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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/06/2025 has been entered.
Response to Arguments
Applicant’s arguments and amendments filed 08/06/2025 have been fully considered.
Regarding the Specification objections, the amendments to the specification have overcome the objection.
Regarding the 35 USC 103 rejection, Applicant's arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Specifically, the Evans reference has been provided to teach the claim amendments.
Response to Amendment
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-21 are rejected under 35 U.S.C. 103 as being unpatentable over Fleming et al. (US 20100045789 A1) in view of Lin (US 20210086177 A1) and Evans (US 20160085913 A1).
Regarding Claim 1, Fleming discloses a testing system comprising (Abstract, an assay system includes an optical imager to acquire high resolution images of assay strips):
a processor (processing unit – element 212a, Figure 2);
memory (system memory – element 214, Figure 2) coupled to the processor (Figure 2) for storing (Paragraph 0129, the processor subsystem 282 may include one or more processors (e.g., microprocessors, DSPs, ASICs, FPGAs), and memory (spinning media or solid-state media such as RAM, ROM, and FLASH media)) a local testing database (database – element 4300 [Examiner notes element 4300 is found in Figure 43 where it illustrates a database on the display]; Paragraph 0167, the processor(s) results for each assay strip in a database on a computer-readable storage medium (e.g., hard disk, optical disk, floppy disk, FLASH card, etc.)) storing a test configuration profile, wherein the test configuration profile has an intensity threshold value (Paragraph 0226, detailed listing of assay results 3706 may provide density values, threshold values and results for each separate assay or control line of the particular assay or assay strip) denoting a positive test result (Figures 22-23 [Examiner notes the figures illustrate screen prints showing positive test results]);
a carrier (assay system – element 3800; Figure 38) for receiving a cassette containing a lateral flow assay ("LFA") strip (Abstract, assay strips may be in a holder or carrier contained in a specimen container also holding a specimen; Figure 38);
an LFA strip reader (imager – element 266; Figure 2) coupled to the processor for reading the LFA strip (Paragraph 0010, an imager subsystem operable to capture images of any of the assay strips received in the interior of the housing...the at least one processor also communicatively coupled to the imager subsystem to receive image information representative of the images captured by the imager subsystem; Figure 6 & 10A, flow charts illustrates the imaging process and storing the images in the processor) regardless of alignment of the cassette within the carrier (Paragraph 0137, the imager 402 is mounted for movement relative to the assay strips 400. For example, the imager 402 may be mounted for translation along rails 410a, 410b. Alternatively, the imager 402 may be mounted for rotation or pivoting with respect to the assay strips 400 [Examiner notes Fleming discloses “the imager 402 may be mounted for rotation or pivoting with respect to the assay strips 400” meaning the assay strips will be read regardless of the alignment and the imager will reposition itself with respect to the assay strip]; elements 400, 402, 410a, and 410b are illustrated in Figure 4) and transmitting an LFA strip image to the processor (Figure 6 and 10A); and
a marking device (reader – element 130) in the testing system coupled to the processor for marking the cassette (Figure 2 [Examiner notes the figure shows how the processor and the reader are coupled]; Paragraph 0128, the reader 130 includes an information acquisition component or engine 280 to optically acquire the machine-readable symbol; Paragraph 0134, the reader 130 may be used to read machine-readable information carried by assay strips, test tubes, cuvettes, cups, plates, wells, trays, or carried on the assay device (e.g., machine-readable symbols 108 marking respective slots 106, illustrated in FIG. 1). The machine-readable information may be carried by a tag or label which is adhered or otherwise attached to the article. Alternatively, the machine-readable information may be printed, engraved, etched, or otherwise applied to the article itself, without the use of a tag or label); [Examiner’s note, the acquire engine (element 280 – Figure 2) is part of the reader (element 130 – Figure 2) where it can print, engrave, and or etch onto the test strip. Additionally, the acquire engine contains the function of machine-readable symbol reader where it reads machine-readable symbols. One can determine the marking device, the reader – element 130, has the function for marking the cassette]);
wherein the processor determines an LFA test result based on comparing a measured intensity value (Figure 23-24 [Examiner notes the two figures illustrate the screen print of a positive and a negative result. Both screen prints have a “Details:” box that shows a controlled intensity value and the actual measured intensity value from the assay strip. The screen print does not explicitly say intensity value rather control/test line density. By broadest reasonable interpretation, one can determine the intensity value are the values shown with the control/test line density.]) of a portion of the LFA strip image to the intensity threshold value (Figure 11).
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Annotated Figure 1 | Flow Chart of Fig. 11 illustrating how the processor determines a test result from the LFA strip image to the intensity threshold.
Though Fleming alludes to a marking device by disclosing a marking on a cassette, but is silent on the marking device specifically (Abstract and Paragraphs 0010, 0128-0129, 0134, 0137, 0167, 0226). However, Lin teaches a marking device (Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Additionally, Fleming in view of Lin is silent in teaching marking the cassette…after the cassette is inserted into the testing system for reading; Evans teaches marking the cassette…after the cassette is inserted into the testing system for reading (Evans | Paragraph 0010). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming in view of Lin to incorporate the teachings of marking the cassette after the cassette is inserted into the testing system for reading from Evans. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Evans | Paragraph 0010).
Regarding Claim 2, Fleming in view of Lin and Evans teaches the testing system of claim 1. Though the primary reference of Fleming alludes to a marking device by disclosing a marking on a cassette but is silent on the marking device specifically, Lin teaches wherein the marking device is a laser (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art to modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin, since it has been held that forming in one piece an article that has formerly been formed in more than one piece and put together involves only routine skill in the art. In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965) (A claim to a fluid transporting vehicle was rejected as obvious over a prior art reference which differed from the prior art in claiming a brake drum integral with a clamping means, whereas the brake disc and clamp of the prior art comprise several parts rigidly secured together as a single unit. The court affirmed the rejection holding, among other reasons, “that the use of a one piece construction instead of the structure disclosed in [the prior art] would be merely a matter of obvious engineering choice.”) MPEP 2144.04-V-B.
Regarding Claim 3, Fleming in view of Lin and Evans teaches the testing system of claim 1. The primary reference of Fleming discloses a unique identifier marking written on a cassette (Fleming | Paragraph 0134, machine-readable information may include unique identification information (e.g., alphanumeric serial number, etc.), which uniquely identifies the article) but is silent on the marking device to write that unique identifier on the cassette, Lin teaches the marking device writes a unique identifier on the cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 4, Fleming in view of Lin and Evans teaches the testing system of claim 1, wherein a code on the cassette selected from a group consisting of: a barcode, QR code, and a data matrix (Fleming | Paragraph 0224, the reader may read or capture an identifier from a piece of identification, for example by scanning or imaging the piece of identification. For instance, the reader may take the form of a machine-readable symbol reader such as a barcode scanner or imager to read machine-readable symbols (e.g., barcode symbols, area or matrix code symbols, stacked code symbols); Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip).
Though Fleming teaches a barcode, QR code, or data matrix marking on a cassette but is silent on the marking device writing those codes unto the cassette, Lin teaches a marking device writes on a cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 5, Fleming in view of Lin and Evans teaches the testing system of claim 4, wherein the code encodes a unique identifier (Fleming | Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip).
Regarding Claim 6, Fleming in view of Lin and Evans teaches the testing system of claim 5, wherein the unique identifier (Fleming | machine-readable symbol – element 108) is serialized (Fleming | Paragraph 0134, the machine-readable information may include unique identification information (e.g., alphanumeric serial number, etc.), which uniquely identifies the article [Examiner note, machine-readable information and machine-readable symbol are synonymous to one another]).
Regarding Claim 7, Fleming in view of Lin and Evans teaches the testing system of claim 6, wherein the unique identifier is sourced from a vendor (Fleming | Paragraph 0106, the reader 130 may take the form of any commercially available machine-readable symbol reader such as those available from Intermec Technologies of Everett, Wash. The machine-readable symbol reader may be configured to read machine-readable symbols encoded in one or more machine-readable symbologies (e.g., Code 93i, Code 39, Datamatrix code, UPC/EAN, etc.). The assay system 100 may employ other automatic data collection devices as readers, for example magnetic stripe readers, radio frequency identification readers or interrogators, etc).
Regarding Claim 8, Fleming in view of Lin and Evans teaches the testing system of claim 1. The primary reference of Fleming teaches a logo on a cassette (Fleming | Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip; [Examiner’s note, the examiner interpreted “a logo” is a unique identifier]) but is silent on the marking device specifically marking that logo, Lin teaches the marking device writes on a logo on the cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 9, Fleming in view of Lin and Evans teaches the testing system of claim 1, personal information of a patient that used the LFA strip onto the cassette (Fleming | Paragraph 0224, the report 3700 may include identification information 3702 identifying the individual being subjected to testing. The identification information 3702 may be read or captured directly from an individual being subjected to testing or from identification material, such as government issued identification (e.g., driver’s license, identity card, passport, military identification card), issued to the individual being subjected to testing. For example, the assay system may include or may be communicatively coupled to a reader that automatically reads information identifying information, either from the individual directly and/or from identification carried by or otherwise associated with the individual; [Examiner note, all the elements mentioned in Paragraph 0224 are found in Figure 37]).
Fleming is silent on a marking device to mark that personal information, Lin teaches a marking device writes on a cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 10, Fleming discloses a method comprising (Paragraph 0020, a method of operating an assay system to perform assays of assay strips):
storing a local testing database (database – element 4300) in a memory (system memory – element 214; Paragraph 0129, the processor subsystem 282 may include one or more processors (e.g., microprocessors, DSPs, ASICs, FPGAs), and memory (spinning media or solid-state media such as RAM, ROM, and FLASH media); Paragraph 0167, at 1030, the processor(s) results for each assay strip in a database on a computer-readable storage medium (e.g., hard disk, optical disk, floppy disk, FLASH card, etc.)), the local testing database including a plurality of test configuration profiles with each test configuration profile having an intensity threshold value denoting a positive test result (Paragraph 0033, at least one processor may be configured to perform the objective assay evaluation by objectively quantifying an intensity of at least one positive results signal line on each of the assay strips…the entrance may include a plurality of slots, each slot sized and dimensioned to receive a respective one or the assay strips therein);
receiving a cassette containing a lateral flow assay ("LFA") strip (Figures 3-5 [Examiner note, the three figures illustrate an isometric diagram of a number of test strips positioned in a carrier]);
reading the LFA strip and a visual feature of the cassette and transmitting an LFA strip image and the visual feature to a processor (Paragraph 0010, an imager subsystem operable to capture images of any of the assay strips received in the interior of the housing...the at least one processor also communicatively coupled to the imager subsystem to receive image information representative of the images captured by the imager subsystem);
the cassette with a unique identifier (machine-readable symbol – element 108) in the LFA strip reader (imager – element 266; Figure 2) coupled to the processor (Figure 2; Paragraph 0010, an imager subsystem operable to capture images of any of the assay strips received in the interior of the housing...the at least one processor also communicatively coupled to the imager subsystem to receive image information representative of the images captured by the imager subsystem; Figure 6 & 10A, flow charts illustrates the imaging process and storing the images in the processor);
determining, using the processor (processing unit – element 212a; Figure 2), a first test configuration profile based on the visual feature and determining an LFA test result based on comparing a measured intensity value (Paragraph 0033, the at least one configurable criteria may include a threshold level to objectively evaluate the test results signal line) of a portion of the LFA strip image to the intensity threshold value of the first test configuration profile (Paragraph 0144, the processing system computationally performs an objective assay evaluation for each assay strip based on a representation of one or more signal lines (e.g., positive test results, control) in the captured high resolution image. For example, the processing system may determine a magnitude of a positive test results signal line and compare the determined magnitude to a threshold value); and
providing the LFA test result (Figure 22-25 [Examiner note, the figures illustrate screen prints of the test results]).
Though Fleming alludes to a marking device by disclosing a marking on a cassette, but is silent on the marking device specifically (Paragraphs 0010, 0020, 0033, 0128, 0134, 0144, 0167). However, Lin teaches a marking device (Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Fleming in view of Lin is silent in teaching inserting the cassette into a testing device; marking the cassette…after the LFA strip is inserted into the testing device; Evans teaches inserting the cassette into a testing device and marking the cassette…after the LFA strip is inserted into the testing device (Evans | Paragraph 0010). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming in view of Lin to incorporate the teachings of marking the cassette after the cassette is inserted into the testing system for reading from Evans. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Evans | Paragraph 0010).
Regarding Claim 11, Fleming in view of Lin and Evans teaches the method claim of 10. The primary reference of Fleming alludes to a marking device by disclosing a marking on a cassette, but is silent on the marking device specifically, Lin teaches the method of claim 10, wherein the marking comprises laser etching (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 12, Fleming in view of Lin and Evans teaches the method of claim 10, wherein a code on the cassette selected from a group consisting of a barcode, QR code, and a data matrix (Fleming | Paragraph 0224, the reader may read or capture an identifier from a piece of identification, for example by scanning or imaging the piece of identification. For instance, the reader may take the form of a machine-readable symbol reader such as a barcode scanner or imager to read machine-readable symbols (e.g., barcode symbols, area or matrix code symbols, stacked code symbols); Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip).
Though Fleming teaches a barcode, QR code, or data matrix marking on a cassette but is silent on the marking device writing those codes unto the cassette, Lin teaches a marking device writes on a cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 13, Fleming in view of Lin and Evans teaches the method of claim 12, wherein the code encodes the unique identifier (Fleming | Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip), and the unique identifier is serialized (Fleming | Paragraph 0134, the machine-readable information may include unique identification information (e.g., alphanumeric serial number, etc.), which uniquely identifies the article).
Regarding Claim 14, Fleming in view of Lin and Evans teaches the method of claim 13, wherein the unique identifier is sourced from a vendor (Fleming | Paragraph 0106, the reader 130 may take the form of any commercially available machine-readable symbol reader such as those available from Intermec Technologies of Everett, Wash. The machine-readable symbol reader may be configured to read machine-readable symbols encoded in one or more machine-readable symbologies (e.g., Code 93i, Code 39, Datamatrix code, UPC/EAN, etc.). The assay system 100 may employ other automatic data collection devices as readers, for example magnetic stripe readers, radio frequency identification readers or interrogators, etc.).
Regarding Claim 15, Fleming in view of Lin and Evans teaches a logo on the cassette (Fleming | Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip; [Examiner’s note, the examiner interpreted “a logo” is a unique identifier]). Fleming is silent on the marking device specifically marking that logo, Lin teaches a marking device writes on a cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 16, Fleming in view of Lin and Evans teaches the method of claim 10, further comprising personal information of a patient tested using the LFA strip onto the cassette (Fleming | Paragraph 0224, "The report 3700 may include identification information 3702 identifying the individual being subjected to testing. The identification information 3702 may be read or captured directly from an individual being subjected to testing or from identification material, such as government issued identification (e.g., driver’s license, identity card, passport, military identification card), issued to the individual being subjected to testing. For example, the assay system may include or may be communicatively coupled to a reader that automatically reads information identifying information, either from the individual directly and/or from identification carried by or otherwise associated with the individual); [Examiner’s note, all the elements mentioned in Paragraph 0224 are found in Figure 37]).
Fleming is silent in teaching the marking device to mark that personal information, Lin teaches a marking device writes on a cassette (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 17, Fleming discloses a testing system comprising (Abstract, an assay system includes an optical imager to acquire high resolution images of assay strips):
a processor (processing unit – element 212a);
memory coupled to the processor (Paragraph 0129, the processor subsystem 282 may include one or more processors (e.g., microprocessors, DSPs, ASICs, FPGAs), and memory (spinning media or solid-state media such as RAM, ROM, and FLASH media));
an opening configured to receive a sample in a sample receptacle (Paragraph 0229, the assay system 3800 may be similar to the previously described assay systems, however includes at least one opening or slot 3804 sized to at least partially receive the container 3802 therein [Examiner note, the elements listed in this paragraph are illustrated in Figure 38]) for testing;
a marking device coupled to the processor (Paragraph 0106, the assay system 100 may optionally include a stand-alone reader 130 communicatively coupled to the assay device [Examiner note, assay device 102 contains a processing unit 212a and illustrated in Figure 2] 102 and/or peripheral computing system 114 [Examiner note, peripheral computing system 114 contains a processing unit 268 and illustrated in Figure 2]); and
a patient identification reader (Paragraph 0224, the reader may read or capture an identifier from a piece of identification, for example by scanning or imaging the piece of identification) coupled to the processor for reading a patient identity (Paragraph 0224, the report 3700 may include identification information 3702 identifying the individual being subjected to testing. The identification information 3702 may be read or captured directly from an individual being subjected to testing or from identification material, such as government issued identification (e.g., driver’s license, identity card, passport, military identification card), issued to the individual being subjected to testing. For example, the assay system may include or may be communicatively coupled to a reader that automatically reads information identifying information, either from the individual directly and/or from identification carried by or otherwise associated with the individual),
wherein the processor (Paragraph 0134, the reader 130 may be used to read the machine-readable information carried by assay strips…the machine-readable information may be printed, engraved, etched, or otherwise applied to the article itself) a unique identifier (Paragraph 0134, machine-readable information may include unique identification information (e.g., alphanumeric serial number, etc.), which uniquely identifies the article) associated with the patient identity on the sample receptacle (Paragraph 0224, the reader may read or capture an identifier from a piece of identification, for example by scanning or imaging the piece of identification; Paragraph 0224, the report 3700 may include identification information 3702 identifying the individual being subjected to testing. The identification information 3702 may be read or captured directly from an individual being subjected to testing or from identification material, such as government issued identification (e.g., driver’s license, identity card, passport, military identification card), issued to the individual being subjected to testing. For example, the assay system may include or may be communicatively coupled to a reader that automatically reads information identifying information, either from the individual directly and/or from identification carried by or otherwise associated with the individual; [Examiner’s note, one can determine there is a communication link between the processing unit (within the assay device 102 and/or the peripheral computer system 114) and the reader 130. With that link, the processor can cause the reader to write patient information (by printing, etching, and or engraving) on the cassette]).
Though Fleming alludes to a marking device by disclosing a marking on a cassette, but is silent on the marking device specifically (Paragraphs 0010, 0020, 0033, 0128, 0134, 0144, 0167). However, Lin teaches a marking device (Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Fleming in view of Lin is silent in teaching an opening in a sample carrier of the testing system; after the sample receptacle is received in the opening; Evans teaches an opening (Evans | Paragraph 0010, The lab SIS comprises a holder that enables a paraffin embedded tissue cassette to easily slide under a fixed-mount camera, label reader, or other digital imaging device; [Examiner’s note, in order to place the cassette into the holder, there must be an opening to allow placement in the lab SIS device.]) in a sample carrier of the testing system and marking the cassette…after the sample receptacle is received in the opening (Evans | Paragraph 0010). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming in view of Lin to incorporate the teachings of marking the cassette after the cassette is inserted into the testing system for reading from Evans. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Evans | Paragraph 0010).
Regarding Claim 18, Fleming in view of Lin and Evans teaches the system of claim 17. The primary reference of Fleming alludes to a marking device by disclosing a marking on a cassette, but is silent on the marking device specifically, Lin teaches the system of claim 17, wherein the marking device is a laser (Lin | Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 19, Fleming in view of Lin and Evans teaches the system of claim 17, wherein the processor further identifies a type of sample receptacle, the type of sample receptacle comprising one of: an assay tube, a cassette, a card, and an LFA strip holder (Fleming | Paragraph 0134, the reader 130 may be used to read machine-readable information carried by assay strips, test tubes, cuvettes, cups, plates, wells, trays, or carried on the assay device (e.g., machine-readable symbols 108 marking respective slots 106, illustrated in FIG. 1); ; Paragraph 0224, the report 3700 may include identification information 3702 identifying the individual being subjected to testing. The identification information 3702 may be read or captured directly from an individual being subjected to testing or from identification material, such as government issued identification (e.g., driver’s license, identity card, passport, military identification card), issued to the individual being subjected to testing; [Examiner’s note, one can determine an assay tub, a cassette and an LFA strip holder is encompassed under “plates, wells, trays or carried on the assay device.” Therefore, the reader 130, coupled to the processor (either within the assay device 102 and/or peripheral computer system), has the ability to identity the sample receptacle. Examples of this feature is illustrated in Figures 37-39, and 42-43.]).
Regarding Claim 20, Fleming in view of Lin and Evans teaches the system of claim 19, wherein a position of the unique identifier (Fleming | Paragraph 0137, the imager 402 may be mounted for rotation or pivoting with respect to the assay strips 400) is based on the type of the sample receptacle (Fleming | Paragraph 0134, the reader 130 may be used to read machine-readable information carried by assay strips, test tubes, cuvettes, cups, plates, wells, trays, or carried on the assay device (e.g., machine-readable symbols 108 marking respective slots 106, illustrated in FIG. 1)).
The primary reference of Fleming alludes to a marking device by disclosing a marking on a cassette, as shown in Claim 1, but is silent on the marking device specifically, Lin teaches a marking device writes on a cassette (Figure 3; Paragraph 0025, the classification mark 35 may be marked or labeled by a laser machine or an inkjet printer. For example, a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine. In the next embodiment, the classification mark 35 is marked by a laser machine with patterns (a, b, c, d, e, f, g, h, i, j, k), dot marks or dot symbols with different gray levels (for example, gray scales 1-11) (as described in the following paragraphs and Table 1 below)).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the array system of Fleming to incorporate the teachings of a marking device having the function to write on a cassette from Lin. Doing so would allow for the marking device to provide a specific identification or mark on the cassette to distinguish it from another cassette (Lin | Paragraph 0025, the classification mark 35 is used to distinguish the groups representative of the variation… a pattern, dot mark or dot symbol with different gray levels is labeled by a laser machine).
Regarding Claim 21, Fleming in view of Lin and Evans teaches the system of claim 17, wherein the unique identifier is encoded in a format selected from a group consisting of a barcode, QR code, and a data matrix (Fleming | Paragraph 0224, the reader may read or capture an identifier from a piece of identification, for example by scanning or imaging the piece of identification. For instance, the reader may take the form of a machine-readable symbol reader such as a barcode scanner or imager to read machine-readable symbols (e.g., barcode symbols, area or matrix code symbols, stacked code symbols); Paragraph 0227, a machine-readable symbol that encodes a unique identifier that identifies the particular assay or assay strip).
Conclusion
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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