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Claims 11, 12 and 18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/16/2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/20/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 1-10, 13-17, 19 and 20 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 in the preamble a “thermal cooling device” and then later in the claim recites once again “a thermal cooling device” making it unclear if these are the same thermal cooling device or two separate thermal cooling devices. For purposes of examination the indefinite limitation has been deemed to claim the same thermal cooling device.
Claim 2 recites the limitation "the thermal controller circuit". There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to depend from Claim 2 to provide proper antecedent basis.
Claim 5 recites the limitation “the thermal control circuit”. There is insufficient antecedent basis for this limitation in the claim. For purposes of examination the indefinite limitation has been deemed to actually claim “the thermal controller circuit” and to also depend from Claim 2 to provide proper antecedent basis.
Claim 6 recites both temperature “data” and temperature “datum” inconsistently, therefore, it is unclear if the “data” and “datum” are related. For purposes of examination the indefinite limitation has been deemed to claim that both the data and datum are the same received data.
Claim 15 recites “the thermal sensor” however, the claims previously set forth both a first and second thermal sensor, therefore, it is unclear what thermal sensor is being referenced. For purposes of examination the indefinite limitation has been deemed to claim the first thermal sensor.
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.
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.
Claim(s) 1, 3, 7, 9, 10, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2008/023193 A2 O’Halloran et al. (hereinafter, O’Halloran).
Regarding Claims 1, 9 and 16, O’Halloran discloses a biopsy system having a thermal cooling device, comprising inter alia:
a biopsy device (Embodiments in FIGS. 12 and 13) (It is noted embodiments in FIGS. 12 and 13, described at page 26 line 24 to page 27 line 6, are essentially the same embodiment aside from Fig. 13 including an optional hollow tip and having a more detailed view of the elements 19 and 26 forming the Peltier cooler cascade. One having an ordinary skill in the art at the time the invention was filed would have found it obvious to combine these embodiments, as the only difference is adding an optional hollow tip.) comprising:
an elongate biopsy needle (probe 33 and housing 31) having a lumen (page 27, lines 2-3 “…probe… with an optional hollow tip.”), a proximal end portion, an intermediate portion, and a distal end portion (as seen below in annotated FIG. 12), the elongate biopsy needle being made of a thermally conductive material (page 15, lines 4-9 “…the probe of the mechanical device are made from materials each having different Peltier potentials (eg. dissimilar materials) such that entire portions (eg. the whole) of the elongate housing and/or entire portions (eg. the whole) of the probe may be reduced in temperature (eg. to a temperature that is less than or equal to about 0 degrees C. Accordingly, the Peltier effect can be used to bring about freezing.”);
a thermal cooling device (power source 39);
a temperature transfer (elements 19) member that extends between the proximal end portion of the elongate biopsy needle and the thermal cooling device (as seen below in annotated FIG. 13), the temperature transfer member having a first end and a second end (proximal-most element 19 and distal-most element 19, respectively);
a first thermo-mechanical coupler (proximal-most plate 26) is connected to the thermal cooling device (Proximal and distal-most plates 26 function as a physical and thermal interface to couple both the biopsy needle and cooling device to facilitate heat transfer, see page 27, lines 3-4, as these plates serve as “sides” that experience the temperature change and allow for localized cooling.); and
a second thermo-mechanical coupler (distal-most plate 26) that connects the second end of the temperature transfer member to the proximal end portion of the elongate biopsy needle (Proximal and distal-most plates 26 function as a physical and thermal interface to couple both the biopsy needle and cooling device to facilitate heat transfer, see page 27, lines 3-4, as these plates serve as “sides” that experience the temperature change and allow for localized cooling.); and
a controller circuit (switch 38) communicatively coupled to the thermal cooling device,
wherein the controller circuit is configured to control a chilling effect at the distal end portion of the elongate biopsy needle (page 26, lines 28-31 “An electrical cable runs to the end of the probe thus providing positive voltage from the battery to the probe to generate the Peltier effect in the Peltier device shown here as a Peltier cascade 32. In one embodiment power is turned on or off with switch 37.”).
Regarding Claim 3, O’Halloran discloses the biopsy system according to claim 1, the controller circuit is configured to selectively connect the first thermo-mechanical coupler to the first end of the temperature transfer member (Switch 38 thermally connects the first thermos-mechanical coupler to the first end of the temperature transfer member, because the switch allows for the Peliter cascade and respective heat transfer).
Regarding Claim 7, O’Halloran discloses the biopsy system according to claim 1, wherein the biopsy system is configured to continuously operate the thermal cooling device during a medical procedure (the biopsy system is configured to continuously operate the thermal cooling device during a medical procedure via the switch 37 being in the “on” position.
Regarding Claim 10, O’Halloran discloses the biopsy device according to claim 9, wherein the elongate biopsy needle includes at least one of an elongate cannula (housing 31) and an elongate stylet (probe 33), and the temperature transfer member is a rigid, elongate solid cylinder comprised of metal (see FIGS. 12 and 13) (page 15, line 19 “…metal rod…”).
Regarding Claim 17, O’Halloran discloses the biopsy device according to claim 16, wherein the elongate biopsy needle includes at least one of an elongate cannula and an elongate stylet, and the thermally conductive mechanical member is a rigid, elongate solid cylinder comprised of metal (page 15, line 19 “…metal rod…”).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran in view of WO 2011073725 A1 to Malarme et al. (hereinafter, Malarme).
O’Halloran discloses the biopsy system according to claim 1, the biopsy device further comprising a driver assembly configured to move the elongate biopsy needle (page 26, lines 31-32 “The probe 33 moves in and out of the area to be sampled using handle 34 pushed against spring 35.”), a thermal controller circuit communicatively coupled to the thermal cooling device (page 28, lines 29-30 “In some embodiments, the handle assembly further incorporates an electronic control circuit for maintaining a constant cryogenic temperature for the probe.”).
O’Halloran discloses the claimed invention except for expressly disclosing wherein the controller circuit comprises a driver assembly circuit, the driver assembly circuit is communicatively coupled to the driver assembly. However, Malarme teaches a biopsy mechanism that includes an actuator 15 that is programmed via a specific algorithm to drive the biopsy probe (page 10, lines 15-25). One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the manual driver assembly of O’Halloran to be the automated driver assembly of Malarme, as Malarme teaches this would have allowed high accuracy in a patient’s body for obtaining biopsy samples (page 1, lines 11-15).
Claim(s) 6 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Halloran in view of US 20070060915 A1 to Kucklick.
The biopsy system according to claim 1, comprising a thermal sensor coupled to the distal elongate biopsy needle (page 5, lines 14-18 “In the absence of current, this couple can act as a thermocouple, a physical property which… uses a sensing and controlling system …” meaning a thermocouple consists of two dissimilar metals, see page 13, lines 27-32, joined on the probe via the Peltier junction that generates a voltage proportional to the temperature different – by pausing the current, the electronic control circuit can measure voltage produced by the thermocouple to determine the temperate at the junction the moment the current is paused, therefore, at least two of the plates, i.e., most proximal plates in FIG. 13 are capable of acting as a thermal sensor), wherein the controller circuit includes a thermal controller circuit (page 29, lines 1-5 “electronic control circuit”), the thermal controller circuit is communicatively coupled to the thermal sensor, the thermal sensor is configured to collect and deliver temperature datum to the thermal control circuit, the thermal controller circuit is communicatively coupled to the thermal cooling device (page 28, lines 29-30 “…the handle assembly further incorporates an electronic control circuit for maintaining a constant cryogenic temperature for the probe.”) (page 33, lines 1-6 “…a constant cryogenic temperature at the trocar, probe… including any probe for capture, by monitoring the Peltier effect through current drawn or by using the material couple as the principle of a thermocouple.”).
While O’Halloran discloses controlling the temperature of the probe, O’Halloran does not expressly disclose where the thermal controller circuit comprises a processor circuit and a memory circuit, the thermal controller circuit is configured to compare the temperature datum to a threshold stored in the memory circuit, if the temperature datum is above the threshold then the thermal controller circuit processes a thermal cooling instruction in the processor circuit to selectively engage the thermal cooling device to generate a chilling effect, if the thermal controller circuit determines that the temperature datum is at or below the threshold then the thermal controller circuit continues to sense all temperature data received from the thermal sensor and the thermal cooling device is not engaged.
However, Kucklick teaches a probe including a temperature control system that can monitor and control temperature (Abstract). Kucklick teaches a thermal controller circuit comprises a processor circuit and a memory circuit (control system 12), the thermal controller circuit is configured to compare the temperature datum to a threshold stored in the memory circuit, if the temperature datum is above the threshold then the thermal controller circuit processes a thermal cooling instruction in the processor circuit to selectively engage the thermal cooling device to generate a chilling effect, if the thermal controller circuit determines that the temperature datum is at or below the threshold then the thermal controller circuit continues to sense all temperature data received from the thermal sensor and the thermal cooling device is not engaged (para. [0034] “The sensors are operably coupled to warning devices that provide visual, audible or visual and audible warnings when temperatures exceed a safe threshold… provide visual, audible or visual and audible warnings when temperatures exceed a safe threshold.”) (para. [0031] “When the temperature exceeds safe levels, such as exceeding 113.degree. C., the control system instructs the Peltier module automatically, without user intervention, to cool the inflow fluid. The inflow fluid is cooled to a temperature sufficient to reduce the temperature within the surgical site to a safe level in order to prevent tissue damage. When the temperature in the surgical site reaches a safe level (a temperature level that does not have the potential to cause damage to surrounding tissue) the control system instructs the cooling module automatically to reduce or cease lowering the temperature of the inflow fluid.”).
One having an ordinary skill in the art at the time the invention was filed would have found it obvious to modify the device of O’Halloran to have the control system of Kucklick that compares a temperature measurement to a temperature threshold of Kucklick, as Kucklick teaches at para. [0006] that this would have ensures that temperatures are kept at safe levels.
Allowable Subject Matter
Claims 4, 5, 8, 13, 15, 19 and 20 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN PATRICK DOUGHERTY whose telephone number is (571)270-5044. The examiner can normally be reached 8am-5pm (Pacific Time).
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/SEAN P DOUGHERTY/Primary Examiner, Art Unit 3791