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 .
Amendment Entered
In response to the amendment filed on 08/21/2025, claim 2 is cancelled and amended claims 17-18, 22-24, 26, 29, and 32 are entered. Claims 1 and 3-19 remain pending in the application.
Response to Amendment
Applicant’s remarks and amendments with respect to the specification and claims have been fully considered and overcome each and every objection, the rejection of claim 14 under 35 U.S.C. 112(a), and the rejection of claims 1-2, 4, 5, 7, 9-11 and 14 under 35 U.S.C. 112(b) previously set forth in the Non-Final Office Action mailed 05/21/2025. The objections and rejections are withdrawn in view of amendments to claims 1, 4, 6-10, 15, 18, and 19, amendments to the specification, amendments to Figs. 1-2 of the drawings, and Applicant’s arguments regarding “an input device”, as recited in claim 14 (see pg. 11-12 of Remarks).
Additionally, in view of reconsideration by Examiner, and further in view of amendments to claim 14 and Applicant’s arguments (see pg. 11-12 of Remarks), Examiner is no longer interpreting claim 14 under 35 U.S.C. 112(f) as reciting means-plus function limitations.
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.
Claim 17, and all claims dependent thereon, 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 17 recites “…wherein the set of values relates to one or more of…the temperature of the target area…” in lines1-3. There is insufficient antecedent basis for this limitation in the claim. Claims 14 and 1, from which claim 17 depends, do not recite a temperature sensor or measuring temperature. Examiner recommends amending this limitation to recite “…“wherein the set of values relates to one or more of…a temperature of the target area…”.
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.
Claims 1 and 4-19 are rejected under 35 U.S.C. 103 as being unpatentable over Kuban in view of US 2016/0350509 A1 to Sharma.
Regarding independent claim 1, Kuban discloses a hand-held device for taking measurements related to sensitivity in a subject (see Fig. 1 and [0011], "...an apparatus 100 for detecting tactile sensitivity...”. See also [0024] , "... apparatus 100 may be readily carried or stored by the user...". apparatus 100 is carried by a user (i.e., hand held), and detects subject sensitivity), said hand-held device comprising:
a housing having a subject engagement end (see Fig. 2 and [0013], "... the internal structure of the housing 102...end plug 210 is located at one end of the housing tube 208…”, housing 102 having end plug 210) for positioning the device against a target area of the subject's body (see Fig. 3D and [0028], "...the user may contact a body portion 342 of the patient with the probe tip 106…", probe tip 106 contacts a portion of a patient’s body 342 (i.e., positions the device against a target area of a patient), and is located on the same end of the housing tube as end plug 210 (i.e., a subject engagement end);
a probe encompassed by the housing and moveable from a first position where the probe is contained within the housing to a second position where one end of the probe extends beyond the subject engagement end of the housing (see Figs. 1-2 and [0012], "... probe 104 is supported by the housing 102…probe 104 is adapted for selective longitudinal movement relative to the housing 102 between a first probe position, in which the probe tip 106 is substantially extended from the housing as shown in FIG. 1, and a second probe position, wherein the probe tip is substantially retracted into the housing", probe 104 is within housing 102, and moves from being contained within housing 102 (i.e., a first position) to extending beyond the housing (i.e., a second position));
an activator positioned on an exterior surface of the housing (see Figs. 3A-3D and [0016], "...setting piston 214 has a setting button 224 located outside the housing 102 and adapted for selective contact with a user...", setting button 224 (i.e., activator) is positioned on housing 102 (i.e., exterior surface)) and connected to the probe for moving the probe between the first and second positions (see Figs. 3A-3D and [0024], "...movement of the probe 104 between the second and first probe positions, and the setting piston 214 between the second and first setting positions...”, setting button 224 connects to probe 104 by setting piston 214, and moves probe 104 between the first and second positions);
a displacement sensor connected to the probe for measuring the distance the probe travels between the first and second positions (see Fig. 2 and [0015] "…changing the location of the calibration fork 220 within the housing 102, the distance between the first and second probe positions may be changed… a calibration scale (not shown) may indicate to the user the location of the calibration fork 220 within the housing 102”, the position of calibration fork 220 (which is connected to probe 104) within housing 102, determines the distance between the first position and the second position of the probe (i.e., a distance the probe 104 travels between the first and second position). Furthermore, the calibration scale indicates the location of calibration fork 220 within housing 102 (i.e., the location of calibration fork 220 within housing 102 indicates the distance the probe travels)); and
a pressure sensor connected to the probe for measuring the force applied to move the probe between the first and second positions (see Fig. 2 and [0029], “…amount of pressure against the probe tip 106 needed to develop the predetermined level of motive force to move the probe away from the first biasing means 228 can then be correlated with the tactile sensitivity of the patient…" , probe tip 106 connects to probe 104, and measures pressure representative of the motive force required (i.e., force applied) to move probe 104 from the first position to the second position).
However, Kuban fails to explicitly disclose an electrical displacement sensor connected to the probe for measuring the distance the probe travels between the first and second positions…an electrical pressure sensor connected to the probe for measuring the force applied to move the probe between the first and second position…and a microprocessor connected to the electrical displacement sensor and the electrical pressure sensor for receiving measurements from the electrical displacement and electrical pressure sensors; and an output for relaying information from the microprocessor to a user.
Kuban further discloses indicating information to a user (see [0015] "… a calibration scale (not shown) may indicate to the user the location of the calibration fork 220 within the housing 102”, indicating (i.e., outputting) to a user a position of calibration fork 220 (i.e., displacement information)) and controlling a magnitude of force applied in order to change a tactile sensitivity (see [0015], “…control a magnitude of the predetermined motive force to change an amount of tactile sensitivity indicated by the apparatus”) .
Sharma teaches a portable pain therapy device applied to a target area of a patient (see Figs. 1-2 and [0113], “ …a portable and versatile pain therapy device…capable of producing and applying different forms of energies when placed on the treatment area (the skin)”) including electrical sensors (see Fig. 2 and [0050], “…applicator 124 can also include built in sensors 308, which include… applicator surface contact sensor… include a substrate component 310 and/or electrode component 311…”), a microprocessor receiving sensor measurements and electrically controlling an applicator (see Fig. 2 and [0045], “MCU 210 is also coupled to sensors for receiving physiological measurements from the user of pain therapy device 100”, see also [0047], “…MCU 210 can also be communicatively coupled to control inputs 222-234 for controlling the characteristics of the pain management therapy as applied by applicator 124…”), and an output for communicating information from the microprocessor to a user (see [0045], “MCU 210 can include logic for connecting to external interfaces…MCU 210 includes…an LCD interface 252 (or interface for any other type of user interface device)”).
Although Kuban fails to explicitly disclose a microprocessor connected to an electrical displacement sensor and an electrical pressure sensor for receiving measurements, Sharma teaches a microprocessor electrically receiving output from electrical sensors which are collecting physiological measurements of a patient.
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the pressure and displacement sensors of Kuban (to be electric sensors) for the purpose of providing patient specific care based on electrical signals received, as evidence by Sharma (see [0039]). Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the sensors of Kuban to be electric sensors, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192. Furthermore, one of ordinary skill in the art would have had predictable success combining Kuban and Sharma since both teachings relate to the same narrow field of endeavor, i.e., utilizing handheld devices to measure subject pain/sensitivity.
Additionally, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify Kuban to incorporate a microprocessor for receiving measurements and relaying information, in order to control the monitoring and communication operations of the device, as taught by Sharma (see par. [0136]). Furthermore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify Kuban to incorporate an output, in order to relay information to a user, as evidence by Sharma (see [0102]).
Regarding claim 4, the Kuban/Sharma combination discloses the device as claimed in claim 1 above.
However, Kuban fails to disclose a temperature sensor connected to the one end of the probe for measuring the temperature of the target area of the subject's body.
Sharma further teaches a temperature sensor connected to the sensing device for measuring a temperature of the target area of the subject's body (see Sharma Fig. 2 and [0045], "…sensors include temperature sensor 230 (for measuring the body temperature of the patient at the point of contact of the applicator 124)…", temperature sensor 230, positioned on applicator 124 (i.e., sensing device) measures patient temperature at a point of contact).
The Kuban/Sharma combination of claim 2 discloses a subject sensitivity measurement device including a pressure sensor and a displacement sensor, in communication with a microprocessor. Sharma teaches a sensing device, including a temperature sensor, measuring temperature at a target area of a subject’s body. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the Kuban/Sharma combination to incorporate a temperature sensor to measure a temperature of a subject, for the purpose of providing a safety feature regarding the device usage on different parts of the body, as evidence by Sharma (see [0051]).
Regarding claim 5, the Kuban/Sharma combination discloses the device as claimed in claim 4/1 above (as described in 35 USC 112(b) rejection above). The Kuban/Sharma combination further discloses wherein the temperature sensor is connected to the microprocessor (see Sharma Fig. 2 and [0045], “MCU 210 is also coupled to sensors for receiving physiological measurements from the user …sensors include temperature sensor 230 (for measuring the body temperature of the patient at the point of contact of the applicator 124)”, temperature sensor 230 is connected to MCU 210 (microprocessor of the Kuban/Sharma combination).
Regarding claim 6, the Kuban/Sharma combination discloses the device as claimed in claim 1 above. The Kuban/Sharma combination further discloses wherein the output is a transmitter (see Sharma Fig. 2 and [0045], “MCU 210 can include logic for connecting to external interfaces…a Bluetooth interface 260, a WiFi interface 262, and a network interface 264…”, connecting to external interfaces (i.e., transmitting)) or a display (see Sharma Fig. 3 and [0050], "…applicator 124 can also include a PCB & LED component 306 that can display…", component 306 is a display, included in applicator 124 (i.e., sensing device)).
However, the Kuban/Sharma combination fails to disclose wherein the output is a transmitter or a display positioned on the exterior surface of the housing.
The Kuban/Sharma combination teaches a display included with a sensing device ((see Sharma Fig. 3 and [0050], "…applicator 124 can also include a PCB & LED component 306 that can display…"), but is silent regarding where the display is positioned. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to position the display (component 306 of Sharma) on the exterior of the housing (housing of the Kuban/Sharma combination), since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claim 7, the Kuban/Sharma combination discloses the device as claimed in claim 6/1 above. The Kuban/Sharma combination further discloses wherein the transmitter is a wireless local area network transmitter or a short-range wireless communication transmitter (see Sharma Fig. 2 and [0090], "…wired/wireless networking capability that communicates with mobile or smart phones or computers either through physical connectivity or remotely (e.g., via Bluetooth or Wi-Fi)..." transmission (done by the transmitter of the Kuban/Sharma combination) done by wireless local area network or a short-range wireless communication).
Regarding claims 8 and 9, the Kuban/Sharma combination discloses the device as claimed in claim 1 above. The Kuban/Sharma combination further discloses wherein the output is a wire connected to a computer or a tablet, and wherein the wire is removably connected to the output and/or computer or tablet (see Sharma Figs. 8A-8B and [0068], “…computing device 110 also includes a communication interface 1010…includes any device or group of devices suitable for establishing a wired or wireless data connection…include an Ethernet network adapter, a modem, and/or the like…device 110 transmits messages as electronic or optical signals via the communication interface 1010”, output (of the Kuban/Sharma combination discussed above), may be a wired connection to a computing device 110 (i.e., a wired connection to a computer), the connection including an adapter (i.e., the wire is removably connected to the computing device).
Furthermore, It would have been obvious to one having ordinary skill in the art at the time the invention was filed to make the wire of the Kuban/Sharma combination removable, since it has been held that making known elements separable is within the skill of a person of ordinary skill in the art. See In re Dulberg, 129 USPQ 348 (CCPA 1961). See also MPEP § 2144.04.
Regarding claim 10, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches a form factor of the exterior surface of the housing (see Kuban Fig. 1 and [0013], “…housing 102 could, however, have any suitable alternative configuration, such as one having cylindrical portions as well as portions ergonomically contoured to facilitate handling the apparatus 100...", cylindrical portion and ergonomically contoured portion, make up form factor of housing 102).
However, the Kuban/Sharma combination is silent regarding specifically a portion of the exterior surface of the housing forms a grip for a user's hand.
Kuban discloses cylindrical and ergonomically contoured portions of the form factor of housing 102 (see [0013]). Examiner notes that there is no significant difference between “portions ergonomically contoured to facilitate handling” and “a portion…forms a grip for the user’s hand”. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify a portion of the exterior housing of Kuban to form a grip for the user’s hand for the purpose of improving handling of the apparatus, as evidence by Kuban (see [0013]). Furthermore, such modification would involve a mere change in configuration. It has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 11, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches wherein the activator is positioned on or near an end of the housing opposite the subject engagement end (see Kuban Fig. 3D and [0016], "...setting piston 214 has a setting button 224 located outside the housing 102 and adapted for selective contact with a user...", setting button 224 (i.e., activator) positioned opposite subject engagement end 342).
Regarding claim 12, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches wherein the subject engagement end of the housing contacts the target area of the subject's body (see Kuban Figs. 2 and 3D, and [0028], “…user may contact a body portion 342 of the patient with the probe tip 106”, probe tip 106 is located at the end of housing tube 208 that contacts patient body portion 342 (i.e., a subject engagement end)). Additionally, Kuban further discloses varying sizes of devices adapted for varying ranges of forces (see Kuban [0038], “Different sizes of apparatuses 100 may be provided, with each size being adapted to require a different amount or range of predetermined motive forces”).
However, Kuban fails to disclose discloses wherein the subject engagement end of the housing comprises a plate to surround the target area of the subject's body.
Sharma teaches a portable pain therapy device (see Figs. 1-2 and [0113], “ …a portable and versatile pain therapy device…”) with various sensing device shapes (see Sharma Figs. 8A-10B and [0079], "...schematic cross sections of different possible pain therapy device designs...") for placing in contact with a patient (see Sharma Figs. 8A-10B and [0049], "…layers for applicator 124 can be placed on the surface area of the tissue of the patient for whom the pain management therapy is applied").
Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify Kuban to incorporate a plate to surround the target area of a subject’s body, for the purpose of providing information about the contact of the device with the patient’s body and allow for prolonged device use, as evidence by Sharma (see [0085]). Furthermore, such modification would involve a mere change in configuration, and it has been held that a change in configuration of shape of a device is obvious, absent persuasive evidence that a particular configuration is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966).
Regarding claim 13, the Kuban/Sharma combination teaches the device as claimed in claim 1 above.
However, Kuban fails to disclose wherein the electrical displacement sensor and electrical pressure sensor are piezoelectric sensors.
Sharma teaches a portable pain therapy device (see Figs. 1-2 and [0113], “ …a portable and versatile pain therapy device…”) with a controller receiving feedback signals from sensors (see [0071], “…controller provides the required electronics to control energies produced by the transducers. The controller is configured to modify the intensity, timing, or duration of the different energies, which are applied over the treatment area (skin) over the feedback control signal obtained from the sensors…”, sensors obtain signals obtained by energy produced by transducers). Furthermore, Sharma teaches sensing patient sensitivity, pressure, and depth information (see Sharma [0107], “…the system may have the capability collect non-invasive sensing information of patient such as…pressure point depth or pressure-pain threshold…”, the system collects sensor information related to patient pressure point depth (i.e., sensing a distance and a pressure) and pressure-pain threshold (i.e., a patient sensitivity)).
Although Sharma does not explicitly disclose piezoelectric sensors, a piezoelectric transducer1 is a known structure in the art for converting measured mechanical energy to electrical signals. Because these two sensors were art-recognized- equivalents at the time the invention was made, one of ordinary skill in the art would have it found obvious to substitute Sharma’s teaching of sensors that obtain signals from energy produced by transducers, for piezoelectric sensors.
Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify Kuban to incorporate piezoelectric sensors, for the purpose of allowing for feedback and control, as evidence by Sharma (see [0078]).
Regarding claim 14, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches a system for measuring and tracking sensitivity in a subject (see [0032], “…may be supplied as an accessory to the apparatus 100…”, device 100 and accessories (i.e., system)) the system comprising:
inputting data related to the subject's sensitivity to the probe being pressed against the target area (see [0029], “…calibrating the apparatus 100…to control a magnitude of the predetermined motive force to change an amount of tactile sensitivity indicated by the apparatus…”, calibrating the device to control motive force magnitude of probe 104 (i.e., inputting data) is related to the sensitivity of the subject); and
outputting a set of values (see [0012], “…tactile sensitivity can be quantified using absolute numbers taken from the motive force needed to move the probe 104”, absolute numbers are taken from the device to quantify sensitivity (i.e., output values)).
However, Kuban fails to disclose an input device connected to the microprocessor adapted to input data related to the subject's sensitivity with respect to the probe being pressed against the target area.
Sharma further teaches an input device connected to a microprocessor (see [0039], "One or more applicators 124 connected to the pain therapy device 100 apply the personalized pain management therapy input via physician interface application 112 or patient interface application 122 or directly through physical therapy device 100").
The Kuban/Sharma combination discloses a device that outputs values (see Kuban [0012]) connected to a microprocessor (see Sharma [0045]), but fails to disclose an input device connected to the microprocessor. Sharma teaches an input device connected to a microprocessor, for inputting patient data (see Sharma [0039]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the system of Kuban to incorporate an input device connected to the microprocessor, for the purpose of providing patient feedback based on personalized subject input data , as evidence by Sharma (see par. [0037]).
Additionally, Kuban fails to disclose a display connected to the microprocessor for displaying a set of values.
Sharma further teaches a pain therapy system (see Figs. 1-2 and abstract, “ … Systems and methods disclosed herein provide efficacious pain management…”) including a microprocessor in communication with sensors and receiving sensor measurements (see Fig. 2 and [0045], “MCU 210 is also coupled to sensors for receiving physiological measurements from the user of pain therapy device 100”), and a display for communicating information from the microprocessor to a user (see [0045], “MCU 210 can include logic for connecting to external interfaces…MCU 210 includes…an LCD interface 252 (or interface for any other type of user interface device)”).
The Kuban/Sharma combination discloses a device that outputs values (see Kuban [0012]) connected to a microprocessor (see Sharma [0045]), but fails to disclose a display connected to the microprocessor to display the values. Sharma teaches a display connected to a microprocessor (see Sharma [0045]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the system of Kuban to incorporate a display connected to the microprocessor (to output values), for the purpose of tracking and managing measured parameters, as evidence by Sharma (see par. [0097]).
Regarding claim 15, the Kuban/Sharma combination discloses the device as claimed in claim 14/1 above. The Kuban/Sharma combination further discloses wherein the microprocessor is wirelessly connected to the hand-held device (see Sharma Fig. 2 and [0090], " a pain therapy device…having a microprocessor and wired/wireless networking capability that communicates with mobile or smart phones or computers either through physical connectivity or remotely (e.g., via Bluetooth or Wi-Fi)...", microprocessor is wirelessly connected to hand-held device (of the Kuban/Sharma combination)).
Regarding claim 16, the Kuban/Sharma combination discloses the device as claimed in claim 14/1 above. The Kuban/Sharma combination further discloses wherein the microprocessor is contained within a computer, tablet, or cellphone (see Sharma Fig. 5 and [0064], “…physician computing device 110 includes a processor 1002… processor 1002 comprises, for example, a microprocessor… processor 1002 includes one processing device or more than one processing device”, microprocessor contained in a computing device (i.e., a computer)).
Regarding claim 17, the Kuban/Sharma combination discloses the device as claimed in claim 14/1 above. The Kuban/Sharma combination further discloses wherein the set of values (set of values of the Kuban/Sharma combination) relates to one or more of the force measured by the electrical pressure sensor, the distance travelled by the probe, the temperature of the target area and the data related to the subject's sensitivity to the probe being pressed against the target area (see Kuban [0012], “…tactile sensitivity can be quantified using absolute numbers taken from the motive force needed to move the probe 104”, absolute numbers are taken from the device to quantify sensitivity (i.e., output values)).
Regarding claim 18, the Kuban/Sharma combination discloses the device as claimed in claim 14/1 above. The Kuban/Sharma combination further discloses wherein the microprocessor comprises a computer- readable medium for storing information (see Sharma [0046], "…MCU 210 is in communication with memory 101, which includes any suitable non-transitory computer-readable medium…storage device capable of providing a processor with computer-readable instructions or other program code... program code includes one or more of a physiological data collection engine 102 …", microprocessor (of the Kuban/Sharma combination) includes a computer readable memory to store information). Sharma further teaches that the stored information is received from sensors (see Sharma [0040], “…a physiological data collection engine 102 executing in memory 101 of pain therapy device 100 may receive information…from connected sensors”, information stored in the microprocessor (of the Kuban/Sharma combination) is received from sensor outputs).
However, the Kuban/Sharma combination fails to disclose wherein the microprocessor comprises computer- readable medium for storing the set of values.
The Kuban/Sharma combination discloses a device that outputs values (see Kuban [0012]) connected to a microprocessor having a computer readable storage medium (see Sharma [0045]), but fails to disclose storing the values. Sharma teaches a microprocessor storing information received from sensors (see Sharma [0040]). Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to further modify the Kuban/Sharma combination to store the values (of the Kuban/Sharma combination) for the purpose of providing adjustments based on personalized physiological feedback, as evidence by Sharma (see par. [0052]).
Regarding claim 19, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches a method of taking measurements related to sensitivity in a subject (see Kuban abstract, “…method for helping to determine tactile sensitivity…”) comprising positioning the device of claim 1 (device as described in claim 1 above) against the target area on the subject's body (see Kuban Figs. 3A-3D and [0028], “…user may contact a body portion 342 of the patient with the probe tip 106”, position device 100 against user body portion 342); and pressing the activator to move the probe from the first position to the second position (see Kuban Figs. 3A-3D and [0025], "When the user is ready to use the apparatus, a positive action is taken to place the probe 103 into the first probe position…a motive force is exerted by the user on the setting button 224 in the direction of arrow 340”, positive action (i.e., pressing) of setting button 240 (i.e., activator) in direction of arrow 340 moves probe 104 from the first position to a second position).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Kuban in view of US 8,573,046 B1 to Ohm et al. (“Ohm”).
Regarding claim 3, the Kuban/Sharma combination teaches the device as claimed in claim 1 above. The Kuban/Sharma combination further teaches wherein the electrical displacement sensor (of the Kuban/Sharma combination) provides a visual indication of the distance the probe travels between the first and second positions (see Kuban Fig. 2 and [0015] "… a calibration scale (not shown) may indicate to the user the location of the calibration fork 220 within the housing 102”, calibration scale indicates the location of calibration fork 220 within housing 102 (i.e., the location of calibration fork 220 within housing 102 indicates the distance the probe travels). Kuban further discloses a cylindrical shaped housing (see [0013], “…housing 102 has a generally cylindrical configuration with a cylindrical housing tube 208”).
However, the Kuban/Sharma combination fails to disclose wherein the electrical displacement sensor comprises a rod having distance intervals marked thereon to provide a visual indication of the distance the probe travels between the first and second positions.
Ohm teaches a pressure indicating measurement tool (see Fig 1 and abstract, “…measurement tool and pressure gauge…includes a housing…and a pneumatic pressure sensor”, tool with a housing and a pressure sensor) including a measurement element marked with a quantitative indication of measurement intervals (Figs. 1-2 and col. 6 line, 55-59 "...the measurement element 13 is marked with quantitative indicators 20…quantitative indicators 20 include evenly spaced hash marks or dots with numerals indicating particular measurements...", measurement element 13 is cylindrical in shape (i.e., a rod), and contains indicators 20 to indicate a measurement quantity (i.e., a visual indicator of a quantity measured)).
The Kuban/Sharma combination discloses a cylindrical shaped hand-held device for taking measurements of subject sensitivity (see Kuban [0013]), including a probe (see Kuban [0024]) and an electrical displacement sensor for measuring a distance the probe travels between a first and second position (of the Kuban/Sharma combination of claim 1, discussed above), but fails to disclose the distance sensor being a rod marked with distance intervals to visualize the distance the probe travels. Ohm teaches using a rod-shaped distance sensor marked with visual indicators as a simple measurement technique. Therefore, it would have been prima facie obvious to one having ordinary skill in the art at the time the invention was filed to modify the electrical displacement sensor of Kuban/Sharma combination to use a rod marked with visual indicators, for the purpose of making it easier for users to see a measurement value, as evidence by Ohm (see col. 1 lines 41-47).
Response to Arguments
Applicant’s arguments (see pg. 13-14 of Remarks), filed on 08/21/2025, with respect to the rejections of claims 1, 11, and 19 under 35 U.S.C. 102, and the rejection of claim 10 under 35 U.S.C. 103, have been fully considered and are persuasive. Therefore, the rejection of record has been withdrawn. However, upon further consideration, new grounds of rejection are made under 35 U.S.C 103 in view of the current combination of references necessitated by amendment. Additionally, Applicant’s arguments with respect to the rejection of claim 2 under 35 U.S.C. 103 (see pg. 15 of Remarks) have been fully considered, but are moot in view of the cancellation of claim 2. Furthermore, Applicant’s arguments regarding the rejection of claims 3-9 and 12-18 under 35 U.S.C. 103 (see pg. 15-17 of Remarks) have been fully considered, but are moot in view of the current combination of references necessitated by amendment.
Applicant argues that the device of Kuban is limited to mechanical components and does not teach or suggest a microprocessor or measuring force or distance with electrical sensors as recited in claim 10 (see pg. 15 of Remarks). Applicant further argues that Kuban offers no teaching or suggestion to modify the device of Kuban to include electrical sensors or electronic processing as recited in amended claim 10. In the instant case, this line of argument is considered not persuasive in view of the treatment of claim 10 above.
Applicant further argues that Kuban and Ohm, taken individually or in combination, fail to teach or suggest a device including electrical sensors and a microprocessor as recited in amended claim 3, and that one of ordinary skill in the art would not be motivated to combine the teachings of Kuban and Ohm to arrive at the claimed invention (see pg. 15 of Remarks), because the interval marked measurement element of Ohm operates under pressure resulting from contacting a tire rather than contacting tissue.
In response to applicant’s argument that the rejection of record there is no teaching, suggestion, or motivation to combine the teachings of Kuban and Ohm, Examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In the instant case, Examiner relies on the Kuban/Sharma combination to teach a rod shaped electrical displacement sensor providing a visual indication of a distance a probe travels between a first and second position, and relies on Ohm to teach markings of distance intervals on a rod shaped displacement sensor, as described above regarding claim 3. Therefore, this argument is considered not persuasive in view of the treatment of claim 3 above.
Regarding Applicant’s argument that the device of Ohm is applied to determine pressure from a tire rather than from tissue, MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention, or is reasonably pertinent to the problem faced by the inventor. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). A reference is “reasonably pertinent” when it “logically commended itself to an inventor’s attention in considering his problem.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656, 658, 23 USPQ2d 1058, 1061 (Fed. Cir. 1992))”.
In the instant case, even if it could be argued that Ohm is not in the same field of endeavor as the claimed invention (i.e., devices for measuring subject sensitivity), Ohm is an analogous art because it is reasonably pertinent to the problem faced by the inventor. Ohm teaches a rod marked with visual distance interval indicators to solve the problem of distorted measurements seen in conventional indicators, by making markings more distinguishable it easier for users to see a measurement value (see col. 1 line 41- col. 2 line 18).
Applicant further argues that one of ordinary skill in the art would not be motivated to combine the teachings of Kuban and Sharma because Kuban and Sharma are not analogous art to the claimed invention. In particular, applicant argues “The functions of the devices and end goals between these two references are materially different” (see page 16 of Remarks) arguing that the device of Kuban is limited to binary event detection and the device of Sharma is used for control of therapy, neither of which determine measurements of sensitivity in the instant invention.
MPEP § 2141.01(a) states that in order for a reference to be used in an obviousness rejection, it must be analogous art to the claimed invention. A reference is analogous art to the claimed invention when it is either from the same field of endeavor as the claimed invention, or is reasonably pertinent to the problem faced by the inventor. A reference is “reasonably pertinent” when it “logically commended itself to an inventor’s attention in considering his problem.” In re ICON Health and Fitness, Inc., 496 F.3d 1374, 1379-80 (Fed. Cir. 2007) (quoting In re Clay, 966 F.2d 656, 658, 23 USPQ2d 1058, 1061 (Fed. Cir. 1992)).
Examiner respectfully disagrees with applicant’s position that Kuban and Sharma are non-analogous art for several reasons. First, both Kuban and Sharma are in the same field of endeavor as the claimed invention. All are in the field of devices for measuring physiological responses of patients exposed to stimuli. Second, even if it could be argued that Kuban and Sharma are not in the same field of endeavor as the claimed invention, both Kuban and Sharma are analogous art because they are reasonably pertinent to the problem faced by the inventor in the claimed invention. Kuban teaches a device measuring tactile sensitivity of a patient to solve the problem of sensing forces applied to the skin of patients, thereby determining pain thresholds in patients (see [0003]). Sharma teaches a portable electronic sensor device measuring changes in patient physiological data to solve the problem of the subjectivity of patient pain feedback as seen in conventional physiological response measurement systems, by accounting for objective and subjective patient data to improve the confidence level of effectiveness (see [0003] – [0006]).
Applicant further argues that the rejection of record is improper because Kuban and Sharma, taken individually or in combination, do not teach or suggest “a displacement and pressure sensor that would provide the precision needed in quantifying sensitivity for purposes such as, a diagnostic tool for evaluating pain levels and healing of a subject” as claimed (see pg. 16 of remarks). Particularly, applicant argues that Kuban fails to provide a quantitative output of displacement or pressure, and further argues that Sharma does not disclose electrical sensors.
MPEP 2145 (III) states that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). Additionally, MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Examiner respectfully disagrees with applicant’s position for several reasons. First, Kuban is relied on to teach “an…displacement sensor connected to the probe…” (i.e., the position of calibration fork 220, connected to probe 104, determines a distance probe 104 travels between a first and second position) and “an…pressure sensor connected to the probe…” (i.e., probe tip 106 measuring motive force required (i.e., pressure applied) to move probe 104 from a first position to a second position)). Sharma is relied on to teach an electrical sensor (see [0050]), as described above. Second, in response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., providing the precision needed in quantifying sensitivity) are not recited in the rejected claims. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant further argues that the rejection of record is improper because Kuban and Sharma disclose devices that are structurally and fundamentally different than that of the claimed invention (see pg. 16-17 of remarks). In particular, applicant argues that the device of Kuban is a mechanical device and the device of Sharma is missing key components of the claimed invention. Applicant further cites portions of the specification to provide technical advantages of the claimed invention.
MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Additionally, MPEP 2145 (III) states that the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). MPEP §2145 (IV) states one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding Applicant’s citations of portions of the specification describing technical advantages of the claimed invention, MPEP § 2145 (II) states that the fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious, see Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
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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/ALYSSA PAIGE NOVAK/Examiner, Art Unit 3791
/ERIC J MESSERSMITH/Primary Examiner, Art Unit 3791
1 Piezoelectric transducer. (n.d.) McGraw-Hill Dictionary of Scientific & Tec