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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 3rd, 2026 has been entered. The amendments to claims 1 and 5 are acknowledged.
Claims 1-5 and 7-18 remain pending in the application.
Response to Arguments
Applicant's arguments filed June 3rd, 2026, with respect to the rejections under 35 USC § 103 with respect to Frei and De Graff have been fully considered but they are not persuasive.
At pages 8-9, Applicant argues that the Office action does not provide a reasoned explanation why a person of ordinary skill in the art would have modified Frei with De Graff and Gentry to arrive at the pressure-transmission architecture as a whole because Frei does not teach the deformable/conformable breast-contact matrix and does not teach the operative relationship in which a deformable breast-conformable material mechanically transmits pressure changes from breast tissue to passive piezoelectric sensors while a rigid material/layer provided the opposing reaction surface. Examiner respectfully disagrees. In response to applicant's arguments against the references individually, 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). Furthermore, De Graff does disclose 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 and applying known strains to depress the breast tissue and sensor array such that the pressure at each location is recorded with pressure sensors (para. [0343, 0349-0350]) and modifying Frei to incorporate the conformable polymeric substrate, would aid in achieving and maintaining close contact with irregular surfaces/breast tissue to increase measurement accuracy when depressing the breast tissue and sensor array to record the pressure at each location (De Graff, Abstract, para. [0305, 0343, 0349-0350]). Frie does disclose a rigid material/layer providing the opposing reaction surface (Frei, “apply a pressure over the entire array”, col. 5 lines 40-57 & claim 1 (Examiner note: the array is between the plate and the breast and provides a reaction surface opposite the external breast surface to apply pressure). Upon the modification of Frei to incorporate the conformable polymeric membrane of De Graff, Frei, as modified by De Graff, discloses 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 the breast tissue (“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 voltage signals 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); wherein, during said compressing, the deformable material conforms to the external breast surface and mechanically transmits pressure changes from the breast tissue to said at least two piezoelectric sensors (Frei, “flexible membrane ... against the breast ... apply a pressure over the entire array ... producing electric outputs”, col. 5 lines 40-57 & claim 1 & De Graff, para. [0147, 0343, 349-0350]), and wherein the rigid material provides a reaction surface opposite the external breast surface (Frei, “apply a pressure over the entire array”, col. 5 lines 40-57 & claim 1 (Examiner note: the array is between the plate and the breast and provides a reaction surface opposite the external breast surface to apply pressure)).
At pages 9-10, Applicant argues that De Graff does not disclose providing a rigid material adjacent said at least two piezoelectric sensors; compressing said at least two piezoelectric sensors between the rigid material and the breast tissue, thereby to produce voltage signals in said at least two piezoelectric sensors, wherein, during said compressing, the deformable material conforms to the external breast surface and mechanically transmits pressure changes from the breast tissue to said at least two piezoelectric sensors, and wherein the rigid material provides a reaction surface opposite the external breast surface. In response to applicant's arguments against the references individually, 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). De Graff was not relied upon to teach disclose providing a rigid material adjacent said at least two piezoelectric sensors; compressing said at least two piezoelectric sensors between the rigid material and the breast tissue, thereby to produce voltage signals in said at least two piezoelectric sensors. Rather, Frei was relied upon to disclose the above limitations, see page 11 of the previous Office action. Furthermore, although De Graff does not expressly disclose providing the rigid material, De Graff does disclose depressing the sensor array with the application of known strains using an air-filled space to record the pressure at each location with the pressure sensors (para. [0349-0350]) and upon the modification of Frei to incorporate the conformable polymeric membrane of De Graff, Frei, as modified by De Graff, discloses 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 the breast tissue (“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 voltage signals 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); wherein, during said compressing, the deformable material conforms to the external breast surface and mechanically transmits pressure changes from the breast tissue to said at least two piezoelectric sensors (Frei, “flexible membrane ... against the breast ... apply a pressure over the entire array ... producing electric outputs”, col. 5 lines 40-57 & claim 1 & De Graff, para. [0147, 0343, 349-0350]), and wherein the rigid material provides a reaction surface opposite the external breast surface (Frei, “apply a pressure over the entire array”, col. 5 lines 40-57 & claim 1 (Examiner note: the array is between the plate and the breast and provides a reaction surface opposite the external breast surface to apply pressure)).
At page 12, Applicant argues that the substitution of the polymeric substrate of De Graff only addresses breast conformity and not why the substituted conformable polymeric substrate would mechanically transmit breast-tissue pressure changes to the piezoelectric sensors in a rigid-backed compression arrangement. Examiner respectfully disagrees. De Graff was not relied upon to teach providing a rigid material adjacent said at least two piezoelectric sensors; compressing said at least two piezoelectric sensors between the rigid material and the breast tissue, thereby to produce voltage signals in said at least two piezoelectric sensors. Rather, Frei was relied upon to disclose the above limitations, see page 11 of the previous Office action. Furthermore, although De Graff does not expressly disclose providing the rigid material, De Graff does teach that using stretchable circuitry described, pressure/contact sensors may be incorporated onto the surface of substrates to measure contact forces applied to tissue, 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 and applying known strains to depress the breast tissue and sensor array such that the pressure at each location is recorded with pressure sensors (para. [0286, 0343, 0349-0350]).
Applicant's arguments filed June 3rd, 2026, with respect to the rejections under 35 USC § 103 with respect to Gentry and piezoelectric sensors that can generate voltage signals without application of external electrical biasing or external control signals have been fully 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, with respect to “generat[ing] the voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors”.
Claim Objections
Claims 4 and 11-12 are objected to because of the following informalities:
Claim 4 line 4 “the sensors” should recite “the at least two piezoelectric sensors”.
Claim 11 line 2 “the voltage signal” should recite “the voltage signals”.
Claim 12 line 3 “the breast” should recite “the breast tissue”.
Appropriate correction is required.
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 1-4, 9-10, 12-14, and 16-17 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 1 recites the limitation "the material being measured" in line 20. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the breast tissue”.
Claims 2-4 are rejected by virtue of depending from rejected claim 1.
Claim 2 (claims 3-4 by virtue of dependency) recites the limitation "the material to be measured" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 (claims 10 and 16 by virtue of dependency) recites the limitation "the material to be measured" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 (claims 13-14 by virtue of dependency) recites the limitation "the material to be measured" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. It is suggested to remove the limitation “wherein the material to be measured is in a form of breast tissue”.
Claim 12 (claims 13-14 by virtue of dependency) recites the limitation "the pressure distribution" in line 3. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “a pressure distribution”.
Claim 17 recites the limitation "the material to be measured" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. The limitation is suggested to recite “the breast tissue”.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS. —Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2-3 and 9-10 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claims 2 and 9 recite the material to be measured is in a form of living tissue. Claims 3 and 10 recites that the living tissue is in the form of breast tissue. Claim 1 lines 1-2 and claim 5 lines 1 & 11-14 already recites detecting/measuring material properties of breast tissue. Breast tissue is a form of living tissue. Therefore, claims 2-3 and 9-10 do not further limit the subject matter of independent claims 1 and 5, respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 – previously cited) in view of De Graff (US 20180076336 A1 – previously cited), and further in view of Passmore (US 20170146493 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); and 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”).
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, a surface opposite the sensors fitted with an additional polymer layer, 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 and applying known strains to depress the breast tissue and sensor array such that the pressure at each location is recorded with pressure sensors (para. [0343, 0349-0350]).
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 when depressing the breast tissue and sensor array to record the pressure at each location (De Graff, Abstract, para. [0305, 0343, 0349-0350]).
Upon the modification of Frei to incorporate the conformable polymeric membrane of De Graff, as described above, Frei, as modified by De Graff hereinabove, discloses 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 the breast tissue (“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 voltage signals 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); wherein, during said compressing, the deformable material conforms to the external breast surface and mechanically transmits pressure changes from the breast tissue to said at least two piezoelectric sensors (Frei, “flexible membrane ... against the breast ... apply a pressure over the entire array ... producing electric outputs”, col. 5 lines 40-57 & claim 1 & De Graff, para. [0147, 0343, 349-0350]), and wherein the rigid material provides a reaction surface opposite the external breast surface (Frei, “apply a pressure over the entire array”, col. 5 lines 40-57 & claim 1 (Examiner note: the array is between the plate and the breast and provides a reaction surface opposite the external breast surface to apply pressure)); 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).
Frei further discloses that while the transducers 16 and 17 may be of any desired type, they are preferably formed of a type which is matched to the impedance of human tissue (col. 4 lines 8-16).
Frei, as modified by De Graff hereinabove, does not disclose wherein said at least two piezoelectric sensors generate the voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors.
In a similar technical field, Passmore directed to a fabric with an integrated piezoelectric sensor array discloses at least two piezoelectric sensors (“piezoelectric sensor arrays”; “any type or types of piezoelectric sensors”, para. [0021-0022, 0055-0057], fig. 11) that generate voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors (“lack of a requirement for an external power source”; “transform pressure variations into electrical signals”; “measure piezoelectrically generated voltages”, para. [0007, 0051, 0055-0057], see also para. [0019, 0041]). Passmore further discloses that piezoelectric sensors offer several benefits, including compact size and lack of a requirement for an external power source, that embodiments may use sensor arrays of any type, measure any desired property or properties of an object, and that the discrete sensor elements may be deposited on or in a substrate such as substrate 1102 which may be flexible, for example to conform to an irregular or curved surface when the fabric is placed on or near an object such as object 210a (para. [0007, 0051, 0056-0057]).
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 generate the voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors, in view of the teachings of Passmore, as such a modification would have been merely a substitution of the piezoelectric transducers of Frei for the piezoelectric sensors of Passmore, and would aid in measuring biological properties using sensors having a compact size, lack of a requirement for an external power source, and can be embedded in a flexible substrate (Passmore, para. [0007, 0051, 0056-0057).
Regarding claim 2, Frei, as modified by De Graff and Passmore 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 De Graff and Passmore 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”), the rigid layer providing, in use, a reaction surface opposite the external breast surface(“apply a pressure over the entire array”, col. 5 lines 40-57 & claim 1 (Examiner note: the array is between the plate and the breast and provides a reaction surface opposite the external breast surface to apply pressure)), 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 the breast tissue and the rigid layer (“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 the 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 and applying known strains to depress the breast tissue and sensor array such that the pressure at each location is recorded with pressure sensors (para. [0343, 0349-0350]).
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 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 when depressing the breast tissue and sensor array to record the pressure at each location (De Graff, Abstract, para. [0305, 0343, 0349-0350]).
Upon the modification of Frei to incorporate the conformable polymeric membrane of De Graff, as described above, Frei, as modified by De Graff hereinabove, discloses wherein, in use, the deformable material layer conforms to the external breast surface and mechanically transmits pressure changes from the breast tissue to said at least two piezoelectric sensors (Frei, “flexible membrane ... against the breast ... apply a pressure over the entire array ... producing electric outputs”, col. 5 lines 40-57 & claim 1 & De Graff, para. [0147, 0343, 349-0350]).
Frei further discloses that while the transducers 16 and 17 may be of any desired type, they are preferably formed of a type which is matched to the impedance of human tissue (col. 4 lines 8-16).
Frei, as modified by De Graff hereinabove, does not disclose wherein said at least two piezoelectric sensors generate the voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors.
In a similar technical field, Passmore directed to a fabric with an integrated piezoelectric sensor array discloses at least two piezoelectric sensors (“piezoelectric sensor arrays”; “any type or types of piezoelectric sensors”, para. [0021-0022, 0055-0057], fig. 11) that generate voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors (“lack of a requirement for an external power source”; “transform pressure variations into electrical signals”; “measure piezoelectrically generated voltages”, para. [0007, 0051, 0055-0057], see also para. [0019, 0041]). Passmore further discloses that piezoelectric sensors offer several benefits, including compact size and lack of a requirement for an external power source, that embodiments may use sensor arrays of any type, measure any desired property or properties of an object, and that the discrete sensor elements may be deposited on or in a substrate such as substrate 1102 which may be flexible, for example to conform to an irregular or curved surface when the fabric is placed on or near an object such as object 210a (para. [0007, 0051, 0056-0057]).
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 generate the voltage signals responsive to the pressure changes without application of external electrical biasing or external control signals to said at least two piezoelectric sensors, in view of the teachings of Passmore, as such a modification would have been merely a substitution of the piezoelectric transducers of Frei for the piezoelectric sensors of Passmore, and would aid in measuring biological properties using sensors having a compact size, lack of a requirement for an external power source, and can be embedded in a flexible substrate (Passmore, para. [0007, 0051, 0056-0057).
Regarding claim 7, Regarding claim 3, Frei, as modified by De Graff and Passmore 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, Regarding claim 3, Frei, as modified by De Graff and Passmore 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, Regarding claim 3, Frei, as modified by De Graff and Passmore 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, Regarding claim 3, Frei, as modified by De Graff and Passmore 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, Regarding claim 3, Frei, as modified by De Graff and Passmore 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 Passmore, as applied to claim 3 above, further in view of Sarvazyan (US 5860934 A – previously cited), further in view of Shih (US 20160331300 A1 – previously cited), further in view of Abe (WO 2021067853 A1 – previously cited), and further in view of Watmough (US 20070219449 A1 – previously cited).
Regarding claim 4, Frei, as modified by De Graff and Passmore hereinabove, discloses the detection method as claimed in Claim 3. Frei, as modified by De Graff and Passmore 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 Passmore 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, Passmore, 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, Passmore, 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, Passmore, 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, Passmore, 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, Passmore, 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, Passmore, 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 Passmore, as applied to claim 7 above, and further in view of Madden (US 20170356815 A1 – previously cited).
Regarding claim 11, Frei, as modified by De Graff and Passmore hereinabove, discloses the detection device as claimed in Claim 7. Frei, as modified by De Graff and Passmore 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 Passmore 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, Passmore, and Madden, as applied to claim 11 above, and further in view of Cundari (US 5989199 A – previously cited).
Regarding claim 12, Frei, as modified by De Graff, Passmore, and Madden hereinabove, discloses the detection device as claimed in Claim 11. Frei, as modified by De Graff, Passmore, 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, Passmore, 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, Passmore, Madden, and Cundari, as applied to claim 12 above, and further in view of Sliwa (US 20070293792 A1 – previously cited).
Regarding claim 13, Frei, as modified by De Graff, Passmore, Madden, and Cundari hereinabove, discloses the detection device as claimed in Claim 12. Frei, as modified by De Graff, Passmore, 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, Passmore, 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, Passmore, Madden, Cundari, and Sliwa hereinabove, discloses the detection device as claimed in Claim 13. Frei, as modified by De Graff, Passmore, 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, Passmore, 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 Passmore, 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 Passmore 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 Passmore 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 Passmore 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, Passmore 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, Passmore 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, Passmore, 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, Passmore, 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 Passmore, as applied to claim 5 above, further in view of Jeong (US 20250103174 A1) and further in view of Cundari 790 (US 6179790 B1 – previously cited).
Regarding claim 17, Frei, as modified by De Graff and Passmore hereinabove, discloses the detection device as claimed in claim 5. Frei, as modified by De Graff and Passmore 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 Passmore 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, Passmore, 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, Passmore, 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 Passmore, as applied to claim 5 above, and further in view of Won (US 11457815 B2 – previously cited).
Regarding claim 18, Frei, as modified by De Graff and Passmore 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 Passmore 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 Passmore 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
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Celik-Butler (US 20160258829 A1) directed to a self-powered tactile pressure sensor including a flexible substrate, an array of piezoelectric crystalline nanorods each having a bottom end and a top end. Poniatowski (US 20150086955 A1) teaches a piezoelectric film that can detect pressure or deformation and produce a voltage signal in proportion to a compression force (para. [0063-0064]); Hembrador (US 20180325448 A1) teaches an array of piezoelectric detectors (para. [0012, 0030-0031]).
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/A.E.H./Examiner, Art Unit 3791
/AURELIE H TU/Primary Examiner, Art Unit 3791
