that are excluded therefrom.
Finally, applicant should keep the following in mind when responding to the rejection set forth above:
“During prosecution, applicant has an opportunity and a duty to amend ambiguous claims to clearly and precisely define the metes and bounds of the claimed invention. The claim places the public on notice of the scope of the patentee’s right to exclude. As the Federal Circuit stated in Halliburton Energy Services:
We note that the patent drafter is in the best position to resolve the ambiguity in the patent claims, and it is highly desirable that patent examiners demand that applicants do so in appropriate circumstances so that the patent can be amended during prosecution rather than attempting to resolve the ambiguity in litigation.
A decision on whether a claim is indefinite under § 112, ¶ 2 requires a determination of whether those skilled in the art would understand what is claimed when the claim is read in light of the specification. Claim terms are typically given their ordinary and customary meaning as understood by one of ordinary skill in the pertinent art, and the generally understood meaning of particular terms may vary from art to art. Therefore, it is important to analyze claim terms in view of the application’s specification from the perspective of those skilled in the relevant art since a particular term used in one patent or application may not have the same meaning when used in a different application.”
(See the Federal Register Notice dated February 9, 2011, pages 7162-7175, footnote citations omitted, available at http://www.gpo.gov/fdsys/pkg/FR-2011-02-09/pdf/2011-2841.pdf, quote from page 7164 right col.).
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, 6-8, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10130721 (cited on an IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Claims 1, 6-8 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 10420846 (cited on an IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Claims 1, 2, 6-8, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6 of U.S. Patent No. 10517960 (cited on an IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
Claims 1, 2, 6-8, 14-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10576162 (cited on an IDS). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARY S SKELDING whose telephone number is (571)272-9033. The examiner can normally be reached M-F 9-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at 571-272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ZACHARY S SKELDING/Primary Examiner, Art Unit 1644