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
Applicant's election with traverse of Species C , in the reply filed on 05/20/2026 is acknowledged. The traversal is on the grounds that the requirement for species A, the slotted return tube is not restricted to just being in the insulated zone and an adjustable length expansion chamber, Species D, could be implemented using either a continuous return shaft (Species C) or a slotted return tube (Species A). Applicant’s arguments directed to species A and D being generic is found to be persuasive and therefore withdrawn. The restriction requirement between the formally listed four species has been changed to the following two patentably distinct:
Species I (formally listed as species B): FIG 10 and 11 (Composite return shaft)
Species II (Formally listed as species C): FIG 12 and 13 (Continuous return tube with constant or variable properties)
The species are independent or distinct because the arrangement of the composite shaft in Species I is an embodiment where the expansion chamber (106) is mounted at the end of the insulated zone (105) and the arrangement of the continuous return tube in Species II is where the expansion chamber and return tube (106) is coaxially mounted within the zone (105). In addition, these species are not obvious variants of each other based on the current record.
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/30/2025, 01/29/2026, and 05/20/2026 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.
Claim 9 is 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.
Regarding claim 9, the term “approximately” is a relative term which renders the claim indefinite. The shore hardness scale ranges from 0 to 100, hence saying “approximately,” renders the claim indefinite as a range or other standard for determining what “approximately” is, is not disclosed. Approximately can therefore be seen as a broad range of values. The specification does not define, or otherwise provide sufficient guidance for determining the scope of the term as used in the claim. The specification does not provide a numerical tolerance, range, or other standard for determining what values are considered to be “approximately.”
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, 2-5, 12, 16-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ramadhyani et al (US20210045794A1) herein referred to as “Ramadhyani” in view of Yang et al (US20250032163A1) herein referred to as “Yang.”
Regarding claim 1, Ramadhyani discloses: A cryoablation probe ([0002] a cryoprobe which is seen as a cryoablation probe) comprising: a working fluid circuit; ([0010] the working channel is seen as the working fluid circuit) a vacuum circuit; ([0006] the vacuum source is seen as a vacuum circuit) and a shaft, ([Abstract] contains a shaft) the shaft comprising: a supply tube; ([0010] the cryogen supply conduit, 152, is seen as the supply tube) a return tube surrounding the supply tube, ([0031] the cryogen return conduit, is seen as the return tube; See FIG 3A where the return tube 158 surrounds the supply tube 152) the return tube comprising: a first polymer layer, ([0032] the shaft lumen makes up the return tube; [0023] the shaft wall includes a second polymer which is seen as the first polymer) wherein the first polymer layer is configured to contain fluid from the working fluid circuit; ([0032] the inner shaft wall contains fluid from the return tube) a reinforcement layer; ([0029] contains a reinforcement layer) and a second polymer layer; ([0029] the reinforcement layer includes a second polymer) an insulated zone, wherein the vacuum circuit is defined within the insulated zone between the return tube and an insulating shaft; ([0041] the insulated region 170 is seen as the insulated zone and contains the vacuum circuit) and an expansion chamber extending distally to the insulated zone, wherein fluid from the working fluid circuit travels through the supply tube and expands in the expansion chamber ([0036] contains a distal expansion chamber where the fluid from the supply tube expands). However, Ramadhyani does not explicitly disclose: a pre-cooler fluid circuit.
Yang explicitly discloses: a pre-cooler fluid circuit ([0004] a refrigeration throttle, which is seen as the pre-cooler fluid circuit, pre-cools the gas, which is seen as the fluid, before it enters the probe).
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 cryoablation probe as disclosed in Ramadhyani to include a pre-cooler fluid circuit as disclosed in Yang. The motivation being that pre-cooling the fluid outside of the probe prevents the probe from consuming a part of the cold and solves the problem that gas sources are expensive and scare. (Yang [0004]).
Regarding claim 2, Ramadhyani discloses: The cryoablation probe of claim 1, wherein the shaft may form a curve having a smallest radius of curvature of less than or equal to 30 mm ([0031] the shaft forms a curve having a smallest radius of curvature of 20mm, 10mm or 5mm which is seen as less than 30mm).
Regarding claim 3, Ramadhyani discloses: The cryoablation probe of claim 1, the first polymer ([0023] the shaft wall includes a second polymer which is seen as the first polymer) and the second polymer layer comprising a polyether block amide ([0039] The second layer comprises Pebax which is polyether block amide), however, Ramadhyani does not explicitly disclose: the first polymer layer can comprise PTFE.
Yang discloses: the first polymer layer can comprise PTFE ([0157] The inner tube, which is seen as the first polymer layer, can be PTFE).
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 polymer of the first layer as disclosed in Ramadhyani to specify that the polymer is PTFE as disclosed in Yang. The motivation being that using PTFE allows for the polymer to be freely bendable. (Yang [0157]).
Regarding claim 4, Ramadhyani discloses: The cryoablation probe of claim 1, wherein the vacuum circuit terminates at a distal end of the insulated zone, (See FIG 3A where the vacuum circuit, which is seen as 180, terminated at the distal end of the insulated zone, 170) wherein the distal end of the insulated zone is a proximal end of the expansion chamber (See FIG 3A where the distal end of the insulated zone 170, is the proximal end of the expansion chamber 156).
Regarding claim 5, Ramadhyani discloses: The cryoablation probe of claim 1, wherein the second polymer layer has an approximately constant durometer of hardness along its length ([0022] the entire length of the shaft is equally flexible which is seen as the polymer layer having approximately a constant durometer of hardness along its length).
Regarding claim 12, Ramadhyani discloses: The cryoablation probe of claim 1, wherein the first polymer layer, reinforcement layer, and second polymer layer extend from a first proximal end of the shaft to the second distal end of the shaft (See FIG 3A and [0042] where the first polymer layer, second polymer layer and reinforcement layer extends from the first proximal end of the shaft to the second distal end of the shaft).
Regarding claim 16, Ramadhyani discloses: The cryoablation probe of claim 1, wherein the reinforcement layer comprises a braided material ([0078] the reinforcement layer comprises a braided structure which is seen as a braided material) and is configured to increase a radial strength of the return tube ([0030] the reinforcement layer provides increased strength for withstanding pressures which is seen as increased radial strength, for the return tube).
Regarding claim 17, Ramadhyani discloses: A cryoablation probe ([0002] a cryoprobe which is seen as a cryoablation probe) comprising: a working fluid circuit; ([0010] the working channel is seen as the working fluid circuit) a vacuum circuit; ([0006] the vacuum source is seen as a vacuum circuit) and a shaft, ([Abstract] contains a shaft) the shaft comprising: an insulated zone, ([0041] the insulated region 170 is seen as the insulated zone and is within the shaft) wherein the vacuum circuit runs through the insulated zone; ([0041] the insulated region 170 is seen as the insulated zone and contains the vacuum circuit) and an expansion chamber extending distally to the insulated zone, the expansion chamber comprising a supply tube having a distal outlet in the expansion chamber, ([0036] contains a distal expansion chamber where the fluid from the supply tube expands) wherein fluid from the working fluid circuit travels through the supply tube and expands in the expansion chamber; ([0036] travels from the supply conduit and expands in the expansion chamber) a first polymer layer, wherein the first polymer layer is configured to contain fluid from the working fluid circuit; ([0032] the shaft lumen makes up the return tube; [0032] the inner shaft wall contains fluid from the return tube) a reinforcement layer configured to increase a radial strength of the shaft; ([0030] the reinforcement layer provides increased strength for withstanding pressures which is seen as increased radial strength, for the return tube) and a second polymer layer as an outermost layer of the expansion chamber, ([0024] the first layer 120, which is seen as the second polymer layer, can be the outermost layer of the outer shaft wall, which is seen as the outermost layer of the expansion chamber) wherein the second polymer layer is configured to contain fluid from the working fluid circuit ([0045] the outer wall which is seen as the second polymer layer contains gases from the shaft which is seen as containing fluid from the working fluid circuit).
Yang explicitly discloses: a pre-cooler fluid circuit ([0004] a refrigeration throttle, which is seen as the pre-cooler fluid circuit, pre-cools the gas, which is seen as the fluid, before it enters the probe).
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 cryoablation probe as disclosed in Ramadhyani to include a pre-cooler fluid circuit as disclosed in Yang. The motivation being that pre-cooling the fluid outside of the probe prevents the probe from consuming a part of the cold and solves the problem that gas sources are expensive and scare. (Yang [0004]).
Regarding claim 19, Ramadhyani discloses: The cryoablation probe of claim 17, the second polymer layer comprising a polyether block amide ([0039] The second layer which is seen as the outer wall, comprises Pebax which is polyether block amide).
Regarding claim 20, Ramadhyani discloses: The cryoablation probe of claim 17, wherein the second polymer layer has an approximately constant durometer of hardness along its length ([0022] the entire length of the shaft is equally flexible which is seen as the polymer layer having approximately a constant durometer of hardness along its length).
Claims 6-10 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Ramadhyani in view of Yang in further view of Clark et al (US10905490B2) herein referred to as “Clark.”
Regarding claim 6, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 1, wherein the second polymer layer is a thermoplastic material however, Ramadhyani in view of Yang does not explicitly disclose: a thermoplastic comprises a plurality of zones of different durometer of hardness along its length.
Clark discloses: a thermoplastic comprises a plurality of zones of different durometer of hardness along its length ([col 8: line 21] the shaft is made of a thermoplastic and comprises a first zone and a second zone, which is seen as a plurality of zones, with different durometers of hardness).
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 polymer of Ramadhyani in view of Yang to include the varying durometers of hardness as disclosed in Clark. The motivation being that varying the durometers of hardness alters the flexibility at varying portions of the shaft. (Clark [col 8: line 21]).
Regarding claim 7, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 6, however, Ramadhyani in view of Yang does not explicitly disclose: wherein the second polymer layer comprises at least one decrease in hardness from a proximal end of the shaft towards a distal end of the shaft.
Clark discloses: wherein the second polymer layer comprises at least one decrease in hardness from a proximal end of the shaft towards a distal end of the shaft ([col 8: lines 22-26] from the proximal end of the shaft to the distal end of the shaft, the hardness decreases from 65D to 55D).
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 zones of Ramadhyani in view of Yang to include the varying durometers of hardness as disclosed in Clark. The motivation being that varying the durometers of hardness alters the flexibility at varying portions of the shaft. (Clark [col 8: line 21]).
Regarding claim 8, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 1, however, Ramadhyani in view of Yang does not explicitly disclose: the second polymer layer comprising at least: a first zone having a first durometer of hardness; and a second zone proximal to the first zone, the second zone having a second durometer of hardness, wherein the first durometer of hardness is greater than the second durometer of hardness.
Clark discloses: the second polymer layer comprising at least: a first zone having a first durometer of hardness; ([col 8: line 24] the first zone has a first durometer of hardness which is 65D) and a second zone proximal to the first zone, ([col 8: line 25] the second zone has a second durometer of hardness which is 55D) the second zone having a second durometer of hardness, wherein the first durometer of hardness is greater than the second durometer of hardness ([col 8: lines 24-25] the first durometer of hardness is 65D and the second durometer of hardness is 55D, hence the first durometer of hardness is greater than the second durometer of hardness).
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 zones of Ramadhyani in view of Yang to include the varying durometers of hardness as disclosed in Clark. The motivation being that varying the durometers of hardness alters the flexibility at varying portions of the shaft. (Clark [col 8: line 21]).
Regarding claim 9, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 8, wherein the first durometer of hardness is approximately 70 shore A and the second durometer of hardness is approximately 55 shore A. (Ramadhyani [0023] the second polymer which is seen as the first polymer is made of PTFE which is known to have a hardness of approximately 70 shore A; the first polymer which is seen as the second durometer is made of polyether block amide which is known to have a hardness of approximately 55 shore A).
Regarding claim 10, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 8, however, Ramadhyani in view of Yang does not explicitly disclose: wherein the first zone and the second zone are each constructed from discrete sections of polymer tubing.
Clark discloses: wherein the first zone and the second zone are each constructed from discrete sections of polymer tubing ([col 8: line 21] the first zone consists of a polymer with a durometer of 65D of hardness, and second zone consists of a polymer that is 55D of hardness hence it is seen as the first zone and second zone being constructed from discrete sections of polymer tubing).
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 zones of Ramadhyani in view of Yang to include the zones being made of discrete polymers as disclosed in Clark. The motivation being that varying the polymers results in varying durometers of hardness that alters the flexibility at varying portions of the shaft. (Clark [col 8: line 21]).
Regarding claim 18, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 17, wherein the first polymer layer comprises a plurality of discrete layers (Yang [0157] the first polymer layer which is seen as the inner tube wall comprises a plurality of discrete layers as it can be made from PTFE braided tubes which is seen as having discrete layers) and wherein the reinforcement layer comprises a braided material (Ramadhyani [0063] the reinforcement layer comprises a braided layer which is seen as comprising a braided material), however Ramadhyani in view of Yang does not explicitly disclose: the layers heat bonded together.
Clark discloses: the layers heat bonded together ([col 27: lines 42-43] flares which are seen as different layers can be heat bonded).
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 cryoablation probe as disclosed in Ramadhyani in view of Yang to include heat bonding the layers as disclosed in Clark. The motivation being that this process can increase the bond strength at the junctions. (Clark [col 27: line 49]).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Ramadhyani in view of Yang in view of Clark in further view of Tegg et al (US20200078560A1) herein referred to as “Tegg.”
Regarding claim 11, Ramadhyani in view of Yang in view of Clark discloses: The cryoablation probe of claim 10, however, Ramadhyani in view of Yang in view of Calrk does not explicitly disclose: wherein the first zone is joined to the second zone using a reflow process.
Tegg discloses: wherein the first zone is joined to the second zone using a reflow process ([0058] the polymeric material that makes up the lumens are joined using a reflow process).
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 cryoablation probe as disclosed in Ramadhyani in view of Yang in view of Clark to include joining the zones using a reflow process. The motivation being that this process allows for gaps to be filled (Tegg [0058]).
Examiner notes, the recitation of a boundary formed by a reflowing process is regarded as a product-by-process limitation. (“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Ramadhyani in view of Yang in further view of Tegg.
Regarding claim 13, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 1, wherein the second polymer layer of the return tube is sealed to the insulating shaft (Ramadhyani [0059] the outer surface of the shaft which is seen as the second polymer layer is sealed to the shaft) however, Ramadhyani in view of Yang does not explicitly disclose: sealed using a reflow process.
Tegg discloses: sealed using a reflow process ([0058] the polymeric material that makes up the lumens are joined using a reflow process).
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 cryoablation probe as disclosed in Ramadhyani in view of Yang to include joining the zones using a reflow process. The motivation being that this process allows for gaps to be filled (Tegg [0058]).
Examiner notes, the recitation of a boundary formed by a reflowing process is regarded as a product-by-process limitation. (“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
Regarding claim 14, Ramadhyani in view of Yang discloses: The cryoablation probe of claim 1, wherein the second polymer layer of the return tube is sealed to a tip of the cryoablation probe (Ramadhyani [0059] the outer surface of the shaft wall which is seen as the second polymer layer is sealed at the proximal end which is seen as sealed to a tip of the cryoablation probe) however, Ramadhyani in view of Yang does not explicitly disclose: sealed using a reflow process.
Tegg discloses: sealed using a reflow process ([0058] the polymeric material that makes up the lumens are joined using a reflow process).
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 cryoablation probe as disclosed in Ramadhyani in view of Yang to include joining the tip and tube using a reflow process. The motivation being that this process allows for gaps to be filled (Tegg [0058]).
Examiner notes, the recitation of a boundary formed by a reflowing process is regarded as a product-by-process limitation. (“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA M GANAN-SINGH whose telephone number is (571)272-3194. The examiner can normally be reached Monday to Friday 7:30am to 5:00pm.
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/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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