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 4, 6, and 18 are cancelled. A complete action on the merits of pending claims 1-3, 5, 7-17, and 19-23 appears herein.
Response to Arguments
Applicant’s arguments with respect to claim(s) 16 and 19 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.
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) 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249) in view of Gannoe (US 2002/0002376 A1).
Regarding claim 16, Arenas teaches a medical device (Fig. 1) comprising:
a handle; (Fig. 1, Char. 26: stiffening handle)
a shaft (Fig. 1-6, Char. 14 and 23) having a first portion, having a rigid outer sheath, (Fig. 2, Char. 23: stiffening member) and a second portion, having a flexible outer sheath, (Fig. 2, Char. 14: coiled wire body) wherein each of the first portion and the second portion of the shaft is configured to be inserted into a body lumen of a subject; (Col. 6, Lines 23-27) and
a rigid ram (Fig. 1-6, Char. 17: curve control wire) that is configured to be transitioned from a first configuration, in which a distal-most end of the ram is proximal of the second portion of the shaft, (Fig. 6) to a second configuration, in which the distal-most end of the ram is within the second portion of the shaft, (Fig. 2) wherein a proximal end of the ram protrudes from a proximal end of the handle, (Fig. 6: Control wire (17) extends proximally past stiffening handle (26)) and wherein the ram is transitioned from the first configuration to the second configuration by moving the proximal end of the ram in a distal direction. (Fig. 1-6 and Col. 4, Lines 64-66)
Arenas, as applied to claim 16 above, is silent regarding the ram extending through (a) a fluid connector that connects multiple fluid conduits within the handle or (b) an actuator within the handle.
Gannoe, in a similar field of endeavor, teaches a medical device comprising a handle (Fig. 11, Char. 58: body) including a grip portion, (Fig. 11, Char. 72: grips) a body portion, (Fig. 11: The portion of body (58) disposed distally of grips (72)) an actuator, (Fig. 12, Char. 66: spring; Par. [0056]: Spring (66) actuates/biases the plunger (42) back to the initial undepressed position) and a ram housing extending proximally of the body portion; (Fig. 11: The portion of body (58) disposed at the grips (72) and extending proximally from said grips) wherein a rigid ram extending through at least a portion of the body portion (Fig. 12: Push rod (50) extends through the distal end of body (58)) and the actuator. (Fig. 12: Push rod (50) extends through the center of spring (66))
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 Arenas, as applied to claim 1 above, to incorporate the teachings of Gannoe, and configure the proximal end of coiled wire body (14) to include the body (58) of Gannoe. Doing so would allow for a user to easily grasp/control coiled wire body as they manipulate stiffening handle (26) and knob (22) of Arenas.
Regarding claim 17, Arenas teaches the second portion of the shaft is bendable in the first configuration, and wherein the second portion of the shaft is rigid in the second configuration. (Claim 1)
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249) in view of Gannoe (US 2002/0002376 A1), as applied to claim 16 above, and further in view of Winston (US 5,916,210).
Regarding claim 23, the combination of Arenas/Ganoe, as applied to claim 16 above, is silent regarding the actuator is a magnetic actuator.
Winston, in a similar field of endeavor, teaches a ram (Fig. 6, Char. 58: rigid actuator wire) extending through a magnetic actuator (Fig. 6, Char. 62: magnetic actuator) configured to extend/retract said ram. (Col. 5, Lines 24-34, and Claim 14)
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 Arenas/Ganoe, as applied to claim 16 above, to incorporate the teachings of Winston, and include the magnetic actuator (62) of Winston in place of the spring (66) of Ganoe. Doing so would allow for automatic extension and retraction of control wire (17) instead of only automatic retraction.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249), in view of Gannoe (US 2002/0002376 A1), in view of Cox (US 2006/0237023 A1).
Regarding claim 19, Arenas teaches a medical method, the method comprising:
inserting a distal end of a shaft of a medical device into a body lumen of a subject; (Col. 3, Lines 14-35)
navigating the distal end of the shaft to a treatment location; (Col. 3, Lines 14-35: The body cavity would be considered a treatment location)
moving a ram (Fig. 1-6, Char. 17: curve control wire) distally from a first configuration (Fig. 6) to a second configuration, (Fig. 1) wherein the ram extends along a longitudinal axis of the shaft, (Fig. 1) wherein a portion of shaft is bendable in the first configuration, and wherein the portion of the shaft is rigid in the second configuration. (Claim 1)
Arenas, as applied to claim 19 above, is silent regarding gripping a first portion of a handle; wherein the first portion of the handle is transverse to a longitudinal axis of the shaft; the movement of the ram distally from the first configuration to the second configuration occurring after navigating the distal end of the shaft to the treatment location; in the second configuration, extending a needle from a distal tip of the shaft; and delivering a vapor from the needle.
Gannoe, in a similar field of endeavor, teaches a medical device comprising a handle (Fig. 11, Char. 58: body) including a grip portion (Fig. 11, Char. 72: grips) disposed transverse to a longitudinal axis of a shaft; (Fig. 11: Grips (72) are disposed transverse to the longitudinal axis of housing (54)) a body portion; (Fig. 11: The portion of body (58) disposed distally of grips (72)) and a ram housing extending proximally of the body portion; (Fig. 11: The portion of body (58) disposed at the grips (72) and extending proximally from said grips) wherein a rigid ram extending through longitudinal axis of the body portion. (Fig. 12: Push rod (50) extends through the distal end of body (58))
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 Arenas, as applied to claim 1 above, to incorporate the teachings of Gannoe, and configure the proximal end of coiled wire body (14) to include the body (58) of Gannoe. Doing so would allow for a user to easily grasp/control coiled wire body as they manipulate stiffening handle (26) and knob (22) of Arenas.
The combination of Arenas/Ganoe, as applied to claim 19 above, is silent regarding the movement of the ram distally from the first configuration to the second configuration occurring after navigating the distal end of the shaft to the treatment location; in the second configuration, extending a needle from a distal tip of the shaft; and delivering a vapor from the needle.
Cox, in a similar field of endeavor, teaches a needle catheter configured to deliver vapor to a target treatment site; (Fig. 8A and Par. [0080]: Needle catheter (70) delivers a fluid or gas to a target treatment site) wherein said needle catheter is disposed within and advanceable from an endoscope. (Par. [0080])
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 Arenas/Gannoe, as applied to claim 19 above, to incorporate the teachings of Cox, and configure the curve control wire (17) of Arenas to comprise the needle catheter (70) of Cox, such that needle catheter (70) extends from curve control wire (17) and cap (12) of Arenas to deliver a fluid or gas to the target treatment site. Doing so would allow the guidewire (10) of Arenas to be used in a wider range of procedures and provide more treatment options.
In this combination, curve control wire (17) would be in the second, distal position in order for needle catheter (70) to extend from wire (17).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249) in view of Gannoe (US 2002/0002376 A1), in view of Cox (US 2006/0237023 A1), as applied to claim 19 above, and further in view of Hoey (US 2009/0216220 A1).
Regarding claim 20, the combination of Arenas/Gannoe/Cox, as applied to claim 19 above, is silent regarding the body lumen is a urethra, and wherein the vapor is configured to ablate at least a portion of a prostate of the subject.
Hoey, in a similar field of endeavor, teaches inserting a vapor ablation needle configured to travel through the urethra to deliver vapor to a target treatment site such that prostate tissue is ablated. (Par. [0086])
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 Arenas/Gannoe/Cox, as applied to claim 19 above, to incorporate the teachings of Hoey, and configure the needle catheter (70) of Cox to deliver vapor to the target site such that tissue at the target site is ablated; and to configure the device to travel through a urethra of a patient such that the device can reach/treat the tissue of the patient’s prostate. Doing so would allow the guidewire (10) of Arenas to be used in a wider range of procedures and provide more treatment options.
Allowable Subject Matter
Claims 1-3, 5, 7-15, 21, and 22 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the prior art of record does not explicitly teach “a medical device, comprising: a handle including: a grip portion; a body portion; and a ram housing extending proximally of the body portion; a shaft having a first, proximal portion and a second, distal portion, wherein the first portion of the shaft includes a first outer sheath, wherein the second portion of the shaft includes a second outer sheath, and wherein the first outer sheath is more rigid than the second outer sheath; a rigid ram extending through at least a portion of the body portion and at least a portion of the shaft, wherein the ram is configured to be transitioned from a first, proximal configuration, in which the second portion of the shaft is flexible, and a second, distal configuration, in which the second portion of the shaft is rigid, wherein the ram includes a guide having a first arm and a second arm, and, wherein each of the first arm and the second arm extends radially inward from a surface of the guide,” as claimed in claim 1.
Examiner has cited Arenas (US 4,676,249) in view of Gannoe (US 2002/0002376 A1) and Hashiguchi (US 6,063,103) as the most pertinent prior art references, each of which disclosing systems, devices, and methods comprising some of the claimed limitations as further discussed in the non-final rejection dated 01/28/2026. However, these references fail to explicitly disclose the specific structure of the ram and guide of claim 1.
Claims 2, 3, 5, 7-15, 21, and 22 would be allowable due to their respective dependencies on claim 1.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
Prosecution Insights