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 .
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
This application is a continuation-in-part of U.S. Application No. 17/516,829 filed on 11/02/2021 which claims priority to the U.S. Provisional Application No. 63/139,921 filed on 01/21/2021.
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.
Claims 1 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1 and 11 recite “incubating the section of the biological sample with a primary antibody to the antigen from the biological sample to bind the primary antibody to the antigen, the primary antibody having an Fe portion, and the primary antibody being one of a mouse antibody and a rabbit antibody” and further recite “incubating the section of the biological sample with a secondary antibody by simultaneously applying the primary antibody and the secondary antibody to the section of the biological sample”. It is not clear from the recited limitation and the order of limitations in claims 1 and 11 if the addition of primary and secondary antibodies is sequential or simultaneous.
To move the prosecution of the case, the Examiner will interpret the addition of primary and secondary antibodies as simultaneous.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 4, 6 and 9 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Zou et al. (US 2011/0244494 A1).
Regarding claim 1, Zou teaches a rapid immunohistochemical method (Page 8, [0154]).
Zou teaches how to deposit a section of the biological sample onto slides after fixation and pre-treatment (Page 8, [0154]).
Zou teaches pre-treating a sample with a Non-specific Competitor Solution to promote specific binding, minimize non-specific binding and solubilize the protein (Page 4, [0059]). Zou teaches that the Non-specific Competitor Solution may contain buffers, detergents, solvents, salts and other substances known to those skilled in the art (Page 4, [0059]). Zou teaches that the buffer might be a Tris (Page 4, [0060]). Zou also teaches using ethylenediaminetetraacetic acid (EDTA) as part of the Non-specific Competitor Solution (Page 7, [0143]).
Zou teaches how to incubate a section of the biological sample with a primary antibody to an antigen (Page 8, [0154], “Mix 4 to 30 ug of a primary antibody specifically against the testing antigen with 2 ml ( sufficient for 10 slides) of the invention described "One-step Reaction Solution"; directly overlay the sample containing slides”). Zou notes that the One-step Reaction Solution combines all of the steps of blocking, primary and secondary antibody binding into a one-step reaction [0054].
Zou teaches that the secondary antibody is directed to the Fc portion of the primary antibody (Page 5, [0070] and [0072])
Zou teaches that the primary antibody can be a mouse and a rabbit antibody (Page 6, [0099]).
Regarding claims 1 and 9, Zou teaches that the primary antibody and the secondary antibody are premixed together before being simultaneously applied to the biological sample (Page 2, [0035]; Page 4, [0054]; page 9, [0179], “1 ), Combination of 1st antibody binding and 2nd antibody binding: To 10 ml of the binding buffer added and mixed with both 10 ug of primary antibody and 10 ug of Specific indicator, and then incubation this solution with the pre-blocked NC membrane (membrane”).
Zou teaches that the secondary antibody binds to the Fc portion of the primary antibody (Page 1, [0009 and 0011], “a Specific Indicator which is a pre-labeled (pre-conjugated) protein or a pre-labeled (pre-conjugated) antibody capable of specifically recognizing a primary antibody … wherein the protein or antibody of the Specific Indicator specifically recognizes a Fc portion of a immunoglobulin or a Fc-fusion protein.”).
Regarding claim 1 and 4, Zou teaches that that the secondary antibody has a detectable label that comprises an enzyme molecule such as horseradish peroxidase (HRP) (Page 5, [0072]).
Zou teaches that the secondary antibody is one of anti-mouse Fc specific when the primary antibody is the mouse antibody and anti-rabbit Fc specific antibody when the primary antibody is the rabbit antibody (Page 5, [0070]).
Zou teaches how to remove non-specific binding and unbound antibodies by a washing step (Page 6, [0118]; page 7, [0120]; page 7, [0121]).
Zou teaches how to mount the biological sample to the slide (Page 9, 5), “mounting the sections with glycerol gelatin and sealing coverslips with clear nail polish”).
Zou teaches how to detect the binding of the secondary antibodies to the antigen section of the biological sample (Page 3, [0051]; page 7, [0130]).
Regarding claim 6, Zou teaches that the detectable label comprises a fluorescent tag (Page 2, [0013], page 4, [0067], “fluorescent markers”).
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, 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 (PHOSITA) to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) as applied to claim 1 above, and further in view of Dalmau et al. (WO 2008/021408 A2).
Regarding claims 2-3, Zou teaches all of the limitations of the claims but fails to teach the following limitations.
Regarding claim 2, Zou does not teach immunohistochemical labeling of cryosections after using a cryostat.
Regarding claim 3, Zou does not teach that the section of the biological sample is produced by embedding the sample in paraffin and then sectioning the biological sample.
Regarding claim 2, Dalmau teaches immunohistochemical labeling of cryosections after using a cryostat (Page 40, [00113]).
Regarding claim 3, Dalmau teaches that the section of the biological sample is produced by embedding the sample in paraffin and then sectioning the biological sample (Page 23, [0092]).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the Dalmau’s method for handling cryosections and paraffinized samples with the rapid immunohistochemical method of Zou to detect and visualize antigens in a sample because Dalmau provided a reliable method that can diagnose the presence of autoimmune encephalitis and possible underlying tumors by using cryosections that allow a skilled artisan to mount sample sections directly on the slides (Abstract; [00113]). Zou further offered a rapid immunodetection method that is rapid, easy to use, adaptable, sensitive, cost-efficient, simple and suitable for most primary antibodies and applications such as immunohistochemistry (Page 1, [0007]). A PHOSITA would have a reasonable expectation of success in combining the methods of Dalmau and Zou because the methods are in immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to combine the immunohistochemical detection method of Dalmau with the premix solution of Fc-specific secondary antibody and primary antibodies of Zou because the Fc-specific secondary antibody will not interfere with the binding of the primary antibody and the simultaneous incubation of primary and secondary antibodies will save a lot of time for inpatients and surgeries.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) as applied to claim 1 above, and further in view of Guo et al. (CN 105566499 A).
Regarding claim 5, Zou teaches all of the limitations of the claim but fails to teach that the detectable label is a polymer having two or more enzymes bound to it.
Regarding claim 5, Guo teaches how to detect a tumor-specific antigen in a pathological specimen using a polymer enzyme-antibody or a multimeric enzyme-secondary antibody method (Invention content, the multimeric enzyme-secondary antibody method).
Guo further describes the technical benefits of using a multimeric enzyme on secondary antibodies (Invention content “The invention has the beneficial technical effects: 1) This invention increases…”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine what Guo taught over to the method of Zou to further improve the immune detection of antigens in biological samples as it has been done using a polymerized antibody with a multimeric enzyme. A skilled artisan would have been motivated to make and use the claimed inventions because Guo mentioned the benefits of using multimeric enzyme-secondary antibodies for detection of tumor specific protein or antigens in a pathological sample and stated that multimeric enzyme antibodies increase the sensitivity of detection and reduce the number of steps for finishing a staining method (Background technology, third paragraph). A PHOSITA would have a reasonable expectation of success in combining the methods of Guo and Zou because the methods are in the field of immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to use a multimeric enzyme label with the Fc-specific secondary antibody of Zou in an immunohistochemical detection method because the multimeric enzyme will increase the sensitivity of detection.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) as applied to claim 1 above, and further in view of Guo et al. (CN 105566499 A) and Ohiro et al. (JP 11295313 A).
Regarding claim 8, Zou teaches all of the limitations of the claims but fails to teach that the secondary antibody is an antibody polymer.
Regarding claim 8, Guo teaches how to detect a tumor-specific antigen in a pathological specimen using a polymer enzyme-antibody or a multimeric enzyme-secondary antibody method (Invention content, the multimeric enzyme-secondary antibody method).
Regarding claim 8, Ohiro teaches how to use a polymerized antibody in an immunoassay and its applications (description [0028], The antibodies or antibody).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine what Guo and Ohiro taught over to the method of Zou to further improve the immune detection of antigens in biological samples as it has been done using a polymerized antibody with a multimeric enzyme. A skilled artisan would have been motivated to make and use the claimed inventions because Guo mentioned the benefits of using multimeric enzyme-secondary antibodies for detection of tumor specific protein or antigens in a pathological sample and stated that multimeric enzyme antibodies increase the sensitivity of detection and reduce the number of steps for finishing a staining method (Background technology, third paragraph). Ohiro noted that a polymerized antibody increases the sensitivity of detection (Description, [0008]) and suggested that polymerized antibodies can be used regardless of animal species, subclasses or the like as noted in the description ([0028]). A PHOSITA would have a reasonable expectation of success in combining the methods of Guo, Ohiro and Zou because the methods are in the field of immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to use a multimeric enzyme label with the Fc-specific secondary antibody of Zou in an immunohistochemical detection method because the multimeric enzyme will increase the sensitivity of detection.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) as applied to claim 1 above, and further in view of McCurdy et al. (J Histochem Cytochem. 1966 May;14(5):427-8).
Regarding claim 7, Zou teaches all of the limitations of the claim but fails to teach that the step of mounting the section of the biological samples comprises applying a mixture of an alcohol and alcohol and water-soluble polymer to the section of the biological sample.
Regarding claims 7, McCurdy teaches on how to apply a mixture of alcohol and an alcohol and a water-soluble polymer such as a plastic mounting medium (Abstract; page 427, left column, first paragraph, lines 9-17).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the mounting method of McCurdy with the method of Zou to further improve the immune detection of antigens in biological samples because McCurdy offered a simple and fast method to mount the slides using non-aqueous mounting agent (Abstract). A PHOSITA would have a reasonable expectation of success in combining the methods of McCurdy and Zou because the methods are in immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to use the mounting method of McCurdy with the method of Zou because it preserved the stains very well for weeks or months (Page 428, left paragraph, “The polyvinyl alcohol resin preserved these stains very well for weeks or months”).
Claims 10, 12, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) as applied to claims 1 and 9 above, and further in view of Kim et al. (Journal of Pathology and Translational Medicine, 2016; 50: 411-418).
Regarding claims 10 and 15, Zou teaches that the primary antibody and the secondary antibody are premixed together before being simultaneously applied to the biological sample (Page 2, [0035]; Page 4, [0054]; page 9, [0179], “1 ), Combination of 1st antibody binding and 2nd antibody binding: To 10 ml of the binding buffer added and mixed with both 10 ug of primary antibody and 10 ug of Specific indicator, and then incubation this solution with the pre-blocked NC membrane (membrane”). Zou teaches that the starting mixing ratio of primary antibody to secondary antibody is 1:1 weight by weight ([0179], “10 ug of primary antibody and 10 ug of Specific indicator”).
Regarding claim 12, Zou teaches that that the secondary antibody has a detectable label that comprises an enzyme molecule such as horseradish peroxidase (HRP) (Page 5, [0072]).
Regarding claim 14, Zou teaches that the detectable label comprises a fluorescent tag (Page 2, [0013], page 4, [0067], “fluorescent markers”).
Regarding claim 17, Zou teaches pre-treating a sample with a Non-specific Competitor Solution to promote specific binding, minimize non-specific binding and solubilize the protein (Page 4, [0059]). Zou teaches that the Non-specific Competitor Solution may contain buffers, detergents, solvents, salts and other substances known to those skilled in the art (Page 4, [0059]). Zou teaches that the buffer might be a Tris (Page 4, [0060]). Zou also teaches using ethylenediaminetetraacetic acid (EDTA) as part of the Non-specific Competitor Solution (Page 7, [0143]).
Regarding claim 10, Zou does not teach that the ratio of primary antibody to secondary antibody is 1:2.5 to 1:3.5 weight by weight.
Regarding claim 10, The premix ratio of primary to secondary antibody is known to start at 1:1 as noted above by Zou and is optimized to get to the proper ratio based on the antibodies used as noted by Kim et al. (Page 414, “Interpretation of IHC stain pattern in control tissues should be done carefully… optimization is necessary to tune antibody dilution, incubation times, and blocking for controlled laboratory conditions. Appropriate validation and optimization of IHC staining method can provide equivalent results between laboratories.”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine optimization approach of Kim with the method of Zou because Kim noted that optimization is necessary to tune antibody dilution, incubation times, and blocking for controlled laboratory conditions (Page 414, second paragraph). A PHOSITA would have a reasonable expectation of success in combining the methods of Kim and Zou because the methods are in immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to optimize the premix solution of Fc-specific secondary antibody and primary antibodies of Zou in an immunohistochemical detection method because Kim noted the necessity of optimization of immunohistochemical methods to provide equivalent results between laboratories (Page 414, left column, second paragraph, “Afterward, optimization is necessary … Appropriate validation and optimization of IHC staining method…”).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) in view of Dalmau et al. (WO 2008/021408 A2), McCurdy et al. (J Histochem Cytochem. 1966 May;14(5):427-8) and Kim et al. (Journal of Pathology and Translational Medicine, 2016; 50: 411-418).
Regarding claim 11, Zou teaches a rapid immunohistochemical method (Page 8, [0154]).
Zou teaches a rapid immunodetection method that requires only 0.5-1 hour as compared to the regular immuno-assay and can be adapted to wide array of application such as immunohistochemistry (Page 1, [0007]) and thus it can be used for surgeries that require a response such as for cancer removal surgeries.
Zou teaches how to deposit a section of the biological sample onto slides after fixation and pre-treatment (Page 8, [0154]).
Zou teaches how to incubate a section of the biological sample with a primary antibody to an antigen (Page 8, [0154], “Mix 4 to 30 ug of a primary antibody specifically against the testing antigen with 2 ml ( sufficient for 10 slides) of the invention described "One-step Reaction Solution"; directly overlay the sample containing slides”).
Zou teaches that the secondary antibody is directed to the Fc portion of the primary antibody (Page 5, [0070] and [0072]).
Zou teaches that the primary antibody can be a mouse and a rabbit antibody (Page 6, [0099]).
Zou teaches that the secondary antibody binds to the Fc portion of the primary antibody (Page 1, [0009 and 0011], “a Specific Indicator which is a pre-labeled (pre-conjugated) protein or a pre-labeled (pre-conjugated) antibody capable of specifically recognizing a primary antibody … wherein the protein or antibody of the Specific Indicator specifically recognizes a Fc portion of a immunoglobulin or a Fc-fusion protein.”).
Zou teaches that the primary antibody and the secondary antibody are premixed together before being simultaneously applied to the biological sample (Page 2, [0035]; Page 4, [0054]; page 9, [0179], “1 ), Combination of 1st antibody binding and 2nd antibody binding: To 10 ml of the binding buffer added and mixed with both 10 ug of primary antibody and 10 ug of Specific indicator, and then incubation this solution with the pre-blocked NC membrane (membrane”).
Zou teaches that that the secondary antibody has a detectable label that comprises an enzyme molecule such as horseradish peroxidase (HRP) (Page 5, [0072]).
Zou teaches that the secondary antibody is one of anti-mouse Fc specific when the primary antibody is the mouse antibody and anti-rabbit Fc specific antibody when the primary antibody is the rabbit antibody (Page 5, [0070]).
Zou teaches how to remove non-specific binding and unbound antibodies by a washing step (Page 6, [0118]; page 7, [0120]; page 7, [0121]).
Zou teaches how to mount the biological sample to the slide (Page 9, 5), “mounting the sections with glycerol gelatin and sealing coverslips with clear nail polish”).
Zou teaches how to detect the binding of the secondary antibodies to the antigen section of the biological sample (Page 3, [0051]; page 7, [0130]).
Regarding claim 11, Zou does not teach that the biological sample is produced by freezing the sample and then sectioning it.
Zou does not teach that that the step of mounting the section of the biological sample to the slide comprises applying a mixture of an alcohol and an alcohol and water-soluble polymer to the section of the biological sample.
Regarding claim 11, Zou does not teach that the ratio of primary antibody to secondary antibody is 1:2.5 to 1:3.5 weight by weight.
Regarding claim 11, Dalmau teaches immunohistochemical labeling of cryosections after using a cryostat (Page 40, [00113]).
Regarding claim 11, McCurdy teaches on how to apply a mixture of alcohol and an alcohol and a water-soluble polymer such as a plastic mounting medium (Abstract; page 427, left column, first paragraph, lines 9-17).
Regarding claim 11, The premix ratio of primary to secondary antibody is known to start at 1:1 as noted above by Zou and is optimized to get to the proper ratio based on the antibodies used as noted by Kim et al. (Page 414, “Interpretation of IHC stain pattern in control tissues should be done carefully… optimization is necessary to tune antibody dilution, incubation times, and blocking for controlled laboratory conditions. Appropriate validation and optimization of IHC staining method can provide equivalent results between laboratories.”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the mounting method of McCurdy with the optimization method of Kim and the antibody premix of Zou with Dalmau’s method for detecting and visualizing multiple antigens in a sample to diagnose the cause of an autoimmune encephalitis because it would have resulted in a rapid immunodetection method that is rapid, easy to use, adaptable, sensitive, cost-efficient, simple and suitable for most primary antibodies and applications such as immunohistochemistry as noted by Zou (Page 1, [0007]). A PHOSITA would have a reasonable expectation of success in combining the methods of McCurdy, Dalmau, Kim and Zou and because the methods are in immunohistochemical staining and antigen detection.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) and Kim et al. (Journal of Pathology and Translational Medicine, 2016; 50: 411-418) as applied to claim 10 above, and further in view of Guo et al. (CN 105566499 A).
Regarding claim 13, Zou and Kim teach all of the limitations of the claims but Zou fails to teach that the detectable label is a polymer having two or more enzymes bound to it.
Regarding claim 13, Guo teaches how to detect a tumor-specific antigen in a pathological specimen using a polymer enzyme-antibody or a multimeric enzyme-secondary antibody method (Invention content, the multimeric enzyme-secondary antibody method).
Guo further describes the technical benefits of using a multimeric enzyme on secondary antibodies (Invention content “The invention has the beneficial technical effects: 1) This invention increases…”).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine what Guo taught over to the method of Zou to further improve the immune detection of antigens in biological samples as it has been done using a polymerized antibody with a multimeric enzyme. A skilled artisan would have been motivated to make and use the claimed inventions because Guo mentioned the benefits of using multimeric enzyme-secondary antibodies for detection of tumor specific protein or antigens in a pathological sample and stated that multimeric enzyme antibodies increase the sensitivity of detection and reduce the number of steps for finishing a staining method (Background technology, third paragraph). A PHOSITA would have a reasonable expectation of success in combining the methods of Guo and Zou because the methods are in the field of immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to use a multimeric enzyme label with the Fc-specific secondary antibody of Zou in an immunohistochemical detection method because the multimeric enzyme will increase the sensitivity of detection.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Zou et al. (US 2011/0244494 A1) and Kim et al. (Journal of Pathology and Translational Medicine, 2016; 50: 411-418) as applied to claim 10 above, and further in view of Guo et al. (CN 105566499 A) and Ohiro et al. (JP 11295313 A).
Regarding claim 16, Zou and Kim teach all of the limitations of the claims but Zou fails to teach the following limitations.
Regarding claim 16, Zou does not teach that the secondary antibody is an antibody polymer.
Regarding claim 16, Guo teaches how to detect a tumor-specific antigen in a pathological specimen using a polymer enzyme-antibody or a multimeric enzyme-secondary antibody method (Invention content, the multimeric enzyme-secondary antibody method).
Guo further describes the technical benefits of using a multimeric enzyme on secondary antibodies (Invention content “The invention has the beneficial technical effects: 1) This invention increases…”).
Regarding claim 16, Ohiro teaches how to use a polymerized antibody in an immunoassay and its applications (description [0028], The antibodies or antibody).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine what Guo and Ohiro taught over to the methods of Kim and Zou to further improve the immune detection of antigens in biological samples as it has been done using a polymerized antibody with a multimeric enzyme because Guo mentioned the benefits of using multimeric enzyme-secondary antibodies for detection of tumor specific protein or antigens in a pathological sample and stated that multimeric enzyme antibodies will increase the sensitivity of detection and reduce the number of steps for finishing a staining method (Background technology, third paragraph). Ohiro further noted that a polymerized antibody will increase the sensitivity of detection (Description, [0008]) and suggested that polymerized antibodies can be used regardless of animal species, subclasses or the like as noted in the description ([0028]). A PHOSITA would have a reasonable expectation of success in combining the methods of Guo, Ohiro, Kim and Zou because the methods are in the field of immunohistochemical staining and antigen detection.
It would have been obvious for a PHOSITA to use the Fc-specific secondary antibody with the primary antibodies as shown by Zou in an immunohistochemical detection method with a multimeric enzyme label, because the multimeric enzyme will increase the sensitivity of detection.
Conclusion
No claims are allowed.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678