DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant’s arguments with respect to claim(s) 1-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
4. It is noted that Claims 18 and 19 are newly added. They are examined in the present office action below.
Claim Rejections - 35 USC § 102
5. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
6. Claims 1, 2, 5, 6, 9, 13, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Levin U.S. 7,481,806 (herein referred to as “Levin”).
7. Regarding Claim 1, Levin teaches an apparatus for cryoablation (Fig. 1) comprising:
a. a supply unit configured to provide sub-cooled liquid nitrogen for streaming (Fig. 1, ref num 101; Col. 4, lines 36-42), the supply unit configured to maintain the liquid nitrogen in a liquid phase at or below its boiling point during delivery (Col. 7, lines 62-63, “a thermo-insulated tank (or a Dewar flask) 101 with cryogenic liquid”), thereby to utilize latent heat of the liquid nitrogen as a primary energy transfer mechanism at a cryoablation site (Col. 10, lines 22-31);
b. catheter tubing (Fig. 4, ref num 407) connecting said supply unit to said cryoablation tip (Col. 10, lines 54-55, “The proximal end of the feeding-venting central lumen is provided with an inlet-outlet connection 407”; Col. 6, lines 17-21, “A portion of the cryogenic liquid is introduced via the feed pipe of the thermo-insulated tank into the duct communicating the multi-way valve with the inlet-outlet connection installed on the proximal end of the central feeding-venting lumen”), the catheter tubing comprising an inner tube for supplying said liquid nitrogen to said tip (Fig. 4, ref num 401) and a concentrically located outer tube for carrying exhaust from said tip (Fig. 4, ref num 404; Col. 10, lines 45-53), wherein said outer tube provides thermal insulation of said inner tube (Col. 10m lines 19-21, “FIG. 4 shows an axial cross-section of a cryosurgical instrument 400 with application of active thermal insulation based of the principle of a heat pipe”);
c. a cryoablation tip for use at a cryoablation site (Fig. 4, ref num 402), the tip configured to receive said super-cooled or boiling liquid nitrogen (Fig. 10, lines 34-36, “which serves for immediate supply of portions of the cryogenic liquid to the internal porous coating 403 of the distal cryotip 402”) and to exchange heat using said liquid nitrogen, thereby to carry out ablation (Col. 10, lines 36-39, “t the same time, for removal of the vapors, generated in the process of boiling the cryogenic liquid in this internal coating 403, into the atmosphere or into a vacuum pump”; Col. 4, lines 41-43, “the [first] one--a cryogenic liquid with low temperature of boiling (for example, liquid nitrogen), which serves for cryogenic treatment of target tissue”).
8. Regarding Claim 2, Levin teaches supply unit comprises a pressure tank and a liquid nitrogen tank (Fig. 1, ref num 101, 103), the pressure tank being connected to the liquid nitrogen tank (Fig. 1, ref num 103 is connected to ref num 101) and being controllable to provide a pressure to maintain the liquid nitrogen as a liquid at boiling point or below, thereby to take advantage of latent heat to prevent changes of temperature of said liquid nitrogen (Col. 7, lines 64-67, “which gives possibility to preset a desired pressure in the thermo-insulated tank, a shut-off valve 102 that serves for filling the thermo-insulated tank 101 with the cryogenic liquid, and manometer 104”).
9. Regarding Claim 5, Levin fails to teach a manifold between said catheter tubing and said tip, the manifold configured to connect the inner tube to provide said liquid nitrogen to an inlet of said tip, and to connect the outer tube to an outlet of said tip.
10. Regarding Claim 6, Levin teaches a sheath (Fig. 1, ref num 105), said sheath having a proximal end and a distal end (see Fig. 1), the distal end containing said tip (Fig 1, distal end of ref num 105 contains tip, ref num 116), the sheath being controllably steerable to enable said distal end to reach a cryoablation site (Col. 2, lines 21-23, “a distal cryotip, which serves for immediate contact with a target tissue to be treated”).
11. Regarding Claim 9, Levin teaches said tip comprises a hollow tube (see Fig. 4), the hollow tube having an inlet for inflow of said liquid nitrogen (Fig. 1, ref num 407) and an outlet for outflow of said liquid nitrogen after use as exhaust (Col. 10, lines 49-53, “the coaxial tubular piece 405 and the mating section of the central feeding-venting lumen 401 is filled with vapors of such a gas that its condensation temperature is higher than the boiling temperature of the applied cryogenic liquid”).
12. Regarding Claim 13, Levin teaches to control pressure at a tip inlet in order to maintain said liquid nitrogen as a boiling liquid (Col. 6, lines 35-38, “The cryogenic liquid is boiling in the porous coating of the cryotip with elevation of pressure of the cryogenic liquid vapor in the central feeding-venting lumen and the main duct”).
13. Regarding Claim 14, Levin teaches a vacuum source connected to an outlet of said tip (Col. 6, lines 57-60, “A pressure gauge is installed on one end of the crossbar and an adjusting valve is installed on the other end, this adjusting valve is connected with the atmosphere or with the vacuum pump”; Fig. 1, ref num 121).
14. Regarding Claim 16, Levin teaches method for cryoablation comprising:
a. providing a supply unit configured to provide sub-cooled liquid nitrogen for streaming (Fig. 1, ref num 101; Col. 4, lines 36-42),
b. maintaining the liquid nitrogen in a liquid phase at or below its boiling point during delivery such that said liquid nitrogen arrives at said tip at or below said boiling point (Col. 7, lines 62-63, “a thermo-insulated tank (or a Dewar flask) 101 with cryogenic liquid”),
c. exchanging heat at said tip using said liquid nitrogen, wherein said liquid nitrogen undergoes a liquid to vapour phase transition at said tip, thereby releasing latent heat of vaporization as a primary energy transfer mechanism (Col. 10, lines 22-31);
d. a cryoablation tip for use at a cryoablation site (Fig. 4, ref num 402), the tip configured to receive said super-cooled or boiling liquid nitrogen (Fig. 10, lines 34-36, “which serves for immediate supply of portions of the cryogenic liquid to the internal porous coating 403 of the distal cryotip 402”) and to exchange heat using said liquid nitrogen, thereby to carry out ablation (Col. 10, lines 36-39, “t the same time, for removal of the vapors, generated in the process of boiling the cryogenic liquid in this internal coating 403, into the atmosphere or into a vacuum pump”; Col. 4, lines 41-43, “the [first] one--a cryogenic liquid with low temperature of boiling (for example, liquid nitrogen), which serves for cryogenic treatment of target tissue”).
Claim Rejections - 35 USC § 103
15. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
16. Claims 3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Levin and in view of Baust U.S. 2016/0022345 (herein referred to as “Baust”).
17. Regarding Claim 3, Levin fails to teach the liquid nitrogen tank comprises two layers of vacuum as insulation.
Baust teaches a liquid nitrogen tank comprises two layers of vacuum as insulation (Fig. 5, ref num 206 and 202a; it is understood that the dewar has one layer of insulation and that the cartridge, ref num 202a would have another layer of insulation; that are vacuum sealed; para 0058 and 0090). It is regularly known in the art to use a double wall tank in order to keep the cryogen at the desired temperature and state (para 0010). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to have two layers of vacuum as insulation for the liquid nitrogen tank in order to keep the liquid nitrogen at the proper temperature.
18. Regarding Claim 10, Levin fails to teach said hollow tube is arranged in a coil.
Baust teaches a hollow tube is arranged in a coil (see embodiment, Fig. 10, ref num 106; para 0115). It would have been an obvious matter of design choice to make the different portions of the hollow tube 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.
19. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Levin and in view of Fominas U.S. 2022/0072276 (herein referred to as “Fominas”).
20. Regarding Claim 7, Levin fails to teach said sheath comprises a closure over said tip, the closure being controllably openable on reaching said cryoablation site to reveal said tip.
Fominas teaches an apparatus of analogous art (Fig. 1), wherein the apparatus comprises a sheath (Fig. 1, ref num 210) and a tip (Figs. 1 and 2, ref num 210 as a tip), wherein the sheath comprises a closure over the tip (Figs. 3 and 11A, ref nums 140 and 142). The closure is controllably openable on reaching a target site to reveal said tip (Fig. 11B, ref num 140/142 is openable at target site; para 0022, 0029). This protects the tip, as well as the surrounding tissue, until the device has reached the target tissue (para 0022). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to include a closure over the tip that opens at the target site in order to protect the tip of the device and surrounding non-target tissue.
21. Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Levin and in view of Adawi U.S. 2022/0249172 (herein referred to as “Adawi”).
22. Regarding Claim 8, Levin fails to teach said sheath comprises electrodes for said controllable steering of said sheath.
Adawi teaches an apparatus of analogous art (Figs. 1, 6, and 9), wherein the apparatus comprises a sheath (Figs. 1 and 6, ref num 130) that comprises electrodes for said controllable steering of said sheath (Figs. 6 and 9, ref num 620; para 0037, “sheath 130 including magnetic sensors 620 and/or locatable electrodes… allows for navigation by discerning the rotation, deflection and orientation of sheath 130”). This aids with navigating the tip to the target site (Fig. 9 and para 0037, 0040). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to include electrodes for controlling the steering of the sheath, as this aids in the proper placement of the device.
23. Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Levin and in view of Yu U.S. 2017/0049495 (herein referred to as “Yu”).
24. Regarding Claim 11, Levin fails to teach the tip is made of a material having a shape memory.
Yu teaches an apparatus of analogous art (Figs. 17 and 20-27), wherein the tip of the apparatus (Fig. 17, ref num 1010) is made of a material having a shape memory (para 0032). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the tip made of a shape memory material, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
25. Regarding Claim 12, Levin fails to teach a controllable release mechanism to release said tip in different shapes for different energy release requirements.
Yu teaches an apparatus of analogous art (Figs. 17 and 20-27), wherein the tip of the apparatus (Fig. 17, ref num 1010) is made of a material having a shape memory (para 0032). The apparatus also has a controllable release mechanism (para 0142, 0145, 0149) to release said tip in different shapes for different energy release requirements (Figs. 25-27, ref nums 1112a, 1112b, and 1112c are the various shapes; para 0148). This is so that the shape of the tip will match closest to the anatomy of the tissue or the target area (para 0145) so that ablation may occur (para 0028). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to include a controllable release mechanism to release the tip into different shapes, as this achieves the expected result of ablation to the target area.
26. Claims 15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Levin and in view of Hancock U.S. 2020/0289199 (herein referred to as “Hancock”).
27. Regarding Claims 15 and 17, Levin fails to teach a control module to regulate an amount of energy released at said tip by calculating an amount of energy needed by a defined volume of tissue.
Hancock teaches an apparatus of analogous art (Figs. 1, 4A, and 4B), wherein the apparatus comprises a control module (para 0086-0087, “a controller may be used to control the various steps in the ablation process”), such that the control module regulates an amount of energy released at said tip by calculating an amount of energy needed by a defined volume of tissue (Figs. 4A and 4B; para 0082, 0085, 0086). This is to ensure that the target tissue is ablated (para 0082, 0086). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to include a control module to control the amount of energy delivered based on the volume of tissue in order to successfully ablated the target tissue.
28. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Levin and Baust, and further in view of Hancock U.S. 2020/0289199 (herein referred to as “Hancock”).
29. Regarding Claim 18, Levin fails to teach said cryoablation tip comprises a hollow tube arranged in a spiral coil having a controllable release mechanism that adjust an ablation footprint of said tip.
Baust teaches a hollow tube is arranged in a coil (see embodiment, Fig. 10, ref num 106; para 0115). It would have been an obvious matter of design choice to make the different portions of the hollow tube 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.
Hancock teaches an apparatus of analogous art (Figs. 1, 4A, and 4B), wherein the apparatus comprises a control module (para 0086-0087, “a controller may be used to control the various steps in the ablation process”), such that the control module regulates an amount of energy released at said tip by calculating an amount of energy needed by a defined volume of tissue (Figs. 4A and 4B; para 0082, 0085, 0086). This is to ensure that the target tissue is ablated (para 0082, 0086). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Levin to include a control module to control the amount of energy delivered based on the volume of tissue in order to successfully ablated the target tissue.
Allowable Subject Matter
30. Claim 19 is 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.
31. The following is a statement of reasons for the indication of allowable subject matter: the prior art of record fails to specifically teach a control module configured to evaluate an amount of energy released at said tip by comparing thermodynamic properties of said liquid nitrogen at an inlet of said tip with thermodynamic properties of exhaust at an outlet of said tip, and to estimate ablation depth based on said comparison. The prior art also fails to provide sufficient motivation to make such specific modifications and would require improper use of hindsight to arrive at the claimed invention when considered along or in any proper combination.
Conclusion
32. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
33. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
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