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 .
Response to Arguments
Applicant’s arguments, see Pages 6-7, filed 3/30/2026, with respect to the 101 rejections have been fully considered and are persuasive. The 101 rejection of 10/29/2025 has been withdrawn.
Applicant's arguments filed 3/30/2026 regarding the 102 rejection of claims 1-13 have been fully considered but they are not persuasive. On Pages 8-10 of the remarks, the Applicant states that the reference of Burg does not teach Applicant's claimed method of assessing the actual color reference card to ensure that it meets a quality threshold before using it to evaluate a color formation reaction.
However, in response to this argument, the Examiner respectfully disagrees as Burg teaches that the color corrected CTP color is compared with color values from the corresponding MICC/ACC to determine the analyte concentration of the sample solution, see [0113], where a color reference is compared to obtained color values to determine whether the results should be rejected or accepted, see [0151].
Election/Restrictions
Newly submitted claims 14-17 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
Inventions I (Claims 1-13) and II (Claims 14-17) are related as combination and subcombination. Inventions in this relationship are distinct if it can be shown that (1) the combination as claimed does not require the particulars of the subcombination as claimed for patentability, and (2) that the subcombination has utility by itself or in other combinations (MPEP § 806.05(c)). In the instant case, the combination as claimed does not require the particulars of the subcombination as claimed because the steps of “iii. identifying low-quality color reference fields; iv. omitting the low-quality color reference fields and determining a color transformation matrix between one or more of the measured reference color values and corresponding known reference color values for the remaining color reference fields,” are not required by the claims of invention I and therefore are restrictable from the original invention. The subcombination has separate utility such as being used to derive a true color value to reject low quality images instead of using a color transformation matrix to determine the highest quality color values.
The examiner has required restriction between combination and subcombination inventions. Where applicant elects a subcombination, and claims thereto are subsequently found allowable, any claim(s) depending from or otherwise requiring all the limitations of the allowable subcombination will be examined for patentability in accordance with 37 CFR 1.104. See MPEP § 821.04(a). Applicant is advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 14-17 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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 1-13 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.
The term “high quality” in claim 1 is a relative term which renders the claim indefinite. The term “high quality” 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. The "item of quality information" that is described as being "high quality" is rendered indefinite as it is unclear what an item of high quality is in reference to. It is unclear as to how the item of quality would have high vs. low quality.
Claims 2-13 are rejected due to their dependence on claim 1.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burg et al. (US 2015/0308961, “Burg”).
Regarding claim 1, Burg teaches a method of evaluating the quality of a color reference card having multiple color reference fields with known reference values (method for evaluating a diagnostic instrument having multiple chemical test pads 22 (CTPs) and a color reference bar 28 (RCB) with previously known and stored color values, see Fig. 1, [0047] - [0049], [0105], and [0149]), wherein the quality of the color reference card refers to whether the color reference card is usable for a method for determining the concentration of an analyte in a body fluid and/or to the degree of suitability or the degree of reliability of the color reference card for use with a method for determining the concentration of analyte in a body fluid (the method determines whether the test strip is suitable for use in the detection of an analyte concentration, see [0069] – [0070] and [0149] – [0150]),
the method comprising:
i. capturing an image of at least a part of the color reference card using a camera of a mobile device (user captures image of RCB using camera of portable device, see [0105], where portable device is a smartphone, see [0054] – [0055]);
ii. determining measured reference color values from the image for one or more of the color reference fields (the color values of the CCRCB are derived using image processing, see [0105]);
iii. determining a relationship between one or more of the measured reference color values and corresponding known reference color values (a numerical value is assigned to the difference between the stored Reference RCB values and the camera-captured RCB, see [0105] – [0112] and [0119]) and
iv. deriving an item of quality information on the quality of the color reference card using the relationship determined in step iii (the relationship calculated between the RefRCB and CCRCB values determine if the test is suitable for the analyte, see [0105] – [0112] and [0117] – [0118]) and
v. when the item of quality information from step iv. is determined as being a high quality, capturing an image of a reagent test region of an optical test strip having a body fluid sample applied thereto and determining analyte concentration based on a color formation reaction of the reagent test region taking into account the result of step iv (color corrected CTP color is compared with color values from the corresponding MICC/ACC to determine the analyte concentration of the sample solution, see [0113]).
Regarding claim 2, Burg teaches the method according to claim 1, wherein the determining of the relationship in step iii comprises fitting the measured reference color values to the corresponding known reference color values (the measured color values (CCRCB) are mapped onto the known color values (RefRCB) for comparison, see [0105]), wherein the deriving of the quality information in step iv comprises determining at least one fit residuum quantifying the quality of the fitting (the Euclidean distance, or sum of square of the residual (obtained value) is calculated to determine if the results are valid, see Figs. 12A-B and [0117]-[0118]).
Regarding claim 3, Burg teaches the method according to claim 1, wherein the relationship between the measured reference color values and the known reference color values comprises a color transformation matrix (an inverse color transformation matrix is derived from expected and measured values, see [0105]) .
Regarding claim 4, Burg teaches the method according to claim 1, wherein the item of quality information in step iv is at least partially derived using the relationship determined in step iii and by transforming measured color coordinates of a first color reference field into expected color coordinates of a second color reference field by using the relationship and by further comparing the expected color coordinates of the second color reference field with measured color coordinates of the second color reference field (the relationship calculated between the RefRCB and CCRCB values are compared by the inverse matrix to obtain color coordinates that are used to determine if the test is suitable for the analyte, see [0105] – [0112]).
Regarding claim 5, Burg teaches the method according to claim 1, wherein the item of quality information is determined by selectively leaving out measured reference color values of at least one selected color reference field in step iii, whereas color coordinates of other color reference fields are taken into account in step iii (results falling outside of the color range defined by the MICC/ACC are discarded and the other color coordinates are left in, see [0070] and [0101]).
Regarding claim 6, Burg teaches the method according to claim 5, wherein a plurality of items of quality information is determined by selectively leaving out measured reference color values of a plurality of selected color reference fields, respectively, wherein the items of quality information are compared in order to identify color reference fields having a low quality (the suitability of the color reference chart is determined by comparing the values obtained after interpolation of the reference RCB values to the camera-captured RCB and removing the improper MICC/ACC values, see [0070] and [0105] – [0112]).
Regarding claim 7, Burg teaches the method for determining the concentration of an analyte in a body fluid using a mobile device having a camera (method where user captures image of chemical test pad to determine analyte concentration using camera of portable device, see Fig. 4 and [0113] and [0117]), where the portable device is a smartphone, see [0054] – [0055]), an optical test strip (chemical test pads, or CTPs 22, see Fig. 1 and 4 and [0064]) and at least one color reference card comprising a plurality of color reference fields having known reference color values (reference color bar, or RCB 28, see Fig. 1 and [0064]), wherein the method comprises:
a. evaluating the quality of the reference card using the method according to claim
1 (see [0105] – [0112]);
b. capturing an image of a reagent test region of the optical test strip having a sample of the body fluid applied thereto using the camera (an image of the CTPs is captured by the phone’s camera after exposure to sample, see [0063] – [0064]); and
c. determining the analyte concentration based on a color formation reaction of the reagent test region taking into account the result of step a (the RCB is normalized to obtained the actual color values to correlate each CTP color to the analyte concentration, see [0105] – [0113]).
Regarding claim 8, Burg teaches the mobile device having a camera and a processor, wherein the mobile device is configured for performing the method of evaluating the quality of a color reference card according to claim 1 (portable device 110 comprises processor 116 used for executing instructions contained within a computer readable medium, where the instructions include the RCB normalization steps, see [0057] – [0059], [0105], and [0112]-[0113]).
Regarding claim 9, Burg teaches the mobile device according to claim 8, wherein the mobile device is further configured for determining the concentration of an analyte in a body fluid by using at least one optical test strip (the analyte concentration is determined using the computer-readable media stored on the portable device and CTPs, see [0113] – [0114]).
Regarding claim 10, Burg teaches a kit (system 100, see Fig. 2 and [0053]), comprising:
a mobile device having a camera and a processor (portable device with camera and processor, see [0057] – [0059]), wherein the mobile device is configured for performing the method of evaluating the quality of a color reference card according to claim
1 (see [0105] – [0112]); and
a color reference card comprising a plurality of color reference fields having known reference color values (RCB 28, see Fig. 1 and [0049]).
Regarding claim 11, Burg teaches the kit according to claim 10, further comprising an optical test strip having at least one reagent test region (CTPs 22 of instrument 10, see Fig. 1 [0047] – [0049]).
Regarding claim 12, Burg teaches a non-transitory computer readable medium having stored thereon computer- executable instructions for performing the method according to claim 1 (computer readable medium contains instructions for comparing reference charts, see [0057] – [0060] and [0105] – [0112]) .
Regarding claim 13, Burg teaches the computer readable medium according to claim 12, further comprising instructions which, when the program is executed by a mobile device, cause the processor of the mobile device to perform steps to determine analyte concentration based on a color formation reaction of a reagent test region (the media contains instructions for prompting the portable device and its processor to determine the concentration of the analyte based on the color change of the CTP, see [0057] – [0060] and [0117] – [0118]).
Conclusion
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 ALEA MARTIN whose telephone number is (571)272-5283. The examiner can normally be reached M-F 10AM-5:00PM (EST).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/A.N.M./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
Prosecution Insights