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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/01/2025 has been entered.
Response to Amendment
The Amendment filed 10/01/2025 has been entered. Claims 1-19 and 21-23 are pending in the application and being examined herein.
Status of Rejections
The rejections under 35 USC 102 and 35 U.S.C. 103 are withdrawn in view of Applicant's amendment.
New grounds of rejection under 35 U.S.C. 103 are necessitated by the amendments.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 8, 10, 11, 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolson (US 20190229907 A1) in view of Price (US 20150350605 A1).
Regarding claim 1, Nicolson teaches a system comprising:
a processor (310);
memory (315) coupled to the processor for storing a local testing database (test result determination component 352) storing a test configuration profile (para. 0071, instructions that call subroutines to configure the processor 301 to analyze assay image data) for a cassette (cartridge 140) containing a lateral flow assay ("LFA") strip (assay 144. Para. 0038, lateral flow assay test strip) including a test line (para. 0023, visual line) with an intensity threshold value for the test line that represents an intensity value which indicates a positive test result (para. 0023, the presence or absence of a visual line indicates positive/negative test; . para. 0071, processor 310 compares analyzes assay image data to determine the test result);
a scanner (barcode scanner 122) for obtaining patient identification information; and
an LFA strip reader (Fig. 3, cartridge reader 335) coupled to the processor (310) for reading the LFA strip and obtaining an LFA strip image (Fig. 3 and para. 0068, cartridge reader 335 includes photodetector 340 for reading an assay held in the inserted cartridge and send image data from the photodetectors to processor 310, paras. 0002 and 0023, the assay is intended to be a LFA strip) from the cassette containing the LFA strip, the cassette having a unique identifier (barcode 142) that uniquely identifies the LFA strip and the cassette (the cassette is not positively recited. While the cassette provide context for the LFA strip reader and other elements of the invention, the cassette itself is not part of the invention. Therefore, the unique identifier of the cassette does not further limit how the LFA strip reader reads the LFA strip or obtain an LFA strip image. Furthermore, the invention references a single cassette and a single unique identifier, and thus the term “unique identifies” does not impart any significance. In addition, para. 0033 and para. 0053, cartridge 140 includes a barcode 142, and the barcode is unique since barcodes are used to associate results to patient identification information, and a user can access the stored test results by scanning a password barcode using the barcode scanner. If it determined that barcode 142 does not uniquely identify cartridge 140, the following rejection is put forth. Nicolson teaches the importance of traceability in medical settings and barcode scanning helps to ensure a high level of traceability (para. 0042-0043). Nicolson further teaches traceability is the ability to verify the information associated with a test performed using a reader device, para. 0042-0043. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified barcode 142 to uniquely identify the corresponding cartridge 140 in order to have additional information associated with a test and thus increase the level of traceability with a reasonable expectation of success (Nicolson, paras. 0042-0043) (MPEP 2143)(I)(G));
the processor (310) further configured to determine an LFA test result based on comparing a measured intensity value of a portion of the test line in the LFA strip image to the intensity threshold value (para. 0068 , cartridge reader 335 sends image data from the photodetectors to processor 310 for analysis of the image data representing the imaged assay to determine a test result of the assay. para. 0023 , the test results is determined by the presence or absence of a visual line. The examiner interprets the value used to determine the presence or absence of a visual line is the threshold value);
the processor (310) further configured to link the determined LFA test result to the unique identifier (barcode 142) of the cassette (para. 0033 teaches barcode uses include associating test results to additional information including patient identification information, test type, device operation mode, sample information, and any other additional test or patient information pertinent to the test performed by the IVD device, and thus the examiner interprets the barcode is linked to the test results and the additional information, and the linking is performed by processor 310 (Fig. 4 and para. 0067). If it is determined that barcode 142 is not linked to the test results, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor 310 to link the test result to barcode 142 of cartridge 140, in order to associate test results to additional information of the test which in the case is the identity and all the associated information of the cartridge 140 that performed the test through barcode 142 with a reasonable expectation of success (para. 0033) (MPEP 2143)(I)(G));
the processor (310) further configured to link the unique identifier (barcode 142) from the LFA strip cassette with the patient identification information (para. 0033, barcode uses include associating test result to additional information including patient identification information, which is linked to barcode 142 as discussed above).
Nicolson teaches a portable medical device for diagnostic assays. Nicolson further teaches the device includes a barcode scanner 122 for obtaining patient identification information (paras. 0040 and 0043, scanning barcode 142 with scanner 122 as a way to input information such as patient and/or physician identification information into the base assay reader device 130). Nicolson further teaches barcode scanning module reduce transcription errors compared to manual entry of identifying information (para. 0090).
Nicolson teaches scanner 122 obtains patient information through scanning of a barcode to input the patient information, and thus fails to teach scanner 122 is for obtaining patient’s identification information from an identification card of a patient and the processor further configured to link the unique identifier from the LFA strip cassette with the patient identification information from the identification card (the examiner interprets the limitation requires the scanner being capable of reading identification card to extract patient information for the processor further link to the unique identifier.)
However, Price (US 20150350605 A1) teaches a portable electronic device for reading diagnostic test results from a test stick and collecting patient data for inclusion in a local chain of evidence database or transferring and receiving data from remote database. Price teaches that the electronic device comprises a scanner (optical edge scanner) for obtaining patient identification information from an identification card for a patient (paras. 0017 and 0022). Price teaches that the test stick includes a unique barcode for identifying the test stick and a test pad, and both the barcode and test pad are scanned by the optical edge scanner. Price further teaches the scanned image is analyzed by a software algorithm to determine the marking indication of the test pad and the unique alpha numeric coded two dimensional scan code, and the resulting data is written into an event file (paras. 0017 and 0037). Price further teaches the software writes the patient ID card data into the same event file (para. 0017), and thus associating the patient identification information and the test results with the unique identifier.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scanner 122 and processor 310 taught by Nicolson with the optical edge scanner and associate software algorithm taught by Price in order to scan not only a barcode but also the test subject/patient’s ID card in order to reduce transcription errors with a reasonable expectation of success (Price, para. 0017 and Nicolson, para. 0090) (MPEP 2143)(I)(G).
The teachings of Nicolson/modified Nicolson as modified by Price would yield the system comprising the scanner (scanner 122 is modified to be an optical edge scanner) for obtaining patient’s identification information from an identification card of a patient (Price, para. 0017) and the processor 310 further configured to link the unique identifier from the LFA strip cassette with the patient identification information from the identification card (processor 310 links barcode 142 with patient ID information as discussed above. In modified Nicolson, patient ID information is scanned from the patient’s ID card).
Regarding claim 2, modified Nicolson teaches all the elements of the current invention in claim 1. Nicolson further teaches the processor further configured to upload obtained data, the obtained data including the unique identifier of the cassette, and the associated patient identification information and the associated LFA test result to a central database. (Figs. 3-4, paras. 0024, 0044, 0072, processor 310 of assay reader device 300 can transmit all available information related to the test including barcode 142, patient identification information and test result to a centralized database.)
Regarding claim 8, modified Nicolson teaches all the elements of the current invention in claim 1. Modified Nicolson further teaches the scanner is a barcode scanner (Price, paras. 0017 and 0037).
Regarding claim 10, Nicolson teaches a method comprising:
receiving a cassette (Fig. 1A, 1B, para. 0053, cartridge 140) having a unique identifier (barcode code 142) that uniquely identifies the cassette (“uniquely identifies” does not impart any significance since there is only a single cassette. Moreover, para. 0033 and para. 0053 teaches cartridge 140 includes a barcode 142, and the barcode is unique since barcodes are used to associate results to patient identification information, and a user can access the stored test results by scanning a password barcode using the barcode scanner. If it determined that barcode 142 does not uniquely identify cartridge 140, the following rejection is put forth. Nicolson teaches the importance of traceability in medical settings and barcode scanning helps to ensure a high level of traceability (para. 0042-0043). Nicolson further teaches traceability is the ability to verify the information associated with a test performed using a reader device, para. 0042-0043. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified barcode 142 to uniquely identify the corresponding cartridge 140 in order to have additional information associated with a test and thus increase the level of traceability with a reasonable expectation of success (Nicolson, paras. 0042-0043) (MPEP 2143)(I)(G)) containing a lateral flow assay ("LFA") strip (assay 144. para. 0038, lateral flow assay test strip; para. 0036, assay reader device 130 receives cartridge 140);
reading the LFA strip to obtain an LFA strip image ( para. 0023, assay readers - CMOS imager or CCD imaging device - detect presence/absence of line; para. 0031, assay reader device captures images of the assay);
determining, using a processor, an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to an intensity threshold value (para. 0068 , processor 310 analyzes image data representing an imaged assay to determine the test result. Paras 0023 and 0071 , the test results is determined by the presence or absence of a visual line. The examiner interprets the value used to determine the presence or absence of a visual line is the threshold value);
receiving patient identification for a patient whose biological material is on the LFA strip, (Fig. 4 and para. 0081 teach processor 310 stores, and thus must have received, test results and any associated data, which includes patient identification information as disclosed in para. 0025);
associating the patient identification with the unique identifier (barcode 142) of the cassette (para. 0033 teaches barcode uses include associating test results to additional information including patient identification information, test type, device operation mode, sample information, and any other additional test or patient information pertinent to the test performed by the IVD device, and thus the examiner interprets the barcode is linked to the test results and patient identification information and other additional information, and the linking is performed by processor 310 (Fig. 4 and para. 0067). If it is determined that barcode 142 is not linked to the test results and the patient identification information, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor 310 to link the test result to barcode 142, which is associated with cartridge 140, in order to associate test results and additional information including patient identification information with the information of the cartridge that performed the test through barcode 142 with a reasonable expectation of success (para. 0033) (MPEP 2143)(I)(G).
Storing, the patient identification and the LFA test result in association with the unique identifier (barcode 142) of the cassette (cartridge 140) containing the LFA strip (Para. 0081 tests processor 310 stores test results and associated data obtained from barcode scanning. Paras 0033 and 0053 teaches cartridge 140 includes barcode 142, and barcodes are used to associate results to patient data including patient identification information).
Nicolson fails to teach receiving patient identification from a scanner for a patient whose biological material is on the LFA strip, the patient identification obtained from an identification card by the scanner; and associating the patient identification with the unique identifier of the cassette;
Nicolson teaches a portable medical device for diagnostic assays. Nicolson further teaches the device includes a barcode scanner 122 for obtaining patient identification information (paras. 0040 and 0043, scanning barcode 142 with scanner 122 as a way to input information such as patient and/or physician identification information into the base assay reader device 130). Nicolson further teaches barcode scanning ensure a high level of traceability and reduce transcription errors compared to manual entry of identifying information (paras. 0042-0043 and 0090).
Nicolson teaches scanner 122 obtains patient information through scanning of a barcode to input the patient information, and thus fail to explicitly teach receiving patient identification from a scanner for a patient whose biological material is on the LFA strip, the patient identification obtained from an identification card by the scanner.
However, Price (US 20150350605 A1) teaches a portable electronic device for reading diagnostic test results from a test stick and collecting patient data for inclusion in a local chain of evidence database or transferring and receiving data from remote database. Price teaches that the electronic device comprises a scanner (optical edge scanner) for obtaining patient identification information from an identification card for a patient (paras. 0017 and 0022). Price teaches that the test stick includes a unique barcode for identifying the test stick and a test pad, and both the barcode and test pad are scanned by the optical edge scanner. Price further teaches the scanned image is analyzed by a software algorithm to determine the marking indication of the test pad and the unique alpha numeric coded two dimensional scan code, and the resulting data is written into an event file (paras. 0017 and 0037). Price further teaches the software writes the patient ID card data into the same event file (para. 0017), and thus associating the patient identification information and the test results with the unique identifier.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scanner 122 and processor 310 taught by Nicolson with the optical edge scanner and associate software algorithm taught by Price in order to scan not only a barcode but also the test subject/patient’s ID card in order to ensure high level of traceability and manual transcription error with a reasonable expectation of success (Price, para. 0017 and Nicolson, para. 0042) (MPEP 2143)(I)(G).
The teachings of Nicolson/modified Nicolson as modified by Price would yield a method comprising receiving patient identification from a scanner (optical edge scanner) for a patient whose biological material is on the LFA strip, the patient identification obtained from an identification card by the scanner (Price, para. 0017).
Regarding claim 11, modified Nicolson teaches all the elements of the current invention in claim 10. Nicolson further teaches the method of claim 10 further comprising:
receiving patient information associated with the patient (Fig. 4 and para. 0081 teach processor 310 stores, and thus must have received, test results and any associated data, which includes patient identification information as disclosed in paras. 0025);
wherein the processor uploads the patient information and the LFA test result to a central database (Figs. 3-4, paras. 0024, 0044, 0072, processor 310 of assay reader device 330 can transmit all available information related to the test including barcode 142, patient identification information and test result to a centralized server).
Regarding claim 22, Nicolson teaches a system to analyze a plurality of cassettes having a unique identifier and containing a lateral flow assay ("LFA") strip, the system comprising, for each of the plurality of cassettes:
an LFA strip reader (cartridge reader 335) to obtain an LFA strip image (Fig. 3 and paras. 0068, cartridge reader 335 includes photodetector 340 for reading an assay held in the inserted cartridge and send image data from the photodetectors to processor 310. Paragraphs 0002 and 0023 teach the assay is intended to be an LFA strip);
a processor (310) to determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to an intensity threshold value (para. 0068, cartridge reader 335 can send image data from the photodetectors to processor 310 for analysis of the image data representing the imaged assay to determine a test result of the assay; paras. 0023 and 007 , the test results are determined by the presence or absence of a visual line. The examiner interprets the value used to determine the presence or absence of a visual line is the threshold value);
a scanner (barcode scanner 122) to receive patient identification for a patient whose biological material is on the LFA strip (paras. 0025, barcode scanner 122 is for use in user input of any needed information such as patent identification information); and
a memory (315) to store the patient identification and LFA test result in association with the unique identifier (barcode 142) of the cassette (cartridge 140) (Fig. 3, paras. 0070-0072 test data results and associated information stored in repository 305 in memory 315; paras. 0033 and 0053, barcode 142, and barcodes can be used to associate results to patient identification information).
Nicolson teaches a portable medical device for diagnostic assays. Nicolson further teaches the device includes an LFA strip reader (cartridge reader 335) to obtain an LFA strip image (para. 0069) and a barcode scanner 122 for obtaining patient identification information (paras. 0033 and 0053). Nicolson further teaches scanning reduce transcription errors compared to manual entry of identifying information (para. 0090)
Nicolson teaches scanner 122 obtains patient information through scanning of a barcode to input the patient information (paras. 0040 and 0043), and thus fails teach scanner 122 receive patient identification information from an identification card for a patient. In addition, Nicolson fails to teach the LFA strip reader (335) obtain the LFA strip image includes the unique identifier. Consequently, Nicolson fails to teach the processor associates the patient identification and the LFA test results with the unique identifier.
However, Price (US 20150350605 A1) teaches a portable electronic device for reading diagnostic test results from a test stick and collecting patient data for inclusion in a local chain of evidence database or transferring and receiving data from remote database. Price further teaches teach a scanner (optical edge scanner) for receiving patient identification information from an identification card for a patient (paras. 0017 and 0022). Price teaches that the test stick includes a unique barcode for identifying the test stick, and both the barcode and test pad are scanned by the optical edge scanner (paras. 0017 and 0037). Price further teaches the scanned image is analyzed by a software algorithm to determine the marking indication of the test pad and the unique alpha numeric coded two dimensional scan code, and the resulting data is written into an event file (paras. 0017). Price further teaches the software writes the patient ID card data into the same event file (para. 0017), and thus associating the patient identification information and the test results with the unique identifier.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the scanner 122 and processor 310 taught by Nicolson with the optical edge scanner and the associate software algorithm to scan not only a barcode but also the test subject/patient’s ID card taught by Price in order to minimize transcription errors of manually inputting the patient identification information with a reasonable expectation of success (Price, para. 0017 and Nicolson, para. 0090) (MPEP 2143)(I)(G).
Modified Nicolson teaches the LFA strip reader obtaining the LFA strip image, but fails to teach the image includes the unique identifier.
However, Nicolson teaches that reader 335 is capable of obtaining image data (Fig. 3 and paras. 0023 and 0068, cartridge reader 335 includes photodetector for reading the LFA strip held in the inserted cartridge and send image data from the photodetectors to processor 310), and Price teaches that both the test result on the test pad of the test stick is scanned along with the unique barcode on the test stick for identifying the test stick, and the scanned image analyzed by a software algorithm to determine the marking indication of the test pad and the unique alpha numeric coded two dimensional scan code (paras. 0017 and 0037).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified reader 335 of Nicolson to capture the image data of the barcode along with the test result as taught by Price in order to identify the test stick/cartridge by the barcode with the test result with a reasonable expectation of success (Price, para. 0017) (MPEP 2143)(I)(G).
The teachings of Nicolson as modified by Price would yield scanner 122 (modified to be optical edge scanner taught by Price) receive patient identification information from an identification card for a patient (Price, para. 0017), and the LFA strip reader (335) obtain the LFA strip image includes the unique identifier, and the processor (310) associates the patient identification and the LFA test results with the unique identifier (para. 0033 teaches barcode uses include associating test results to additional information including patient identification information, test type, device operation mode, sample information, and any other additional test or patient information pertinent to the test performed by the IVD device, and thus the examiner interprets the barcode is linked to the test results and the additional information, and the linking is performed by processor 310 (Fig. 4 and para. 0067). If it is determined that barcode 142 is not linked to the test results, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor 310 to link the test result to barcode 142, which is associated with cartridge 140, in order to associate test results with the information of the cartridge that performed the test through barcode 142 with a reasonable expectation of success (para. 0033) (MPEP 2143)(I)(G). Alternatively, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor 310 taught by Nicolson to include the software to write the test result, the barcode and patient ID card data into the same event file, and thus associating the patient identification information and the test results with the unique identifier taught by Price in order to have inclusion in a local chain of evidence database and for transferring and receiving data from remote databases with a reasonable expectation of success (Price, abstract) (MPEP 2143)(I)(G).
The examiner notes that the plurality of cassette is not given patentable weight because it is in the preamble.
Regarding claim 23, modified Nicolson teaches all of the elements of the current invention as stated above with respect to claim 1. With respect to “the unique identifier is associated with the cassette”, neither the cassette nor the unique identifier is positively recited, and thus neither is part of the invention. Since the limitation is directed to the unique identifier, this claim does not further limit the invention.
Claims 17-19 and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolson (US 20190229907 A1) in view of Worrell et al. (US 20140018779 A1).
Regarding claim 17, Nicolson teaches a system comprising:
a processor (310);
memory (315) coupled to the processor for storing a local testing database (module recognition component 320 and test result determination component 325), the testing database including a test configuration profile (para. 0071, instructions that call subroutines to configure the processor 310 to read an information element of an inserted module and instructions that call subroutines to configure process to analyze assay image data) for a cassette (cartridge 140) with a lateral flow assay ("LFA") strip (assay 144. Paragraph 0038 , the assay can be a lateral flow assay test strip) having a test line (para. 0023, visual line), the test configuration profile including an intensity threshold value for the test line that represents an intensity value which indicates a positive test result (para. 0071, test result determination component 325 can include instructions that call subroutines to configure the processor 310 to analyze assay image data received from the photodetector 340 to determine a result of the assay. The processor can compare image data to a number of templates or pre-identified patterns to determine the test result. Paragraph 0023 , the presence or absence of a visual line on the lateral flow gives positive/negative test indication. The examiner interprets the value used to determine the presence or absence of a visual line is the threshold value); and
an LFA strip reader (Fig. 3, cartridge reader 335) coupled to the processor for reading the LFA strip in the cassette (cartridge 140)(Fig. 3 and para. 0071), the cassette having a unique identifier (barcode 142) that uniquely identifies the cassette (the cassette is not positively recited. While the cassette provide context for the LFA strip reader and other elements of the invention, the cassette itself is not part of the invention. Therefore, the unique identifier of the cassette does not further limit how the LFA strip reader reads the LFA. Furthermore, uniquely identifies” does not impart any significance since there is only a single cassette. Moreover, para. 0033 and para. 0053, cartridge 140 include a barcode 142, and the barcode is unique since barcodes are used to associate results to patient identification information, and a user can access the stored test results by scanning a password barcode using the barcode scanner. If it determined that barcode 142 does not uniquely identify cartridge 140, the following rejection is put forth. Nicolson teaches the importance of traceability in medical settings and barcode scanning helps to ensure a high level of traceability (para. 0042-0043). Nicolson further teaches traceability is the ability to verify the information associated with a test performed using a reader device, para. 0042-0043. Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified barcode 142 to uniquely identify the corresponding cartridge 140 in order to have additional information associated with a test and thus increase the level of traceability with a reasonable expectation of success (Nicolson, paras. 0042-0043) (MPEP 2143)(I)(G);
the processor further configured to determine an LFA test result based on comparing a measured intensity value of a portion of the LFA strip image to the intensity threshold value (para. 0071 , test result determination processor 310 analyze assay image and determine a result of the assay. The processor can compare image data to a number of templates or pre-identified patterns to determine the test result. Paragraph 0023 , the presence or absence of a visual line on the lateral flow gives positive/negative test indication. The examiner interprets the value used to determine the presence or absence of a visual line is the threshold value);
the processor (310) further configured to associate the unique identifier (barcode 142) with the result data of the testing (para. 0033 teaches barcode uses include associating test results to additional information including patient identification information, test type, device operation mode, sample information, and any other additional test or patient information pertinent to the test performed by the IVD device, and thus the examiner interprets the barcode is linked to the test result and other additional information, and the linking is performed by processor 310 (Fig. 4 and para. 0067). If it is determined that barcode 142 is not linked to the test result, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the processor 310 to link the test result to barcode 142 of cartridge 140, in order to associate the test result and additional information, which in case the identity and all the associated information of cartridge 140 that performed the test through barcode 142 with a reasonable expectation of success (para. 0033) (MPEP 2143)(I)(G;
the processor (310) further configured to store the result data including the LFA test result (Fig. 4 and para. 0081 teach processor 310 stores test results and any associated data, which includes patient identification information as disclosed in paras. 0025. paras. 0033, 0053, barcodes are used to associate results to patient identification information, and para. 0081, processor 310 stores test results and associated data obtained from barcode scanning).
Nicolson further teaches the disclosed the system is designed to have a bay for receiving a number of different modules. Such a modular design approach allows the system to expand its functionalities (para. 0025).
Nicolson fails to teach a symptom entry device coupled to the processor for receiving a patient symptom, and the processor configured to receive the symptom from the symptom entry and store the patient symptom associated with a unique identifier of the cassette;
However, Worrell teaches a patient-care system comprises a patient care unit that can perform diagnostic tests using test strips (para. 0100). Worrell further teaches the patient care unit includes a processor. Worrell teaches a symptom entry (para. 0233, touch sensitive display) coupled to the processor (processing device 230) for receiving a patient symptom (paras. 0009, 0119, 0205, 0233) and the processor configured to receive the symptom from the symptom entry ( paras. 0009, 0119, 0205, 0233) and store the patient symptom associated with patient-specific information (Fig. 8 and para. 0009 , that the processor generates a patient care unit interface configured to receive data from the patient care unit and an electronic medical records interface configured to retrieve data from an electronic medical record associated with the patient. The received data symptom of the patient from the patient are unit is uploaded and stored along with patient’s historical medical data in server 306, indicating that the symptom of the patient is associated with the patient-specific information).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient-care system device taught by Nicolson to have the symptom entry coupled to the processor for receiving a patient symptom; and the processor configured to receive the symptom from the symptom entry and store the patient symptom associated with a unique identifier of the cassette disclosed by Worrell. One of ordinary skill in the art would be motivated to make this modification in order to expand the remote patient-care system’s functionalities with a reasonable expectation of success. (Nicolson, para. 0025) (MPEP 2143)(I)(G).
The teachings of the Nicolson as modified by Worrell would yield the processor configured to store the patient symptom associated with patient-specific information because Worrell teaches associating, by the processor, the symptom of the patient with the patient-specific information; and uploading to a central database, by the processor, the symptom of the patient in association with the patient-specific information, and Nicolson teaches the use of the unique identifier of the cassette to associate patient’s data with the patient identification information.
Regarding claim 18, modified Nicolson in view of Worrell teaches all of the elements of the current invention as stated above with respect to claim 17.
Modified Nicolson further teaches the system of claim 17, further comprising a scanner (Nicolson, para. 0040, barcode scanner 122) to obtain patient identification information (Nicolson, paras. 0025 , barcode scanner 122 is for use in user input of any needed information such as patent identification information); the processor further configured to receive the patient identification information (Nicolson, Fig. 4 and para. 0081 teach processor 310 stores, and thus must have received, test results and any associated data, which includes patient identification information as disclosed in paras. 0025), and associate the patient identification information with the unique identifier (barcode 142)(para. 0033 and 0053 , barcodes are used to associate test results to data including patient identification information, and para. 0081, processor 310 stores test results and associated data obtained from barcode scanning).
Regarding claim 19, modified Nicolson in view of Worrell teaches all of the elements of the current invention as stated above with respect to claim 17.
Modified Nicolson fails to teach the system of claim 17, further comprising one or more of: a pulse oximeter, a scale, thermometer, a sphygmomanometer, providing patient data to the processor, wherein the processor associates the patient data with the unique identifier.
However, Worrell further teaches a patient-care system comprises a patient care unit that can perform diagnostic tests using test strips (para. 0100). Worrell teaches the system comprises a processor (processing device 230) and a pulse oximeter (Fig. 4 and para. 0122, pulse oximeter 204), providing patient data to the processor (paras. 0095 and 0119 teach pulse oximeter 204 takes a reading of the blood oxygen saturation, and the reading is transmitted to processing device 230), wherein the processor associates the patient data with the patient-specific information (Worrell in Fig. 8 and para. 0009 , that the processing device generates a patient care unit interface configured to receive data from the patient care unit and an electronic medical records interface configured to retrieve data from an electronic medical record associated with the patient. The received data from the patient are unit is stored along with patient’s historical medical data in server 306, indicating that the blood oxygen saturation is associated with the patient-specific information).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient-care system taught by modified Nicolson to have a pulse oximeter, providing patient data to the processor, wherein the processor associates the patient data with the patient-specific information disclosed by Worrell. One of ordinary skill in the art would be motivated to make this modification in order to expand the remote patient-care system’s functionalities with a reasonable expectation of success. (Nicolson, para. 0025) (MPEP 2143)(I)(G).
The teachings of the Nicolson as modified by Worrell would a pulse oximeter providing patient data to the processor, wherein the processor associates the patient data with the unique identifier because Worrell teaches associating the patient data the blood oxygen saturation reading with the patient-specific information, and Nicolson teaches the use of the unique identifier to associate patient’s data with the patient identification information.
Regarding claim 21, modified Nicolson in view of Worrell teaches all of the elements of the current invention as stated above with respect to claim 17.
Modified Nicolson further teaches wherein the processor uploads the result data to a central database (Figs. 3-4, paras. 0024, 0044, 0072, processor 310 of assay reader device 300 can transmit all available information related to the test including barcode 142, patient identification information and test result to a centralized database).
Claims 3-7 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nicolson (US 20190229907 A1) in view of Price (US 20150350605 A1) as applied to claim 1 above, and further in view of Worrell et al. (US 20140018779 A1).
Regarding claim 3, modified Nicolson teaches all of the elements of the current invention as stated above with respect to claim 1. Nicholson teaches a remote patient-care system that perform diagnostic tests using assay cassettes, and subsequently send the test results and associated patient identification information to a central database. Nicolson teaches a test result and the associated patient identification are linked with a unique identifier of the cassette. Nicolson further teaches the disclosed the system is designed to have a bay for receiving a number of different modules. Such a modular design approach allows the system to expand its functionalities (para. 0025).
Nicolson fails to teach a thermometer to take a temperature reading of the patient; the processor configured to receive the temperature reading of the patient and associate the temperature reading with the unique identifier of the cassette.
However, Worrell teaches a patient-care system comprises a patient care unit that can perform diagnostic tests using test strips (para. 0100). Worrell teaches the patient care unit includes a thermometer (instrument 120; para. 0122, instrument 120 can be a thermometer) to take a temperature reading of the patient (para. 0071, instrument 120 are provided to collect data regarding patient’s current condition; para. 0122, a thermometer is a possible instrument 120. The examiner interprets the data collected by thermometer is a temperature reading. Fig. 17 also discloses temperature is shown in a patient care interface); the processor (processing device 230) configured to receive the temperature reading of the patient ( paras. 0118-0119 teach processing device 230 stores the data from instrument 120 or passes the data to another device. In order to store or pass the data, processing device 230 must have received the data from instrument 120) and associate the temperature reading with the patient-specific information (Fig. 8 and para. 0009, that the processing device generates a patient care unit interface configured to receive data temperature reading from the patient care unit and an electronic medical records interface configured to retrieve data from an electronic medical record associated with the patient. The received data temperature reading from the patient care unit is stored along with patient’s historical medical data in server 306, indicating that the temperature reading is associated with the patient-specific information.)
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient-care system taught by Nicolson to have the thermometer to take a temperature reading of the patient; the processor configured to receive the temperature reading of the patient and associate the temperature reading with patient-specific information disclosed by Worrell. One of ordinary skill in the art would be motivated to make this modification in order to expand the remote patient-care system’s functionalities with a reasonable expectation of success. (Nicolson, para. 0025) (MPEP 2143)(I)(G).
The teachings of the Nicolson as modified by Worrell would yield the processor associate the temperature reading with the unique identifier of the cassette because Worrell teaches associating the temperature with the patient-specific information, and Nicolson teaches the use of the unique identifier of the cassette to associate patient’s data (e.g., test result) with the patient identification information.
Regarding claim 4, modified Nicolson teaches all of the elements of the current invention as stated above with respect to claim 1. Nicholson teaches a remote patient-care system that perform diagnostic tests using assay cassettes, and subsequently send the test results and associated patient identification information to a central database. Nicolson teaches a test result and the associated patient identification are linked with a unique identifier of the cassette. Nicolson further teaches the disclosed the system is designed to have a bay for receiving a number of different modules. Such a modular design approach allows the system to expand its functionalities (para. 0025).
Nicolson fails to teach a pulse oximeter to take a blood oxygen saturation measurement of the patient; the processor further to receive the blood oxygen saturation measurement of the patient and associated it with the unique identifier of the cassette.
However, Worrell teaches a patient-care system comprises a patient care unit that can perform diagnostic tests using test strips (para. 0100). Worrell teaches the patient care unit includes a pulse oximeter (para. 0095, pulse oximeter 204) to take a blood oxygen saturation measurement of the patient (para. 0095); the processor (processing device 230) configured to receive the blood oxygen saturation measurement of the patient ( paras. 0095 and 0119, the measurement is transmitted to processing device 230) and associate the blood oxygen saturation measurement with the patient-specific information (Fig. 8 and para. 0009 , that the processing device generates a patient care unit interface configured to receive data the blood oxygen saturation measurement from the patient care unit and an electronic medical records interface configured to retrieve data from an electronic medical record associated with the patient. The received data the blood oxygen saturation measurement from the patient are unit is stored along with patient’s historical medical data in server 306, indicating that the data the blood oxygen saturation measurement is associated with the patient-specific information.
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the patient-care system taught by Nicolson to have a pulse oximeter to take a blood oxygen saturation measurement of the patient; the processor further to receive the blood oxygen saturation measurement of the patient and associated it with the patient-specific information disclosed by Worrell. One of ordinary skill in the art would be motivated to make this modification in order to expand the remote patient-care system’s functionalities with a reasonable expectation of success. (Nicolson, para. 0025) (MPEP 2143)(I)(G).
The teachings of the Nicolson as modified by Worrell would yield the processor associate the blood oxygen saturation measurement with the unique identifier of the cassette because Worrell teaches associating the blood oxygen saturation measurement with the patient-specific information, and Nicolson teaches the use of the unique identifier of the cassette to associate patient’s data (e.g., test results) with the patient identification information.
Regarding claim 5, modified Nicolson teaches all of the elements of the current invention as stated above with respect to claim 1. Nicholson teaches a remote patient-care system that perform diagnostic tests using assay cassettes, and subsequently send the test results and associated patient identification information to a central database. Nicolson teaches a test result and the associated patient identification are linked with a unique identifier of the cassette. Nicolson further teaches the disclosed the system is designed to have a bay for receiving a number of different modules. Such a modular design approach allows the system to expand its functionalities (para. 0025).
Nicolson fails to teach a scale to measure a weight of the patient; the processor further to receive the weight of the patient and associate the weight with the unique identifier of the cassette.
However, Worrell teaches a patient-care system comprises a patient care unit that can perform diagnostic tests using test strips (para. 0100). Worrell teaches the patient care unit includes a scale (Fig. 7 and para. 0122, wireless weight scale) to measure a wei