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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 2, 2026 has been entered.
Response to Amendment
The amendment filed September 2, 2026 has been entered.
Applicant’s amendments obviate the rejection of claim 10 under 35 U.S.C. 112(a).
Applicant’s amendments obviate previous rejections under 35 U.S.C. 112(b).
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 103.
Claims 1-13 are pending.
Response to Arguments
Applicant’s arguments with respect to the rejection of claims under 35 U.S.C. 103 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
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-5, 8, 12, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard).
Re. Claims 1, 12, and 13: Hirata teaches a hardness calculation device (Page 1/15, Abstract: “In a tactile sensor probe 1 to measure hardness of an object by contacting it with the object such as an organic tissue…;” see related processing components shown in Figs. 4, 5)
comprising:
a computer configured to execute a program to:
acquire distance measurement information indicating a distance to a reference position that is a part of a body of an animal (Figs. 4, 5: distance measuring unit 29; Page 1/15, Abstract: “The sensor part 3 has a hardness measuring sensor 6, but in this case, for example, four distance sensors 7 to measure a distance up to a measuring part are arranged around the sensor 6;” Examiner notes that “distance up to a measuring part around the sensor” constitutes a reference position – see position of distance sensors 7 in Figs. 1, 2, 6, 7 relative to hardness measuring sensor 6);
acquire pressure information indicating a pressure when a contact section is pressed against a target position that is a part of the body of the animal, the target position being a position different from the reference position (Figs. 4, 5: hardness detecting section 28; Figs. 6, 7; Page 2/15: “The hardness measuring sensor 6 includes, for example, a pressure sensor for measuring a repulsive force when it comes into contact with a living tissue”);
calculate a hardness information that is information about a hardness of a tissue existing in the body of the animal at the target position based on the distance measurement information acquired and the pressure information acquired (Figs. 4, 5: hardness detecting section (analyzing means) 28; Page 3/15: “Here, the distance measuring unit 29 measures a position when the tactile sensor probe 1 comes into contact with a living tissue based on output signals from the four distance sensors 7 when the tactile sensor probe 1 is used. Further, the bending drive control unit 30 drives the bending mechanism 14 of the bending unit 4 based on the output signal from the distance measurement unit 29, changes the direction of the hardness measurement sensor 6 of the tactile sensor probe 1, and changes the direction of the measured object and are arranged substantially vertically facing each other. Then, the signal of the hardness measurement sensor 6 of the tactile sensor probe 1 is analyzed by the hardness detection unit 28 to detect the hardness of the measured object;” Page 5/15: “… the bending unit 41 is driven to bend in accordance with the outputs from the four distance sensors 7, so that the orientation of the sensor unit 3 is Can be changed to a state in which the sensor unit 3 is arranged to be substantially vertically opposed to the direction of the object H, so that the hardness of the object H can be measured similarly to the first embodiment. As a result, the measurement accuracy can be improved, and the hardness of the living tissue can be accurately measured”).
Hirata does not teach the invention explicitly acquiring a distance measurement wherein the distance measurement comprises a distance to a surface of a skin of the animal, and determining hardness of a tissue existing inside the skin of the animal. Instead, Hirata is directed to measurement of distance to “living tissue” (Page 2/15), without reference to skin.
Kurdy (previously cited to address claim 3), teaches a similar technology in measuring tissue hardnesses (Abstract), and provides a technique which allows for such a device to measure eyeball and eyelid hardnesses (Paragraph 0050: “Paragraph 0050: “… contact tip against an eyelid of the same eye of the subject, moving the contact tip towards the eye until a predetermined force threshold is obtained by the force sensor; recording the correlated position of the contact tip as the “Zero Point” in the memory; causing the contact tip to move further a preset distance into the eyelid of the subject towards the eye and obtaining a second measurement force; recording the second measurement force in the memory; causing the microprocessor to calculate an intraocular pressure and or ocular durometer based on the second measurement force obtained from the force sensor…”).
Hirata as modified by Kurdy does not explicitly teach the invention:
when the contact section is pressed against the surface of the skin, a correspondence between multiple press depth and multiple pressure information is obtained, and a slope of a straight line based on the correspondence is calculated as the hardness information; and
output the hardness information.
Such a concept for evaluating tissue characteristics is known from Leonard (see also, pertinent arts of record of Williams and Steinburg cited in Conclusion). Leonard teaches analogous art in the technology of evaluating tissue responsiveness to applied force (Abstract). Leonard further teaches the invention:
when the contact section is pressed against the surface of the skin, a correspondence between multiple press depth and multiple pressure information is obtained, and a slope of a straight line based on the correspondence is calculated as the hardness information (Col. 2, lines 23-37: “In operation, the device is placed on a patient's skin. A probe is gently pressed downward on the skin surface. The probe does not penetrate the skin but merely pushes against the skin. The measurements taken by the present invention includes the amount of deformation (skin displacement) which results when a given unit of force is exerted on the underlying muscle, first, in its relaxed (resting) state and, second, in its maximally contracted state. Values derived from a rested state provide an accurate assessment of muscle tone and muscle compliance. Values derived from a contracted state provide an accurate assessment of muscle strength. The differences between the two sets of values when graphed linearly reflect slopes whose differences represent an assessment of the severity level of the person's spasticity;” Figs. 6-9); and
output the hardness information (Abstract: “…display and compare measurement averages between sessions;” Figs. 6-9).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hirata as modified by Kurdy to utilize the slope-based method and display of results thereof of Leonard, the motivation being that identifying a slope provides a linear metric for assessing spasticity of underlying tissue across a range of pressure values and allows for an operator to quantify tissue condition readily upon viewing results (see citations of Leonard).
Claim 12 recites limitations of claim 1 mutatis mutandis as a method claim; thus, claim 12 is rejected analogously to that of claim 1.
Claim 13, as best understood, recites a hardness calculation device akin to that of claim 1, but instead acquiring data from “an inspection target object.” This is broader than the recitation of “a part of a body of an animal” as recited in claim 1. An animal may be considered an object. Thus, claim 13 is rejected analogously by citations of the narrower claim 1.
Re. Claim 3: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 2. Kurdy, in teaching further detail regarding the incorporated technique, further teaches wherein the computer is further configured to execute the program to:
calculate a first hardness when a distance to the reference position is a first distance and a second hardness when a distance to the reference position is a second distance, the second hardness being different from the first hardness (Paragraph 0050: “… contact tip against an eyelid of the same eye of the subject, moving the contact tip towards the eye until a predetermined force threshold is obtained by the force sensor; recording the correlated position of the contact tip as the “Zero Point” in the memory; causing the contact tip to move further a preset distance into the eyelid of the subject towards the eye and obtaining a second measurement force; recording the second measurement force in the memory; causing the microprocessor to calculate an intraocular pressure and or ocular durometer based on the second measurement force obtained from the force sensor…”).
Re. Claim 4: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 3. Kurdy further teaches the invention wherein the part of the body of the animal is an eyelid of a human, the first hardness is a hardness of the eyelid, and the second hardness is a hardness of an eyeball (see rejection of claim 3).
Re. Claim 5: Hirata as modified by Kurdy and Leonard teaches a hardness measurement device comprising:
the hardness calculation device according to claim 1 (Figs. 4, 5: system includes processing components which receive signals from distance and pressure sensors);
a distance measurement sensor configured to measure a distance to the reference position (Figs. 1, 2, 6, 7: distance sensor 7),
the distance measurement sensor being configured to output the measured distance as the distance measurement information (Figs. 4, 5; Page 3/15: “Here, the distance measuring unit 29 measures a position when the tactile sensor probe 1 comes into contact with a living tissue based on output signals from the four distance sensors 7 when the tactile sensor probe 1 is used. Further, the bending drive control unit 30 drives the bending mechanism 14 of the bending unit 4 based on the output signal from the distance measurement unit 29, changes the direction of the hardness measurement sensor 6 of the tactile sensor probe 1, and changes the direction of the measured object”); and
a pressure sensor configured to measure a pressure when the contact section is pressed against the target position (Figs. 1, 2, 6, 7: hardness detector 6; Page 2/15: “The hardness measuring sensor 6 includes, for example, a pressure sensor for measuring a repulsive force when it comes into contact with a living tissue…”),
the pressure sensor being configured to output the measured pressure as the pressure information (Figs. 4, 5: hardness detecting section 28).
Re. Claim 8: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 5. Hirata further teaches the invention wherein the distance measurement sensor measures the distance to the reference position without contact (Page 2/15: “The distance sensor 7 comprises a semiconductor laser 9 for emitting laser light and a photodiode 10 for detecting the intensity of the reflected light. The distance measurement is performed by changing the intensity of the detected light according to the distance. The four distance sensors 7 are arranged at equal intervals at four locations around the hardness measurement sensor 6. These distance sensors 7 are also covered on the front so as not to come into direct contact with the living body”).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Imoto (US 5879312 A) (hereinafter – Imoto).
Re. Claim 2: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 1, but does not teach wherein the computer is further configured to execute the program to:
acquire a plurality of pieces of the distance measurement information acquired at different moments from each other,
acquire a plurality of pieces of the pressure information acquired at moments corresponding to the moments at which the plurality of pieces of the distance measurement information are acquired, and
calculate the hardness information based on the acquired plurality of pieces of distance measurement information and the acquired plurality of pieces of pressure information.
Hirata teaches the acquiring a single piece pressure information acquired at moments corresponding to the moments at which the plurality of pieces of the distance measurement information are acquired (see previous citation regarding a single hardness sensor 6).
Imoto teaches analogous art in the technology of hardness testing devices (Abstract). Imoto teaches acquiring hardness information about a plurality of points in proximity to an object point and calculating a final hardness based on an average of those points (Col. 7, lines 23-34).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hirata as modified by Kurdy and Leonard to include the hardness testing method and necessary components thereof as taught by Imoto, the motivation being that a measurement result of hardness can change by even a small displacement or tilt of the detection mechanism; thus, identifying a plurality of points and obtaining an average is suitable for obtaining a reliable measurement result (Col. 2, lines 54-63).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Livne et al. (US 8317701 B2) (hereinafter – Livne).
Re. Claim 6: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 5, but does not teach the invention wherein
the pressure sensor includes a deformation section including a contact surface including the contact section,
the deformation section being configured to deform in response to pressure when the contact surface comes into contact with the target position,
a marker provided on a back side of the contact surface, and
wherein the computer is further configured to execute the program to:
capture an image of the marker from the back side of the contact surface.
Livne teaches analogous art in the technology of measuring ocular pressure (Abstract). Livne teaches a method of measuring a force applied to a biological tissue using a pressure sensor, wherein the pressure sensor includes
a deformation section including a contact surface including the contact section (Fig. 2: probe unit 12 having flexible membrane 18),
the deformation section being configured to deform in response to pressure when the contact surface comes into contact with the target position (Fig. 2B),
a marker provided on a back side of the contact surface (Fig. 2C: illuminator unit illuminates an inner surface 18B of contacting membrane to form a pattern of concentric rings), and
wherein the computer is further configured to execute the program to:
capture an image of the marker from the back side of the contact surface (Col. 3, lines 37-56: “…the imaging unit captures an image of both the marker and an object existing on a contact surface side of the deformation section… The device includes an optical system configured for directing light of the certain light spectrum towards the membrane and detecting light returned from the membrane (detecting reflection or obtaining an optical image). The optical system includes an illuminator unit and a light detection unit (e.g. sensor array)”).
Hirata is not specific regarding the type of pressure sensor 6 used. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is, in the substitution of the pressure sensing system of Livne for the non-descript pressure sensor of Hirata as modified by Kurdy and Leonard. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Livne et al. (US 8317701 B2) (hereinafter – Livne) in further view of
Srinivasan et al. (US 20210153755 A1) (hereinafter – Srinivasan).
Re. Claim 7: Hirata as modified by Kurdy, Leonard, and Livne teaches the invention according to claim 6. Livne, in the combination, does not teach the invention wherein the deformation section is made of a transparent material. Thus, the imaging taught in the combination does not capture an image of both the marker and an object existing on a contact surface side of the deformation section.
Srinivasan teaches analogous art in the technology of measuring forces on a compressed surface to detect physiological characteristics (e.g., blood pressure) therefrom (Abstract). Srinivasan teaches a device for ascertaining variation in pressure on a surface, wherein the deformation section is made of a transparent material (Fig. 4A; Paragraph 0050: silicone elastomer 309 is transparent),
wherein the computer is further configured to execute the program to:
capture an image of both the marker and an object existing on a contact surface side of the deformation section (Fig. 4A: camera 303).
It would have been obvious to one having skill in the art before the effective filing date to have modified the membrane of Hirata as modified by Kurdy, Leonard, and Livne to be transparent as taught by Srinivasan and to further output such captured images, the motivation being that doing so would allow the device of Hirata as modified by Kurdy, Leonard, and Livne to be accurately placed against an intended measurement location by utilizing captured images thereof obtained from the optical system.
Leonard, in the combination or references, already teaches an output unit which outputs the hardness information (see rejection of claim 1).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Cunningham et al. (US 20150208979 A1) (hereinafter – Cunningham).
Re. Claim 9: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 5. Hirata teaches the invention further comprising:
a posture sensor configured to detect at least an inclination of the hardness measurement device (Figs. 1, 2, 4-7: distance sensors 7 measuring different distances to output a state of contact angle).
Leonard, in the combination or references, already teaches wherein the computer is further configured to execute the program to output the hardness information (see rejection of claim 1).
Hirata as modified by Kurdy and Leonard does not teach further display of a detected inclination.
Cunningham teaches analogous art in the technology of assessment of biological tissues (Abstract). Cunningham further teaches a device which measures a tilt angle and display thereof (Paragraph 0103).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hirata as modified by Kurdy and Leonard to also output inclination as taught by Cunningham, the motivation being that doing so provides feedback for a user to adjust a direction of the device (Paragraph 0103), which reduces the need for the system of Hirata to perform large contact angle adjustments.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Cunningham et al. (US 20150208979 A1) (hereinafter – Cunningham) in further view of
Martin (US 20200196864 A1) (hereinafter – Martin).
Re. Claim 10: Hirata as modified by Kurdy, Leonard, and Cunningham teaches the invention according to claim 9, but does not teach the invention wherein the computer is further configured to execute the program to: calculation unit further includes a correction unit configured to correct the hardness indicated by the calculated hardness information according to the information indicating the inclination.
Martin teaches analogous art in the technology of intraocular pressure measurements (Abstract), particularly using a device which contacts the eye (i.e., a tonometer). Martin further teaches the invention wherein the computer is further configured to execute the program to: correct the hardness indicated by the calculated hardness information according to the information indicating the inclination (Paragraph 0045: compensation of detected forces based on inclination of measurement direction).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hirata as modified by Kurdy, Leonard, and Cunningham to further include correcting a measurement force (akin to sensed pressure) based on an inclination angle of the device relative to a measurement surface as taught by Martin, the motivation being that doing so allows for correction of measuring force at varying tilt angles relative to gravity.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over:
Hirata et al. (JPH1176169A) (disclosed by Applicant, citing Google Patents translation) (hereinafter – Hirata) in view of
Kurdy et al. (US 20190117066 A1) (hereinafter – Kurdy) in further view of
Leonard et al. (US 6063044 A) (hereinafter – Leonard) in further view of
Gurses (US 20060052729 A1) (hereinafter – Gurses).
Re. Claim 11: Hirata as modified by Kurdy and Leonard teaches the invention according to claim 5. Hirata as modified by Sano does not teach the invention further comprising:
wherein the computer is further configured to execute the program to: acquire diagnostic information that is information to be acquired according to a result of the hardness information output; and
perform a treatment included in the diagnostic information.
Gurses teaches analogous art in the technology of systems which apply mechanical pressure to soft tissues after diagnosis (Abstract).
It would have been obvious to one having skill in the art before the effective filing date to have modified Hirata as modified by Kurdy and Leonard to include integrating a treatment device with the invention, performing a diagnosis, and applying appropriate treatment based thereon as taught by Gurses, the motivation being that doing so allows for simultaneous diagnosis and treatment, reducing the time needed to ameliorate possible adverse conditions.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Steinberg (US 20070028929 A1) – Abstract: “A system and method are disclosed for noninvasively diagnosing limb compartment syndrome by measuring a quantitative modulus of hardness. In the preferred embodiment, a nonmovable pressure probe mounted in the center of a movable spring loaded platform is applied against a limb compartment. Force is gradually applied to the probe and the platform, compressing a limb compartment. Pressure on the probe is measured as the probe pushes into the limb. The spring loaded platform displaces, and the distance of the probe tip to the platform is measured. This distance is the depth of compression into the limb by the probe. The relationship of incremental pressures in the probe and the corresponding distance of the probe tip to the platform for each pressure is plotted. A linear regression analysis is performed whose slope forms a quantitative modulus of hardness;”
Williams et al. (US 20080200843 A1) – Paragraph 0007: “The compliance function may be formed by determining a best fit line that describes the displacement as a function of applied force and selecting the slope of the line to model a compliance of the target tissue. The compliance function may be formed by determining a best fit curve that describes the displacement as a function of applied force and selecting the slope of the curve at each applied force interval to model a compliance of the target tissue.”
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
