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 .
A complete action on the merits of pending claims 1-20 appears herein.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 16 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arenas (US 4,676,249).
Regarding claim 16, Arenas teaches
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)
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 Rejections - 35 USC § 103
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.
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.
Claim(s) 1, 2, 6-8 and 15 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 1, Arenas teaches
a handle including:
a grip portion; (Fig. 1-6, Char. 26: stiffening handle)
a shaft (Fig. 1-6, Char. 14 and 23) having a first, proximal portion (Fig. 4 and 6: The portion of coiled wire body (14) disposed between stiffening handle (26) and the distal coil end (25) of stiffening member (23)) and a second, distal portion, (Fig. 4 and 6: The portion of coiled wire body (14) extending distally past the distal coil end (25) of stiffening member (23)) wherein the first portion of the shaft includes a first outer sheath, (Fig. 6, Char. 23: stiffening member) wherein the second portion of the shaft includes a second outer sheath, (Fig. 6, Char. 14: coiled wire body) and wherein the first outer sheath is more rigid than the second outer sheath; (Col. 4, Line 67 – Col. 5, Line 14) and
a rigid ram extending through at least a portion of the shaft, (Fig. 1-6, Char. 17: curve control wire) wherein the ram is configured to be transitioned from a first, proximal configuration, in which the second portion of the shaft is flexible, (Fig. 6) and a second, distal configuration, in which the second portion of the shaft is rigid. (Fig. 2)
Arenas, as applied to claim 1 above, is silent regarding the handle including a body portion and a ram housing extending proximally of the body portion; and the rigid ram extending through at least a portion of the body portion.
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)) 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))
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 2, the combination of Arenas/Gannoe, as applied to claim 1 above, teaches a proximal end of the ram protrudes from a proximal end of the body portion of the handle, (Arenas: Fig. 1: Knob (22) protrudes from a proximal end of the device, and would therefore be expected to extend from body (58) of Gannoe, similar to plunger (42) of Gannoe) and wherein the ram is transitioned from the first configuration to the second configuration by moving the proximal end of the ram distally. (Arenas: Fig. 1-6 and Col. 5, Lines 27-33)
Regarding claim 6, the combination of Arenas/Gannoe, as applied to claim 2 above, teaches an axis of the grip portion is transverse to a longitudinal axis of the first portion of the shaft. (Gannoe: Fig. 11: Grips (72) extend radially from body (58) – it is implicit that this feature be present in the Arenas/Gannoe combination based on the rejection to claim 1 above.)
Regarding claim 7, the combination of Arenas/Gannoe, as applied to claim 1 above, teaches in the first configuration, a distal-most end of the ram is proximal of at least a portion of the second portion of the shaft. (Arenas: Fig. 6)
Regarding claim 8, the combination of Arenas/Gannoe, as applied to claim 1 above, teaches the first outer sheath is approximately as rigid as a distal portion of the ram. (Arenas: Fig. 5: The distal half of core wire (17) would have approximately the same rigidity as stiffening member (23) at least in that stiffening member (23) and core wire (17) would be able to bend about the same amount while stiffening member (23) encases core wire (17))
Regarding claim 15, the combination of Arenas/Gannoe, as applied to claim 1 above, teaches the second portion of the shaft includes a flexible, tubular sheath. (Arenas: Fig. 1-6)
Claim(s) 3-5 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 2 above, and further in view of Ward (US 2015/0094735 A1).
Regarding claim 3, the combination of Arenas/Gannoe, as applied to claim 2 above, is silent regarding the proximal end of the ram including a tab.
Ward, in a similar field of endeavor, teaches a handle (Fig. 2A, Char. 210: handle assembly) including: a grip portion; (Fig. 2A: The portion of handle assembly (201) extending proximally from slot (201)) a body portion; (Fig. 2A: The portion of handle assembly (201) extending distally from slot (201)) and a ram housing extending proximally of the body portion; (Fig. 2A: The portion of handle assembly (201) extending along the length slot (201)) a ram extending through at least a portion of the body portion and the ram housing; (Par. [0021]: Pull wire (224)) the proximal end of the ram including a tab. (Fig. 2A, Char. 211: control member)
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 2 above, to incorporate the teachings of Ward and include the handle assembly (210) in place of body (58) of Gannoe, such that stiffening member (23) and curve control wire (17) of Arenas include control members (212) and (211) respectively. Doing so would be a simple substitution of one handle assembly for another for the predictable result of allowing a user to easily hold/manipulate the device, and would provide a mechanism for a user to easily translate both stiffening member (23) and curve control wire (17) as desired.
Regarding claim 4, the combination of Arenas/Gannoe/Ward, as applied to claim 3 above, teaches the proximal end of the ram is received within the ram housing, and wherein the tab extends through a slot in the ram housing. (In the rejection to claim 3 above, curve control wire was configured to include the control member (211) of Ward, which extends through slot (201) of Ward)
Regarding claim 5, the combination of Arenas/Gannoe/Ward, as applied to claim 3 above, in the second configuration, the tab abuts a proximal surface of the body portion of the handle. (Ward: Fig. 2A - it is implicit that this feature be present in the Arenas/Gannoe/Ward combination based on the rejection to claim 3 above.)
Claim(s) 9 and 10 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 1 above, and further in view of Hashiguchi (US 6,063,103).
Regarding claims 9 and 10, the combination of Arenas/Gannoe, as applied to claim 1 above, is silent regarding at least a portion of the ram has a cross-sectional shape that is approximately a segment of a circle or approximately an arc of a circle; and wherein the at least the portion of the ram includes a curved, radially outward-facing surface, and an approximately planar, radially inward-facing surface.
Hashiguchi, in a similar field of endeavor, teaches push rods (Fig. 10A, Char. 8: operating rod) capable of having a variety of cross section shapes, including either a circle or a semicircle. (Col. 8, Lines 51-54)
Absent a statement of criticality AND unexpected results, it would have been an obvious matter of design choice to make the different portions of the cross-section of curve control wire (17) of Arenas of whatever form or shape was desired or expedient, including a semi-circle as taught by Hashiguchi. 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.
In this combination, the flat/planar portion of the semicircle would face radially inward, and the curved portion of the semicircle would face radially outward.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249), as applied to claim 16 above, and further in view of Ward (US 2015/0094735 A1).
Regarding claim 18, Arenas, as applied to claim 16 above, is silent regarding the proximal end of the ram is received within a ram housing, and wherein a tab of the proximal end of the ram extends through a slot in the ram housing.
Ward, in a similar field of endeavor, teaches a device comprising a housing; (Fig. 2A, Char. 210: handle assembly) wherein a pull wire is received within the housing, (Fig. 2A and Par. [0021]: Control member is coupled to the pull wire (224)) and wherein a tab of the proximal end of the pull wire extends through a slot in the housing. (Fig. 2A: Control member (211) extends through a slot in handle assembly (210))
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 18 above, to incorporate the teachings of Ward and include the handle assembly (210), such that stiffening member (23) and curve control wire (17) of Arenas include control members (212) and (211) respectively. Doing so would be a simple substitution of one handle assembly for another for the predictable result of allowing a user to easily hold/manipulate the device, and would provide a mechanism for a user to easily translate both stiffening member (23) and curve control wire (17) as desired.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Arenas (US 4,676,249) in view of Cox (US 2006/0237023 A1).
Regarding claim 19, Arenas teaches
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 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 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 Arenas, 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 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/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/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
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 11-14 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 11, the prior art of record does not explicitly teach all of the limitations of claim 10, and further teach “a guide, having a first arm and a second arm, extends radially inwardly from the approximately planar, radially inward-facing surface.”
Claims 12-14 would be allowable due to their respective dependencies on claim 11.
Conclusion
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/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/N.S.B./Examiner, Art Unit 3794