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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 25, 2025 has been entered.
Response to Amendment
The Amendment filed November 25, 2025 has been entered. Claims 1, 3, 6-7 and 11-26 remain pending in the application.
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 22-23 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 22 recites “wherein the elasticity measurement device measures back pressure generated by gas introduced percutaneously to the tissue plane.”. However, claim 11 recites, “an elasticity measurement device coupled to the electrosurgical generator and configured to mechanically measure elasticity of the portion of the surface of skin by applying a controlled displacement and determining a slope of stress versus displacement;”. It is unclear how the elasticity measurement device performs both ways together. It appears embodiments are incorrectly combined. Appropriate correction is required.
Claim 23 similarly recites, “wherein the elasticity measurement device measures changes in density of a contrast fluid introduced into the subcutaneous tissue plane.” Which has the same issues as claim 22.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-3 and 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Knowlton (US 2004/0206365 A1) (“Knowlton”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Linhart et al. (US 2018/0103991 A1) (“Linhart”).
Regarding claim 1, Knowlton discloses A method comprising (Abstract):
measuring elasticity of the skin to establish a baseline (Knowlton, [0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).” In order to observe a qualitative elasticity measurement, the initial measurement must be measured or known. See also [0242])
performing a first elasticity altering procedure in a subcutaneous tissue plane beneath the portion of the surface of skin ([0011], “Specific embodiments can also include a combination of energy and force delivery with liposuction and related plastic surgery procedures using a port incision or other minimally invasive surgical methods known in the art.” And [0022], “Yet another embodiment provides a method whereby energy is topically delivered to produce heating of the subjacent soft tissue such as the subcutaneous fat layer,” and [0240 -0243]);
performing a second elasticity altering procedure in a subcutaneous tissue plane ([0243], “After each re-treatment step 650 another evaluation step 640 can be performed until the desired endpoint 660 is obtained.”)
Knowlton fails to disclose mechanically measuring elasticity of a portion of a surface of skin by applying a controlled displacement to the portion of the surface of skin, measuring stress at a plurality of displacements, and determining a baseline slope of stress versus displacement corresponding to a baseline elasticity value;
establishing a quantitative elasticity threshold value based on the baseline slope;
However, in the same field of endeavor, Kalra teaches mechanically measuring elasticity of a portion of a surface of skin by applying a controlled displacement to the portion of the surface of skin, measuring stress at a plurality of displacements, and determining a baseline slope of stress versus displacement corresponding to a baseline elasticity value (Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin, which is interpreted as a baseline slope of stress versus displacement corresponding to a baseline elasticity value);
establishing a quantitative elasticity threshold value based on the baseline slope (Pages 1-3 discusses measuring the young’s modulus to determine a baseline to track behavior of the skin over time, to follow the course of a disease or the effects of cosmetic treatment);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Knowlton to include mechanically measuring elasticity of a portion of a surface of skin by applying a controlled displacement to the portion of the surface of skin, measuring stress at a plurality of displacements, and determining a baseline slope of stress versus displacement corresponding to a baseline elasticity value; establishing a quantitative elasticity threshold value based on the baseline slope; as taught by Kalra to quantitatively track progress of treatment (Page 1).
Knowlton as modified further discloses mechanically re-measuring elasticity of the portion of the surface of skin by applying the controlled displacement and determining an updated slope of stress versus displacement; determining if the updated elasticity slope is greater than the elasticity threshold value; and iteratively performing the second elasticity altering procedure in the subcutaneous tissue plane until the elasticity measurement is greater than the threshold (Knowlton discloses [0243], “In an embodiment, treatment and re-treatment steps 600 and 620 are performed essentially during a single patient visit to produce a selected aesthetic or clinical primary endpoint 630 (e.g., 50% reduction in wrinkle depth, 25% reduction thigh diameter, raising of the eyebrow by 0.5 inch, etc.).” Thus a threshold value is determined, see [0243], “After each re-treatment step 650 another evaluation step 640 can be performed until the desired endpoint 660 is obtained.” Treatment is iteratively performed until the desired endpoint (threshold) is reached. See also [0242], “As shown in FIG. 42, in an embodiment an initial energy application step 600 (which can be a series of overlapping energy applications) can be followed by a treatment evaluation step 610 where the results of the initial treatment are quantitatively and/or qualitatively evaluated, for example, using visual observation or tissue property measurement methods described herein.” Wherein ‘described herein’ refers to the present embodiment such as discussed in [0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).” Which discusses tissue elasticity as a quantitative indicia. Wherein, as shown above, Kalra teaches that the elasticity modulus is measured mechanically as claimed to establish the baseline slope and updated slope, as the Young’s modulus taught.).
Thus, Knowlton discloses determining a elasticity slope having a elasticity threshold value and iteratively performing tissue treatment procedures and measurements until the measurements are within the threshold range, but fails to explicitly disclose that the threshold range is a tissue elasticity threshold range. Para. [0240] as discussed above states that the quantitative indicia can be tissue elasticity.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Knowlton to determining a elasticity slope having a elasticity threshold value and iteratively performing tissue treatment procedures and measurements until the measurements are within the threshold range specifically over the threshold elasticity value as taught by Kalra to quantitatively track progress of treatment (Page 1).
Knowlton as modified fails to disclose performing a second elasticity altering procedure in a subcutaneous tissue plane to coagulate tissue in the subcutaneous tissue plane, second elasticity altering procedure includes applying a plasma beam in the subcutaneous tissue plane;
However, in the same field of endeavor, Linhart teaches performing a second elasticity altering procedure in a subcutaneous tissue plane to coagulate tissue in the subcutaneous tissue plane, second elasticity altering procedure includes applying a plasma beam in the subcutaneous tissue plane ([0060] – [0061] and [0090], “Method of treatment may include following steps: positioning of the applicator including one or more energy delivery elements adjacent (e.g. in contact) with the tissue; transferring the energy (e.g. radiofrequency energy) into the tissue; delivering the source gas and/or secondary gas from gas supply adjacent to another and/or the same energy delivery element and generating of plasma by energy delivery element.” And FIG. 3A and [0107 – 0109], “At least one hollow needle 312 delivering plasma and/or analgesics may be located on the treatment device. Needle 312 may still deliver the radiofrequency energy. All needles or some of the needles may deliver plasma.”);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the method as taught by Knowlton as modified to include performing a second elasticity altering procedure in a subcutaneous tissue plane to coagulate tissue in the subcutaneous tissue plane, second elasticity altering procedure includes applying a plasma beam in the subcutaneous tissue plane as taught by Linhart in order to improve healing ([0020], “A combination of radiofrequency (RF) energy with plasma supplemented with nitric oxide may provide effective tissue treatment with stimulation of regenerative process. Combination may provide improved healing process without risk of inflammation.”).
Regarding claim 3, Knowlton as modified discloses The method of claim 1, wherein the elasticity altering procedure is a liposuction procedure ([0012], “Other related embodiments can include the performance of a liposuction procedure substantially at the tissue site.”).
Regarding claim 6, Knowlton as modified discloses The method of claim 1, Knowlton as modified further discloses wherein the tissue plane is heated by the plasma beam to a temperature of at least 85 degrees C for 0.04 seconds to 0.08 seconds (Linhart, [0061], “Plasma pulse duration may be in the range of 0.1 nanoseconds to 30 seconds, more preferably in the range of 0.1 nanosecond to 5 s, even more preferably in the range of 0.5 nanosecond to 3 s, most preferably in the range of 1 nanosecond to 1 second. Temperature of non-thermal plasma when it reaches the tissue may be in the range of −50° C. to 150° C., more preferably in the range of −25° C. to 100° C., even more preferably in the range of −15° C. to 90° C., most preferably in the range of 0° C. to 85° C.”).
Regarding claim 7, Knowlton as modified discloses The method of claim 1, Knowlton as modified further discloses wherein a power output of the plasma beam is 24 Watts to 32 Watts (Linhart, [0061], “When the plasma is produced by a voltage between two electrodes, the voltage may be in the range of 1 V to 30 kV, more preferably in the range of 1 kV to 30 kV, most preferably in the range of 1 kV to 20 kV.”).
Claims 11-21 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Linhart et al. (US 2018/0103991 A1) (“Linhart”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Knowlton (US 2004/0206365 A1) (“Knowlton”).
Regarding claim 11, Linhart discloses A system comprising (Abstract):
an applicator coupled to an electrosurgical generator and configured to apply a plasma beam in a subcutaneous tissue plane, the subcutaneous tissue plane beneath a portion of a surface of skin and receiving an elasticity altering procedure ([0060] – [0061] and [0090], “Method of treatment may include following steps: positioning of the applicator including one or more energy delivery elements adjacent (e.g. in contact) with the tissue; transferring the energy (e.g. radiofrequency energy) into the tissue; delivering the source gas and/or secondary gas from gas supply adjacent to another and/or the same energy delivery element and generating of plasma by energy delivery element.” And [0017], “Combination of energy and plasma may be used for an aesthetic treatments focusing on tissue problems. More detailed methods of their treatment is disclosed below. The treatment methods may use at least one energy source and/or plasma source” And FIG. 3A and [0107 – 0109], “At least one hollow needle 312 delivering plasma and/or analgesics may be located on the treatment device. Needle 312 may still deliver the radiofrequency energy. All needles or some of the needles may deliver plasma.”);
the electrosurgical generator unit for supplying electrosurgical energy to the applicator ([0068], “the plasma source may have a case 102 which may include an energy source 103, a control unit 104 and a user interface 105. Control unit 103 may be connected to power supply 101. The energy source 103, connected to control unit 104, produces output energy. The power supply may include an electricity network and/or at least one battery.”),
Linhart fails to disclose an elasticity measurement device coupled to the electrosurgical generator and configured to mechanically measure elasticity of the portion of the surface of skin by applying a controlled displacement and determining a slope of stress versus displacement; and
receive the elasticity measurement,
determining if the elasticity measurement received from the elasticity measurement device is greater than a predetermined elasticity threshold value based on a baseline slope measured before plasma treatment, and iteratively applying the plasma beam to the subcutaneous tissue plane until the elasticity measurement is greater than the predetermined elasticity threshold value.
However, in the same field of endeavor, Kalra teaches an elasticity measurement device coupled to the electrosurgical generator and configured to mechanically measure elasticity of the portion of the surface of skin by applying a controlled displacement and determining a slope of stress versus displacement (Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin, which is interpreted as a baseline slope of stress versus displacement corresponding to a baseline elasticity value); and
receive the elasticity measurement, determining if the elasticity measurement received from the elasticity measurement device is greater than a predetermined elasticity threshold value based on a baseline slope measured before plasma treatment (Pages 1-3 discusses measuring the young’s modulus to determine a baseline to track behavior of the skin over time, to follow the course of a disease or the effects of cosmetic treatment);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart to include an elasticity measurement device coupled to the electrosurgical generator and configured to mechanically measure elasticity of the portion of the surface of skin by applying a controlled displacement and determining a slope of stress versus displacement; and receive the elasticity measurement, determining if the elasticity measurement received from the elasticity measurement device is greater than a predetermined elasticity threshold value based on a baseline slope measured before plasma treatment as taught by Kalra to quantitatively track progress of treatment (Page 1).
Linhart as modified fails to disclose determining if the elasticity measurement received from the elasticity measurement device is greater than a predetermined elasticity threshold value based on a baseline slope measured before plasma treatment, and iteratively applying the plasma beam to the subcutaneous tissue plane until the elasticity measurement is greater than the predetermined elasticity threshold value.
However, in the same field of endeavor, Knowlton teaches determining if the elasticity measurement received from the elasticity measurement device is greater than a predetermined elasticity threshold value based on a baseline slope measured before plasma treatment, and iteratively applying the plasma beam to the subcutaneous tissue plane until the elasticity measurement is greater than the predetermined elasticity threshold value ([0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).” See also [0242] and Knowlton discloses [0243], “In an embodiment, treatment and re-treatment steps 600 and 620 are performed essentially during a single patient visit to produce a selected aesthetic or clinical primary endpoint 630 (e.g., 50% reduction in wrinkle depth, 25% reduction thigh diameter, raising of the eyebrow by 0.5 inch, etc.).” Thus a threshold value is determined, see [0243], “After each re-treatment step 650 another evaluation step 640 can be performed until the desired endpoint 660 is obtained.” Treatment is iteratively performed until the desired endpoint (threshold) is reached. See also [0242], “As shown in FIG. 42, in an embodiment an initial energy application step 600 (which can be a series of overlapping energy applications) can be followed by a treatment evaluation step 610 where the results of the initial treatment are quantitatively and/or qualitatively evaluated, for example, using visual observation or tissue property measurement methods described herein.” Wherein ‘described herein’ refers to the present embodiment such as discussed in [0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).” Which discusses tissue elasticity as a quantitative indicia. Wherein, as shown above, Kalra teaches that the elasticity modulus is measured mechanically as claimed to establish the baseline slope and updated slope, as the Young’s modulus taught.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include an elasticity measurement device coupled to an electrosurgical generator and for measuring elasticity of the portion of the surface of skin; determining if the elasticity measurement received from the elasticity measurement device is greater than a threshold value and iteratively applying the plasma beam to the subcutaneous tissue plane until the elasticity measurement is greater than the threshold value as taught by Knowlton in order to determine that adequate treatment was performed ([0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).”).
Regarding claim 12, Linhart as modified discloses The system of claim 11, wherein the predetermined elasticity threshold value is the elasticity measurement of the portion of the surface of skin before the elasticity altering procedure is performed (Knowlton, [0240], “In an embodiment, determination of the adequacy of the thermal dose can be made by delivering energy until visible tightening of the treatment area is observed or another qualitative or quantitative indicia of tightening is observed. Such indicia can include, without limitation, skin temperature, elasticity, displacement, tension, and impedance (thermal or electrical).” In order to observe a qualitative elasticity measurement, the initial measurement must be measured or known. See also [0242]).
Regarding claim 13, Linhart as modified discloses The system of claim 11, Linhart fails to disclose further comprising an elasticity altering device that performs the elasticity altering procedure, wherein the elasticity altering procedure is a liposuction procedure.
However, in the same field of endeavor, Knowlton teaches further comprising an elasticity altering device that performs the elasticity altering procedure, wherein the elasticity altering procedure is a liposuction procedure (Knowlton, [0012], “Other related embodiments can include the performance of a liposuction procedure substantially at the tissue site.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include wherein the elasticity altering procedure is a liposuction procedure as taught by Knowlton in order to have an improved aesthetic outcome ([0022], “In use, these embodiments allow for an improved aesthetic outcome in tissue remodeling procedures such as face lifts, eyebrow lifts and liposuction of the face, thighs, buttocks and stomach by producing substantially uniform amounts of skin tightening and/or controlled release or severing of the fibrous septae.”).
Regarding claim 14, Linhart as modified discloses The system of claim 11, wherein the applicator is configured to heat the subcutaneous tissue plane to a temperature of at least 85 degrees C for 0.04 seconds to 0.08 seconds (Linhart, [0061], “Plasma pulse duration may be in the range of 0.1 nanoseconds to 30 seconds, more preferably in the range of 0.1 nanosecond to 5 s, even more preferably in the range of 0.5 nanosecond to 3 s, most preferably in the range of 1 nanosecond to 1 second. Temperature of non-thermal plasma when it reaches the tissue may be in the range of −50° C. to 150° C., more preferably in the range of −25° C. to 100° C., even more preferably in the range of −15° C. to 90° C., most preferably in the range of 0° C. to 85° C.”).
Regarding claim 15, Linhart as modified discloses The system of claim 14, wherein a power output of the plasma beam is 24 Watts to 32 Watts (Linhart, [0061], “When the plasma is produced by a voltage between two electrodes, the voltage may be in the range of 1 V to 30 kV, more preferably in the range of 1 kV to 30 kV, most preferably in the range of 1 kV to 20 kV.” Based on the temperature and the timing being within the range it follows that the power is within range ).
Regarding claim 16, Linhart as modified discloses The system of claim 11, Linhart as modified further discloses wherein the elasticity measurement device measures elasticity by measuring stress at the plurality of displacements of the portion of the surface of skin to obtain a plurality of data points and determining the slope of the data points (Kalra, Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin, which is interpreted as a baseline slope of stress versus displacement corresponding to a baseline elasticity value and further discusses measuring the young’s modulus to determine a baseline to track behavior of the skin over time, to follow the course of a disease or the effects of cosmetic treatment).
Regarding claim 17, Linhart as modified discloses The system of claim 16, Linhart as modified further discloses wherein the electrosurgical generator unit determines if the elasticity measurement is within the predetermined elasticity threshold value by comparing the determined slope to the predetermined elasticity threshold value (Kalra, Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin, which is interpreted as a baseline slope of stress versus displacement corresponding to a baseline elasticity value and further discusses measuring the young’s modulus to determine a baseline to track behavior of the skin over time, to follow the course of a disease or the effects of cosmetic treatment).
Regarding claim 18, Linhart as modified discloses The system of claim 11, Linhart as modified fails to disclose wherein the elasticity measurement device is a tensile testing device (Kalra, Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin).
Regarding claim 19, Linhart as modified discloses The system of claim 11, Linhart as modified further discloses wherein the elasticity measurement device is a vacuum assisted device (Linhart, [0078], “The device may include a source of negative and/or positive pressure which may apply pressure on the tissue before, during and/or after the treatment. Source of negative and/or positive pressure may be a vacuum pump.”).
Regarding claim 20, Linhart as modified discloses The system of claim 11, Linhart as modified further discloses wherein the elasticity measurement device is a lateral shear measurement device (Kalra, Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin).
Regarding claim 21, Linhart as modified discloses The system of claim 11, Linhart as modified further discloses wherein the elasticity measurement device is a lateral load measurement device (Kalra, Pages 1-3, discussing mechanically measuring elasticity of a portion of a surface of skin by a controlled displacement e.g. tensile/indentation/suction/torsion testing to determine Young’s Modulus of the skin).
Regarding claim 25, Linhart as modified discloses The system of claim 11, further discloses wherein the elasticity measurement device is an ultrasound device that introduces sound waves into the subcutaneous tissue plane and measures returning sounds waves propagating through the subcutaneous tissue plane (Linhart, [0054], “The mechanical energy may be ultrasound energy, shock wave energy and/or vibrational energy. Mechanical energy may be targeted into the tissue in the form of focused, defocused and/or planar waves.”).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Linhart et al. (US 2018/0103991 A1) (“Linhart”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Knowlton (US 2004/0206365 A1) (“Knowlton”) in further view of East (JP 2004-108794 A2) (“East”).
Regarding claim 22, Linhart as modified discloses The system of claim 11, Linhart as modified fails to disclose wherein the elasticity measurement device measures back pressure generated by gas introduced percutaneously to the tissue plane.
However, in the same field of endeavor, East teaches wherein the elasticity measurement device measures back pressure generated by gas introduced percutaneously to the tissue plane (Abstract and [0008] discussing compressed gas/measurements and tissue elasticity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include wherein the elasticity measurement device measures back pressure generated by gas introduced percutaneously to the tissue plane as taught by East in order to measure in a non-contact manner ([0003], discussing non-contact benefits).
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Linhart et al. (US 2018/0103991 A1) (“Linhart”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Knowlton (US 2004/0206365 A1) (“Knowlton”) in further view of Hope Simpson et al. (US 2019/0336108 A1) (“Hope”).
Regarding claim 23, Linhart as modified discloses The system of claim 11, Linhart as modified fails to disclose wherein the elasticity measurement device measures changes in density of a contrast fluid introduced into the subcutaneous tissue plane.
However, in the same field of endeavor, Hope teaches wherein the elasticity measurement device measures changes in density of a contrast fluid introduced into the subcutaneous tissue plane ([0049] discussing determining changes in density of contrast agents to determine tissue characteristics).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include wherein the elasticity measurement device measures changes in density of a contrast fluid introduced into the subcutaneous tissue plane as taught by Hope in order to characterize the tissue of interest ([0049], “In yet further examples, the neural network may be trained to characterize tissue with respect to the presence of ultrasonic contrast agents.”).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Linhart et al. (US 2018/0103991 A1) (“Linhart”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Knowlton (US 2004/0206365 A1) (“Knowlton”) in further view of Sprigle et al. (US 2009/0076732 A1) (“Sprigle”).
Regarding claim 24, Linhart as modified discloses The system of claim 11, Linhart as modified fails to disclose wherein the elasticity measurement device is pressure sensitive forceps.
However, in the same field of endeavor, Sprigle teaches wherein the elasticity measurement device is pressure sensitive forceps (Abstract, [0014], [0067] and [0114] discussing pressure sensitive forceps).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include wherein the elasticity measurement device is pressure sensitive forceps as taught by Sprigle in order to detect subtle changes ([0113], “The Tissue Interrogation Device (TID) is capable of detecting subtle changes in mechanical properties of skin and soft tissue.”).
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Linhart et al. (US 2018/0103991 A1) (“Linhart”) in view of Kalra A, Lowe A, Al-Jumaily AM (2016) Mechanical Behaviour of Skin: A Review. J Material Sci Eng 5: 254. doi:10.4172/2169-0022.1000254) (“Kalra”) in further view of Knowlton (US 2004/0206365 A1) (“Knowlton”) in further view of Aguero Villarreal et al. (US 2016/0310006) (“Aguero”).
Regarding claim 26, Linhart as modified discloses The system of claim 11, Linhart as modified fails to disclose wherein the elasticity measurement device includes at least one inflatable element, the at least one inflatable element includes a pressure sensor.
However, in the same field of endeavor, Aguero teaches wherein the elasticity measurement device includes at least one inflatable element, the at least one inflatable element includes a pressure sensor (Abstract, [0052, claim 15 discussing the pressure sensor as a balloon).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the system as taught by Linhart as modified to include wherein the elasticity measurement device includes at least one inflatable element, the at least one inflatable element includes a pressure sensor as taught by Aguero in order to have fast, accurate, and portable measurements ([0012], “In another aspect, the invention provides a device that provides a fast, accurate, portable, cost-effective and user-friendly detection system for the cricothyroid membrane.”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 3, 6-7 and 11-26 have been considered but are moot because the new ground of rejection does not rely solely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A TOMBERS whose telephone number is (571)272-6851. The examiner can normally be reached on M-TH 7:00-16:00, F 7:00-11:00(Eastern).
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/JOSEPH A TOMBERS/Examiner, Art Unit 3791