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 .
Claim Rejections - 35 USC § 102
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.
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.
Claims 1, 3, 5-8, 10, 12, 14, 16-19 and 21 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Huffmaster et al (PG Pub 2021/0121219).
Referring to claim 1, Huffmaster et al teaches a cryogenic device for ablating tissue (Figures 1A, 1B and 2A), comprising: a handle (210/250) comprising one or more tabs (240) on the handle, wherein the handle comprises an unlocked configuration in which the one or more tabs (240) are configured to be pressed into an interior of the handle (paragraph 0041). Paragraph 0041 states that each of the input elements 240 may be moved, for example, in the respective directions depicted by the arrows 270a and 270b in FIG. 2D, compressing the elastic element 230 and thereby displacing the handpiece clips 225 toward each other to cause the handpiece clips 225 to be in the disengaging position.
Huffman et al teaches an elongated probe (110) extending from the handle (250), the elongated probe (110) having a proximal end and a distal end, the distal end defining an end effector (115) (paragraphs 0034-0038; Figures 1A, 1B and 2A); one or more fluid supply passageways (probe lumen) extending within the elongated probe from the handle (paragraph 0037); and wherein the handle comprises a locked configuration (when 110 is connected to 250), wherein the one or more tabs are in a first position (when 240 are coupled) in the locked configuration and a second position (when 240 are moved in direction of arrows 270) in the unlocked configuration (paragraph 0042; shown best in Figure 2D), wherein the one or more fluid supply passageways is pressurized when the handle is in the locked configuration (paragraphs 0041-0042).
Referring to claim 3, Huffmaster et al teaches further comprising an identification (118) card within the handle (paragraphs 0038-0039).
Referring to claim 5, Huffmaster et al teaches wherein the identification card is replaceable (paragraphs 0038-0039).
Referring to claim 6, Huffmaster et al teaches a receptacle configured to be locked to the handle (paragraphs 0035, 0037, 0038, 0041 and 0049).
Referring to claim 7, Huffmaster et al teaches a receptacle is configured to be unlocked from the handle upon actuation of a locking tab positioned on the handle (paragraphs 0035, 0037, 0038, 0041 and 0049).
Referring to claim 8, Huffmaster et al teaches one or more electrical connections coupled to the handle (paragraphs 0038-0040).
Referring to claim 10, Huffmaster et al teaches wherein the one or more tabs release to the unlocked configuration when pressure within the one or more fluid supply passageways is reduced to a predetermined threshold (paragraphs 0041, 0042, 0046-0047 and 0059). Huffmaster et al teaches that the one or more tabs release when the procedure is complete.
Referring to claim 12, Huffmaster et al teaches a method for ablating tissue with a cryogenic device (Figures 1A, 1B and 2A), the method comprising: connecting a handle (210/250) to a receptacle coupled to an elongated probe (110) (paragraphs 0034-0038; Figures 1A, 1B and 2A), wherein the handle (250) comprises one or more tabs (240) on the handle (paragraph 0041); pressurizing one or more fluid supply passageways (probe lumen as described in paragraph 0037) extending within the elongated probe from the handle (paragraphs 0041-0042); delivering fluid to a distal end of the elongated probe (paragraphs 0037 and 0053); ablating at least a portion of the tissue in contact with the distal end of the elongated probe (paragraphs 0033 and 0037); and unlocking the handle (250) by pressing the one or more tabs (240) from a first position (when 240 are coupled) defining a locked configuration to a second position (when 240 are moved in direction of arrows 270) defining an unlocked configuration (paragraph 0042; shown best in Figure 2D), wherein the one or more fluid supply passageways is pressurized when the handle is in the locked configuration (paragraphs 0041-0042), wherein the one or more tabs (240) are pressed into an interior (direction of 270) of the handle in the unlocked configuration (paragraph 0041; Figure 2D).
Referring to claim 14, Huffmaster et al teaches further comprising an identification (118) card within the handle (paragraphs 0038-0039).
Referring to claim 16, Huffmaster et al teaches wherein the identification card is replaceable (paragraphs 0038-0039).
Referring to claim 17, Huffmaster et al teaches a receptacle configured to be locked to the handle (paragraphs 0035, 0037, 0038, 0041 and 0049).
Referring to claim 18, Huffmaster et al teaches a receptacle is configured to be unlocked from the handle upon actuation of a locking tab positioned on the handle (paragraphs 0035, 0037, 0038, 0041 and 0049).
Referring to claim 19, Huffmaster et al teaches one or more electrical connections coupled to the handle (paragraphs 0038-0040).
Referring to claim 21, Huffmaster et al teaches wherein the one or more tabs release to the unlocked configuration when pressure within the one or more fluid supply passageways is reduced to a predetermined threshold (paragraphs 0041, 0042, 0046-0047 and 0059). Huffmaster et al teaches that the one or more tabs release when the procedure is complete.
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.
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.
Claims 2 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Huffmaster et al (PG Pub 2021/0121219) as applied to the claims above, and further in view of Fox et al (PG Pub 2022/0257298).
Referring to claims 2 and 13, Huffmaster et al teaches at least one fluid supply passageways including an inlet passageway, however fails to expressly teach an exhaust passageway. Fox et al teaches an analogous cryogenic device and corresponding method comprising and inlet and exhaust passageway (paragraphs 0082, 0083, 0085 and 0087). 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 at least on fluid supply passageway, as taught by Huffmaster et al, to include and exhaust passageway, as taught by Fox et al, in order to achieve a desired pressure within the end effector (paragraph 0083).
Claims 4 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Huffmaster et al (PG Pub 2021/0121219) as applied to the claims above, and further in view of Owens et al (PG Pub 2019/0350648).
Referring to claims 4 and 15, Huffmaster et al teaches an indentification card, however fails to expressly teach a FRAM card. Owens et al teaches an analogous cryogenic device and corresponding method comprising that a non-volatile memory can comprise a FRAM card (paragraph 0158). 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 identification card, as taught by Huffmaster et al, to be a FRAM card, as taught by Owens et al, because this is a simple substitution of one known element for another to obtain predictable results since it is an example of a type of memory (paragraph 0158).
Claims 9, 11, 20 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Huffmaster et al (PG Pub 2021/0121219) as applied to the claims above, and further in view of Hilleli et al (PG Pub 2023/0270483).
Referring to claims 9 and 20, Huffmaster et al teaches one or more electrical connections, however fails to teach a thermocouple. Hilleli et al teaches an analogous cryogenic device and corresponding method comprising an electrical connection with a thermocouple (paragraphs 0069, 0078 and 0079). 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 electrical connections, as taught by Huffmaster et al, to include a thermocouple, as taught by Hilleli et al, in order to use a processor to control an output pump in order to keep it at a preset rate (paragraphs 0059 and 0079).
Referring to claims 11 and 22, Huffmaster et al fails to teach a pressure sensor. Hilleli et al teaches an analogous cryogenic device and corresponding method comprising one or more pressure sensors (100) coupled to the handle (104) (paragraph 0078; Figure 3). 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 cryogenic device and method, as taught by Huffmaster et al, to have one or more pressure sensors coupled to the handle, as taught by Hilleli et al, in order to use a processor to control an output pump in order to keep it at a preset rate (paragraphs 0059 and 0079).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
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