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
This Office action is responsive to the Amendment filed on December 5th, 2025. The examiner acknowledges the amendments to claims 1, 5, 7, 11, 15, and 17 as well as the cancellation of claims 6. Claims 1-5 and 7-18 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed December 5th, 2025, with respect to the rejections under 35 U.S.C. 112(b) have been considered. The rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s arguments, filed December 5th, 2025, with respect to the rejections under 35 U.S.C. 103 regarding “wherein said at least two piezoelectric sensors are configured to detect pressure changes without external electrical biasing or control signals” 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.
Furthermore, at page 8, Applicant argues that Frei does not disclose the rigid material adjacent said at least two piezoelectric sensors. Examiner respectfully disagrees. Upon the modification of Frei to substitute the piezoelectric sensors of Gentry (US 20050190068 A1 - see claim 1 below) in place of the piezoelectric transducer to detect voltage, Frei, as modified by De Graff and Gentry, does disclose providing a rigid material (“plate”, col. 5 lines 41-57) adjacent said at least two piezoelectric sensors (“placing the array against the breast and then having the patient lie flat against a plate”, col. 5 lines 41-57, see also claim 1 “planar pressure applying member in surface-to-surface contact with one surface of said support sheet”) because the piezoelectric sensors made of PVDF of Gentry do not require the electrodes for external biasing or control signals (Gentry, para. [0044-0047]).
Applicant's arguments filed December 12th, 2025, with respect to the rejections under 35 U.S.C. 103 regarding De Graff have been fully considered but they are not persuasive.
At pages 9-10, Applicant argues that De Graff does not disclose a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast because De Graff discloses the polymeric membrane 220T in the shape of a breast and further because De Graff discloses that the substrate 200 can be made of plastic or elastic material and plastic may refer to material that can be molded or shaped, generally when heated, into a desired shape. Examiner respectfully disagrees. De Graff discloses in para. [0091] that the substrate can be made of a plastic material or can be made of an elastomeric material. Examiner did not rely on plastic materials to teach the deformable material, rather the elastomeric and polymer materials were relied upon (see page 8 of the Non-final rejection mailed 10/17/25). Further, in para. [0092, 0363-0364] De Graff discloses materials/soft polymers that the substrate can be made of which are similar to the soft polymer material disclosed on page 6 of the instant application specification and that an embodiment of the substrate of the invention may comprise a conformal sheet or tape to wrap conformally fit on the body. De Graff further discloses in para. [0095] that the substrate can be of any possible number of shapes and configurations and that the substrate is flexible and/or stretchable such that substrate 200 can be folded, furled, bunched, wrapped or otherwise contained. De Graff further discloses in para. [0016, 0363-0364, 0367] that the substrate comprises a conformal sheet or tape to wrap conformally fit on the body, that the substrate is covered with an array of piezoelectric crystals, and that the sheet-like substrate provided with an adhesive for attachment to the individual's body is able to conform to the contours of the individual's body. Therefore, De Graff does disclose providing a deformable material forming a flexible, yet stable matrix (substrate 200/conformable polymeric membrane 200T, fig. 54; “polymeric material”; “the materials apply to any of the embodiments disclosed”; “matrix”; “conformal sheet or tape to wrap conformally fit on the body”, para. [0091-0094, 0216-0217, 0363-0364, 0347, 0360] (Examiner note: The instant application specification defines the deformable material on page 6 sixth paragraph as “a polymer soft material”. Examiner is interpreting the materials/soft polymers disclosed in para. [0091-0094] of De Graff, as reading on the deformable material)) which can conform to a shape of an external breast surface (as seen in fig. 54, “conformal sensing contact with tissues”; “conformable polymeric membrane … shape … breast”; ““conformal sheet or tape to wrap conformally fit on the body””, Abstract, para. [0016, 0347, 0366-0364]), and locating said at least two piezoelectric sensors on the deformable material (circuitry 1000t, as seen in fig. 54, “circuitry 1000S comprises … piezoelectric sensors”; “configurations for circuitry 1000S … any embodiment of circuitry … apply to any of the exemplary embodiments”; “array(s) 1000T are physically integrated into … membrane 200T”, para. [0137, 0156, 0347-0349]) for maintaining sensory contact with breast tissue(“conformal sensing contact with tissues”; “flexible/stretchable … achieve—and maintain—close contact with irregular surfaces”; “sensors … positioned in direct contact with the breast tissue”, Abstract, para. [0147, 0155, 0305; 0349], fig. 54). De Graff further discloses that the device is fitted over an entire surface area of the breast and by pressing the array of pressure transducers to the surface of the breast, a profile of the body-part stiffness can be mapped with high spatial resolution (para. [0343]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei such the method further includes providing a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast surface, and locating said at least two piezoelectric sensors on the deformable material for maintaining sensory contact with breast tissue, in view of the teachings of De Graff, as such a modification would have been merely a substitution of the flexible membrane support/sheet of Frei for the for the conformable polymeric substrate of De Graff and integrating the piezoelectric transducers of Frei into the conformable polymeric substrate as this would aid in achieving and maintaining close contact with irregular surfaces/breast tissue to increase measurement accuracy (De Graff, Abstract, para. [0305, 0343]).
Applicant's arguments filed December 12th, 2025, with respect to the rejections under 35 U.S.C. 103 regarding claim 11 have been fully considered but they are not persuasive. Frei was not relied upon to disclose that the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors. Rather Madden directed to sensor arrays for sensing pressure was relied upon to disclose that the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors.
Further, upon the substitution of the piezoelectric transducers of Frei for the piezoelectric sensors of Gentry to detect voltage for pressure sensing, see claim 1, Frei would disclose readings taken at non-confined regions of electrodes because the piezoelectric sensors made of PVDF of Gentry do not require the electrodes of Frei, but rather the piezoelectric sensors each have a set of terminals 29, as seen in fig. 2 of Gentry and each sensor element in the array may independently measure/produce voltage (Gentry, para. [0044-0047]).
Furthermore, Madden discloses adjacent sensors (first pair of electrodes 442 … plurality of adjacent electrodes 442, see figs. 4 & 11, para. [0332]) and measuring the output voltage for each of the electrode pairs to obtain a pressure map and further discloses that intersections 872 of sensing surface 110 have voltage values and the voltage map maybe converted to a pressure map based on empirically determined relationship between voltage and pressure for piezoionic layer 804 (para. [0342]). Therefore, Madden does disclose wherein the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors (“adjacent …output voltage … plurality … repeats … pressure map”; “voltages are known for a plurality of mesh line intersections (and/or finer mesh line intersections) this voltage map maybe converted to a pressure map based on empirically determined relationship between voltage and pressure for piezoionic layer 804, para. [0332, 0342]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, such that the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors, in view of the teachings of Madden, as this would aid in obtaining a pressure map by converting voltages to pressure using an empirically determined relationship.
Applicant's arguments filed December 12th, 2025, with respect to the rejections under 35 U.S.C. 103 regarding claim 17 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 § 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5-10, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Frei (US 4250894 A) in view of De Graff (US 20180076336 A1), and further in view of Gentry (US 20050190068 A1).
Regarding claim 1, Frei discloses a detection method for detecting material properties of breast tissue (Abstract) includes: providing at least two piezoelectric sensors (col. 4 lines 26-30, transducer elements 50/16 and 17, “piezoelectric”, figs. 3 & 6) spaced a predetermined distance apart from one another (col. 4 lines 53-58, “transducer … five millimeters' spacing” (see also col. 1 lines 46-49, “spaced by one to five millimeters”) & col. 6 lines 8-13) and operable for measuring pressure (“pressure”; “compressive force”, col. 5 lines 41-57 & col. 7 lines 20-32); providing a material/flexible support/sheet 15/50 (support 15/sheet 50, figs. 3 & 6; “thin, flexible rubber membrane”, col. 5 lines 58-63), and locating said at least two piezoelectric sensors on the material/flexible support/sheet 15/50 (as seen in figs. 3 & 6-7).
Frei does not disclose that the method includes providing a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast surface, and locating said at least two piezoelectric sensors on the deformable material for maintaining sensory contact with the breast tissue.
However, De Graff directed to a device for sensing the presence and mechanical properties of the tissue/mechanical stiffness of breast tissue (para. [0280, 0343-0344, 0347], fig. 54) discloses providing a deformable material forming a flexible, yet stable matrix (substrate 200/conformable polymeric membrane 200T, fig. 54; “polymeric material”; “the materials apply to any of the embodiments disclosed”; “matrix” para. [0091-0094, 0216-0217, 0347, 0360] (Examiner note: The instant application specification defines the deformable material on page 6 sixth paragraph as “a polymer soft material”. Examiner is interpreting the materials/soft polymers disclosed in para. [0091-0094] of De Graff, as reading on the deformable material)) which can conform to a shape of an external breast surface (as seen in fig. 54, “conformal sensing contact with tissues”; “conformable polymeric membrane … shape … breast”, Abstract, para. [0347]), and locating said at least two piezoelectric sensors on the deformable material (circuitry 1000t, as seen in fig. 54, “circuitry 1000S comprises … piezoelectric sensors”; “configurations for circuitry 1000S … any embodiment of circuitry … apply to any of the exemplary embodiments”; “array(s) 1000T are physically integrated into … membrane 200T”, para. [0137, 0156, 0347-0349]) for maintaining sensory contact with breast tissue (“conformal sensing contact with tissues”; “flexible/stretchable … achieve—and maintain—close contact with irregular surfaces”; “sensors … positioned in direct contact with the breast tissue”, Abstract, para. [0147, 0155, 0305; 0349], fig. 54). De Graff further discloses that the device is fitted over an entire surface area of the breast and by pressing the array of pressure transducers to the surface of the breast, a profile of the body-part stiffness can be mapped with high spatial resolution (para. [0343]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei such the method further includes providing a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast surface, and locating said at least two piezoelectric sensors on the deformable material for maintaining sensory contact with breast tissue, in view of the teachings of De Graff, as such a modification would have been merely a substitution of the flexible membrane support/sheet of Frei for the for the conformable polymeric substrate of De Graff and integrating the piezoelectric transducers of Frei into the conformable polymeric substrate as this would aid in achieving and maintaining close contact with irregular surfaces/breast tissue to increase measurement accuracy (De Graff, Abstract, para. [0305, 0343]).
Frei, as modified by De Graff hereinabove, does not disclose wherein said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals.
In a similar technical field, Gentry directed to a passive sensor device/array 21 having at least two piezoelectric sensors 23 mounted on a surface of a urethane carrier sheet (Abstract, para. [0044, 0050-0051, 0054]) discloses at least two piezoelectric sensors (piezoelectric sensors 23, para. [0044-0047]) and wherein said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals (“measure changes in stress … each piezoelectric sensor … polyvinylidene fluoride (PVDF) polymer … voltage … pressure sensing”, para. [0014, 0044-0047] (Examiner note; piezoelectric sensors made of PVDF do not require external biasing or control signals)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff hereinabove, such that said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals, in view of the teachings of Gentry, as such a modification would have been merely a substitution of the piezoelectric transducers of Frei for the piezoelectric sensors made polyvinylidene fluoride (PVDF) polymer of Gentry in order to detect voltage signals for pressure sensing.
Furthermore, upon the substitution of the piezoelectric transducers of Frei for the piezoelectric sensors of Gentry to detect voltage for pressure sensing, Frei, as modified by De Graff and Gentry hereinabove, discloses providing a rigid material (“plate”, col. 5 lines 41-57) adjacent said at least two piezoelectric sensors (“placing the array against the breast and then having the patient lie flat against a plate”, col. 5 lines 41-57, see also claim 1 “planar pressure applying member in surface-to-surface contact with one surface of said support sheet”); compressing (“pressing”, claim 1 & col. 6 lines 47-48) said at least two piezoelectric sensors (“array”, col. 5 lines 40-57) between the rigid material (“plate”, col. 5 lines 40-57) and a material to be measured (“breast”, col. 5 lines 40-57) (“apply a pressure over the entire array”, col. 5 lines 40-57, see also claim 1), thereby to produce a voltage signal in said at least two piezoelectric sensors (“breast palpation … apply a pressure over the entire array … electric outputs related to the tissue viscoelastic properties”; “electric voltages”, col. 5 lines 40-57 & col. 6 lines 53-56, Abstract, fig. 11); and transforming the voltage signals from said at least two piezoelectric sensors into a measurement of a desired property of the material being measured (“viscoelastic properties”; “size and depth of the inclusion”, col. 5 lines 5-28 & col. 6 lines 47-56, fig. 10 & col. 7 lines 58-68).
Regarding claim 2, Frei, as modified by Gentry and De Graff hereinabove, discloses the detection method as claimed in Claim 1, wherein the material to be measured is in a form of living tissue (“breast”, col. 5 lines 40-57, Abstract).
Regarding claim 3, Frei, as modified by Gentry and De Graff hereinabove, discloses the detection method as claimed in Claim 2, wherein the living tissue is in the form of breast tissue (“breast”, col. 5 lines 40-57, Abstract).
Regarding claim 5, Frei discloses a detection device for detecting material properties of breast tissue (Abstract) including: at least two piezoelectric sensors (col. 4 lines 26-30, transducer elements 50/16 and 17, “piezoelectric”, figs. 3 & 6) spaced a predetermined distance apart from one another (col. 4 lines 53-58, “transducer … five millimeters' spacing” (see also col. 1 lines 46-49, “spaced by one to five millimeters”) & col. 6 lines 8-13) and operable for measuring pressure (“pressure”; “compressive force”, col. 5 lines 41-57 & col. 7 lines 20-32); a material/flexible support/sheet 15/50 (support 15/sheet 50, figs. 3 & 6; “thin, flexible rubber membrane”, col. 5 lines 58-63); said at least two piezoelectric sensors being located adjacent the material/flexible support/sheet 15/50 (as seen in figs. 3 & 6-7); and a rigid layer (“plate”, col. 5 lines 41-57) located adjacent the material/flexible support/sheet 15/50 (“placing the array against the breast and then having the patient lie flat against a plate”, col. 5 lines 41-57, see also claim 1 “planar pressure applying member in surface-to-surface contact with one surface of said support sheet”), in an arrangement wherein, in use, said at least two piezoelectric sensors each produce a voltage signal (“breast palpation … apply a pressure over the entire array … electric outputs related to the tissue viscoelastic properties”; “electric voltages”, col. 5 lines 40-57 & col. 6 lines 53-56, Abstract, fig. 11) in response to a force applied (“pressing”; “apply a pressure over the entire array”, col. 5 lines 40-57 & col. 6 lines 47-48, see also claim 1) to said at least two piezoelectric sensors when said at least two piezoelectric sensors (“array”, col. 5 lines 40-57) are compressed, in use, between a material to be measured (“plate”, col. 5 lines 40-57) (“apply a pressure over the entire array”, col. 5 lines 40-57, see also claim 1).
Frei does not disclose the detection device including a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast surface; said at least two piezoelectric sensors being located adjacent the deformable material layer for maintaining sensory contact with breast tissue.
However, De Graff directed to a device for sensing the presence and mechanical properties of the tissue/mechanical stiffness of breast tissue (para. [0280, 0343-0344, 0347], fig. 54) discloses a deformable material forming a flexible, yet stable matrix (substrate 200/conformable polymeric membrane 200T, fig. 54; “polymeric material”; “the materials apply to any of the embodiments disclosed”; “matrix” para. [0091-0094, 0216-0217, 0347, 0360] (Examiner note: The instant application specification defines the deformable material on page 6 sixth paragraph as “a polymer soft material”. Examiner is interpreting the materials/soft polymers disclosed in para. [0091-0094] of De Graff, as reading on the deformable material)) which can conform to a shape of an external breast surface (as seen in fig. 54, “conformal sensing contact with tissues”; “conformable polymeric membrane … shape … breast”, Abstract, para. [0347]), said at least two piezoelectric sensors being located adjacent the deformable material layer (circuitry 1000t, as seen in fig. 54, “circuitry 1000S comprises … piezoelectric sensors”; “configurations for circuitry 1000S … any embodiment of circuitry … apply to any of the exemplary embodiments”; “array(s) 1000T are physically integrated into … membrane 200T”, para. [0137, 0156, 0347-0349]) for maintaining sensory contact with breast tissue (“conformal sensing contact with tissues”; “flexible/stretchable … achieve—and maintain—close contact with irregular surfaces”; “sensors … positioned in direct contact with the breast tissue”, Abstract, para. [0147, 0155, 0305; 0349], fig. 54). De Graff further discloses that the device is fitted over an entire surface area of the breast and by pressing the array of pressure transducers to the surface of the breast, a profile of the body-part stiffness can be mapped with high spatial resolution (para. [0343]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei such that the detection device includes a deformable material forming a flexible, yet stable matrix which can conform to a shape of an external breast surface; said at least two piezoelectric sensors being located adjacent the deformable material layer for maintaining sensory contact with breast tissue, in view of the teachings of De Graff, as such a modification would have been merely a substitution of the flexible membrane support/sheet of Frei for the for the conformable polymeric substrate of De Graff and integrating the piezoelectric transducers of Frei into the conformable polymeric substrate as this would aid in achieving and maintaining close contact with irregular surfaces/breast tissue to increase measurement accuracy (De Graff, Abstract, para. [0305, 0343]).
Frei, as modified by De Graff hereinabove, does not disclose wherein said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals.
However, Gentry directed to a passive sensor device/array 21 having at least two piezoelectric sensors 23 mounted on a surface of a urethane carrier sheet (Abstract, para. [0044, 0050-0051, 0054]) discloses at least two piezoelectric sensors (piezoelectric sensors 23, para. [0044-0047]) and wherein said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals (“measure changes in stress … each piezoelectric sensor … polyvinylidene fluoride (PVDF) polymer … voltage … pressure sensing”, para. [0014, 0044-0047] (Examiner note; piezoelectric sensors made of PVDF do not require external biasing or control signals)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff hereinabove, such that said at least two piezoelectric sensors are configured to detect pressure changes without external biasing or control signals, in view of the teachings of Gentry, as such a modification would have been merely a substitution of the piezoelectric transducers of Frei for the piezoelectric sensors made polyvinylidene fluoride (PVDF) polymer of Gentry in order to detect voltage signals for pressure sensing.
Regarding claim 7, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 5, wherein the said at least two piezoelectric sensors comprises an array of sensors arranged a predetermined distance apart from one another (col. 4 lines 53-58, “transducer … five millimeters' spacing” (see also col. 1 lines 46-49, “spaced by one to five millimeters”) & col. 6 lines 8-13).
Regarding claim 8, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 7, wherein said predetermined distance is a uniform distance such that the array of sensors are spaced an equal distance apart from one another (as seen in fig. 6, col. 4 lines 53-58, “transducer … five millimeters' spacing” (see also col. 1 lines 46-49, “spaced by one to five millimeters”) & col. 6 lines 8-13).
Regarding claim 9, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 5, wherein the material to be measured is in a form of living tissue (“breast”, col. 5 lines 40-57, Abstract).
Regarding claim 10, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 9, wherein the living tissue is breast tissue (“breast”, col. 5 lines 40-57, Abstract).
Regarding claim 15, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 5, wherein said at least two piezoelectric sensors are at least partially imbedded in the deformable layer (Frei, as seen in fig. 6 & De Graff para. [0137, 0156, 0347-0349]), “array(s) 1000T are physically integrated into … membrane 200T”, para. [0347]).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff and Gentry, as applied to claim 3 above, further in view of Sarvazyan (US 5860934 A), further in view of Shih (US 20160331300 A1), further in view of Abe (WO 2021067853 A1), and further in view of Watmough (US 20070219449 A1).
Regarding claim 4, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection method as claimed in Claim 3. Frei, as modified by De Graff and Gentry hereinabove, does not expressly disclose wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: viscosity of blood flowing in the breast tissue beneath the sensors, reaction forces of the breast tissue, radius of a blood vessel of the breast tissue, velocity of blood flow in a blood vessel of the breast tissue.
However, Sarvazyan directed to a pressure sensing array for diagnosing breast cancer discloses wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from the group comprising: viscosity of blood flowing in the breast tissue beneath the sensors ("viscosity", col. 4 lines 10 - col. 5 line 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, such that the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from the group comprising: viscosity of blood flowing in the breast tissue beneath the sensors, in view of the teachings of Sarvazyan, as this would aid in describing the mechanical characteristics of living tissue in both viscous and elastic components (Sarvazyan, col. 4 lines 10 - col. 5 line 28).
Frei, as modified by De Graff, Gentry, and Sarvazyan hereinabove, does not disclose wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: reaction forces of the breast tissue, radius of a blood vessel of the breast tissue, velocity of blood flow in a blood vessel of the breast tissue.
However, Shih directed to piezoelectric sensors discloses wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: reaction forces of the breast tissue (para. [0109], "resulting reaction force").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, and Sarvazyan hereinabove, such that the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: reaction forces of the breast tissue, in view of the teachings of Shih, as this would aid in calculating the elastic modulus of the dermis layer using the obtained the reaction forces (Shih, para. [0109]).
Frei, as modified by De Graff, Gentry, Sarvazyan, and Shih hereinabove, does not disclose wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: radius of a blood vessel of the breast tissue, velocity of blood flow in a blood vessel of the breast tissue.
However, Abe directed to approaches to non-invasively characterize a tumor discloses wherein the material properties are one or more of the following: a radius of a blood vessel of the breast tissue ("local vascular radius", para. [0082]). Abe further discloses that a combination of morphological vascular metrics and functional vascular metrics may be used to characterize the tumor (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, Sarvazyan, and Shih hereinabove, such that the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from the group comprising: a radius of a blood vessel of the breast tissue, in view of the teachings of Abe, as this would aid in characterizing the tumor based morphological vascular metrics and functional vascular metrics (Abe, Abstract, para. [0082]).
Frei, as modified by De Graff, Gentry, Sarvazyan, Shih, and Abe hereinabove, does not disclose wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: velocity of blood flow in a blood vessel of the breast tissue.
However, Watmough directed to an apparatus for examining a body of living tissues having piezoelectric elements (para. [0021]) discloses wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from the group comprising: velocity of blood flow in a blood vessel of the breast tissue ("blood flow velocities ...", para. [0041, 0073]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, Sarvazyan, Shih, and Abe hereinabove, such that the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: velocity of blood flow in a blood vessel of the breast tissue, in view of the teachings of Watmough, as this would aid in detecting and analyzing blood flow in living tissues which may contain neoplasm (Watmough, Abstract, para. [0041, 0073]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff and Gentry, as applied to claim 7 above, and further in view of Madden (US 20170356815 A1).
Regarding claim 11, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 7. Frei, as modified by De Graff and Gentry hereinabove, does not disclose wherein the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors.
However, Madden directed to sensor arrays for sensing pressure discloses wherein the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors (“ adjacent …output voltage … plurality … repeats … pressure map”; “voltages are known for a plurality of mesh line intersections (and/or finer mesh line intersections) this voltage map maybe converted to a pressure map based on empirically determined relationship between voltage and pressure for piezoionic layer 804, para. [0332, 0342]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, such that the device is operable for transforming the voltage signal from the array of sensors into pressure readings for detecting changes in pressure between adjacent sensors in the array of sensors, in view of the teachings of, in view of the teachings of Madden, as this would aid in obtaining a pressure map by converting voltages to pressure using an empirically determined relationship.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff, Gentry, and Madden, as applied to claim 11 above, and further in view of Cundari (US 5989199 A).
Regarding claim 12, Frei, as modified by De Graff, Gentry, and Madden hereinabove, discloses the detection device as claimed in Claim 11. Frei, as modified by De Graff, Gentry, and Madden hereinabove, does not disclose wherein the material to be measured is in a form of breast tissue and wherein the device is operable to construct a map of the pressure distribution for specific areas of the breast.
However, Cundari directed to a tissue examination device including a plurality of sensors discloses wherein the material to be measured is in a form of breast tissue (“breast tissue”, col. 5 lines 23-34) and wherein the device is operable to construct a map of the pressure distribution for specific areas of the breast (“"map" of the pressures …"pressure signature" of the tissue structures beneath array 12 … breast”, col. 5 lines 50-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, and Madden hereinabove, such that the material to be measured is in a form of breast tissue and wherein the device is operable to construct a map of the pressure distribution for specific areas of the breast, in view of the teachings of Cundari, as this would aid in discriminating normal underlying tissue structures from potentially foreign structures using distinguishable pressure signatures (Cundari, col. 5 lines 50-67 & col. 10 lines 52-60).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff, Gentry, Madden, and Cundari, as applied to claim 12 above, and further in view of Sliwa (US 20070293792 A1).
Regarding claim 13, Frei, as modified by De Graff, Gentry, Madden, and Cundari hereinabove, discloses the detection device as claimed in Claim 12. Frei, as modified by De Graff, Gentry, Madden, and Cundari hereinabove, does not disclose wherein the device is operable to compare the map with one or more maps obtained from a reference library.
However, discloses Sliwa directed to a probe 1 having a pressure sensing array 2a discloses wherein the device (probe 1 having pressure sensing array 2a, fig. 1) is operable to compare the map with one or more maps obtained from a reference library (“compare the new results with database results”; "referencing... database ... force/pressure maps", para. [0076, 0082-0083]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, Madden, and Cundari hereinabove, such that the device is operable to compare the map with one or more maps obtained from a reference library, in view of the teachings of Sliwa, as this would aid in making nonsubjective quantifiable comparisons for palpation-examination of patient anatomical tissues for abnormalities or assessing states of firmness (Sliwa, Abstract, para. [0076]).
Regarding claim 14, Frei, as modified by De Graff, Gentry, Madden, Cundari, and Sliwa hereinabove, discloses the detection device as claimed in Claim 13. Frei, as modified by De Graff, Gentry, Madden, Cundari, and Sliwa hereinabove, does not disclose wherein said reference library includes one or more maps of pressure distributions obtained from healthy individuals using the device.
However, Cundari discloses one or more maps of pressure distributions obtained from healthy individuals using the device ("pressure signatures ... empirically determined ... normal structures", col. 1 lines 41-45, (see also col. 7 lines 37-39)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, Madden, Cundari, and Sliwa hereinabove, such that said reference library includes one or more maps of pressure distributions obtained from healthy individuals using the device, in view of the teachings of Cundari, as this would aid in discriminating normal underlying tissue structures from potentially foreign structures using distinguishable pressure signatures (Cundari, col. 5 lines 50-67 & col. 10 lines 52-60).
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff and Gentry, as applied to claim 10 above, further in view of Sarvazyan, further in view of Shih, and further in view of Abe.
Regarding claim 16, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in Claim 10, wherein the material properties are one or more of the following: a mechanical stress of the breast tissue (“stress”, col. 1 line 65 – col. 2 line 10 & col. 6 lines 47-56)
Frei, as modified by De Graff and Gentry hereinabove, does not disclose wherein the material properties are one or more of the following: a viscosity of the tissue, a radius of a blood vessel of the tissue, a reaction force of the tissue.
However, Sarvazyan directed to a pressure sensing array for diagnosing breast cancer discloses wherein the material properties are one or more of the following: a viscosity of the tissue ("viscosity", col. 4 lines 10 - col. 5 line 28).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, such that the material properties are one or more of the following: a viscosity of the tissue, in view of the teachings of Sarvazyan, as this would aid in describing the mechanical characteristics of living tissue in both viscous and elastic components (Sarvazyan, col. 4 lines 10 - col. 5 line 28).
Frei, as modified by De Graff, Gentry and Sarvazyan hereinabove, does not disclose wherein the material properties are one or more of the following: a radius of a blood vessel of the tissue, a reaction force of the tissue.
However, Shih directed to piezoelectric sensors discloses wherein the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: reaction forces of the breast tissue (para. [0109], "resulting reaction force").
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry and Sarvazyan hereinabove, such that the voltage signals from said at least two piezoelectric sensors is transformed into a measurement of one or more selected from a group comprising: reaction forces of the breast tissue, in view of the teachings of Shih, as this would aid in calculating the elastic modulus of the dermis layer using the obtained the reaction forces (Shih, para. [0109]).
Frei, as modified by De Graff, Gentry, Sarvazyan, and Shih hereinabove, does not disclose wherein the material properties are one or more of the following: a radius of a blood vessel of the tissue.
However, Abe directed to approaches to non-invasively characterize a tumor discloses wherein the material properties are one or more of the following: a radius of a blood vessel of the tissue ("local vascular radius", para. [0082]). Abe further discloses that a combination of morphological vascular metrics and functional vascular metrics may be used to characterize the tumor (Abstract).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, Sarvazyan, and Shih hereinabove, such that the material properties are one or more of the following: a radius of a blood vessel of the tissue, in view of the teachings of Abe, as this would aid in characterizing the tumor based morphological vascular metrics and functional vascular metrics (Abe, Abstract, para. [0082]).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff and Gentry, as applied to claim 5 above, further in view of Jeong (US 20250103174 A1) and further in view of Cundari 790 (US 6179790 B1).
Regarding claim 17, Frei, as modified by De Graff and Gentry hereinabove, discloses the detection device as claimed in claim 5. Frei, as modified by De Graff and Gentry hereinabove, does not disclose wherein the rigid layer has a hemispherical shape and defines a convex side which is placed in contact with said at least two piezoelectric sensors, when said at least two piezoelectric sensors are compressed between the rigid material and the material to be measured.
However, Jeong directed to a two-terminal stretchable touch array sensor discloses a rigid layer (“probe”, para. [0170, 0174]), wherein the rigid layer has a hemispherical shape (“hemispherical probe”, para. [0170, 0174]) and defines a convex side (unlabeled, but as seen in fig. 11, “hemispherical probe”, para. [0170, 0174]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, such that the rigid layer has a hemispherical shape and defines a convex side, in view of the teachings of Jeong, as such a modification would have been merely a substitution of the plate that applies pressure of Frei for the hemispherical probe that applies pressure of Jeong and using the probe as a pressure source.
Frei, as modified by De Graff, Gentry, and Jeong hereinabove, does not disclose wherein the rigid layer defines a convex side which is placed in contact with said at least two piezoelectric sensors, when said at least two piezoelectric sensors are compressed between the rigid material and the material to be measured.
However, Cundari 790 directed to examining tissue with pressure sensors discloses an array 104 of pressure sensors 102 (figs. 1& 2A) and a rigid layer (housing 50 having lower surface 205, fig. 2; “rigid polymer”, col. 4 lines 35-52), wherein the rigid layer defines a convex side (lower surface 205, as seen in fig. 2A, “convex”, col. 4 lines 35-52) which is placed in contact with said at least two sensors (sensor array 104 is mounted lower surface 205, as seen in figs. 2A, col. 4 lines 35-52), when said at least two sensors are compressed between the rigid material and the material to be measured (“enhance the mechanical coupling between sensors 102 and the underlying tissue … presses sensor head 202 against the breast”, col. 4 lines 35-52).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff, Gentry, and Jeong hereinabove, such that the rigid layer defines the convex side which is placed in contact with said at least two piezoelectric sensors, when said at least two piezoelectric sensors are compressed between the rigid material and the material to be measured, in view of the teachings of Cundari 790, as this would aid in enhancing the mechanical coupling between the sensor and the underlying tissue (Cundari 790 , col. 4 lines 35-52).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Frei in view of De Graff and Gentry, as applied to claim 5 above, and further in view of Won (US 11457815 B2).
Regarding claim 18, Frei, as modified by De Graff and Gentry hereinabove, discloses a piezoelectric detection system (fig. 1), the system including: a device as claimed in Claim 5 (see claim 5 above). Frei, as modified by De Graff and Gentry hereinabove, does not disclose a portable piezoelectric detection system and a mobile application which can be installed, in use, on a smartphone or cellular phone and which is operable for displaying information received from the device.
However, Won discloses a portable piezoelectric detection system (“portable” & “frontend attachment 24 … force sensors … piezoelectric”, col. 4 lines 3-15 & col. 9 lines 55-67) a mobile application (application software 34) which can be installed, in use, on a smartphone or cellular phone (mobile device 22) (col. 6 lines 5-27) and which is operable for displaying information received from the device (frontend attachment 24) (display 106 for force readings) (col. 15 lines 10-26 & col. 9 lines 55-67, fig. 1). Won further discloses using the mobile-platform in the detection of malignant human tumors and aiding physicians in the prescreening of tumors (col. 5 lines 30-37).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Frei, as modified by De Graff and Gentry hereinabove, to include a portable piezoelectric detection system and mobile application which can be installed, in use, on a smartphone or cellular phone and which is operable for displaying information received from the device, in view of the teachings of Won, as this would aid physicians in prescreening of tumors by providing and using the mobile-platform in the detection of malignant human tumors (Won, col. 5 lines 30-37).
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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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791