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 .
Status of Claims
Claims 49 has been amended. Claims 49-69 are pending and have been examined.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 49-69 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 49 is indefinite because it recites that at least one control marking corresponds to a lower limit of optical detectability for analysis of the diagnostic test and it is unclear if the optical detectability is referring to a lower limit of concentration that can be optically detected or a lower limit of capabilities for whatever means is providing the optical detection – which is additionally confusing because no optical detection has previously been mentioned in the claim for there to be a lower limit.
Claim 49 is rejected because the term “lower” is a relative term which renders the claim indefinite. The term “lower” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 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.
Claims 49-57 and 62-63 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 8,877,140 B2, IDS) in view of Lakdawala (US 2016/0139156 A1, IDS) and further in view of Polwart et al. (US 2014/0154789, Pub Date: 06/05/2014, hereinafter “Polwart”).
Regarding claim 49, Chen describes a device and method for facilitating analysis of a diagnostic test (abstract), comprising:
a diagnostic test comprising a test region for indicating a test result (column 4 “biological material test strip”):
a scan surface comprising one or more control markings, wherein the one or more control markings are representative of one or more predetermined test results for the diagnostic test (column 4 “biological specimen analyzer may be used to capture one or more images of the test strip and adjacently-located reference color chart, both being affixed to a side of the cup.”).
While Chen does not specifically teach that the device can be including as a diagnostic test kit, Lakdawala teaches systems and apparatuses for monitoring a condition of a user (abstract). More specifically, Lakdawala teaches that the system may be provided to a user as a kit including all the components of the device (paragraph 0097).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate the device components of Chen within a kit as taught by Lakdawala because it would have been desirable to simplify delivery of the test to the user (Lakdawala, paragraph 0097).
While Chen and Lakdawala teach the presence of one or more control markings, the references do not specifically teach that the control markings correspond to a lower limit of optical detectability. Polwart teaches throughout the publication a testing apparatus (abstract) and more specifically wherein one or more control markings comprise a control marking corresponding to a lower limit of optical detectability for analysis of the diagnostic test (paragraphs 0111-0112: "The test result is normally obtained by visually comparing the result to a reference chart [25], often printed or included on the packaging [34, 35]… software may then identify the correct portions of the image, along with any scale/labelling information [37] and derive the estimated concentration in the sample by colour matching the reference scale [25] and the exposed or working area of the test strip [24]. Optionally the software may include a correction for differences in printing or surface finishes which are hard to match by eye." And paragraph 0051: " Where the dynamic range of the resulting image is inadequate for the limit of detection, or where the constraints on lighting mean exposure settings force the dynamic range to be too poor it may be desirable to capture multiple images at different exposure settings and then combine these into a single higher dynamic range ‘virtual’ image, using appropriate algorithms to reorient the images between frames, and to discard unwanted or low value data.").
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the color reference chart of Chen in view of Lakdawala to incorporate a marking corresponding to a lower limit of optical detectability as taught by Polwart because it would have been desirable to distinguish between low value data and utilize a system that can correct for images that are inadequate for the limit of detection (Polwart, paragraph 0051). One skilled in the art would have a reasonable expectation of success in making this modification since Chen in view of Lakdawala teach the use of a reference chart for result comparison and Polwart teaches that using an image based color reference chart of their invention remedies variations in the visual acuity of the operator that can make it difficult to obtain precise results, particularly when the result is close to the limit of detection or where it must be matched to a sliding scale of hue to quantify the results (paragraph 0004), while also providing necessary steps to keep the dynamic range of the resulting image within the appropriate limit of detection (paragraph 0051).
Regarding claim 50, Chen describes all the limitations of claim 1, however is silent to the diagnostic test comprises a lateral flow immunoassay test, and the one or more control markings comprises one or more lines.
Lakdawala describes “The test strips used in various analyte testing may be clinical membrane strips suitable for lateral flow assays such as lateral flow chromatographic assays, for example… The fluid may automatically flow through the test strip into the measurement area or areas of the test strip. The test strip may include one or more measurement areas including labeled reagents, such as antibodies, to specifically react with an antigen present in the analyte to produce a color change in the measurement area… The test strip may include a single band as a measurement area, which is a test band, in which a color change will occur when the analyte is present. The test strip may optionally include a second band as a second measurement area, which is a control band. The test strip may optionally include additional bands including test bands and control bands ” ([0085-0086]). Furthermore Lakdawala suggests that this type of immunoassay test allows for the testing of many different types of fluids ([0085]), suggesting motivation to incorporate it into color detection methods.
Therefore it would have been obvious for one skilled in the art at the time the invention was filed to modify the device of Chen to incorporate a lateral flow immunoassay test, and the one or more control markings comprises one or more lines as suggested by Lakdawala because this would allow for the testing of many different types of fluids.
Regarding claims 51-54, the combination described above describes that the one or more lines vary in at least one of thickness, color, hue, and reflectivity (Lakdawala: [0060] “For example, the analyte sensing unit 60 may detect the presence or absence of lines of different colors. Examples of imaging units 66 which may be used include laser scanners, optical sensors, photo diodes, RGBC sensors, digital camera module and infrared sensors, among others. For example, in some embodiments the imaging unit 66 is an RGBC sensor to read the color of the test and control lines of the test strip and optionally to read any test strip identification mark which may be an identifying color. Such RGBC sensors may provide red, green, blue and clear light sensing for precise color measurement, determination, and discrimination of the test strip, with or without illumination. In some embodiments, the analyte sensing unit 60 may use reflectance or refraction photo colorimetry to read the test strip. Further, the analyte sensing unit 60 may read different colors present on different test strips without the need of recalibration between readings.” And Chen: at least column 2).
Regarding claim 55, the combination described above describes that the one or more lines includes black and/or gray lines (Chen: column 10 “ In the RGB color space, each pixel has a 'red' component, a 'green' component, and a 'blue' component 45 which, when mixed together, produces the colors we see on a computer screen. In contrast, however, the Lab color space is a color-opponent space with dimension L for lightness, and dimensions a and b for the color-opponent dimensions.” And Lakdawala: [0060] “For example, the analyte sensing unit 60 may detect the presence or absence of lines of different colors. Examples of imaging units 66 which may be used include laser scanners, optical sensors, photo diodes, RGBC sensors, digital camera module and infrared sensors, among others. For example, in some embodiments the imaging unit 66 is an RGBC sensor to read the color of the test and control lines of the test strip and optionally to read any test strip identification mark which may be an identifying color. Such RGBC sensors may provide red, green, blue and clear light sensing for precise color measurement, determination, and discrimination of the test strip, with or without illumination. In some embodiments, the analyte sensing unit 60 may use reflectance or refraction photo colorimetry to read the test strip. Further, the analyte sensing unit 60 may read different colors present on different test strips without the need of recalibration between readings.”).
Regarding claim 56, Chen teaches the diagnostic test wherein the diagnostic test comprises a colorimetric immunoassay test, and the one or more control markings comprises a plurality of colors (column 4, “operation may be performed to identify any color matches between the test pads and the corresponding reference block…this color matching operation may be performed using a Lab color space analysis”).
Regarding claim 57, Chen describes that the diagnostic test comprises a colorimetric immunoassay test, and the one or more control markings comprises one or more colors (figure 3 and column 4 “biological specimen analyzer may be used to capture one or more images of the test strip and adjacently-located reference color chart, both being affixed to a side of the cup.”).
Regarding claim 62, Chen describes that the scan surface further comprises a test placement guide proximate the one or more control markings, wherein the test placement guide is configured to guide placement of the diagnostic test (figure 1 column 6 “test strip 125 affixed to a flat side 120 of the lid portion 105”).
Regarding claim 63, Chen describes the diagnostic device wherein the scan surface is a first scan surface, and wherein the diagnostic test kit further comprises a second scan surface separate from the first scan surface and comprising a test placement guide (column 6, “Additionally, a color reference chart 130 is shown as also being affixed to the flat side 120 and adjacent to the test strip 125. While the reference color chart 130 is shown as having multiple rows and columns to accommodate running multiple tests on a single sample, in the event that only one test is to be performed on the collected specimen, the reference color chart 130 may only consist of a single strip of reference colors”.).
Claims 58-61 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 8,877,140 B2, IDS) in view of Lakdawala (US 2016/0139156 A1, IDS), as applied to claim 49 above (hereinafter “Modified Chen”) and further in view of Kumar et al. (US 2019/0187154).
Regarding claim 58, Modified Chen teaches the kit as described above including the reference color lines but fails to specifically teach that the markings are printed on the scan surface with fluorescent ink comprising one of europium, rhodamine, fluorescein, alexa fluor, quantum dots, and fluorescent nanoparticles.
Kumar teaches throughout the publication a test strip for quantitative detection (abstract). More specifically, Kumar teaches that lines on the test strip can be printed with fluorescent ink such as Eu-chelate or fluorescein or fluorescent beads (paragraphs 0060-0062).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the control markings of Modified Chen to be printed with fluorescent ink as taught by Kumar because Modified Chen is generic regarding the means of attaching the control substance to the test strip and therefore one skilled in the art would be motivated to choose the appropriate attachment method based on the desired test specifications.
Claims 64-69 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US 8,877,140 B2, IDS) in view of Lakdawala (US 2016/0139156 A1, IDS), as applied to claim 49 above (hereinafter “Modified Chen”) and further in view of Thomas et al. (US 2018/0304260).
Regarding claim 64, Modified Chen teaches the diagnostic kit as described above but fails to teach the presence of a heating device.
Thomas teaches throughout the publication a disposable cassette for performing assays (abstract) wherein the cassette comprises a sample cup (see Figure 1B) comprising a sample input chamber in sufficient proximity to a heater circuit board (paragraphs 0100-0101).
It would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to incorporate within the kit of Modified Chen, a heater as taught by Thomas because it would have been desirable to provide functionality to heat samples dependent on the type of sample or assays to be conducted (Thomas, paragraph 0100). One skilled in the art would have had a reasonable expectation of success in incorporating a heater as taught by Thomas within the cup diagnostic kit of Modified Chen since Thomas teaches that a sample input cup can be constructed to be in communication with a heater to heat sample and reagents (Thomas, paragraphs 0100-0101).
Regarding claim 65, Modified Chen in view of Thomas teach the kit further comprising a housing comprising the heating device and a test placement guide proximate the heating device, wherein the test placement guide is configured to guide placement of the diagnostic test (Thomas, paragraph 0100-0101 and Chen, column 4 and Figure 1 showing device housing).
Regarding claim 66, Chen teaches the kit wherein the scan surface is arranged on the housing (see Figures 1).
Regarding claims 67-68, Chen teaches the kit wherein the housing is configured to receive a test sample and wherein the housing comprises a receptacle configured to receive a test sample vessel (column 2, “cup comprises a container portion configured to receive a biological specimen” – thus capable of receiving the broadly claimed vessel).
Regarding claim 69, Modified Chen in view of Thomas teaches the kit wherein the receptacle is proximate the heating device (Thomas, paragraph 0100, “sample input chamber…situated in register with an in sufficient proximity to the heater elements on the heater circuit board”).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 49-55 and 62 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6-8 and 10 of U.S. Patent No. 11,996,183. Although the claims at issue are not identical, they are not patentably distinct from each other because regarding instant claim 49, Patent 183 recites a method for facilitating analysis of a diagnostic test, the method comprising: at one or more processors of a mobile computing device having at least one image sensor and a display: receiving an image captured at the at least one image sensor, the image depicting the diagnostic test, one or more static control markings on a scan surface, and a plurality of image region markers on the scan surface defining a boundary of an image region including the diagnostic test and the one or more static control markings, wherein the one or more static control markings comprise a control marking corresponding to a lower limit of optical detectability for analysis of the diagnostic test; prior to analyzing the diagnostic test, assessing an adequacy of at least one of lighting, orientation, and focus conditions associated with the image by verifying detection of the one or more static control markings in the image using at least one computer vision technique, wherein verifying detection of the one or more static control markings comprises: determining pixel values for multiple linear series of image pixels in the image, generating a 1D array of metrics, each metric in the 1D array of metrics comprising a value calculated based on the pixel values of an individual one of the multiple linear series of image pixels, and identifying one or more peaks in the 1D array of metrics; and when the one or more processors determine that the at least one of lighting, orientation, and focus conditions is adequate based on the identified one or more peaks in the 1D array of metrics: automatically analyzing the diagnostic test based on at least one computer vision technique to determine at least one test result; and causing the display to display the at least one test result (see patent claim 1).
Additionally, patent claim 6 reads on instant claim 50, patent claim 7 reads on instant claims 51-54, patent claim 8 reads on instant claim 55, and patent claim 10 reads on instant claim 62.
Response to Arguments
Applicant's arguments filed 01/02/2026 have been fully considered but they are not persuasive. Applicant argues that Chen and Lakdawala fail to teach any markings corresponding to a lower limit of optical detectability, however, these arguments are moot in view of the new grounds of rejection applied to the newly amended claims. Chen and Lakdawala in view of Polwart teach the claimed invention, as described above, and therefore the claims remain unpatentable.
Lastly, regarding applicant’s arguments drawn to Kumar, Chen in view of Lakdawala teach the control markings on the scan surface. Kumar is only relied upon for teaching that lines can be printed using a fluorescent ink such as fluorescein of instant claim 61 (see paragraphs 0060-0062).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lim et al. (CN 110785116, Pub Date: 02/11/2020 – citations taken from US equivalent US2021/0164974, hereinafter “Lim”) teaches chromatographic test strips and methods for qualitatively or qualitatively analyzing a target material (abstract) with an included color reference table for comparing signal intensity to determine concentration of the target material (paragraph 0063).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA M GIERE whose telephone number is (571)272-5084. The examiner can normally be reached M-F 8:30-4:30.
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/REBECCA M GIERE/Primary Examiner, Art Unit 1677