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) 11-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez (US 2018/0264284) in view of Barrows (US 2018/0199864).
Regarding claim 11, Alvarez discloses a measurement device for determining a tear fluid characteristic, the measurement device comprising:
a body having a crescent shape so as to extend only partially along a curvature of an eye and sized to be positioned within a fornix of a subject without extending over a pupil or onto a cornea of the eye (element 100; figures 1, 5);
a sensor mounted to or embedded in the body and configured to measure concentration of a constituent of a tear fluid of the subject, the sensor including a sensing surface configured to be in contact with the tear fluid (paragraph [0031]); and
a wireless communication module mounted to or embedded in the body and communicatively coupled to the sensor so as to receive concentration data signals from the sensor (paragraph [0110]).
Alvarez does not disclose the body being sized to be positioned within an inferior fornix; Barrows teaches a measurement device comprising a body having a crescent shape so as to extend only partially along a curvature of an eye (paragraph [0004]; figures 2A, 2B) and sized to be positioned within either of an inferior fornix or a superior fornix of a subject (paragraph [0089]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Alvarez, where same size of device can also be positioned in an inferior fornix, as taught by Barrows, as Barrows teaches that the same device can be positioned in either fornix by merely flipping the device over (“upside-down implementation”) without requiring a change in size.
Regarding claim 12, Alvarez further discloses that said sensor is an electrochemical sensor that measures impedance of the tear fluid along the sensing surface (paragraph [0031]).
Regarding claim 13, Alvarez does not explicitly disclose the electrochemical sensor comprising a plurality of electrodes exposed along the sensing surface. Barrows further teaches the measurement device comprising a plurality of electrodes exposed along a sensing surface for measuring an impedance of tear fluid (paragraphs [0041]-[0042]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the device of Alvarez as modified by Barrows and further included a plurality of electrodes exposed along the sensing surface, as further taught by Barrows, in order to enable the sensing of the impedance.
Regarding claim 14, Alvarez further discloses that the crescent shape comprises two opposing arcuate edges each contiguous at a pair of apexes with the other of said two opposing arcuate edges (figure 1).
Regarding claim 15, Alvarez further discloses that the concentration is osmolarity of the tear fluid (paragraph [0031]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Alvarez in vie of Barrows, as applied above, and further in view of Gutierrez (US 2020/0306538).
Regarding claim 16, Alvarez, as modified above, further discloses a system comprising the measurement device of claim 11 (see above) and an external computing device in wireless communication with the measurement device, the external computing device comprising a signal processor configured to compare different measurements of the concentration taken at different times (paragraph [0112]). Alvarez, as modified, does not further disclose the signal processor being configured to use the comparison of the measurements of the concentration to determine attainment of a stable or state of equilibrium value and being further configured to automatically communicate the stable or equilibrium value to the subject.
Gutierrez teaches a system comprising:
a measurement device for determining a tear fluid characteristic comprising a body configured to be positioned within a fornix of a subject without extending over a pupil or onto a cornea of the eye (figures 1, 4), a sensor in the body configured to measure concentration of a constituent of a tear fluid of the subject (paragraph [0026]), and a wireless communication module in the body configured to receive concentration data signals from the sensor (paragraph [0036]); and
an external computing device in wireless communication with the measurement device (element 120; figure 7), the external computing device comprising a signal processor configured to compare different measurements of the concentration taken at different times to thereby determine attainment of a stable or state of equilibrium value of the concentration (paragraph [0036]), the external computing device being configured to automatically communicate said stable or equilibrium value to the subject (figure 9; paragraph [0039]).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Alvarez, as modified above, and further configured the signal processor to determine attainment of a stable state of concentration and to automatically communicate that to the subject, as taught by Gutierrez, in order to enable the subject to be aware of their control of their current condition.
Response to Arguments
Applicant's arguments filed 13 August have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 11-16 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. Applicant argues only that neither Gutierrez nor Alvarez discloses a device which is “sized” to be positioned in an inferior fornix; as Barrows teaches sizing a similar device for such a location, Applicant’s remarks are moot.
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.
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/KAREN E TOTH/Examiner, Art Unit 3791
