Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
DETAILED ACTION
The amendment filed June 5, 2026, is acknowledged and has been entered. Claims 1-16, 22, 31 and 39 have been amended. Claims 42-50 have been newly added. As discussed in the interview of May 6, 2026, cancellation of all pending claims and presentation of new claims would render the restriction requirement mailed January 8, 2026, moot, such that Applicant need not elect a Group and species from said requirement. As claims 42-50 are drawn to a single invention, a new restriction requirement is not necessary.
Claims 42-50 are pending in the application and are under examination.
Information Disclosure Statement
The information disclosure statement has been considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 42-50 are rejected under 35 U.S.C. 102(b) as being anticipated by Dorken et al (US 2006/0193852 A1, IDS) as evidenced by the definition of “polyclonal antibody” attached as Exhibit A and Lippincott-Schwartz (Current Protocols in Cell Biology, 16.0.1-16.0.2, 2002).
With respect to claims 42-50, Dorken et al disclose methods of binding both a target cell and a cytotoxic T cell, comprising contacting the cytotoxic T cell and the target cell with a bispecific single chain antibody molecules comprising scFv binding domains comprising a VL and VH that that bind human CD3 epsilon (antigen on the cytotoxic T cell) and CD19 (antigen on the target cell), wherein the human CD3 epsilon comprises an epitope comprising at least the amino acid sequence of instant SEQ ID NO:2 (approximately 25% of the extracellular domain of CD3 epsilon) (see entire document, e.g., abstract, page 1, pages 3-4, Examples and Figures). Dorken et al further teach that the binding domains can be from polyclonal antibodies, monoclonal antibodies, human antibodies and humanized antibodies (human and humanized antibodies comprise human germline sequences in framework regions) (see pages 4-9 and 67-78).
In this case, as evidenced by the attached Exhibit A, polyclonal antibodies bind to multiple epitope sites on an antigen of interest. Accordingly, while Dorken et al do not test their polyclonal antibodies for cross-reactivity to other CD3 epsilon polypeptides from the other claimed species, since polyclonal antibodies comprise a heterogeneous population of antibodies that bind the multiple immunogenic epitopes of an antigen, the polyclonal antibodies of Dorken et al necessarily cross react with the claimed species. Notably, Dorken et al teach making polyclonal antibodies to the antigen which comprises the epitope bound by the claimed antibody, so this epitope is one of the multiple epitopes on the antigen that would generate specific antibodies that would necessarily be present in the polyclonal antibodies of Dorken et al. Furthermore, as evidenced by Lippincott-Schwartz polyclonal antibodies are a collection of monoclonal antibodies (see 16.0.1), so the antibodies of Dorken et al also include monoclonal, human and humanized antibodies that bind in this region.
Notably, the Office does not have the facilities for examining and comparing Applicant's products with the products of the prior art in order to establish that the products of the prior art possesses the same material, structural, and functional characteristics as Applicant’s products. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the products to which the claims are directed are different than that taught by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
Therefore, Dorken et al is deemed to anticipate the instant claims absent a showing otherwise.
Claims 42-50 are rejected under 35 U.S.C. 102(b) as being anticipated by Kufer et al (WO 2004/106380 A2) as evidenced by the definition of “polyclonal antibody” attached as Exhibit A and Lippincott-Schwartz (Current Protocols in Cell Biology, 16.0.1-16.0.2, 2002).
With respect to claims 42-50, Kufer et al disclose methods of binding both a target cell and a cytotoxic T cell, comprising contacting the cytotoxic T cell and the target cell with a bispecific single chain antibody molecules comprising scFv binding domains that that bind CD3 epsilon extracellular domain (antigen on the cytotoxic T cell) and CD19 (antigen on the target cell), wherein the human CD3 epsilon comprises an epitope comprising SEQ ID NO:2 (see entire document, e.g., abstract, pages 8, 16-17, 30, 61 and 72-75, Examples, claims and Figures). Kufer et al further teach that the binding domains can be from monoclonal antibodies, human and humanized antibodies (human and humanized antibodies comprise human germline sequences in framework regions) (see pages 14, 17 and 30 and claims).
In this case, as evidenced by the attached Exhibit A, polyclonal antibodies bind to multiple epitope sites on an antigen of interest. Notably, as evidenced by Lippincott-Schwartz polyclonal antibodies are a collection of monoclonal antibodies (see 16.0.1), so the antibodies of Ebert et al includes monoclonal, human and humanized antibodies that bind in these regions.
Notably, the Office does not have the facilities for examining and comparing Applicant's products with the products of the prior art in order to establish that the products of the prior art possesses the same material, structural, and functional characteristics as Applicant’s products. In the absence of evidence to the contrary, the burden is upon the applicant to prove that the products to which the claims are directed are different than that taught by the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA, 1977) and Ex parte Gray, 10 USPQ2d 1922 1923 (PTO Board of Patent Appeals and Interferences, 1988 and 1989).
Therefore, Kufer et al is deemed to anticipate the instant claims absent a showing otherwise.
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 obviousness-type 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); and 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 a nonstatutory double patenting ground provided the conflicting application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 42-50 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-34 of US Patent 9,587,036 in view of the art cited above(Kufer et al (WO 2004/106380 A2) and Dorken et al (US 2006/0193852 A1, IDS)). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The claims of the patent recite bispecific single chain antibodies that bind CD3 and a cell surface antigen PMSA and methods of contact cells as claimed with the antibodies (treating subjects). The prior art cited above is discussed supra and is incorporated herein which clearly establishes that it would have been obvious to modify the claims of the patent to include the limitations of the instant claims because such methods would be seen as combining prior art elements according to known methods to yield predictable results.
Accordingly, any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent.
Claims 42-50 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1, 7-15, 41, 44 and 48-71 of copending Application No. 12/594,713 in view of the art cited above (Kufer et al (WO 2004/106380 A2) and Dorken et al (US 2006/0193852 A1, IDS)). Although the conflicting claims are not identical, they are not patentably distinct from each other for the following reasons:
The claims of copending Application No. 12/594,713 recite bispecific single chain antibodies that bind CD3 and a cell surface antigen, CD19. The prior art cited above is discussed supra and is incorporated herein which clearly establishes that it would have been obvious to modify the claims of the patent by administering such antibodies in methods of treating cancer that expresses CD19 and to modify the antibodies to include the limitations of the instant claims because such methods would be seen as combining prior art elements according to known methods to yield predictable results.
Accordingly, any minor differences in the subject matter claimed in the instant application would be seen as an obvious variation of the subject matter claimed in the patent.
This is a provisional obviousness-type double patenting rejection because the conflicting claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Brad Duffy whose telephone number is (571) 272-9935. The Examiner works a flexible schedule and can normally be reached on Monday through Friday.
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Respectfully,
Brad Duffy
571-272-9935
/Brad Duffy/
Primary Examiner, Art Unit 1643
June 26, 2026
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