DETAILED ACTION
This action is in response to applicant’s election received on 2/9/2026. Claims 1-24 were previously restricted. Applicant elected Group I, Species I, subspecies a. Claims 14-15 and 17-24 have been withdrawn from further consideration. A complete action on the merits of claims 1-13 and 16 follows below.
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 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.
Election/Restrictions
Claims 14-15 and 17-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2/9/2026.
In addition, claims 10 and 11 have been withdrawn by the examiner as being directed to a non-elect species/sub-species. Claim 10 is directed to “the cold therapy assembly comprises a plurality of therapeutic elements that include the one or more surfaces” and Claim 11 “the plurality of therapeutic elements comprises a plurality of thermoelectric elements configured to change temperature in response to an applied voltage”. According to the specification “In some examples, such as illustrated in FIGS. 4A-4C and 5D, cold therapy assembly 14 includes one or more therapeutic elements configured to change temperature in response to an electric voltage, such as thermoelectric elements. The thermal medium and/or plurality of therapeutic elements may create a temperature differential between one or more surfaces of cold therapy assembly 14 and the wall of the vessel, such that heat may transfer from the wall of the vessel to the thermal medium and/or the one or more therapeutic elements” [0047]. Therefore, claims 10-11 are directed to Species I, subspecies c, which is a non-elect species, thus these claims have been withdrawn from further consideration.
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 1-9, 12-13 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ryba (US Pub. No. 2012/0089047).
Regarding Claim 1, Ryba teaches a system (Figs. 5A, 7A-8C, 13A-18B, 32A-B, 36-37) comprising:
an intravascular medical device 102 comprising: a cold therapy assembly 124/160 that includes one or more surfaces 122 configured to remove heat from a wall of a vessel ([0098], [0144]-[0149], [0153]-[0154], [0168]-[0187] generally discuss the use of cryo-balloon 124 or metal tip 160 having cryo-applicator region 122 to create lesions 172 in blood vessel to remove heat from a wall of a vessel); and
an elongated member (supply tube 108) coupled to the cold therapy assembly (cryo-console 100, [0108], [0122]-[0128], [0145] and Fig. 5A); and
a therapeutic medical device 114 communicatively coupled to the cold therapy assembly 100 and configured to control the cold therapy assembly to ablate smooth muscle cells of the wall of the vessel without substantially denaturing one or more structural proteins of the wall of the vessel ([0103], [0109], [0125]-[0126], [0299] and Fig. 5A).
Regarding Claim 2, Ryba teaches wherein the one or more structural proteins comprise elastin and collagen ([0103]).
Regarding Claim 3, Ryba teaches wherein, to ablate the smooth muscle cells without substantially denaturing the one or more structural proteins, the therapeutic medical device is configured to control the cold therapy assembly to maintain a temperature of the smooth muscle cells within a target temperature range ([0282] and [0300]-[0304]).
Regarding Claim 4, Ryba teaches wherein the target temperature range is defined by an upper temperature threshold value associated with death of the smooth muscle cells and above a lower temperature threshold value associated with denaturing of the one or more structural proteins (“the cryo-console 100 may include one or more of a user interface, circuitry for monitoring sensors 112, if present in the cryo-catheter 102, one or more processors 114 or dedicated circuitry for implementing a computerized control algorithm, and control valves 110, 116 for controlling the flow of the refrigerant 106 to the cryo-catheter 102 and/or the flow of the evaporated refrigerant 118 from the cryo-catheter 102 through a return tube or lumen 120” [0109], “the cryo-catheter 102 may include a controller or computer system having programmed instructions for controlling delivery of refrigerant 106, evacuation of evaporated refrigerant 118, and/or other aspects of the treatment” [0125] and “one or more sensors 112 (e.g., a thermocouple) may be provided on the cryo-catheter 102, such as on shaft 130 and/or on the delivery sheath shaft to monitor the temperature inside the delivery sheath 168 and/or on the surface of the cryo-catheter 102. The measured temperature signal may be used as feedback in a software control algorithm to control the flow rate of infused cooling fluid 122, such as from cooling fluid supply 218, to maintain a target temperature within the delivery sheath” [0282], [0098] and claims 86-90; therefore, the controller is configured to control and maintain the target temperature at a threshold such as by an upper temperature threshold value associated with death of the smooth muscle cells and above a lower temperature threshold value associated with denaturing of the one or more structural proteins if the system is used in that manner).
Regarding Claim 5, Ryba teaches wherein the upper temperature threshold value is less than about 0 ℃, and wherein the lower temperature threshold value is greater than about -70 ℃ ([0159], [0300]-[0304]).
Regarding Claim 6, Ryba teaches wherein the one or more surfaces 122 are configured to contact the wall of the vessel and remove the heat from the wall of the vessel ([0095]-[0096], [0098], [0101], [0104], [0123], [0129], [0168] and [0170], also see Figs. 13A-15, 20-22 and 32A-B).
Regarding Claim 7, Ryba teaches wherein the one or more surfaces are configured to contact a medium in the vessel and remove heat from the medium in the vessel to remove the heat from the wall of the vessel ([0098], [0168] and [0170], also see Figs. 13A-15, 20-22 and 32A-B).
Regarding Claim 8, Ryba teaches wherein the cold therapy assembly comprises a balloon 124 comprising a cavity 134 configured to contain a thermal medium, the balloon defining the one or more surfaces 122, and wherein the one or more surfaces 122 are configured to transfer the heat from the wall of the vessel to the thermal medium ([0095]-[0096], [0098], [0101], [0104], [0123], [0129], [0168] and [0170], also see Figs. 13A-15, 20-22 and 32A-B).
Regarding Claim 9, Ryba teaches wherein the thermal medium comprises at least one of a cooling fluid, a phase change fluid, or a product of an endothermic chemical process, and wherein the therapeutic medical device is configured to control a cooling load of the cooling fluid, the phase change fluid, or the endothermic chemical process ([0098]-[0099], [0108], [0123] and [0125]).
Regarding Claim 12, Ryba teaches wherein the cold therapy assembly comprises an expansion device (balloon 124), and wherein the expansion device 124 is configured to radially extend the one or more surfaces to contact the wall of the vessel ([0095]-[0096], [0098], [0101], [0104], [0123], [0129], [0168] and [0170], also see Figs. 13A-15, 20-22 and 32A-B).
Regarding Claim 13, Ryba teaches wherein the expansion device comprises a balloon 124 configured to transform from a delivery configuration to an inflated deployed configuration (Figs. 13A-D, [0168] and “Expandable balloons may be delivered to the treatment site in a collapsed configuration and inflated/expanded once in place” [0174]).
Regarding Claim 16, Ryba teaches wherein the expansion device is configured to expand the vessel beyond an initial diameter of the vessel (Figs. 32A-B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794