DETAILED ACTION
The following is a First Action, Office Action on the merits.
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. PCT/EP2023/069519 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 7/13/2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The preliminary amendment filed 1/6/2025 is objected to under 35 U.S.C. 132(a) because it introduces new matter into the disclosure. 35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention. The added material which is not supported by the original disclosure is as follows: the preliminary amendment incorporating by reference the PCT and foreign application is considered new matter as it is made after the filing date of the application. An international application designating the U.S. has two stages (international and national) with the filing date being the same in both stages. Often the date of entry into the national stage is confused with the filing date (see MPEP 1893.03(b)). An incorporation by reference statement added after an application’s filing date is not effective because no new matter can be added to an application after its filing date (see 35 U.S.C. 132(a)) (see MPEP 608.01(p) I B).
Applicant is required to cancel the new matter in the reply to this Office Action.
Claim Objections
Claim 12 is objected to because of the following informalities: amend “the heating” to -the heating element- in ll. 12. Appropriate correction is required.
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.
(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.
Claim(s) 1, 9-16 & 20 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Farley et al. (2007/0055326).
Concerning claim 1, as illustrated in at least Figs. 1-7B & 14-15B, Farley et al. disclose a device for treating varicose veins (resistive element system to treat a HAS such as a vein; [0235]), comprising:
an energy generator configured to generate an electric signal (energy source 18 comprises an AC source or DC source; [0237]);
a controller operatively connected to the energy generator to control the generation of the electric signal (controller that, through the use of a processor, applies power based at least upon readings from a temperature sensor 12 or sensors (e.g., a thermocouple, a thermistor, a resistance temperature device, an optical or infrared sensor, combinations of the same or the like) located in the working portion (e.g., therapeutic portion) of the catheter 11; [0237]); and
a catheter connected to the energy generator (catheter 11 connected to energy source 18; [0235], [0237]) comprising:
a handle (handle 15; [0236]);
an elongated shaft connected to the handle having a proximal end and a distal end portion terminating at a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (catheter 13 is sized to fit within a vascular structure that may be between approximately one millimeter and approximately twenty-five millimeters in diameter and, preferably, between approximately two millimeters and approximately 18 millimeters; [0236]); and
a heating element disposed near the distal end of the elongated shaft (distal portion/resistive element/heating element 14/50/70/208/340 transfer energy (e.g., heat); [0236], [0252], [0258], [0263], [0267], [0271], [0328], [0403]), the heating element comprising a first heating coil comprising a plurality of first windings about the shaft in a first direction, and a second heating coil comprising a plurality of second windings about the shaft in a second direction different than the first direction, wherein at least some of the second windings cross over the first windings at locations spaced along a length of the distal end portion (resistive element 14/50/70/208/340 comprises two layers 54 and 55 of winds that are counter-wound to overlap and have a variable pitch over the shaft length; [0267]), and wherein the first and second heating coils are operatively connected to the energy generator and configured to generate thermal energy in response to receiving the electric signal from the energy generator (resistive element 14/50/70/208/340 of the catheter is made of resistive wire that generates heat when an energy source (e.g., energy source 18 of FIG. 1) is connected and applied thereto; [0258]).
Concerning claim 9, Farley disclose the first and second heating coils (54, 55) are resistance heating coils ([0267]; Fig. 5).
Concerning claim 10, Farley disclose the electric signal is a radiofrequency alternating current and the first and second heating coils (54, 55) are configured to deliver ablative energy to target tissue in the target blood vessel ([0237], [0331]; Fig. 1).
Concerning claim 11, Farley disclose an opening (positioned in the coil winds) is formed along the length of the distal end portion, wherein a temperature sensor (334, 336) is disposed in the opening and configured to generate a temperature signal indicative of a temperature, wherein the controller is configured to control the electric signal generated by the energy generator (14) to be selectively delivered to one or both of the first and second conductor wires (54, 55) based on the temperature signal ([0403]; Fig. 24).
Concerning claim 12, as illustrated in at least Figs. 1-7B & 14-15B, Farley et al. disclose a device for treating varicose veins (resistive element system to treat a HAS such as a vein; [0235]), comprising:
an energy generator configured to generate an electric signal (energy source 18 comprises an AC source or DC source; [0237]);
a controller operatively connected to the energy generator to control the generation of the electric signal (controller that, through the use of a processor, applies power based at least upon readings from a temperature sensor 12 or sensors (e.g., a thermocouple, a thermistor, a resistance temperature device, an optical or infrared sensor, combinations of the same or the like) located in the working portion (e.g., therapeutic portion) of the catheter 11; [0237]); and
a catheter connected to the energy generator (catheter 11 connected to energy source 18; [0235], [0237]) comprising:
a handle (handle 15; [0236]);
an elongated shaft connected to the handle having a proximal end and a distal end portion terminating at a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (catheter 13 is sized to fit within a vascular structure that may be between approximately one millimeter and approximately twenty-five millimeters in diameter and, preferably, between approximately two millimeters and approximately 18 millimeters; [0236]); and
a heating element disposed near the distal end of the elongated shaft (distal portion/resistive element/heating element 14/50/70/208/340 transfer energy (e.g., heat); [0236], [0252], [0258], [0263], [0267], [0271], [0328], [0403]), the heating comprising a first heating coil comprising a plurality of first windings about the shaft in a first direction, and a second heating coil comprising a plurality of second windings about the shaft in the first direction and co-radially with the first heating coil (heating element 14/50/70/208/340 can comprise bifilar wire 60 made of first and second co-radial windings; [0269]), wherein the first and second heating coils are each operatively connected to the energy generator and configured to generate thermal energy when the current supplied by the energy generator is delivered thereto, and wherein the first and second heating coils are electrically isolated from one another and individually addressable by the energy generator (energy is applied separately to each wire of the bifilar wire coil via signal wires 64, 66 that are insulated from one another via the insulative layer; [0258], [0269-0270]).
Concerning claim 13, Farley et al. disclose the controller is configured to control the current generated by the energy generator (14) to be selectively delivered to one or both of the first and second conductor wires (64, 66) ([0258], [0270]; Fig. 6).
Claims 14-15 are rejected upon the same rationale as applied to claim 11.
Concerning claim 16, as illustrated in at least Figs. 1-7B & 14-15B, Farley et al. disclose a catheter connected to the energy generator (catheter 11 connected to energy source 18; [0235], [0237]) comprising:
a handle (handle 15; [0236]);
an elongated shaft connected to the handle having a proximal end and a distal end portion terminating at a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (catheter 13 is sized to fit within a vascular structure that may be between approximately one millimeter and approximately twenty-five millimeters in diameter and, preferably, between approximately two millimeters and approximately 18 millimeters; [0236]); and
a heating element disposed near the distal end of the elongated shaft and configured to be operatively coupled to a current source of an energy generator (distal portion/resistive element/heating element 14/50/70/208/340 transfer energy (e.g., heat) and connected to power supply 18; [0236-0237], [0252], [0258], [0263], [0267], [0271], [0328], [0403]), the heating element comprising a first heating coil comprising a plurality of first windings about the shaft in a first direction, and a second heating coil comprising a plurality of second windings about the shaft in a second direction different than the first direction, wherein at least some of the second windings cross over the first windings at locations spaced along a length of the distal end portion (resistive element 14/50/70/208/340 comprises two layers 54 and 55 of winds that are counter-wound to overlap and have a variable pitch over the shaft length; [0267]), and wherein the first and second heating coils are electrically isolated from one another and are individually addressable by the energy generator when the heating element is operatively connected thereto (resistive element 14/50/70/208/340 of the catheter is made of resistive wire that generates heat when an energy source (e.g., energy source 18 of FIG. 1) is connected and applied thereto; [0258]).
Claim 20 is rejected upon the same rationale as applied to claim 9.
Claim(s) 12-13 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as being anticipated by Zikorus et al. (2006/0085054)
Concerning claim 12, as illustrated in at least Fig. 1, 23 & 34, Zikorus et al. disclose a device for treating varicose veins (device 10 for applying energy to a hollow anatomical structure such as a vein; [0117]), comprising:
an energy generator configured to generate an electric signal (energy source 24 can be either alternating current (AC) or direct current (DC) like an RF generator or other type of power supply; [0117]]);
a controller operatively connected to the energy generator to control the generation of the electric signal (power source 702 may also incorporate a controller that, by use of a microprocessor, applies power; [0235]); and
a catheter connected to the energy generator (catheter 10; [0117]]) comprising:
a handle (handle 14; [0117]);
an elongated shaft connected to the handle having a proximal end and a distal end portion terminating at a distal end, the shaft being sized and configured such that the distal end can be inserted into a target blood vessel (catheter shaft 12 is sized to fit within a vascular structure that may be between 5 and 9 French, which corresponds to a diameter of between about 1.7 mm (0.07 in) and about 3.0 mm (1.2 in), or other sizes as appropriate to correlate to the HAS; [0117]]); and
a heating element disposed near the distal end of the elongated shaft (wires 122; [0151]), the heating comprising a first heating coil comprising a plurality of first windings about the shaft in a first direction, and a second heating coil comprising a plurality of second windings about the shaft in the first direction and co-radially with the first heating coil (pair of helically wound wires embedded within the tube extrusion wall, wound in the same direction and co-radial; [0151]), wherein the first and second heating coils are each operatively connected to the energy generator and configured to generate thermal energy when the current supplied by the energy generator is delivered thereto, and wherein the first and second heating coils are electrically isolated from one another and individually addressable by the energy generator (the wire pairs of electrodes 122 are electrically insulated along the length and have exposed portions that are electrodes that can be multiplexed or otherwise operated or controlled separately in pair-wise fashion, in order to increase or vary the overall treatment length while minimizing the power required for the treatment; [0152]).
Concerning claim 13, Zikorus et al. disclose the controller is configured to control the current generated by the energy generator (24) to be selectively delivered to one or both of the first and second conductor wires (122) ([0152]).
Claim Rejections - 35 USC § 102/103
Claim(s) 2-8 & 17-19 is/are rejected under 35 U.S.C. 102(a)(1) or 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Farley et al. (2007/0055326), as applied to claims 1 & 16.
Concerning claims 2-3 & 17-18, Farley et al. disclose various heating coil embodiments (14/50/70/208/340) that comprise a single filar or multi/bifilar conductor wire ([0258], [0328]; Fig. 5-6). In the alternative, It would have been an obvious matter of design choice to one having ordinary skill in the art at the time the invention was effectively filed to modify the invention of Farley et al. such that the first heating coil comprises a single-filar or multi-filar conductive wire, since Applicant has not disclosed that a single-filar or multi-filar conductive wire solves any stated problem or is for any particular purpose and it appears that the invention would perform equally as well with either a single or multi-filar wire as Farley et al. teaches single and multi-filar conductive wires to be equivalents in the art for the purposes of heating tissue.
Concerning claims 4-5, Farley et al. disclose the first heating coil (54) comprises a first conductor wire comprising one filar (wire connected to signal wire 64), and the second heating coil (55) comprises a second conductor wire comprising one filar (wire connecting to signal wire 66) (since the heating element can be bi-filar, there are a total of two conductor wires, each comprising one of the filar wires of the bifilar wire) ([0258], [0267], [0328]; Fig. 5-6).
Concerning claim 6, Farley disclose the first and second conductor wires (64, 66) are electrically connected in series via solder joints (62) ([0269-0270]; Fig. 6).
Concerning claim 7, Farley et al. disclose the first and second conductor wires (connected to signal wires 64, 66) are electrically isolated (insulative layer) from one another and are each individually addressable by the energy generator (14); wherein the controller is configured to control the electric signal generated by the energy generator (14) to be selectively delivered to one or both of the first and second conductor wires (64, 66) ([0258], [0270]; Fig. 6).
Concerning claims 8 & 19, Farley et al. disclose the heating element (14/50/70/208/340) comprises a plurality of coil segments (71-78) longitudinally spaced from one another along a length of the distal end portion, wherein each coil segment of the plurality of coil segments (71-78) is individually addressable by the energy generator. Farley et al. fail to specifically disclose each coil segment of the plurality of coil segments includes a portion of the first heating coil and a portion of the second heating coil. However, Farley et al. teach the advantage of multiple heating coils in the heating element (50) of Fig. 5. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Farley et al. such that the each coil segment of the plurality of coil segments includes a portion of the first heating coil and a portion of the second heating coil in order to provide the benefit of provide a greater heating density and/or to provide more uniform heating if the coil winds are spaced to increase the length of the heating segment while using a limited length of coil wire as taught by Farley et al. ([0267]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Webster, Jr. (6,090,104) first and second heating coils with windings in the same or different directions (Figs. 12-14).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached on (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
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