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 .
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 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.
Claim Objections
1. Claim 10 is objected to because of the following informalities:
In claim 10, line 5; the word “enviromental” should be changed to --environmental-- for correct spelling.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
2. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 4 and 7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1; the limitation, “computerized device” appears to lack support in the application as originally filed. The present application does not further disclose a structure capable of enabling the functions recited within the claim. The present disclosure does not provide details on how one of ordinary skill in the art would measure, maintain, or ensure this condition.
Claims 2-3 are rejected based upon their dependency from claim 1.
Regarding claim 1; the limitation, “functional ability to add” appears to lack support in the application as originally filed. The present application does not further disclose a structure capable of enabling the functions recited within the claim. The present disclosure does not provide details on how one of ordinary skill in the art would measure, maintain, or ensure this condition.
Claims 2-3 are rejected based upon their dependency from claim 1.
Regarding claim 4; the limitation, “computerized device” appears to lack support in the application as originally filed. The present application does not further disclose a structure capable of enabling the functions recited within the claim. The present disclosure does not provide details on how one of ordinary skill in the art would measure, maintain, or ensure this condition.
Claims 5-6 are rejected based upon their dependency from claim 4.
Regarding claim 7; the limitation, “computerized device” appears to lack support in the application as originally filed. The present application does not further disclose a structure capable of enabling the functions recited within the claim. The present disclosure does not provide details on how one of ordinary skill in the art would measure, maintain, or ensure this condition.
Claims 8-9 are rejected based upon their dependency from claim 7.
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.
Claim 1 is 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 pre-AIA the applicant regards as the invention.
Regarding claim 1; the limitation, “computerized device” is unclear. In so far that this limitation may require a structure, is not understood what that structure is (manually or other means). It is unclear what structure would yield this function as described within the claim. As such the claim limitation is indefinite.
Claims 2-3 are rejected based upon their dependency from claim 1.
Regarding claim 1; the limitations, “functional ability to add” is unclear. In so far that this limitation may require a structure, is not understood what that structure is (manually or other means). It is unclear what structure would yield this function as described within the claim. As such the claim limitation is indefinite.
Claims 2-3 are rejected based upon their dependency from claim 1.
Regarding claim 4; the limitation, “computerized device” is unclear. In so far that this limitation may require a structure, is not understood what that structure is (manually or other means). It is unclear what structure would yield this function as described within the claim. As such the claim limitation is indefinite.
Claims 5-6 are rejected based upon their dependency from claim 4.
Regarding claim 7; the limitation, “computerized device” is unclear. In so far that this limitation may require a structure, is not understood what that structure is (manually or other means). It is unclear what structure would yield this function as described within the claim. As such the claim limitation is indefinite.
Claims 8-9 are rejected based upon their dependency from claim 7.
Claim Rejections - 35 USC § 102
3. 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, 3-7 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rooyen et al (U.S. PG Pub No.: 20130017807 A1), hereinafter referred to as Rooyen et al ‘807.
Regarding claim 1, Rooyen et al ‘807 disclose a system (Fig. 1) for remote analyte testing, comprising: a computerized device (12) having a camera (516) configured to capture images from a completed test of a biological sample (blood sample) from a subject (11) and functional ability to add contextual data regarding the test {as shown in Figs. 1, 4 and 5: Abstract, ¶¶ [0007-0008], [0010], [0118], [0022-0023], [0041], [0047], [0082] and [0141-0142]}; a processor (510) executing software configured to analyze the captured data {as shown in Fig. 5: ¶¶ [0007-0010], [0022-0024], [0053], [0055] and [0141-0142]}; and a data repository (117) configured to store the analyzed data {see Fig. 41: ¶¶ [0007], [0009], [0023], [0041], [0047] and [0144]}.
Regarding claim 3, Rooyen et al ‘807 disclose the system of claim 1, wherein the processing unit provides enhanced interpretation of the test result based on the contextual data {see ¶¶ [0043], [0055] and [0062]}.
Regarding claim 4, Rooyen et al ‘807 disclose a system (Fig. 1) for remote analyte testing comprising: a test apparatus (reader) having a strip or solution that changes optically when in contact with a biological sample (blood sample) from a subject {see Abstract, ¶¶ [0008], [0118], [0022-0023], [0039] and [0141-0142]}; a code displayed on or proximate the test apparatus {see ¶¶ [0009] and [0039-0042]; a computerized device (12) having a camera (516) configured to capture images of the test apparatus, the computerized device also having Internet connectivity {see Figs. 1 and 5: ¶¶ [0022-0023] and [0142]}; and a processor (510) executing software configured to analyze the captured data and to generate feedback (112) {as shown in Figs. 1, 5: ¶¶ [0007-0010], [0022-0023] and [0141-0142]}.
Regarding claim 5, Rooyen et al ‘807 disclose the system of claim 4, wherein the processor executing software is configured to cross-reference the captured data with a manufacturer database (118) to verify integrity of a test medium used in the test {see ¶ [0007-0009], [0023], [0038] and [0143]}.
Regarding claim 6, Rooyen et al ‘807 disclose the system of claim 4, wherein the feedback includes alerts to a user regarding potential issues with the test medium {see ¶¶ [0008] and [0088-0089].
Regarding claim 7, Rooyen et al ‘807 disclose a system (Fig. 1) for remote analyte testing comprising: a computerized device (12) having a camera (516) configured to capture multiple data results from a single test medium{as shown in Figs. 1 and 5: ¶¶ [0007-0008], [0041], [0010], [0022-0023], [0047], [0082] and [0141-0142]}; and a processor (510) executing software configured to analyze the captured data {as shown in Fig. 5: ¶¶ [0007-0010], [0022-0024], [0053], [0055] and [0141-0142]}.
Regarding claim 13, Rooyen et al ‘807 disclose a system (Fig. 1) for remote analyte testing comprising: a test apparatus (reader) having a strip or solution that changes optically when in contact with a biological sample (blood sample) from a subject (11) and a camera (516) to capture data {see Figs. 1, 4 and 5: Abstract, ¶¶ [0008], [0118], [0022-0023], [0039] and [0141-0142]}; a repository (117) configured to store the captured store data {see Figs. 1 and 4: ¶¶ [0023], [0041], [0047] and [0144]}; and a software analysis module (120) configured to analyze the captured data for patterns and to generate feedback (112) {see Fig. 4: ¶¶ [0023] and [0141]}.
Claim Rejections - 35 USC § 103
4. 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 of this title, 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.
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 2 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Rooyen et al ‘807, in view of Hong et al (U.S. PG Pub No.:2014/0278229 A1), hereinafter referred to as Hong et al ‘229.
Regarding claim 2, Rooyen et al ‘807 disclose the system of claim 1, EXCEPT for the limitations of wherein the contextual data includes environmental conditions comprising one or more of temperature, humidity, and light exposure at the time of data capture.
Hong et al ‘229 teach: the concept of the contextual data includes environmental conditions comprising one or more of temperature, humidity, and light exposure at the time of data capture {see Fig. 12C: ¶¶ [0077], [0135], [0142], [0214], [0217-0218], [0227] and [0272]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 contextual data by the contextual data of Hong et al ‘229 so as to include environmental conditions comprising one or more of temperature, humidity, and light exposure at the time of data capture, in order to motive a user maintain certain activity level {Hong et al ‘229 - ¶ [0316]}.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Hong et al ‘229 to obtain the invention as specified in claim 2.
Regarding claim 10, Rooyen et al ‘807 disclose a system (Fig. 1) for remote analyte testing comprising: a test apparatus (reader) having a strip or solution that changes optically when in contact with a biological sample (117) from a subject adapted to perform a test and capture data {see Abstract, ¶¶ [0008], [0022-0023], [0039] and [0141]}.
However, Rooyen et al ‘807 fail to disclose the limitations of an environmental sensor configured to measure ambient conditions during the data capture, and to append the measurements to the data; and a processor executing software configured to analyze the data and provide feedback.
Hong et al ‘229 teach: the concept of an environmental sensor configured to measure ambient conditions during the data capture, and to append the measurements to the data {see Fig. 12C: ¶¶ [0077], [0135], [0142], [0214], [0217-0218] and [0227] and [0272]}; and a processor executing software configured to analyze the data and provide feedback {see Fig. 12C: ¶¶ [0077], [0108], [0216], [0227] and [0229-0230]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 in view of Hong et al ‘229 to include the use of an environmental sensor configured to measure ambient conditions during the data capture, and to append the measurements to the data; and a processor executing software configured to analyze the data and provide feedback, in order to facilitate acquisition environmental data{Hong et al ‘229 - ¶ [0214]}.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Hong et al ‘229 to obtain the invention as specified in claim 10.
Regarding claim 11, the combination of Rooyen et al ‘807 and Hong et al ‘229 disclose and teach the environmental system of claim 10, Rooyen et al ‘807 as modified by Hong et al ‘229 further teach the limitations of wherein the environmental sensor measures environmental conditions including one or more of temperature, humidity, and light exposure {see Fig. 12C: ¶¶ [0077], [0135], [0142], [0214], [0217-0218] and [0227] and [0272]}.
Regarding claim 12, the combination of Rooyen et al ‘807 and Hong et al ‘229 disclose and teach the system of claim 10, Rooyen et al ‘807 as modified by Hong et al ‘229 further teach the limitations wherein the feedback comprises real-time feedback to a user based on analysis of the environmental conditions {see Fig. 12C: ¶¶ [0010], [0174], [0211], [0272], [0315], [0413] and [0445]}.
Claims 8, 9, 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Rooyen et al ‘807, in view of Fadem (U.S. PG Pub No.:2014/0128763 A1), hereinafter referred to as Fadem ‘763.
Regarding claim 8, Rooyen et al ‘807 disclose the system of claim 7, EXCEPT for the limitation of wherein the processor executing software is configured to differentiate between data from multiple tests performed on the single test medium.
Fadem ‘763 teaches: the concept of the processor executing software is configured to differentiate between data from multiple tests performed on the single test medium {see Fig. 9: ¶¶ [0069-0070], [0089] and [0104-0105]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 processor executing software by the processor executing software of Fadem ‘763 so as to enable the configuration to differentiate between data from multiple tests performed on the single test medium, in order to save on cost.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Fadem ‘763 to obtain the invention as specified in claim 8.
Regarding claim 9, Rooyen et al ‘807 disclose the system of claim 7, EXCEPT for the limitation of wherein the processor executing software provides separate interpretations for each test result.
Fadem ‘763 teaches: the concept of wherein the processor executing software provides separate interpretations for each test result {see ¶¶ [0028] and [0052]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 processor executing software by the processor executing software of Fadem ‘763 so as to provides separate interpretations for each test result, in order to facilitate stimulus discrimination, and target selection {Fadem ‘763 -¶ [0028]}.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Fadem ‘763 to obtain the invention as specified in claim 9.
Regarding claim 14, Rooyen et al ‘807 disclose the system of claim 13, EXCEPT for the limitations of wherein the analysis module performs predictive analysis based on data patterns identified across multiple users.
Fadem ‘763 teaches: the concept of wherein the analysis module performs predictive analysis based on data patterns identified across multiple users {see ¶¶ [0101], [0127], [0152] and [0162]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 software analysis module by the software analysis module of Fadem ‘763 so as to performs predictive analysis based on data patterns identified across multiple users, in order to facilitate generation of classification report {Fadem ‘763 - ¶ [0152]}.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Fadem ‘763 to obtain the invention as specified in claim 14.
Regarding claim 15, Rooyen et al ‘807 disclose the system of claim 13, EXCEPT for the limitation of wherein the feedback generated is tailored to the specific context of the test results and data patterns.
Fadem ‘763 teaches: the concept of the feedback generated is tailored to the specific context of the test results and data patterns {see ¶¶ [0018], [0032], [0101], [0157], [0162-0163], and [0165]}.
Since all claimed elements were known in the art at the time of the invention, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify Rooyen et al ‘807 in view of Fadem ‘763 to include the feedback generated tailored to the specific context of the test results and data patterns, in order to constantly improving the classification accuracy and performance of the ERP classification system {Fadem ‘763 - ¶ [0162]}.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to modify the Rooyen et al ‘807 in view of Fadem ‘763 to obtain the invention as specified in claim 15.
Response to Arguments
5. Applicant's arguments, see pages 5-8, filed 04/27/2026, with respect to the rejection(s) of claim(s) 1-15 under 35 USC § 102(b) have been fully considered but are moot in view of the new ground(s) of rejection as detailed above.
Conclusion
6. Applicant's amendment necessitated the new grounds 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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMMANUEL E DUKE whose telephone number is (571)270-5290. The examiner can normally be reached on Monday thru Friday; 6:00 AM to 2:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FRANTZ JULES can be reached on (571)272-6681. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EMMANUEL E DUKE/
Primary Examiner, Art Unit 3763
05/29/2026
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