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 .
Claims 2-60 are cancelled. A complete action on the merits of pending claims 1 and 61-79 appears herein.
Response to Arguments
Applicant's arguments filed 12/10/2025 have been fully considered but they are not persuasive.
Applicant argues a POSITA in cardiac procedures would not look to Tearney due in part to “Tearney's procedure is performed through an airway (nasogastric tube) with the subject conscious (paragraph [0056]), addressing the discomfort of conventional endoscopy. This is fundamentally different from cardiac procedures, which require navigation through blood vessels into cardiac chambers filled with blood.”
Examiner respectfuly disagrees and contends that a POSITA in cryobiopsy procedures/devices would look to Tearney at least due to Tearney teaching cryogenic biopsy devices/systems/methods. Even if Tearney is silent regarding use in cardiac tissue, a POSITA in cardiac cryobiopsy, as further discussed in the rejection to claim 1 below, would be able to configure the device/procedure taught in Tearney to operate in a plurality of tissue environments, including cardiac tissue.
Applicant argues a POSITA in cardiac procedures would not look to Tearney due in part to “Tearney's small diameter probe (1.5 mm / 4-5 French) would be invisible or nearly invisible under the radiographic imaging required for cardiac procedures. The POSITA would understand that cardiac procedures require probes of at least 12 gauge for adequate radiographic visibility when navigating through blood-filled vessels and chambers where direct visualization is impossible.”
Examiner respectfully disagrees and contends that a POSITA in cardiac biopsy devices/procedures would be able to modify the probe/method of Tearney to either operate using another visualization technique more suited to the probe size taught by Tearney, or resize the probe of Tearney to the larger 12-gauge size required, according to applicant, for radiographic visibility.
Applicant argues a POSITA in cardiac procedures would not look to Tearney due in part to “Tearney's device is designed for collecting tissue from static organs (gastrointestinal tract) where the tissue remains relatively stationary. The POSITA would recognize that the dynamic, continuously beating heart presents entirely different challenges not addressed by Tearney.”
Examiner contends that a POSITA in cryogenic biopsy devices/procedures would, as further discussed in the rejection to claim 1 below, be able to appropriately modify the probe/procedure of Tearney to be able to operate in cardiac tissue using features/techniques known in the art used by cardiac probes/procedures. For example, Thiel teaches a mechanism for attaching/securing a probe to a target tissue. (Par. [0043])
Applicant further argues a “POSITA would understand that increasing Tearney's probe from approximately 4-5 French to at least 12 gauge (approximately 2.8 mm) for radiographic visibility would require more than doubling the external diameter. This is not a simple scaling exercise. The cooling dynamics, pressure relationships, and refrigerant flow characteristics described in Tearney are specifically designed for its small diameter configuration. Substantially increasing the size would fundamentally alter these carefully balanced parameters, with no guidance in Tearney on how to maintain functionality at larger sizes. Tearney teaches preferred size ranges that would discourage the POSITA from making such modifications. Although Tearney mentions that the probe "can have any length that is suitable to reach a site from which a tissue sample is to be taken" (paragraph [0061]), there is no teaching suggesting that the diameter could or should be substantially increased. The POSITA would have to assume that Tearney's cooling system performs best within the disclosed size ranges, and that moving substantially outside those ranges would compromise performance. There is no teaching in the prior art that would prompt the POSITA to ignore Tearney's dimensional teachings to make such a substantial size increase. More than that, the POSITA would fear that increasing the size of Tearney's probe outside of the disclosed ranges would reduce the performance of the assembly to an unworkable or unacceptable level.”
In response to applicant's argument that a POSITA would not be able to function with a change in size, the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981). In this case Tearney teaches a cryogenic biopsy device configured to use cryogenic fluid to cool a probe tip to a target temperature and place said tip in contact with a target tissue. Thiel, as further discussed in the rejection to claim 1 below, teaches a cryogenic probe configured to use cryo energy to affect a plurality of target tissues, including cardiac tissue. (Par. [0096], [0121], and [0215]) Furthermore, Examiner contends that a POSITA would be able to determine, through routine experimentation, the optimal values required to make the probe of Tearney function under the size changes made in the rejection to claim 1 below. Examiner further contends that Thiel teaches a probe configured to be used in tissue harvesting procedures (Par. [0090]) (e.g. biopsy procedures) wherein said probe uses cryo energy (Par. [0096])
Applicant further argues “Thiel teaches energy delivery devices "capable of using cryogenic energy" for treating tissue in various locations, "such as cardiac tissue and intestinal tissue" (paragraph [0122]). However, Thiel's uses include "tissue ablation, resection, cautery, vascular thrombosis, treatment of cardiac arrhythmias and dysrhythmias, electrosurgery, tissue harvest, etc." (paragraph [0002]). These are all destructive or therapeutic procedures, not tissue sampling for diagnostic purposes.”
Examiner respectfully disagrees and contends that the teaching of Thiel cited by applicant that the device/method of Thiel may be used in tissue harvesting procedures (Par. [0002]) would include biopsy procedures.
Applicant further argues “the POSITA would recognize that cryoablation (which Thiel addresses) and cryobiopsy are diametrically opposed in their goals: cryoablation seeks to cause cell death through freezing, while cryobiopsy seeks to remove living tissue cells for subsequent analysis without causing cell death (paragraphs [067]-[068] of the present specification). Because of these diametrically opposed goals, "even if somewhat similar devices can be used in each, the method of using them would be dramatically different" (paragraph [068] of the present specification).”
Examiner respectfully disagrees and contends that, as discussed above, Thiel teaches a device configured to use cryo energy; (Par. [0096]) wherein said device is capable of being used in tissue harvesting procedures, (Par. [0090]) which would include biopsy procedures. Therefore, Thiel and Tearney would not have diametrically opposed goals.
Applicant further argues “the combination of Tearney/Thiel would therefore present the POSITA with conflicting teachings: Tearney's gastrointestinal biopsy approach (unsuitable for cardiac use for the reasons above) combined with Thiel's ablation/destruction approach (fundamentally incompatible with the goal of harvesting living cells). There is no teaching that would lead the POSITA to adapt either reference for cardiac cryobiopsy.”
Examiner respectfully disagrees and contends that, as discussed above, Tearney could be modified by a POSITA to function in a cardiac tissue environment, and Thiel teaches use in tissue harvesting procedures and not just ablation/destruction.
Applicant further argues “However, Crowley is directed to an acoustic imaging system for cardiac ablation, teaching "a chemical ablation device" or ablation using "low-frequency RF energy" to "create a burn" causing tissue to "heat up and desiccate and finally necrose" (col. 2, lines 11-14). Like Thiel, Crowley is fundamentally concerned with tissue destruction, not tissue sampling. More importantly, Crowley does nothing to address the fundamental incompatibility between Tearney's small-diameter gastrointestinal probe and the requirements of cardiac procedures. Simply adding Crowley's steering mechanism to the Tearney/Thiel combination does not solve the problems of: i. Inadequate size for radiographic visibility. ii. Cooling system designed for static gastrointestinal tissue rather than dynamic cardiac tissue. iii. Lack of guidance on adapting a gastrointestinal biopsy device for the blood-filled cardiac environment.
iv. Conflicting teachings regarding tissue destruction (ablation) versus tissue preservation (biopsy).”
Examiner respectfully contends that Crowley, as further discussed in the rejection to claim 1 below, was merely used to teach a method of introducing a catheter into a heart via blood vessels and a steering mechanism configured for said introduction. (Col. 7, Lines 44-49; and Col. 13, Lines 11-14)
Applicant further argues “Even if the POSITA were to consider the Tearney/Thiel/Crowley combination (which they would not for the reasons above), an inventive step would be required to: i. Recognize that a gastrointestinal cryobiopsy device could potentially be adapted for cardiac use, despite the fundamental differences in the environments and the lack of any teaching suggesting such adaptation.”
Examiner respectfully contends that, as further discussed in the rejection to claim 1 below, Thiel teaches a device configured to use cryo energy; (Par. [0096]) wherein said device is capable of being used in tissue harvesting procedures, (Par. [0090]) which would include biopsy procedures.
Applicant further argues “Even if the POSITA were to consider the Tearney/Thiel/Crowley combination (which they would not for the reasons above), an inventive step would be required to: ii. Overcome the size incompatibility by substantially increasing Tearney's probe dimensions (more than doubling the diameter) whilst maintaining cooling functionality, with no guidance on how to do so.
Examiner respectfully contends that a POSITA would be able to determine, through routine experimentation, the optimal values required to make the probe of Tearney function under the size changes made in the rejection to claim 1 below. Thiel teaches a device configured to use cryo energy; (Par. [0096]) wherein said device is capable of being used in tissue harvesting procedures, (Par. [0090]) which would include biopsy procedures.
Applicant further argues “Even if the POSITA were to consider the Tearney/Thiel/Crowley combination (which they would not for the reasons above), an inventive step would be required to: iii. Adapt the cooling parameters for the dynamic cardiac environment rather than static gastrointestinal tissue.
Examiner respectfully contends that a POSITA in cryogenic biopsy devices/procedures would, as further discussed in the rejection to claim 1 below, be able to appropriately modify the probe/procedure of Tearney to be able to operate in cardiac tissue using features/techniques known in the art used by cardiac probes/procedures. For example, Thiel teaches a mechanism for attaching/securing a probe to a target tissue. (Par. [0043])
Applicant further argues “Even if the POSITA were to consider the Tearney/Thiel/Crowley combination (which they would not for the reasons above), an inventive step would be required to: iv. Ensure adequate radiographic visibility for navigation through blood-filled cardiac chambers.
Examiner respectfully disagrees and contends that a POSITA in cardiac biopsy devices/procedures would be able to modify the probe/method of Tearney to either operate using another visualization technique more suited to the probe size taught by Tearney, or resize the probe of Tearney to the larger 12-gauge size required, according to applicant, for radiographic visibility.
Applicant further argues “Even if the POSITA were to consider the Tearney/Thiel/Crowley combination (which they would not for the reasons above), an inventive step would be required to: v. Distinguish the cryobiopsy approach (harvesting living cells) from the cryoablation teachings of Thiel and Crowley (causing cell death).
Examiner respectfully disagrees and contends that, as discussed above, Tearney could be modified by a POSITA to function in a cardiac tissue environment, and Thiel teaches use in tissue harvesting procedures and not just ablation/destruction.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 63-67, 70 and 73-77 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tearney (US 2021/0000521 A1) in view of Thiel (US 2013/0165915 A1) in view of Crowley (US 5,588,432).
Regarding claim 70, Tearney teaches
a cryoprobe (Fig. 1, Char. 102: cryogenic probe) having a cryogenic probe tip (Fig. 1, Char. 104: tip) and
a controller (Fig. 10, Char. 1008: controller) comprising a processor (Par. [0087]: controller (1008) can be any combination of processors) and configured to:
bring the probe tip to a temperature at or below freezing to adhere cardiac tissue or cells to the probe tip; (Claim 13 and Par. [0133]) and
maintain the probe tip temperature at or below freezing through retraction of the probe tip from the body with the harvested cardiac tissue or cells adhered to the probe tip. (Claim 33)
Tearney, as applied to claim 70 above, is silent regarding the cryogenic probe tip being configured for introduction into a cardiac chamber via a blood vessel; and a steering mechanism configured to steer the probe tip to a tissue harvesting site within the cardiac chamber;
Thiel, in a similar field of endeavor, teaches an electrosurgical device capable of using cryogenic energy (Par. [0096]) and configured to treat tissue in a plurality of locations, such as cardiac tissue and intestinal tissue. (Par. [0121] and [0215])
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 Tearney, as applied to claim 70 above, to incorporate the teachings of Thiel, and configure the device of Tearney to be used in cardiac tissue since such a modification would have involved a mere change in the size of a component. 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).
The combination of Tearney/Thiel, as applied to claim 70 above, is silent regarding the cryogenic probe tip being configured for introduction into a cardiac chamber via a blood vessel; and a steering mechanism configured to steer the probe tip to a tissue harvesting site within the cardiac chamber.
Crowley, in a similar field of endeavor, teaches an electrosurgical catheter configured to be introduced into a heart through various blood vessels; (Fig. 15 and Col. 7, Lines 44-49) wherein the catheter comprises a steering mechanism configured to steer the probe tip to a tissue harvesting site within the cardiac chamber. (Col. 13, Lines 11-14: steering wire)
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 the combination of Tearney/Thiel, as applied to claim 70 above, to incorporate the teachings of Crowley, and configure the cryogenic probe (102) of Tearney for introduction into a cardiac chamber via a blood vessel and to include the steering wire of Crowley, such that manipulation of the steering wire repositions the probe tip of Tearney. Doing so would allow for easy navigation to/from a target treatment site.
Regarding method claim 1, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 70, since operation of the prior art relied on to reject apparatus claim 70 would naturally result in the step of method claim 1 being satisfied.
Regarding claim 73, the combination of Tearney/Thiel/Crowley, as applied to claim 70 above, teaches the cryoprobe further includes:
a proximal end comprising an inlet port (Tearney: Fig. 3, Char. 120: tube) and an outlet port; (Tearney: Fig. 3, Char. 112: arm) and
at least one microtube configured to inject a liquid refrigerant received via the inlet port into the probe tip, (Tearney: Par. [0063] and Fig. 3, Char. 204: inner tube)
wherein the probe tip defines a chamber configured to receive the liquid refrigerant and transition the liquid refrigerant from a liquid state to a gas state to lower the probe tip temperature, (Tearney: Par. [0062] and Fig. 3: The coolant transitions from a liquid state to a gaseous state within the inner chamber of tip (104))
wherein the probe defines a gas evacuation path from the probe tip to the outlet port. (Tearney: Par. [0063] and Fig. 3, Char. 202: outer tube)
Regarding method claim 63, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 73, since operation of the prior art relied on to reject apparatus claim 73 would naturally result in the step of method claim 63 being satisfied.
Regarding claim 74, the combination of Tearney/Thiel/Crowley, as applied to claim 73 above, teaches the controller is further configured to control the flow of the refrigerant within the probe to control the temperature of the probe tip. (Tearney: Par. [0129])
Regarding method claim 64, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 74, since operation of the prior art relied on to reject apparatus claim 74 would naturally result in the step of method claim 64 being satisfied.
Regarding claims 75 and 76, the combination of Tearney/Thiel/Crowley, as applied to claim 73 above, teaches the probe tip includes at least one sensor, including an optical sensor, coupled to the processor (Tearney: Claim 21: optical fiber and optical coherence tomography system and Par. [0133]: Some form of temperature sensor would be required to send a signal indicative of a temperature at tip (104)) and configured to sense at least one condition at the probe tip, the at least one condition including a temperature condition or a presence of the harvested cardiac tissue or cells adhered to the probe tip. (The optical coherence tomography system uses the reflected light to generate data indicative of the distance between the target tissue and the distal end of the probe tip; Image data indicating the distance between the probe tip and a tissue being greater than 0 would indicate the absence of tissue on the probe tip; and Tearney: Par. [0133]: A temperature condition is sent to feedback component (3804))
Regarding method claims 65 and 66, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claims 75 and 76, since operation of the prior art relied on to reject apparatus claims 75 and 76 would naturally result in the step of method claims 65 and 66 being satisfied.
Regarding claim 77, the combination of Tearney/Thiel/Crowley, as applied to claim 75 above, teaches a feedback loop between the at least one sensor and the controller configured to enable the controller to monitor and regulate the probe tip temperature. (Tearney: Par. [0133])
Regarding method claim 67, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 77, since operation of the prior art relied on to reject apparatus claim 77 would naturally result in the step of method claim 67 being satisfied.
Claim(s) 61 and 71 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tearney (US 2021/0000521 A1) in view of Thiel (US 2013/0165915 A1) in view of Crowley (US 5,588,432), as applied to claims 1 and 70 respectively above, and further in view of Potocky (US 5,108,390).
Regarding claim 71, the combination of Tearney/Thiel/Crowley, as applied to claim 70 above, is silent regarding the controller is further configured to: raise the temperature of the probe tip to above freezing to release the harvested cardiac tissue or cells from the probe tip once the probe tip is removed from the body.
Potocky, in a similar field of endeavor, teaches flooding a cryoprobe with a low pressure, room temperature gas to warm and defrost a cryoadhesion probe to detach the probe from a target tissue. (Col. 2, Lines 19-22)
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 the combination of Tearney/Thiel/Crowley, as applied to claim 70 above, to incorporate the teachings of Potocky, and configure the controller (1008) of Tearney to use the room temperature gas of Potocky to warm the cryogenic probe (102) of Tearney after the probe has been extracted from the body. Doing so would provide for a much faster retrieval of the extracted tissue, and would allow the tissue to be more quickly analyzed/used.
Regarding method claim 61, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 71, since operation of the prior art relied on to reject apparatus claim 71 would naturally result in the step of method claim 61 being satisfied.
Claim(s) 62 and 72 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tearney (US 2021/0000521 A1) in view of Thiel (US 2013/0165915 A1) in view of Crowley (US 5,588,432), as applied to claims 1 and 70 respectively above, and further in view of Chin (US 7,938,842 B1).
Regarding claim 72, the combination of Tearney/Thiel/Crowley, as applied to claim 70 above, is silent regarding the probe tip, or a portion thereof, is detachable from the probe with the adhered harvested cardiac tissue or cells once the probe tip is removed from the body.
Chin, in a similar field of endeavor, teaches an electrosurgical device comprising a probe with a distal tip detachable from an elongated shaft. (Fig. 7 and Col. 6, Lines 1-4)
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 the combination of Tearney/Thiel/Crowley, as applied to claim 70 above, to incorporate the teachings of Chin, and configure the tip (104) of Tearney to be detachable from the rest of probe (102) of Tearney. Doing so would allow for the probe (102) to be ready to use again more quickly, as a new probe tip may be attached instead of having to wait for the old probe tip to warm up. Furthermore, a detachable probe tip would allow the probe (102) to be usable even if the probe tip becomes damaged.
Regarding method claim 62, the claim is rejected by the same or substantially the same rationale as applied to the rejection of apparatus claim 72, since operation of the prior art relied on to reject apparatus claim 72 would naturally result in the step of method claim 62 being satisfied.
Allowable Subject Matter
As allowable subject matter has been indicated, applicant's reply must either comply with all formal requirements or specifically traverse each requirement not complied with. See 37 CFR 1.111(b) and MPEP § 707.07(a).
Claims 68, 69, 78, and 79 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.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 68, the prior art of record fails to explicitly teach all of the limitations of claim 64 and further teach the limitation “sensing an ambient temperature outside the body; and setting the probe tip temperature within the cardiac chamber based on the sensed ambient temperature outside the body.”
Claim 69 would be allowable due to its dependency on claim 68.
Regarding claim 78, the prior art of record fails to explicitly teach all of the limitations of claim 74 and further teach the limitation “the controller comprises an ambient temperature sensor and the controller is further configured to set the probe tip temperature within the cardiac chamber based on a sensed ambient temperature outside the body.”
Claim 79 would be allowable due to its dependency on claim 78.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794