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 .
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.
Claims 1-20 are 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.
Claims 1 and 14 each recite “a system for use with an endoscope” and then “a sleeve configured to be coupled to an outer surface of an endoscope,” and thereafter “the endoscope.” Claim 20 recites “disposing an endoscope” and later “the endoscope.”
It is unclear whether “the endoscope” is the preamble endoscope, the endoscope recited in the sleeve limitation, or two different instruments.
Amendment is required.
Claims 2-13 depend from claim 1 and inherit the defect.
Claims 15-19 depend from claim 14 and inherit the defect.
Claim 20 recites the same structure in the “wherein the fluid delivery system comprises” block.
Claim 1 recites “a distal ring member…being axially fixed relative to the sleeve and relative to the housing,” and also “wherein the housing is configured to shift relative to the endoscope between a first position and a second position.”
Those limitations cannot both be true on their face. If the ring is axially fixed relative to the housing, the housing cannot shift axially relative to the ring. Claims 12 and 13 confirm the conflict: the ring is adjacent to the proximal end region of the housing in the first position and distal of that region in the second position, i.e., the ring and housing move relative to each other.
Amendment is required.
Claims 2-13 depend from claim 1 and inherit the defect.
Claim 20 recites “deliver a fluid…through the plurality of openings in the arcuate distal face of the fluid casing an out from the fluid casing.”
“An out” is not an introduced element and has no ordinary meaning in the claim. As written, the last step is indefinite.
Amendment is required.
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.
Claims 1-9, 12-17 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,544,226) in view of Zirps (US 2007/0265493).
Regarding claim 1, Gaiser discloses a system for use with an endoscope (operative element 24 in figs. 2-9; catheter body 38 provides endoscope functions and can comprise a standard endoscope E in figs. 3-4; col. 5, lines 5-7), the system comprising:
a sleeve (ancillary silicone sleeve/elastomeric collar on body 26; col. 4, lines 46-59) configured to be coupled to an outer surface of an endoscope (ancillary silicone sleeve/elastomeric collar on body 26 provided on the operative element 24 body to releasably hold the operative element 24 on the catheter body 38; col. 4, lines 56-59);
a housing (body 26 in figs. 3-4) coupled to the sleeve (ancillary silicone sleeve/elastomeric collar on body 26; col. 4, lines 46-59), the housing having a proximal end region (proximal end of body 26), a distal end region (distal end of body 26), and a fluid chamber defined therein (interior chamber 74 of body 26 in figs. 7-8; col. 8, lines 34-37);
wherein a plurality of openings (openings 78 in fig. 9; col. 8, lines 47-48) are formed in the distal end region (openings 78 are formed on distal end of body 26 in fig. 9);
an actuator (cable 30 in figs. 2-4, 9; col. 4, lines 1-12 and lines 42-44) coupled to the proximal end region of the housing and extending proximally therefrom (cable 30 is coupled to proximal end of body 26 and from there extends proximally and is coupled to control handle 32).
Gaiser fails, however, to disclose a distal ring member disposed within the housing, the distal ring member being axially fixed relative to the sleeve and relative to the housing; and
wherein the housing is configured to shift relative to the endoscope between a first position and a second position.
Zirps teaches a distal ring member (Zirps: static sleeve 20 in figs. 3, 5-6) disposed within the housing (Zirps: static sleeve 20 sits inside of band carrier 22 which sits inside of band driver 24 in figs. 3, 5-6; para [0049], [0051] and [0056]), the distal ring member being axially fixed relative to the sleeve and relative to the housing (Zirps’ static sleeve 20 and Gaiser’s ancillary silicone sleeve/elastomeric collar are both on the endoscope, so Zirps’ static sleeve 20 can be axially fixed relative to Gaiser’s sleeve); and
wherein the housing is configured to shift relative to the endoscope between a first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 in fig. 5, 12B; para [0048]) and a second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 in figs. 3, 12A; para [0048]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal housing of Gaiser to include a distal ring member disposed within the housing and axially fixed relative to the sleeve, with the housing configured to shift relative to the endoscope between a first position and a second position, as taught by Zirps, in order to provide a controlled axial stroke of the fluid housing on a scope-mounted inner member so that fluid in chamber 74 can be expelled through openings 78.
Regarding claim 2, modified Gaiser discloses the system of claim 1, wherein the sleeve comprises silicone (ancillary silicone sleeve/elastomeric collar on body 26; col. 4, lines 46-59).
Regarding claim 3, modified Gaiser discloses the system of claim 1, wherein the housing includes an inner wall (Zirps: outer surface of static sleeve 20; [0054]) and an outer wall (Zirps: interior surface of band carrier 22; [0054]), and wherein the fluid chamber is defined between the inner wall and the outer wall (combination of Gaiser’s chamber 74 in figs. 7-8; col. 8, lines 34-37; and Zirps’ annulus between static sleeve 20 and band carrier 22 in which seal ring 32 sits; para [0054]).
Regarding claim 4, modified Gaiser discloses the system of claim 1, wherein the distal end region of the housing has an arcuate shape (openings 78 are formed on curved distal end of body 26 in fig. 9; col. 8, lines 47-48; four electrodes 44 are arranged in a side-by-side, arcuate (i.e., curved) array on the distal end of the body 26 in fig. 7; col. 6, lines 40-44).
Regarding claim 5, modified Gaiser discloses the system of claim 1, wherein the actuator includes a pull wire (wire 62 through lumens 34 in cable 30 to control mechanism 60 in figs. 6-7; col. 6, lines 51-56).
Regarding claim 6, modified Gaiser discloses the system of claim 1, but fails to disclose that the system further comprises one or more additional actuators.
Zirps teaches an additional actuator (Zirps: control sheath 16 containing static wire 52 and driver wire 53 all joined to control handle 14 in fig. 9; para [0061]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single actuator of Gaiser to include an additional actuator, as taught by Zirps, in order to separately control axial motion of the inner and outer sliding members of the distal assembly.
Regarding claim 7, modified Gaiser discloses the system of claim 1, further comprising a proximal ring member (Zirps: large diameter proximal portion 21 of static sleeve 20; para [0049]) configured to be disposed about the endoscope and positioned proximal of the distal ring member (Zirps: small diameter distal portion 23 of static sleeve 20 sized to closely fit the endoscope; para [0049]).
Regarding claim 8, modified Gaiser discloses the system of claim 7, further comprising a spacer member extending between the distal ring member and the proximal ring member (Zirps: intervening body of static sleeve 20 between small-diameter portion 23 and large-diameter proximal portion 21 holding the two ends axially fixed relative to each other; para [0049]).
Regarding claim 9, modified Gaiser discloses the system of claim 7, wherein the actuator extends through the proximal ring member (Zirps: sheath 16 is fixed in receptacle 29 of proximal retainer 28; static wire 52 passes through static sleeve 20 and proximal retainer 28; para [0050] and [0055]).
Regarding claim 12, modified Gaiser discloses the system of claim 1, wherein the distal ring member is disposed adjacent to the proximal end region of the housing (Zirps: static sleeve 20 sits at the proximal end of extended band carrier 22 / band driver 24 in figs. 5, 12B) when the housing is in the first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 in fig. 5, 12B; para [0048]).
Regarding claim 13, modified Gaiser discloses the system of claim 12, wherein the distal ring member is disposed distally of the proximal end region of the housing (Zirps: distal end of static sleeve 20 is distal of the proximal end of retracted band carrier 22 / band driver 24 in figs. 3, 12A) when the housing is in the second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 in figs. 3, 12A; para [0048]).
Regarding claim 14, Gaiser discloses a system for use with an endoscope (operative element 24 in figs. 2-9; catheter body 38 provides endoscope functions and can comprise a standard endoscope E in figs. 3-4; col. 5, lines 5-7), the system comprising:
a sleeve (ancillary silicone sleeve/elastomeric collar on body 26; col. 4, lines 46-59) configured to be coupled to an outer surface of an endoscope (ancillary silicone sleeve/elastomeric collar on body 26 provided on the operative element 24 body to releasably hold the operative element 24 on the catheter body 38; col. 4, lines 56-59);
a fluid chamber (chamber 74 in figs. 7-8) and an arcuate distal face having a plurality of openings formed therein (openings 78 are formed on curved distal end of body 26 in fig. 9; col. 8, lines 47-48);
a proximal end region (proximal end of band carrier 22 and band driver 24); and an actuator (cable 30 in figs. 3-5, 9; col. 4, lines 1-14 and lines 39-44).
Gaiser fails, however, to disclose a fluid casing coupled to the sleeve, the fluid casing including an inner wall member, an outer wall member, a fluid chamber defined between the inner wall member and the outer wall member;
a distal ring member disposed within the fluid casing, the distal ring member being axially fixed relative to the endoscope;
wherein the fluid casing is configured to shift between a first position;
wherein the distal ring member is disposed adjacent to a proximal end region of the fluid casing when the fluid casing is in the first position;
wherein the distal ring member is disposed distally of the proximal end region of the fluid casing when the fluid casing is in the second position; and
the actuator being configured to shift the fluid casing between the first position and the second position.
Zirps teaches a fluid casing (Zirps: band carrier 22 with band driver 24 as the outer sliding assembly in figs. 3, 5-6) coupled to the sleeve, the fluid casing including an inner wall member (Zirps: outer surface of static sleeve 20; para [0054]), an outer wall member (Zirps: interior surface of band carrier 22; para [0054]), a fluid chamber defined between the inner wall member and the outer wall member (combination of Gaiser’s chamber 74 in figs. 7-8; col. 8, lines 34-37; and Zirps’ annulus between static sleeve 20 and band carrier 22 in which seal ring 32 sits; para [0054]);
a distal ring member (Zirps: static sleeve 20 in figs. 3, 5-6) disposed within the fluid casing (Zirps: static sleeve 20 sits inside of band carrier 22 which sits inside of band driver 24 in figs. 3, 5-6; para [0049], [0051] and [0056]), the distal ring member being axially fixed relative to the endoscope (Zirps: static sleeve 20 is axially fixed relative to endoscope 18; para [0046], [0049]);
wherein the fluid casing is configured to shift between a first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 in fig. 5, 12B; para [0048]) and a second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 in figs. 3, 12A; para [0048]);
wherein the distal ring member is disposed adjacent to a proximal end region of the fluid casing when the fluid casing is in the first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 so that 20 sits at the proximal end of the extended outer tubes in fig. 5, 12B; para [0048]);
wherein the distal ring member is disposed distally of the proximal end region of the fluid casing when the fluid casing is in the second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 so that the distal end of 20 is distal of the proximal end of 22/24 in figs. 3, 12A; para [0048]); and
the actuator being configured to shift the fluid casing between the first position and the second position (Zirps: static control wire 52 and driver control wire 53 in sheath 16 to handle 14; wire 52 is caused to project distally from the sheath 16, causing the band carrier 22 to be pushed distally relative to static sleeve 20 in fig. 12b; para [0055] and [0072]; slide 102 returns band carrier 22 / band driver 24 proximally, shifting both directions; para [0048] and [0068]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal body and chamber of Gaiser to be a fluid casing having an inner wall member, and outer wall member, and a fluid chamber defined between those walls, with a distal ring member disposed within the casing and axially fixed relative to the endoscope, and with the casing configured to shift between a first position (ring adjacent the proximal end region of the casing) and a second position (ring distal of that proximal end region), as taught by Zirps, in order to provide a coaxial, scope-fixed inner member and a sliding outer casing so that fluid in the chamber 74 can be expelled through openings 78.
Regarding claim 15, modified Gaiser discloses the system of claim 14, further comprising a proximal ring member (Zirps: large diameter proximal portion 21 of static sleeve 20; para [0049]) configured to be disposed about the endoscope and positioned proximal of the distal ring member (Zirps: small diameter distal portion 23 of static sleeve 20 sized to closely fit the endoscope; para [0049]).
Regarding claim 16, modified Gaiser discloses the system of claim 15, further comprising a spacer member extending between the distal ring member and the proximal ring member (Zirps: intervening body of static sleeve 20 between small-diameter portion 23 and large-diameter proximal portion 21 holding the two ends axially fixed relative to each other; para [0049]).
Regarding claim 17, modified Gaiser discloses the system of claim 15, wherein the actuator extends through the proximal ring member (Zirps: sheath 16 is fixed in receptacle 29 of proximal retainer 28; static wire 52 passes through static sleeve 20 and proximal retainer 28; para [0050] and [0055]).
Regarding claim 20, Gaiser discloses a method for delivering fluid during an endoscopic procedure, the method comprising: disposing an endoscope having a fluid delivery system coupled thereto (operative element 24 in figs. 2-9; catheter body 38 provides endoscope functions and can comprise a standard endoscope E in figs. 3-4; col. 5, lines 5-7) adjacent to a target site (target site in figs. 11-13);
wherein the fluid delivery system comprises: a sleeve (ancillary silicone sleeve/elastomeric collar on body 26; col. 4, lines 46-59)configured to be coupled to an outer surface of the endoscope (ancillary silicone sleeve/elastomeric collar on body 26 provided on the operative element 24 body to releasably hold the operative element 24 on the catheter body 38; col. 4, lines 56-59),
a fluid chamber (chamber 74 in figs. 7-8) and an arcuate distal face having a plurality of openings formed therein (openings 78 are formed on curved distal end of body 26 in fig. 9; col. 8, lines 47-48),
a proximal end region (proximal end of band carrier 22 and band driver 24), and an actuator (cable 30 in figs. 3-5, 9; col. 4, lines 1-14 and lines 39-44).
Gaiser fails, however, to disclose a fluid casing coupled to the sleeve, the fluid casing including an inner wall member, an outer wall member, a fluid chamber defined between the inner wall member and the outer wall member,
a distal ring member disposed within the fluid casing, the distal ring member being axially fixed relative to the endoscope,
wherein the fluid casing is configured to shift between a first position and a second position,
wherein the distal ring member is disposed adjacent to a proximal end region of the fluid casing when the fluid casing is in the first position,
wherein the distal ring member is disposed distally of the proximal end region of the fluid casing when the fluid casing is in the second position, and
that the actuator is coupled to the fluid casing and extending proximally therefrom, the actuator being configured to shift the fluid casing between the first position and the second position; and
actuating the actuator to shift the fluid casing toward the second position and to deliver a fluid disposed in the fluid chamber through the plurality of openings in the arcuate distal face of the fluid casing an out from the fluid casing.
Zirps teaches a fluid casing (Zirps: band carrier 22 with band driver 24 as the outer sliding assembly in figs. 3, 5-6) coupled to the sleeve, the fluid casing including an inner wall member (Zirps: outer surface of static sleeve 20; para [0054]), an outer wall member (Zirps: interior surface of band carrier 22; para [0054]), a fluid chamber defined between the inner wall member and the outer wall member (combination of Gaiser’s chamber 74 in figs. 7-8; col. 8, lines 34-37; and Zirps’ annulus between static sleeve 20 and band carrier 22 in which seal ring 32 sits; para [0054]), and an arcuate distal face having a plurality of openings formed therein (openings 78 are formed on curved distal end of body 26 in fig. 9; col. 8, lines 47-48),
a distal ring member (Zirps: static sleeve 20 in figs. 3, 5-6) disposed within the fluid casing (Zirps: static sleeve 20 sits inside of band carrier 22 which sits inside of band driver 24 in figs. 3, 5-6; para [0049], [0051] and [0056]), the distal ring member being axially fixed relative to the endoscope (Zirps: static sleeve 20 is axially fixed relative to endoscope 18; para [0046], [0049]),
wherein the fluid casing is configured to shift between a first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 in fig. 5, 12B; para [0048]) and a second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 in figs. 3, 12A; para [0048]),
wherein the distal ring member is disposed adjacent to a proximal end region (proximal end of band carrier 22 and band driver 24) of the fluid casing when the fluid casing is in the first position (Zirps: band carrier 22 and band driver 24 extended distally on static sleeve 20 so that 20 sits at the proximal end of the extended outer tubes in fig. 5, 12B; para [0048]),
wherein the distal ring member is disposed distally of the proximal end region of the fluid casing when the fluid casing is in the second position (Zirps: band carrier 22 and band driver 24 retracted proximally on static sleeve 20 so that the distal end of 20 is distal of the proximal end of 22/24 in figs. 3, 12A; para [0048]), and
an actuator (cable 30 in figs. 3-5, 9; col. 4, lines 1-14 and lines 39-44) coupled to the fluid casing and extending proximally therefrom, the actuator being configured to shift the fluid casing between the first position and the second position (Zirps: static control wire 52 and driver control wire 53 in sheath 16 to handle 14; wire 52 is caused to project distally from the sheath 16, causing the band carrier 22 to be pushed distally relative to static sleeve 20 in fig. 12b; para [0055] and [0072]; slide 102 returns band carrier 22/band driver 24 proximally, shifting both directions; para [0048] and [0068]); and
actuating the actuator to shift the fluid casing toward the second position and to deliver a fluid disposed in the fluid chamber through the plurality of openings in the arcuate distal face of the fluid casing an out from the fluid casing (combination step of Zirps’ slide of band carrier 22 and band driver 24 on static sleeve 20 toward the second (retracted) position and Gaiser’s bolus out of openings 78; col. 11, lines 29-39).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Gaiser by disposing the endoscope and fluid delivery system adjacent a target site and actuating the actuator to shift the fluid casing toward the second position and deliver fluid from chamber 74 through openings 78, as taught by Gaiser’s bolus through openings 78 together with Zirps’ advancement to the target in the retracted position, in order to place the distal fluid housing at the tissue and empty the chamber through the distal openings with a controlled proximal stroke.
Claims 10-11 and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Gaiser (US 6,544,226) and Zirps (US 2007/0265493) and further in view of Waller (US 8,506,477).
Regarding claim 10, modified Gaiser discloses the system of claim 1, but fails to disclose that the system further comprises one or more coil members configured to be disposed about the endoscope.
Waller teaches a coil member (Waller: helical band 55 in fig. 5A; col. 6, lines 24-47) configured to be disposed about the endoscope (Waller: helical band 55 wraps around the endoscope in fig. 5A; col. 6, lines 24-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Gaiser to include one or more coil members disposed about the endoscope, as taught by Waller, in order to secure the distal assembly on the endoscope shaft and conform the mount to the shaft outer diameter.
Regarding claim 11, modified Gaiser discloses the system of claim 10 comprising an actuator (cable 30 in figs. 2-4, 9; cable 30 can extend either along side the exterior of the catheter body 38 or through a lumen in the catheter body 38; col. 4, lines 42-44).
Modified Gaiser fails, however, to disclose wherein the actuator is disposed between the one or more coil members and the outer surface of the endoscope.
Waller teaches coil members and the outer surface of the endoscope (Waller’s helical band 55 around the endoscope in fig. 5A; col. 6, lines 24-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator of modified Gaiser so that the actuator lies between the coil members and the outer surface of the endoscope by routing the cable along the exterior of the endoscope under the coil member, as taught by Waller, in order to keep the external actuator against the shaft and under the coil wrap so it does not snag while the coil grips the scope.
Regarding claim 18, modified Gaiser discloses the system of claim 15, but fails to disclose that the system further comprises one or more coil members configured to be disposed about the endoscope.
Waller teaches a coil member (Waller: helical band 55 in fig. 5A; col. 6, lines 24-47) configured to be disposed about the endoscope (Waller: helical band 55 wraps around the endoscope in fig. 5A; col. 6, lines 24-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Gaiser to include one or more coil members disposed about the endoscope, as taught by Waller, in order to secure the distal assembly on the endoscope shaft and conform the mount to the shaft outer diameter.
Regarding claim 19, modified Gaiser discloses the system of claim 18 comprising an actuator (cable 30 in figs. 2-4, 9; cable 30 can extend either along side the exterior of the catheter body 38 or through a lumen in the catheter body 38; col. 4, lines 42-44).
Modified Gaiser fails, however, to disclose wherein the actuator is disposed between the one or more coil members and the outer surface of the endoscope.
Waller teaches coil members and the outer surface of the endoscope (Waller’s helical band 55 around the endoscope in fig. 5A; col. 6, lines 24-47).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the actuator of modified Gaiser so that the actuator lies between the coil members and the outer surface of the endoscope by routing the cable along the exterior of the endoscope under the coil member, as taught by Waller, in order to keep the external actuator against the shaft and under the coil wrap so it does not snag while the coil grips the scope.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZACHARIAH K WHITROCK whose telephone number is (571) 272-3534. The examiner can normally be reached Monday - Friday 8:00 am - 5:00 pm.
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/ZACHARIAH K WHITROCK/Patent Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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