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
As restated in the Office action of 06/23/2025, 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. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) and 120 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application No. PRO 63/035,129 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 1, 76, 83 and 88 of the instant application teaches that the evolved gaseous product is confined by the depression where the gaseous product evolves. Claims 1, 76, 83 and 88 of the instant application further teaches relating the image of at least some of the gaseous reaction product confined by the depression to the level of the analyte by quantification of individual instances of the gaseous reaction product. The claims of PRO 63/035,129 application do not teach that the evolved gaseous product is confined by the depression where the gaseous product evolves. Also, the claims of PRO 63/035,129 application do not teach relating the image of at least some of the gaseous reaction product confined by the depression to the level of the analyte by quantification of individual instances of the gaseous reaction product. Last, the specification of PRO 63/035,129 application does not teach relating the image of at least some of the gaseous reaction product confined by the depression to the level of the analyte by quantification of individual instances of the gaseous reaction product. Thus, for purposes of applying prior art, claims 57-69, 71-81, 83-85 and 87-89 are subject to a priority date of 03 March 2021.
The disclosure of the prior-filed application Nos. PCT/US2019/050776 and PRO 62/730,719 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Claims 58-61, 65 and 77-80 of the instant application define the analyte to be detected as SARS-CoV-2 coronavirus nucleocapsid or spike protein. The invention was fully described in application No. 17/199,926, which was filed on 03 March of 2021. Thus, for purposes of applying prior art, claims 58-61, 65 and 77-80 are subject to a priority date of 03 March 2021.
The disclosure of the prior-filed application Nos. PCT/US2019/050776 and PRO 62/730,719 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The specification of the PCT application teaches using blood or serum as sample for testing (Page 2, [0009]; page 19, [0089]; page 34, [00160] and page 35, [00162]). The claims and specification of the PCT/US2019/050776 and PRO 62/730,719 applications do not teach using samples that are different from blood or serum. Claims 62-64 of the instant application define the analyte to be collected from different types of samples (e.g., a nasopharyngeal sample, a nasal sample, a urine sample, a stool sample, a saliva sample). The invention was fully described in application No. 17/199,926, which was filed on 03 March of 2021. Thus, for purposes of applying prior art, claims 62-64 are subject to a priority date of 03 March 2021.
Should applicant disagree with the examiner’s factual determination above, applicant should provide evidence that either or both of the provisional applications provide support for the invention now claimed in the manner required by 35 USC 112, first paragraph. This could be accomplished, for example, by pointing to the specific page and line numbers within the provisional applications which disclose each limitation of the claimed invention.
Claim Status
The amendments and remarks filed 03/02/2026 have been received and entered in full. Claims 1-56, 70, 82 and 86 are cancelled at the Applicant request. Claims 57-63, 65-69, 71-81, 83-85 and 87-89 are previously presented. Claim 64 is original. Claims 90-92 are new and the Applicant notes that no new matter is added.
Thus, claims 57-69, 71-81, 83-85 and 87-92 are pending and are under examination.
New Objections necessitated by the Addition of New Claims
Claim Objections
Claim 91 is objected to because of the following grammatical informalities: the claim recites on lines 2-3 “the first analyte that is present an a concentration”. Appropriate correction is required.
Maintained Rejections
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.
Claim 57, 62, 64, 66-68, 71-76, 81, 83-85, 87-88 and 90-92 are rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (US 2011/0300555 A1) in view of Wilson et al. (US 2014/0227720 A1).
Claims 90-92 are new claims and are included in this now modified rejection.
Claim 57 recites:
“A method, comprising:
contacting an analyte, a promoter tag, and an anchor,
the promoter tag being configured to bind to the analyte,
the promoter tag further comprising a reaction promoter,
the anchor being configured to bind to the analyte,
the contacting being performed under conditions such that the promoter tag binds with
the analyte and the anchor binds with the analyte so as to form a complex;
contacting the complex with a reaction substrate located in a depression so as to evolve a
gaseous reaction product confined by the depression where the gaseous reaction product
evolves;
collecting an image of at least some of the gaseous reaction product confined by the
depression; and
relating the image of the at least some of the gaseous reaction product to a level of the
analyte by quantification of individual instances of the gaseous reaction product”.
Regarding claim 57, Raj teaches a method, comprising contacting an analyte, a promoter tag such as a gas generating substance, and an anchor such as immobilized antibody (Abstract; page 2, [0022-0024]).
Raj teaches that the promoter tag such as a tagged antibody with catalase is being configured to bind an analyte such as hCG (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches that the promoter tag such as a tagged antibody further comprising a reaction promoter such as catalase (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches that an anchor such as an immobilized antibody is being configured to bind to the analyte (Sheet 5 of 14, figure 5, “hCG”; page 3, [0033]).
Raj teaches the contacting being performed under conditions such that a promoter tag such as a tagged antibody with catalase binds with an analyte such as hCG and an anchor such as an immobilized antibody binds with an analyte such as hCG so as to form a complex (Sheet 5 of 14, figure 5, “hCG”; page 1, [003]; page3, [0033]).
Raj teaches contacting the complex with a reaction substrate such as H2O2 so as to evolve a reaction product such as O2 gas (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]).
Raj teaches detecting at least some of the reaction product such as O2 bubbles with a bubble capture tooth (Sheet 5 of 14, figure 5, “Bubble capture teeth”; page 2, [0019], [0023] and [0031]).
Regarding claims 57, 76, 83 and 88, Raj teaches that collecting image comprises counting instances of the reaction product (Page 3, [0046] and [0048], “Thus formation of one or more gas bubbles at the accumulation zone will be principally due to reaction between the second reagent and any first reagent accumulated at the accumulation zone and thus indicative of the presence and/or
amount of analyte present.”; page 12, [0242-0243]).
Regarding claim 62, Raj teaches that the analyte is collected from a biological sample such as a urine or a saliva sample (Page 5, [0080]).
Regarding claim 64, Raj teaches that the analyte is collected from a saliva sample (Page 5, [0080]). Regarding claim 66, Raj teaches that the promoter tag comprises an antibody complementary to the analyte (Sheet 1 of 14, figure 1, “hCG”, “catalase”; page 3, [0033]).
Regarding claim 67, Raj teaches that the promoter tag such as a tagged antibody comprises a catalyst portion such as a catalase (Sheet 5 of 14, figure 5, “hCG”; page 1, [003]; page3, [0033]).
Regarding claim 68, Raj teaches that the catalyst portion comprises an enzyme such as a catalase (Sheet 1 of 14, figure 1, “hCG”, “catalase”; sheet 5 of 14, figure 5, “hCG”; page 1, [003]; page3, [0033]).
Regarding claim 71, Raj teaches applying a gradient such as a magnetic field so as to direct the complex to a location, the anchor such as a second antibody being sensitive to the gradient of a magnetic field due to the antibody being attached to a magnetic particle (Page 3, [0035]).
Regarding claim 72, Raj teaches that collecting an image comprises visual detection or by a video (Page 1, [0004]; page 6, [0093]; page 12, [0227] and [0242-0243]).
Regarding claim 73, Raj teaches that the image collection is performed manually (Page 1, [0004]; page 6, [0093]; page 12, [0242-0243]).
Regarding claim 74, Raj teaches that the detection is performed in an automated fashion (Page 1, [0004]).
Regarding claim 75, Raj teaches that collecting image comprises counting instances of the reaction product (Page 3, [0046]; page 12, [0242-0243]).
Claim 76 recites:
“A kit, comprising:
a plate comprising a depression;
a supply of a promoter tag configured to bind specifically to an analyte,
a supply of an anchor configured to bind specifically to the analyte,
the anchor optionally comprising a magnetizable material, and
the promoter tag comprising a material configured to evolve a gaseous reaction
product, the gaseous reaction product being confined by the depression where the
gaseous reaction product forms when the material is contacted with a reaction
substrate under effective conditions, and
wherein the kit is configured to engage with a portable computing device
configured to observe gaseous reaction product confined by the depression in
order to quantify of individual instances of the gaseous reaction product”.
Regarding claim 76, Raj teaches a kit comprising a supply of a promoter tag such as tagged antibody with catalase configured to bind specifically to an analyte such as hCG (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches a supply of an anchor such as an immobilized antibody that is configured to bind specifically to the analyte (Sheet 5 of 14, figure 5, “hCG”; page 3, [0033]).
Raj teaches that an anchor optionally comprises a magnetizable material (Page 3, [0035]).
Raj teaches that the promoter tag such as a tagged antibody comprises a material such as catalase configured to evolve a gaseous product such as O2 gas when contacted with a reaction substrate such as H2O2 under effective conditions of binding to an analyte such as hCG (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]).
Regarding claim 81, Raj teaches a kit further comprising a translucent portion configured to permit observation of the gaseous product such as O2 gas (Page 10, [0144] and [0156]).
Claim 83 recites:
“A system, comprising:
an amount of a first promoter tag, the first promoter tag being configured to bind to a first
analyte,
the first promoter tag further comprising a first reaction promoter,
an amount of a first anchor, the first anchor being configured to bind to the first analyte
and the first anchor further comprising a ferromagnetic portion;
a substrate located within a depression of a container,
an imager configured to detect an image of a gaseous reaction product (1) evolved from
interaction between the first reaction promoter and the substrate and (2) confined by the
depression in order to permit quantification of individual instances of the gaseous
reaction product; and
a gradient source configured to exert a force on the ferromagnetic portion of the first
anchor”.
Regarding claim 83, Raj teaches a system comprising an amount of a first promoter tag such as a tagged antibody, the first promoter tag being configured to bind to a first analyte such as hCG (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches that the first promoter tag further comprises a first reaction promoter such as catalase (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches an amount of a first anchor such as an immobilized antibody, the first anchor being configured to bind to the first analyte such as hCG (Sheet 5 of 14, figure 5, “hCG”; page 3, [0033]).
Raj teaches the first anchor such as an immobilized antibody further comprises a ferromagnetic portion such as a magnetic particle (Page 3, [0035]).
Raj teaches a substrate such as 2H2O2 (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]).
Raj teaches a gradient source such as a magnetic field configured to exert a force on the ferromagnetic portion of the first anchor of an immobilized antibody that attached to a magnetic bead (Page 3, [0035]).
Regarding claim 84, Raj teaches a system comprising an amount of a promoter tag such as a tagged antibody, the promoter tag being configured to bind to an analyte such as hCG (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches that the promoter tag further comprises a reaction promoter such as catalase (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches an amount of an anchor such as an immobilized antibody, the anchor being configured to bind to an analyte such as hCG (Sheet 5 of 14, figure 5, “hCG”; page 3, [0033]).
Raj teaches the anchor such as an immobilized antibody further comprising a ferromagnetic portion such as a magnetic particle (Page 3, [0035]).
Regarding claim 85, Raj teaches a gradient source such as a magnetic field that is configured to direct the first anchor such as an antibody with a magnetic bead to a location (Page 3, [0035]).
Claim 88 recites:
“A method, comprising:
reacting a sample comprising an amount of an analyte with a promoter tag configured to
bind specifically to the analyte under such conditions that the promoter tag binds to the
analyte;
contacting the sample with an anchor under such conditions that the anchor binds
specifically to the analyte,
the anchor optionally comprising a magnetizable material,
the reacting and contacting being performed so as to give rise to a complex that
comprises the analyte, the promoter tag, and the anchor,
immobilizing the complex within a depression;
contacting the complex with a reaction substrate so as to evolve a gaseous reaction
product confined by the depression where the gaseous reaction product evolves;
collecting an image at least some of the gaseous reaction product; and
relating the image of the at least some of the gaseous reaction product to a level of the
analyte in the sample by quantification of individual instances of the gaseous reaction
product”.
Regarding claim 88, Raj teaches a method comprising reacting a sample comprising an amount of an analyte such as hCG with a promoter tag such as a tagged antibody with catalase configured to bind specifically to the analyte under such conditions that the promoter tag binds to the analyte (Sheet 1 of 14, figure 1, “hCG”, “catalase”).
Raj teaches contacting the sample with an anchor such as an immobilized antibody under such conditions that the anchor binds specifically to an analyte such as hCG (Sheet 5 of 14, figure 5, “hCG”; page 3, [0033]).
Raj teaches that an anchor such as an immobilized antibody comprises a magnetizable material (Page 3, [0035]).
Raj teaches that the reacting and contacting are performed so as to give rise to a complex that comprises the analyte such as hCG, the promoter tag such as a tagged antibody with a catalase, and an anchor such as an immobilized antibody (Sheet 5 of 14, figure 5, “hCG”; page 1, [003]; page3, [0033]).
Raj teaches immobilizing the complex (Sheet 5 of 14, figure 5, “hCG”; page 1, [003]; page3, [0033])).
Raj teaches contacting the complex with a reaction substrate such as H2O2 so as to evolve a gaseous reaction product such as O2 (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]).
Raj teaches detecting with a video at least some of the gaseous reaction product of O2 bubbles with a bubble capture tooth (Sheet 5 of 14, figure 5, “Bubble capture teeth”; page 2, [0019], [0023] and [0031]; page 12, [0242-0243]).
Regarding claim 57, Raj does not teach contacting the complex with a reaction substrate that is located in a depression to generate a product in depression.
Raj does not teach collecting an image of at least some of the reaction product that is confined within the depression.
Raj does not teach relating the image of the captured reaction product to a level of the analyte.
Regarding claim 76, Raj does not teach a plate comprising a depression.
Raj does not teach a material that is confined within a depression to produce a product.
Raj does not teach that the kit is configured to engage with a portable computing device configured to observe the gaseous product.
Regarding claim 83, Raj does not teach that the substrate is located within a depression of a container.
Raj does not teach that a product is produced from the interaction between the first reaction promoter and the substrate and confined to the depression.
Raj does not teach using an imager that is configured to detect an image of a first reaction that evolved from interaction between the first reaction promoter and the substrate.
Regarding claim 84, Raj does not teach a second promoter that binds a second analyte nor a second anchor that can bind to the second analyte.
Raj does not teach a second anchor with a magnetic part.
Regarding claim 85, Raj does not teach that the substrate comprises a plurality of depressions.
Raj does not teach directing the first anchor to a location within a depression.
Regarding claim 87, Raj does not teach detecting a product of a second reaction because of a contact between a second reaction promoter and a reaction substrate.
Regarding claim 88, Raj does not teach immobilizing a complex within a depression.
Raj does not teach that the reaction product is confined to a depression.
Raj does not teach relating an image of the product to a level of the analyte in the sample.
Regarding claims 90 and 92, Raj does not teach that the step of relating the image of the at
least some of the gaseous reaction product is performed when the level of analyte
correlates to a concentration as low as in the order of picogram / mL.
Regarding claim 91, Raj does not teach that the system is further configured to relate
quantified individual instances of the gaseous reaction product to a level of the first
analyte that is present in a concentration as low as in the order of picogram / mL.
Regarding claim 57, Wilson teaches contacting the complex with a reaction substrate located in a depression (Page 6, [0051]). Wilson teaches making a measure that is indicative of the number/ percentage/ fractions of locations containing at least one biomarker molecule (Page 6, [0051]).
Wilson teaches collecting an image of at least some of the reaction product and relating the image of the captured reaction product to a level of the analyte (Page 7, [0053]; page 8, [0056]; page 14, [0099]; page 19, [0156]).
Regarding claim 76, Wilson teaches a plate comprising a depression or a well (Page 6, [0051]).
Wilson teaches a material that is confined within a depression or a well to produce a product (Page 6, [0051]). Wilson teaches making a measure that is indicative of the number/ percentage/ fractions of locations containing at least one biomarker molecule (Page 6, [0051]). A skilled artisan would have been motivated to combine the gaseous product generation method of Raj with the depression approach of Wilson because of suitable detection of small analytes and simple reagent use as noted by Raj ( Pages 5-6 [0085]) and localization of signal to one spot as noted by Wilson (Page 6, [0051], “in some embodiments, the locations may be configured in a manner such that each location can be individually addressed”).
Wilson teaches that the kit is configured to engage with a portable computing device configured to observe a product (Page 7, [0053]; page 8, [0056]; page 14, [0099]; page 19, [0156-0157]).
Regarding claim 83, Wilson teaches that substrate is located within a depression of a container (Page 6, [0051]).
Wilson teaches that product is produced from the interaction between the first reaction promoter and the substrate and confined to the depression (Page 6, [0051]).
Wilson teaches using an imaging system to detect an image of the reaction as it progresses to monitor the interaction between the first reaction promoter and the substrate or the biomarker (Page 7, [0053], “At least some of the capture objects (e.g., at least some associated with at least one biomarker molecule) may be spatially separated/segregated into a plurality of locations, and at least some of the locations may be addressed/interrogated (e.g., using an imaging system). A measure of the concentration of biomarker molecules in the fluid sample may be determined based on the information received when addressing the locations ( e.g., using the information received from the imaging system and/or processed using a computer implemented control system).”).
Regarding claim 84, Wilson teaches a system further comprising an amount of a second promoter tag in which more than one type of binding may be employed in the assay (Page8, [0059]).
Wilson teaches a second promoter tag being configured to bind to a second analyte (Page8, [0059]; Page 10, [0068]).
Wilson teaches an amount of a second anchor such as an immobilized biomarker in which it is being configured to bind to a second analyte such as a second biomarker (Page 6, [0051]; page 9, [0065]).
Regarding claim 85, Wilson teaches a system wherein the substrate comprises plurality of depressions (Page 10, [0069]).
Wilson teaches that the gradient source such as a magnetic field is configured to direct an anchor such as an antibody with a magnetic bead to a location within an array of depressions which are formed from a plurality of reaction vessels (Page 10, [0069]; Page 19, [0152]).
Regarding claim 87, Wilson teaches a system further comprising an imager configured to detect a product of a second reaction related to contact between a second reaction promoter and a substrate (Page 10, [0066]).
Regarding claim 88, Wilson teaches immobilizing a complex within a depression or a well (Page 6, [0051]).
Wilson teaches the reaction product is confined to a depression or a well (Page 6, [0051]). Wilson teaches making a measure that is indicative of the number/ percentage/ fractions of locations containing at least one biomarker molecule (Page 6, [0051]). A skilled artisan is motivated to combine the gaseous product generation method of Raj with the depression approach of Wilson because of suitable detection of small analytes and simple reagent use as noted by Raj ( Pages 5-6 [0085]) and localization of signal to one spot as noted by Wilson (Page 6, [0051]).
Wilson further teaches collecting an image of at least some of the reaction product and relating the image of the captured reaction product to a level of the analyte (Page 7, [0053]; page 8, [0056]; page 14, [0099]; page 19, [0156]).
Regarding claims 90 and 92, Wilson teaches that the step of relating the image of the at least some of the gaseous reaction product is performed when the level of analyte correlates to a concentration as low as in the order of picogram / mL (Sheet 4 of 12, Fig 3A and Fig. 3B, “pg/mL”).
Regarding claim 91, Wilson teaches that the system is further configured to relate quantified individual instances of the gaseous reaction product to a level of the first analyte that is present in a concentration as low as in the order of picogram / mL (Sheet 4 of 12, Fig 3A and Fig. 3B, “pg/mL”; page 3, [0032]).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the simultaneous detection method of different analytes of Wilson with the assay device of Raj to detect an analyte because Wilson provides the ability to detect a plurality of different analytes simultaneously by using a depression system to localize the signal and teaches configuring the locations in a manner such that each location is individually addressed which will detect different epitopes of the same antigen such as with SARS-CoV-2 virus and thus increase the sensitivity and specificity of an assay (Page 6, [0051]; page 10, [0066]). Raj teaches a method to use with different analytes including a virus (Page 5, [0079]), and teaches a method of detection that is easy to use and visualize (Page 1, [0004]; page 6, [0093]). A PHOSITA would have a reasonable expectation of success in combining the methods of Wilson and Raj based on the methods being in the field of detecting the binding of a target to its binding agent. Consequently, it would have been obvious for a PHOSITA to combine the detection approach of Wilson with the bubble forming assay device of Raj to improve the sensitivity of detection of an analyte.
Claims 58-59, 61, 63, 65, 77-78 and 80 are rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (US 2011/0300555 A1) and Wilson et al. (US 2014/0227720 A1) as applied to claims 57, 62, 64, 66-68, 71-76, 81, 83-85, 87-88 and 90-92 above, and further in view of Kondo et al. (Sci. Adv. 2020; 6: eabd3916, 14 October 2020).
Regarding claims 58 and 77, the teachings and suggestions of Raj and Wilson are discussed previously.
Additionally, regarding claims 58 and 77, Raj teaches a virus analyte (Page 5, [0079]).
Regarding claim 58, Raj does not teach that the analyte is a coronavirus nucleocapsid or a coronavirus spike.
Regarding claim 59, Raj does not teach that the coronavirus is SARS-CoV-2.
Regarding claim 61, Raj does not teach that the analyte is a spike protein of SARS-CoV-2.
Regarding claim 63, Raj does not teach that the analyte is collected from a nasal sample.
Regarding claim 65, Raj does not teach using a sample that is taken from an individual who is known or suspected to be post-infection with SARS-CoV-2, known or suspected to have received treatment for SARS-CoV-2, known or suspected to have received a vaccine for SARS-CoV-2.
Regarding claim 77, Raj does not teach that the analyte is a coronavirus nucleocapsid or a coronavirus spike.
Regarding claim 78, Raj does not teach that the coronavirus is SARS-CoV-2.
Regarding claim 80, Raj does not teach that the analyte is a spike protein of SARS-CoV-2.
However, regarding claim 58, Kondo teaches a corona virus spike as an analyte for antibody-like proteins (Abstract).
Regarding claim 59, Kondo teaches that the coronavirus is SARS-CoV-2 (Abstract).
Regarding claim 61, Kondo teaches that the analyte is a spike protein of SARS-CoV-2 (Abstract).
Regarding claim 63, Kondo teaches the collection of a nasal sample with a SARS-CoV-2 analyte (Abstract).
Regarding claim 65, Kondo teaches that the sample is taken from an individual who is known or suspected to be post-infection with SARS-CoV-2 (Page 7, Left column, second paragraph, lines 5-14).
Regarding claim 77, Kondo teaches a corona virus spike as an analyte for antibody-like proteins (Abstract).
Regarding claim 78, Kondo teaches that the coronavirus is SARS-CoV-2 (Abstract).
Regarding claim 80, Kondo teaches that the analyte is a spike protein of SARS-CoV-2 (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine antibody-like proteins of Kondo with the methods of Wilson and Raj to detect SARS-CoV-2 because Kondo offered antibody-like proteins to detect SARS-CoV-2 with high specificity (Page 5 of 12, right column, first paragraph, lines 6-9). Kondo further noted the possibility of using the antibody-like proteins in the detection and neutralization of SARS-CoV-2 in any future pandemic (Abstract). A PHOSITA would have a reasonable expectation of success in combining the methods of Kondo, Raj and Wilson based on the methods being in the field of detecting the binding of a target to its binding agent.
It would have been obvious for a PHOSITA to combine the antibody-like proteins or monobodies of Kondo with a bubble-forming assay device of Raj and the imaging system of Wilson to detect SARS-CoV-2 in a specific and simple manner and to maintain proper documentation and visualization.
Claims 60 and 79 are rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (US 2011/0300555 A1) and Wilson et al. (US 2014/0227720 A1) as applied to claims 57, 62, 64, 66-68, 71-76, 81, 83-85, 87-88 and 90-92 above, and further in view of Terry et al. (bioRxiv 2020.09.03.280370; doi: https://doi.org/10.1101/2020.09.03.280370, Posted September 03, 2020).
Regarding claims 60 and 79, the teachings and suggestions of Raj and Wilson are discussed previously, but Raj fails to teach the following limitation.
Regarding claims 60 and 79, Raj does not teach an analyte as a nucleocapsid protein of SARS-CoV-2.
Regarding claims 60 and 79, Terry teaches that the analyte is a nucleocapsid protein of SARS-CoV-2 that an antibody was developed for (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine the monoclonal antibody of Terry with the methods of Wilson and Raj to detect SARS-CoV-2 because Terry offered a monoclonal antibody to detect the nucleocapsid part of SARS-CoV-2 with high specificity (Page 7, third paragraph, conclusion, “The hybridoma antibodies characterized …”). Terry further noted that such an antibody will have a significant value in the fight against COVID-19 (Page1, abstract) and for the development of diagnostic assays (Page 2, second paragraph, “Overall, our data provides …”). A PHOSITA would have a reasonable expectation of success in combining the methods of Terry, Raj and Wilson based on the methods being in the field of detecting the binding of a target to its binding agent.
It would have been obvious for a PHOSITA to combine the monoclonal antibodies of Terry with a bubble-forming assay device of Raj and an imaging system of Wilson to detect SARS-CoV-2 in a specific and simple manner with proper documentation and visualization.
Claim 69 is rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (US 2011/0300555 A1) and Wilson et al. (US 2014/0227720 A1) as applied to claims 57, 62, 64, 66-68, 71-76, 81, 83-85, 87-88 and 90-92 above, and further in view of Serra-Maria et al. (ACS Appl. Mater. Interfaces 2018, 10, 21224−21234).
Regarding claim 69, the teachings and suggestions of Raj and Wilson are discussed previously.
Additionally, regarding claim 69, Raj teaches that the reaction substrate comprises hydrogen peroxide or H2O2 (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]).
Regarding claim 69, Raj does not teach that a metal comprises platinum.
Regarding claim 69, Serra-Maria teaches using platinum nanocatalyst to decompose a substrate such as H2O2 (Abstract).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine platinum catalyst method of Serra-Maria with the methods of Wilson and Raj to detect an analyte using platinum as a catalyst in a bubbly assay device of Raj because Serra-Maria showed the ability of platinum to decompose H2O2 and produce O2 as a gas (Abstract’s figure, “H2O2” and “O2”) and Raj used H2O2 as a reaction substrate so as to evolve a reaction product such as O2 gas that indicate the presence of an analyte (Sheet 5 of 14, figure 5, “2H2O2”, “O2”; page 3, [0046]). Serra-Maria teaches that platinum works very efficiently as catalyst for the decomposition of H2O2 (Page 21224, left column, “Our study aimed to …”), Also, Serra-Maria studied reaction conditions for the catalysis of decomposition of H2O2 by platinum to help in the design of efficient catalysts (Page 21230, right column, Conclusions, “The multivariate analysis utilized in this work highlights the integrated effect of particle size, surface chemistry, and the reaction conditions in the catalytic activity of Pt nanocatalysts in the decomposition of H2O2.”). A skilled artisan is motivated to combine the reaction conditions of Serra-Maria for decomposing H2O2 under platinum catalysis with the bubbly assay of Raj to achieve an efficient release of O2 gas and to increase the sensitivity of the assay. A PHOSITA would have a reasonable expectation of success in combining the methods of Serra-Maria, Wilson and Raj based on the methods being in the field of generating a detectable signal.
It would have been obvious for a PHOSITA to combine the platinum catalyst of Serra-Maria with the bubble-forming assay device of Raj and the imaging system of Wilson to further improve the detection method of the assay.
Claim 89 is rejected under 35 U.S.C. 103 as being unpatentable over Raj et al. (US 2011/0300555 A1) and Wilson et al. (US 2014/0227720 A1) as applied to claims 57, 62, 64, 66-68, 71-76, 81, 83-85, 87-88 and 90-92 above, and further in view of Bennett et al. (US 2018/0096497 A1).
Regarding claim 89, the teachings and suggestions of Raj and Wilson are discussed previously, but Raj fails to teach the following.
Regarding claim 89, Raj does not teach that the image collection is performed with a mobile computing device.
Regarding claim 89, Bennett teaches that the image collection is performed with a mobile computing device (Abstract; sheet 1 of 11, Fig. 1, “MOBILE COMPUTING DEVICE”; page 1, [0016]).
It would have been obvious for a PHOSITA before the effective filing date of the application to combine mobile computing device for image collection of Bennett with the analyte detection methods of Wilson and Raj because Bennett offered an affordable mobile computing device for image collection and editing that allows easy access of data information for comparison and storage (Abstract). Bennett further offered a flexible system to adapt according to the assay needs for uploading images from a mobile computing device (Page 1, [0016-0017]). A PHOSITA would have a reasonable expectation of success in combining the capture method of Bennett with the detection methods of Raj and Wilson based on the methods being about capture an event such as the binding of a target molecule to its binding agent.
It would have been obvious for a PHOSITA to combine the above methods to improve the detection method of a target antigen.
Response to Arguments
Applicant's arguments filed 03/02/2026 have been fully considered but they are not persuasive.
The Applicant argued that neither Reference Raj nor Reference Wilson teaches or suggests quantifying individual instances of the gaseous reaction product, i.e., more simply put, a step of counting bubbles. Specifically, the Applicant argued that relying on paragraphs [0046], [0048] and [0242-0243] is an erroneous interpretation of Raj’s invention. The Applicant further argued that Raj uses the characteristics of the flow of a fluid ( e.g., stopping distance) to provide an assessment of the amount of an analyte and does not teach that the number of individual bubbles is counted in order to determine "the presence and/or amount of analyte".
This argument is not persuasive because the claims recite “quantifying individual instances of the gaseous reaction product” and do not recite a step of counting bubbles. And according to the broadest reasonable interpretation (BRI), different methods exist to quantify individual instances of the gaseous reaction products. Furthermore, Raj teaches that different methods are present to measure the generated gaseous product (Page 8, [0110], “The flow path or paths in the assay device may be essentially linear. Alternatively in order to provide a compact configuration, the flow path may follow a serpentine or other convoluted path. The flow path may comprise a bubble retaining means”). While the stopping distance of the fluid is correlated with the amount of the analyte (i.e., hCG) to generate a graph of stopping distance vs hCG concentration (Sheet 6 of 14, Figure 6, “stopping distance”, “[hCG]/mIU/ml”; page 12, [0242-0243]), the stopping distance is directly proportional to the generated gaseous product which is dependent on the amount of analyte in the sample (Page 3, [0046]; [0048]). Thus, measuring the stopping distance is one method of how to quantify the individual instances of a gaseous reaction product.
The Applicant further questioned the motivation for combining the references of Raj and Wilson in a 103 rejection.
A skilled artisan would have been motivated to combine the gaseous product generation method of Raj with the depression approach of Wilson because Wilson teaches that localizing biomarker molecules to one location or spot generates a signal that is easily detected and quantified (Page 6, [0051], "in some embodiments, the locations may be configured in a manner such that each location can be individually addressed … At least a portion of the locations may be addressed and a measure indicative of the number/ percentage/ fraction of the locations containing at least one biomarker molecule may be made."). Furthermore, the addition of individualized detection method of analytes of Wilson to the gas production method of Raj is an advantageous addition because Wilson teaches quantifying an analyte at very low concentrations to correlate with the recurrence of a patient’s condition (Page 3, [0031-0032]).
Thus, the previous rejections of claims 57-69, 71-81, 83-85 and 87-89 under 35 U.S.C. 103, regarding obviousness, are still maintained and are made final.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/OMAR RAMADAN/Examiner, Art Unit 1678
/GREGORY S EMCH/Supervisory Patent Examiner, Art Unit 1678
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