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 61-85 appears herein.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/17/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/17/2026 have been fully considered but they are not persuasive.
Applicant argues “The Office Action contends that the proposed combination of Tearney and Thiel renders the claimed invention obvious, asserting that Thiel's disclosure of "tissue harvest" in paragraph [0002] equates to the claimed biopsy of viable cells. Applicants respectfully disagree and submit that the Office Action has misconstrued the fundamental mechanism and surgical context of Thiel's disclosure. More specifically, Thiel is directed to tissue destruction and macroscopic resection. While Thiel briefly mentions "tissue harvest," the entire context of Thiel's disclosure is directed to thermal and electrical surgical tools designed for tissue ablation, cutting, and permanent sealing (i.e., inducing localized necrosis or desiccation). In the surgical arts, "tissue harvest" in this context refers to macroscopic structural tissue resection (such as harvesting a vessel for bypass grafting), where surrounding cellular viability at the cut boundary is secondary to the physical removal of the structure. Put simply, Thiel fails to teach or suggest any cryoadhesive viability mechanisms. Indeed, Thiel provides no teaching or roadmap for using cryoadhesion- the controlled freezing of a probe tip to adhere to and cleanly retract intact, living cells-while actively preserving the viability of those cells.”
Examiner respectfully contends that the current claim language of claims 1, 70, and/or 83 is not limited to the biopsy of cells. Claims 1, 70, and 83 all recite harvesting cardiac tissue OR cells, with no restrictions on the size of the harvested tissue. Furthermore, as best understood by examiner, one of ordinary skill in the art would expect at least some of the cardiac tissue harvested in Thiel to retain cellular viability during/post harvesting as doing so would allow the harvested tissue to be in the best possible condition for whatever use the user has for said tissue. (e.g. testing) Examiner further contends that, as further discussed in the rejection to claim 70 below, Thiel was not relied on to teach using cryogenic energy or cryoadhesion to biopsy tissue. Thiel was merely relied on to teach a cryogenic device configured to harvest/treat tissue in a plurality of tissue locations including the heart. Tearney, as further discussed in the rejection to claim 70 below, teaches using cryoadhesion to biopsy target tissue.
Applicant further argues “Further, the combination proposed in the Office Action teaches away from cellular preservation. Both Thiel and Crowley are heavily focused on utilizing extreme thermal energy to destroy tissue or cause permanent cellular death (necrosis). If a POSITA were to introduce the high-energy ablation principles of Thiel or Crowley into the gastrointestinal cryoprobe of Tearney, the logical expectation would be the total destruction or desiccation of the sampled cells. Accordingly, nothing in the cited art teaches or suggests configuring a cryoprobe to operate at a specific retraction temperature profile dedicated to maintaining cellular viability of harvested cardiac tissue, as required by amended independent Claims 1 and 70.”
Examiner respectfully contends that, as further discussed in the rejection to claim 70 below, Tearney teaches a cryoprobe configured to operate at a specific retraction temperature profile (Par. [00133]) dedicated to maintaining cellular viability of harvested tissue. (Claims 13 and 33; as best understood by examiner, one of ordinary skill in the art would expect the cellular viability to be maintained due to the procedure being a biopsy procedure.) Thiel, as further discussed in the rejection to claim 70 below, was relied on to teach using the cryoadhesive biopsy device of Tearney in a plurality of target tissue regions, including cardiac tissue. Crowley, as further discussed in the rejection to claim 70 below, was used to teach a navigation path/mechanism for delivering a catheter to a target tissue location. The “high-energy ablation principles” of Thiel and Crowley were not introduced into the cryoadhesive biopsy device of Tearney.
Applicant further argues “The independent claims require a probe configured for a cardiac environment. Introducing a micro-sized probe into a contracting cardiac chamber filled with rapidly flowing blood alters the thermodynamic dissipation at the probe tip compared to the static environment of Tearney's GI tract.”
Examiner respectfully contends that, as further discussed in the rejection to claim 70 below, Tearney teaches using a cryoadhesion biopsy probe to harvest tissue from a target tissue region. Thiel, as further discussed in the rejection to claim 70 below, teaches a cryogenic probe configured to harvest tissue from a plurality of tissue regions, including the intestines and cardiac tissue. Thiel further teaches reducing a probe temperature low enough such that tissue adheres to said probe and maintaining said low temperature. (Par. [0043]) 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 such that the probe temperature is maintained relatively constant even in a cardiac environment. Doing so would allow the device of Tearney to be used in a wider range of biopsy locations/procedures, thereby minimizing the number of biopsy probes required to biopsy said tissue regions.
Applicant’s arguments, see Remarks, filed 06/17/2026, with respect to the rejection(s) of claim(s) 1 and 70 under U.S.C. 103 regarding changing the size of the cryoprobe of Tearney have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, Examiner respectfully contends that the catheter diameter of Tearney would not have to be scaled/changed to operate in a cardiac environment. As best understood by examiner, Par. [0072] of Applicant’s specification appears to recite that probe diameters within the range of 1.1-2.4mm are suitable for cryopbiopsy probes usable in cardiac tissue. As further discussed in the rejection to claim 70 below, the cryobiopsy probe of Tearney has a diameter of 1.5mm, (Par. [0061]) which is within the range specified by Applicant’s disclosure. As such, one of ordinary skill in the art would expect the size of the cryobiopsy probe of Tearney to not impede said probe’s use in treating/harvesting cardiac tissue/cells. Given that Thiel teaches using a cryogenic probe to harvest tissue in a plurality of tissue regions, including the intestines and cardiac tissue, and that Tearney teaches a cryoadhesion biopsy of an appropriate size to operate in cardiac tissue, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the cryoadhesion biopsy device of Tearney to operate in the plurality of tissue regions taught by Thiel, including cardiac tissue as doing so would allow the device of Tearney to be used in a wider range of biopsy locations/procedures, thereby minimizing the number of biopsy probes required to biopsy said tissue regions. Therefore, a new ground(s) of rejection is made in view of Tearney (US 2021/0000521 A1) in view of Thiel (US 2013/0165915 A1) in view of Crowley (US 5,588,432).
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.
Claim 85 is 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 85 recites the limitation “based on light reflected within the probe tip being blocked by the adhered tissue.” This limitation renders the claim unclear as to how the light being reflected within the probe tip could be blocked by tissue outside the probe. For the purpose of examination, the limitation “based on light reflected within the probe tip being blocked by the adhered tissue” is interpreted as “based on light reflected within the probe tip being reflected off of the adhered tissue.”
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, 73-77, 80-83, and 85 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 cryobiopsy apparatus, (Fig. 1) comprising:
a cryoprobe (Fig. 1, Char. 102: cryogenic probe) having a cryogenic probe tip; (Fig. 1, Char. 104: tip) and
a temperature sensor at the probe tip configured to measure the temperature of said probe tip; (Fig. 15, Char. 1402: temperature sensor; Par. [0102])
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 harvesting temperature at or below freezing to induce cryoadhesion of cardiac tissue or cells to the probe tip; (Claim 13 and Par. [0133]) and
maintain the probe tip temperature at a retraction temperature at or below freezing through retraction of the probe tip from the body so that the harvested tissue or cells remain adhered to the probe tip, (Par. [0133] and Claim 33: The temperature of the probe tip on which the biopsy samples are adhered when the probe (102) is retracted from the tissue region would be considered the retraction temperature.) wherein the retraction temperature maintains cellular viability of the harvested tissue or cells. (As best understood by examiner, one of ordinary skill in the art would expect the cellular viability of the harvested tissue to be maintained at least due to the fact that probe (102) is used in a biopsy procedure)
wherein the probe tip temperature is maintained via a feedback loop between the temperature sensor and the controller in which the controller adjusts the coolant flow in response to real-time temperature measurements from the temperature sensor. (Par. [0102])
Tearney further teaches the cryoprobe diameter is around 1.5mm, (Par. [0061]) which, is within the 1.1-2.4mm diameter range for cryobiopsy probes usable in cardiac tissue disclosed in Par. [0072] of Applicant’s currently filed specification.
Tearney, as applied to claim 70 above, is silent regarding the harvested tissue being cardiac tissue; the cryoprobe 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]) to harvest tissue; (Par. [0090]) wherein a probe temperature is maintained at or below freezing such that tissue adheres to a portion of the probe; (Par. [0043]) wherein the electrosurgical device is configured to operate 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 cryogenic probe (102) of Tearney to operate in the plurality of tissue regions taught by Thiel, including the cardiac region. Doing so would allow for cryogenic probe (102) to be used in a wider range of cryobiopsy procedures, thereby minimizing the number of different probes required for a user to have in order to perform said procedures in various tissue regions throughout the body.
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 claims 1 and 83, 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 80, the combination of Tearney/Theil/Crowley, as applied to claim 1 above, is silent regarding maintaining the probe tip temperature at or below freezing after exiting the body for at least 10 seconds.
However, Tearney teaches maintaining cryoadhesion of the biopsied tissue to the cryogenic probe after said probe is removed from the target tissue until histology paper can be applied to the tissue sample, after which the tissue is thawed to induce loss of adhesion. (Tearney: Claim 33 and Par. [0108])
Absent a statement of criticality AND unexpected results, the time spent retrieving and applying the histology paper to the tissue sample of Tearney after exiting the patient’s body is interpreted as reading on the claimed 10 seconds.
Regarding claim 82, the combination of Tearney/Theil/Crowley, as applied to claim 1 above, teaches the harvesting temperature and the retraction temperature are defined based on at least one of: temperature magnitude, surface area of the probe tip in contact with tissue, probe tip pressure against the cardiac wall, and duration. (The harvesting temperature and retraction temperature would each have at least a temperature magnitude and a duration)
Regarding claim 85, the combination of Tearney/Thiel/Crowley, as applied to claim 83 above, teaches the at least one sensor comprises an optical sensor, (Tearney: Fig. 4, Char. 402 and 404) and wherein the feedback loop determines that cardiac tissue or cells have adhered to the probe tip based on light reflected within the probe tip being blocked by the adhered tissue. (Tearney: Par. [0099]: the distance between tissue and the cryogenic probe is determined based on optical coherence tomography (OCT) data using light reflected from said tissue; A determination that tissue is contacting the cryogenic probe tip and that the probe tip temperature has reached the cryoadhesion threshold would indicate that tissue is adhered to the probe tip.)
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 claim 81, the combination of Tearney/Theil/Crowley, as applied to claim 64 above, teaches the controller is configured to control a magnitude (Tearney: Par. [0133]) and a duration of freezing temperatures (Tearney: Par. [0090]) at the probe tip to maintain cellular viability of the harvested cardiac tissue or cells. (As best understood by examiner, the cellular viability of the biopsied tissue harvested by the cryogenic probe (102) of Tearney would be maintained due to the procedure being a biopsy procedure.)
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, teaches raising 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. (Tearney: Claim 33 and Par. [0108])
The combination of Tearney/Thiel/Crowley, as applied to claim 70 above, is silent regarding the controller being configured to control the thawing of the probe tip.
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 be a simple substitution of one probe tip warming mechanism for another for the predictable result of detaching the harvested biopsy samples from the probe tip of Tearney, and would remove the need for a user to apply a warming pad to the probe tip.
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.
Claim(s) 84 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 claim 83 above, and further in view of Spero (US 2005/0182394 A1).
Regarding claim 84, the combination of Tearney/Thiel/Crowley, as applied to claim 83 above, teaches a harvesting temperature and a retraction temperature; (Tearney: Par. [0133] and Claim 33: The temperature of the probe tip on which the biopsy samples are adhered when the probe (102) is retracted from the tissue region would be considered the retraction temperature.) and the feedback loop indicating that cardiac tissue or cells have adhered to the probe tip. (Tearney: Par. [0099]: the distance between tissue and the cryogenic probe is determined based on optical coherence tomography (OCT) data using light reflected from said tissue; A determination that tissue is contacting the cryogenic probe tip and that the probe tip temperature has reached the cryoadhesion threshold would indicate that tissue is adhered to the probe tip.)
The combination of Tearney/Thiel/Crowley, as applied to claim 83 above, is silent regarding the harvesting temperature and the retraction temperature are different; and the controller being configured to transition the probe tip from the harvesting temperature to the retraction temperature in response to the feedback loop indicating that cardiac tissue or cells have adhered to the probe tip.
Spero, in a similar field of endeavor, teaches a biopsy device comprising a liquid-cryogen adhesion probe; (Fig. 3) in which the adhesion probe is cooled to a harvesting temperature and preservation temperature different from the harvesting temperature. (Par. [0035]: A final temperature of around -20 0C is preferred for biopsy and a final temperature of below -30 0C is preferred for cryo-preservation.)
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 combination of Tearney/Thiel/Crowley, as applied to claim 83 above, to incorporate the teachings of Spero, and configure the controller (1008) of Tearney to set the probe temperature of cryogenic probe (102) at the preferred biopsy temperature taught by Spero for cryo adhesion and transition the probe tip temperature to the preferred cryo-preservation temperature of Spero in response to the feedback loop indicating tissue is adhered to the probe tip. Doing so would allow the harvested tissue to be better preserved, as suggested in Spero. (Par. [0035])
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
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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