NON-FINAL OFFICE ACTION
Acknowledgements
1. This non-final Office Action addresses broadening reissue U.S. Application No. 18/751,064 (“instant application”). Examiners find the actual filing date of the instant application is June 21, 2024.
2. The instant application is a broadening reissue application of U.S. Patent No. 11,363,997, (“‘997 Patent”) issued June 21, 2022. The ‘997 Patent was filed on Sep. 24, 2020 as U.S. Application No. 17/031,784 (“784 Application”), titled “ELECTRODE PADS FOR BIOIMPEDANCE”.
3. Examiners do not find any certificates of correction, ongoing/previous proceedings before the Office, or current ongoing litigation involving the ‘997 Patent.
4. The ‘997 Patent issued with claims 1-18 (“Patented Claims”). The preliminary amendment filed June 21, 2024 ("JUNE 2024 CLAIM AMENDMENTS") have been entered.
5. Claims 1-18 are pending and grouped as follows:
claims 1-6;
claims 7-13; and
claims 14-18.
Priority Claims
6. Examiners find the instant application is claiming domestic priority under 35 U.S.C. § 120 or 35 U.S.C. § 119(e) to U.S. App. No. 16/365,191 filed on Mar. 26, 2019, now abandoned.
7. Examiners find the instant application does not claim foreign priority.
8. Because the instant application claims domestic priority to the ‘191 Application, the presumed effective U.S. filing date of the instant application is Mar. 26, 2019.
Claim Objections
9. Claim 5 is objected to because of a typographical error. Because “a surface area” is claimed, “3mm to 25 mm” should be “3mm2 to 25mm2.” See similar claim 8, which claims the same range.
Claim Rejections - 35 USC § 103
10. Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over US 10,405,810 to McNair filed May 23, 2016 (“McNair”).
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As to claim 1, McNair discloses “[a] device, comprising: a housing comprising: an outer surface that defines a 1st side of the housing and a 2nd side of the housing, wherein the 1st side of the housing is an underside of the housing shaped to be affixed to a body of a user an inner cavity that houses electronic components” as shown in the Examiner annotated figure 7A above. The electrodes (#706, #708) read on the claimed “electrical components.”
McNair discloses “an impedance sensor, comprising: a 1st contact terminal disposed adjacent to the outer surface; and a 2nd contact terminal disposed adjacent to the outer surface and separated by a fixed distance from the 1st contact terminal” at figure 7A, wherein electrodes (#706 and #708) read on the claimed “contact terminal[s].”
McNair discloses “a sensor interface positioned in the inner cavity of the housing and electronically coupled to the impedance sensor, wherein the sensor interface is configured to: generate an electric signal by the 1st contact terminal; receive the electric signal from the 2nd contact terminal through a skin layer below a surface of the body of the user; and determine an impedance measurement between the 1st contact terminal and the 2nd contact terminal based on the electric signal” at col.20:10-26.
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McNair discloses “a processing device electronically coupled to the sensor interface or the impedance sensor, wherein the processing device is configured to determine, based on the impedance measurement a condition of a vascular system of the user; an amount of a constituent of the vascular system of the user; or a hydration condition of the user.” See figures 2A-2B.
McNair discloses “a non-conductive material adjacent to and positioned between the 1st contact terminal and the 2nd contact terminal, wherein the non-conductive material prevents a portion of the electric signal that has been transmitted from the 1st contact terminal and that has not entered the body of the user from reaching the 2nd contact terminal” because the material between the electrodes is silicone rubber. See col.20:12.
In contrast to the claimed “fixed distance ranging from 1 mmm to 60 mm,” however, McNair teaches a separation of the electrodes on the order of multiple centimeters. See col.20:50-52.
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In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Here, McNair discloses the same body-worn hydration measurement device of the instant claimed invention except that the distance between the electrodes of the sensor is on the order of several centimeters whereas the instant claimed invention requires the fixed distance to be between 1mm and 60mm. McNair’s device is wrist-worn whereas the instant claimed invention appears to be worn on a finger. Examiners find, however, that the relative dimensions would not perform any differently than the prior art device because both measure hydration as a function of a current in portions of the human body and the distance between the electrodes merely reflects the size of the body-worn device.
As to claim 2, McNair figure 7A discloses electrodes (#706, #708) “recessed within the housing relative to the outer surface.”
As to claim 3, McNair figure 7A discloses “the fixed distance is greater than 25 mm” because McNair teaches a separation of the electrodes on the order of multiple centimeters. See col.20:50-52.
As to claim 4, McNair figure 7A discloses “the processing device is further configured to determine an amount or identity of the constituent based on a difference between the electric signal generated by the 1st contact terminal and the electric signal received by the 2nd contact terminal” at receiver operating curve show in figure 3.
As to claim 5, McNair does not specifically disclose “the 1st contact terminal or the 2nd contact terminal has a surface area of contact with the surface of the body of the user ranging from 3 mm2 to 25 mm2” because McNair teaches the electrodes have a surface area of 1 cm2.
In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Here, McNair discloses the same body-worn hydration measurement device of the instant claimed invention except that the distance between the electrodes of the sensor is 1 cm2 whereas the instant claimed invention requires the surface area to range from 3 mm2 to 25 mm2. McNair’s device is wrist-worn whereas the instant claimed invention appears to be worn on a finger. Examiners find, however, that the relative dimensions would not perform any differently than the prior art device because both measure hydration as a function of a current in portions of the human body and the distance between the electrodes merely reflects the size of the body-worn device.
As to claim 6, McNair discloses “the non-conductive material comprises glass, porcelain, plastic, or rubber” because the material between the electrodes is silicone rubber. See col.20:12.
As to claims 7-13, this method is merely the method of operation of the apparatus as claimed in claims 1-6.
Reissue Declaration
11. Claims 1-18 are rejected as being based upon a defective reissue declaration under 35 U.S.C. 251. See 37 CFR 1.175.
Specifically, the reissue oath/declaration filed with this application is defective (see 37 CFR 1.175 and MPEP § 1414) for two reasons.
First, the statement “..the independent claims have an overly large range of fixed distance between the impedance pads” is inconsistent with the stated broadening of the range from 7mm-60mm to 1mm-60mm. Examiners recommend the following sufficient error statement:
--Claim 1 has been broadened by amending the range “7mm to 60mm” to “1mm to 60mm” because the range “7mm to 60mm” was unduly narrowing.—
Second, the listed inventors must be incorporated into a single reissue declaration. Here, the main reissue declaration marks the following box.
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A PTO/AIA /10 form, however, is not provided. Rather, three separate reissue declarations, each signed by a different inventor, has been submitted, which is insufficient. Examiners recommend supplementing a reissue declaration signed by the first inventor with an PTO AIA -10 form that list the other two inventors.
Allowable Subject Matter
12. If a proper reissue declaration is filed, then claims 14-18 would be in condition for allowance. The prior art does not disclose or make obvious “determining a contact impedance between the 1st impedance pad or the 2nd impedance pad and the surface of the body, wherein: the contact impedance is determined not to factor into the current impedance measurement when the current impedance measurement is less than 1,000 ohms; and the contact impedance is determined to be a factor in the current impedance measurement when the current impedance measurement ranges from 1,000 ohms to 20,000 ohms; and notifying the user the contact impedance is interfering with correct measurement of the current hydration condition of the user” in combination with the other limitations of the claims.
Conclusion
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANDRA M HUGHES whose telephone number is (571)272-6982. The examiner can normally be reached Generally M-Th 8AM-6PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Hetul Patel can be reached at 571-272-4184. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Signed:
/DEANDRA M HUGHES/Reexamination Specialist, Art Unit 3992
Conferees:
/CHRISTINA Y. LEUNG/Primary Examiner, Art Unit 3991
/H.B.P/
Hetul PatelSupervisory Patent Examiner, Art Unit 3992