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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show clear lines toward each element. Additionally, drawings are blurry and fail to show structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 10 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3 and 8 of copending Application No. 18709498 (J-T slot position adjustable cryoablation needle). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims are merely broader than the ‘498 applications claims. For example, regarding claim 1 each claims A cryoablation needle with an adjustable position, comprising a vacuum wall, a J-T slot, wherein the wherein the vacuum wall comprises: a needle rod and an inner tube; the needle rod is provided with a needle tip at a distal end; the inner tube penetrates through the needle rod, and a cavity is formed between the inner tube and the needle rod, the cavity being capable of forming a vacuum; in an axis direction of the vacuum wall, a first preset distance exists between a distal end of the inner tube and the distal end of the needle rod; the distal end of the inner tube is an end of the inner tube close to the needle tip; Thus, the invention claimed in the current application is merely generic to the species claimed in the related application and it has been held that the generic invention is anticipated by species.
Regarding claim 3, each claims the cryoablation needle according to claim 2, further comprising: a first sealing assembly, wherein the first sealing assembly is hermetically connected to a proximal end of the inner tube; the proximal end of the inner tube is an end of the inner tube far away from the needle tip; and a dynamic seal is formed between the first sealing assembly and the first sliding block guiding portion. Thus, the invention claimed in the current application is merely generic to the species claimed in the related application and it has been held that the generic invention is anticipated by species.
Regarding claims 10 and 17, each claims The cryoablation needle further comprising: a temperature measuring wire, wherein a distal end of the temperature measuring wire is a temperature measuring point; the distal end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip; and the temperature measuring point is arranged at the distal end of the J-T slot, and used for measuring temperature at the distal end of the J-T slot. Thus, the invention claimed in the current application is merely generic to the species claimed in the related application and it has been held that the generic invention is anticipated by species.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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 1-4, and 6-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al (CN110507405A) herein referred to as “Yang ‘405” in view of Yang et al (CN110251224B) herein referred to as “Yang ‘224”
Regarding claim 1, Yang ‘405 discloses: A cryoablation needle ([Abstract] A cryoablation needle) with an adjustable vacuum wall position, ([Abstract] contains an adjusting part) comprising a vacuum wall, (See annotated FIG 1 below where outer tube and inner tube constitutes the vacuum wall) a J-T slot (FIG 9 below; JT groove which is equivalent to a JT slot) and a vacuum wall adjusting apparatus, ([page 3: paragraph 4 full;] cryoablation needle includes an adjustment component) wherein the vacuum wall comprises: a needle rod (See annotated FIG 1; Outer tube forms the needle rod) and an inner tube; (See annotated FIG 1 below for labelled inner tube) the needle rod is provided with a needle tip at a distal end; (See annotated FIG 1 below; Needle tip which is located at the distal end) the inner tube penetrates through the needle rod, and a cavity is formed between the inner tube and the needle rod, (See annotated FIG 1 below showing vacuum interlayer, which is equivalent to the cavity) the cavity being capable of forming a vacuum; ([page 6: paragraph 3 under heading “Example 1”] inner and outer layer form a vacuum interlayer, sealing through vacuum welding, along with the movement of the mandrel forms a vacuum) in an axis direction of the vacuum wall, a first preset distance exists between a distal end of the inner tube and the distal end of the needle rod; ([page 3: paragraph 4 under ‘Contents of invention’ starting with “The adjustment component includes”] When the mandrel (11) moves toward the distal end, the distance changes essentially forming a ‘first preset distance’ where the needle rod is in the target area) the distal end of the inner tube is an end of the inner tube close to the needle tip; (See annotated FIG 1 below showing distal end taken as the end close to the needle tip) the J-T slot penetrates through the inner tube; (FIG 9 below showing the J-T slot 241 penetrating through the inner tube) the needle tip is capable of being switched between at least two adjusting positions relative to the J-T slot, ([page 8: paragraph 5] Forward and backward constitutes at least 2 adjusting positions; [page 3: paragraph 4 under ‘Contents of invention’ starting with “The adjustment component includes”] the adjustment component moves relative to the heat insulation layer which is the vacuum wall, and a mandrel ) the at least two adjusting positions comprising: a first adjusting position and a second adjusting position; ([page 8: paragraph 5] adjustment can be made forward which will be interpreted as the first adjusting position, and backward, which will be interpreted as the second adjusting position; Forward and backward constitutes at least 2 adjusting positions) in areas in which the vacuum wall is distributed in the axis direction of the vacuum wall, an area in which the cavity is located is a vacuum insulation area, ([page 4:paragraph 13] vacuum interlayer is an insulation area since the pipes forming it are ‘heat-insulation’ pipes) and an area in which the first preset distance exists is a target area; ([page 6: paragraph 2] area formed at a preset distance which is the outer surface of the ablation needle between the front end surface and the needle tip is the target area known as targeting area 3) when the needle tip is located at the first adjusting position, a distal end of the J-T slot is located in the target area; ([page 8: paragraph 5]the forward movement equivalent to the first adjusting position moves the needle into the targeting area 3) the distal end of the J-T slot is an end of the J-T slot close to the needle tip; ([See annotated FIG 1 below; Needle tip which is located at the distal end and distal end of the J-T slot is close to needle tip]) when the needle tip is located at the second adjusting position, the distal end of the J-T slot is located in the vacuum insulation area; ([page 8: paragraph 5] The backward movement which is equivalent to the second adjusting position is in the vacuum insulation area) the vacuum wall adjusting apparatus is configured to enable the needle tip to be switched between the at least two adjusting positions by adjusting a position of the needle tip; ([page 6: paragraph 2] the heat insulation area 4 corresponds to the second preset distance; this distance occurs in the first adjusting position during the forward movement and describes a different position whilst in the same state) the vacuum wall adjusting apparatus comprises: a first sliding block and a first sliding block guiding portion; ([See FIG 1 below; Mandrel 11 is equivalent to the first sliding block guiding portion] and [page 8: paragraph 5] the adjusting sleeve acts as the sliding block as it is used to move the mandrel which is used to adjust the position) the first sliding block and the vacuum wall are capable of being controlled to synchronously move in a direction guided by the first sliding block guiding portion, to switch the needle tip between the adjusting positions; ([page 3: paragraph 4 under “Contents of invention”] the adjustment component, the mandrel and the front section which encompasses the J-T slot straight section is axially slidable, all these components must move together synchronously to achieve this motion) the first sliding block guiding portion is configured to guide the first sliding block and the vacuum wall to move in the axis direction of the vacuum wall; when the needle tip is located at the first adjusting position, in the axis direction of the vacuum wall, a second preset distance exists between the distal end of the J-T slot and the needle tip, ([page 6: paragraph 2] the heat insulation area 4 corresponds to the second preset distance; this distance occurs in the first adjusting position during the forward movement) and the second preset distance at least ensures that an ice ball formed; ([page 8: paragraph 7] ice balls produced) and when the needle tip is located at the second adjusting position, in the axis direction of the vacuum wall, a third preset distance exists between the distal end of the J-T slot and a distal end of the vacuum insulation area, and the third preset distance at least ensures that a refrigerant directly returns from the inside of the vacuum insulation area after being sprayed from the J-T slot, ([page 6: paragraph 5] contains a return air groove in connection with the heat layer (12), zone 3 corresponds to a third preset distance when the cold energy returns through the return pipe) the distal end of the vacuum insulation area being an end of the vacuum insulation area close to the needle tip (See annotated FIG 1 below showing distal end taken as the end close to the needle tip). However, Yang ‘405 does not explicitly disclose: the ice ball formed by freezing is wrapped around the needle tip
Yang ‘224 discloses: the ice ball formed by freezing is wrapped around the needle tip ([page 12: paragraph 4] the position of the needle bar and the J-T groove are relatively fixed so that the ice ball can completely cover the needle tip)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ice ball formed through freezing as disclosed in Yang ‘405 to include the ice ball formed by freezing completely covering the needle tip as disclosed in Yang ‘224. The motivation to do so being, when the ice ball completely covers the needle tip, the risk of puncturing organs and blood vessels can be prevented (Yang ‘224 [page 12: paragraph 4]).
PNG
media_image1.png
566
1483
media_image1.png
Greyscale
FIG 1
PNG
media_image2.png
466
1630
media_image2.png
Greyscale
FIG 9
PNG
media_image3.png
431
787
media_image3.png
Greyscale
FIG 7
Regarding claim 2, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 1, wherein the first sliding block guiding portion is arranged in the axis direction of the vacuum wall; ([See FIG 1 of Yang ‘405 above where the mandrel, taken as the sliding guiding portion is arranged in the axis direction within the vacuum wall]) the first sliding block is connected to the vacuum wall, and a position of the first sliding block guiding portion is fixed relative to the first sliding block or the J-T slot; ([See annotated FIG 9 of Yang ‘405 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion are moving relative to each other]) if the position of the first sliding block guiding portion is fixed relative to the first sliding block, the first sliding block guiding portion and the J-T slot are capable of sliding relatively; (Yang ‘405 [page 3: paragraph 4 under “Contents of invention”] the adjustment component, the mandrel and the front section which encompasses the J-T slot straight section is axially slidable, all these components must move together synchronously to achieve this motion]) and if the position of the first sliding block guiding portion is fixed relative to the J-T slot, the first sliding block and the first sliding block guiding portion are capable of sliding relatively ([See annotated FIG 9 of Yang ‘405 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion are moving relative to each other])
Regarding claim 3, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 2, further comprising: a first sealing assembly, wherein the first sealing assembly is hermetically connected to a proximal end of the inner tube; (Yang ‘405 [page 3: paragraph 11 under “Contents of the invention”] rare end sealing assembly is at the proximal end) the proximal end of the inner tube is an end of the inner tube far away from the needle tip; (Yang ‘405 [See annotated FIG 1 showing that the proximal end of the inner tube is far away from the needle tip]) and a dynamic seal is formed between the first sealing assembly and the first sliding block (Yang ‘405 [page 6: paragraph 9] sealing assembly is in dynamic sealing connection with the sealing ring).
Regarding claim 4, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 3, wherein the first sealing assembly comprises: a sealing ring, a sealing slot and a sealing press piece, wherein a distal end of the sealing slot is hermetically fixed to the proximal end of the inner tube, (Yang ‘405 [page 7: paragraph 10, sealing connection is the same as saying hermetically sealed which is seen as airtight]) the distal end of the sealing slot being an end of the sealing slot close to the needle tip; (See FIG 1 above from Yang ‘405) the sealing ring is arranged between the sealing press piece and the first sliding block, and the sealing press piece is arranged between the sealing ring and the sealing slot; the sealing ring and the sealing press piece are slidably connected to the sealing slot; (Yang ‘405 [page 6: paragraph 9] sealing assembly is in dynamic sealing connection with the sealing ring) and the first sliding block, the sealing ring, and the sealing press piece are capable of being controlled to synchronously move in the axis direction (Yang ‘405 [Page 4: paragraph 8] in contact with the inner wall and dynamically sealed with it is seen as being able to move synchronously in the axial direction).
Regarding claim 6, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 5, further comprising: a first handle, (Yang ‘405 [Page 4: Paragraph 6] includes a handle) wherein the first handle comprises: a front handle section and a rear handle section; (Yang ‘405 [Page 4: paragraph 6] it is located in the middle of the adjustment sleeve which is seen as the handle having a front section and a rare section) the front handle section is fixedly connected to the vacuum wall; (Yang ‘405 [Page 4: Paragraph 6] it is fixedly connected) a distal end of the rear handle section is inserted into a proximal end of the front handle section, and the two are capable of sliding relatively; (Yang ‘405 [Page 8: paragraph 6] the gap allows it to slide relatively to each other) and the front handle section and/or the rear handle section is provided with a limiting ring, and the limiting ring is configured to limit the furthest distance of the vacuum wall moving toward the distal end (Yang ‘405 [Page 4: Paragraph 8] fixing ring is seen as being able to limit).
Regarding claim 8, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 1, wherein the vacuum wall further comprises: an outer tube and a gasket, wherein a distal end of the outer tube is hermetically connected to a proximal end of the needle rod, (Yang ‘405 [page 3: paragraph 5 under “Contents of invention”] dynamically sealed means it is hermetically connected, indicating that it is air tight) a proximal end of the outer tube is hermetically connected to the proximal end of the inner tube, (Yang ‘405 [page 3: paragraph 12 under “Contents of invention”] dynamically sealed means it is hermetically connected, indicating that it is air tight) the distal end of the outer tube is an end of the outer tube close to the needle tip, ([See annotated FIG 1 of Yang ‘405 above]) and the proximal end of the outer tube is an end of the outer tube far away from the needle tip; ([See annotated FIG 1 of Yang ‘405 above]) the gasket is arranged between an outer wall of the inner tube and an inner wall of the needle rod to form a sealed connection; ([See annotated FIG 1 of Yang ‘405 above]) from the distal end to the proximal end of the inner tube, the inner tube sequentially comprises: an inner tube front section and an inner tube rear section; ([See annotated FIG 1 of Yang ‘405 above]) the inner tube front section penetrates through the needle rod; ([See annotated FIG 1 of Yang ‘405 above]) the inner tube rear section penetrates through the outer tube; ([See annotated FIG 1 of Yang ‘405 above]) and if the vacuum wall comprises: a front vacuum wall section and a rear vacuum wall section, the front vacuum wall section comprises the needle rod ([See annotated FIG 1 of Yang ‘405 above]) and the inner tube front section, and the rear vacuum wall section comprises the outer tube and the inner tube rear section ([See annotated FIG 1 of Yang ‘405 above]).
Regarding claim 9, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 8, wherein an outer diameter of the outer tube is greater than an outer diameter of the needle rod, (Yang ‘405 [page 3: paragraph 8 under “Contents of invention”] the vacuum wall is larger than the needle rod) and an inner diameter of the outer tube is greater than an inner diameter of the needle rod; (Yang ‘405 [page 3: paragraph 8 under “Contents of invention”] the outer tube is larger than the needle rod) and an outer diameter of the inner tube rear section is greater than an outer diameter of the inner tube front section; ([See annotated FIG 1 of Yang ‘405 above]) an inner diameter of the inner tube rear section is greater than an inner diameter of the inner tube front section ([See annotated FIG 1 of Yang ‘405 above]).
Regarding claim 10, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 1, further comprising: a temperature measuring wire, (Yang ‘405 [page 8: paragraph 1 under heading ‘Example 3’] cryoablation needle with a temperature measuring wire) wherein a distal end of the temperature measuring wire is a temperature measuring point; (See annotated FIG 17 of Yang ‘405 below; the temperature measurement point 2711 is located at the distal end ) the distal end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip; (See annotated FIG 17 of Yang ‘405 below; temperature measuring wire point is close to the needle tip) and the temperature measuring point is arranged at the distal end of the J-T slot, and used for measuring temperature at the distal end of the J-T slot (Yang ‘405 [page 8: paragraph 1 under heading ‘Example 3’] temperature measurement wire is placed at the front end of the J-T slot which places it at the distal end; also see annotated FIG 17 of Yang ‘405 below).
PNG
media_image4.png
507
1344
media_image4.png
Greyscale
FIG 17
Regarding claim 11, Yang ‘405 discloses: A cryoablation needle ([Abstract] A cryoablation needle) with an adjustable vacuum wall position, ([Abstract] contains an adjusting part) comprising a vacuum wall, (See annotated FIG 1 above where outer tube and inner tube constitutes the vacuum wall) a J-T slot (FIG 9 above; JT groove which is equivalent to a JT slot) and a vacuum wall adjusting apparatus, ([page 3: paragraph 4 full;] cryoablation needle includes an adjustment component) wherein the vacuum wall comprises: a needle rod (See annotated FIG 1 above; Outer tube forms the needle rod) and an inner tube; (See annotated FIG 1 above for labelled inner tube) the needle rod is provided with a needle tip at a distal end; (See annotated FIG 1 above; Needle tip which is located at the distal end) the inner tube penetrates through the needle rod, and a cavity is formed between the inner tube and the needle rod, (See annotated FIG 1 above showing vacuum interlayer, which is equivalent to the cavity) the cavity being capable of forming a vacuum; ([page 6: paragraph 3 under heading “Example 1”] inner and outer layer form a vacuum interlayer, sealing through vacuum welding, along with the movement of the mandrel forms a vacuum) in an axis direction of the vacuum wall, a first preset distance exists between a distal end of the inner tube and the distal end of the needle rod; ([page 3: paragraph 4 under ‘Contents of invention’ starting with “The adjustment component includes”] When the mandrel (11) moves toward the distal end, the distance changes essentially forming a ‘first preset distance’ where the needle rod is in the target area) the distal end of the inner tube is an end of the inner tube close to the needle tip; (See annotated FIG 1 above showing distal end taken as the end close to the needle tip) the J-T slot penetrates through the inner tube; (FIG 9 above showing the J-T slot 241 penetrating through the inner tube) the needle tip is capable of being switched between at least two adjusting positions relative to the J-T slot, ([page 8: paragraph 5] Forward and backward constitutes at least 2 adjusting positions; [page 3: paragraph 4 under ‘Contents of invention’ starting with “The adjustment component includes”] the adjustment component moves relative to the heat insulation layer which is the vacuum wall, and a mandrel) the at least two adjusting positions comprising: a first adjusting position and a second adjusting position; ([page 8: paragraph 5] adjustment can be made forward which will be interpreted as the first adjusting position, and backward, which will be interpreted as the second adjusting position; Forward and backward constitutes at least 2 adjusting positions) in areas in which the vacuum wall is distributed in the axis direction of the vacuum wall, an area in which the cavity is located is a vacuum insulation area, ([page 4:paragraph 13] vacuum interlayer is an insulation area since the pipes forming it are ‘heat-insulation’ pipes) and an area in which the first preset distance exists is a target area; ([page 6: paragraph 2] area formed at a preset distance which is the outer surface of the ablation needle between the front end surface and the needle tip is the target area known as targeting area 3) when the needle tip is located at the first adjusting position, a distal end of the J-T slot is located in the target area; ([page 8: paragraph 5]the forward movement equivalent to the first adjusting position moves the needle into the targeting area 3) the distal end of the J-T slot is an end of the J-T slot close to the needle tip; ([See annotated FIG 1 above; Needle tip which is located at the distal end and distal end of the J-T slot is close to needle tip]) when the needle tip is located at the second adjusting position, the distal end of the J-T slot is located in the vacuum insulation area; ([page 8: paragraph 5] The backward movement which is equivalent to the second adjusting position is in the vacuum insulation area) the vacuum wall comprises: a front vacuum wall section and a rear vacuum wall section, from a distal end to a proximal end of the vacuum wall, the front vacuum wall section and the rear vacuum wall section are sequentially distributed, (See annotated FIG 1 above where the vacuum wall is separated into the distal and the proximal end which is seen as the front section and the rare section respectively) and the front vacuum wall section and the rear vacuum wall section are capable of moving relatively; ([See annotated FIG 9 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion which are located at the front are rare sections, can move relatively]) the needle tip is located at the front vacuum wall section; (See annotated FIG 1 above) the vacuum wall adjusting apparatus enables the needle tip to be switched between the at least two adjusting positions by adjusting the relative position of the front vacuum wall section and the rear vacuum wall section; ([page 8: paragraph 5] adjustment can be made forward which will be interpreted as the first adjusting position, and backward, which will be interpreted as the second adjusting position; Forward and backward constitutes at least 2 adjusting positions) the vacuum wall adjusting apparatus comprises: a second sliding block and a second sliding block guiding portion; (The word “second” is used, however a “second” sliding block is just seen as a sliding block, there is no “first” [See FIG 1 above; Mandrel 11 is equivalent to the sliding block guiding portion][page 8: paragraph 5] the driving lever is taken as the push tube) the second sliding block and the front vacuum wall section are capable of being controlled to synchronously move in a direction guided by the second sliding block guiding portion, ([See annotated FIG 9 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion are moving relative to each other]) to switch the needle tip between the adjusting positions; the second sliding block guiding portion is configured to guide the second sliding block and the front vacuum wall section to move in the axis direction of the vacuum wall; ([page 3: paragraph 4 under “Contents of invention”] the adjustment component, the mandrel and the front section which encompasses the vacuum wall, is axially slidable, all these components must move together synchronously to achieve this motion]) when the needle tip is located at the first adjusting position, in the axis direction of the vacuum wall, a second preset distance exists between the distal end of the J-T slot and the needle tip,([page 6: paragraph 2] the heat insulation area 4 corresponds to the second preset distance; this distance occurs in the first adjusting position during the forward movement) and the second preset distance at least ensures that an ice ball formed; ([page 8: paragraph 7] ice balls produced) and when a distal end of the vacuum wall is located at the second adjusting position, in the axis direction of the vacuum wall, a third preset distance exists between the distal end of the J-T slot and a distal end of the vacuum insulation area, and the third preset distance at least ensures that a refrigerant directly returns from the inside of the vacuum insulation area after being sprayed from the J-T slot, ([page 6: paragraph 5] contains a return air groove in connection with the heat layer (12), zone 3 corresponds to a third preset distance when the cold energy returns through the return pipe) the distal end of the vacuum insulation area being an end of the vacuum insulation area close to the needle tip (See annotated FIG 1 above showing distal end taken as the end close to the needle tip). However, Yang ‘405 does not explicitly disclose: the ice ball formed by freezing is wrapped around the needle tip
Yang ‘224 discloses: the ice ball formed by freezing is wrapped around the needle tip ([page 12: paragraph 4] the position of the needle bar and the J-T groove are relatively fixed so that the ice ball can completely cover the needle tip)
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the ice ball formed through freezing as disclosed in Yang ‘405 to include the ice ball formed by freezing completely covering the needle tip as disclosed in Yang ‘224. The motivation to do so being, when the ice ball completely covers the needle tip, the risk of puncturing organs and blood vessels can be prevented (Yang ‘224 [page 12: paragraph 4]).
Regarding claim 12, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 11, wherein the second sliding block guiding portion is arranged in the axis direction of the vacuum wall; (The word “second” is used, however a “second” sliding block is just seen as a sliding block, there is no “first” [See FIG 1 of Yang ‘405 above; Mandrel 11 is equivalent to the sliding block guiding portion][page 8: paragraph 5] the driving lever is taken as the push tube and they are arranged and capable of sliding in the axis direction) the second sliding block is connected to the front vacuum wall section, and a position of the second sliding block guiding portion is fixed relative to the front vacuum wall section or the rear vacuum wall section; (See FIG 9 of Yang ‘405 above) and if the position of the second sliding block guiding portion is fixed relative to the rear vacuum wall section, the second sliding block and the second sliding block guiding portion are capable of sliding relatively; (See annotated FIG 9 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion are moving relative to each other) and if the position of the second sliding block guiding portion is fixed relative to the front vacuum wall section, the rear vacuum wall section and the second sliding block guiding portion are capable of sliding relatively (See annotated FIG 9 above which shows a gap therefore indicating that the sliding block and sliding block guiding portion are moving relative to each other).
Regarding claim 13, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 12, further comprising: a second sealing assembly, wherein the second sealing assembly is arranged between the front vacuum wall section and the rear vacuum wall section, (See annotated FIG 1 above of Yang ‘405 showing a second sealing assembly located between the front and rare vacuum wall section) and is configured to form a dynamic seal between the front vacuum wall section and the rear vacuum wall section (Yang ‘405 [page 6: paragraph 9] sealing assembly is in dynamic sealing connection with the sealing ring).
Regarding claim 14, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 12, further comprising: a shifting block (See annotated FIG 9 above of Yang ‘405) and a second handle, (The word “second” is used, however a “second” sliding handle is just seen as a handle, there is no “first” [page 8: paragraph 6] wherein the second handle comprises: a handle adjusting slot; ([page 8: paragraph 6] the adjustment groove is seen as the handle adjusting slot) the shifting block is connected to the second sliding block, (See FIG 9 of Yang ‘405 above) the shifting block is arranged in the handle adjusting slot, (See FIG 9 of Yang ‘405 above) and the shifting block extends out of an outer wall of the second handle; (See FIG 9 of Yang ‘405 above) the shifting block is slidably connected to the handle adjusting slot; and the shifting block and the second sliding block are capable of being controlled to synchronously move in the axis direction (See annotated FIG 9 above which shows a gap therefore indicating that the shifting block and sliding block guiding portion are moving relative to each other).
Regarding claim 16, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 15, wherein an outer diameter of the outer tube is greater than an outer diameter of the needle rod, ([page 3: paragraph 8 under “Contents of invention”] the vacuum wall is larger than the needle rod) and an inner diameter of the outer tube is greater than an inner diameter of the needle rod; ([page 3: paragraph 8 under “Contents of invention”] the outer tube is larger than the needle rod) and an outer diameter of the inner tube rear section is greater than an outer diameter of the inner tube front section; ([See annotated FIG 1 above]) an inner diameter of the inner tube rear section is greater than an inner diameter of the inner tube front section ([See annotated FIG 1 above]).
Regarding claim 17, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 11, further comprising: a temperature measuring wire, ([page 8: paragraph 1 under heading ‘Example 3’] cryoablation needle with a temperature measuring wire) wherein a distal end of the temperature measuring wire is a temperature measuring point; (See annotated FIG 17 above; the temperature measurement point 2711 is located at the distal end ) the distal end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip; (See annotated FIG 17 above; temperature measuring wire point is close to the needle tip) and the temperature measuring point is arranged at the distal end of the J-T slot, and used for measuring temperature at the distal end of the J-T slot ([page 8: paragraph 1 under heading ‘Example 3’] temperature measurement wire is placed at the front end of the J-T slot which places it at the distal end; also see annotated FIG 17 above).
Regarding claims 15, and 18-20, which depend off of claim 11 and relate to the same structure, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 12, wherein the vacuum wall further comprises: an outer tube and a gasket, wherein a distal end of the outer tube is hermetically connected to a proximal end of the needle rod, (Yang ‘405 [page 3: paragraph 5 under “Contents of invention”] dynamically sealed means it is hermetically connected, indicating that it is air tight) a proximal end of the outer tube is hermetically connected to the proximal end of the inner tube, (Yang ‘405 [page 3: paragraph 12 under “Contents of invention”] dynamically sealed means it is hermetically connected, indicating that it is air tight) the distal end of the outer tube is an end of the outer tube close to the needle tip, ([See annotated FIG 1 of Yang ‘405 above]) and the proximal end of the outer tube is an end of the outer tube far away from the needle tip; ([See annotated FIG 1 of Yang ‘405 above]) the gasket is arranged between an outer wall of the inner tube and an inner wall of the needle rod to form a sealed connection; ([See annotated FIG 1 of Yang ‘405 above]) from the distal end to the proximal end of the inner tube, the inner tube sequentially comprises: an inner tube front section and an inner tube rear section; ([See annotated FIG 1 of Yang ‘405 above]) the inner tube front section penetrates through the needle rod; ([See annotated FIG 1 of Yang ‘405 above]) the inner tube rear section penetrates through the outer tube; ([See annotated FIG 1 of Yang ‘405 above]) and if the vacuum wall comprises: a front vacuum wall section and a rear vacuum wall section, the front vacuum wall section comprises the needle rod and the inner tube front section, ([See annotated FIG 1 of Yang ‘405 above]) and the rear vacuum wall section comprises the outer tube and the inner tube rear section ([See annotated FIG 1 of Yang ‘405 above]).
Claims 5 and 7 are rejected under 35 U.S.C. 103 as being unpatentable over Yang ‘405 in view of Yang ‘224 in further view of Shi et al (CN 209826949U) herein referred to as Shi
Regarding claim 5, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 2, further comprising: a spring wherein one end of the spring moves synchronously with the distal end of the J-T slot; (Yang ‘405 [page 3: paragraph 4 under “Contents of invention”] the adjustment component, the mandrel and the front section which encompasses the J-T slot straight section is axially slidable, all these components must move together synchronously to achieve this motion]) the other end of the spring is fixed relative to the J-T slot; ,(Yang ‘405 [page 6: paragraph 5] the spiral section can be welded which indicates that it is fixed to the wall which is relative to the J-T slot). However, Yang ‘405 in view of Yang ‘224 does not disclose: a clamping piece, and is further connected to the clamping piece; the clamping piece is capable of entering and exiting from a clamped position when the clamping piece is located at the clamped position, the spring is limited by the clamping piece to keep in a deformation state, and a distal end of the vacuum wall is located at the second adjusting position; the deformation state is a compression state or a tension state; and when the clamping piece exits from the clamped position, the spring is capable of generating a restoring force for restoring from the deformation state to a natural state, and the restoring force is capable of driving the distal end of the vacuum wall to enter the first adjusting position from the second adjusting position.
Shi discloses: a clamping piece, and is further connected to the clamping piece; the clamping piece is capable of entering and exiting from a clamped position; ([page 2: paragraph 7 under “Summary of the utility model”] clamping piece which can clamp and unclamp the spring) when the clamping piece is located at the clamped position, the spring is limited by the clamping piece to keep in a deformation state, and a distal end of the vacuum wall is located at the second adjusting position; ([page 4: paragraph 2] the clamping piece pulls the elastic member which causes it to be in a deformation state and has the ability to lock it in this position) the deformation state is a compression state or a tension state; (Yang ‘224 [page 9: last paragraph into page 10: first paragraph] the spring-like structure can be stretched and compressed, additionally, the spring can be made by winding the J-T groove) and when the clamping piece exits from the clamped position, the spring is capable of generating a restoring force for restoring from the deformation state to a natural state, and the restoring force is capable of driving the distal end of the vacuum wall to enter the first adjusting position from the second adjusting position ([page 3: paragraph 7 under “Detailed Description”] describes the sequence of the elastic member reverting to the natural state when the acting force provided by the clamp is removed)
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 spring structure as disclosed in Yang ‘405 in view of Yang ‘224 to include the clamp as disclosed in Shi. The motivation to do so being having a clamp can allow for the rapid and accurate puncture of the ablation needle, which can in turn reduce the pain of the patient caused by the fact that the patient needs to be punctured many times (Shi [page 3: paragraph 7 under “detailed description”] and [page 4: paragraph 2]).
Regarding claim 7, Yang ‘405 in view of Yang ‘224 discloses: The cryoablation needle with the adjustable vacuum wall position according to claim 6, a hand-held portion and a C-shaped ring, wherein the hand-held portion is arranged on the C-shaped ring; and the C-shaped ring is wrapped around an outer wall of the rear handle section (Yang ‘405 [page 8: paragraph 9] the ring is fixed on the outside of the heat insulation which is equivalent to the outside of the vacuum wall). However, Yang ‘405 in view of Yang ‘224 does not explicitly disclose: the clamping piece
Shi discloses: a clamping piece ([page 2: paragraph 7] a clamping device with a clamping piece)
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 spring structure as disclosed in Yang ‘405 in view of Yang ‘224 to include the clamp as disclosed in Shi. The motivation to do so being having a clamp can allow for the rapid and accurate puncture of the ablation needle, which can in turn reduce the pain of the patient caused by the fact that the patient needs to be punctured many times (Shi [page 3: paragraph 7 under “detailed description”] and [page 4: paragraph 2]).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C.G.S/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights