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 .
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 1-15 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 1 recites “program instructions configured to operate the system to perform an analyte testing operation on a bodily fluid sample, said operation comprising:
- removing a test strip from a vail by a user;
- producing a bodily fluid sample;
- applying the bodily fluid sample to a deposit site of the test strip.”
However, this recitation is unclear as the steps of removing, producing and applying are apparently carried out by a user and not system and it does not appear that the program instructions can operate the system to perform these steps. Claims 2-15 are rejected by virtue of their dependence on a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2015/0209510, hereinafter Burkholz in view of United States Application Publication No. 2019/0086296, hereinafter West.
Regarding claim 1, Burkholz teaches a system for measurement of an analyte (paragraph [0073]) comprising: a wearable electronic device (item 10a) and a remote device (paragraph [0045]), the wearable electronic device comprising: a camera (item 12) configured to generate a video stream and at least one image having optically measurable properties (paragraph [0016]); a first communication transceiver (item 14) configured to transmit and receive communications to and from a second communication transceiver at the remote device (paragraph [0048]); a head-up display (HUD) (item 22); a first memory (item 21) configured to store program instructions (paragraph [0050]); and a first processor (paragraph [0052]) operatively connected to the first communication transceiver, the camera, and the first memory, the first processor being configured to execute the program instructions (paragraph [0052]); the remote device (paragraph [0048]) further comprising: a second memory configured to store program instructions (paragraph [0048]); and a second processor (paragraph [0048]) operatively connected to the second transceiver and the second memory (paragraph [0048]), the second transceiver configured to transmit and receive communications to and from the first communication transceiver (paragraph [0048]); the wearable electronic device and the remote device being operatively connected to each other (paragraph [0048]), wherein the first processor and second processor cooperate to execute the program instructions, wherein the program instructions are configured to operate the system to perform an analyte testing operation on a bodily fluid sample (paragraphs [0074] and [0083]), said operation comprising: removing a test strip from a vial by a user (paragraph [0083]); producing a bodily fluid sample (paragraph [0074]); applying the bodily fluid sample to a deposit site of the test strip (paragraph [0083]); activating a timer in response to confirmation of the application of the bodily fluid sample (paragraph [0083]); after a minimum period of time and before a maximum period of time from the activation of the timer, generating via the camera at least one image of the test strip including at least a portion of a measurement site (paragraph [0083]); analyzing optical properties of at least a portion of the measurement site within the image to determine a level of an analyte (paragraph [0083]); and displaying the level of the analyte (paragraph [0083]) on the HUD (paragraph [0059]).
Burkholz fails to teach the at least one image being captured after guidance to the user via the HUD for positioning the test strip a predetermined distance and angular orientation relative to the camera.
West teaches a point of care device in which a HUD displaces an outline on the display showing a desired placement for the test strip during test strip imaging in order to aid in identifying the locations of the one or more lines (West, paragraph [0113]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided guidance to the user via the HUD for positioning the test strip a predetermined distance and angular orientation relative to the camera because it would aid in identifying the locations of the one or more lines (West, paragraph [0113]).
Regarding claim 2, Burkholz teaches the program instructions proceed with the execution of the analyte testing operation based on one or more inputs from the user upon completion of at least one of the steps of removing the test strip (paragraph [0083]), producing the bodily fluid sample (paragraph [0074]), application of the bodily fluid sample to a deposit site of the test strip (paragraph [0083]), and generating the at least one image (paragraph [0083]).
Regarding claim 3, Burkholz teaches the program instructions proceed with the execution of the analyte testing operation based on an automatic tracking of user activities and automatic identification of components required for the analyte testing operation, at least one of the first processor and second processor being configured for performing the automatic tracking and automatic identification via a video stream generated by the camera (paragraphs [0074]-[0075]).
Regarding claim 4, Burkholz teaches at least one of the first and second processors is further configured to: identify a vial in the video stream generated by the camera based on at least one registration mark located on the vial depicted in the video stream (paragraph [0083]); identify an opening of the vial in the video stream based on at least one registration mark located on a lid of the vial (paragraph [0083]); and identify extraction of the test strip from the vial after the identification of the opening of the vial in the video stream based on at least one registration mark associated with the test strip depicted in the video stream (paragraph [0083]).
Regarding claim 5, Burkholz teaches the at least one registration mark (item 30) associated with the vial further comprises an indicator formed on a label of the vial (paragraph [0083]).
Regarding claim 6, Burkholz teaches the at least one registration mark associated with the vial further comprises an indicator formed on a label of the vial (paragraph [0083]).
Regarding claim 7, Burkholz teaches the at least one registration mark associated with the test strip further comprises an indicator formed on a surface of the test strip at a predetermined position relative to the deposit site (paragraph [0083]).
Regarding claim 8, modified Burkholz teaches at least one of the first and second processors is further configured to: identify that a reverse side of the test strip is exposed in the video stream based on an absence of the indicator formed on the surface of the test strip (West, paragraph [0113]); and generate on the HUD an output message indicating that the test strip should be rotated to expose the surface of the test strip bearing the indicator (West, paragraph [0113]).
Regarding claim 9, Burkholz teaches the at least one registration mark associated with the test strip further comprises an indicator formed on a rear surface of a color card that holds the test strip (paragraph [0083]).
Regarding claim 10, Burkholz teaches at least one of the first and second processors is further configured to: identify a finger of a user in the video stream (paragraph [0086]); and identify contact between the finger and the deposit site in the video stream (paragraph [0092]); and identify the application of the dose in response to a change in an optical property of the deposit site in the video stream after the contact between the finger and the deposit site (paragraphs [0083] and [0092]).
Regarding claim 11, Burkholz teaches at least one of the first and second processors is further configured to identify the application of the dose in response to a change in an optical property of the deposit site in the video stream (paragraph [0083]).
Regarding claim 12, Burkholz teaches at least one of the first and second processors is further configured to generate on the HUD an output message informing the user that the measurement of the analyte in the fluid dose cannot be completed in response to no optical measurement of the measurement site being generated after the predetermined minimum time period has elapsed and prior to the predetermined maximum time period elapsing (paragraph [0083]).
Regarding claim 13, Burkholz teaches the remote device further comprising a display operatively connected to the second processor (paragraph [0048]), and wherein the operation further comprises displaying the level of the analyte on the display (paragraph [0048]).
Regarding claim 14, Burkholz teaches the remote device comprises a mobile electronic device (paragraph [0049]).
Regarding claim 15, Burkholz teaches the mobile electronic device comprises a smartphone where the program instructions comprise a software application stored on the second memory and executed by the second processor in communication with the first processor for directing the wearable electronic device in the performance of the analyte testing operation (paragraphs [0048]-[0049]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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