DETAILED ACTION
Status of the Claims
Claims 1-18 are currently pending and are examined herein.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections – 35 U.S.C. 103
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 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.
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Brix et al., Shen et al., and Kivioja et al.
Claims 1-18 are rejected under 35 U.S.C. 103 as being unpatentable over Brix et al. (U.S. PGPub 2010/0168390 A1, cited in IDS of 04/21/2023) in view of Shen et al. (WO 03/031591 A2, cited in IDS of 04/21/2023), further in view of Kivioja et al. (Nat. Meth., 2012, (9)1:72-76, cited in IDS of 04/21/2023).
Regarding claims 1 (in part), and 16-18, Brix teaches a detection molecule comprising:
at least two identical binding molecules, wherein said binding molecules are selected from the group consisting of a pMHC complex, a protein and an anti-target molecule, (e.g. MHC molecules as per the MHC Multimers section of para 0040-0044, for use in flow cytometry, ELISA, and other cell-specific labeling techniques and assays, as per at least para 0045-0048 and 0054-0055), and wherein said binding molecules have a binding specificity for a T-cell receptor or B-cell receptor (e.g., binding specificity for T-cell receptors as per para 0031, 0045, 0060, and/or 0617),
a multimerization domain associated, optionally via one or more connector molecules, with the at least two binding molecules (e.g. covalently or non-covalently as per para 0051, 0091-0095, 0242-0243, etc.), and wherein said multimerization domain is dextran (e.g. as per para 0044, 0051, 0055-0056, 0086, 0093, etc.) or streptavidin (e.g. as per para 0042, 0051, 0056, 0200, 0207, 0213, 0220, etc.); and
second label, wherein the second label is selected from the group consisting of fluorophores, chromophores, and peptides, and wherein the second label is coupled with the multimerization domain or with at least one of said at least two identical binding molecules (e.g. a peptide, as per the peptide in the peptide-MHC complex as per para 0058-0059 or 0134+, or a fluorophore suitable for FACS attached to the MHC, as per para 0047, 0054, 0358, or 0418+).
However, it is noted that while Brix discusses several methods of labeling the MHC multimers (e.g., as per para 0399-0420) specifically including nucleic acids (e.g. as per para 0488), the reference is silent on the limitation of “at least one nucleic acid label associated with said multimerization domain, wherein said nucleic acid label is 30-200 nucleotides in length and comprises a 5' first primer region (forward), a barcode region and a 3' second primer region (reverse)”, as set forth in claim 1, and wherein said nucleic acid label is selected from the group consisting of a DNA label, an RNA label, and an artificial nucleic acid label, as set forth in claim 2.
Regarding claims 1-2, Shen teaches multiplexed immuno-PCR detection molecules (e.g. Fig. 6 and at least para 0007-0008) comprising binding molecules (e.g. specific for cell surface proteins as per Fig. 6 and para 0011, 0016-0018, 0080, and 0127) coupled with DNA labels comprising barcode regions which correspond to the binding molecule flanked by primer binding annealing sites (e.g. barcoded tags are termed “oligonucleotide ID” tags by Shen, being designed with primer binding sites for PCR amplification, as per Fig. 8, and para 0011, 0018-0027, and 0113-0116, and each different binding molecule is uniquely identified by a “unique identifier sequence of the oligonucleotide ID tag” and is used as an identification code for the particular binding molecule, and can be quantitative as per para 0080). Shen teaches in para 0110 that the nucleic acid label (termed “unique identifier nucleotide sequence” by Shen) “may range in length from 10-1000 nucleotides (nt), or basepairs, usually from 15-500 nucleotides or basepairs, more usually from 20-250 nucleotides, or basepairs” and in accordance with MPEP 2144.05(I), in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. Further, Shen teaches the specific length of about 75 nucleotides in all of Examples 1-6.
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to use the MHC multimers as per Brix in the immuno-PCR of Shen. One of ordinary skill in the art would have been motivated to do so since Brix teaches that MHC multimers are useful due to their specificity for T-cells and subsets thereof (e.g. as per para 0039-0049 and 0638+) and that their MHC multimers can be used for flow cytometry, ELISA-like assays, and antigen specific T-cell labeling (e.g. as per para 0054-0055), Brix acknowledges the need for sensitivity (e.g., in detecting rare T-cells, as per para 0045). Also, Brix specifically states in para 0410 “[t]hus, if several different MHC multimers with different labelling compounds are present, it is possible simultaneously to identify more than one specific receptor, if each of the MHC multimers present a different peptide”,
In turn, Shen teaches that immuno-PCR is much more sensitive than fluorescence-based assays, for example, in ELISA and cell-labeling assays (e.g. as per Shen Fig. 6 and para 0007-0008). Therefore, the skilled artisan would have been motivated to use the immuno-PCR method of Shen to increase sensitivity in the assays of Brix.
However, Brix in view of Shen is silent on the explicit limitation of the nucleic acid label having “a random nucleotide region between the 5' first primer region and the 3' second primer region, wherein said random nucleotide region comprises 7 to 20 nucleotides”, as set forth in claim 1.
Regarding claim 1, Kivioja discloses addition of a 10-mer random UMI sequence to make each molecule in a population distinct (e.g., as per the Abstract and Fig. 1).
It would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the application to utilize a random sequence in the nucleic acid label as per Kivioja for absolute and/or relative quantification in the assays of Shen. One of ordinary skill in the art would have been motivated to do so since while Shen discloses sequencing of PCR-amplified identification tags (e.g. as per para 0022-0023) by measuring frequency of amplified ID tags or addition of a known amount of reference target to the sample, Kivioja discloses an improved and more accurate method of quantification that allows for multiplexing, is not prone to errors associated with amplification bias, and does not require the use of an added reference or standard (e.g. as per the Introduction of Kivioja), noting that the random sequence would need to be amplified during detection, and therefore would reasonably be placed between the 5’- and 3’-primers, as set forth in claim 1.
One of ordinary skill in the art would have had a reasonable expectation of success as of the application' s effective filing date in combining the teachings of the prior art references to arrive at the invention as presently claimed since Brix already discloses the attachment of nucleic acids to the detection molecule, and the addition of a UMI as per Kivioja merely requires the well-established methods to be added during polynucleotide synthesis, which was well known in the art at the time.
Regarding claim 3, Shen discloses the above, wherein said nucleic acid label further comprises an annealing region (e.g., for primer binding during PCR as per para 0022).
Regarding claim 4, Shen discloses the above, wherein said nucleic acid label further comprises one or more adaptors for sequencing (e.g., for subsequent sequence analysis as per para 0022).
Regarding claim 5, Shen discloses the above, wherein said at least one nucleic acid label comprises at least two random nucleotide regions (e.g., as per Fig. 1).
Regarding claim 6, Shen discloses the above, wherein said random nucleotide region comprises 7 to 15 nucleotides (e.g., 10 nucleotides as per Fig. 1).
Regarding claims 7-8, Shen discloses the above, wherein said barcode region of said nucleic acid label consists of 5 to 30 nucleotides (e.g., as per para 0105).
Regarding claim 9, Brix discloses the above, wherein said multimerization domain is selected from the group consisting of a polysaccharide, a dextran (e.g. as per para 0044, 0051, 0055-0056, 0086, 0093, etc.) and a streptavidin (e.g. as per para 0042, 0051, 0056, 0200, 0207, 0213, 0220, etc.).
Regarding claims 10-13, Brix discloses the above, wherein the multimerization domain comprises a dextran and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g. as per para 0051).
Regarding claim 14, Brix discloses the above, wherein said detection molecule is a multimeric major histocompatibility complex (MHC) complex comprising as binding molecules three or more pMHC complexes (e.g., as per para 0044).
Regarding claim 15, Brix discloses the above, wherein the at least one nucleic acid label is attached to the multimerization domain (e.g., as per para 0401-0462).
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).
U.S. 11,668,705 B2
Claims 1-16 and 18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,668,705 B2 (the ‘705 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘705 patent disclose a detection molecule comprising a. at least two identical binding molecules, wherein said binding molecules are selected from the group consisting of a pMHC complex, a protein and an anti-target molecule, and wherein said binding molecules have a binding specificity for a T-cell receptor or B-cell receptor;
b. a multimerization domain associated, optionally via one or more connector molecules, with the at least two binding molecules, wherein the multimerization domain is selected from the group consisting of a peptide, a protein, a streptactin, a polysaccharide, a dextran, an avidin and a streptavidin; and
c. at least one nucleic acid label associated with said multimerization domain, optionally via one or more connector molecules, wherein said nucleic acid label is 30-200 nucleotides in length and comprises a5' first primer region (forward), a barcode region and a 3' second primer region (reverse), and a random nucleotide region between the 5' first primer region and the 3' second primer region, wherein said random nucleotide region comprises 7 to 20 nucleotides, wherein said barcode region serves as an identification tag for the binding specificity of said at least two binding molecules, and wherein said random nucleotide region uniquely represents the nucleic acid label in which it is found; and
d. a second label, wherein the second label is selected from the group consisting of fluorophores, chromophores, and peptides, and wherein the second label is coupled with the multimerization domain or with at least one of said at least two identical binding molecules (e.g., as per claims 1 and 10 of the ‘705 patent).
Regarding claim 2, the claims of the ‘705 patent disclose the above, wherein said nucleic acid label is selected from the group consisting of a DNA label, an RNA label, and an artificial nucleic acid label (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 3, the claims of the ‘705 patent disclose the above, wherein said nucleic acid label further comprises an annealing region (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 4, the claims of the ‘705 patent disclose the above, wherein said nucleic acid label further comprises one or more adaptors for sequencing (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 5, the claims of the ‘705 patent disclose the above, wherein said at least one nucleic acid label comprises at least two random nucleotide regions (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 6, the claims of the ‘705 patent disclose the above, wherein said random nucleotide region comprises 7 to 15 nucleotides (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 7, the claims of the ‘705 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 3 to 30 nucleotides (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 8, the claims of the ‘705 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 5 to 30 nucleotides (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 9, the claims of the ‘705 patent disclose the above, wherein said multimerization domain is selected from the group consisting of a polysaccharide, a dextran and a streptavidin (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 10, the claims of the ‘705 patent disclose the above, wherein the multimerization domain comprises a polysaccharide and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 11, the claims of the ‘705 patent disclose the above, wherein the multimerization domain comprises dextran and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 12, the claims of the ‘705 patent disclose the above, wherein the multimerization domain comprises a streptavidin (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 13, the claims of the ‘705 patent disclose the above, wherein said binding molecules and/or said at least one nucleic acid label comprise biotin (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 14, the claims of the ‘705 patent disclose the above, wherein said detection molecule is a multimeric major histocompatibility complex (MHC) complex comprising as binding molecules three or more pMHC complexes (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 15, the claims of the ‘705 patent disclose the above, wherein the at least one nucleic acid label is attached to the multimerization domain (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 16, the claims of the ‘705 patent disclose the above, wherein said at least two binding molecules are selected from the group consisting of CD1, MR1, MHC Class I and MHC Class II (e.g., as per claim 1 of the ‘705 patent).
Regarding claim 18, the claims of the ‘705 patent disclose the above, wherein said binding molecules have a binding specificity for a B-cell receptor (e.g., as per claim 1 of the ‘705 patent).
U.S. 11,402,373 B2
Claims 1-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,402,373 B2 (the ‘373 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘373 patent disclose a detection molecule comprising a. at least two identical binding molecules, wherein said binding molecules are selected from the group consisting of a pMHC complex, a protein and an anti-target molecule, and wherein said binding molecules have a binding specificity for a T-cell receptor or B-cell receptor;
b. a multimerization domain associated, optionally via one or more connector molecules, with the at least two binding molecules, wherein the multimerization domain is selected from the group consisting of a peptide, a protein, a streptactin, a polysaccharide, a dextran, an avidin and a streptavidin; and
c. at least one nucleic acid label associated with said multimerization domain, optionally via one or more connector molecules, wherein said nucleic acid label is 30-200 nucleotides in length and comprises a5' first primer region (forward), a barcode region and a 3' second primer region (reverse), and a random nucleotide region between the 5' first primer region and the 3' second primer region, wherein said random nucleotide region comprises 7 to 20 nucleotides, wherein said barcode region serves as an identification tag for the binding specificity of said at least two binding molecules, and wherein said random nucleotide region uniquely represents the nucleic acid label in which it is found; and
d. a second label, wherein the second label is selected from the group consisting of fluorophores, chromophores, and peptides, and wherein the second label is coupled with the multimerization domain or with at least one of said at least two identical binding molecules (e.g., as per claims 1, 10, and 13 of the ‘373 patent).
Regarding claim 2, the claims of the ‘373 patent disclose the above, wherein said nucleic acid label is selected from the group consisting of a DNA label, an RNA label, and an artificial nucleic acid label (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 3, the claims of the ‘373 patent disclose the above, wherein said nucleic acid label further comprises an annealing region (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 4, the claims of the ‘373 patent disclose the above, wherein said nucleic acid label further comprises one or more adaptors for sequencing (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 5, the claims of the ‘373 patent disclose the above, wherein said at least one nucleic acid label comprises at least two random nucleotide regions (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 6, the claims of the ‘373 patent disclose the above, wherein said random nucleotide region comprises 7 to 15 nucleotides (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 7, the claims of the ‘373 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 3 to 30 nucleotides (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 8, the claims of the ‘373 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 5 to 30 nucleotides (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 9, the claims of the ‘373 patent disclose the above, wherein said multimerization domain is selected from the group consisting of a polysaccharide, a dextran and a streptavidin (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 10, the claims of the ‘373 patent disclose the above, wherein the multimerization domain comprises a polysaccharide and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 11, the claims of the ‘373 patent disclose the above, wherein the multimerization domain comprises dextran and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 12, the claims of the ‘373 patent disclose the above, wherein the multimerization domain comprises a streptavidin (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 13, the claims of the ‘373 patent disclose the above, wherein said binding molecules and/or said at least one nucleic acid label comprise biotin (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 14, the claims of the ‘373 patent disclose the above, wherein said detection molecule is a multimeric major histocompatibility complex (MHC) complex comprising as binding molecules three or more pMHC complexes (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 15, the claims of the ‘373 patent disclose the above, wherein the at least one nucleic acid label is attached to the multimerization domain (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 16, the claims of the ‘373 patent disclose the above, wherein said at least two binding molecules are selected from the group consisting of CD1, MR1, MHC Class I and MHC Class II (e.g., as per claim 1 of the ‘373 patent).
Regarding claim 17, the claims of the ‘373 patent disclose the above, wherein said binding molecules have a binding specificity for a T-cell receptor (e.g., as per claim 13 of the ‘373 patent).
U.S. 11,585,806 B2
Claims 1-18 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of U.S. Patent No. 11,585,806 B2 (the ‘806 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the rejected claims of the present invention would be anticipated and/or rendered obvious by the subject matter in the claims of the reference patent.
Regarding claim 1, the claims of the ‘806 patent disclose a detection molecule comprising a. at least two identical binding molecules, wherein said binding molecules are selected from the group consisting of a pMHC complex, a protein and an anti-target molecule, and wherein said binding molecules have a binding specificity for a T-cell receptor or B-cell receptor;
b. a multimerization domain associated, optionally via one or more connector molecules, with the at least two binding molecules, wherein the multimerization domain is selected from the group consisting of a peptide, a protein, a streptactin, a polysaccharide, a dextran, an avidin and a streptavidin; and
c. at least one nucleic acid label associated with said multimerization domain, optionally via one or more connector molecules, wherein said nucleic acid label is 30-200 nucleotides in length and comprises a5' first primer region (forward), a barcode region and a 3' second primer region (reverse), and a random nucleotide region between the 5' first primer region and the 3' second primer region, wherein said random nucleotide region comprises 7 to 20 nucleotides, wherein said barcode region serves as an identification tag for the binding specificity of said at least two binding molecules, and wherein said random nucleotide region uniquely represents the nucleic acid label in which it is found; and
d. a second label, wherein the second label is selected from the group consisting of fluorophores, chromophores, and peptides, and wherein the second label is coupled with the multimerization domain or with at least one of said at least two identical binding molecules (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 2, the claims of the ‘806 patent disclose the above, wherein said nucleic acid label is selected from the group consisting of a DNA label, an RNA label, and an artificial nucleic acid label (e.g., as per claim 2 of the ‘806 patent).
Regarding claim 3, the claims of the ‘806 patent disclose the above, wherein said nucleic acid label further comprises an annealing region (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 4, the claims of the ‘806 patent disclose the above, wherein said nucleic acid label further comprises one or more adaptors for sequencing (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 5, the claims of the ‘806 patent disclose the above, wherein said at least one nucleic acid label comprises at least two random nucleotide regions (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 6, the claims of the ‘806 patent disclose the above, wherein said random nucleotide region comprises 7 to 15 nucleotides (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 7, the claims of the ‘806 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 3 to 30 nucleotides (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 8, the claims of the ‘806 patent disclose the above, wherein said barcode region of said nucleic acid label consists of 5 to 30 nucleotides (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 9, the claims of the ‘806 patent disclose the above, wherein said multimerization domain is selected from the group consisting of a polysaccharide, a dextran and a streptavidin (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 10, the claims of the ‘806 patent disclose the above, wherein the multimerization domain comprises a polysaccharide and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claim 5 of the ‘806 patent).
Regarding claim 11, the claims of the ‘806 patent disclose the above, wherein the multimerization domain comprises dextran and wherein the detection molecule further comprises one or more connector molecules between any two components of the detection molecule, the connector molecules comprising one or more streptavidins and/or avidins (e.g., as per claims 5-6 of the ‘806 patent).
Regarding claim 12, the claims of the ‘806 patent disclose the above, wherein the multimerization domain comprises a streptavidin (e.g., as per claim 5 of the ‘806 patent).
Regarding claim 13, the claims of the ‘806 patent disclose the above, wherein said binding molecules and/or said at least one nucleic acid label comprise biotin (e.g., as per claim 5 of the ‘806 patent).
Regarding claim 14, the claims of the ‘806 patent disclose the above, wherein said detection molecule is a multimeric major histocompatibility complex (MHC) complex comprising as binding molecules three or more pMHC complexes (e.g., as per claim 9 of the ‘806 patent).
Regarding claim 15, the claims of the ‘806 patent disclose the above, wherein the at least one nucleic acid label is attached to the multimerization domain (e.g., as per claim 1 of the ‘806 patent).
Regarding claim 16, the claims of the ‘806 patent disclose the above, wherein said at least two binding molecules are selected from the group consisting of CD1, MR1, MHC Class I and MHC Class II (e.g., as per claim 4 of the ‘806 patent).
Regarding claim 17, the claims of the ‘806 patent disclose the above, wherein said binding molecules have a binding specificity for a T-cell receptor (e.g., as per claim 26 of the ‘806 patent).
Regarding claim 18, the claims of the ‘806 patent disclose the above, wherein said binding molecules have a binding specificity for a B-cell receptor (e.g., as per claim 27 of the ‘806 patent).
Conclusion
No claims are allowed.
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/JEREMY C FLINDERS/
Primary Examiner, Art Unit 1684
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