DETAILED ACTION
Applicant's remarks, filed 5/19/26, are fully acknowledged by the Examiner. Currently, claims 1-20 are pending. The following is a complete response to the 5/19/26 communication.
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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1, 6-7, 10-12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik (US 2020/0206024) in view of Davis (US 2012/0265189).
Regarding claim 1, Karnik teaches a cryo-treatment apparatus comprising:
a cryoprobe assembly comprising a needle for insertion at a target tissue (needle as in par. [0076] of probe 26);
a cryogen delivery apparatus fluidly connected to the cryoprobe assembly (supply 18); and
a cryo-treatment control apparatus comprising at least one processor and memory (22 with processor and memory as in at least par. [0081]),
wherein the cryo-treatment control apparatus is configured to:
obtain cryoprobe operating information from one or more sensors positioned in the needle of the cryoprobe (52), the cryoprobe operating information characterizing one or more operating parameters of the cryoprobe (temperature);
deliver a cryogen to the cryoprobe to produce a cryo-treatment zone in an area of the target tissue (par. [0124]), the cryo-treatment zone having a predetermined treatment temperature range (par. [0125]);
And maintain the cryo-treatment zone in the treatment temperature range for a predetermined period of time (par. [0123]).Karnik teaches a sensor, but is not explicit regarding the sensor positioned in the needle of the cryoprobe.However, Davis teaches sensing with a sensor positioned in the needle of a cryoprobe to deliver the information to a sensing module at a similar location to Karnik (par. [0028] sensors within cryoprobe 102, par. [0058] temperature sensor at 128 or near 128 as in Fig. 2).It would have been obvious to one of ordinary skill in the art to modify Karnik such that the sensor is at the needle of the cryoprobe, as in Davis, to deliver temperature readings to the sensing controller of Karnik.
Regarding claim 6, Karnik is silent wherein the cryogen comprises Argon.
However, Davis teaches argon, nitrogen, or other gases as known cooling gases for a cryoprobe (par. [0004]).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen is argon, as a known gas that may be used in tissue treatment.
Regarding claim 7, Karnik teaches wherein the needle comprises a heater (heater 44) and the cryo-treatment control apparatus is configured to energize and de-energize the heater to maintain the cryo-treatment zone in the treatment temperature range (controller 22 to adjust heater 44 power delivery as in par. [0086]).
Regarding claim 10, Karnik teaches wherein the target tissue comprises a neurological tissue (at least par. [0112]).
Regarding claim 11, Karnik teaches wherein the cryo-treatment zone changes a function of the target tissue but does not permanently damage the target tissue (par. [0074] temporarily impair nerves).
Regarding claim 12, Karnik teaches wherein the cryo-treatment zone is maintained in the treatment temperature range by adjusting a pressure of the cryogen delivered to the needle (par. [0085]) and adjusting a power signal delivered to a heater in the needle (controller 22 to adjust heater 44 power delivery as in par. [0086]).
Regarding claim 18, Karnik teaches a method comprising:
obtaining, via a cryo-treatment control apparatus comprising at least one processor and memory (22 with processor and memory as in at least par. [0081]), cryoprobe operating information from one or more sensors positioned in a needle of a cryoprobe (52 with temperature sensed), the cryoprobe operating information characterizing one or more operating parameters of the cryoprobe (temperature sensed by 52);
delivering, via a cryogen delivery apparatus coupled to the cryo-treatment control apparatus (via cooling fluid supply 18), a cryogen to the cryoprobe to produce a cryo-treatment zone in an area of the target tissue (cryozone as in par. [0193]), the cryo-treatment zone having a treatment temperature range of about -50 degrees C to about -100 degrees C (par. [0074]); and
maintaining, via the cryogen delivery apparatus and the cryo-treatment control apparatus, the cryo-treatment zone in the treatment temperature range for a predetermined period of time (period of time as in par. [0074]).
Claim(s) 2-5, 13, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik in view of Baust (US 2014/0350537).
Regarding claim 2, Karnik teaches wherein the predetermined treatment temperature range is
maintained in a range of about -50 degrees Celsius to about -100 degrees Celsius (par. [0074]), but is not explicit regarding the predetermined period of time is between about 3 minutes to about 10 minutes.However, Baust teaches treatment time at a treatment site at 3 minutes (par. [0025]).
It would have been obvious to one of ordinary skill in the art to modify Karnik with the treatment time of Baust as a known treatment time in cryogen treatment of tissue.
Regarding claim 3, Karnik is silent, but Baust teaches wherein the needle defines a Joule-
Thompson expansion chamber at a distal end thereof (cooling chamber as in par. [0012]).
It would have been obvious to one of ordinary skill in the art to modify Karnik with the Joule-Thompson expansion chamber as in Baust, as a known method of delivering low temperature cryogen to tissue.
Regarding claim 4, Karnik is not explicit, but Baust teaches wherein the cryogen delivery apparatus comprises a Dewar and a pump configured to deliver the cryogen to the cryoprobe assembly (par. [0053] dewar with a pump to deliver cryogen to a cryoprobe).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen delivery apparatus is a Dewar, as in Baust, as a known storage container that can store cryogens that have low boiling points.
Regarding claim 5, Karnik teaches wherein the cryo-treatment zone is maintained in the treatment temperature range by adjusting a pressure of the cryogen delivered to the needle (par. [0085] controlling pressure).
Regarding claim 13, Karnik does not teach wherein the delivery of the cryogen to the cryoprobe causes an iceball to form at the target tissue, a desired diameter of the iceball being less than 2 cm.However, Baust teaches iceball formation in cryogenic devices with a diameter of less than 2 cm (par. [0102] iceball formation may have a diameter of 2mm).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that iceball formation would be less than 2 cm as in Baust, as a known cryogenic treatment size for tissue.
Regarding claim 19, Karnik teaches the cryo-treatment zone is maintained in the treatment temperature range by adjusting a pressure of the cryogen delivered to the needle (par. [0085] controlling pressure). Karnik is silent wherein the needle defines a Joule-Thompson expansion chamber at a distal end thereof.
However, Baust teaches wherein the needle defines a Joule-Thompson expansion chamber at a distal end thereof (cooling chamber as in par. [0012]).
It would have been obvious to one of ordinary skill in the art to modify Karnik with the Joule-Thompson expansion chamber as in Baust, as a known method of delivering low temperature cryogen to tissue.
Regarding claim 20, Karnik teaches the cryo-treatment zone is maintained in the treatment
temperature range by adjusting a pressure of the cryogen delivered to the needle (par. [0085] controlling pressure) and adjusting a power signal delivered to a heater in the needle (par. [0086] adjust power delivered to the heater 44).
Karnik is silent regarding wherein the cryogen delivery apparatus comprises a Dewar and a pump configured to deliver liquid nitrogen to the cryoprobe assembly.However, Baust teaches wherein the cryogen delivery apparatus comprises a Dewar and a pump
configured to deliver liquid nitrogen to the cryoprobe assembly (par. [0053] dewar with a pump to deliver cryogen to a cryoprobe).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen delivery apparatus is a Dewar, as in Baust, as a known storage container that can store cryogens that have low boiling points.
Claim(s) 8, 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik in view of Davis.
Regarding claim 8, Karnik is not explicit wherein the cryogen comprises liquid Nitrogen.
However, Davis teaches argon, nitrogen, or other gases as known cryogen for a cryoprobe (par. [0004]).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen is nitrogen, as a known cryogen that may be used in tissue treatment.
Regarding claim 16, Karnik is silent wherein the cryogen comprises liquid Nitrogen.
However, Davis teaches argon, nitrogen, or other gases as known cryogen for a cryoprobe (par. [0004]).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen is nitrogen, as a known cryogen that may be used in tissue treatment.
Regarding claim 17, Karnik is silent wherein the cryogen comprises Argon.
However, Davis teaches argon, nitrogen, or other gases as known cryogen for a cryoprobe (par. [0004]).
It would have been obvious to one of ordinary skill in the art to modify Karnik such that the cryogen is Argon, as a known cryogen that may be used in tissue treatment.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik in view of Nebrigic (US 2011/0202048).
Regarding claim 9, Karnik is not explicit wherein the step of delivering the cryogen to the cryoprobe comprises pulsing the cryogen.
However, Nebrigic teaches pulsing cryogen to an end effector of a cryogen delivery device (par. [0014] cryogen pulses delivered to end effector).
It would have been obvious to one of ordinary skill in the art to modify Karnik with the cryogen pulses in Nebrigic to allow for intermittent cooling of the end effector, depending on treatment of energy.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik in view of Burger (US 2009/0248001).
Regarding claim 14, Karnik is not explicit wherein the needle comprises a conductive tip coupled to a power source for electrical stimulation of target tissue.
However, Burger teaches an electrical conductor used as an electrode for neurostimulation of tissue (par. [0052]).
It would have been obvious to one of ordinary skill in the art to modify Karnik with the needle being electrically conductive to be used as an electrode for neurostimulation, as in Burger, to facilitate locating a nerve as in par. [0052].
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Karnik in view of Abdulqader (US 2024/0057856).
Regarding claim 15, Karnik is silent wherein the cryo-treatment control apparatus comprises a
trained machine learning model configured to control at least one of a supply valve, a supply pump, a heater in a Dewar, and a heater in the needle.
However, Abdulqader teaches machine learning to control a surgical pump (par. [0073]). It would have been obvious to one of ordinary skill in the art to modify Karnik with machine learning to control the pump, as an algorithmic method of automating control of the device.
Response to Arguments
Applicant’s arguments, see the remarks, filed 5/19/26, with respect to the rejection(s) of claim(s) 1 under 35 USC 102(a)(1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Davis as a secondary reference.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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