Prosecution Insights
Last updated: August 06, 2026
Application No. 18/272,097

COPOLYMER, ANTIBODY-COPOLYMER CONJUGATE PREPARATION KIT, ANTIBODY-COPOLYMER CONJUGATE, METHOD FOR CONCENTRATING ANTIGEN, AND METHOD FOR DETECTING ANTIGEN

Non-Final OA §102§103
Filed
Jul 13, 2023
Priority
Apr 12, 2021 — JP 2021-066984 +1 more
Examiner
KARST, DAVID THOMAS
Art Unit
1767
Tech Center
1700 — Chemical & Materials Engineering
Assignee
National Institute for Materials Science
OA Round
1 (Non-Final)
64%
Grant Probability
Moderate
1-2
OA Rounds
0m
Est. Remaining
74%
With Interview

Examiner Intelligence

Grants 64% of resolved cases
64%
Career Allowance Rate
644 granted / 999 resolved
-0.5% vs TC avg
Moderate +10% lift
Without
With
+9.9%
Interview Lift
resolved cases with interview
Typical timeline
2y 11m
Avg Prosecution
58 currently pending
Career history
1048
Total Applications
across all art units

Statute-Specific Performance

§101
1.3%
-38.7% vs TC avg
§103
49.1%
+9.1% vs TC avg
§102
13.4%
-26.6% vs TC avg
§112
27.5%
-12.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 999 resolved cases

Office Action

§102 §103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Election/Restrictions Applicant’s election without traverse of Group I, claims 1-7 and 16-20, in the reply filed on 03/18/2026 is acknowledged. Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/18/2026. Priority Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. Claim Objections Claims 1-7 and 16-20 are objected to because of the following informalities: Claim 1 recites “a hydrogen atom a linear or branched alkyl” in line 4, which should have a comma and “or” separating “a hydrogen atom” and “a linear or branched alkyl” since they are different species in the list. The Office suggests that Applicant change this to “a hydrogen atom, or a linear or branched alkyl”. Appropriate correction is required. Claim Rejections - 35 USC § 102 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. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action: A person shall be entitled to a patent unless – (a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention. Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Huffman et al. (JP 2012-2016634 A, cited in IDS, machine translation in English or untranslated patent used for citation as indicated, made of record on 07/13/2023). Regarding claim 1, Huffman teaches a copolymer composed of isopropylacrylamide derivatives having two or more alkyne groups represented by the following chemical formula (translation [0035]) PNG media_image1.png 92 186 media_image1.png Greyscale (untranslated [0036]), which reads on a copolymer comprising a repeating unit 1 represented by the claimed formula (1) and a repeating unit 2 represented by the claimed formula (2), in the formula (1), X1 represents a hydrogen atom, and in the formula (2), X2 represents a hydrogen atom, L2 represents a divalent group, multiple R1s are same as each other and are each selected from a hydrogen atom, Z is selected from C(R1)2, a’ is an integer of 0 to 1, a’’ is an integer of 0 to 1, and a sum of a’ and a’’ is 1 as claimed Claim Rejections - 35 USC § 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 (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. 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. Claims 1, 2, 5, 6, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (US 2017/0304420 A1). Regarding claim 1, Fisher teaches a statistical copolymer having the formula PNG media_image2.png 892 472 media_image2.png Greyscale , wherein PNG media_image3.png 26 54 media_image3.png Greyscale PNG media_image4.png 32 86 media_image4.png Greyscale , PNG media_image5.png 28 118 media_image5.png Greyscale , and PNG media_image6.png 24 58 media_image6.png Greyscale PNG media_image7.png 208 350 media_image7.png Greyscale [0119], which reads on a copolymer comprising a repeating unit 1 represented by the claimed formula (1) and a repeating unit 2, in the formula (1), X1 represents a hydrogen atom as claimed. Fisher teaches that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], wherein the SPs include diamines (1,3-propylenediamine, etc.) [0117], which suggests modifying Fisher’s PNG media_image8.png 32 84 media_image8.png Greyscale group in Fisher’s X group in Fisher’s formula for Fisher’s statistical copolymer to be a different species, such as -CH(CH3)CH2-, such that the -CH- group is bonded to the -CONH- group bonded to the backbone of Fisher’s statistical copolymer, and the -CH2- group is bonded to the -NHCO- bonded to the -(CH2)2- group in the side group of Fisher’s statistical copolymer. Fisher therefore suggests the copolymer further comprising a repeating unit 2 represented by the claimed formula (2), in the formula (2), X2 represents a linear alkyl group having 1 carbon atom, L2 represents a divalent group, multiple R1s are same as or different from each other and are each selected from a hydrogen atom, an alkenyl group having 1 to 4 carbon atoms, where two or more R1s bind to each other to form a ring, Z is selected from NR1, a’ is an integer of 2 to 3, a’’ is an integer of 2 to 3, and a sum of a’ and a’’ is 5. Fisher does not teach that the copolymer further comprises a repeating unit 2 represented by the claimed formula (2). Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to modify Fisher’s PNG media_image8.png 32 84 media_image8.png Greyscale group in Fisher’s X group in Fisher’s formula for Fisher’s statistical copolymer to be -CH(CH3)CH2-, such that the -CH- group is bonded to the -CONH- group bonded to the backbone of Fisher’s statistical copolymer, and the -CH2- group is bonded to the -NHCO- bonded to the -(CH2)2- group in the side group of Fisher’s statistical copolymer. The proposed modification would read on the copolymer further comprising a repeating unit 2 represented by the claimed formula (2), in the formula (2), X2 represents a linear alkyl group having 1 carbon atom, L2 represents a divalent group, multiple R1s are same as or different from each other and are each selected from a hydrogen atom, an alkenyl group having 1 to 4 carbon atoms, where two or more R1s bind to each other to form a ring, Z is selected from NR1, a’ is an integer of 2 to 3, a’’ is an integer of 2 to 3, and a sum of a’ and a’’ is 5 as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been obvious to try with a reasonable expectation of success because Fisher teaches that the statistical copolymer has the formula PNG media_image2.png 892 472 media_image2.png Greyscale , wherein PNG media_image3.png 26 54 media_image3.png Greyscale PNG media_image4.png 32 86 media_image4.png Greyscale [0119], that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], and that the SPs include diamines (1,3-propylenediamine, etc.) [0117], which means that Fisher’s PNG media_image8.png 32 84 media_image8.png Greyscale group in Fisher’s X group in Fisher’s formula for Fisher’s statistical copolymer and a -CH(CH3)CH2-, such that the -CH- group is bonded to the -CONH- group bonded to the backbone of Fisher’s statistical copolymer, and the -CH2- group is bonded to the -NHCO- bonded to the -(CH2)2- group in the side group of Fisher’s statistical copolymer, are of sufficiently close structural similarity that the resulting statistical copolymer would possess similar properties because they are isomers, and which means that Fisher permits the X group in the formula for the statistical copolymer to be any alkylene group. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties (MPEP 2144.09(II)). Examples of rationales that may support a conclusion of obviousness include "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143(I)(E)). Regarding claim 2, Fisher teaches that the statistical copolymer has the formula PNG media_image2.png 892 472 media_image2.png Greyscale [0119], that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], and that the SPs include diamines (1,3-propylenediamine, etc.) [0117], which means that Fisher’s m and n in the backbone of Fisher’s formula for Fisher’s statistical copolymer can be any integer that is 1 or greater, which reads on wherein a content of the unit 2 is greater than 0 mol% and less than 100 mol% when a total of the repeating unit is defined as 100 mol%. Fisher does not teach that a content of the unit 2 is 1.0 to 30.0 mol% when a total of the repeating units is defined as 100 mol%. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to optimize Fisher’s n in the backbone of Fisher’s statistical copolymer to be from 1.0 to 30.0 % of the total value of Fisher’s m and Fisher’s n in the backbone of Fisher’s statistical copolymer. The proposed modification would read on wherein a content of the unit 2 is 1.0 to 30.0 mol% when a total of the repeating units is defined as 100 mol% as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for optimizing thermoresponsive properties of Fisher’s statistical copolymer because Fisher teaches that the statistical copolymer has the formula PNG media_image2.png 892 472 media_image2.png Greyscale [0119], that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], and that the SPs include diamines (1,3-propylenediamine, etc.) [0117], which means that Fisher’s n in the backbone of Fisher’s statistical copolymer in % of the total value of Fisher’s m and Fisher’s n in the backbone of Fisher’s statistical copolymer would have affected the thermoresponsive properties of Fisher’s statistical copolymer. Regarding claims 5 and 20, Fisher teaches that the statistical copolymer has the formula PNG media_image2.png 892 472 media_image2.png Greyscale [0119], that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], and that the SPs include diamines (1,3-propylenediamine, etc.) [0117], which means that Fisher’s m and n in the backbone of Fisher’s formula for Fisher’s statistical copolymer can be any integer that is 1 or greater, which reads on wherein a content of the unit 2 is greater than 0 mol% and less than 100 mol% when the total of repeating units is defined as 100 mol%. Fisher does not teach that a content of the unit 2 is from 5 mol% to 30 mol% or less when the total of repeating units is defined as 100 mol%. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to optimize Fisher’s n in the backbone of Fisher’s statistical copolymer to be from 5 to 30 % of the total value of Fisher’s m and Fisher’s n in the backbone of Fisher’s statistical copolymer. The proposed modification would read on wherein a content of the unit 2 is from 5 mol% to 30 mol% or less when the total of repeating units is defined as 100 mol% as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for optimizing thermoresponsive properties of Fisher’s statistical copolymer because Fisher teaches that the statistical copolymer has the formula PNG media_image2.png 892 472 media_image2.png Greyscale [0119], that the polymer comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116], and that the SPs include diamines (1,3-propylenediamine, etc.) [0117], which means that Fisher’s n in the backbone of Fisher’s statistical copolymer in % of the total value of Fisher’s m and Fisher’s n in the backbone of Fisher’s statistical copolymer would have affected the thermoresponsive properties of Fisher’s statistical copolymer. Regarding claim 6, Fisher teaches that the average molecular weights of the polymer may be between about 5,000 to 1,000,000 g/mol [0029], which reads on the copolymer according to claim 1, having a number average molecular weight of about 5000 to 1000000. Fisher does not teach with sufficient specificity that the copolymer has a number average molecular weight of 5000 to 50000. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to select the average molecular weights of Fisher’s statistical copolymer to be from 5,000 to 50,000. The proposed modification would read on the copolymer according to claim 1, having a number average molecular weight of 5000 to 50000 as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for providing an average molecular weight that is suitable for Fisher’s statistical copolymer or because it would have been obvious to try with a reasonable expectation of success because Fisher teaches that the average molecular weights of the polymer may be between about 5,000 to 1,000,000 g/mol [0029], which encompasses from 5,000 to 50,000. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05(I)). Examples of rationales that may support a conclusion of obviousness include "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143(I)(E)). Claims 1-6 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Simon Jacques (Simon Jacques, “Polymer/DNA Bio-conjugates via Grafting-from and Grafting-to”, thesis at Flinders University, Adelaide South Australia, November 2017, cited in IDS, made of record on 10/09/2025). Regarding claims 1, 3, and 4, Simon Jacques teaches a copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale and that is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135), which reads on a copolymer comprising a repeating unit 1 represented by the claimed formula (1) and a repeating unit (2), in the formula (1), X1 represents a hydrogen atom as claimed. Simon Jacques a copolymer that has the formula PNG media_image12.png 380 238 media_image12.png Greyscale and that is used to synthesize another copolymer (p. 27). Simon Jacques’s teachings suggest using a PNG media_image13.png 54 50 media_image13.png Greyscale group to substitute for the PNG media_image14.png 20 18 media_image14.png Greyscale group in Simon Jacques’s PNG media_image15.png 146 112 media_image15.png Greyscale and PNG media_image16.png 306 124 media_image16.png Greyscale groups in Simon Jacques’s formula PNG media_image9.png 344 508 media_image9.png Greyscale . Simon Jacques therefore suggests the copolymer further comprising a repeating unit 2 represented by the claimed formula (2), in the formula (2), X2 represents a hydrogen atom, L2 represents a divalent group, multiple R1s are same as or different from each other and are each selected from a hydrogen atom, and an alkenyl group having 4 carbon atoms, where two or more R1s bind to each other to form a ring, Z is selected from NR1, a’ is an integer of 2 to 3, a’’ is an integer of 2 to 3, and a sum of a’ and a’’ is 5 as claimed, wherein the unit 2 is a unit 3 represented by the claimed unit 4 represented by the claimed formula (4), in the formula (4), X2 represents a hydrogen atom, in the formula (4), L2 represents a divalent group as claimed, and the copolymer according to claim 1, further comprising a repeating unit represented by the claimed formula (5), in the formula (5), X5 represents a hydrogen atom as claimed. Simon Jacques does not teach that the copolymer further comprises a repeating unit (2) represented by the claimed formula (2), that the unit 2 is a unit 3 represented by the claimed formula (3) or a unit 4 represented by the claimed formula 4, and that the copolymer further comprises a repeating unit represented by the claimed formula (5). Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use a PNG media_image13.png 54 50 media_image13.png Greyscale group to substitute for the PNG media_image14.png 20 18 media_image14.png Greyscale group in Simon Jacques’s PNG media_image15.png 146 112 media_image15.png Greyscale and PNG media_image16.png 306 124 media_image16.png Greyscale groups in Simon Jacques’s formula PNG media_image9.png 344 508 media_image9.png Greyscale . The proposed modification would read on the copolymer further comprising a repeating unit 2 represented by the claimed formula (2), in the formula (2), X2 represents a hydrogen atom, L2 represents a divalent group, multiple R1s are same as or different from each other and are each selected from a hydrogen atom, and an alkenyl group having 4 carbon atoms, where two or more R1s bind to each other to form a ring, Z is selected from NR1, a’ is an integer of 2 to 3, a’’ is an integer of 2 to 3, and a sum of a’ and a’’ is 5 as claimed, wherein the unit 2 is a unit 4 represented by the claimed formula (4), in the formula (4), X2 represents a hydrogen atom, in the formula (4), L2 represents a divalent group as claimed, and the copolymer according to claim 1, further comprising a repeating unit represented by the claimed formula (5), in the formula (5), X5 represents a hydrogen atom as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been obvious to try with a reasonable expectation of success because Simon Jacques teaches that the copolymer has the formula PNG media_image9.png 344 508 media_image9.png Greyscale and is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135), that the copolymer is temperature responsive and can be conjugated to dsDNA (p. 157), that another copolymer has the formula PNG media_image12.png 380 238 media_image12.png Greyscale , is used to synthesize another copolymer, and is a pNIPAAm copolymer (p. 27), that copolymers of NIPAAm and DMA are temperature responsive copolymers (p. 28), that DNA can be conjugated to pNIPAAM (p. 29), and that a monoclonal antibody can be conjugated to pNIPAA, (p. 31), which means that a PNG media_image13.png 54 50 media_image13.png Greyscale group and the PNG media_image14.png 20 18 media_image14.png Greyscale group are of sufficiently close structural similarity that the resulting copolymer would possess similar properties because they are isomers and are both present in a copolymer that is temperature responsive and that can be conjugated to DNA or an antibody. Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties (MPEP 2144.09(II)). Examples of rationales that may support a conclusion of obviousness include "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success (MPEP 2143(I)(E)). Regarding claim 2, Simon Jacques teaches that in the copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale (p. 135), the proportion of the PNG media_image17.png 264 104 media_image17.png Greyscale is 4, 1, 3.5, 3, or 1.5 mol% (p. 137), which reads on wherein a content of the unit 2 is 1.0, 1.5, 3, 3.5, or 4.0 mol% when a total of the repeating units is defined as 100 mol% as claimed. Regarding claims 5 and 20, Simon Jacques teaches that in the copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale (p. 135), the proportion of the PNG media_image17.png 264 104 media_image17.png Greyscale is 4, 1, 3.5, 3, or 1.5 mol%, and the proportion of the PNG media_image18.png 128 96 media_image18.png Greyscale is 8, 4, 4, 7, or 11 mol% (p. 137), and that the copolymer is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135), which reads on wherein a content of the unit 2 is 1.0, 1.5, 3, 3.5, or 4.0 mol% when the total of repeating units is defined as 100 mol%, and which suggests when a content of the unit 2 is greater than 0 mol% when the total of repeating units is defined as 100 mol%. Simon Jacques does not teach that a content of the unit 2 is from 5 mol% to 30 mol% or less when the total of repeating units is defined as 100 mol%. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to modify the proportion of Simon Jacques’s PNG media_image17.png 264 104 media_image17.png Greyscale in Simon Jacques’s copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale to be from 5 to 12.5 mol%. The proposed modification would read on wherein a content of the unit 2 is from 5 mol% to 12.5 mol% or less when the total of repeating units is defined as 100 mol% as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for modifying the temperature responsive properties of Simon Jacques’s copolymer and for modifying an ability of an antibody to be conjugated to Simon Jacques’s copolymer because Simon Jacques teaches that in the copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale (p. 135), the proportion of the PNG media_image17.png 264 104 media_image17.png Greyscale is 4, 1, 3.5, 3, or 1.5 mol%, and the proportion of the PNG media_image18.png 128 96 media_image18.png Greyscale is 8, 4, 4, 7, or 11 mol% (p. 137), that the copolymer is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135), that the copolymer is temperature responsive and can be conjugated to dsDNA (p. 157), and that a monoclonal antibody can be conjugated to pNIPAA, (p. 31). Regarding claim 6, Simon Jacques that the copolymer PNG media_image10.png 182 398 media_image10.png Greyscale (p. 135) has a number average molecular weight Mn of 26000, 34000, or 39000 (p. 105), that the copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135), which reads on the copolymer according claim 1, having a number average molecular of within 5000 to 50000 as claimed. Regarding claim 16, as explained above for claims 1, 3, and 4, Simon Jacques renders it obvious that the unit 2 is a unit 4 represented by the claimed formula (4), in the formula (4), X2 represents a hydrogen atom, in the formula (4), L2 represents a divalent group as claimed. Regarding claims 17-19, as explained above for claims 1, 3, and 4, Simon Jacques renders it obvious that the copolymer according to claim 2, 3, or 16, further comprises a repeating unit represented by the claimed formula (5), in the formula (5), X5 represents a hydrogen atom as claimed. Claims 3 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Fisher et al. (US 2017/0304420 A1) as applied to claims 1 and 2, and further in view of Simon Jacques (Simon Jacques, “Polymer/DNA Bio-conjugates via Grafting-from and Grafting-to”, thesis at Flinders University, Adelaide South Australia, November 2017, cited in IDS made of record on 10/09/2025). Regarding claims 3 and 16, Fisher renders obvious the copolymer according to claims 1 and 2 as explained above. Fisher does not teach that the unit 2 is a unit 3 represented by the claimed formula (3) or a unit 4 represented by the claimed formula (4). However, Simon Jacques teaches a copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale and that is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135). Fisher and Simon Jacques are analogous art because both references are in the same field of endeavor of a copolymer comprising a repeating unit represented by the claimed formula (1) and a repeating unit 2. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use a PNG media_image19.png 156 100 media_image19.png Greyscale group to substitute for the PNG media_image20.png 224 58 media_image20.png Greyscale group in Fisher’s formula PNG media_image2.png 892 472 media_image2.png Greyscale for Fisher’s statistical copolymer. The proposed modification would read on wherein the unit 2 is a unit 4 represented by the claimed formula (4), in the formula (4), X2 represents a hydrogen atom, and in the formula (4), L2 represents a divalent group as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for modifying temperature responsive properties and thermoresponsive properties of Fisher’s statistical copolymer because Simon Jacques teaches that a copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale and that is synthesized by reacting PNG media_image10.png 182 398 media_image10.png Greyscale with PNG media_image11.png 186 118 media_image11.png Greyscale (p. 135) is temperature responsive and can be conjugated to dsDNA (p. 157), and Fisher teaches that the statistical copolymer having the formula PNG media_image2.png 892 472 media_image2.png Greyscale , wherein PNG media_image3.png 26 54 media_image3.png Greyscale PNG media_image4.png 32 86 media_image4.png Greyscale , PNG media_image5.png 28 118 media_image5.png Greyscale , and PNG media_image6.png 24 58 media_image6.png Greyscale PNG media_image7.png 208 350 media_image7.png Greyscale [0119], comprises thermoresponsive macromolecules-forming monomeric units (NIPAAm and NIPMAm) and methacrylamide-based monomeric units bearing the functional groups (FGs) attached to the methacryloyl moiety through various spacers (SPs) [0116]. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Simon Jacques (Simon Jacques, “Polymer/DNA Bio-conjugates via Grafting-from and Grafting-to”, thesis at Flinders University, Adelaide South Australia, November 2017, cited in IDS, made of record on 10/09/2025) as applied to claim 1, and further in view of Sedlak et al. (US 2020/0299780 A1). Regarding claim 7, Simon Jacques renders obvious the copolymer according to claim 1 as explained above. Simon Jacques teaches conjugating a monoclonal antibody to pNIPAAm (p. 31), that the polymer-antibody conjugate is used as an antigen bio-separation tool (p. 31), and antibody-pNIPAAm conjugates (p. 133). Simon Jacques teaches that the copolymer has the formula PNG media_image9.png 344 508 media_image9.png Greyscale (p. 135), which is a pNIPAAm. Simon Jacques therefore suggests an antibody-copolymer preparation kit comprising the copolymer according to claim 1. Simon Jacques does not teach an antibody-copolymer conjugate preparation kit comprising the copolymer according to claim 1. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to use Simon Jacques’s copolymer that has the formula PNG media_image9.png 344 508 media_image9.png Greyscale in a kit for conjugating an antibody to Simon Jacques’s copolymer. The proposed modification would read on an antibody-copolymer conjugate preparation kit comprising the copolymer according to claim 1 as claimed. One of ordinary skill in the art would have been motivated to do so because it would have been beneficial for providing a utility for Simon Jacques’s copolymer because Simon Jacques teaches conjugating a monoclonal antibody to pNIPAAm (p. 31), that the polymer-antibody conjugate is used as an antigen bio-separation tool (p. 31), antibody-pNIPAAm conjugates (p. 133), and that the copolymer has the formula PNG media_image9.png 344 508 media_image9.png Greyscale (p. 135), which is a pNIPAAm, which would therefore be useful for conjugating an antibody to Simon Jacques’s copolymer. Simon Jacques does not teach that the antibody-copolymer conjugate preparation kit further comprises a linker represented by the claimed formula (6). However, Sedlak teaches a linker comprising a spacer group at either end with a reactive functional group capable of covalent attachment to a target-binding moiety [0185], wherein exemplary reaction functional groups are azidoacetic acid NHS ester [0185]. Sedlak teaches a kit that finds use in practicing technologies described in the reference [0296], wherein the kit comprises a plurality of detection probes directed at different targets [0296]. Sedlak teaches that a target-binding moiety is or comprises an antibody agent directed at a specific target [0016]. Simon Jacques and Sedlak are analogous art because both references are in the same field of endeavor of a conjugate comprising an antibody. Before the effective filing date of the claimed invention, one of ordinary skill in the art would have found it obvious to combine Sedlak’s linker that is azidoacetic acid NHS ester with the kit for conjugating an antibody. The proposed modification would read on the antibody-copolymer conjugate preparation kit further comprising a linker represented by the claimed formula (6), in the formula (6) L6 represents a divalent hydrocarbon group as claimed. One of ordinary skill in the art would have been motivated to do so because Sedlak teaches that the linker that is azidoacetic acid NHS ester is beneficial for comprising a spacer group at either end with a reactive functional group capable of covalent attachment to a target-binding moiety [0185], that a kit finds use in practicing technologies described in the reference [0296], that the kit comprises a plurality of detection probes directed at different targets [0296], and that a target-binding moiety is or comprises an antibody agent directed at a specific target [0016], which would have been desirable in combination with the kit for conjugating an antibody because Simon Jacques teaches conjugating a monoclonal antibody to pNIPAAm (p. 31), that the polymer-antibody conjugate is used as an antigen bio-separation tool (p. 31), antibody-pNIPAAm conjugates (p. 133), and that the copolymer is a pNIPAAm (p. 135). Correspondence Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID KARST whose telephone number is (571)270-7732. The examiner can normally be reached Monday-Friday 8:00 AM-5:00 PM. 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, Mark Eashoo can be reached at 571-272-1197. 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. /DAVID T KARST/Primary Examiner, Art Unit 1767
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Prosecution Timeline

Jul 13, 2023
Application Filed
May 19, 2026
Non-Final Rejection mailed — §102, §103 (current)

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Prosecution Projections

1-2
Expected OA Rounds
64%
Grant Probability
74%
With Interview (+9.9%)
2y 11m (~0m remaining)
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