Notice of Pre-AIA or AIA Status
The present application, filed on or after March 1o6, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/21/25 has been entered.
Priority
According to the most recent filing receipt of 10 March 2022, this application is a 371 of PCT/US2020/030436, filed 04/29/2020, which claims benefit of U.S. provisional application, 62/840,699, filed 04/30/2019.
No foreign priority is claimed under 35 U.S.C. 119(a)-(d) or (f).
Claim Rejections - 35 USC § 103
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 16, 17, 19 and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Pescovitz et al. (WO 2009/120651 A1, IDS, 10/28/2021), in view of van de Donk et al. (Blood. 2016, IDS, 10/28/2021), and in further view of Doshi (2015 US 2015/0246123 A1, IDS, 10/28/2021).
Regarding claim 16, Pescovitz discloses a kit for removing one or more therapeutic monoclonal antibodies from a biological sample, said kit comprising a solid support and one or more antigens, wherein the one or more antigens are specific for the one or more therapeutic antibodies (para [0012] "there is provided a kit for treating a sample ..., wherein the patient has been administered a monoclonal antibody treatment, the kit comprising a peptide, wherein the peptide selectively binds the monoclonal antibody and a solid support, wherein the peptide is conjugated to the solid support. The solid support may be a magnetic bead, a non-magnetic bead, a microtiter plate or a tube").
Regarding claim 17, Pescovitz discloses a kit for removing one or more therapeutic monoclonal antibodies from a biological sample using peptides linked to a solid support, as discussed for claim 16. Pescovitz further discloses the kit of claim 16, wherein the solid support is a bead or particle (para [0025] “After the desired peptide or peptides have been selected they may be immobilized by conjugation onto a solid support such as, but not limited to, beads").
Regarding claim 19, Pescovitz teaches a kit for removing one or more therapeutic monoclonal antibodies from a biological sample using peptides linked to a solid support, as required by claims 16 and 17.
Pescovitz fails to teach the monoclonal antibody is either daratumumab and elotuzumab (required by claim 16), the antigen is CD38 (required by claim 18), wherein the CD38 comprises the amino acid sequence of SEQ ID NO: 8 (required by claim 19).
However, van de Donk teaches that CD38 is an antigen targeted by therapeutic monoclonal antibodies (abstract “Immunotherapeutic strategies are emerging as promising therapeutic approaches in multiple myeloma (MM), with several monoclonal antibodies in advanced stages of clinical development. Of these agents, CD38-targeting antibodies have marked single agent activity”, pg 682, col 1, para 3 "Daratumumab… isatuximab... and MOR202… are CD38-targeting antibodies"). Van de Donk teaches there are interference problems with these monoclonal antibodies in laboratory tests which need a solution (abstract "Therapeutic antibodies interfere with several laboratory tests. First, interference of therapeutic antibodies with immunofixation and serum protein electrophoresis assays may lead to underestimation of complete response”, pg 689, col 1 para 2 “mitigation strategies are needed to remove interference of the therapeutic antibody").
Van de Donk fails to teach the CD38 antigen sequence.
However, Doshi teaches SEQ ID NO: 2, a 14 amino acid CD38 peptide that binds to a therapeutic monoclonal antibody, the peptide having 100% identity to SEQ ID NO: 8 of this application (para [0079] “a method of treating a subject having a CD38-positive hematological malignancy, comprising administering to a patient in need thereof an anti-CD38 antibody that binds to the region SKRNIQFSCKNIYR (SEQ ID NO: 2)… of human CD38", para [0045] "the CD-38 positive hematological malignancy is multiple myeloma").
It would have been prima facie obvious for one of ordinary skill in the art at the time of filing to modify the kit of Pescovitz by substituting the CD38 peptide for the CD20 peptide, thereby resulting in a CD38 conjugated bead, in order to remove interfering therapeutic monoclonal anti-CD38 antibodies from biological samples as described by van de Donk.
Further, it would have been prima facie obvious to use the specific CD38 peptide sequence taught by Doshi with the beads in the kit taught by Pescovitz to remove therapeutic monoclonal anti-CD38 antibodies from biological samples, because it was known that anti-CD38 antibodies bind to this sequence, as taught by Doshi. It is obvious to use a known antigen for its art recognized purpose. In this case, the anti-CD38 antibodies that would have been removed would necessarily include daratumumab as required by independent claim 16. One would have had a reasonable expectation of success in combining the CD38 peptide of Doshi with the kit of Pescovitz because conjugation of peptides to beads was well known in the art at the time of filing as described by Pescovitz (para [0025] “the peptide may be conjugated to the solid support by methods known in the art”), and as such, the artisan would have expected success in conjugating CD38 peptide in the same way the CD20 peptide was conjugated to beads as taught by Pescovitz.
Applicant’s amended claim 16 recites “the one or more antigens is each at an approximate total concentration of between 1x10-6M and 5x10-5M on an aggregate of more than one of the solid support.”
Pescovitz teaches the kit of claim 16, wherein the one or more antigens is each at an approximate total concentration of between 1x10-6 M and 5x10-5 M on an aggregate of more than one of the solid support (para [0026] “the amount of peptide added may be from about 1 nmol/ml to about 50 nmol/ml. The peptide may… be conjugated to the solid support before being mixed with the serum sample”). Note: “1X10-6 M” is equivalent to “1 nmol/ml”.
Moreover, Examiner notes that, under the broadest reasonable interpretation, “an aggregate of more than one of the solid support” encompasses all of the solid supports (beads) used, or any subset of the solid supports (beads) used. In any case, the recited concentration of beads falls within a workable or optimum range. Where the general conditions of the claim are disclosed, discovery of a workable or optimum range requires ordinary skills in the art, rendering the discovery obvious. One skilled in the art would have been motivated to discover a workable range, or to optimize to achieve the best result. Such discovery merely requires modifying a known parameter, in this case, the concentration of the antigens on an aggregate of the beads. Such modification requires ordinary skills in the art, rendering the modification obvious.
Regarding claims 22-25, Pescovitz discloses a kit for removing one or more therapeutic monoclonal antibodies from a biological sample using peptides linked to a solid support, as discussed for claim 16. The “wherein” clauses of these claims recite limitations that further define the preamble of claim 16 “a kit for removing one or more therapeutic monoclonal antibodies from a biological sample”:
However, the “biological sample” in claim 16 is only part of the intended use of the kit. If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention's limitations, then the preamble is not considered a limitation and is of no significance to claim construction. In other words, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). The prior art kit would be capable of performing the claimed uses for a “biological sample”. Regardless, Pescovitz teaches that the biological sample is serum (para [0021] “the biological sample, may be, but is not limited to, a serum or plasma sample”, abstract), derived from a subject having a plasma cell disorder (para [0002], “Rituximab was initially developed for the treatment of B cell lymphoma, using its ability to bind to CD20 on B cells”, para [0011] a method of treating a biological sample from a patient …wherein the patient has been administered rituximab”), and from a human patient (para [0021] “depleting a biological sample from a patient … of at least one monoclonal antibody”, [0014-0017], “human serum”).
Claims 18 and 20 stand rejected under 35 U.S.C. 103 as being unpatentable over Pescovitz et al. (WO 2009/120651 A1, IDS, 10/28/2021), in view of van de Donk et al. (Blood. 2016, IDS, 10/28/2021), and in further view of Andre et al. (US 2016/0257750 A1, PTO-892, 04/22/2025).
Regarding claim 18, Pescovitz teaches a kit for removing one or more therapeutic monoclonal antibodies from a biological sample using peptides linked to a solid support.
Pescovitz and van de Donk teach as set forth above but fail to teach that the antigen is SLAMF7 (required by claim 18), wherein the SLAMF7 comprises the amino acid sequence of SEQ ID NO: 11 (required by claim 20).
However, van de Donk teaches that SLAMF7 is an antigen targeted by therapeutic monoclonal antibodies (abstract “Immunotherapeutic strategies are emerging as promising therapeutic approaches in multiple myeloma (MM), with several monoclonal antibodies in advanced stages of clinical development… elotuzumab (anti-SLAMF7)”, pg 682, col 1, para 2 “Elotuzumab… is an antibody targeting signaling lymphocytic activation molecule F7 (SLAMF7, also called CS1)”. van de Donk teaches there are interference problems with these monoclonal antibodies in laboratory tests which need a solution (abstract "Therapeutic antibodies interfere with several laboratory tests. First, interference of therapeutic antibodies with immunofixation and serum protein electrophoresis assays may lead to underestimation of complete response”, pg 689, col 1 para 2 “mitigation strategies are needed to remove interference of the therapeutic antibody"). Van de Donk fails to teach the SLAMF7 antigen sequence.
However, Andre teaches SEQ ID NO: 29, a 334 amino acid SLAMF7 polypeptide comprising an amino acid sequence with 100% sequence identity to SEQ ID NO: 11 of this application (para [0003] “CS1 (also known as SLAMF7…) is a cell surface glycoprotein that is highly expressed on multiple myeloma (MM) cells”, [0102] “The complete CS1 sequence can be found under GenBank Accession No.: NM_021181.3 and is as follows: (SEQ ID NO:29)”) and is a target of therapeutic antibodies (para [0008] “An exemplary anti-CS1 antibody is elotuzumab”).
It would have been prima facie obvious for one of ordinary skill in the art at the time of filing to modify the kit of Pescovitz by substituting the SLAMF7 peptide for the CD20 peptide, thereby resulting in a SLAMF7 conjugated bead, in order to remove interfering therapeutic monoclonal anti-SLAMF7 antibodies, including elotuzumab, from biological samples as described by van de Donk. Further, it would have been prima facie obvious to use the specific SLAMF7 (CS1) peptide sequence taught by Andre with the beads in the kit taught by Pescovitz to remove therapeutic monoclonal anti-SLAMF7 (anti-CS1) antibodies from biological samples, because it is was known that anti-SLAMF7 (anti-CS1) antibodies (e.g. elotuzumab) bind to this sequence, as taught by Andre. It is obvious to use a known antigen for its art recognized purpose. The artisan would have had a reasonable expectation of success in combining the SLAMF7 (CS1) peptide of Andre with the kit of Pescovitz because conjugation of peptides to beads was well known in the art at the time of filing as described by Pescovitz (para [0025] “the peptide may be conjugated to the solid support by methods known in the art”). As such, the artisan would have expected success in conjugating the SLAMF7 (CS1) peptide as was done for the CD20 peptide taught by Pescovitz.
Response to Arguments
Applicant's arguments filed 11/21/25 regarding the newly amended claims have been considered but are not persuasive.
Applicant argues that Pescovitz does not teach or suggest the claim element of “the one or more antigens is each at an approximate total concentration of between 1x10-6M and
5x10-5M on an aggregate of more than one of the solid support.” Applicant states that at best, Pescovitz teaches that the amount of the one or more antigens is from about 1 nmol/ml to about 50 nmol/ml once added to the biological sample. Applicant states one of skill in the art would interpret paragraph 26 as teaching the concentration of the antigen once added to the biological sample, or the final concentration to be achieved. Applicant asserts that Pescovitz is silent on the concentration of antigen on the solid support.
Applicant further argues that the present claim 16 is different from the teaching in Pescovitz and instead covers the amount of one or more antigens “on an aggregate of more than one of the solid support”. Applicant asserts that the particular range of antigen [as claimed] on the solid support provides surprisingly good results. Applicant further asserts the neither the van de Donk reference nor the Doshi reference teach or suggest use of one or more antigens is each at an approximate total concentration of between 1x10-6M and 5x10-5M on an aggregate of more than one of the solid support as required by independent claim 16.
These arguments are not persuasive for the following reasons.
Applicant’s amended claim 1 recites “the one or more antigens is each at an approximate total concentration of between 1x10-6M and 5x10-5M on an aggregate of more than one of the solid support.”
As indicated above in the amended grounds for rejection, Examiner notes that, under the broadest reasonable interpretation, “an aggregate of more than one of the solid support” encompasses all of the solid supports (beads) used, or any subset of the solid supports (beads) used. In any case, the recited concentration of beads falls within a workable or optimum range. Where the general conditions of the claim are disclosed, discovery of a workable or optimum range requires ordinary skills in the art, rendering the discovery obvious. One skilled in the art would have been motivated to discover a workable range, or to optimize to achieve the best result. Such discovery merely requires modifying a known parameter, in this case, the concentration of the antigens on an aggregate of the beads. Such modification requires ordinary skills in the art, rendering the modification obvious.
Conclusion
No claim is allowed.
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/Ann Montgomery/ Primary Examiner, Art Unit 1678