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 .
Response to Amendment
The amendment filed June 8, 2026 has been entered.
Claims 21-34 and 41-46 are pending. Claims 32-34 and 41-46 remain withdrawn as being directed to a non-elected invention. Claims 21-31 are presently examined.
Applicant’s amendments have obviated previous drawing objections.
Applicant’s amendments have obviated previous claim objections.
Applicant’s amendments have partially overcome the rejection to the claims under 35 U.S.C. 112(b). An updated rejection to the claims under 35 U.S.C. 112(b) is presented in light of Applicant’s amendment.
Response to Argument
Applicant’s arguments with respect to the claims 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.
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.
Claims 21 and 29 and dependent claims thereof 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.
Re. Claim 21: Claim 21 possesses multiple issues of indefiniteness.
The following highlighted terms are not provided with sufficient antecedent basis:
“the conductive tissue” – it is unclear if “the tissue of the subject” is not defined prior art possessing the property of being conductive; if such a property is implicit, Examiner recommends amending the claim to recite “the tissue” instead to remove ambiguity as to what type of tissue is referenced as the antecedent basis.
Additionally, claim 21 recites a controller having sensor chips configured to:
generate to generate signals used to stimulate the electrode pairs located in the substrate;
to receive and process the signals subsequently induced, generated and transmitted by the capacitive tactile sensor input device in response to the pressure imposed upon the outward facing sensor surface by contact with the skin or other soft tissue surface;
to induce, generate and transmit the signals derived from the processing of the signals induced, generated and transmitted to the IC capacitive sensor chip(s) by the capacitive tactile sensor input device.
At point (ii), the antecedent basis for signals which are 1) induced, 2) generated), and 3) transmitted by the capacitive tactile sensor device are not clearly provided with antecedent basis in the claim. Examiner requests clarification as to which limitation provides support for transmitted signals since the earlier recitation of “transmit” appears to reference “the transmitting electrode” recited prior, and the step of transmission in point (iii) relates to a separate instance of signal transmission.
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.
Claims 21, 24-26, 30, and 31 are rejected under 35 U.S.C. 103 as being unpatentable over:
Sarvazyan et al. (US 20040267165 A1) (disclosed by Applicant) (hereinafter – Sarvazyan) in view of
Mamigonians et al. (US 20200141819 A1) (hereinafter – Mamigonians) in further view of
Egorov et al. (US 8069735 B1) (disclosed by Applicant) (hereinafter – Egorov).
Re. Claim 21: Sarvazyan teaches a capacitive tactile sensor device for detecting, documenting, measuring and mapping a size, shape and location of lesions underlying the surface of a skin or other soft tissue in a subject by measuring variations in a tactile pressure of the skin or other tissue surface (Abstract; Fig. 3),
comprising:
a housing (Fig. 1A-1C: housing 13)
having at least one exposure window (Fig. 1B: see portion of exposed tactile sensor array 12)
and exposed conductive surfaces placed so that an operator or the device will be in contact with the conductive surfaces at all times while operating the device (Figs. 1A-1C: as best understood, exposed conductive surfaces (i.e., sensor array 12) are placed such that the device is in contact with (e.g., structurally connected to a portion thereof) the conductive surfaces).
Sarvazyan does not teach the invention comprising a substrate located within the housing comprising a plurality of pairs of separate coplanar, co-located electrodes, arranged in a Cartesian grid, on an electrically non-conductive material.
Mamigonians teaches analogous art in the technology of detecting attributes of a human or animal body (Abstract) using capacitive coupling (Paragraph 0030). Mamigonians further teaches the invention comprising a substrate located within the housing comprising a plurality of pairs of separate coplanar, co-located electrodes, arranged in a Cartesian grid, on an electrically non-conductive material (Paragraph 0030: “A sensor 201 includes multiple coplanar electrodes that experience a degree of capacitive coupling between each other;” Fig. 3: areas 302 and 303 are separate from one another and co-planar; Paragraph 0032: “In this example, the transmit tracks and receive tracks are orthogonal to one another. Alternatively, the transmit tracks and receive tracks may be parallel to each other or the transmit tracks may be inclined at an angle between 0 and 90 degrees to the receive tracks. Each transmit track is configured to capacitively couple to at least one receive-track on application of a voltage to the transmit track. Hence, one transmit-track may couple to one or more receive tracks;” Fig. 5: analogous structure to the electrically active membrane of Fig. 3 is shown at laminated membrane 502; Paragraph 0041: “To form the laminate, conductive tracks may be applied to the membrane by a process of screen printing conductive ink… the tracks may be printed on the same side and separated by an appropriate dielectric material”), and
Sarvazyan states that a variety of pressure sensors used in the tactile breast imager may be based on a variety of different types of sensors and further provides an exemplary capacitive sensor (Sarvazyan, Paragraph 0045). Mamigonians teaches a capacitive sensor which performs the same function (see citations above), only differing in construction. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the capacitive sensing structure disclosed by Mamigonians for the capacitive sensor array of Sarvazyan. Thus, the simple substitution of one known element for another (the capacitive pressure sensor of Sarvazyan for the capacitive pressure sensor of Mamigonians) producing a predictable result (implementation in a device utilizing a capacitive pressure sensor) renders the claim obvious.
Mamigonians, in teaching further detail regarding the incorporated conductive array, further teaches the substrate configured such that any two adjacent electrodes are electrically independent and can be stimulated independently by an externally generated stimulating voltage or current signal, creating a capacitor between each such electrode pair ( Fig. 2; Paragraph 0034: “In operation, the transmitter multiplexer 203 directs input signals from the signal-generator 202 to transmit electrodes in sequence, while signals from one or more receive electrodes are received. The demultiplexer 205 then switches to the next receive electrode and input signals are then applied to the next sequence of selected transmit electrodes;” see electric field lines at Fig. 4),
with a space above an outward facing surface of the Cartesian grid of electrodes serving as a dielectric (Paragraph 0042: “After application, the ink may have a thickness of between ten and twelve micrometres and a ten-micrometre coating of a dielectric material may be applied to prevent corrosion;”);
a layer of insulating material positioned over the outward facing surface of the Cartesian grid of electrodes (Fig. 5: cover 512 and/or mattress 503 overlaying laminated-membrane 502 (i.e., the analogous structure to sensor shown in Fig. 3));
a homogenous, compressible, non-ferrite and non-conductive membrane covering the insulating layer positioned over the outward facing surface of the Cartesian grid of electrodes (Fig. 5: second-compressible-layer 506, formed from neoprene as described in Paragraph 0045),
wherein the membrane:
(a) has uniform thickness across an entire surface of each pair of adjacent electrode forming the capacitor, and across an entire surface area of the Cartesian grid of electrodes (Fig. 5: layers are uniform and cover the entirety of laminated-membrane 502);
(b) has a fixed, uniform and known compression ratio and hardness score across the entire surface area of the Cartesian grid of electrodes (Paragraph 0045: “In an embodiment, the second-compressible-layer 506 is a second-neoprene-layer;” Examiner notes that such a uniform layer of neoprene material possesses qualities which read upon the requirements of the claim); and
(c) has a steady-state equilibrium shape such that, when not subject to external forces, its volume remains constant (see previous citation – neoprene is a solid);
wherein the membrane is arranged to deform non-uniformly in response to a non-uniform normal pressure applied between the skin or other tissue surface and the plurality of pairs of separate coplanar electrodes (see previous citation – neoprene is a rubber which allows for non-uniform compression), and
wherein the non-uniform deformation of the membrane causes a measurable variation in the distance between the skin or other tissue surface and the outward-facing surface of the Cartesian grid of electrodes, thereby producing localized variations in capacitance between adjacent electrode pairs (Fig. 4: see electric field lines).
Sarvazyan as modified by Mamigonians does not teach a non-conductive cover material positioned over an outward surface of the homogeneous, compressible, non-ferrite and non-conductive membrane.
Egorov teaches analogous art in the technology of soft tissue elasticity imaging (Title; Abstract). Egorov further teaches the invention comprising a non-conductive cover material positioned over the outward surface of the homogeneous, compressible, non-ferrite and compressible membrane (Col. 6, lines 48-56: “An optional additional protective elastic cover 23 is used to seal the entire tactile sensor array to prevent it from wear and tear. It also allows dipping the tactile sensor array in various disinfection and sanitization liquids without the risk of damaging the sensor. The elastic cover 23 may be made from polyurethane, PVC, PMMA or any other suitable material. It is preferred to have the cover 23 to be as thin and as flexible as possible to avoid any reduction in the tactile sensor sensitivity”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Sarvazyan as modified by Mamigonians to include an additional protective cover, the motivation being that providing a protective elastic cover as suggested by Egorov allows for the device to seal an entire sensor array, providing an additional layer of protection and further allowing the sensor to be sanitized without risk of damaging the sensor (see citation of Egorov above).
Sarvazyan as modified by Mamigonians and Egorov further teaches the invention wherein at least a portion of which is accessible through the exposure window of the housing, which serves as an outward facing sensor surface and which, together with the membrane, effectively replaces air as a dielectric for the capacitor created by each pair of adjacent electrodes, one functioning as the transmitting electrode and one functioning as the receiving electrode (Examiner notes that replacing the pressure sensing array 12 of Sarvazyan with the sensing structure of Mamigonians and further providing an additional cover as suggested by Egorov encompasses such a claim limitation);
wherein the outward sensor surface is configured to be placed completely and firmly in contact with the surface of the tissue of the subject such that electromechanical properties including normal surface pressure of the conductive tissue will disrupt an electric field in the dielectric comprised of the compressible membrane and disturb a capacitive coupling between relevant pairs of coplanar electrodes (Sarvazyan, Paragraph 0036: sensing is tactile; operation of the capacitive sensor array would necessarily perform as required by the claim, see Mamigonians Fig. 4);
wherein the capacitive tactile sensor device induces and generates at least one signal in response to a pressure imposed upon the sensor surface by contact with the skin or other soft tissue surface (see previous citation), and
the resulting compression of the compressible membrane and disturbance of the capacitive coupling between the relevant pairs of coplanar electrodes, in accordance with varying composition and properties of tissue underlying the skin or other surface, as an indicator of a location, dynamic features and spatial features of localized areas of stiffer tissue underlying the skin or other tissue surface being investigated (see previous citation; Sarvazyan, Fig. 3, Abstract, Paragraphs 0036-0042); and
a controller disposed within the housing comprised of:
(a) one or more commercially available IC capacitive sensor chips configured:
(i) to generate signals used to stimulate the electrode pairs located in the substrate (as best understood, integrated circuits (IC) chips configured to apply signals to capacitive sensors are implicit at Paragraph 0045);
(ii) to receive and process the signals subsequently induced, generated and transmitted by the capacitive tactile sensor input device in response to the pressure imposed upon outward facing the sensor surface by contact with the skin or other soft tissue surface (Paragraph 0045: responses from each capacitive sensor received); and
(iii) to induce, generate and transmit the signals derived from the processing of the signals induced, generated and transmitted to the IC capacitive sensor chip(s) by the capacitive tactile sensor input device (Paragraph 0045: implicit by programming causing application of AC signal to capacitive sensors which are multiplexed and to obtain offset and gain correction factors); and
(b) one or more integrated circuits and processors configured
(i) to receive and process the signals induced, generated and transmitted by the IC capacitive sensor chip(s) to calculate one or more parameters of the underlying tissue structure, based on changes in a perceived capacitance between adjacent relevant electrode pairs caused by the pressure imposed upon the outward facing sensor surface by contact with the skin or other soft tissue surface (as best understood, signals of capacitive sensors (each comprising first and second electrodes) are processed to identify pressure signals to produce pressure patterns in tactile scanning); and
(ii) to communicatively connect with a visualization device comprising a display and an integrated storage device (Paragraph 0043: “The device 30 comprises 2-D tactile sensor array 51 mounted on a touch pad 52 and an electronic unit 56 with a display means 55 optionally secured on a patient's wrist or hand by a strap 54”).
Re. Claim 24: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Mamigonians, in the combination, further teaches wherein the plurality of electrodes comprises at least 2 electrodes (Paragraph 0002: “…a laminated-membrane having electrodes connected to a control-circuit…;” Figs. 3, 4).
Re. Claim 25: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Mamigonians, who teaches details regarding the incorporated capacitive sensor array, does not recite a particular dimension for the electrodes; however, Mamigonians demonstrates that the distribution and spacing and relative size of active areas influences the distribution of electric field lines (Fig. 4). Therefore, individual electrode surface area appears to be a result-effective variable dependent on the implementation and objective of the measurement apparatus. Applicant fails to provide a teaching of criticality as to the particular range of the surface area of an electrode being between 1 mm2 and 16 mm2. Since Sarvazyan describes that an objective of their invention is to detect tumors of less than about one centimeter in size (Paragraph 0009), and Mamigonians’ pressure sensor array requires spacing between adjacent electrodes (Paragraph 0035), the combination of prior arts constrains the surface area of each of the plurality of electrodes to a range of suitable electrode separations and dimensions whereby the skilled artisan would have been able to determine optimized values for electrode surface area and separation, since it has generally been held to be within the skill level of the art to perform routine experimentation to determine optimal operation parameters.
Re. Claim 26: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Sarvazyan further teaches the invention further comprising a visualization device communicatively connected to the controller, the visualization device comprising a display (Paragraph 0043: “The device 30 comprises 2-D tactile sensor array 51 mounted on a touch pad 52 and an electronic unit 56 with a display means 55 optionally secured on a patient's wrist or hand by a strap 54… The device 30 allows transmission of received breast examination data into a home computer;” Fig. 6: transmission to home computer 66 having a display).
Re. Claim 30: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Sarvazyan further teaches the invention wherein the at least one parameter comprises tissue firmness (Sarvazyan, Abstract: pressure data is used to identify a lesion, i.e., differentiating hardness of surrounding tissues).
Re. Claim 31: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Sarvazyan further teaches the invention wherein the tissue comprises breast tissue (Title; Abstract).
Claims 22 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over:
Sarvazyan et al. (US 20040267165 A1) (disclosed by Applicant) (hereinafter – Sarvazyan) in view of
Mamigonians et al. (US 20200141819 A1) (hereinafter – Mamigonians) in further view of
Egorov et al. (US 8069735 B1) (disclosed by Applicant) (hereinafter – Egorov) in further view of
Goldman (US 5449002 A) (hereinafter – Goldman).
Re. Claim 22: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 21. Mamigonians, in the combination, teaches a neoprene layer which reads upon the homogeneous, compressible, non-ferrite and non-conductive membrane required by claim 21. However, Sarvazyan as modified by Mamigonians and Egorov does not teach the invention wherein the homogeneous, compressible, non-ferrite and non-conductive membrane comprises a polyurethane, silicon, or thermoplastic elastomer foam.
Goldman teaches analogous art in the technology of capacitive feedback systems (Abstract). Goldman further states that “PPT.RTM. was found superior to neoprene and polyethylene foams in resiliency on extensive dynamic testing (Brodsky, et. al., Foot and Ankle, Vol. 9, December, 1988, pp. 111-116)” (Col. 7, lines 40-43), wherein PPT is a polyurethane foam commonly used for weight bearing applications in the field of rehabilitation (Col. 7, lines 17-39).
It would have been obvious to one having skill in the art before the effective filing date to have modified the neoprene layer in the combination of Sarvazyan as modified by Mamigonians and Egorov to instead utilize the polyurethane foam as taught by Goldman, the motivation being that such a material has greater resiliency to dynamics and static loading than neoprene (Col. 7; see citations above).
Re. Claim 23: Sarvazyan as modified by Mamigonians, Egorov, and Goldman teaches the invention according to claim 22. Goldman, in teaching further detail regarding the modification, further teaches the invention wherein the foam has a hardness in a range of 00-0 to 00-20 (Col. 7, lines 5-6: “The preferred firmness range for the instant invention is 0.1-100 psi.=;” Examiner notes that, considering the hemispherical radius of a Shore hardness indenter and application of 1.11 Newtons at full deflection of 2.5 mm, the range of firmness for Jackson indicates that the material quality of the preferred polyurethane foam incorporated lies within the required Shore OO Hardness range, roughly corresponding to 0 to 2 PSI).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over:
Sarvazyan et al. (US 20040267165 A1) (disclosed by Applicant) (hereinafter – Sarvazyan) in view of
Mamigonians et al. (US 20200141819 A1) (hereinafter – Mamigonians) in further view of
Egorov et al. (US 8069735 B1) (disclosed by Applicant) (hereinafter – Egorov) in further view of
Yao et al. (US 20190029592 A1) (hereinafter – Yao).
Re. Claim 27: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 26, but does not teach the invention wherein the controller is connected to the visualization device via a Bluetooth connection.
Yao teaches the invention wherein the controller is connected to the visualization device via a Bluetooth connection (Paragraph 0116: “In some embodiments, signal processing unit 940 includes a communications component (e.g., a wireless communications component, such as a transceiver) that can communicate data and/or camera images to a separate computer or other electronic device. In some embodiments, the communication can be wireless (e.g., Bluetooth)”).
Sarvazyan teaches the use of a wireless protocol to communicate to an external computer having a display, but does not specify that the wireless protocol is Bluetooth. It would have been obvious to one of ordinary skill in the art before effective filing date of the invention to include the use of Bluetooth as the wireless communication protocol as taught by Yao in the system of Sarvazyan as modified by Mamigonians and Egorov, since the claimed invention is merely a combination of old elements (the modified Sarvazyan: a device utilizing a wireless protocol; Yao: using Bluetooth as a suitable wireless protocol), and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable (providing a capacitive tactile sensor having Bluetooth communication protocols for transferring data).
Claims 28 and 29 are rejected under 35 U.S.C. 103 as being unpatentable over:
Sarvazyan et al. (US 20040267165 A1) (disclosed by Applicant) (hereinafter – Sarvazyan) in view of
Mamigonians et al. (US 20200141819 A1) (hereinafter – Mamigonians) in further view of
Egorov et al. (US 8069735 B1) (disclosed by Applicant) (hereinafter – Egorov) in further view of
Lisogurski et al. (US 20150157269 A1) (hereinafter – Lisogurski).
Re. Claims 28 and 29: Sarvazyan as modified by Mamigonians and Egorov teaches the invention according to claim 26, but does not teach the invention
further comprising conducting elements on the exterior of the housing configured to deliver a voltage reference used for all subsequent capacitive calculations (as required by claim 28); or
including a grounding pad or strap providing conductive contact between an uninsulated portion of the electron plane (as required by claim 29).
Lisogurski teaches the invention further comprising conducting elements on the exterior of the housing configured to deliver a voltage reference used for all subsequent capacitive calculations (Paragraph 0050: “The tissue interface portions can include clamp-on probes, adhesive pads, conductive foams, or conducting gels which interface electrically to tissue of the patient. The electrical grounding or reference potential connection can be employed to enhance signal measurement of the single-plate capacitor. Some measurements of the capacitance signal can be affected by unwanted influence from the environment around tissue 140, such as nearby objects, nearby people, things the patient is presently touching or contacting, among other influences”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the tissue interface portions of Sarvazyan as modified by Mamigonians and Egorov to include a conductive electrical grounding or interface voltage reference as taught by Mamigonians (thus encompassing the requirements of both claims 28 and 29), the motivation being that doing so enhances signal measurement by reducing unwanted influence from the environment around the tissue, nearby objects, or things the patient is presently touching, among other influences (Paragraph 0050).
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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