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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3 and 5-14 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 1 recites “recording in a memory of the mobile device” in lines 6, 10 and 12-13.
Since the step of “calculating the difference between the first and second items of position information” can be performed in the mentally the claimed invention is directed to an abstract idea and is not directed to eligible subject matter.
As for the recitations of “recording in a memory of the mobile device,” this type of limitation merely confines the use of the abstract idea to a particular technological environment (mobile device memory) and thus fails to add an inventive concept to the claimed invention and can be considered “field of use” and not subject matter eligible. The mobile device memory is merely the environment where the data is collected and does not teach a practical application and therefore the claim remain ineligible. (See MPEP 2106.05(h))
The steps of “calculating” the difference between the first and second items of position information is not integrated into a practical application. The courts have indicated that gathering and analyzing information using conventional techniques is not sufficient to show an improvement to technology.
Claim 1 does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the other elements of the claims other than the abstract idea and determine are not beyond what is well understood, routine and conventional within the prior art, including “recording data into the memory of a mobile device.
Claims 2, 3 and 5-14 are rejected as being dependent on independent claim 1.
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.
1. Claims 1-3, 5 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0024049 to Shyam et al. in view of U.S. Patent Application Publication No. 2018/0107790 to Pulitzer et al.
Shyam et al. teaches a method of colorimetric analysis of a test fluid to evaluate associated physiological parameters which involves providing a test strip 104, using a camera to capture a first image of the test strip, applying a sample of body fluid to the test strip, taking a second image of the test strip and determining an analytical measurement result using the first and second images of the test strip. [0007], [0025]-[0027]
Shyam et al. teaches resizing and comparing the first and second images, but does not teach recording first and second items of position information, on the position of the mobile device at the time the first and second images are recorded.
Pulitzer et al. teaches an alignment target disposed on the testing device and a plurality of immunoassay test strips receiving at the server an image of the testing device from the mobile device application. (Abstract) The alignment target 310 on a testing device 300 is shown in Figs. 3-6
It would have been obvious to one of ordinary skill in the art to modify Shyam et al. and provide an alignment target together with the test strip as taught by Pulitzer et al. for purposes of providing and determining position information (“alignment”) with both the test strip (first positional information) and alignment target (second positional information) when taking first and second images that can be compared based the alignment of the test strip and alignment target.
It would further be obvious to one of ordinary skill in the art to determining that when the alignment of the test strip and alignment target are the same for the first and second images, the admissibility of the comparison is satisfactory for comparing the images.
I.) As noted above, Shyam et al. in view of Pulitzer et al. teaches all the limitations of claim 1.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 2 depends.
Claim 2 recites that when the item of admissibility indicates inadmissibility, performing one or both of: displaying an error message on the display of the mobile device; and aborting the method of performing an analytical measurement.
In Shyam et al. in view of Pulitzer et al., it would have been obvious to abort the method of performing an analytical measurement when the correct orientation (“admissibility”) of the test strip and/or the alignment target are unsatisfactory.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 2 obvious.
III.) Regarding applicant’s claim 3, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 3 depends.
Claim 3 recites retrieving first and second items of position information from the position sensor and comparing the first and second items of position information, wherein the first item of position information comprises information on a position of the mobile device when capturing the first image in step b) and the second item of position information comprises information on a position of the mobile device when capturing the second image in step d).
As noted above, Shyam et al in view of Pulitzer et al. includes correctly orienting or aligning the mobile device which would require or render obvious position information of the device when capturing images.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 3 obvious.
IV.) Regarding applicant’s claim 5, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that camera is a front camera of the mobile device, wherein the camera and the display are both positioned on a front of the mobile device.
Shyam et al. teaches mobile or smartphones [0002] which are known to have front- and rear-facing cameras, rendering it obvious to us a camera on the same side of the device as the display.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 5 obvious.
V.) Regarding applicant’s claim 8, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that when capturing the first image in step b), the test field is illuminated by using the display of the mobile device, wherein when capturing the second image in step d), the test field of the optical test strip is illuminated by using the display of the mobile device.
In Shyam et al. in view of Pulitzer et al. it would have been obvious to capture the images using a smartphone with the camera on the front side of the smartphone using the display to illuminate the image captured by the camera.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 8 obvious.
VI.) Regarding applicant’s claim 9, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 9 depends.
Claim 9 recites providing indications concerning where to locate the optical test strip for capturing the first and/or the second image by using the mobile device.
As noted above, Shyam et al. teaches using mobile or smartphones to capture images.
Pulitzer et al. teaches providing alignment when capturing images which would involve locating the test strip and alignment target.
It would accordingly have been obvious to provide instructions/indications to locate the test strip in an area to properly align the test strip and alignment target with respect to the image capturing device.
Therefore. Shyam et al. in view of Pulitzer et al. renders claim 9 obvious.
VII.) Regarding applicant’s claim 10, as noted above Shyam et al. in view of Pulitzer et al. renders claim 9 obvious from which claim 10 depends.
Claim 10 recites that indication is provided by using the display of the mobile device, wherein the indication concerning where to locate the optical test strip of step h) comprises superposing a live image of the camera on the display of the mobile device with a visual guidance.
Shyam et al. in view of Pulitzer et al. do not teach that the indication concerning where to locate the optical test strip of step h) comprises superposing a live image of the camera on the display of the mobile device with a visual guidance.
It would have been obvious to one of ordinary skill in the to configure the mobile device to provide a live image on the display and indicate if a flash mode is required or if focusing requires moving the mobile device. Smartphones display live images until shutter button is pressed to capture an image.
Therefore. Shyam et al. in view of Pulitzer et al. renders claim 10 obvious.
VIII.) Regarding applicant’s claim 11, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 11 depends.
Claim 11 recites that step d) comprises capturing a plurality of second images, wherein the method comprises monitoring reaction kinetics by using the plurality of second images.
In Shyam et al. in view of Pulitzer et al. it would have been obvious to capture any number of images after exposing the test strip to the sample for purposes of monitoring changes to the test strip over time.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 11 obvious.
IX.) Regarding applicant’s claim 12, claim 12 recites a non-transitory computer readable medium having stored thereon executable instructions for performing the method according to claim 1.
Shyam et al. teaches computer-readable medium including random access memory (RAM), read-only memory (ROM), volatile memory, nonvolatile memory, hard drives, CD ROMs, DVDs, flash drives, disks, and any other known physical storage media. [0056].
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 12 obvious.
2. Claims 13 and 14 are rejected under 35 USC 103 as being unpatentable over Shyam et al. in view of Pulitzer et al.
Shyam et al. teaches a method of colorimetric analysis of a test fluid to evaluate associated physiological parameters which involves providing a test strip 104, using a camera to capture a first image of the test strip, applying a sample of body fluid to the test strip, taking a second image of the test strip and determining an analytical measurement result using the first and second images of the test strip. [0007], [0025]-[0027]
Shyam et al. teaches resizing and comparing the first and second images, but does not teach recording first and second items of position information, on the position of the mobile device at the time the first and second images are recorded.
Pulitzer et al. teaches alignment target disposed on the testing device and a plurality of immunoassay test strips receiving at the server an image of the testing device from the mobile device application. (Abstract) The alignment target 310 on a testing device 300 is shown in Figs. 3-6.
Shyam et al. teaches using a smartphone to capture images.
It would have been obvious to one of ordinary skill in the art to use a smart phone as taught by Shyam et al. and provide an alignment target together with the test strip as taught by Pulitzer et al. for purposes of providing and determining position information (“alignment”) with both the test strip (first positional information) and alignment target (second positional information) when taking first and second images that can be compared based the alignment of the test strip and alignment target.
The alignment of the test strip and alignment target when taking images renders a position sensor (including displayed and aligned images) obvious inasmuch as alignment involves positioning of the images as they are taken.
It would further be obvious to one of ordinary skill in the art to determining that when the alignment of the test strip and alignment target are the same for the first and second images, the admissibility of the comparison is satisfactory for comparing the images.
As for providing the mobile device has a processor with a memory having stored thereon executable instructions for performing the method, Shyam et al, teaches providing for routine or periodic check up in a person's busy life [0002] and “instructions comprising instructions to: receive a first image of the test strip captured by the image capturing device at a first height before dipping the test strip into the test fluid, and a second image of the test strip captured at a second height after dipping the test strip into the test fluid.” (claim 8)
It would have been obvious to modify Shyam et al. in view of Pulitzer et al. to provide the imaging capture device with a processor having a memory having stored thereon executable instructions for performing the method for purposes of allowing individuals to perform the method of capturing images of the test strip before and after applying a sample to the test strip.
I.) As noted above, Shyam et al. in view of Pulitzer et al. renders all the elements of claim 13 obvious.
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 13 obvious.
II.) Regarding applicant’s claim 14, claim 14 recites a kit for performing an analytical measurement, the kit comprising: the mobile device of claim 13; and an optical test strip having a test field.
As noted above, Shyam et al, teaches providing for routine or periodic check up in a person's busy life [0002] and “instructions comprising instructions to: receive a first image of the test strip captured by the image capturing device at a first height before dipping the test strip into the test fluid, and a second image of the test strip captured at a second height after dipping the test strip into the test fluid.” (claim 8)
It would have been obvious to modify Shyam et al. in view of Pulitzer et al. to provide a kit to allow people to perform their own analytical measurements of claim 13 with the kit including a mobile device for performing an analytical measurement
Therefore, Shyam et al. in view of Pulitzer et al. renders claim 14 obvious.
3. Claims 6 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Shyam et al. in view of Pulitzer et al. as applied to claim 1 above, and further in view of International Patent Application Publication No. WO2009063185 to Campbell.
I.) Regarding applicant’s claim 6, as noted above Shyam et al. in view of Pulitzer et al. renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that in steps b) and d) the mobile device is positioned in a fixed position by one or both of: using a holder for the mobile device; and placing the mobile device on a fixed surface.
Shyam et al. in view of Pulitzer et al. does not teach a holder for the mobile device.
Campbell teaches a method of recording and optionally transmitting results from rapid point of care tests and drug tests. Campbell uses a camera to capture images of test areas and teaches that “the camera will be presented in a holder to provide a set distance between the photo illustrative test and the camera.” (page 4, paragraph 9 of English translation).
It would have been obvious to one of ordinary skill in the art to modify Shyam et al. in view of Pulitzer et al. to include a holder for the image capturing device as taught by Campbell for purposes of standardizing the imagines based on the distance between the test strips and image capturing device.
Therefore, Shyam et al. in view of Pulitzer et al. and Campbell renders claim 6 obvious.
II.) Regarding applicant’s claim 7, as noted above Shyam et al. in view of Pulitzer et al. and Campbell renders claim 6 obvious from which claim 7 depends.
Claim 7 recites that the fixed surface is a surface selected from the group consisting of a level surface, a seating surface, a floor, a shelf board, an inclined or sloped surface, a flat surface and an irregular surface.
While Shyam et al. in view of Pulitzer et al. and Campbell teaches a holder to hold imagine capturing device, Shyam et al. in view of Pulitzer et al. and Campbell does not specifically teach placing the imagine capturing device on a fixed surface selected from the group consisting of a level surface, a seating surface, a floor, a shelf board, an inclined or sloped surface, a flat surface and an irregular surface.
It would have been obvious to one of ordinary skill in the art to support the imaging capture device of Shyam et al. in view of Pulitzer et al. and Campbell in any stable manner including placing the image capturing device on any suitable fixed surface including a level surface, a seating surface, a floor, a shelf board, an inclined or sloped surface, a flat surface and an irregular surface with the test strip held, positioned or mounted at a fixed distance for purposes of capturing the images.
Therefore, Shyam et al. in view of Pulitzer et al. and Campbell renders claim 7 obvious.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2012/0189509 to Hsiao teaches a test strip unit has a reacting region, an image calibration region and a plurality of marks for positioning and alignment. [0008]
U.S. Patent Application Publication No. 2014/0051173 to Barstis et al teaches the use of alignment references that include a plurality of fiducial markers for orienting the captured images of a test strip using a mobile phone. [0010], [0024]
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.
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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