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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-14 and 37-39 in the reply filed on 8/15/2025 is acknowledged.
Claims 15-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/15/2025.
Priority
Acknowledgment is made of the present application as a proper National Stage (371) entry of PCT Application No. PCT/US2021/018015, filed 02/12/2021, which claims benefit under 35 U.S.C. 119(e) to provisional application No. 63/014,088, filed 04/22/2020 and to provisional application No. 62/977,133, filed 02/14/2020.
Information Disclosure Statement
The information disclosure statements filed 9/15/2022, 1/30/2023, 4/19/2023, 5/2/2024, 12/6/2024 and 7/21/2025 are being considered by the examiner.
Specification
The disclosure is objected to because of the following informalities:
In Table 1, paragraph 37, the antibodies “H00002950- M03” and “H00002950- M01” appear to be assigned to the supplier “Abcam” in error. The supplier to said antibodies should read “Abnova” as per Figure 2.
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.
Claims 4-6 and 10-11 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.
Claim 4 recites “wherein at least a portion of the test strip comprises a nitrocellulose membrane with an average pore size of at least, at most, or about 5, 10, 15, 20, 25, or 30 µm”. The phrase “at least, at most, or about 5, 10, 15, 20, 25, or 30 µm” is indefinite. A person having ordinary skill in the art would not be able to recognize the metes and bounds of the claim. The language “at most” encompasses a pore size that is infinitesimally small, the language “at least” encompasses a pore size that is infinitely large, and the language “about” is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 5 recites “wherein the capture antibody and the detection antibody are configured to bind to different moieties of GST-Pi”. However, it is not clear what is being referred to by “different moieties of GST-Pi” because “different moieties of GST-Pi” is not recited in claims 1 or 5. Furthermore, the specification fails to define “different moieties of GST-Pi”. Therefore, a person having ordinary skill in the art would not be able to able to recognize the metes and bounds of the claim.
Claim 6 recites “[t]he lateral flow immunoassay device of claim 1, wherein the capture antibody and/or the detection antibody are each selected from any of the antibodies described herein”. However, it is not clear what is being referred to by “herein” and therefore what antibodies are being claimed because claims 1 and 6 do not describe any specific antibodies.
Claims 10 recites “…the capture antibody comprises A303-628A and the detection antibody comprises H00002950-M01”, claim 11 recites “…the capture antibody comprises MAB10823 and the detection antibody comprises H00002950-M01”. The language “comprises” renders the claim indefinite because it is not clear what additional elements of an antibody an antibody can encompass based on the specification. A person having ordinary skill in the art would be confused as to what is encompassed by the language “comprises” as used in claims 10-11. Furthermore, claim 11 recites “MAB10823”, however, it is not clear to what antibody “MAB10823” refers to because “MAB10823” appears to not be drawn to an antibody. A search of “MAB10823” in the website of the company Randox (supplier of MAB10823 according to Table 1 of the specification) does not show information of the antibody (Randox Search Results for "MAB10823" retrieved online https://www.randox.com/?s=MAB10823 on 10/23/2025).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 12 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 12 recites “[t]he lateral flow immunoassay device of claim 1, wherein the biological fluid comprises a sample of whole blood from a human subject”. However, the sample used does not appear to further limit the device of claim 1 because the sample does not provide any additional structural limitations to the device.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(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, 3-4, 6-7, 9, 12 and 37 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Doyle et al. (US 6080551 A) ("Doyle") (Cite No. 1 of IDS 5/2/2024).
Regarding claims 1 and 37, Doyle teaches a kit comprising for detecting and/or measuring the concentration of glutathione S-transferase Pi (GST-Pi) in a sample of a biological fluid (“a kit for carrying out a method for the detection of GST as hereinbefore defined” col. 5 lines 18-19, “Most preferably the GST is… πGST” col. 3 line 43), comprising a lateral flow immunoassay device (“Rapid assay” Title, see Figures 1-2 showing a lateral flow immunoassay device), for detecting and/or measuring the concentration of glutathione S-transferase Pi (GST-Pi) in a sample of a biological fluid (“based on the detection of one or more isoenzymes of glutathione S-transferase ( GST) in diverse biological fluids” Abstract, col. 3 line 43), said device comprising a test strip for detecting GST-Pi in the sample (“The technique is also illustrated with reference to FIG. 1. In FIG. 1 a nitrocellulose membrane strip is indicated generally at 10” col. 9 lines 3-5, “nitrocellulose membrane, pre-coated with anti-πGST IgG” col. 11 lines 9-10), wherein the test strip comprises: a) a sample pad, wherein the sample pad comprises an absorbent material and is configured to receive the sample (“in the case of a nitrocellulose membrane, the provision of a wick at the sample application end and another at the top of the membrane will facilitate chromatographic movement of gold-labelled IgG previously sprayed onto the membrane” col. 5 lines 5-9, “FIG. 1…Direction of flow of the sample on the nitrocellulose membrane 10 is indicated by the arrow… sample application end 13” col. 9 lines 3, 8-10 and 21). Note that although Doyle fails to use the language “sample pad”, the teaching of a sample application end on a nitrocellulose membrane which may include a wick for providing flow of the sample, inherently provides a sample pad comprising absorbent material configured to receive the sample. Doyle further teaches b) a conjugate pad configured to store a detection antibody specific for GST-Pi and to release at least a portion of the stored detection antibody in the presence of a liquid, wherein the detection antibody is conjugated to a colored label (“The biological fluid is contacted with particle-labelled anti-GST antibody so that the GST isoenzyme to be detected is bound to said particle-labelled anti-GST antibody prior to being contacted with solid phase immobilised antibody. Particles which can be used as labels include colloidal particles, latex particles and metallic sol particles. Metallic sol particles are suitably gold particles… The particle-labelled anti-GST antibody can also be disposed adjacent the sample application end” col. 4 lines 40-51, “in the case of a nitrocellulose membrane…liquid present in a biological sample resuspends the gold-labelled anti-GST IgG and any GST isoenzyme present is bound by the gold-labelled IgG” col. 5 lines 5 and 13-15, “produces a pink-red line” col. 13 lines 40-41). Note that although Doyle fails to use the language “conjugate pad” the teaching of a particle-labelled anti-GST antibody adjacent to the sample application end on the nitrocellulose membrane inherently provides a conjugate pad to store and release the labeled antibody. Also note that although Doyle fails to use the language “colored label” the teaching that the gold nanoparticle produces a color inherently provides a colored label. Doyle further teaches c) a colorimetric indicator site positioned downstream from the absorbent pad, wherein said colorimetric indicator site comprises a capture antibody specific for GST-Pi fixed to the test strip (“If sufficient GST isoenzyme is present, then the GST/gold-labelled anti-GST IgG complex is immobilized onto the membrane where bound anti-GST IgG is present. This results in a positive signal indicating that GST is present in the sample” col. 5 lines 17-21, col. 13 lines 40-41, see Figure 1B). Doyle further teaches one or more buffers (col. 5 lines 18-19, “Non-specific binding sites on the nitrocellulose membrane are optionally blocked depending on the format of the assay adopted as hereinafter described” col. 4 lines 3-5, “The strips were blocked by incubation for 30 minutes at room temperature in a solution of 2% (w/v) non-fat milk and 2% (w/v) polyvinylpyrrolidone in Tris buffered saline, pH 7.4” col. 12 lines 16-19).
Regarding claim 3, Doyle further teaches wherein at least a portion of the test strip comprises a nitrocellulose membrane (col. 9 lines 3-5, col. 11 lines 9-10).
Regarding claim 4, Doyle further teaches wherein at least a portion of the test strip comprises a nitrocellulose membrane with an average pore size of at least, at most, or about 5, 10, 15, 20, 25, or 30 µm (“Suitably, the nitrocellulose membrane has a pore size in the range 5-10 µm” col. 4 lines 1-2).
Regarding claim 6, although the claim is indefinite (see 112b rejection above), in the interest of compact prosecution, the antibodies “described herein” are interpreted as the antibodies specific for GST-Pi.
Doyle further teaches wherein the capture and/or the detection antibody are each selected from any of the antibodies described herein (col. 10 line 58).
Regarding claim 7, Doyle further teaches wherein the colored label comprises a gold or latex nanoparticle (“gold particles having an average diameter in the range 15-40 nm” col. 4 lines 45-47).
Regarding claim 9, Doyle further teaches wherein the capture antibody and/or the detection antibody are present at a concentration of 0.1, 0.2, 0.3, 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1.0, 1.1, 1.2, 1.3, 1.4 or 1.5, 1.6, 1.7, 1.8, 1.9 or 2.0 mg/mL (“Anti-πGST IgG (murine monoclonal; 0.6 mg/ml” col. 10 line 58).
Regarding claim 12, Doyle teaches the lateral flow immunoassay device of claim 1 as discussed above.
Doyle further provides wherein the biological fluid comprises a sample of whole blood from a human subject (“The biological fluid used in the method according to the invention is suitably bile, plasma, serum or urine, more especially plasma, serum or urine” col. 4 lines 22-24, “measurement of either plasma or urinary GST levels will facilitate the monitoring of either the hepatic or renal status of an individual” col. 1 lines 24-26).
Note that claim 12 does not appear to further limit the device of claim 1 (see 112d rejection above). Therefore, Doyle would inherently also provide for wherein the biological fluid comprises a sample of whole blood because Doyle teaches the claimed device and thus is capable of assaying whole blood.
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 to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle as applied to claim 1 above, and further in view of Nelson et al. (US 20180021026 A1) ("Nelson").
Regarding claim 2, Doyle teaches the lateral flow immunoassay device of claim 1 as discussed above.
Doyle fails to teach wherein the device further comprises a lancet with a capillary channel.
Nelson teaches a “self-contained sampling device for processing whole blood” (Title). Nelson teaches that the sampling device is used for sampling whole blood and dispensing and analyzing the whole blood in lateral flow assays (“diagnostic sampling device for processing whole blood and dispensing the processed whole blood” para. 2, “or drawing fluids, such as whole blood from a finger stick, for further processing or analysis, such as direct use in…lateral flow assays” para. 5). Nelson further teaches wherein the device comprises a lancet with a capillary channel (“While some exemplary embodiments use a capillary to draw blood from a finger stick, it is also envisioned to integrate a lancet and/or needle directly into the device, so that the puncture for the blood draw can be integrated into the device” para. 43, see Figure 1 showing the capillary channel 14).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Doyle to include a lancet with a capillary channel taught by Nelson because Nelson teaches that this enables direct collection, processing and dispensing of the sample onto a lateral flow assay. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Doyle and Nelson are drawn to lateral flow assays.
Claim 5, 13-14 and 38-39 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle as applied to claim 1 above, and further in view of Aharinejad (US 20120213761 A1) (Cite No. 3 of IDS file 9/15/2022).
Regarding claims 5, 13-14 and 38-39, Doyle teaches the lateral flow immunoassay device of claim 1 as discussed above.
Doyle further teaches that an “area where a rapid assay format is required is in assessing organs prior to transplantation” (col. 2 lines 19-20). Doyle further teaches that “[a] monoclonal-polyclonal antibody sandwich was found to be necessary for πGST detection by this assay format” (col. 12 lines 1-2).
Doyle fails to teach wherein the capture antibody and the detection antibody are configured to bind to different moieties of GST-Pi. Doyle fails to further teach wherein the GST-Pi comprises a polypeptide sequence of SEQ ID NO: 1, wherein the GST-Pi comprises a polypeptide sequence sharing at least 90%, 95%, or 99% sequence identity with SEQ ID NO: 1.
Aharinejad teaches “use of GSTP1” (Title). Aharinejad further teaches detecting GSTP1 using an immunoassay (“Preferred techniques for determining the amount of GSTP1 include antibody-liked techniques” paragraph 33). Aharinejad further suggests wherein the capture antibody and the detection antibody are configured to bind to different moieties of GST-Pi (“GSTP1 can be caught out of a biological sample with a GSTP1-specific antibody and detected and quantified with a second antibody directed against a different epitope of GSTP1” para. 38). Aharinejad further teaches that “[d]etection and quantification of GSTP1 by using anti GSTP1 antibodies is well established in the art” (para. 43). Aharinejad further suggests measuring GST-Pi prior to heart transplantation in order to diagnose cardiomyopathies or ischemic heart disease (“the present invention relates to GSTP1 as a diagnostic target for CMP or IHD” para. 30, “Importantly, patients who develop CMP based on IHD, in particular end-stage CMP, have currently only limited therapeutic options (e.g. cardiac transplantation” para. 6, “Serum GSTP1 is a Sensitive Marker of CMP…The study cohort comprised 141 end-stage CMP patients scheduled for cardiac transplantation” paras. 76-77, “ For protein array randomly selected serum samples were obtained from end-stage CMP patients shortly before transplant” para. 80, “In the targeted protein array screen of pooled serum samples in selected CMP patients GSTP1 was identified as a novel protein to be associated with CMP” para. 87). Aharinejad further teaches wherein the GST-Pi comprises a polypeptide sequence of SEQ ID NO: 1, wherein the GST-Pi comprises a polypeptide sequence sharing at least 90%, 95%, or 99% sequence identity with SEQ ID NO: 1 (“The human sequence (Seq. ID. No. 1) is listed as "GSTPl HUMAN, P09211" in the UniProtKB/SwissProt database (HGNC:4638, Entrez Gene: 2950)” para. 21). Note that SEQ ID NO: 1 of Aharinejad is 100% matched to SEQ ID NO: 1 of the instant claims.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Doyle to rely on the capture antibody and detection antibody being configured to bind to different moieties of GST-Pi and wherein the GST-Pi comprises a polypeptide sharing at least 90%, 95%, or 99% sequence identity with SEQ ID NO: 1 taught by Aharinejad because Aharinejad suggests that this enables the diagnosis of cardiomyopathies of patients scheduled for organ transplantation and Doyle teaches that rapid assay formats are needed for patients under organ transplantation. Furthermore, Doyle teaches a sandwich-type immunoassay where the detection antibody and the capture antibody both have to bind to GST-Pi and thus would require antibodies, such as those taught by Aharinejad that can bind to different epitopes on GST-Pi. A person having ordinary skill in the art would have had a reasonable expectation of success because Aharinejad teaches that detection and quantification of GSTP1 by using anti GSTP1 antibodies is well established in the art and both Doyle and Aharinejad are drawn to measuring GST-Pi levels of patients before organ transplantation.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Doyle as applied to claim 1 above, and further in view of Serebrennikova et al. Nano-Micro Lett. 10, 24 (2018). https://doi.org/10.1007/s40820-017-0180-2.
Regarding claim 8, Doyle teaches the lateral flow immunoassay device of claim 1 as discussed above.
Doyle fails to teach wherein the colored label is present at an optical density of 1, 2, 3, 4, 5, 6, 7, 8, 9, or 10 OD.
Serebrennikova teaches “hierarchical nanogold labels to improve the sensitivity of lateral flow assay immunoassay” (Title). Serebrennikova further teaches a lateral flow immunoassay device for detecting antigens in a fluid sample comprising a sample pad, a conjugate pad and a colorimetric indicator (Fig. 1 page 24). Serebrennikova further suggests that a colored label (gold nanoparticle) present at an optical density of 2 or 4 OD provides optimal color intensity with low background (“In order to choose the optimal dilution of gold nanoparticle–antibody conjugates for LFIA, the optical density of solutions at an appropriate wavelength was varied from 0.5 to 4. Sufficient color intensity of the test line with low background was achieved by the spreading of pAb-GNS with optical density of 2, pAb-GNPN, and pAb-GNST with optical density of 4” page 23 col. 2 para. 2).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Doyle to rely on the colored label being present at an optical density of 2 or 4 OD taught by Serebrennikova because Serebrennikova suggests this provides an optimal color intensity with low background. A person having ordinary skill in the art would have had a reasonable expectation of success given that both Doyle and Serebrennikova teach a lateral flow immunoassay device for detecting antigens in a fluid sample comprising a sample pad, a conjugate pad and a colorimetric indicator, and gold nanoparticles as colored labels.
Claims 10-11 are rejected under 35 U.S.C. 103 as being unpatentable over Doyle as applied to claim 1 above, and further in view of Andrukhova et al. Journal of Cardiac Failure Volume 20, Issue 2, February 2014, Pages 135-145 https://doi.org/10.1016/j.cardfail.2013.11.012 (“Andrukhova”) and Maney et al. (WO 2014/193999 A2) (“Maney”) as evidenced by Rabbit anti-GSTP1 Antibody Affinity Purified (retrieved online https://www.fortislife.com/products/primary-antibodies/rabbit-anti-gstp1-antibody/BETHYL-A303-628?selected=A303-628A on 10/24/2025) (“Bethyl”).
Regarding claims 10-11, Doyle teaches the lateral flow immunoassay device of claim 1 as discussed above.
Regarding claims 10-11, although the claims are indefinite (see 112b rejection above), in the interest of compact prosecution, the language “comprises” is interpreted as reciting “is”, i.e. “wherein the capture/detection antibody is…”. Regarding claim 11, in the interest of compact prosecution, MAB10823 is interpreted to be any antibody specific for GST-Pi.
Based on the above interpretation, Doyle teaches wherein the capture antibody is MAB10823 (col. 10 line 58).
Doyle fails to teach wherein the capture antibody is A303-628A and the detection antibody is H00002950-M01.
Andrukhova teaches “single-dose GSTP1 prevents infarction-induced heart failure” (Title). Andrukhova further teaches detecting and/or measuring GST-Pi using A303-628A antibody (“For GSTP1-TRAF2, GSTP1-JNK1, and GSTP1-p38 complex detection… use of GSTP1 antibody (Bethyl, Montgomery, Texas)” page 136 col. 2 para. 3). Note that as evidenced by Bethyl, the “GSTP1 antibody (Bethyl, Montgomery, Texas)” taught by Andrukhova is A303-628A (“Product Citations: 1 Single-dose GSTP1 prevents infarction-induced heart failure. In Journal of Cardiac Failure on 1 February 2014 by Andrukhova, O., Salama, M., et al.” page 4).
Maney teaches “biomarker methods and compositions” (Title). Maney further teaches that “[b]iomarkers can be assessed for diagnostic, therapy-related or prognostic methods to identify phenotypes, such as a condition or disease, or the stage or progression of a disease, select candidate treatment regimens for diseases, conditions, disease stages, and stages of a condition, and to determine treatment efficacy. Circulating biomarkers from a bodily fluid can be used in profiling of physiological states or determining phenotypes. These include…protein” (Abstract). Maney further suggests that antibodies conjugated to a particle can be used for assessing biomarkers in body fluids (“[v]arious types of binding agents can be used in the methods of the invention…antibody… The at least one binding agent can be labeled” para. 22, “A binding agent can also be bound to particles such as beads or microspheres” para. 190, “the
detection agent is labeled and the label is detected, thereby detecting the biomarker or vesicle. The detection agent can be a binding agent, e.g., an antibody” para. 497). Maney further suggests detecting and/or measuring GST-Pi using the detection antibody H00002950-M01 (“the invention provides use of the at least one reagent to carry out the methods of invention… reagent capable of binding to a target protein in Table 46” para. 29, “The detection agent, which may also be an…antibody, carries a detectable label” para. 39, “Table 46: Capture Antibodies… GSTPl NOVUS BIOLOGICALS H00002950-M01 12174-S2 GSTPl NOVUS BIOLOGICALS H00002950-M01 D5092-S2” pages 321 and 323, “One of skill will appreciate that targets of capture agents and detection agents can be used interchangeably” para. 501). Note that although Maney teaches the H00002950-M01 antibody in the Table labeled “Capture Antibodies”, the teachings that “[o]ne of skill will appreciate that targets of capture agents and detection agents can be used interchangeably” suggests that the H00002950-M01 antibody is a detection antibody.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Doyle to rely on the capture antibody being A303-628A taught by Andrukhova because it would have been a simple matter of applying a known technique to a known method. In this case, both Doyle and Andrukhova teach measuring and/or detecting GSTP1 using an antibody specific for GSTP1. Andrukhova simply applies the art-recognized technique of using the commercially available antibody A303-628A from Bethyl. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Andrukhova to the base method taught by both Doyle and Andrukhova. A person having ordinary skill in the art would have had a reasonable expectation of success because antibody A303-628A is commercially available from the company Bethyl.
It would have been further prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the teachings of Doyle in view of Andrukhova to rely on the detection antibody being H00002950-M01 taught by Maney because it would have been a simple matter of applying a known technique to a known method. In this case, both Doyle and Maney teach measuring and/or detecting GSTP1 using an antibody specific for GSTP1 conjugated to a particle label for diagnostics. Maney simply applies the art-recognized technique of using the commercially available antibody H00002950-M01. Therefore, a person having ordinary skill in the art would have found it obvious to apply the technique of Maney to the base method taught by both Doyle and Maney. A person having ordinary skill in the art would have been motivated to try picking antibody H00002950-M01 from the finite list of antibodies taught by Maney because Maney suggests that GSTP1 is a diagnostic and prognostic biomarker of disease as well as a biomarker for treatment efficacy. Therefore, it would have been obvious to try picking H00002950-M01 from said finite list. A person having ordinary skill in the art would have had a reasonable expectation of success given that Maney teaches the vendor and two lot numbers of the H00002950-M01 antibody.
Conclusion
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/Fernando Ivich/Examiner, Art Unit 1678
/CHRISTOPHER L CHIN/Primary Examiner, Art Unit 1677