Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of Claims
Claims 1-32 are pending. Claims 1-16 have been withdrawn as drawn to a non-elected invention. Claims 17-32 have been examined.
Election/Restriction
Applicant’s election without traverse of Group II, claims 17-32, in the reply filed on 09/29/2025 is acknowledged.
Priority
This application, Serial No. 18/149,707 (PGPub: US2023/213503) was filed 01/04/2023.
Information Disclosure Statements
No Information Disclosure Statements have been filed.
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 17-32 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 17 is indefinite because it recites that the method is for “measuring an amount of an analyte” and then states a photosensitive detector to quantitatively determine the amount of analyte, however the body of the claim has not provided any link between the analyte and any of the method components that make clear what the analyte is binding to that allows it to be detected by the photosensitive detector.
Claim 17 is indefinite because line 15 recites “bound pairs” and it is unclear which bound pairs are being referenced. For example, one of the reagents bound with the analyte or alternatively are the reagents bound to one another?
Claim 18 is confusing because it is unclear what is being referred to by “outside of the immunoassay device”. For example, is the means for dispensing the reagent provided outside of the device and not an integrated component of the claimed assay device, or is the reagent provided into the reaction well during device manufacture or further is the reaction well removed from the device during the reaction to provide the reagent and then placed back into the device? Clarification is needed.
Claim 22 is indefinite because it recites “the first particle” and this limitation lacks antecedent basis.
Claim 22 is indefinite because it recites “one of the reagents of the first reagent pair” and “the other of the reagents of the first reagent pair” and this is confusing because claims 17 and 19 have not claimed a first reagent pair or more than one first reagent pair.
Claim 22 is unclear because it begins stating detection of an antigen but then goes on to state mixing the analyte with the reagents and it is unclear if the antigen is intended to be the analyte or part of a different binding reaction.
Claim 23 is indefinite because it recites “one of the reagents of the first reagent pair” and “the other of the reagents of the first reagent pair” and this is confusing because claims 17 and 19 have not claimed a first reagent pair or more than one first reagent pair.
Claim 23 is unclear because it begins stating detection of an antibody but then goes on to state mixing the analyte with the reagents and it is unclear if the antibody is intended to be the analyte or part of a different binding reaction.
Claim 23 is indefinite because it recites “the first particle” and this limitation lacks antecedent basis.
Claim 25 is indefinite because it states at line 2, “where a result lies on a scale” and it is unclear what result is being referenced or if the claim is intending to limit the photosensitive detector results claimed in the first part of the claim.
Claim 27 is indefinite because it recites “the first particle” and this limitation lacks antecedent basis.
Claim 31 is indefinite because it recites that the method is for “measuring an amount of a first analyte” and then states a photosensitive detector to quantitatively determine the amount of the first analyte, however the body of the claim has not provided any link between the first analyte and any of the method components that make clear what the analyte is binding to that allows it to be detected by the photosensitive detector.
Claim 31 is indefinite because line 11 recites “bound” and it is unclear what bound component is intended to be separated.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 17-20, 22-26, 29 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over Yabutani et al. (US 2019/0041386, 02/07/2019, hereinafter “Yabutani”) in view of Rosmalen (US 2017/0246636, Pub Date: 08/31/2017).
Regarding claims 17 and 31, Yabutani teaches throughout the publication an immunoassay method for quantitatively measuring an amount of an analyte in a fluid sample (paragraph 0010), comprising:
providing a transport that moves along a path; providing a set of reaction wells holding a fluid sample; mounting the set of reaction wells to the transport (see Figure 1 and paragraph 0036, reaction disc 10 holding wells 11 that are provided on the inherent transport that rotates the reaction disc in a circumferential direction; paragraph 0046, sample in reaction cell 11);
providing reagent discs holding reagent containers that contain reagent solutions corresponding to analysis items to be analyzed by the device (paragraph 0039);
operating a dispenser for withdrawing reagent from one of the two reagent holders; coordinating movement of the transport with operation of the dispenser to dispense the withdrawn reagent into one of the reaction wells, and, operating the transport to reciprocate the set of reaction wells along the path for mixing the fluid sample with the reagents (paragraph 0040, pipette dispensing mechanisms 33 suck reagents from the reagent discs and discharge the reagents into the appropriate reagent cell positioned at a dispensing position to create a mixed solution of the sample and reagents),
and operating a photosensitive detector to quantitatively determine the amount of analyte (paragraphs 0041 and 0049-0050).
While Yabutani teaches the presence of plural reagents holders holding reagents for completing the reaction (paragraph 0039), the reference fails to specifically teach providing in respective ones of the reagent holders a) a labelled reagent including one of a binding pair coupled with a label, and b) a magnetic reagent including a magnetic particle coupled with the other of the binding pair; before subsequently applying a magnetic field in a magnetization direction to the contents of the set of reaction wells such that bound pairs are thereby separated.
Rosmalen teaches throughout the publication point of care biomarker assays for measuring a presence or concentration of biomarkers in a sample (abstract). More specifically, Rosmalen teaches an apparatus comprising multiple chambers for holding reaction media including a labelled binding reagent capable of binding to said biomarker or competing with said biomarker as well as magnetic bead reagents capable of binding to said biomarker or competing binding reagent (paragraphs 0014-0015). Furthermore, Rosmalen teaches a magnetic coil assembly arranged for applying a magnetic field to the liquid mixture for separating bound magnetic beads as well as a photosensitive detector to measure the presence or concentration of labeled binding reagent (paragraphs 0023-0024).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the reaction containers in the methods of Yabutani, labeled binding reagents and magnetic bead reagents as taught by Rosmalen because Yabutani is generic regarding the types of reagents that can be incorporated to conduct the reactions and one skilled in the art would have been motivated to choose the appropriate reagents based on the desired assay to be conducted. And thus, it would have been obvious to one skilled in the art to incorporate within the reaction disc in the method of Yabutani, a magnetic coil assembly arrangement as taught by Rosmalen because it would have been desirable to manipulate and separate the reacted magnetic beads for further detection of the analyte (Rosmalen, paragraphs 0023 and 0131).
Regarding claim 18, Yabutani in view of Rosmalen teach performing the method using an immunoassay device comprising: a set of reaction wells (Yabutani, reaction cells 11), a transport which moves the set of reaction wells along a path (Yabutani, see Figure 1 and paragraph 0036, reaction disc 10 holding wells 11 that are provided on the inherent transport that rotates the reaction disc in a circumferential direction), first and second reagent holders disposed alongside the path for holding respective reagents (Yabutani, Figure 1, see reagent discs 30 disposed alongside the path of reaction disc 10; paragraph 0039), a dispenser configured for withdrawing reagent from the reagent holders and dispensing the reagent into ones of the reaction wells (paragraph 0040, pipette dispensing mechanisms 33 suck reagents from the reagent discs and discharge the reagents into the appropriate reagent cell positioned at a dispensing position to create a mixed solution of the sample and reagents), wherein the reagents comprise: a labelled reagent including one of a binding pair coupled with a label, and a magnetic reagent including a magnetic particle coupled with the other of the binding pair (Rosmalen, paragraphs 0014-0015), a magnet disposed alongside the path for applying a magnetic field in a magnetization direction to the contents of the set of reaction wells such that bound pairs are thereby separated (Rosmalen, paragraph 0023), a photosensitive detector configured to quantitatively measure the amount of analyte (Yabutani, paragraphs 0041 and 0049-0050), and a controller operable to coordinate movement of the transport with operation of the dispenser for dispensing of the reagents and operating the transport to reciprocate the set of reaction wells along the path for mixing the fluid sample with the reagents (Yabutani, paragraphs 0043-0045), the method further including: dispensing the reagents into the reaction wells by the dispenser of the immunoassay device (Yabutani, paragraph 0040).
Although Yabutani in view of Rosmalen do not teach that one of the reagents is dispensed into the reaction well outside of the immunoassay device, it would have been obvious to one skilled in the art to dispense outside of the device as an obvious matter of design choice since the same expected reaction conditions would be met and since patentable significance or unexpected results from the outside dispensing have not been provided (See MPEP 2144.04).
Regarding claim 19, while Yabutani in view of Rosmalen teach addition of the reagents in the reagent containers by the dispensing means, wherein the solutions are inherently mixed during rotation of the discs to create mixed reaction solutions (Yabutani, paragraphs 0039-0042), the references do not specifically teach first and second mixing periods during which the transport is operated to reciprocate the set of reaction wells along the path for mixing, the first mixing period following the dispensing of one of the magnetic reagent and labelled reagent, the second mixing period following the dispensing of the other of the magnetic reagent and labelled reagent. However, it would have been obvious to one skilled in the art to modify the sequence of dispensing the reagents along the transport path for mixing (during rotation) because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (See MPEP 2144.04).
Regarding claim 20, Yabutani in view of Rosmalen teaches the method wherein the label comprises one of a fluorescent label or a chemilumiscent label (Rosmalen, paragraph 0037).
Regarding claim 22, Yabutani in view of Rosmalen teaches the method wherein, for the detection of an antigen (paragraph 0030), the binding pair comprises an antigen and antibody pair and the first particle is coupled with the antibody (Rosmalen, paragraph 0109), and the magnetic particle is coupled with the antigen (Rosmalen, see paragraphs 0049 and 0127-0132, competitive assay schematics), and the transport reciprocates the reaction wells to mix the analyte and reagents (Yabutani, paragraph 0040). Although Yabutani in view of Rosmalen do not specifically teach that one reagent is mixed before dispensing of the other reagent, it would have been obvious to one skilled in the art to modify the sequence of dispensing the reagents along the transport path for mixing (during rotation) because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (See MPEP 2144.04).
Regarding claim 23, Yabutani in view of Rosmalen teaches the method wherein, for the detection of an antibody, the binding pair comprises an antigen and antibody pair and the first particle is coupled with the antigen (Rosmalen, paragraph 0109), and the magnetic particle is coupled with the antibody (Rosmalen, see paragraphs 0049 and 0127-0132, competitive assay schematics), and the transport reciprocates the reaction wells to mix the analyte and reagents (Yabutani, paragraph 0040). Although Yabutani in view of Rosmalen do not specifically teach that one reagent is mixed before dispensing of the other reagent, it would have been obvious to one skilled in the art to modify the sequence of dispensing the reagents along the transport path for mixing (during rotation) because selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results (See MPEP 2144.04).
Regarding claim 24, Yabutani teaches a photosensitive detector to detect irradiated light (paragraphs 0041-0042) and Rosmalen specifically teaches that the detector measures fluorescence or chemiluminescence (paragraphs 0037-0038).
Regarding claim 25, Yabutani teaches the method wherein the results derived from the photosensitive detector are output in analog form (paragraph 0042, results are output in analog form and sent to A/D converter, which reads on the claim as the claim has not limited what happens to the analog signals after they are output), with an indicator highlighting where a result lies on a scale (paragraph 0064, arithmetic processing is performed on the measurement data and obtained result is reflected in the measurement sample progress list).
Regarding claim 26, Yabutani teaches that different types of tests can be performed on the patient sample (paragraph 0084) and Rosmalen teaches the device is capable of performing multiple distinct test protocols to test the samples for the presence of different biomarkers (paragraph 0039). While the references do not explicitly teach additional reagent pairs to conduct the various additional test protocols, it would be obvious to one skilled in the art at the time the invention was filed that in order to conduct various tests for different biomarkers, different reagents would be necessary to react with the desired biomarkers.
Regarding claim 29, Yabutani teaches the method wherein the dispenser comprises first and second pipette modules, and wherein operating the dispenser comprises withdrawing reagent from a respective one of the two reagent holders using a respective one of the first and second pipette modules (paragraph 0040, pipette 30-1 and 30-2).
Claim(s) 21 and 27-28 are rejected under 35 U.S.C. 103 as being unpatentable over Yabutani et al. (US 2019/0041386, 02/07/2019, hereinafter “Yabutani”) in view of Rosmalen (US 2017/0246636, Pub Date: 08/31/2017), as applied to claim 17 above (hereinafter “Modified Yabutani”), and further in view of Straus (US 2021/0349082 Pub Date: 11/11/2021).
Regarding claim 21, Modified Yabutani teaches the method as described above but does not specifically teach that the labelled reagent further comprises a first particle, the first particle coupled to the label and to the one of the binding pair. Straus teaches throughout the publication an instrument for automatically carrying out a variety of tests on targets in specimens (abstract). More specifically, Straus teaches that magnetic tags and fluorescent labels are used for binding complex and the fluorescent labels are preferably fluorescent particles (paragraph 0048).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the labeled reagent of Modified Yabutani to include a first particle as taught by Straus since Modified Yabutani is generic regarding the types of reagents that can be incorporated and one skilled in the art would have been motivated to choose the desired reagents for the desired assay reactions.
Regarding claims 27-28, Modified Yabutani fails to teach the method wherein the antibody used on the binding pair is a mixture of monoclonal antibodies with different sub-specificities for the corresponding antigen. However, Straus teaches that particles can be conjugated with monoclonal antibodies that bind complementary epitopes of the desired target protein (paragraph 0561). It would have been prima facie obvious to one having ordinary skill in the art to modify the binding agent on the conjugates of Modified Yabutani with monoclonal antibodies as taught by Straus since Modified Yabutani is generic regarding the types of reagents that can be incorporated and one skilled in the art would have been motivated to choose the desired reagents for the desired assay reactions.
Claim(s) 30 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Yabutani et al. (US 2019/0041386, 02/07/2019, hereinafter “Yabutani”) in view of Rosmalen (US 2017/0246636, Pub Date: 08/31/2017), as applied to claims 17, 19 and 22 above (hereinafter “Modified Yabutani”), and further in view of Schermer et al. (US 2005/0110989 Pub Date: 01/06/2011).
Regarding claims 30 and 32, Modified Yabutani teaches the method as described above with reaction wells having outer walls aligned substantially parallel to the path (Yabutani, see Figure 1, wells 11 arranged around the disc circumference and thus having outer walls aligned substantially parallel with the disc circumference) but fails to teach that the reaction wells are generally trapezium-shaped in cross section, with the transparent opposing outer walls forming bases of the trapezium.
Schermer teaches throughout the publication an optical device for providing information about samples (abstract). More specifically, Schermer teaches wells with a generally trapezoidal shaped cross-section (see Figure 4). Schermer further teaches that the microplate is molded from a transparent polymer thus reading on the outer walls comprising a transparent material (paragraph 0065).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the well shape in the method of Modified Yabutani with a trapezoidal shaped transparent well as taught by Schermer because Modified Yabutani is generic regarding the well shape that can be incorporated on the disc and therefore one skilled in the art would have been motivated to choose the appropriate well shape and manufacture material based on the desired analysis to be conducted within the wells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bao-Thuy L Nguyen can be reached at 571-272-0824. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677