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 .
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.
Information Disclosure Statement
2. The Information Disclosure Statement submitted on 09 October 2023 has been considered by the Examiner.
Claim Objections
3. Claim 4 is objected to because of the following informalities.
Claim 4 contains a minor typographical error.
Claim 4, line 3: The Examiner suggests changing “the angled connection” to “the angle-selecting connector”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
4. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
5. Claims 28-29 are rejected under 35 U.S.C. 103 as being unpatentable over Mody et al. (US 2007/0219546 A1).
Regarding claim 28, Mody teaches a method of operating a cryoablation device (the system 10 comprises an ablation portion 20 having an ablating element 22 that delivers a cryogenic or cryoablation treatment [0112, 0132]) comprising:
inserting a sheath of the device through an entry aperture in a tissue wall (the sheath 12 is inserted through an opening of the left atrium 106 towards a target tissue [0185]);
bending a portion of the sheath inserted past the tissue wall to any desirable angle ranging from about 0° to about 90° (the sheath 12 is inserted through an opening of the left atrium 106 towards a target tissue [0185]. Specifically, the sheath 12 may be rotated or bent at any desirable angle ranging from about 0° to about 90° [0147, 0150]);
linearly translating a cryofluid conduit along a longitudinal axis of a distal portion of the sheath (the sheath 12 comprises a flexible outer tube 14 and an inner lumen 11 [0132]. Specifically, the conduit or transmission medium line 13 is slidably positioned within the lumen 11 of the outer tube 14 [0132]. In other words, the conduit or transmission medium 13 extends through the longitudinal axis of the outer tube 14 [0132]. Furthermore, the transmission medium 13 delivers the cryogenic medium to the cryoablation element 22 of the ablation portion 20 [0132]), causing a longitudinally extended ablation element to emerge from the sheath (the conduit or transmission medium line 13 extends through the outer tube 14 of the sheath 12 [0132]. Specifically, figures 1 and 2A illustrates the ablation portion 20 of the transmission medium line 13 exiting or emerging from the sheath 12 [0132, 0142, 0146, FIG. 1, FIG. 2A]) and rotate to assume an orientation of a plane perpendicular to the longitudinal axis (the deflection or steering elements are configured to rotate or deflect the ablation portion 20 of the transmission medium line 13 at various desired angles [0114, 0150, FIG. 2A]. For example, figure 1 and figure 2A illustrates the ablation portion 20 being deflected angle that is perpendicular to the longitudinal axis of the sheath 12 [FIG. 1, FIG. 2A]);
rotate the longitudinally extended ablation element around the longitudinal axis by rotation of the cryofluid conduit (the deflection or steering elements are configured to bend or deflect the ablation portion 20 of the transmission medium line 13 [0132, 0150]. In other words, the deflection or steering elements are configured to rotate or bend the transmission line 13 which positions the ablation portion 20 at a desired angle [0114, 0132, 0150]);
and further linearly translating the cryofluid conduit to bring a cryoablation surface of the longitudinally extended ablation element into contact with tissue of the tissue wall, within 2 cm of the entry aperture (the conduit or transmission medium line 13 extends through the outer tube 14 of the sheath 12 [0132]. Specifically, figures 1 and 2A illustrates the ablation portion 20 of the transmission medium line 13 exiting or emerging from the sheath 12 [0132, 0142, 0146, FIG. 1, FIG. 2A]. Furthermore, the cryoablation element 22 of the ablation portion 20 is positioned into the contact with the target tissue or anatomical region [abstract, 0112, 0132]).
Mody does not bending a portion of the sheath to angle more than 90°. However, the Examiner respectfully submits that Mody’s sheath may bent at angle ranging from about 0° to about 90° which approaches Applicant’s claimed range of more than 90° ([0150]). Therefore, a prima facie case of obviousness exists. Based on the approaching range, a person having ordinary skill in the art would have found it obvious to modify Mody’s sheath to be bent at an angle that is more than about 90° (MPEP 2144.05). The advantage of such modification will allow the sheath to be deflected at larger angles to improve the positioning of the cryoablation surface against various tissue or anatomical regions ([0132, 0150]).
Mody does not explicitly teach the longitudinally extended ablation element to be oriented within about 20° of the plane perpendicular to the longitudinal axis. However, the Examiner respectfully submits that Mody teaches the use of deflecting or steerable elements which deflect or rotate the longitudinally extended ablation element to assume a desired orientation of a plane perpendicular to the longitudinal axis (the deflection or steering elements are configured to deflect the ablation portion 20 of the transmission medium line 13 at various desired angles [0114, 0150, FIG. 2A]. For example, figure 1 and figure 2A illustrates the ablation portion 20 being deflected angle that is perpendicular to the longitudinal axis of the sheath 12 [FIG. 1, FIG. 2A]). Therefore, a person having ordinary skill in the art would have found it obvious to use the deflecting or steerable element to rotate the longitudinally extended ablation element into an orientation within about 20° of a plane perpendicular to the longitudinal axis. The advantage of such modification may improve the positioning of the longitudinally extended ablation element against various tissue or anatomical regions ([0114, 0132, 0150]). The Examiner further submits that the skilled artisan could arrive at the claimed limitation via routine experimentation (MPEP 2144.05)
Mody does not explicitly teach the cryoablation surface to contact the tissue within 2 cm of the entry aperture. However, Mody teaches wherein the cryoablation surface is inserted through the entry aperture of the left atrium and further guided to any desired location along a target tissue surface within the left atrium (the sheath 12 is configured to guide the cryoablation element 22 of the ablation portion 20 through an opening of the left atrium 106 and towards any desired tissue [0132, 0158]). Thus, the Examiner respectfully submits that a person would have obvious to guide the cryoablation device through the entry aperture such that cryoablation surface contacts the tissue within 2 cm of the entry aperture. This modification is beneficial, as the cryoablation surface can form a desired lesion pattern on a tissue that is within 2 cm of the entry aperture (e.g., an opening of left atrium) which may improve the treatment of cardiac arrythmias ([abstract, 0129, 0132, 0158]). The Examiner further submits that the skilled artisan could arrive at the claimed distance via routine experimentation (MPEP 2144.05).
Regarding claim 29, Mody teaches partially withdrawing the inserted portion of the sheath to bring the cryoablation surface into contact with tissue of the tissue wall (the handle portion may include a slider to translate the sheath 12 along its longitudinal axis [0132, 0187-0188]. Specifically, the slider is adapted to selectively engage the guide sheath 12 at a specific position [0132, 0187-0188]. For example, the slider can be used to withdraw a portion of sheath 12 which allows the cryoablation element 22 of the ablation portion 20 to be exposed for contact with the target tissue [0034, 0132, 0142, 0159, 0187]).
6. Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Mody et al. in view of Chin et al. (US 2002/0128636 A1).
Mody suggests the method of claim 28. Mody does not explicitly teach bending the portion of the sheath through an angle of more than 135°.
The prior art by Chin is analogous to Mody, as they both teach a cryoablation device comprising a sheath that is configured to be deflected at various angles ([abstract, 0020-0021, 0060, 0169]).
Chin teaches teach bending the portion of the sheath through an angle of more than 135° (the deflectable tip 106 of the sheath 104 may be bent at any angle having a value between 0° and approximately 180° [0161, 0169]. For example, the deflectable tip 106 of the sheath 104 may be bent at an angle of approximately 180° [0161, 0169, claim 1, claim 11]).
Therefore, it would have been obvious to a person having ordinary skill in the art at the time the application was effectively filed to modify Chin’s sheath to be bent at an angle of more than 135°, as taught by Chin. The advantage of such modification will allow the sheath to be bent at a larger angle to access various tissue site within the patient’s body (see paragraphs [0161, 0169] by Chin).
Allowable Subject Matter
7. Claims 1-2, 4, 6-9, 11-14, 16, 19-21, 23, and 26 are allowed.
8. The following is a statement of reasons for the indication of allowable subject matter: The prior art of record does not disclose or suggest a cryoablation device comprising a sheath, a cryogenic fluid conduit, a longitudinally extended ablation element, and an angle-selecting connector similar to those recited by the pending claims. The prior art of record does not explicitly suggest an angle-selecting connector between the longitudinally extended ablation element and the fluid supply conduit, the angle-selecting connector bending to orient the longitudinally extended ablation surface to within about 20° of perpendicular to the longitudinal axis when the longitudinally extended element is outside the sheath.
Regarding claim 1, Mody teaches a cryoablation device configured to be inserted to a heart chamber via transcutaneous, transvascular route (the system 10 is configured to deliver a cryogenic or cryoablation treatment [0112, 0132]. Specifically, the system 10 comprises a sheath 12 that may be routed through the patient’s vasculature and into the left atrium to perform an ablation procedure [0132, 0158, 0185]), and comprising:
a sheath (the sheath 12 is inserted through an opening of the left atrium 106 towards a target tissue [0185]), the sheath being actuatable to bend and thereby rotate a longitudinal axis of a distal end of the sheath to a selected angle within a range of angles between a straightened sheath angle, and at least 90° away from that angle (the sheath 12 is inserted through an aperture or opening of the left atrium 106 towards a target tissue [0185]. Specifically, the sheath 12 may be rotated or bent at any desirable angle ranging from about 0° to about 90° [0147, 0150]);
a cryogenic fluid conduit, actuatable to translate linearly along the longitudinal axis with respect to the sheath (the sheath 12 comprises a flexible outer tube 14 and an inner lumen 11 [0132]. Specifically, the conduit or transmission medium line 13 is slidably positioned within the lumen 11 of the outer tube 14 [0132]. In other words, the conduit or transmission medium 13 extends through the longitudinal axis of the outer tube 14 [0132]. Furthermore, the transmission medium 13 delivers the cryogenic medium to the ablation element 22 of the ablation portion 20 [0132]), a longitudinally extended ablation element attached to a distal end of the cryogenic fluid conduit (the ablation portion 22 of the transmission medium 13 [0132, FIG. 1, FIG. 2A]), sized to fit within the distal end of the sheath (the ablation portion 20 of the transmission medium line 13 is sized to fit within the sheath 12 [0132, 0142, 0146, 0161]), and configured to receive coolant from the cryogenic fluid conduit to cool down to generate a longitudinally extended cryoablation surface along a longitudinal extent of the longitudinally extended ablation element (the transmission medium 13 delivers the cryogenic medium to the cryoablation ablation element 22 of the ablation portion 20 [0132]); and
a deflecting or steerable element that is configured to deflect or rotate the longitudinally extended ablation element to assume a desired orientation of a plane perpendicular to the longitudinal axis (the deflection or steering elements are configured to deflect the ablation portion 20 of the transmission medium line 13 at various desired angles [0114, 0150, FIG. 2A]. For example, figure 1 and figure 2A illustrates the ablation portion 20 being deflected angle that is perpendicular to the longitudinal axis of the sheath 12 [FIG. 1, FIG. 2A]).
However, Mody does not explicitly teach an angle-selecting connector between the longitudinally extended ablation element and the fluid supply conduit, the angle-selecting connector bending to orient the longitudinally extended ablation surface to within about 20° of perpendicular to the longitudinal axis when the longitudinally extended element is outside the sheath. The Examiner respectfully submits that that Mody’s deflecting or steerable element (e.g., pull wires) does not provide sufficient structure to suggests an angle-selecting connector that is disposed between the longitudinally extended ablation element and the fluid supply conduit ([0134, 0150]).
The Examiner concludes that the prior art does not provide the requisite teaching, suggestion, and motivation to suggest the recited claim limitation. Therefore, the inventive features recited in the pending claims are not disclosed by the prior art and are not suggested by an obvious combination of the most analogous prior art elements.
Claims 2, 4, 6-9, 11-14, 16, 19-21, 23, and 26 are considered to contain allowable subject matter, as claims 2, 4, 6-9, 11-14, 16, 19-21, 23, and 26 depend upon claim 1.
Statement on Communication via Internet
9. Communications via Internet email are at the discretion of the applicant. All Internet communications between USPTO employees and applicants must be made using USPTO tools.
Without a written authorization by applicant in place, the USPTO will not respond via Internet email to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. A paper copy of such correspondence and response will be placed in the appropriate patent application. Except for correspondence that only sets up an interview time, all correspondence between the Office and the applicant including applicant's representative must be placed in the appropriate patent application. If an email contains any information beyond scheduling an interview such as an interview agenda or authorization, it must be placed in the application.
For those applications where applicant wishes to communicate with the examiner via Internet communications, e.g., email or video conferencing tools, the following is a sample authorization form which may be used by applicant:
"Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file."
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSHUA BRENDON SOLOMON whose telephone number is (571)270-7208. The examiner can normally be reached on 7:30am -4:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Niketa Patel can be reached on (571)272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOSHUA BRENDON SOLOMON/Examiner, Art Unit 3792