DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 28 January 2026 and 06 February 2026 has been considered by the Examiner.
Claim Rejections - 35 USC § 102
3. 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
4. Claims 1-6 and 9 are rejected under 35 U.S.C. 102 (a) (1) and (a) (2) as being anticipated by Reid (US 2011/0264084 A1).
Regarding claim 1, Reid teaches a cryoprobe (the cooling probe 200 is configured to provide cryogenic cooling to the subject’s tissue [0012, 0042]) comprising:
a shell extending in an axial direction and defining an inner cavity (figure 4 illustrates the shell or housing of the cooling probe 200 extending in an axial direction [FIG. 4]. Furthermore, figure 4 illustrates the shell of the cooling probe 200 defining an inner cavity or interior space [0042, FIG. 4]);
a tip connected to a distal end of the shell (figure 4 illustrates the cooling probe 200 comprising a tip 240 at the distal end [0042, FIG. 4]);
a cryogen supply extending in the inner cavity (figure 4 illustrates the cooling inlet passageway 150 extending within the inner cavity or interior space of the cooling probe 200 [0042, FIG. 4]) and configured to provide a flow of cryogen toward the distal end of the shell (the cooling inlet passageway 150 is configured to deliver the coolant towards the probe tip 240 at the distal end [0042, FIG. 4]); and
a directional insulator positioned radially outward of the cryogen supply in the inner cavity (the insulation jacket 120 comprises a directional insulator or passageway wall 152 [abstract, 0039, 0042, FIGS. 3-4]. Specifically, figure 4 illustrates the directional insulator or passageway wall 152 being positioned radially outward of the cooling inlet passageway 150 [0039, 0042, FIG. 4]), the directional insulator guiding the cryogen flow in a direction away from the distal end of the shell along a predetermined return path between the cryogen supply and the shell (figure 4 illustrates the passageway wall 152 is configured to guide the coolant from the probe tip 240 and through the coolant return passageway 160 [0039]. Specifically, the coolant return passageway 160 is formed interior to the directional insulator or passageway wall 152 for allowing low pressure fluid to exit the sleeve assembly 110 after adiabatic expansion [0039, 0042, FIG. 4]. Furthermore, figure 4 illustrates the coolant return passageway 160 being arranged between the cooling inlet passageway 150 and the shell of the cooling probe 200 [FIG. 4]).
Regarding claim 2, Reid teaches wherein the directional insulator insulates a portion of the of the shell from the cryogen flow (the directional insulator or passageway wall 152 is disposed within an insulation jacket 120 which insulates a portion of the shell of probe 200 from the coolant inlet passageway 150 and the coolant return passageway 160 [FIGS. 3-4, 0039, 0042]).
Regarding claim 3, Reid teaches wherein the directional insulator comprises an open annulus cross-sectional shape and the open portion of the annulus defines the predetermined return path for the cryogen flow (the insulation jacket 120 comprises a directional insulator or passageway wall 152 [abstract, 0039, 0042, FIGS. 3-4]. Specifically, figures 3-4 illustrates the directional insulator or passageway wall 152 having an open annulus cross-sectional shape that defines the coolant return passageway 160 [FIGS. 3-4, 0039, 0042]).
Regarding claim 4, Reid teaches wherein the cryoprobe is configured to produce ice that grows in a direction outward from the predetermined return path (the cooling probe 200 may form ice on the cooling tip 240 which is positioned outward from the coolant return passageway 160 [FIG. 4, 0042, 0051]. Specifically, figure 4 illustrates the cooling tip 240 being positioned outward from the coolant return passageway 160 [FIG. 4]).
Regarding claim 5, Reid teaches wherein the cryoprobe is configured to limit growth of ice at locations on the shell other than at the predetermined return path (the shell or housing of the cooling probe 200 comprises the cooling tip 240 [0042, FIG. 4]. Specifically, the cooling probe 200 may form ice on the cooling tip 240 which is positioned outward from the coolant return passageway 160 [FIG. 4, 0042, 0051]).
Regarding claim 6, Reid teaches a vacuum sleeve positioned inside the inner cavity, the vacuum sleeve connected to an end of the directional insulator (the vacuum sleeve walls 124 and 126 form annular vacuum space 122 having vents 128 and 128’ [0038-0039]. Specifically, figures 3-4 illustrates the directional insulator or passageway wall 152 being coupled to the vacuum sleeve walls 124 and 126 [FIGS. 3-4]).
Regarding claim 9, Reid teaches wherein the directional insulator fills a space between the cryogen supply and the shell except at the predetermined return path (the insulation jacket 120 comprises a directional insulator or passageway wall 152 [abstract, 0039, 0042, FIGS. 3-4]. Specifically, figures 4 illustrates a portion of the passageway wall 152 filling a space between the coolant inlet passageway 150 and the shell of the cooling probe 200 [FIG. 4]).
Claim Rejections - 35 USC § 103
5. 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.
6. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Reid in view of Groves et al. (US 2013/0110100 A1).
Regarding claim 8, Reid teaches the cryoprobe of claim 1. Reid does not explicitly teach one or more indicators positioned on an external surface of the shell, the one or more indicators indicating a location of the predetermined return path.
The prior art by Groves is analogous to Reid, as they both teach a cryogenic fluid delivery device ([abstract, 0037]).
Groves teaches one or more indicators positioned on an external surface of the shell, the one or more indicators indicating a location of the predetermined return path (the visualization or radiopaque markers 92 may be positioned on the housing of the device 12 to identify the position of the fluid flow components (e.g., fluid delivery and exhaust lumens) [0041, 0043, 0053]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the Reid’s shell to include one or more indicators that are configured to indicate the location of the predetermined return path, as taught by Groves. The advantage of such modification will allow for visualizing the fluid flow or dispersion characteristics within the fluid pathway (see paragraphs [0041, 0043, 0053] by Groves).
7. Claims 10, 15-16, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Reid in view of Baust et al. (US 2014/0350537 A1).
Regarding claim 10, Reid teaches a cryoprobe (the cooling probe 200 is configured to provide cryogenic cooling to the subject’s tissue [0012, 0042]) comprising:
a shell extending in an axial direction and defining an inner cavity (figure 4 illustrates the shell or housing of the cooling probe 200 extending in an axial direction [FIG. 4]. Furthermore, figure 4 illustrates the shell of the cooling probe 200 defining an inner cavity or interior space [0042, FIG. 4]);
a tip connected to a distal end of the shell (figure 4 illustrates the cooling probe 200 comprising a tip 240 at the distal end [0042, FIG. 4]);
a cryogen supply extending in the inner cavity (figure 4 illustrates the cooling inlet passageway 150 extending within the inner cavity or interior space of the cooling probe 200 [0042, FIG. 4]) and configured to provide a flow of cryogen toward the distal end of the shell (the cooling inlet passageway 150 is configured to deliver the coolant towards the probe tip 240 at the distal end [0042, FIG. 4]).
Reid does not explicitly teach at least one heater positioned on the shell.
The prior art by Baust is analogous to Reid, as they both teach a cryogenic system comprising a cryoprobe ([abstract, 0034]).
Baust teaches at least one heater positioned on the shell (the heater coil 20 is positioned on the internal lumen or surface of the cryoprobe shell tip (e.g., freeze zone 8) [0034]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Reid’s shell to include a heater, as taught by Baust. The advantage of such modification will allow for controlling the thawing of an ice ball at the tip of the cryoprobe (see paragraph [0034] by Baust).
Regarding claim 15, Reid in view of Baust suggests the cryoprobe of claim 10. Reid teaches a vacuum sleeve positioned in the inner cavity (the vacuum sleeve walls 124 and 126 form annular vacuum space 122 having vents 128 and 128’ [0038-0039]), wherein an ice formation zone is located at an axial location on the shell between the tip and the vacuum sleeve (the shell or housing of the cooling probe 200 comprises the cooling tip 240 [0042, FIG. 4]. Specifically, the cooling probe 200 may form ice on a region of the cooling tip 240 [FIG. 4, 0042]. Thus, the ice formation would be located between the cooling tip 240 and the vacuum sleeve walls 124 and 126 that form annular vacuum space 122 [FIG. 4, 0038-0039, 0042])
Reid does not explicitly teach the at least one heater located on the shell in the ice formation zone.
However, Baust teaches the at least one heater located on the shell in the ice formation zone (the heater coil 20 is positioned on the internal lumen or surface of the cryoprobe shell tip (e.g., freeze zone 8) to control the formation of the ice ball [0034]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the heater suggested by Reid in view of Baust to be positioned on the shell in the ice formation zone, as taught by Baust. The advantage of such modification will allow for controlling the thawing of an ice ball at the tip of the cryoprobe (see paragraph [0034] by Baust).
Regarding claim 16, Reid teaches a cryoablation apparatus ([abstract, 0012]) comprising:
a cryogen delivery apparatus configured to supply a flow of cryogen (a source of cryogenic (the conduit 162 is connected to any source of coolant fluid [0039]); and
a cryoprobe operably coupled to the cryogen delivery apparatus, the cryoprobe comprising an ice formation limiting device (the coolant source is configured to supply the fluid through a conduit 162 and into the coolant inlet passageway 150 within the cooling probe 200 [0039, 0042, FIG. 4]).
Reid does not explicitly teach the cryoprobe comprising an ice formation limiting device.
The prior art by Baust is analogous to Reid, as they both teach a cryogenic system comprising a cryoprobe ([abstract, 0034]).
Baust teaches the cryoprobe comprising an ice formation limiting device (the ice formation limiting device (e.g., heater coil 20) is positioned on the internal lumen or surface of the cryoprobe shell tip (e.g., freeze zone 8) to control the formation of the ice ball [0034]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Reid’s cryoprobe to include an ice formation limiting device, as taught by Baust. The advantage of such modification will allow for controlling the thawing of an ice ball at the tip of the cryoprobe (see paragraph [0034] by Baust).
Regarding claim 19, Reid in view of Baust suggests the cryoablation apparatus of claim 16. Reid does not explicitly teach wherein the ice formation limiting device comprises a heater positioned on a needle of the cryoprobe,
However, Baust teaches wherein the ice formation limiting device comprises a heater positioned on a needle of the cryoprobe (the ice formation limiting device (e.g., heater coil 20) is positioned on the internal lumen or surface of the cryoprobe tip (e.g., freeze zone 8) to control the formation of the ice ball [0034, FIG. 3]. Furthermore, figure 2 and figure 3 illustrates the cryoprobe tip (e.g., freeze zone 8) comprising a needle or piercing portion (e.g., needle 14) [0032, 0034, FIG. 2, FIG. 3]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify the ice formation limiting device suggested by Reid in view of Baust to include a heater positioned on a needle of the cryoprobe, as further taught by Baust. The advantage of such modification will allow for controlling the thawing of an ice ball at the tip of the cryoprobe (see paragraph [0034] by Baust).
Allowable Subject Matter
8. Claims 7, 11-14, 17-18, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The Examiner has provided an explanation below that describes how the prior art of record fails to suggest the corresponding claims.
Regarding claim 7, Reid teaches wherein the directional insulator is fixed within the inner cavity of the shell (the insulation jacket 120 comprises a directional insulator or passageway wall 152 that is fixed within the inner cavity or interior space of the cooling probe 200 [abstract, 0039, 0042, FIGS. 3-4]).
However, Reid does not explicitly teach the directional insulator being configured to rotate about an axis of the shell inside the inner cavity.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Regarding claim 11, Reid in view of Baust suggests the cryoprobe of claim 10. Although Baust teaches the use of at least one heater ([0034]), Baust does not explicitly teach wherein the at least one heater is deposited on an external surface of the shell in a conductive ink.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claim 12 is considered to contain allowable subject matter, as claim 12 depends upon claim 11.
Regarding claim 13, Reid in view of Baust suggests the cryoprobe of claim 10. Although Baust teaches the use of at least one heater, Baust does not explicitly teach wherein the at least one heater comprises a plurality of heaters each positioned at a different circumferential location on the external surface of the shell.
Claim 14 is considered to contain allowable subject matter, as claim 14 depends upon claim 13.
Regarding claim 17, Reid in view of Baust suggests the cryoablation apparatus of claim 16. Baust teaches wherein the ice formation limiting device comprises a directional insulator that coils around a cryogen supply in a needle of the cryoprobe (the heater coil 20 comprises an insulation coating [0034, FIG. 3]. Specifically, the heater coil 20 wraps around the supply tube or lumen 4 that extends within the needle 14 of cryoprobe tip (e.g., freezing zone 8) [FIG. 2, FIG. 3, 0032, 0034]).
However, Reid and Baust do not explicitly teach wherein the ice formation limiting device comprises a directional insulator positioned radially outward of a cryogen supply in a needle of the cryoprobe.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claim 18 is considered to contain allowable subject matter, as claim 18 depends upon claim 17.
Regarding claim 20, Reid in view of Baust suggests the cryoablation apparatus of claim 19, wherein the heater is positioned on a surface of the needle (the ice formation limiting device (e.g., heater coil 20) is positioned on the internal lumen or surface of the cryoprobe tip (e.g., freeze zone 8) to control the formation of the ice ball [0034, FIG. 3]. Furthermore, figure 2 and figure 3 illustrates the cryoprobe tip (e.g., freeze zone 8) comprising a needle or piercing portion (e.g., needle 14) [0032, 0034, FIG. 2, FIG. 3]).
However, Reid and Baust do not explicitly teach wherein the heater is deposited on an external surface of the needle in at least two different conductive inks each having a different resistance.
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Statement on Communication via Internet
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Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792
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