CTNF 18/126,819 CTNF 90066 DETAILED ACTION 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. 07-06 AIA 15-10-15 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. Priority The present application filed 03/27/2023 claims benefit under 35 U.S.C. 119(e) to provisional application No. 63/326,104, filed 03/31/2022. Information Disclosure Statement The information disclosure statement (IDS) filed 08/03/2023 and 04/06/2026 are considered, initialed and are attached hereto. Drawings 06-24-01 AIA Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification: The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee. Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2). Drawings 03/27/2023 are submitted as color drawings. Specification 07-29 AIA The disclosure is objected to because of the following informalities: The use of trademark/trade names has been noted in this application (e.g., BODIPY®, pages 29-30, 32-33). Trademarks/trade names should be capitalized wherever they appear and be accompanied by the generic terminology. Although the use of trademarks is permissible in patent applications, the proprietary nature of the marks should be respected, and every effort made to prevent their use in any manner which might adversely affect their validity as trademarks . Appropriate correction is required. Claim Rejections - 35 USC § 112 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 16 and 17 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. 07-35-01 Claims 16 and 17 recite the trademark/trade name BODIPY®. Where a trademark or tradename is used in a claim as a limitation to identify or describe a particular material or product, the claims does not comply with the requirements of 35 U.S.C. 112(b). See Ex parte Simpson , 218 USPQ1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or tradename cannot be used to properly identify any particular material or product. A trademark or tradename is used to identify a source of goods, and not the good themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the term is relied upon to indicate a particular/specific fluorophore. Claim Rejections - 35 USC § 103 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. 07-21-aia AIA Claim (s) 1-11 and 13-21 are rejected under 35 U.S.C. 103 as being unpatentable over Liang et al., WO2019/191482A1 in view of Gonzalez-Sapienza et al., Single-Domain Antibodies As Versatile Affinity Reagents for Analytical and Diagnostic Applications, Frontiers in Immunology, 8(977), (2017), p. 1-12 . Liang et al. teach a water soluble polymeric fluorescent tandem dye conjugate (see e.g., abstract, also provided labeled specific binding members, page 2, lines 1-6) comprising polymeric tandem fluorescent dye having a polymeric backbone comprising non-conjugated repeat units (see abstract, page 1, line 29-page 2, line8, ), a plurality of pendant donor fluorophores independently linked to a non-conjugated repeat unit of the polymeric backbone (page 1, line 29 to page 2, Figure 4 and 6 and descriptions at page 2, page 3, Figures 7 and 9), and one or more acceptor fluorophores linked to a non-conjugated repeat unit of the polymeric backbone, wherein the pendant donor and acceptor fluorophores are in energy transfer relationship (figure 6, description page 2, page 14, lines 25-27, page 15, line 23, page 64, lines 15-24). The specific binding member of Liang’s conjugate include for example, antibody conjugates (page 77-78). However, Liang’s conjugate differs from that presently claimed only in that it fails to teach the antibody as a single domain antibody. Gonzalez-Sapienza teach camelid heavy chain only antibodies (HcAbs, a type of single domain antibody) have more limited structural diversity than that of conventional antibodies, however, even so, they are not limited in their specificity or binding affinity against a broad range of structurally diverse antigens (see abstract). Gonzalez-Sapienza teach their variable domain (nanobody) has outstanding properties, allowing them to reach analytical and diagnostic performances that cannot be accomplished with conventional antibodies (see attributes including easily adapted to high through put screening, exceptional stability, minimal size, and versatility as affinity building blocks (abstract)). Gonzalez-Sapienza teach camelids and sharks as having a special type of antibody devoid of light chain (see page 2, col. 1 and Figure 1). See at page 2, col. 1, Gonzalez-Sapienza teach VHHs and VNARs share convergent features distinct from conventional antibodies which make them soluble and increase their stability and diversity, teaching they have smaller antigen binding domains (giving them an advantage in terms of binding hidden epitopes (see page 2, col. 2). Gonzalez-Sapienza teach these reagents as having enormous potential as immunoreagents (page 9, col. 1, para 2, see referring to their growth in studies related to immunodetection). These reagents (nanobodies) are recognized as having broad recognition capability and bind with affinity values rivaling conventional antibodies (also para 2). Gonzalez-Sapienza teach their size itself as an advantage in analytical and diagnostic applications (page 5, col. 2, last paragraph to page 4), referring to how conventional antibodies are limited in terms of their tissue penetration as a result of their larger size. In particular, Gonzalez-Sapienza teach the reduced size of nanobodies is an asset for the development of homogeneous immunoassays based on FRET. It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the antibodies of Liang et al. in order to instead provide the conjugate comprising a single domain antibody (such as a VHH or VNAR as in Gonzalez-Sapienza), one having ordinary skill in the art motivated to substitute the single domain antibodies as taught by Gonzalez-Sapienza in place of conventional antibodies as in Liang et al. because of the many advantages afforded by single domain antibodies, including their small size, stability, versatility, all while maintaining high specificity and affinity to a broad range of targeted antigens. One having ordinary skill in the art would have a reasonable expectation of success because they are still recognized as reagent usable for immunoconjugate (usable for analytical and diagnostic applications involving detectable labeling, see as referred to in Gonzalez-Sapienza). Regarding claims 2-4, the combination of the cited art is teaching single domain antibody having only a heavy chain domain (VHH or VNAR). Regarding claims 5-6, Liang teach target analyte for conjugate comprising intracellular target or cell surface antigen (see page 81, lines 16-20). Regarding claim 7, see also Liang teach target antigen that is an antibody (page 81, line 5). Regarding claim 8, Liang teach a conjugate comprising two or more polymeric tandem units (see page 16, lines 23-31, page 29, line 11-13). Regarding claim 9, Liang teach polymeric tandem fluorescent dye described by the formula at claim 9, SM1 and SM2 comprise comonomers that are each independently a non-conjugated co-monomer (page 14, lines 19-33), regarding x and y (75 mol% at x and 25 mol% at y), see for example Figure 4 and also page 16, lines 15-22, further see page 64, lines 24-29. Regarding claim 10, see Liang teaching repeat units of polymeric backbone having a defined linear sequence ( page 15, line 30 to page 16). Regarding claim 11, see further Liang at page 16, lines 23-32 (co-monomers derived from amino acids). Regarding claim 13, see Liang at page 16, lines 23-25, a linear polymer scaffold. Regarding claim 14, Liang teach donor fluorophores in energy-transferring proximity (see for example, page 64, lines 24-30, light harvesting multichromophore system to each other and/or to an acceptor fluorophore provides for efficient energy transfer). Regarding claim 15, see Liang at page 67, lines 16-19, tandem dye with Stokes shift of 100 nm or more. Regarding claims 16 and 17, pendant chromophore, such as the fluorophore BODIPY® (see page 1, line 29 to page 2). Regarding claims 18 and 19, see Liang at page 101, regarding additional embodiments (clause 2, substituted water soluble group), see further page 53, water soluble polymer groups including PEG. Regarding claims 20 and 21, Liang teach acceptor fluorophore is a small molecule (see page 65, lines 17-19), see cyanine (page 65, lines 20-21), rhodamine, xanthene, coumarin, polymethine, pyrene, dipyrromethene borondifluoride, napthalimide, thiazine, and an acridine . Double Patenting 08-33 AIA The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg , 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman , 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi , 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum , 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel , 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington , 418 F.2d 528, 163 USPQ 644 (CCPA 1969). A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b). The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13. The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA/25, or PTO/AIA/26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer. 18/120,554 (recently allowed, not yet issued) Claims 1-4, 10-11, 15 and 18-21 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 3-20 of copending Application No. 18/120,554 (recently allowed, not yet issued) in view of Gonzalez-Sapienza et al. Although the claims at issue are not identical, they are not patentably distinct from each other because copending ‘554 similarly recites a polymeric fluorescent tandem dye see comprising one or more polymeric tandem fluorescent dyes (see claim 1 tandem dye), wherein the one or more polymeric tandem fluorescent dyes comprises: (i) a polymeric backbone comprising non-conjugated repeat units (see non-conjugated polymeric backbone, claim 1); (ii) a plurality of pendant donor fluorophores (one or more violet excitable donor fluorophores attached to the backbone, i.e., pendant fluorophore) each independently linked to a non- conjugated repeat unit of the polymeric backbone; and (iii) one or more pendant acceptor fluorophores (see claim 1 of ‘554) linked to a non-conjugated repeat unit of the polymeric backbone, wherein pendant donor and acceptor fluorophores are in energy transfer relationship. ‘554 further teach the polymeric tandem dye as an antibody conjugate (see claims 16-17). ‘554 differs from the claimed invention in that it merely teaches an antibody, not a single domain antibody. Gonzalez-Sapienza teach advantages to single domain antibodies (VHH and VNAR) as cited in detail previously above (see complete citation above, under 35 U.S.C. 103). It would have been prima facie obvious to have modified the antibodies of ‘554 for the single domain antibodies (VHH or VNAR) of Gonzalez-Sapienza for the reasons as discussed in detail previously above (see as above, as the same rationale as applied above also applies presently). Regarding claim 2-4, see the combination of the cited art teaches single domain antibodies VHH and VNAR (i.e., single domain antibody comprising heavy chain). Regarding claims 10-11 and 13, see copending claims 19 and 20, the backbone comprising a peptide having an amino acid sequence (a defined linear sequence). Regarding claim 15, see as evidenced by ‘554 specification (at page 36), the violet excitable donor fluorophores/acceptors pair exhibit Stokes shift as claimed (100 nm or more). Regarding claims 18 and 19, see copending claims 5-7. Regarding claims 20-21, see copending claim 10. Claims 5-7, 14 and 16-17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over 1 and 3-20 of copending Application No. 18/120,554 over Gonzalez-Sapienza et al., as applied to claim 1 above, and further in view of Liang et al. (WO2019/191482A1). ‘554 in view of Gonzalez- Sapienza teach a conjugate substantially as claimed, however fails to specify a specific or particular targeted analyte, i.e., fails to teach conjugate targeting a target analyte that is an intracellular antigen, cell surface antigen, or a primary antibody (claims 5-7). Liang et al. teach conjugates substantially as recited at copending ‘554 (polymeric tandem dyes antibody conjugates). Liang et al. teach binding agents targeting any target analytes including cell surface proteins (page 80, lines 15-34 to page 81, lines 20), intracellular target analytes (lines 19-20) or a targeted antibody (page 81, line 5). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have modified the conjugate as taught by ‘554 in view of Gonzalez- Sapienza in order to provide the singe domain antibody as any of one an intracellular antigen, surface antigen, or antibody target, as taught by Liang an obvious matter of providing a known conjugate for art recognized, known targeted analytes/antigens of interest recognized in the prior art. In particular, the base conjugate, namely antibody fluorescent tandem dye conjugates were known in the and available, as supported by the prior art (referring to ‘554 and further Liang). It was known to apply such conjugates as intended for binding/detection biological/protein targeted analytes, such as intracellular antigens, surface antigens, or other antibodies (Liang). Considering the copending is not particularly limited regarding targeted antigen, it would have been obvious to modify the conjugate such that it can be applied intended for detection of known, art recognized antigens, detectable by this type of conjugate. Further, one having ordinary skill would have a reasonable expectation of success given that the copending is not limited to a particular antigen, and because the art recognized these types of conjugate applicable for nearly any antigen, including intracellular, surface or other antibodies (Liang). Regarding claim 8, Liang further teach a conjugate comprising two or more polymeric tandem units (see page 16, lines 23-31, page 29, line 11-13). It would have been prima facie obvious to one having ordinary skill in the art to have modified the conjugate-tandem dye in order to include two or more polymeric tandem fluorescent dyes as an obvious matter of applying a known technique applied to a known product, in particular see Liang et al. it was known in the prior art, comprising such structures, to provide the more than one polymeric tandem units for polymeric tandem dye structures (such as those of ‘554 and Liang). One having ordinary skill would have a reasonable expectation of success given that Liang teach providing two or more, and considering the addition of more fluorescent components would be expected to improve detection signal (more signal producing components). Regarding claim 9, referring to the ‘554 cited claims above, the copending appears to result in a formula as presently described structurally (polymeric backbone comprising a peptide sequence, donor and acceptor each linked to the backbone, i.e., each themselves linked reading on “independently” as claimed). “554 is merely silent as to mol% for x and y as recited at claim 9. Liang teach polymeric tandem fluorescent dye described by the formula at claim 9, SM1 and SM2 comprise comonomers that are each independently a non-conjugated co-monomer (page 14, lines 19-33), regarding x and y (75 mol% at x and 25 mol% at y), see for example Figure 4 and also page 16, lines 15-22, further see page 64, lines 24-29. It would have been prima facie obvious to one having ordinary skill in the art to have modified the conjugate-tandem dye in order to include the segments as claimed (referring to donor and acceptor attached at the backbone) as 75 mol% or more at x and 25 mol% or more at y as an obvious matter of a known technique applied to a known product, in particular see Liang et al. it was known in the prior art, comprising such structures, to provide the units in ratios in terms of mol% as claimed as an obvious matter of applying a known technique to a known product, particularly considering ‘554 is not limited in terms of the %mol of each segment (broadly encompasses any). One having ordinary skill would have a reasonable expectation of success given that Liang teach conjugate consistent with those as in ‘554. Regarding claim 14, ‘554 and the cited art teach a conjugate substantially as claimed, however is silent as to whether or not the donor fluorophores are configured in energy transferring proximity to one another. Liang teach donor fluorophores in energy-transferring proximity (see for example, page 64, lines 24-30, light harvesting multichromophore system to each other and/or to an acceptor fluorophore provides for efficient energy transfer). It would have been further obvious that the donor fluorophores be configured in energy transferring proximity in order to achieve operation of the conjugate as intended (see as is supported by Liang). One having ordinary skill would have a reasonable expectation of success because ‘554 is silent as to the positional arrangement of the donors to one another (merely specifies relationship between donor and acceptor). Considering the intention is for the donors to transfer to acceptor, logically it would be expected that proximity to one another (in addition to the acceptor) would be close enough for energy transfer. Regarding claims 16-17, ’554 recites violet excitable donor fluorophore (for example a coumarin, see claim 4 of copending ‘554), and as such fails to teach fluorophore that is BODIPY®. However, see also Liang teach for example, a fluorophore such as a coumarin can be used as an acceptor molecule, that BODIPY® can be used as a donor for such an acceptor (see e.g., Figure 7A-B description at page 3, also page 34, page 76, lines 3-8). It would have been further prima facie obvious to one having ordinary skill in the art have used coumarin as an acceptor, namely, to use BODIPY and a coumarin as a donor acceptor pair for energy transfer, as a simple substitution of one art recognized energy transfer pair for another, particularly considering specific energy transfer donor-acceptor pairs such as BODIPY and a coumarin were known and available to those skilled in the art (and also known implemented for polymeric tandem dye structures). In particular, both the combination of ‘554, or BODIPY and a coumarin as in Liang were both known in the art and recognized as achieving the same result (applicable for polymeric tandem dye structures), namely transfer of energy and a shift in signal in these polymeric tandem structures. One having ordinary skill would have found it obvious to use one in place of the other and the results of the modification would have been predictable and achieved energy transfer causing a change in detectable signal. Based on the cited art, the indicated pairs appear to be alternatives for one another. One having ordinary skill in the art would have a reasonable expectation of success because of the similarity between the invention of ‘554 and the tandem dye of Liang, and because such FRET pairs were recognized and available to those of ordinary skill in the art. As such, one of ordinary skill using either would expect the same result. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented. US 10, 844, 228 (formerly 16/368,513) 08-36 AIA Claim s 1-4, 10-11, 13, 15-18 and 20-21 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 10,844,228B2 in view of Gonzalez-Sapienza et al . ‘228 at claim 17 teach an antibody-polymeric tandem dye conjugate species, see the conjugate comprising an antibody (18-20), a polymeric backbone comprising non-conjugated repeat units (claim 17), plurality of pendant donor fluorophores independently linked to repeat units (claim 17), an acceptor fluorophore linked to repeat units of the backbone (claim 17), see described in energy transfer proximity (claim 17), see also the polymeric tandem dye of their invention further described at claims 1-16 of ‘228. ‘228 differs from the claimed invention in that it merely teaches an antibody, not a single domain antibody. Gonzalez-Sapienza teach advantages to single domain antibodies (VHH and VNAR) as cited in detail previously above (see complete citation above, under 35 U.S.C. 103). It would have been prima facie obvious to have modified the antibodies of ‘228 for the single domain antibodies (VHH or VNAR) of Gonzalez-Sapienza for the reasons as discussed in detail previously above (see as above, as the same rationale as applied above also applies presently). Regarding claim 2-4, see the combination of the cited art teaches single domain antibodies VHH and VNAR (i.e., single domain antibody comprising heavy chain). Regarding claims 10-11 and 13, see ‘228 recite the backbone comprising a peptide having an amino acid sequence (claims 17, also claim 14). Regarding claim 15, see as evidenced by ‘228 specification (at col. 63, lines 23-27), donor fluorophores/acceptors pairs (e.g., BODIPY, claim 2, e.g., a coumarin, claim 14) exhibit Stokes shift as claimed (100 nm or more). Regarding claims 16-17, ‘228 recites donor that is BODIPY® (claims 2 and 3). Regarding claim 18, see ‘228 at claim 3 (substituted water solubilizing group). Regarding claims 20 and 21, see ‘228 at claim 16 (same acceptor species as claimed) . 08-36 AIA Claim s 5-9, 14 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-20 of U.S. Patent No. 10,844,228B2 in view of Gonzalez-Sapienza et al., as applied to claim 1 above, and further in view of Liang et al. (WO2019/191482A1) . ‘228 in view of Gonzalez- Sapienza teach a conjugate substantially as claimed, however fails to specify a specific or particular targeted analyte, i.e., fails to teach conjugate targeting a target analyte that is an intracellular antigen, cell surface antigen, or a primary antibody (claims 5-7). Liang et al. teach conjugates substantially as recited at copending ‘554 (polymeric tandem dyes antibody conjugates). Liang et al. teach binding agents targeting any target analytes including cell surface proteins (page 80, lines 15-34 to page 81, lines 20), intracellular target analytes (lines 19-20) or a targeted antibody (page 81, line 5). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention, to have modified the conjugate as taught by ‘228 in view of Gonzalez- Sapienza in order to provide the singe domain antibody as any of one an intracellular antigen, surface antigen, or antibody target, as taught by Liang an obvious matter of providing a known conjugate for art recognized, known targeted analytes/antigens of interest recognized in the prior art. In particular, the base conjugate, namely antibody fluorescent tandem dye conjugates were known in the and available, as supported by the prior art (referring to ‘228 and further Liang). It was known to apply such conjugates as intended for binding/detection biological/protein targeted analytes, such as intracellular antigens, surface antigens, or other antibodies (Liang). Considering the copending is not particularly limited regarding targeted antigen, it would have been obvious to modify the conjugate such that it can be applied intended for detection of known, art recognized antigens, detectable by this type of conjugate. Further, one having ordinary skill would have a reasonable expectation of success given that the copending is not limited to a particular antigen, and because the art recognized these types of conjugate applicable for nearly any antigen, including intracellular, surface or other antibodies (Liang). Regarding claim 8, ‘228 teach a polymeric tandem dye conjugate, however, fails to teach comprising two more polymeric tandem units. Liang Further teach a conjugate comprising two or more polymeric tandem units (see page 16, lines 23-31, page 29, line 11-13). It would have been prima facie obvious to one having ordinary skill in the art to have modified the conjugate-tandem dye in order to include two or more polymeric tandem fluorescent dyes as an obvious matter of a known technique applied to a known product, in particular see Liang et al., it was known in the prior art, comprising such structures, to provide the more than one polymeric tandem units. One having ordinary skill would have a reasonable expectation of success given that Liang teach providing two or more, and considering the addition of more fluorescent components would be expected to improve detection signal (more signal producing components). Regarding claim 9, referring to the ‘228 cited claims above, the copending appears to result in a formula as presently described structurally (polymeric backbone comprising a peptide sequence, donor and acceptor each linked to the backbone, i.e., each themselves linked reading on “independently” as claimed). However, the claims of ‘228 are silent as to mol% for x and y as recited at claim 9. Liang teach polymeric tandem fluorescent dye described by the formula at claim 9, SM1 and SM2 comprise comonomers that are each independently a non-conjugated co-monomer (page 14, lines 19-33), regarding x and y (75 mol% at x and 25 mol% at y), see for example Figure 4 and also page 16, lines 15-22, further see page 64, lines 24-29. It would have been prima facie obvious to one having ordinary skill in the art to have modified the conjugate-tandem dye in order to include the segments as claimed (referring to donor and acceptor attached at the backbone) as 75 mol% or more at x and 25 mol% or more at y as an obvious matter of a known technique applied to a known product, in particular see Liang et al. it was known in the prior art, comprising such structures, to provide the units in ratios in terms of mol% as claimed as an obvious matter of applying a known technique to a known product, particularly considering ‘228 is not limited in terms of the %mol of each segment (broadly encompasses any). One having ordinary skill would have a reasonable expectation of success given that Liang teach conjugate consistent with those as in ‘228. Regarding claim 14, ‘228 and the cited art teach a conjugate substantially as claimed, however is silent as to whether or not the donor fluorophores are configured in energy transferring proximity to one another (see as cited teaches donor and acceptor in proximity, however silent as to whether donors are in proximity). Liang teach donor fluorophores in energy-transferring proximity (see for example, page 64, lines 24-30, light harvesting multichromophore system to each other and/or to an acceptor fluorophore provides for efficient energy transfer). It would have been further obvious that the donor fluorophores be configured in energy transferring proximity in order to achieve operation of the conjugate as intended (see as is supported by Liang). One having ordinary skill would have a reasonable expectation of success because ‘228 is silent as to the positional arrangement of the donors to one another (merely specifies relationship between donor and acceptor). Considering the intention is for the donors to transfer to acceptor, logically it would be expected that proximity to one another (in addition to the acceptor) would be close enough for energy transfer. Regarding claim 19, ‘228 recite a conjugate substantially as claimed (substituted with a water soluble group), however, fails to recite the water soluble group comprises polyethylene glycol. Liang et al. further teach example of water soluble groups including PEG (see at page 53, particularly line 30, page 53 teaching convenient water soluble groups to provide increased water-solubility). It would have been prima facie obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the conjugate of ‘228 and the cited art to have provided PEG as the water soluble group as an obvious matter to try, namely selecting from a finite list of art recognized suitable species known to increase solubility. In particular, Liang teach a specific finite list of suitable species, one having ordinary skill could have pursued the list of known species, thereby arriving at PEG as in Liang, in the interest of increasing solubility with a reasonable expectation of success (namely by choosing from those listed known to be suitable for this purpose). Further one would have a reasonable expectation of success because the claims of ‘228 fail to limit the water soluble group to any particular species. Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELLEN J MARCSISIN whose telephone number is (571)272-6001. The examiner can normally be reached M-F 8:00am-4:30pm. 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, Bao-Thuy Nguyen can be reached at 571-272-0824. 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. /ELLEN J MARCSISIN/Primary Examiner, Art Unit 1677 /YVONNE L EYLER/Director, Technology Center 1600 Application/Control Number: 18/126,819 Page 2 Art Unit: 1677 Application/Control Number: 18/126,819 Page 3 Art Unit: 1677 Application/Control Number: 18/126,819 Page 4 Art Unit: 1677 Application/Control Number: 18/126,819 Page 5 Art Unit: 1677 Application/Control Number: 18/126,819 Page 6 Art Unit: 1677 Application/Control Number: 18/126,819 Page 7 Art Unit: 1677 Application/Control Number: 18/126,819 Page 8 Art Unit: 1677 Application/Control Number: 18/126,819 Page 9 Art Unit: 1677 Application/Control Number: 18/126,819 Page 10 Art Unit: 1677 Application/Control Number: 18/126,819 Page 11 Art Unit: 1677 Application/Control Number: 18/126,819 Page 12 Art Unit: 1677 Application/Control Number: 18/126,819 Page 13 Art Unit: 1677 Application/Control Number: 18/126,819 Page 14 Art Unit: 1677 Application/Control Number: 18/126,819 Page 15 Art Unit: 1677 Application/Control Number: 18/126,819 Page 16 Art Unit: 1677 Application/Control Number: 18/126,819 Page 17 Art Unit: 1677 Application/Control Number: 18/126,819 Page 18 Art Unit: 1677 Application/Control Number: 18/126,819 Page 19 Art Unit: 1677 Application/Control Number: 18/126,819 Page 20 Art Unit: 1677
Prosecution Insights