CTNF 17/258,039 CTNF 98734 Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Continued Examination Under 37 CFR 1.114 07-42-04 AIA 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 9/11/2025 has been entered. Response to Amendment The amendment filed 09/11/2025, amending claim(s) 1, 17, and 18 and cancelling claim(s) 16 is acknowledged. Claims 1-3, 5-7, 9-16, 17-20, and 22 are pending and under examination. Priority Applicant’s claim for the benefit of a prior-filed application provisional application 62/696,191 filed on 07/10/2018, 62/821,879 filed 3/21/2019, and PCT/US2019/041064 filed 07/09/2019 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. Claim Rejections - 35 USC § 112(b) – New, necessitated by amendment 07-30-02 AIA 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. 07-34-01 Claims 10-14, and 20 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. Claims 10 and 11 refers multiple times to “the specific-binding pair”. Claim 10 depends upon claim 1, which in the preamble recites “A method of providing a first member of a specific-binding pair to a cell comprising a second member of the specific binding pair”. However, claim 1 appears to recite two different specific binding pairs (one pair in paragraphs 3-5 of claim 1, the second pair in paragraphs 6 and 7). As such, it is unclear whether claims 10 and 11 are referring to one of the two pairs or both pairs. Additionally, if “the specific binding pair” only refers to one of the two pairs, does it matter which pair is being referred to (e.g., is claim 10 referring to either pair? Is there a difference in claim 10 referring to the first versus second pair?)? Similarly, claims 12, 13 and 14 refer to “the first binding member” and “the second binding member”. However, there are multiple first binding members and multiple second binding members recited in base claim 1. As such, it is unclear which binding members claims 13 and 14 are further limiting. For examination purposes, the limitations of claims 10-14 are interpreted to refer to either/any pair/binding member. It would be remedial to amend the claims to clarify what pair and first and second binding members of the base claim are being referred to, or to clarify that the claims are not specific to a specific pair/binding member and may refer to either pair/first and second binding members (e.g., similar to claim 19). Claim Rejections - 35 USC § 103 – Maintained, updated in view of amendments 07-20-aia AIA 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. 07-23-aia AIA 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. The Examiner notes that the broadest reasonable interpretation of “second member of the specific binding pair” reads on targeting ligands (e.g. synthetic targeting ligands), including aptamer ligands (i.e., a single-stranded nucleic acid). 07-21-aia AIA Claim (s) 1-3, 5-7, 9, 12-14, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yale (US 20160303052 A1, published October 20 th , 2016) and further in view of Liu (Liu, Juewen, and Yi Lu. "Non-base pairing DNA provides a new dimension for controlling aptamer-linked nanoparticles and sensors." Journal of the American Chemical Society 129.27 (2007): 8634-8643.) . Regarding claim 1 , Yale teaches nanoparticles (i.e., nanolipogel) interacting with a cell (i.e., a method of providing a first member of a specific-binding pair to a cell comprising a second member of the specific-binding pair, comprising contacting a polymeric particle with the cell) (Abstract, Figure 4). Additionally, the nanoparticle constructs (i.e., nanolipogels) taught by Yale comprise a polymeric core with biotinylated PEG added to PLGA to create block co-polymers that are cross-linked (e.g., non-covalently via biotin-avidin bridges) with a polymeric core (e.g., para 0050, 0070; Fig. 7). Further, Yale teaches the polymer of a nucleic acid-polymer conjugate being a PLGA-PEG block polymer (e.g., para 0050, 0070; [0062, 0070]; Fig. 7; [0198, 0204, 0205]). In addition, the particles contain polymer conjugates with end-to-end linkages between the polymer and a targeting moiety, detectable label, or other active agent via avidin-biotin bridges (e.g., para 0099). The targeting moiety, detectable label, or active agent (i.e., a binding member), which is present on the surface of the particle (e.g., Abstract), associates with a target cell (i.e., by binding to a secondary binding member, such as cell surface receptors) (e.g., para 0333- Example 1; Figure 4). Further, Yale teaches that the nanolipogels can be constructed to incorporate a variety of active agents that can subsequently be released in a controlled fashion (e.g., the polymeric particle taught by Yale as part of a method comprising contacting a polymeric particle with a cell is modular) (e.g., para 0051). Yale teaches the particle comprising two or more active agents (i.e., multiple sets of specific-binding pairs) (e.g., paras 0009, 0106). Yale does not teach the ratio of the first binding member (i.e., active agent) of the first specific-binding pair and the first binding member of the second specific-binding pair. However, it would have been obvious to an artisan to determine the ratio using routine optimization to arrive at the claimed invention. Yale does not teach the polymer and binding member conjugates being associated by first and secondary complementary single-stranded nucleic acids that hybridize (Yale teaches biotin-avidin bridges, which also form strong non-covalent bonds, for the same purpose). An Artisan, interested in nanoparticle systems, would be aware of Liu for teaching variables influencing the assembly of nanoparticles. Liu teaches an adenosine aptamer-linked gold nanoparticle system (Abstract). The linker DNA of the nanoparticle system contains an adenosine aptamer fragment (i.e., single-stranded nucleic acid), which binds to a target ligand, and extensions, which hybridize to the nanoparticles (i.e., via single-stranded nucleic acids) (Figure 1; Figure 4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the ssDNA-linkers taught by Liu for the avidin-biotin bridges taught by Yale in order to present the first binding member on the surface of the polymeric particle. An artisan would have a reasonable expectation of success because the DNA linkers taught by Liu are known in the art and are an alternative that serves the same purpose as the avidin-biotin bridges taught by Yale. One would be motivated to make this substitution because as taught by Liu, DNA aptamers (ssDNA) are used as simple and fast colorimic sensors for a wide range of molecules and for directed assembly of nanomaterials (Abstract; pg. 8635, col 2, para 2). Regarding claims 2 and 3 , Yale teaches the polymeric core being PLGA (e.g., Figure 4). Regarding claims 5-7 , Liu teaches the first and second single-stranded ( claim 7 ) nucleic acid being DNA (e.g., Figure 1). Additionally, Liu teaches the ssDNA comprising 5-200 bases ( claims 6 and 7 ) (e.g., Figure 1; Figure 2). Regarding claim 9 , Yale teaches the cell being a dendritic cell (e.g., para 0030 and 0331 – Example 1). Regarding claim 12 , Yales teaches the first member or second binding member being an antigen or antibody (e.g., para 0013). Regarding claim 13 , Yale teaches the first binding member comprising IL-2, and the IL-2 is presented on the surface of the polymeric particle (e.g., para 0335 – Example 2; Abstract; para 0016). Regarding claim 14 , Yale teaches the second binding member being a nanobody (i.e., antigen binding fragment) that specifically binds to an antigen wherein the first binding member is the antigen (e.g., para 0013, 0199). Regarding claim 22 , Yale teaches administering the cell (contacted with a particle) (i.e., trafficking of nanoparticles to spleen and presentation to dendritic cells – Example 1) to a subject (i.e., melanoma cells injected into mice, followed by injection with nanoparticles) (e.g., para 0028; Fig 11; Example 1 – starting para 0329; para 0383 – Example 10) . 07-21-aia AIA Claim (s) 1-7, 9, 12-14, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yale (US 20160303052 A1, published October 20 th , 2016) and further in view of Luo (US20100136614 A1, published June 3 rd , 2010) . Regarding claim 1 , Yale teaches nanoparticles (i.e., nanolipogel) interacting with a cell (i.e., a method of providing a first member of a specific-binding pair to a cell comprising a second member of the specific-binding pair, comprising contacting a polymeric particle with the cell) (e.g., Abstract, Figure 4). Additionally, the nanoparticle constructs (i.e., nanolipogels) taught by Yale comprise a polymeric core with biotinylated PEG added to PLGA (e.g., para 0330- Example 1) to create block co-polymers that are cross-linked (i.e., non-covalently via biotin-avidin bridges) with a polymeric core (e.g., para 0050, 0070; Fig. 7). In addition, the particles contain polymer conjugates with end-to-end linkages between the polymer and a targeting moiety, detectable label, or other active agent via avidin-biotin bridges (e.g., para 0099). The targeting moiety, detectable label, or active agent (i.e., a binding member), which is present on the surface of the particle (e.g., Abstract), associates with a target cell (i.e., by binding to a secondary binding member, such as cell surface receptors) (e.g., para 0333- Example 1; Figure 4). Further, Yale teaches that the nanolipogels can be constructed to incorporate a variety of active agents that can subsequently be released in a controlled fashion (i.e., the polymeric particle taught by Yale as part of a method comprising contacting a polymeric particle with a cell is modular) (e.g., para 0051). Yale teaches the particle comprising two or more active agents (i.e., multiple sets of specific-binding pairs) (e.g., paras 0009, 0106). Yale does not teach the ratio of the first binding member (i.e., active agent) of the first specific-binding pair and the first binding member of the second specific-binding pair. However, it would have been obvious to an artisan to determine the ratio using routine optimization to arrive at the claimed invention. Yale does not teach the polymer and binding member conjugates being associated by first and secondary complementary single-stranded nucleic acids that hybridize (Yale teaches biotin-avidin bridges, which also form strong non-covalent bonds, for the same purpose). An Artisan, interested in delivering biomaterials/bioactive agents to cells using nanotechnology, would be aware of Luo for teaching compositions comprising nanoparticles used to deliver a plurality of the same or distinct bioactive agents. Luo teaches nucleic acids used to form dendrimers that are useful as supports, carriers, or delivery vehicles, including for therapeutic uses, e.g., (Abstract) [0161-0163]. Luo teaches hybridized single-stranded DNAs (i.e., first and second binding members) attaching protein/peptide moieties (i.e., synthetic targeting ligands) to nanoparticles, e.g., (Figure 19) [0010; 0049; 0081; 0153]. It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute the hybridized ssDNA taught by Luo for the avidin-biotin bridges taught by Yale in order to present the first binding member on the surface of the polymeric particle. An artisan would have a reasonable expectation of success because Luo teaches the nucleic acid binding pairs being an alternative that serves the same purpose as the avidin-biotin bridges taught by Yale, e.g., [0139]. One would be motivated to make this substitution because as taught by Luo, nucleic acid molecules, such as the single-stranded nucleic acid binding members, are easily manipulable, can self-assemble under the proper conditions, and be amplified exponentially and ligated specifically, making them ideal candidate for constructing nano-materials, e.g., [0006]. Regarding claims 2 and 3 , Yale teaches the polymeric core being PLGA (e.g., Figure 4). Regarding claim 4 , Yale teaches the polymer of a nucleic acid-polymer conjugate being a PLGA-PEG block polymer (e.g., para 0050, 0070). Regarding claims 5-7 , Luo teaches the first and second single-stranded ( claim 7 ) nucleic acid being DNA (e.g., Figure 19). Additionally, Luo teaches the ssDNA comprising 5-200 bases ( claims 6 and 7 ), e.g., [0114; each polynucleotide is 30 nucleotides in length]. Regarding claim 9 , Yale teaches the cell being a dendritic cell (e.g., para 0030 and 0331 – Example 1). Regarding claim 12 , Yales teaches the first member or second binding member being an antigen or antibody (e.g., para 0013). Regarding claim 13 , Yale teaches the first binding member comprising IL-2, and the IL-2 is presented on the surface of the polymeric particle (e.g., para 0335 – Example 2; Abstract; para 0016). Regarding claim 14 , Yale teaches the second binding member being a nanobody (i.e., antigen binding fragment) that specifically binds to an antigen wherein the first binding member is the antigen (e.g., para 0013, 0199). Regarding claim 22 , Yale teaches administering the cell (contacted with a particle) (i.e., trafficking of nanoparticles to spleen and presentation to dendritic cells – Example 1) to a subject (i.e., melanoma cells injected into mice, followed by injection with nanoparticles) (e.g., para 0028; Fig 11; Example 1 – starting para 0329; para 0383 – Example 10) . 07-22-aia AIA Claim (s) 10, 11, 15, 17, 18, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yale and Liu or Yale and Luo as applied to claim s 1-7, 9, 12-14, and 22 above, and further in view of Lim (WO2016138034A1, published September 1 st , 2016) . Yale, Liu, and Luo teach the claim limitations discussed above. As shown above, the base claims are obvious over the base art. Regarding claims 10 , Yale, Liu, and Luo do not teach the cell comprising a binding- triggered transcription switch (BTSS) comprising: a) an extracellular domain comprising the second member of the specific-binding pair that specifically binds to the first member of the specific-binding pair; b) a binding transducer; and c) an intracellular domain comprising a transcriptional activator or a transcriptional repressor, wherein binding of the first member of the specific-binding pair to the second member of the specific- binding pair activates the intracellular domain (i.e., a chimeric Notch polypeptide, synNotch). An Artisan, interested in binding-triggered transcriptional switches, would be aware of Lim for teaching compositions comprising binding-triggered transcriptional switch polypeptides, such as chimeric Notch receptor polypeptides used to genetically modify cells and modulate cell activity. Lim teaches binding-triggered transcriptional switch (BTSS) polypeptides, as well as cells comprising these binding-triggered transcriptional switch polypeptides (e.g., Abstract). Further, Lim teaches the BTSS comprising: a) an extracellular domain comprising the second member of the specific-binding pair that specifically binds to the first member of the specific-binding pair; b) a binding transducer; and c) an intracellular domain comprising a transcriptional activator or a transcriptional repressor, wherein binding of the first member of the specific-binding pair to the second member of the specific- binding pair activates the intracellular domain (e.g., para 0016). It would have been obvious to an artisan before the effective filing date of the current invention to add the BTSS taught by Lim to the system (i.e., method comprising contacting a polymeric particle with a cell) taught by Yale and Liu/Luo with a reasonable expectation of success. One would be motivated to combine the BTSS taught by Lim with the method taught by Yale and Liu or Luo because as taught by Lim, the BTSS can locally modulate the activation of a cell (e.g., para 0005 of Lim). Additionally, as discussed above, Yale teaches that the system can be used to deliver a variety of agents to cells and can be modified to deliver agents in a controlled fashion (i.e., is modular) (e.g., para 0051 of Yale). Regarding claim 11 , Lim teaches the BTTS being a chimeric Notch polypeptide (i.e., synNotch) comprising, from N-terminus to C-terminus and in covalent linkage: a) an extracellular domain comprising the second member of the specific-binding pair that is not naturally present in a Notch receptor polypeptide and that specifically binds to the first member of the specific-binding pair; b) a Notch regulatory region comprising a Lin 12-Notch repeat, an S2 proteolytic cleavage site, and a transmembrane domain comprising an S3 proteolytic cleavage site; c) an intracellular domain comprising a transcriptional activator or a transcriptional repressor that is heterologous to the Notch regulatory region and replaces a naturally-occurring intracellular Notch domain, wherein binding of the first member of the specific-binding pair to the second member of the specific-binding pair induces cleavage at the S2 and S3 proteolytic cleavage sites, thereby releasing the intracellular domain (e.g., para 0007; Figure 1; para 00176). It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to add the chimeric Notch polypeptide taught by Lim to the system taught by Yale and Liu or Luo with a reasonable expectation of success. As discussed above, Yale teaches that the system can be used to deliver a variety of agents to cells and can be modified to deliver agents in a controlled fashion (i.e., is modular) (e.g., para 0051). One would be motivated to combine the chimeric Notch polypeptide (synNotch receptors) taught by Lim with the method taught by Yale and Liu/Luo because as taught by Lim, the synNotch receptors can serve as regulators that allow T cells to monitor and selectively modulate their microenvironment (e.g., para 0093; Fig 102). Regarding claim 15 , Yale, Liu, and Luo do not teach the cell from the method of claim 1 further comprising a transcriptional control element, responsive to the transcriptional activator, operably linked to a nucleotide sequence encoding a chimeric antigen receptor (CAR). Lim teaches the cell further comprising a transcriptional control element (i.e., promoter, enhancer), responsive to the transcriptional activator, operably linked to a nucleotide sequence encoding a chimeric antigen receptor (CAR) (e.g., para 0008, 00463, 00518). It would have been obvious to an artisan before the effective filing date of the current invention to add the transcriptional control element and nucleotide encoding CAR taught by Lim to the system taught by Yale in combination with Liu or Luo and arrive at the claimed invention, as the system of Yale can be used to deliver a variety of agents to cells and can be modified to deliver agents in a controlled fashion (i.e., is modular) (para 0051). One would have a reasonable expectation of success since Lim teach the CAR and operably linked to a transcriptional control element providing activation for the cell (i.e., T cell) following binding of an antigen (para 0012). Regarding claims 17 and 18 , Yale teaches the first binding member of the second specific-binding pair is an antibody (i.e., anti-CD40) that binds to a second binding member of the second specific- binding pair expressed on cell surface of a tumor cell (i.e., melanoma cells), wherein the method comprises contacting the cell expressing the second binding member of the first specific-binding pair and the tumor cell expressing the second binding member of the second specific-binding pair with the particle (e.g., para 0341, 0342 – Example 3). Yale, Liu, and Luo do not the cell expressing the second binding member of the first specific-binding pair being a T cell. Lim teaches a tumor cell expressing an antibody (i.e., CD19+, first binding member), which contacts a T cell that expresses a second binding member (i.e., synNotch receptor) (e.g., Figure 101, para 0092). Additionally, Lim teaches the binding of the specific-binding pairs inducing T-cell proliferation without significant increase in cytokine production (i.e., Lim teaches the binding of the binding members on the tumor cell and T cell leading to the expression of a custom cytokine profile, which an artisan can select for such as IL-2; therefore, since Lim teaches the production of a selected cytokine but not others, the teaching of Lim read on the limitations of claim 18 ) (e.g., Figure 98E). It would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to substitute a T cell, such as the one taught by Lim, for the cell in the method taught by Yale and Liu or Luo. One would have a reasonable expectation of success because a T cell is a known target for antibodies. As taught by Lim, one would be motivated to substitute the cell of Yale with a T cell as taught by Lim because the receptor (i.e., binding member) on the T cell can help the T cell monitor and selectively modulate their microenvironment (e.g., para 0093; Fig 102). Regarding claim 20 , Yale teaches the particle comprising two or more active agents (i.e., multiple sets of specific-binding pairs) (e.g., paras 0009, 0106). Additionally, Luo and Lim teach single-stranded nucleic acid covalently attached to polymers, with complementary single-stranded nucleic acids associated via hybridization, and the teachings of Luo and Yale and Liu and Yale can be combined as discussed above. Yale, Liu, and Luo do not teach the first binding member binding to CAR expressed by the cell in response to binding of the first member of the first specific-binding pair to the BTTS expressed by the cell, wherein the cell is a T-cell and wherein binding of the CAR antigen to the T-cell induces T-cell proliferation without significant increase in cytokine production, optionally wherein the BTTS is a chimeric Notch polypeptide. As discussed above for claims 15, 17, and 18, Lim teaches a first binding member of a specific binding pair being an antigen that binds to CAR expressed by a T cell in response to binding of the first member of the first specific-binding pair to the BTTS expressed by the T-cell, wherein binding of the CAR antigen to the T-cell induces T-cell proliferation without significant increase in cytokine production (e.g., Figure 98E; Figure 101, para 0092; para 0008, 00463, 00518) . 07-22-aia AIA Claim (s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yale and Liu or Yale and Luo as applied to claim s 1-7, 9, 12-14, 16, and 22 above, and further in view of Stephan (US 20160008399 A1, published January 14th, 2016) . Yale, Liu, and Luo teach the claim limitations discussed above. As shown above, the base claims are obvious over the base art. An Artisan, interested injectable polymers targeting T cells, would be aware of Stephan for teaching polymers and scaffolds that can be administered to subjects to target lymphocytes. Stephan teaches microparticles, nanoparticles, and biopolymer scaffolds comprising lymphocyte-activating moieties and immune stimulants (e.g., para 0009, 0011, 0037), Additionally, Stephan teaches stimulatory microparticles triggering the expansion of loaded T-cells within the interior pore spaces of a biopolymer scaffold (e.g., para 0022; Figure 3). Regarding claim 19 , Yale teaches that the system can be used to deliver a variety of agents to cells and can be modified to deliver agents in a controlled fashion (i.e., is modular) (e.g., para 0051). Yale and Chou do not teach one of the second binding members of the first or second specific-binding pairs is CD3 and the other is CD28, optionally wherein the first binding member that binds CD3 and the first binding member that binds CD28 are present at a ratio of 1:3 to 5:1, further optionally wherein the first binding member that binds CD3 and the first binding member that binds CD28 are present at a ratio of 3:1. Stephan teaches lymphocyte-activating moieties (i.e., binding members) being antibodies specific for CD3 and CD28 on polymer microparticles (e.g., para 0010; para 0027, Figure 8; para 0143). It would have been obvious to an artisan before the effective filing date of the current invention to substitute CD3 and CD28 as taught by Stephan for the binding pairs taught by Yale and Liu or Luo. One would have a reasonable expectation of success because CD3 and CD28 are known targets and an artisan can select binding members depending on their target on interest. One would be motivated to select CD3 and CD28 because as taught by Stephan, polymer microparticles coated with anti-CD3 and CD28 antibodies support the proliferation of lymphocytes (e.g., para 0143) . Response to Arguments Applicant’s arguments, see pgs. 1-5 of Remarks filed 09/11/2025, with respect to the rejection(s) of claim(s) 1-3, 5-7, 9, 12-14, 16, and 22 under 35 U.S.C. 103 as being obvious over Yale in view of Liu have been fully considered but they are not persuasive. Applicant argues that Yale does not disclose an enabling disclosure for how to achieve two or more specific binding pairs. Applicant’s argument(s) has been fully considered, but is not persuasive. The specification need not contain an example if the invention is otherwise disclosed in such manner that one skilled in the art will be able to practice it without an undue amount of experimentation. In re Borkowski , 422 F.2d 904, 908, 164 USPQ 642, 645 (CCPA 1970). A reference contains an "enabling disclosure" if the public was in possession of the claimed invention before the date of invention. "Such possession is effected if one of ordinary skill in the art could have combined the publication's description of the invention with his [or her] own knowledge to make the claimed invention." In re Donohue , 766 F.2d 531, 226 USPQ 619 (Fed. Cir. 1985). Applicant fails to provide objective evidence that two or more specific binding pairs constitutes undue experimentation, for example. Similarly, Applicant fails to provide objective evidence that the teachings of Yale regarding multiple binding pairs (e.g., Fig. 4, Fig. 7) constitute undue experimentation. Additionally, it is noted that the features upon which applicant relies (i.e., two or more) are not recited in the rejected claim(s) (claims only recite two pairs). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns , 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). 07-37-04 AIA In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine , 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones , 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc. , 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the Applicant argues it would not have been obvious to replace the covalent connections with the non-specific binding of single stranded nucleic acid of Liu. The Applicant fails to address/respond to the Examiner’s rationale and motivation for replacing the hybridized ssDNA taught by Luo for the avidin-biotin bridges taught by Yale (e.g., why would an artisan not be motivated in view of the cited teachings of Luo? Why would one not have found it obvious when the bridges and hybridized ssDNA serve the same purpose in the art?) . In addition, the Applicant argues that since Yale lack third and fourth binding members, such non-existence binding members could not have been replaces by third and fourth ss nucleic acids. This argument is not persuasive. The Applicant fails to explain/provide evidence for why Yale must have third and fourth binding members for the substitute to work. Additionally, it is unclear what these third and fourth binding members are supposed to be, as in the claim language, the ss nucleic acids are not considered binding members. For example, the specification teaches the binding members being antibodies. How would the presence of third and fourth antibodies be relevant to this substitution? The Applicant mentions that the Office interpreted the avidin and biotin moieties to be binding members. For clarification, the Examiner notes that active agents taught by Yale are interpreted to be binding members, not the avidin-biotin bridges (the bridges are interpreted to be how the polymer and binding member are attached). Conclusion No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALLISON M JOHNSON whose telephone number is (703)756-1396. The examiner can normally be reached Monday-Friday 9am-5pm. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached on (571) 272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ALLISON MARIE JOHNSON/Examiner, Art Unit 1638 /ROBERT M KELLY/Primary Examiner, Art Unit 1638 Application/Control Number: 17/258,039 Page 2 Art Unit: 1638 Application/Control Number: 17/258,039 Page 3 Art Unit: 1638 Application/Control Number: 17/258,039 Page 4 Art Unit: 1638 Application/Control Number: 17/258,039 Page 5 Art Unit: 1638 Application/Control Number: 17/258,039 Page 6 Art Unit: 1638 Application/Control Number: 17/258,039 Page 7 Art Unit: 1638 Application/Control Number: 17/258,039 Page 8 Art Unit: 1638 Application/Control Number: 17/258,039 Page 9 Art Unit: 1638 Application/Control Number: 17/258,039 Page 10 Art Unit: 1638 Application/Control Number: 17/258,039 Page 11 Art Unit: 1638 Application/Control Number: 17/258,039 Page 12 Art Unit: 1638 Application/Control Number: 17/258,039 Page 13 Art Unit: 1638 Application/Control Number: 17/258,039 Page 14 Art Unit: 1638 Application/Control Number: 17/258,039 Page 15 Art Unit: 1638 Application/Control Number: 17/258,039 Page 16 Art Unit: 1638 Application/Control Number: 17/258,039 Page 17 Art Unit: 1638 Application/Control Number: 17/258,039 Page 18 Art Unit: 1638
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