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 .
DETAILED ACTION
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Restriction/Election
Applicant’s election of Group I, claims 4-11, in response to restriction requirement is acknowledged. Applicant’s election of the followings in response to election of species requirement is also acknowledged:
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Since Applicant did not traverse the restriction/election requirements, the election has been treated as an election without traverse. Therefore, claims 1-3 are withdrawn from further consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03. Applicants preserve their right to file a divisional on the non-elected subject matter.
Status of the claims
Claims 4-11 are examined on merits in this office action to the extant it encompasses the elected species.
Claim Objections
Claim 4 is objected to because of the following informalities: dependent on claim 1, which claim is non-elected and is being withdrawn. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claim 8 is 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.
Claim 8 recites “Method according to claim 4, characterized in that steps a) to e) are performed in at least two subsequent sequences”. Claim 4, from which claim 8 depends, does not recite a step e). Thus it is unclear what step is intended for by the recitation step e)?
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, 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 4-11 are rejected under 35 U.S.C. 103 as obvious over Pankratz et al. (US 20180164296A1) in view of Zeng et al (J. Mater. Chem. B. 2020, published 10 Feb 2020).
In regards to claim 4, Pankratz discloses a method of detecting a target moiety in a sample of biological specimens by:
a) providing at least one conjugate with the general formula (I)
An-P-Bm-Cq-Xo (I)
with
A: antigen recognizing moiety;
P: enzymatically degradable spacer;
B: first binding moiety
C second binding moiety
X: detection moiety;
n, m, q, o integers between 1 and 100,
wherein B and C are non-covalently bound to each other and A and B are covalently bound to P
b) labelling the target moiety recognized by the antigen recognizing moiety A with at least one conjugate
c) detecting the labelled target moiety via detecting moiety X
d) cleaving Cq-Xo by disrupting the non-covalent bond between Bm and Cq from the labelled target moiety (claim 1).
Pankratz teaches that the binding moiety B and binding moiety C are binding partners able to bind non-covalently and reversibly to each other (para [0058]). Pankratz teaches that the binding moiety B may be a biotin or a biotin derivative and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0060]).
Pankratz however, does not teach that the first binding moiety and the second binding moiety are a thiamine unit and a corresponding binding partner of the thiamine unit (i.e. a moiety recognizing thiamine).
Zeng teaches monoclonal antibody for detection of vitamin B1 (also referred to as Thiamine) ( Introduction and Title). Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection (page 1939, 2nd para of 1st col.). Zeng teaches that the monoclonal antibody is very specific having less than 0.1% cross reactivity with vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, or vitamin B12 (page 1937, 1st para of 2nd col. and Table 1). Table 1 discloses that thiamine has the structure
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Therefore, from the description in mind of Pankratz and Zeng, it would be obvious to one of ordinary skilled in the art to envisage utilizing the binding partner of thiamine and anti-thiamine antibody disclosed by Zeng for the first and the second binding moiety with the expectation of expanding the corresponding binding partners for the detection process of Pankratz with a reasonable expectation of success. Pankratz teaches that the binding moiety B may be a biotin or a biotin derivative (i.e. a hapten) and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0060]) (i.e. an anti-hapten antibody) and from the reading of Pankratz, one of ordinary killed in the art can easily envisage considering other known haptens as binding partners if the corresponding binding partners, as for example, corresponding anti-hapten antibody is available. Since Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection and since Zeng discloses the monoclonal antibody is highly specific (less than 0.1% cross-reactivity to other closely related haptens), one of ordinary skilled in the art would be motivated to include thiamine and anti-thiamine antibody as first and second corresponding binding partners with a reasonable expectation of success.
In regards to claim 5, Pankratz teaches that the labelling of the target moiety with the conjugate is performed in step b) by labeling the target moiety with the conjugate An-P-Bm-Cq-Xo (see claim 4).
In regards to claim 6, Pankratz teaches that the labelling the target moiety in step b) with the conjugate is performed by first labelling the target moiety with a first conjugate An-P-Bm and second labelling the first labelled target moiety with a second conjugate Cq-Xo (see claim 5).
In regards to claim 7, Pankratz teaches washing step between the first and the second labeling (see claim 6).
In regards to claim 8, Pankratz teaches that the steps a) to e) are performed in at least two subsequent sequences, wherein in each sequence conjugates An-P-Bm-Cq-Xo (I) are used having different detection moieties X (see claim 8).
In regards to claim 9, Pankratz teaches that the method is characterized in that step a) comprises at least two conjugates An-P-Bm-Cq-Xo (I) having different detection moieties X are provided and in at least two steps c) the labelled target moieties are detected via the different detection moieties X (see claim 9).
In regards to claims 10 and 11, Pankratz teaches that the method is characterized in that in step a) at least two conjugates An-P-Bm-Cq-Xo (I) having different antigen recognizing moieties A, different detection moieties X and different first binding moieties B or second binding moieties C are provided, and wherein the fragments Cq-Xo are cleaved from the target moieties labelled by the different conjugates by disrupting the non-covalent bond between Bm and Cq in separate steps d). One of ordinary skilled in the art would easily understand that providing second conjugate would provide multiplexing for detection different targets in a sample with different binding partners and different separation processes. Pankratz throughout the references teaches various embodiments utilizing the conjugates including utilizing second conjugate for multiplexing (para [0155]). One of ordinary skilled in the art would easily understand that when thiamine and anti-thiamine antibody is used for first conjugate as shown obvious by the combination of the references, for the second conjugate, the first and the second binding partner can be biotin and anti-biotin antibody as Pankratz, as described above teaches biotin and anti-biotin for corresponding binding partner.
Claims 4-11 are rejected under 35 U.S.C. 103 as obvious over Brieden et al. (EP 3336546A1) in view of Zeng et al (J. Mater. Chem. B. 2020, published 10 Feb 2020).
In regards to claim 4, Brieden discloses a method of detecting a target moiety in a sample of biological specimens by:
a) providing at least one conjugate with the general formula (I)
An-P-Bm-Cq-Xo (I)
with
A: antigen recognizing moiety;
P: enzymatically degradable spacer;
B: first binding moiety
C second binding moiety
X: detection moiety;
n, m, q, o integers between 1 and 100,
wherein B and C are non-covalently bound to each other and A and B are covalently bound to P
b) labelling the target moiety recognized by the antigen recognizing moiety A with at least one conjugate
c) detecting the labelled target moiety via detecting moiety X
d) cleaving Cq-Xo by disrupting the non-covalent bond between Bm and Cq from the labelled target moiety (claim 1).
Brieden teaches that the binding moiety B and binding moiety C are binding partners able to bind non-covalently and reversibly to each other (para [0058]). Brieden teaches that the binding moiety B may be a biotin or a biotin derivative and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0046]).
Brieden however, does not teach that the first binding moiety and the second binding moiety are a thiamine unit and a corresponding binding partner of the thiamine unit (i.e. a moiety recognizing thiamine).
Zeng teaches monoclonal antibody for detection of vitamin B1 (also referred to as Thiamine) ( Introduction and Title). Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection (page 1939, 2nd para of 1st col.). Zeng teaches that the monoclonal antibody is very specific having less than 0.1% cross reactivity with vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, or vitamin B12 (page 1937, 1st para of 2nd col. and Table 1). Table 1 discloses that thiamine has the structure
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Therefore, from the description in mind of Brieden z and Zeng, it would be obvious to one of ordinary skilled in the art to envisage utilizing the binding partner of thiamine and anti-thiamine antibody disclosed by Zeng for the first and the second binding moiety with the expectation of expanding the corresponding binding partners for the detection process of Brieden with a reasonable expectation of success. Brieden teaches that the binding moiety B may be a biotin or a biotin derivative (i.e. a hapten) and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0060]) (i.e. an anti-hapten antibody) and from the reading of Brieden, one of ordinary killed in the art can easily envisage considering other known haptens as binding partners if the corresponding binding partners, as for example, corresponding anti-hapten antibody is available. Since Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection and since Zeng discloses the monoclonal antibody is highly specific (less than 0.1% cross-reactivity to other closely related haptens), one of ordinary skilled in the art would be motivated to include thiamine and anti-thiamine antibody as first and second corresponding binding partners with a reasonable expectation of success.
In regards to claim 5, Brieden teaches that the labelling of the target moiety with the conjugate is performed in step b) by labeling the target moiety with the conjugate An-P-Bm-Cq-Xo (see claim 4).
In regards to claim 6, Brieden teaches that the labelling the target moiety in step b) with the conjugate is performed by first labelling the target moiety with a first conjugate An-P-Bm and second labelling the first labelled target moiety with a second conjugate Cq-Xo (see claim 5).
In regards to claim 7, Brieden teaches washing step between the first and the second labeling (see claim 6).
In regards to claim 8, Brieden teaches that the steps a) to e) are performed in at least two subsequent sequences, wherein in each sequence conjugates An-P-Bm-Cq-Xo (I) are used having different detection moieties X (see claim 8).
In regards to claim 9, Brieden teaches that the method is characterized in that step a) comprises at least two conjugates An-P-Bm-Cq-Xo (I) having different detection moieties X are provided and in at least two steps c) the labelled target moieties are detected via the different detection moieties X (see claim 9).
In regards to claims 10 and 11, Brieden teaches that the method is characterized in that in step a) at least two conjugates An-P-Bm-Cq-Xo (I) having different antigen recognizing moieties A, different detection moieties X and different first binding moieties B or second binding moieties C are provided, and wherein the fragments Cq-Xo are cleaved from the target moieties labelled by the different conjugates by disrupting the non-covalent bond between Bm and Cq in separate steps d). One of ordinary skilled in the art would easily understand that providing second conjugate would provide multiplexing for detection different targets in a sample with different binding partners and different separation processes. Brieden throughout the reference teaches various embodiments utilizing the conjugates including utilizing second conjugate for multiplexing (para [0128-0149]). One of ordinary skilled in the art would easily understand that when thiamine and anti-thiamine antibody is used for first conjugate as shown obvious by the combination of the references, for the second conjugate, the first and the second binding partner can be biotin and anti-biotin antibody as Brieden, as described above teaches biotin and anti-biotin for corresponding binding partner.
Claims 4-11 are rejected under 35 U.S.C. 103 as obvious over Pankratz et al. (US 10890580) in view of Zeng et al (J. Mater. Chem. B. 2020, published 10 Feb 2020).
The applied reference has a common Inventors with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
In regards to claim 4, Pankratz discloses a method of detecting a target moiety in a sample of biological specimens by:
a) providing at least one conjugate with the general formula (I)
An-P-Bm-Cq-Xo (I)
with
A: antigen recognizing moiety;
P: enzymatically degradable spacer;
B: first binding moiety
C second binding moiety
X: detection moiety;
n, m, q, o integers between 1 and 100,
wherein B and C are non-covalently bound to each other and A and B are covalently bound to P
b) labelling the target moiety recognized by the antigen recognizing moiety A with at least one conjugate
c) detecting the labelled target moiety via detecting moiety X
d) cleaving Cq-Xo by disrupting the non-covalent bond between Bm and Cq from the labelled target moiety (claim 1).
Pankratz teaches that the binding moiety B and binding moiety C are binding partners able to bind non-covalently and reversibly to each other (para [0058]). Pankratz teaches that the binding moiety B may be a biotin or a biotin derivative and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0060]).
Pankratz however, does not teach that the first binding moiety and the second binding moiety are a thiamine unit and a corresponding binding partner of the thiamine unit (i.e. a moiety recognizing thiamine).
Zeng teaches monoclonal antibody for detection of vitamin B1 (also referred to as Thiamine) ( Introduction and Title). Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection (page 1939, 2nd para of 1st col.). Zeng teaches that the monoclonal antibody is very specific having less than 0.1% cross reactivity with vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, or vitamin B12 (page 1937, 1st para of 2nd col. and Table 1). Table 1 discloses that thiamine has the structure
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244
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Therefore, from the description in mind of Pankratz and Zeng, it would be obvious to one of ordinary skilled in the art to envisage utilizing the binding partner of thiamine and anti-thiamine antibody disclosed by Zeng for the first and the second binding moiety with the expectation of expanding the corresponding binding partners for the detection process of Pankratz with a reasonable expectation of success. Pankratz teaches that the binding moiety B may be a biotin or a biotin derivative (i.e. a hapten) and the binding moiety C may be a corresponding binding partner streptavidin, avidin, analogue thereof, anti-biotin antibody (para [0060]) (i.e. an anti-hapten antibody) and from the reading of Pankratz, one of ordinary killed in the art can easily envisage considering other known haptens as binding partners if the corresponding binding partners, as for example, corresponding anti-hapten antibody is available. Since Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection and since Zeng discloses the monoclonal antibody is highly specific (less than 0.1% cross-reactivity to other closely related haptens), one of ordinary skilled in the art would be motivated to include thiamine and anti-thiamine antibody as first and second corresponding binding partners with a reasonable expectation of success.
In regards to claim 5, Pankratz teaches that the labelling of the target moiety with the conjugate is performed in step b) by labeling the target moiety with the conjugate An-P-Bm-Cq-Xo (col. 12, lines 60-65).
In regards to claim 6, Pankratz teaches that the labelling the target moiety in step b) with the conjugate is performed by first labelling the target moiety with a first conjugate An-P-Bm and second labelling the first labelled target moiety with a second conjugate Cq-Xo (col. 12, lines 47-55).
In regards to claim 7, Pankratz teaches washing step between the first and the second labeling (col. 12, lines 47-55).
In regards to claim 8, Pankratz teaches that the steps a) to e) are performed in at least two subsequent sequences, wherein in each sequence conjugates An-P-Bm-Cq-Xo (I) are used having different detection moieties X (col. 12, lines 8-18).
In regards to claim 9, Pankratz teaches that the method is characterized in that step a) comprises at least two conjugates An-P-Bm-Cq-Xo (I) having different detection moieties X are provided and in at least two steps c) the labelled target moieties are detected via the different detection moieties X (col. 12, lines 8-40).
In regards to claims 10 and 11, Pankratz teaches that the method is characterized in that in step a) at least two conjugates An-P-Bm-Cq-Xo (I) having different antigen recognizing moieties A, different detection moieties X and different first binding moieties B or second binding moieties C are provided, and wherein the fragments Cq-Xo are cleaved from the target moieties labelled by the different conjugates by disrupting the non-covalent bond between Bm and Cq in separate steps d). One of ordinary skilled in the art would easily understand that providing second conjugate would provide multiplexing for detection different targets in a sample with different binding partners and different separation processes. Pankratz throughout the references teaches various embodiments utilizing the conjugates including utilizing second conjugate for multiplexing (Cols. 12-20). One of ordinary skilled in the art would easily understand that when thiamine and anti-thiamine antibody is used for first conjugate as shown obvious by the combination of the references, for the second conjugate, the first and the second binding partner can be biotin and anti-biotin antibody as Pankratz, as described above teaches biotin and anti-biotin for corresponding binding partner.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory 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.
Claims 4-8 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-11 of U.S. Patent No. 10,890,580 in view of Zeng et al (J. Mater. Chem. B. 2020, published 10 Feb 2020).
Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 of US patent ‘580 discloses a method of detecting a target moiety in a sample of biological specimens by:
a) providing at least one conjugate with the general formula (I)
An-P-Bm-Cq-Xo (I)
with
A: antigen recognizing moiety;
P: enzymatically degradable spacer;
B: first binding moiety
C second binding moiety
X: detection moiety;
n, m, q, o integers between 1 and 100,
wherein B and C are non-covalently bound to each other and A and B are covalently bound to P
b) labelling the target moiety recognized by the antigen recognizing moiety A with at least one conjugate
c) detecting the labelled target moiety via detecting moiety X
d) cleaving Cq-Xo by disrupting the non-covalent bond between Bm and Cq from the labelled target moiety (claim 1).
US patent ‘580 does not specifically disclose the first and the second binding moiety but teaches that the binding moiety B and C are bound non-covalently to each other.
US patent ‘580 however, does not teach that the first binding moiety and the second binding moiety are a thiamine unit and a corresponding binding partner of the thiamine unit (i.e. a moiety recognizing thiamine).
Zeng teaches monoclonal antibody for detection of vitamin B1 (also referred to as Thiamine) ( Introduction and Title). Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection (page 1939, 2nd para of 1st col.). Zeng teaches that the monoclonal antibody is very specific having less than 0.1% cross reactivity with vitamin B2, vitamin B3, vitamin B5, vitamin B6, vitamin B7, vitamin B9, or vitamin B12 (page 1937, 1st para of 2nd col. and Table 1). Table 1 discloses that thiamine has the structure
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244
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.
Therefore, from the description in mind of US patent ‘580 and Zeng, it would be obvious to one of ordinary skilled in the art to envisage utilizing the binding partner of thiamine and anti-thiamine antibody disclosed by Zeng for the first and the second binding moiety with the expectation of expanding the corresponding binding partners for the detection process of US patent ‘580 with a reasonable expectation of success. Since US patent ‘580 teaches binding partners that associates non-covalently, one of ordinary killed in the art can easily envisage considering various known haptens as binding partners if the corresponding binding partners, as for example, corresponding anti-hapten antibody is available. Since Zeng teaches that the specificity of the antibody should be considered the most important factor affecting analyte detection and since Zeng discloses the monoclonal antibody is highly specific (less than 0.1% cross-reactivity to other closely related haptens), one of ordinary skilled in the art would be motivated to include thiamine and anti-thiamine antibody as first and second corresponding binding partners with a reasonable expectation of success.
In regards to claim 5, US patent ‘580 teaches that the labelling of the target moiety with the conjugate is performed in step b) by labeling the target moiety with the conjugate of formula (I), which formula is An-P-Bm-Cq-Xo (see claim 1).
In regards to claims 6 and 7, claims of US patent ‘580 does not teach that the labelling the target moiety in step b) with the conjugate is performed by first labelling the target moiety with a first conjugate An-P-Bm and second labelling the first labelled target moiety with a second conjugate Cq-Xo and there is a washing step in between. However, since US patent ‘580 teaches A is an antigen recognition moiety and B and C are binding partner non-covalently bound, one of ordinary skilled in the art can easily envisage various embodiments for providing the complete conjugate of formula (I) with target moiety. One of ordinary skilled in the art would understand that since A binds to target, An-P-Bm is essential for binding to target by contacting the target moiety in the sample and one of ordinary skilled in the art can easily envisage that other part of the conjugate Cq-Xo can be joined before or after binding to the target moiety as they are binding partners for non-covalent binding. Moreover, one of ordinary skilled in the art would understand that when conjugating the Cq-Xo part separately after binding of the An-P-Bm to the target moiety, other non-bound components and samples needed to wash out before contacting with the Cq-Xo and which is withing the purview of one of ordinary skilled in the art.
In regards to claim 8, there in no step (e) recited in the claim and thus the step is considered not present.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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