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 § 103
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.
Claim(s) 1-13, 15, 19, and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2005/0069925 to Ford in further view of U.S. Patent 10,881,339 to Peyser et al.
As to claims 1, 19, and 20 Ford discloses the method of measuring body fluid content, the method comprising:
by a device used for measuring body fluid sample content, measuring content of a body fluid sample taken from a subject (Ford [0343]);
by the device, measuring a value of a temperature of the subject, using a temperature
meter (Ford [0346]-[0348]);
by the device, generating corrective data based on the measured temperature value (Ford [0346]-[0348] and [0144]-[0145]); and
by the device, correcting a result of said measuring of the content of the body fluid sample taken from the subject, using the generated corrective data (Ford [0346]-[0348] and [0144]-[0145]).
Ford does not explicitly teach but Peyser discloses by the device, changing the temperature of the body part into a predetermined value prior to taking the body fluid sample (Peyser column 31 lines 5-29 see thermistor in self heating mode that can determine tissue properties that would indicate edema or higher blood flow to the sensor area in a closed loop glucose monitoring system).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to affect body temperature when performing a process including measuring sample content as in Peyser in the process of Ford to improve the accuracy of the sample measurements.
As to claim 2, see the discussion of claim 1, additionally, Ford discloses the method wherein said correcting comprises replacing the result of said measuring of the content with a range of values based on the corrective data (Ford [0144]-[0145] and [0344]-[0345]).
As to claim 3, see the discussion of claim 1, additionally, Ford discloses the method wherein said correcting comprises changing the result of said measuring of the content only when the result is not within a range of values based on the corrective data (Ford [0332]-[0347]).
As to claim 4, see the discussion of claim 1, additionally, Ford discloses the method wherein said generating of the corrective data is based on data received from a computer in communication with the device (Ford abstract).
As to claim 5, see the discussion of claim 1, additionally, Ford discloses the method further comprising forwarding the measured value of the temperature of the subject to the computer that is in communication with the device, wherein the data received from the computer that is in communication with the device, is data generated on the computer that is in communication with the device, based on the forwarded measured temperature value (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 6, see the discussion of claim 1, additionally, Ford discloses the method wherein the corrective data is further based on previously gathered data, the previously gathered data comprising for each one of a plurality of previously taken test samples, a respective temperature value measured when taking the test sample and a respective content value measured using the test sample (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 7, see the discussion of claim 1, additionally, Ford discloses the method wherein the corrective data is further based on previously gathered data, the previously gathered data comprising for each one of a plurality of previously taken test samples, a respective temperature value measured when taking the test sample, a respective content value measured using the test sample, and a respective time indication (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 8, see the discussion of claim 1, additionally, Ford discloses the method wherein the corrective data is farther based on previously gathered data, the previously gathered data comprising for each one of a plurality of previously taken test samples, a respective temperature value measured when taking the test sample, a respective content value measured using the test sample, and an at least one other parameter value (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 9, see the discussion of claim 1, additionally, Ford discloses the method further comprising taking the body fluid sample from the subject (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 12, see the discussion of claim 1, additionally, Ford discloses the method further comprising generating disease progress data based on the measured content and on previously gathered data (Ford [0346]-[0348] and [0144]-[0145]).
As to claim 13, see the discussion of claim 12, additionally, Ford discloses the method wherein said generating of the disease progress data is based on data received from a computer in communication with the device (Ford [0346]-[0348] and [0144]-[0145]).
Claim Rejections - 35 USC § 103
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.
Claim(s) 10 -11 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2005/0069925 to Ford in view of U.S. Patent 10,881,339 to Peyser et al. in further view of U.S. Patent Application Publication 2015/0317855 to Sezan et al.
As to claim 10-11, see the discussion of claim 1, however, Ford does not explicitly teach the method further comprising receiving biometric data taken from the body part of the subject. Sezan discloses receiving biometric data (fingerprint data) taken from the body part of the subject (Sezan [0023], [0048], and [0058]-[0059]). It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by applicant to take fingerprint data as in Sezan to allow for more accurate patient identification.
Claims 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2005/0069925 to Ford in further view of U.S. Patent 10,881,339 to Peyser et al. in view of U.S. Patent Application Publication 2016/0069743 to Innopix
As to claim 15, see the discussion of claim 31, however, Ford does not explicitly teach the method further comprising capturing an image of the body part. Innopix discloses capturing an image of the body part (Innopix [00244). It would have been obvious to conduct imaging as in Innopix as in Ford to improve the ability of the system to capture additional data
Allowable Subject Matter
Claims 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 7/15/2025 have been fully considered but they are not persuasive.
Applicant argues Peyser does not teach at least “changing the temperature of the body part into a predetermined value prior to taking the body fluid sample”. Peyton teaches heating a thermistor in a body
worn sensor (that performs continuous blood glucose monitoring measurements) to a specific temperature
for a specific duration. This is accomplished to measure the effect of the specific temperature change on
the surrounding body tissue. The reference therefore teaches changing the temperature of the body part
into a predetermined value (the value being heat applied at X degrees for X seconds) and as it is a
continuous glucose monitor, glucose measurements are taken before and after this process. Applicant
argues that it does not attempt to modify the tissue temperature for sampling purposes. The purpose of the
temperature modification is not claimed.
Examiner agrees that Peyser was inadvertently omitted from the rejection of claim 15. It is rejected for the same reasons as claim 1 from which it depends.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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, Peter Choi can be reached on 469-295-9171. 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.
/ELIZA A LAM/Primary Examiner, Art Unit 3686