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 .
Election/Restrictions
Claims 21-30 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 7 and 8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Election was made without traverse in the reply filed on January 5, 2026.
Applicant’s election without traverse of 1-20 in the reply filed on January 5, 2026 is acknowledged.
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 and dependent claims thereof are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Re. Claim 1: Claim 1 recites “a controller configured to determine a value of the tightness of the tissue” (emphasis added). There is insufficient antecedent basis for “the tightness.” Examiner recommends amending the claim as follows: “…a controller configured to determine a value of a
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 12, 13, and 15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Pailler-Mattei et al. (US 20130291658 A1) (disclosed by Applicant) (hereinafter – PM).
Re. Claim 1: PM teaches a tissue tightness measurement device (Abstract)
comprising:
a displacement mechanism that displaces tissue (Fig. 6: micromotor 15 that displaces tissue skin S);
at least one position sensor that measures displacement of the tissue (Abstract: “… at least one position sensor (20) able to determine the vertical position of said indenter (6) with respect to said reference position”);
a load sensor that measures force applied to the tissue as the tissue is being displaced (Abstract: “… at least one sensor (11) for measuring the load applied by the indenter on the material (S) along a direction normal to the application surface on the material…”),
the load sensor being coupled to the displacement mechanism (Fig. 6: force sensor 11 coupled to stressing mechanism 5 possessing micromotor 15); and
a controller configured to determine a value of the tightness of the tissue based on the measured displacement of the tissue and the measured force applied to the tissue during the displacement (Fig. 1: computer control console CC; Paragraphs 0051-0052: measurement of normal force and position as indenter 6 is applied to skin tissue in order to assess mechanical behavior of material).
Re. Claim 2: PM teaches the invention according to claim 1. PM further teaches the invention wherein the controller generates a force/displacement curve based on the measured displacement of the tissue and the measured force applied to the tissue during the displacement (Figs. 6, 7, 8, 10, 11, 12: curves of force/load per penetration depth and/or penetrator position).
Re. Claim 3: PM teaches the invention according to claim 2. PM further teaches the invention wherein the controller determines the value of the tightness of the tissue by calculating a slope of the line of best fit over at least a portion of the force/displacement curve for a range of displacements (Figs. 8-12: curves of force/load per penetration depth and/or penetrator position have differing slopes, thus differentiating force per displacement for various tissue types).
Re. Claim 12: PM teaches the invention according to claim 1. PM further teaches the invention further comprising at least one alignment device to align the at least one position sensor to a desired location on tissue (Figs. 1-4: see circumferential surfaces of the outer shell 4; Examiner notes that “alignment device” possesses the broadest reasonable interpretation of any structure which may be allowed to align a position sensor relative to a desired location, whereby any portion of the circumference of the outer shell 4 can allow a user to align the position sensor over a desired location by observing a target location and placing the circumferential surfaces equidistantly over the target location).
Re. Claim 13: PM teaches the invention according to claim 1. PM further teaches the invention wherein two alignment devices are positioned on opposite sides of each of the at least one position sensor (see rejection of claim 12 – opposing circumferential surfaces of the outer shell 4 can be considered an “alignment device” on opposite sides of the at least one position sensor).
Re. Claim 15: PM teaches the invention according to claim 1. PM further teaches the invention further comprising a housing, wherein the at least one position sensor is adjustably disposed on a surface of the housing (Figs. 3-7: position sensor 20 is rotatable relative to crown, as described in Paragraph 0054”).
Claim 4 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
Bjerrin et al. (WO 9116003 A1) (disclosed by Applicant) (hereinafter – Bjerrin).
Re. Claim 4: Bjerrin teaches each limitation of claim 1, including:
a displacement mechanism that displaces tissue (Fig. 1: suction cup 7);
at least one position sensor that measures displacement of the tissue (Fig. 1: acceleration transducer 14; Abstract: “…said transducers performing dynamic measurements of the displacement occurring during the vibration of the skin”);
a load sensor that measures force applied to the tissue as the tissue is being displaced (Fig. 1: force transducer 13),
the load sensor being coupled to the displacement mechanism (Fig. 1: see connection of force transducer to suction cup 7); and
a controller configured to determine a value of the tightness of the tissue based on the measured displacement of the tissue and the measured force applied to the tissue during the displacement (Fig. 1: data processing unit 3; Abstract: “… mathematical methods of calculation can be directly applied to calculate the mechanical parameters of the skin, such as elasticity, attenuation, mass and resonance frequency”).
Bjerrin further teaches the requirements of claim 4, including wherein the displacement mechanism is a suction cup that draws tissue into the suction cup when a vacuum is applied to the suction cup (Fig. 1: suction cup 7).
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 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over:
Pailler-Mattei et al. (US 20130291658 A1) (disclosed by Applicant) (hereinafter – PM) in view of
Hirata et al. (JPH1176169A) (citing Google Patents translation) (hereinafter – Hirata).
Re. Claim 9: PM teaches the invention according to claim 1, but does not teach the invention wherein the at least one position sensor includes a transmitter and receiver to determine a distance from the at least one position sensor to a surface of the tissue.
Hirata teaches analogous art in the technology of tactile hardness sensors particularly for organic tissue (Abstract). Hirata further teaches wherein the at least one position sensor includes a transmitter and receiver to determine a distance from the at least one position sensor to a surface of the tissue (Figs. 7, 8: distance sensors 7; Paragraph 0007: “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. Is what you do. 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. In this case, the front cover of the distance sensor 7 is formed of a transparent material such as transparent glass so as not to hinder the emission of laser light”).
It would have been obvious to one having skill in the art before the effective filing date to have modified the position sensor of PM to utilize the distance (i.e., position) sensors of Hirata, the motivation being that multiple sensors allow for compensation of a contact angle of the device (Abstract), thus increasing measurement accuracy (Paragraph 0003).
Re. Claim 10: PM as modified by Hirata teaches the invention according to claim 9. Hirata, in teaching further details regarding the modification, further teaches wherein at least two position sensors are employed to compensate for non-uniform tissue (see citation of rejection of claim 9 – more than one distance sensor is incorporated by Hirata; Examiner notes that “to compensate for non-uniform tissue” is a recitation of intended use).
Re. Claim 11: PM as modified by Hirata teaches the invention according to claim 9. Hirata, in teaching further details regarding the modification wherein at least two position sensors are employed to compensate for tilting of the device by the user during measurements (see citation of rejection of claim 9 – multiple distance sensors are used to compensate for angle of attack).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over:
Pailler-Mattei et al. (US 20130291658 A1) (disclosed by Applicant) (hereinafter – PM) in view of
Hashimshony et al. (US 20070032747 A1) (disclosed by Applicant) (hereinafter – Hashimshony).
Re. Claim 14: PM teaches the invention according to claim 1, but does not teach the invention further comprising a transceiver that sends and receives data and/or signals with an external device.
Hashimshony teaches analogous art in the technology of tissue characterization (Paragraph 0002). Hashimshony teaches the invention further comprising a transceiver that sends and receives data and/or signals with an external device (Fig. 2B: transceiver 82; Paragraph 0186: “…a transceiver 82 may be employed, for example, located at the distal end 21, for wireless operation of the probe 50 and for wireless communication with the signal-generation and analyzer station 60;” Fig. 3, as described in Paragraph 0194: “Preferably, a signal generator and analyzer 60 communicates with the sensors 24, either via a cable 38 or in a wireless manner, as known).
It would have been obvious to one having skill in the art before the effective filing date to have modified PM to include a transceiver as taught by Hashimshony, the motivation being that doing so allows a third-party device to wirelessly control and/or analyze signals of the device (Paragraphs 0186, 0194).
Claims 17-20 is rejected under 35 U.S.C. 103 as being unpatentable over:
Pailler-Mattei et al. (US 20130291658 A1) (disclosed by Applicant) (hereinafter – PM) in view of
Hashimshony et al. (US 20070032747 A1) (disclosed by Applicant) (hereinafter – Hashimshony).
Re. Claim 17: PM teaches the invention according to claim 1, but does not teach the invention wherein the controller is coupled to a data acquisition and display device that displays at least one of measurements taken, load/displacement curves and/or values of tissue tightness.
Brannan teaches analogous art in the technology of electrosurgical tissue treatment systems (Abstract). Brannan further teaches the invention wherein the controller is coupled to a data acquisition and display device (Fig. 2: memory 202; Paragraph 0072: “Memory 202 may include any non-transitory computer-readable storage medium for storing data and/or software that is executable by processor 204 and which controls the operation of computing device 180;” Paragraph 0075: “…return signals may then be analyzed by ultrasound workstation 150 and/or computing device 180;” Examiner notes that a data acquisition device is implicit in the system of Figs. 1, 2)
that displays at least one of measurements taken, load/displacement curves and/or values of tissue tightness (Paragraph 0061: system shows elastic properties of tissue and elasticity thereof based on measurements; Paragraph 0076: “Computing device 180 then displays, or causes display device 110 to display, at step S312, a representation of the ablation zone characteristic”).
It would have been obvious to one having skill in the art before the effective filing date to have included the sensor of PM to display tissue property information in the system as taught by Brannan, the motivation being that doing so enables provides the electrosurgical system with an additional modality to assess a tissue property of a measured area in the case that the ultrasound imaging component is non-operational.
Re. Claim 18: PM as modified by Brannan teaches the invention according to claim 17. Brannan, in teaching further detail regarding the modification, further teaches the invention wherein the controller communicates to the data acquisition and display device via hardwired or/and wireless means (Fig. 1: computing device 180 is hardwired to display device 110).
Re. Claim 19: PM as modified by Brannan teaches the invention according to claim 17. Brannan, in teaching further detail regarding the modification, further teaches the invention wherein the data acquisition and display device is an electrosurgical generator unit (ESU) (Paragraphs 0078, 0094: the system is an electrosurgical system).
Re. Claim 20: PM as modified by Brannan teaches the invention according to claim 19. Brannan, in teaching further detail regarding the modification, further teaches the invention wherein the ESU uses data provided from the controller to control a tissue tightening procedure and/or to determine the effectiveness of the tissue tightening procedure (see modification in displaying data from the sensor of PM; Paragraph 0061: elastic properties of tissue are monitored during ablation, which “hardens due to ablation;” thus, tissue ablation may be seen as a procedure which “tightens tissue” as claimed).
Allowable Subject Matter
Claims 5, 6, and 16 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Claims 5 and 6 recite elements of a switch disposed inside the suction cup and start/stop signals associated based on tissue contact therewith, which are not taught or suggested in the closest prior art of record.
Claim 16 recites limitations involving a position sensor being radially adjustable, which is not taught or suggested in the closest prior art of record. Examiner is presently interpreting “radially adjustable” as “movable along a radial direction of the cylindrical housing.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JUSTIN XU whose telephone number is (571)272-6617. The examiner can normally be reached Mon-Fri 7:30-5:00.
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/JUSTIN XU/Primary Examiner, Art Unit 3791
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