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 .
DETAILED ACTION
1. This Action replaces the previously issued Non-Final Action to address an inadvertent typo in Item #9 below.
2. Claims 1, 97, 153 are amended. Claims 2, 3, 6-11, 13-18, 20-27, 29, 31, 32, 34, 36-45, 47-56, 58-85, 87, 89-90, 92-95, 98-100, 103-104, 106 are canceled. Claims 1, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-128, 130, 153 are under consideration.
3. Due to the new rejections below, this Action is a Non-Final Action.
Information Disclosure Statement
4. The information disclosure statement (IDS) was submitted on 3/24/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
5. (previous objection, withdrawn) The disclosure was objected to because of informalities.
Applicant contends: the specification has been amended.
In view of applicant’s amendments, the objection is withdrawn.
Sequences
6. It is noted as indicated that applicant has amended previous “SEQ ID NO: 60” to recite “SEQ ID NO: 5”. In view of applicant’s amendments, the objection is withdrawn.
Claim Objections
7. (new objection) Claim 105 is objected to because of the following informalities: Claim 105 recites “respectively” twice. Appropriate correction is required.
Claim Rejections - 35 USC § 112
8. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 97, 107, 115, 117, 120, 124, 126-128, 130, 153 were rejected under 35 U.S.C. 112(a) or 35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.
Applicant contends: claim 1 is amended; the skilled artisan would recognize that applicant was in full possession of the claimed antigen binding regions; applicant was in full possession of the antigen-binding regions that binds to CD3; what is conventional or well known need not be disclosed in detail; full length IgG1 T-cell engaging bispecific antibodies are known in the art.
Upon further consideration, the rejection is withdrawn.
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.
9. (previous rejection, maintained as to claims 4, 5, 12, 33, 57, 88, 91, 115, 117, 127, 128, 130; withdrawn as to claims 1, 97 and canceled claim 2; new, necessitated by amendment as to claims 1, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-127, 153) Claims 1, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-128, 130, 153 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.
See claims 1, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-128, 130, 153 as submitted 3/24/2026.
Applicant contends: the claims are amended; the EU numbering system is internationally recognized; a skilled artisan would readily understand what positions are being referred to; recently granted antibody-related patents demonstrates that the USPTO accepts reference to the EU numbering system; the phrase is clear.
Applicant’s arguments are considered and found persuasive as to claims 1, 97, but maintained as to the other claims as indicated below.
With respect to “such as”, the rejection is withdrawn as to claim 1 but maintained as to claims 12, 33, 57, 88, 91, 127, 128, 130 as said claims have not been amended.
With respect to “e.g.”, the rejection is maintained as to claims 4, 5, 88 as said claims have not been amended.
With respect to EU numbering, the rejection applies to the instant claims and the instant case. The rejection is maintained as to claims 115, 117, 127, as it is not clear what the positions are relative to or what constitutes position 1.
With respect to claim 97, the claim is amended and the rejection is withdrawn.
Further, as to applicant’s amendments, as to amended claims 1, 153, it is not clear what the structure of the “a T-cell engaging bispecific antibody which is a full length IgG1 antibody
comprising an antigen-binding region that binds to CD3 and an antigen-binding region that binds to a target antigen on cells of said tumor or cancer” is. It is not clear what “full length” constitutes or refers to, as antibodies comprise specific, separate structures including CDRs and heavy and light chains. See also Gaudet et al. cited below. Claims 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-127 depend on claim 1.
Further as to claims 115, 117, 120, 124, 126, 127, said claims recite “binding agent”.
There is insufficient antecedent basis for this limitation in the claims.
Thus, the rejection is maintained and extended for reasons of record.
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.
10. (new, necessitated by amendment) Claims 28, 30 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 it depends, or for failing to include all the limitations of the claim upon which it depends.
See claims 28, 30 as submitted 3/24/2026.
As to claim 28, the claim recites “tumor specific antigen”. However claim 1 on which the claim depends recites “non-tumor specific antigen”. Thus, claim 28 is not further limiting of claim 1.
As to claim 30, the claim recites “wherein the target antigen and the vaccine antigen are both expressed by the tumor or cancer.” However claim 1 on which the claim depends recites “non-tumor specific antigen”. Thus, claim 30 is not further limiting of claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the clam(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.
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.
11. (new rejection) Claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-128, 130, 153 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 claim(s) contains 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(s), at the time the application was filed, had possession of the claimed invention.
See claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 96, 97, 101, 105, 107, 115, 117, 120, 124, 126-128, 130, 153 as submitted 3/24/2026.
See also the 35 U.S.C. 112(b) rejection above.
Claim 1 recites a T-cell engaging bispecific antibody which is a full length IgG1 antibody binding agent comprising an antigen-binding region that binds to CD3 and an antigen-binding region that binds to a target antigen on cells of said tumor or cancer. Claim 128 recites a binding agent comprising an antigen-binding region that binds to CD3, such as a human CD3, and an antigen-binding region that binds to a target antigen on cells of said tumor or cancer. Claim 130 recites a nucleic acid construct encoding a binding agent comprising an antigen-binding region that binds to CD3, such as human CD3, and an antigen-binding region that binds to a target antigen on cells of said tumor or cancer. Claim 153 recites a kit comprising a T-cell engaging bispecific antibody which is a full length IgG1 antibody comprising a binding region that binds to CD3 and a binding region that binds to a target on cells of a tumor or cancer, an immunogenic composition comprising at least one non-tumor specific vaccine antigen, and instructions for use.
Each of the claims is thus drawn, inherently or explicitly, to IgG1 antibody (claims 1, 153) or binding agent (claims 128, 130) comprising “any” antigen-binding regions that bind to CD3 and "any” target antigen on cells of said tumor or cancer. Thus, the claims are drawn to compositions comprising or methods of using a genus of IgG1 antibodies or binding agents comprising any antigen-binding regions that bind to CD3 and any target antigen on cells of said tumor or cancer.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the specification recites: CDRs and heavy and light chain regions as
recited in SEQ ID NOs: 1-58; CD3xTA99 (Examples 1-4, 12).
However, the instant claims still recite or read on "any" IgG1 antibody or binding agent comprising “any” antigen-binding regions that bind to human CD3 and any target antigen on cells of said tumor or cancer. Said IgG1 and binding agents could possess any other light chains or any other heavy chains as well.
It is known in the art that even the most minor differences can have significant effects on
antigen-antibody binding ability. The art relating to antibodies recognizes that the formation of
an intact antigen-binding site generally requires the association of the complete heavy and light
chain variable regions of a given antibody, each of which consists of three CDRs which provide
the majority of the contact residues for the binding of the antibody to its target epitope. The
amino acid sequences and conformations of each of the heavy and light chain CDRs are critical
in maintaining the antigen binding specificity and affinity that is characteristic of the parent
immunoglobulin. It is expected that all of the heavy and light chain CDRs in their proper order
and in the context of framework sequences which maintain their required conformation, are
required in order to produce a protein having antigen-binding function and that proper
association of heavy and light chain variable regions is required in order to form functional
antigen binding sites. Even minor changes in the amino acid sequences of the heavy and light
variable regions, particularly in the CDRs, may dramatically affect antigen-binding function as
evidenced by Rudikoff et al. ("Single amino acid substitution altering antigen-binding
specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982); previously cited). Rudikoff et al. teaches that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function.
Thus, in light of the knowledge in the art, the broad scope of the claims, and the teachings
in the specification, there is still a high level of uncertainty as to which IgG1 and binding agents comprising which antigen-binding regions fall within the scope of the indicated genus.
There is no apparent common conserved structure to the different antigen-binding regions of the IgG1 and binding agents that distinguishes those that bind CD3 and any target antigen on cells of said tumor or cancer as compared to those that do not. There is therefore a high level of uncertainty as to which IgG1 and binding agents comprising which antigen-binding regions fall within the scope of the indicated genus.
Further, the specification has identified IgG1 and binding agents and antigen binding regions only by function: the ability to binds CD3 and any target antigen on cells of said tumor or cancer.
The specification does not provide a specific structure of any IgG1 or binding agents or antigen-binding regions within the genus that correlates with the required function. Because there is no identification of structures common to each IgG1 and binding agent and antigen-binding regions, nor sufficient representative examples of the IgG1 and binding agent and antigen-binding regions by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of IgG1 and binding agents and antigen-binding regions through identification of a structure and function. While the IgG1 and binding agents and antigen-binding regions are required to bind to CD3 and any target antigen on cells of said tumor or cancer, this is not alone sufficient structure to correlate with the function. This is because the mere presence of a domain does not demonstrate that the IgG1 or binding agent and its regions would be able to bind CD3 and any target antigen on cells of said tumor or cancer.
In view of the fact that the examples provided do not demonstrate possession of the genus
encompassing IgG1 and binding agents and antigen-binding regions showing the binding activity, and that the application has identified no structure correlating with antigen-binding regions ability to bind, there is insufficient written description support for the indicated genus of IgG1 and binding agents and antigen-binding regions, and therefore for the methods of using them.
For the reasons above, and in view of the uncertainty as to which IgG1 and binding agents comprising any antigen-binding regions would be able to bind CD3 and any target antigen on cells of said tumor or cancer, the application has not provided sufficient written description support for the use of the genus of IgG1 and binding agents and binding regions identified in claims 1, 126, 130, 153 and dependent clams. The application therefore fails to provide adequate support for methods of using this genus of IgG1 and binding agents and antigen-binding regions.
Response to Arguments
Turning to applicant’s arguments, in view of the instant claims, it is maintained that in view of the uncertainty as to which IgG1 and binding agents comprising any antigen-binding regions would be able to bind CD3 and any target antigen on cells of said tumor or cancer, the application has not provided sufficient written description support for the use of the genus of IgG1 and binding agents identified in claims 1, 126, 130, 153.
It is maintained that it is known in the art that antibody structure is highly variable in the CDR regions - even the most minor differences can have significant effects on antigen-antibody binding ability. In addition to Rudikoff et al. ("Single amino acid substitution altering antigen-binding specificity," Proc Natl Acad Sci USA 79:1979-1983 (1982); previously cited) teaching that the alteration of a single amino acid in the CDR of a phosphocholine-binding myeloma protein resulted in the loss of antigen-binding function, Goel et al. (“Plasticity within the Antigen-Combining Site May Manifest as Molecular Mimicry in the Humoral Immune Response,” J. Immunol. 173: 7358-7367 (2004))(See PTO-892: Notice of References Cited) teaches antibodies that bind to the same 12-mer but have very different CDRs. Lloyd et al. (“Modelling the human immune response: performance of a 1011 human antibody repertoire against a broad panel of therapeutically relevant antigens,” Protein Engineering, Design & Selection, Vol. 22, No. 3: 159-168 (2009))(See PTO-892: Notice of References Cited) teaches: on average, about 120 different antibodies in a library can bind to a given antigen.
Further, Edwards et al. (“The Remarkable Flexibility of The Human Antibody Repertoire; Isolation of Over One Thousand Different Antibodies to a Single Protein, BLys,” J. Mol. Biol. 334: 103-118 (2003))(See PTO-892: Notice of References Cited) teaches: a library contained over 1000 antibodies that bound to a single 51kDA protein, including unique VH and 705 VL sequences; there were 568 different CDR3 regions. Even with respect to binding regions more generally, Manning et al. ("Alanine Scanning Mutagenesis of an aß T Cell Receptor: Mapping the Energy of Antigen Recognition," Immunity Vol. 8: 413-425 (1998))(See PTO-892: Notice of References Cited) teaches: mutations in all 6 of the TCR CDRs leads to unpredictable changes in functions (Fig. 2). Given the highly-diverse nature of antibodies, one generally cannot envision the structure of an antibody by knowing its binding characteristics.
The rejection is made for reasons of record.
Claim Rejections - 35 USC § 103
12. (previous rejection, withdrawn) Claims 1, 4, 5, 12, 19, 28, 30, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 were rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. (WO2019224717A2; previously cited) in view of Maianti et al. (WO2018165631; previously cited).
Applicant contends: claim 1 has been amended to recite “non-tumor specific”; there was no motivation to combine antibody as claimed with composition comprising at least one non-tumor specific vaccine antigen; efficacy could not have been reasonably expected; Gaudet et al. fails to provide teaching or suggestion that compositions of a least one non-tumor specific vaccine antigen can be used; Maianti et al. fails to cure the deficiencies.
Upon further consideration, the rejection is withdrawn.
13. (previous rejection, withdrawn) Claim 57 was rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. in view of Maianti et al. as applied to claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 above, and further in view of Li et al. (WO 2020088605 A1; previously cited)(See also WIPO English translation of WO 2020088605 A1; previously cited).
In view of the withdrawal of the rejection over Gaudet et al. in view of Maianti et al. on which the instant rejection depends, the instant rejection is also withdrawn.
14. (previous rejection, withdrawn) Claims 96, 97, 105, 107, 115, 117, 126, 127 were rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. in view of Maianti et al. as applied to claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 above, and further in view of Labrijn et al. (WO2014108483; previously cited).
In view of the withdrawal of the rejection over Gaudet et al. in view of Maianti et al. on which the instant rejection depends, the instant rejection is also withdrawn.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
15. (previous rejection, maintained) Claim 130 is rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. (WO2019224717A2; previously cited) in view of Maianti et al. (WO2018165631; previously cited), and further in view of Apgar et al. (WO2019224715A1; previously cited).
See claim 130 as submitted 3/24/2026.
Applicant contends: these references do not provide motivation to arrive at the instantly claimed invention.
Applicant’s arguments are considered but found unpersuasive.
See the rejection as recited in the previous Office Action.
The rejection is maintained for reasons of record.
16. (new rejection) Claims 1, 4, 5, 12, 19, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 are rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. (WO2019224717A2; previously cited) in view of Weiner et al. (WO2014144885A3)(See PTO-892: Notice of References Cited).
See claims 1, 4, 5, 12, 19, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 as submitted 3/24/2026.
See also the 35 U.S.C. 112(b) rejection above as to the structure of the IgG1 antibody recited in claims 1, 153.
See the teachings of Gaudet et al. in the previous Office Action. As to claim amendments in claims 1, 153, Gaudet et al. teaches or suggests such embodiments. Gaudet et al. teaches: antibodies that bind CD3 and PSMA (abstract); as well as CD33 (p. 1); wherein antibodies may be IgG isotype; IgG1 (as recited in claims 1, 153); in some embodiments, the anti-CD3, anti-PSMA, anti-CD33 antibodies are IgG1 isotypes (p. 29); in some embodiments, the bispecific antibodies include recombinant IgG-like dual targeting molecules wherein the two sides of the molecule each contain the Fab fragment or part of Fab fragment of at least two different antibodies; wherein full length IgG antibodies are fused to an extra Fab fragment or parts of Fab fragment (p. 39). As to “T-cell engaging”, it is noted that Gaudet et al. already teaches the structural features of bispecific antibody, IgG1, as well as the CD3 binding region and antigen binding region. Thus, Gaudet et al. is considered to meet the instant claim language, since the language “T-cell engaging” does not appear to impart additional structural features to the bispecific antibody as claimed (See MPEP 2112: 2112.01 Composition, Product, and Apparatus Claims: I. PRODUCT AND APPARATUS CLAIMS WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT: Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977); II. COMPOSITION CLAIMS: IF THE COMPOSITION IS PHYSICALLY THE SAME, IT MUST HAVE THE SAME PROPERTIES: Products of identical chemical composition can not have mutually exclusive properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.).
Gaudet et al. does not teach non-tumor specific vaccine antigen (as recited in claims 1, 153; also read upon in claims 128, 130).
Weiner et al. teaches: cancer vaccines (title)(as recited in claims 1, 128, 130, 153); including cancer antigens that are no longer self antigens and stimulate immune response to particular cancer or tumor associated with a particular cancer [0006]; a number of cancer antigens for treating or preventing a particular cancer [0007]; any combination for prevention or treatment of the cancer [0023]; combined with antibodies [0026]; bispecific antibodies [0031]; prevention, reduction of tumor [0057]; foreign antigen in order to be recognized by the immune system [0058]; the introduction of mutations does not alter the cancer antigen so much that it cannot be universally applied to subjects [0069]; including vaccines comprising proteins used to induce broad immunity against an antigen [0034]; including nucleic acid sequences that encode consensus polypeptide [0034](as recited in claim 12); HPV antigens [0070](as recited in claims 4, 5, 19, 33); viral antigen [0070]; T-cell response [0077](as recited in claim 35); adjuvant [00407](as recited in claim 46).
One of ordinary skill in the art would have been motivated to combine and use
immunogenic composition as taught by Weiner et al. with the method and composition as taught
by Gaudet et al. Gaudet et al. teaches treatment of cancer and combination with additional
agents, and Weiner et al. also teaches or suggests eliciting immune response against cancer, as well as such an agent and use with antibodies (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I. COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.. [T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); see MPEP 2144.06: Substituting equivalents known for the same purpose).
As to claim 153, the instructions do not distinguish the composition as taught by Gaudet
et al. in view of Weiner et al. (See MPEP 2112.01: III. PRODUCT CLAIMS -
NONFUNCTIONAL PRINTED MATTER DOES NOT DISTINGUISH CLAIMED PRODUCT
FROM OTHERWISE IDENTICAL PRIOR ART PRODUCT: Where the only difference
between a prior art product and a claimed product is printed matter that is not functionally related
to the product, the content of the printed matter will not distinguish the claimed product from the
prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004)).
One of ordinary skill in the art would have had a reasonable expectation of success for
combining and using immunogenic composition as taught by Weiner et al. with the method and
composition as taught by Gaudet et al. There would have been a reasonable expectation of
success given the underlying materials and methods (eliciting immune response against cancer as
taught by Gaudet et al. and Weiner et al.) are known, successfully demonstrated, and commonly
used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
17. (new rejection) Claim 57 is rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. in view of Weiner et al. as applied to claims 1, 4, 5, 12, 19, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 above, and further in view of Li et al. (WO 2020088605 A1; previously cited)(See also WIPO English translation of WO 2020088605 A1; previously cited).
See claim 57 as submitted 3/24/2026.
See the teachings of Gaudet et al. in view of Weiner et al. above, including as to
additional agents.
Gaudet et al. in view of Weiner et al. does not teach: wherein the method comprises
administering the immunogenic composition in combination with a cytokine, or wherein
immunogenic composition or the adjuvant comprises a cytokine, optionally wherein the
cytokine is an interleukin-2 (IL2) receptor agonist, such as IL2/aldesleukin or interleukin-15.
Li et al. teaches: bispecific antibodies targeting CD3 (p. 1); administration thereof with
cytokines [0079].
One of ordinary skill in the art would have been motivated to administer cytokine as
taught by Li et al. with the method as taught by Gaudet et al. in view of Weiner et al. Gaudet et
al. in view of Weiner et al. teaches administration of anti-CD3 antibodies, and Li et al., which
also teaches administration of anti-CD3 antibodies, teaches the advantage of combining such
methods with additional agents such as cytokines.
One of ordinary skill in the art would have had a reasonable expectation of success for
administering cytokine as taught by Li et al. with the method as taught by Gaudet et al. in view
of Weiner et al. There would have been a reasonable expectation of success given the underlying
materials and methods (administering anti-CD3 antibodies as taught by Li et al. and Gaudet et al.
in view of Weiner et al.) are known, successfully demonstrated, and commonly used as
evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
18. (new rejection) Claim 130 is rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. in view of Weiner et al. as applied to claims 1, 4, 5, 12, 19, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 above, and further in view of Apgar et al. (WO2019224715A1; previously cited).
See claim 130 as submitted 3/24/2026.
See the teachings of Gaudet et al. in view of Weiner et al. above. It is noted that Gaudet
et al. teaches polynucleotides encoding anti-CD3 antibodies (p. 31); culturing host cells
comprising said vectors (p. 5).
Gaudet et al. in view of Weiner et al. does not teach: a method for preventing or reducing
growth of a tumor, or for treatment of cancer in a subject in need thereof, the method comprising
providing to the subject (a) a nucleic acid construct encoding a binding agent comprising an
antigen-binding region that binds to CD3, such as human CD3, and an antigen-binding region
that binds to a target antigen on cells of said tumor or cancer; and (b) an immunogenic
composition comprising at least one vaccine antigen.
Apgar et al. teaches: antibodies specific for CD3 (title); nucleotides encoding said
antibodies (p. 4); administering said antibodies for inhibiting growth of tumor cells (p. 3); as well
as administration of expression vectors directing expressing of CD3 antibody (p. 90); introducing
vectors into host cells (p. 67).
One of ordinary skill in the art would have been motivated to administer vector and
nucleotides as taught by Apgar et al. using vector and nucleotides as taught by Gaudet et al. in view of Weiner et al. Apgar et al. teaches administration of vectors directing expressing of CD3
antibody, and Gaudet et al. in view of Weiner et al. teaches such a vector and nucleotides (See
MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
administering vector and nucleotides as taught by Apgar et al. using vector and nucleotides as
taught by Gaudet et al. in view of Weiner et al. There would have been a reasonable expectation
of success given the underlying materials (nucleotide sequences encoding anti-CD3 antibodies as
taught by Apgar et al. and Gaudet et al. in view of Weiner et al.) and methods are known,
successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
19. (new rejection) Claims 96, 97, 105, 107, 115, 117, 126, 127 are rejected under 35 U.S.C. 103 as being unpatentable over Gaudet et al. in view of Weiner et al. as applied to claims 1, 4, 5, 12, 19, 33, 35, 46, 86, 88, 91, 120, 128, 130, 153 above, and further in view of Labrijn et al. (WO2014108483; previously cited).
See claims 96, 97, 105, 107, 115, 117, 126, 127 as submitted 3/24/2026.
See the teachings of Gaudet et al. in view of Weiner et al. above.
Gaudet et al. in view of Weiner et al. does not teach regions/SEQ ID NOs: as instantly
claimed.
See the teachings of Labrijn et al. in the previous Office Action. To reiterate in part,
Labrijn et al. teaches: binding regions that bind CD3 (p. 18);
One of ordinary skill in the art would have been motivated to use regions as taught by
Labrijn et al. with the method as taught by Gaudet et al. in view of Weiner et al. Gaudet et al. in view of Weiner et al. teaches anti-CD3 antibodies, and Labrijn et al., which also teaches anti-
CD3 antibodies, teaches such regions known and used in the art for anti-CD3 antibodies (See
MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using regions as taught by Labrijn et al. with the method as taught by Gaudet et al. in view of Weiner et al. There would have been a reasonable expectation of success given the underlying
materials (anti-CD3 antibodies as taught by Labriijn et al. and Gaudet et al. in view of Weiner et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the
applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
Double Patenting
20. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 120, 128, 130, 153 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11613575 in view of Maianti et al. (cited above).
Applicant contends: the references do not disclose the invention as claimed; the instant claims recite non-tumor specific vaccine antigen.
Upon further consideration, the rejection is withdrawn.
21. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 120, 128, 130, 153 were rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11578141 in view of Gaudet et al. in view of Maianti et al. (cited above).
Applicant contends: the references do not disclose the invention as claimed; the instant claims recite non-tumor specific vaccine antigen.
Upon further consideration, the rejection is withdrawn.
22. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 12, 19, 28, 33, 35, 46, 57, 86, 88, 91, 117, 120, 128, 130, 150 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 in view of Maianti et al. (cited above).
Applicant contends: the references do not disclose the invention as claimed; the instant claims recite non-tumor specific vaccine antigen.
Upon further consideration, the rejection is withdrawn.
23. (previous rejection, withdrawn) Claims 1, 2, 4, 5, 12, 19, 28, 30, 33, 35, 46, 57, 86, 88, 91, 120, 128, 130, 153 were provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 78, 86-103 of copending Application No. 17/739923 in view of Gaudet ct al. and Maianti et al. (cited above).
Applicant contends: the references do not disclose the invention as claimed; the instant claims recite non-tumor specific vaccine antigen.
Upon further consideration, the rejection is withdrawn.
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.
24. (new rejection) Claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 117, 120, 128, 130, 153 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 in view of Weiner et al. (cited above).
See the recitations of claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 117, 120, 128, 130, 153 as submitted 3/24/2026.
See the recitations of claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 in the previous Office Action. Said claims also recite IgG1. As to “T-cell engaging”, it is noted that claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 already teaches the structural features of bispecific antibody, IgG1, as well as the CD3 binding region and antigen binding region. Thus, claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 is considered to meet the instant claim language, since “T-cell engaging” does not appear to impart additional structures to the bispecific antibody.
Claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428 do not recite
the immunogenic composition.
See the teachings of Weiner et al. above.
One of ordinary skill in the art would have been motivated to combine and use
immunogenic composition as taught by Weiner et al. with the method and composition as
recited in claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428. Claims 56,
58-66, 71-74, 79-85 of copending Application No. 16/582428 recite treatment of cancer, and
Weiner et al. also teaches eliciting immune response against cancer, as
well as such an agent (See MPEP 2144.06: Art Recognized Equivalence for the Same Purpose: I.
COMBINING EQUIVALENTS KNOWN FOR THE SAME PURPOSE: "It is prima facie
obvious to combine two compositions each of which is taught by the prior art to be useful for the
same purpose, in order to form a third composition to be used for the very same purpose. [T]he
idea of combining them flows logically from their having been individually taught in the prior
art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980); see MPEP
2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
combining and using immunogenic composition as taught by Weiner et al. with the method as
recited in claims 56, 58-66, 71-74, 79-85 of copending Application No. 16/582428. There would
have been a reasonable expectation of success given the underlying materials and methods are
known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
25. (new rejection) Claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 120, 128, 130, 153 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 78, 86-103 of copending Application No. 17/739923 in view of Gaudet et al. and Weiner et al. (cited above).
See the recitations of claims 1, 4, 5, 12, 19, 33, 35, 46, 57, 86, 88, 91, 120, 128, 130, 153 as submitted 3/24/2026.
See the recitations of claims 78, 86-103 of copending Application No. 17/739923 in the previous Office Action. Said claims also recite IgG1. As to “T-cell engaging”, it is noted that claims 78, 86-103 of copending Application No. 17/739923 already teach the structural features of bispecific antibody, IgG1, as well as the CD3 binding region and antigen binding region. Thus, claims 78, 86-103 of copending Application No. 17/739923 are considered to meet the instant claim language, since “T-cell engaging” does not appear to impart additional structures to the bispecific antibody.
Claims 78, 86-103 of copending Application No. 17/739923 do not recite the instantly
claimed method and immunogenic composition.
See the teachings of Gaudet et al. in view of Weiner et al. above.
One of ordinary skill in the art would have been motivated to use antibody as recited in
claims 78, 86-103 of copending Application No. 17/739923 in the method as taught by Gaudet et al. in view of Weiner et al. Gaudet et al. in view of Weiner et al. teach use of anti-CD3
antibody, and claims 78, 86-103 of copending Application No. 17/739923 recite such an
antibody (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for
using antibody as recited in claims 78, 86-103 of copending Application No. 17/739923 in the
method as taught by Gaudet et al. in view of Weiner et al. There would have been a reasonable
expectation of success given the underlying materials and methods are known, successfully
demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of
ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
26. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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