DETAILED ACTION
This action is pursuant to claims filed on 5/11/2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
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). The drawings must show every feature of the invention specified in the claims. The drawings do not show the structure of the sealing assembly between the push tube and the mandrel as described in the specification and claimed in claims 4 and 5. Figs. 3, 5, and 7-9 have the sealing assembly labelled, but the drawings are zoomed out and blurry and it is very difficult to ascertain the structure recited in the claims and specification. Additionally, it is unclear how the sealing element is intended to function because it does not appear to form a seal between the push tube and the mandrel. Therefore, the sealing assembly between the push tube and the mandrel must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
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.
Claim Objections
Claims 1-11 are objected to because they recite “J-T slot” which is an acronym for “Joule Thompson slot.” The acronym should be introduced or defined upon the first use, and then the acronym can be used throughout the claims. Using the acronym without first introducing the definition of the acronym can lead to confusion. Appropriate corrections are required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION. —The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “in areas in which the vacuum wall is distributed in the axis direction of the vacuum wall, an area in which a cavity is located is a vacuum insulation area” in lines 13-14. This limitation is unclear as written because the vacuum wall comprises both the inner tube and the needle tip, so the recited “vacuum insulation area” is essentially the entire length of the probe. Based on the specification of the instant application, this should be --in areas in which the inner tube is distributed in the axis direction of the vacuum wall--.
Claim 1 also recites “the J-T slot is capable of moving” in line 17. Based on the specification of the instant application, specifically paragraphs [027], [060], [0141]-[0142], and the remainder of the claims, this should be the JT-slot sleeve that is movable. The specification does not disclose the JT slot moving. Thus, the claim is indefinite because the claim language is inconsistent with the remainder of the disclosure.
Claims 2-20 are rejected due to their dependance on claim 1.
Claim 9 states the “vacuum wall further comprises: an outer tube […] a distal end of the outer tube is hermetically connected to a proximal end of the needle rod, a proximal end of the outer tube is hermetically connected to a proximal end of the inner tube […] the inner tube front section penetrates through the needle rod; and the inner tube rear section penetrates through the outer tube.” According to Figs. 1 and 2 of the instant application, the outer tube is a continuation of the needle rod since the edge of 21 continues directly into 23. Based on claim 1, the vacuum wall comprises a needle rod (21 in Figs. 1 and 2) and an inner tube (22 in Figs. 1 and 2) wherein the “inner tube penetrates through the needle rod.” Fig. 5 and 6 show a conflicting embodiment where the outer tube 23 is in the proximal section of the device and connects to a rear section of the inner tube. The issue is it is unclear which embodiment is intended. The contradictions in the drawings makes it unclear if the outer tube is meant to be a continuation of the needle rod or if it is supposed to be a completely separate tube. Thus, it is unclear based on the instant application how the outer tube connects to the needle rod and the inner tube or how the inner tube penetrates the needle rod and outer tube as required by claim 9. Therefore, the claim is rejected because it is unclear whether there is another tube around the needle rod and inner tube as shown in Figs. 3-5 or if the outer tube is a continuation of the needle rod over the inner tube as shown in Figs. 1 and 2.
Claims 10, 19, and 20 are rejected due to their dependance on claim 9.
Claim Rejections - 35 USC § 103
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 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.
Claim(s) 1-5, 9-15, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (hereinafter ‘Yang’, CN 110507405 A) in view of Dobak et al. (hereinafter ‘Dobak’, US 6241722 B1) and in further view of Hancock et al. (hereinafter ‘Hancock’, US 20200289199 A1).
Regarding independent claim 1, Yang discloses a cryoablation needle having a J-T slot sleeve, comprising: a vacuum wall (vacuum wall consists of outer wall and inner wall highlighted in Fig. 1 below), a J-T slot ([Page 6 of translation]: J-T slot 241, also highlighted in Fig. 1 below) and a J-T slot sleeve ([Page 5 of translation]: front section 12 of adjusting member 1, highlighted in Fig. 1 below), wherein
the vacuum wall comprises: a needle rod (outer wall highlighted in Fig. 1 below) and an inner tube (inner tube highlighted in Fig. 1 below);
the needle rod is provided with a needle tip at a distal end (needle tip at distal end of the needle rod 21 highlighted in Fig. 1 below);
the inner tube penetrates through the needle rod (inner tube penetrates through a portion of the needle rod as seen in the annotated Fig. 1 below), and a cavity is formed between the inner tube and the needle rod (there is a cavity between the outer wall and the inner tube in Fig. 1 below), the cavity being capable of forming a vacuum ([Page 6 of translation]: heat insulating pipe 22 is a double-layer vacuum wall – thus the space between the outer wall and the inner wall 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 (first preset distance highlighted below); the distal end of the inner tube is an end of the inner tube close to the needle tip (distal end of inner tube is closest to the needle tip);
the J-T slot sleeve is sleeved outside a distal end of the J-T slot (as seen in Figs. 1 and 9, the slot sleeve is located on the outside of the JT slot on the distal end; outside can be any direction and in this case is interpreted as perpendicular to the direction of the JT slot; the claim does not require that the slot sleeve always extend beyond the distal tip of the JT slot); the distal end of the J-T slot is an end of the J-T slot close to the needle tip (distal end of JT slot is the end closest to the needle tip);
the J-T slot and the J-T slot sleeve penetrate through the inner tube (the JT slot and sleeve penetrate the inner tube as seen in Fig. 1 below);
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 (vacuum insulation area highlighted below), and an area in which the first preset distance exists is a target area (first preset distance highlighted below);
the J-T slot [sleeve] is capable of moving in the axis direction of the vacuum wall relative to the J-T slot ([Page 5 of translation]: sleeve 12 is axially slidably disposed in the accommodation cavity to adjust the length of the targeting area);
a distal end of the J-T slot sleeve is capable of being switched between at least two adjusting positions relative to the vacuum wall, the at least two adjusting positions comprising: a first adjusting position and a second adjusting position ([Page 9 of translation]: the adjustment of target zone three is done by moving the adjusting lever forward and backwards which moves the adjustment component, forming a least two target area sizes – a large treatment area and a small treatment area);
the first adjusting position is located in the target area ([Page 9 of translation]: when adjusted to the shortest area, a small ice cube can be formed; this is like the treatment area shown in Fig. 9 where the sleeve is in the target area);
the second adjusting position creates the largest treatment zone ([Page 9 of translation]: when adjusted to the longest targeting area, the position of the entire adjustment assembly is rearmost relative to the fixed part);
when the distal end of the J-T slot sleeve 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 sleeve and the needle tip (second preset distance between the JT slot sleeve and the needle tip as seen in Fig. 9), and the second preset distance at least ensures that an ice ball formed by freezing is wrapped around the needle tip ([Page 9 of translation]: in the shortest target area an ice ball is formed; as seen in Fig. 9, the ice ball would be around the needle tip); and
when the distal end of the J-T slot sleeve is located at the second adjusting position, in the axis direction of the vacuum wall, a third preset distance exists third preset distance exists between the distal end of the J-T slot sleeve and a distal end of the vacuum insulation area (third preset distance is the distance between the end of the slot sleeve and the vacuum insulation area as seen in Fig. 10 – but the slot extends past the insulation area), and the third preset distance at least ensures that a refrigerant directly returns after being sprayed from the J-T slot sleeve (the middle connecting pipe is provided with a gas return slot 1331 for discharging the gas for the sleeve 12 – as seen through Figs. 5, 9, 10, 17, the return slot is provided directly with the JT slot and penetrates through the vacuum insulation area); the distal end of the vacuum insulation area being an end of the vacuum insulation area close to the needle tip (the distal end of the vacuum insulation area is the area closest to the needle tip).
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However, Yang does not disclose the distal end of the J-T slot is located in the vacuum insulation area, or the second adjusting position is located in the vacuum insulation area, or the third preset distance resulting in the refrigerant directly returning from the vacuum insulation area after being sprayed.
Dobak discloses a cryogenic device and system ([Abstract]). Dobak further discloses that the expanding means 22, which is a JT slot, can be located in a variety of positions to form a cooling region at a desired position along the device ([Col 9, lines 1-17]). This aligns with the goal of Yang which is to modify the size of the treatment region ([Page 9 of translation]). Furthermore, modifying the JT slot of Yang to terminate in the vacuum insulation area is simply a change in the size of the JT slot. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Additionally, modifying the JT-sleeve of Yang to have a second adjustment position in the vacuum insulation area is also a mere change in the size of the device as it simply requires the adjustment slider to slide further back. Such a modification would be well within the level of ordinary skill in the art. This would additionally result in the size of the treatment area being in the largest setting since the refrigerant would fill the distal end of the cryoprobe, forming a larger treatment zone. Lastly, this would result in the refrigerant returning directly from the vacuum insulation area since that is where the return groove is located and when refrigerant enters the vacuum insulation area, it can be removed through the return groove. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the length of the JT slot and sliding distance of the JT slot sleeve since such a modification is merely a change in the size of the components and would result in the ability to increase the size of the treatment area as taught by Dobak.
However, the Yang/Dobak combination does not disclose a dynamic seal is formed between the J-T slot sleeve and the J-T slot.
Hancock teaches a surgical instrument capable of freezing biological tissue ([Abstract]). Hancock further teaches that the tissue-freezing element resides within a thermally insulating sleeve, similar to that of Yang ([0066]). The fit between the outer surface of the freezing element and the insulating sleeve is sufficiently tight to form an air-tight sliding seal ([0066]). Forming the slot and sleeve of sufficient size to form a slidable, air-tight seal is merely a change in the size/shape of the components. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955). Utilizing a seal between the JT slot and sleeve would ensure the refrigerant is expelled and does not back flow into the sleeve, as that is the basic function of a seal. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the sizes of the JT slot and sleeve as taught by Hancock to form a slidable, air-tight sleeve that would prevent the flow of refrigerant between the JT slot and sleeve.
Regarding claim 2, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 1, further comprising: a J-T slot sleeve adjusting apparatus (sleeve adjusting apparatus highlighted in Fig. 3 below), wherein the J-T slot sleeve adjusting apparatus is configured to enable the distal end of the J-T slot sleeve to be switched between the at least two adjusting positions ([Page 9 of translation]: the adjustment of target zone three is done by moving the adjusting lever forward and backwards which moves the adjustment component, forming a least two target area sizes – a large treatment area and a small treatment area).
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Regarding claim 3, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 2, wherein the J-T slot sleeve adjusting apparatus comprises: a push tube (push tube 11 in Fig. 1) and a mandrel (tube 233 in Figs. 1 and 7 – the claim does not provide any structure or function to the mandrel and is simply interpreted as a cylindrical support), wherein the mandrel is arranged in the axis direction of the vacuum wall (the mandrel is arranged in the axis direction of the vacuum wall as seen in Fig. 1 and 7); the push tube penetrates through the mandrel ([Pages 7-8 of translation]: tube 11 passes through tube 233); a distal end of the push tube is connected to a proximal end of the J-T slot sleeve (distal end of the push tube is connected to the proximal end of the JT slot sleeve 12 as seen in Fig. 3); the distal end of the push tube is an end of the push tube close to the needle tip (the distal end of the push tube is the end closest to the needle tip); and the push tube and the J-T slot sleeve are capable of being controlled to synchronously move in the axis direction, to switch the distal end of the J-T slot sleeve between the adjusting positions ([Page 9 of translation]: the adjustment of target zone three is done by moving the adjusting lever forward and backwards which moves the adjustment component, forming a least two target area sizes – the control is inherently synchronous as they are all directly to each other so movement of the push tube directly controls the movement of the JT slot sleeve).
Regarding claim 4, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 3, further comprising: a sealing assembly (sealing assembly 23 in Fig. 7), wherein the sealing assembly is configured to form a dynamic seal between the mandrel and the push tube ([Pages 7 and 8 of translation]: the push tube 11 passes through tube 233 and is dynamically sealed).
Regarding claim 5, the Yang/Dobak/Hancock discloses the cryoablation needle having the J-T slot sleeve according to claim 4, wherein the sealing assembly comprises: a sealing ring (sealing ring 231 in Fig. 7), a sealing slot (slot that is surrounded by ring 231 in Fig. 7) and a sealing press piece (sealing press piece 232 in Fig. 7), wherein the sealing slot is fixedly sealed with a proximal end of the mandrel (the sealing slot is fixedly sealed with the proximal end of the mandrel as seen in Fig. 7 since the sealing ring 231 covers the connection between 233 and 232 in Fig. 7); the sealing ring is arranged between the mandrel and the sealing slot (as seen in Fig. 7, the sealing ring extends down slightly below the mandrel 233 in Fig. 7 and is positioned laterally between the back edge of the sealing slot and the mandrel 233 in Fig. 7), and the sealing press piece is arranged between the sealing ring and the sealing slot (the press piece is arranged between the ring and the very back of the sealing slot in the axial direction); and the sealing press piece is capable of being controlled to extrude axially ([Pages 7-8 of translation]: the piece 232 can translate along the threads), so that the sealing ring radially extrudes the mandrel, to form the dynamic seal between the mandrel and the push tube ([Pages 7-8 of translation]: the ring can
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slide and form a dynamic seal between the mandrel and push tube).
Regarding claim 9, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 1, wherein the vacuum wall further comprises: an outer tube (outer tube highlighted below), wherein a distal end of the outer tube is hermetically connected to a proximal end of the needle rod (outer tube connects to needle rod as seen in Fig. 6 below since it is a continuation of the needle rode in Fig. 1 – this is consistent with the embodiment shown in Fig. 2 of the instant application), a proximal end of the outer tube is hermetically connected to a proximal end of the inner tube (proximal end of the outer tube connects to the proximal end of the inner tube as seen below); the distal end of the outer tube is an end of the outer tube close to the needle tip, and the proximal end of the outer tube is an end of the outer tube far away from the needle tip (corresponding as seen below); an outer diameter of the outer tube is greater than an outer diameter of the needle rod (outer diameter is greater as seen below), and an inner diameter of the outer tube is greater than an inner diameter of the needle rod (inner diameters are greater as seen below); from the distal end to the proximal end of the inner tube, the inner tube sequentially comprises: an inner tube front section (portion that connects to the needle rod as seen below) and an inner tube rear section (portion where the inner tube is horizontal in the handle as seen below); an outer diameter of the inner tube rear section is greater than an outer diameter of the inner tube front section (the widest section of the inner tube is greater than the portion that penetrates into the needle rod); an inner diameter of the inner tube rear section is greater than an inner diameter of the inner tube front section (inner diameter of the rear section is greater than the inner diameter of the very front section); and the inner tube front section penetrates through the needle rod; and the inner tube rear section penetrates through the outer tube (inner tube penetrates into the needle rod as highlighted below and the remainer, which forms the rear section, penetrates through the outer tube).
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Regarding claim 10, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 9, wherein a dynamic sealing point between the J-T slot sleeve and the J-T slot is located at a proximal end of the J-T slot sleeve (in the combination described above, the sleeve and JT slot are sized to form a slidable seal, thus the seal extends the entire length of the JT-slot, thus it is located at the proximal end); and the dynamic sealing point is located inside the inner tube rear section (in the second treatment position, the sealing point is located in the inner tube rear section as seen in claim 10).
Regarding claim 11, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 1, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a distal end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the distal end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip (close to the tip as seen in Fig. 17); and the temperature measuring point is arranged at the distal end of the J-T slot sleeve and used for measuring temperature at the distal end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 12, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 2, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire
close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 13, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 3, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire
close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 14, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 4, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire
close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 15, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 5, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire
close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 19, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 9, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 20, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 10, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Claim(s) 6-7 and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Yang/Dobak/Hancock combination as applied to claim 4/3/2/1 as described above, in further view of Van Bladel (US 20030195436 A1).
Regarding claim 6, the Yang/Dobak/Hancock combination discloses the cryoablation needle having the J-T slot sleeve according to claim 4 as described above. Yang further discloses an adjusting sleeve 14 with a rod 143 for adjusting the adjusting member between the various treatment positions ([Pages 8-9 of translation]). The adjusting sleeve 14 can function as a clamping piece because connected to the adjusting tube 11 and 12 as seen in Fig. 3 which moves the adjusting tube, thus entering and exiting a clamped position ([Pages 8-9 of translation]).
However, Yang is silent to a spring, wherein one end of the spring is capable of moving synchronously with the distal end of the J-T slot sleeve, and is further connected to the clamping piece; the other end of the spring is fixed relative to the vacuum wall; 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 the distal end of the J-T slot sleeve 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 J-T slot sleeve to enter the first adjusting position from the second adjusting position.
Van Bladel teaches a probe for securing a tumor and delivering coolant to the distal tip ([Abstract]). Similar to Yang, Van Bladel teaches a center probe with a slidable lumen overtop as seen in Figs. 3-6. The slidable cannula is controlled via a spring 35 and a block 32. The spring urges the block forward by providing a distal force to translate the lumen over the distal tip of the center probe ([0036]). As shown in Figs. 5 and 6, the spring comprises a compressed state and a relaxed state. In the compressed state, the spring is compressed by the block 32 and retracts the lumen as seen in Fig. 5. In the relaxed/tension state, the spring is released and the lumen is in the forward-most position over the distal end of the center probe as seen in Fig. 6. Utilizing a spring positioned between the back of the adjusting portion 14 and the back end of the vacuum wall in Yang would function in the exact same way. The spring would move the adjusting portion 14 and adjusting tube forward when de-compressed. The spring provides for a quicker release of the lumen in the handle ([0031]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to combine the spring of Van Bladel with the device of the Yang/Dobak/Hancock combination to provide for a quick transition between the second and first adjusting positions.
Regarding claim 7, the Yang/Dobak/Hancock/Van Bladel combination discloses the cryoablation needle having the J-T slot sleeve according to claim 6, wherein the clamping piece comprises: a positioning pin (pin 143 in Figs. 2 and 3 of Yang) and a ring (ring is the sleeve 14), wherein the positioning pin is arranged on the C-shaped ring (143 is on the ring as seen in Fig. 3) ; the C-shaped ring is wrapped around an outer wall (wrapped around outer wall as seen in Fig. 9) with a fixed position relative to the vacuum wall ([Pages 8-9 of translation]: the adjusting sleeve 14 is sheathed on the head insulation tube – this is interpreted as a fixed position because based on the specification of the instant application, the sheath is not stationary but fixed as in attached to so it does not fall off); and when the distal end of the J-T slot sleeve is located at the first adjusting position, the positioning pin is configured to keep the spring in the deformation state (this would be in the tension state as the spring is fully extended in the combination as described above).
However, the ring of Yang is a complete circle and not C-shaped.
It would have been an obvious matter of design choice to make the different portions of the ring of the clamp of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Regarding claim 16, the Yang/Dobak/Hancock/Van Bladel combination discloses the cryoablation needle having the J-T slot sleeve according to claim 6, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Regarding claim 17, the Yang/Dobak/Hancock/Van Bladel combination discloses the cryoablation needle having the J-T slot sleeve according to claim 7, further comprising: a temperature measuring wire ([Pages 9-10 of translation]: temperature measuring wire 271), wherein a far end of the temperature measuring wire is a temperature measuring point ([Pages 9-10 of translation]: temperature measuring point is 2711 which is the distal end of the temperature measuring wire); the far end of the temperature measuring wire is an end of the temperature measuring wire close to the needle tip (as seen in Fig. 17, the far end of the temperature measuring wire is close to the needle tip); and the temperature measuring point is arranged at the far end of the J-T slot sleeve and used for measuring temperature at the far end of the J-T slot sleeve (it is located at the distal end of the JT slot as seen in Fig. 17, which also places it on the distal end of the JT slot sleeve in the treatment position where the slot sleeve is even with the end of the JT slot; since it is a temperature measuring wire, it would inherently measure the temperature at the end of the JT slot sleeve when the end of the slot sleeve and the JT slot are even with each other).
Allowable Subject Matter
Claims 8 and 18 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.
Regarding claim 8, the Yang/Dobak/Hancock/Van Bladel combination discloses the cryoablation needle having the J-T slot sleeve according to claim 7, further comprising: a handle (handle 26 in Fig. 6), wherein the handle is arranged at a proximal end of the vacuum wall (the handle is on the proximal end of the vacuum wall as seen in Fig. 6), and a position of the handle is fixed relative to the vacuum wall (the handle is fixed to the vacuum wall as seen in Fig. 6); the proximal end of the vacuum wall is an end of the vacuum wall far away from the needle tip (the proximal end of the vacuum wall is the side away from the tip in Fig. 6); the handle is provided with a handle positioning slot (positioning slot is the portion where lever 143 penetrates through the handle as seen in Figs. 9 and 10); and the positioning pin is capable of being controlled to be inserted into the handle positioning portion (the portion 143 penetrates through the handle slot as seen in Figs. 9 and 10 at the same time), so that positions of the handle and the vacuum wall are relatively fixed, and in this case, the distal end of the J-T slot sleeve is located at the second adjusting position (they are relatively fixed as seen in Figs. 9 and 10, showing both adjusting positions).
However, the combination does not disclose a sliding block that is connected to the proximal end of the push tube and the clamping piece through which the positioning pin is inserted that is controlled to synchronously move with the push tube and the JT slot sleeve.
The adjusting portion of Yang does not require a sliding block to operate. The lever/pin 143 is directly connected to the ring to control the position of the push tube and JT slot sleeve. Adding an additional block through which the pin 143 penetrates would not add any additional function, nor is there any obvious benefit. Additionally, after a thorough search, no prior art was found that disclosed adding a sliding block to an sliding control system similar to that of Yang. Therefore, the claim is objected to as dependent upon a rejected base claim because the prior art of record does not disclose, teach, or suggest the sliding block of claim 8.
Claim 18 objected to because it is dependent upon claim 8.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM E MOSSBROOK whose telephone number is (703)756-1936. The examiner can normally be reached M-F 8-5.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/W.M./Examiner, Art Unit 3794