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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/21/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 7/21/2025.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 15 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. Previously, claim 1 was rejected under 35 U.S.C. 103 as being unpatentable over Pai in view of Zhang and Bonnette and claim 15 was rejected under 35 U.S.C. 103 as being unpatentable over Pai in view of Zhang. Now, claims 1 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brucker in view of Zhang.
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 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.
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.
Claims 1-3, 7, 15, 21, 24-25, 27-28, 31-32, 34-36, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over Brucker et al., US 20150272669, herein referred to as "Brucker", in view of Zhang et al., US 20190209312, herein referred to as “Zhang”.
Regarding claim 1, Brucker discloses a device for a radial spray catheter (Figures 1 and 11A), comprising: a body (Figure 1: catheter assembly 190) having a longitudinal axis (Figure 1: shaft 110), a proximal end (Figure 1: handle 120), a distal end (Figure 1: irrigated ablation electrode assembly 170 and Figure 11A), a mid-portion extending therebetween (Figure 1: shaft 110); a central lumen (Figure 11A: fluid passageway 1186) extending within the body along the longitudinal axis ([0232]); wherein the central lumen expands from a smaller diameter to a larger diameter (Figure 11A: diameter of fluid plenum 1184 expands from the smaller diameter of the shaft to the larger diameter of shell 1120), wherein the central lumen extends at the larger diameter through the distal end of the body (Figure 11A: the distal end of the shell 1120 is the larger diameter); a plurality of apertures distributed about the exterior radial surface of the body (Figure 11A: apertures 1108); and a flow distribution element (Figure 11A: fluid plenum 1184) that includes a plurality of fluid distribution lumens (Figure 11A: passageways 1182), wherein each flow distribution lumen is in fluid communication with the central lumen ([0232]) and extends to at least one aperture of the plurality of apertures ([0232]); wherein the device is configured to move fluid through the plurality of fluid distribution lumens and the plurality of apertures to spray a body lumen of a patient ([0232]: “Fluid passes into fluid plenum 1084 and then into passageways 1082 and exits the electrode assembly through apertures 1080 providing active cooling of the exterior surfaces of shell 1010.” And [0119]); wherein the flow distribution element is disposed distally to the smaller diameter of the central lumen (Figure 11A: fluid plenum 1184 is disposed distally to the smaller diameter); and wherein the fluid distribution lumens are concentrically arranged about the longitudinal axis (Figure 11A: passageways 1182 are arranged concentrically about the longitudinal axis). Brucker does not explicitly disclose a device wherein the central lumen expands conically from a smaller diameter to a larger diameter at a transition angle of 25-30 degrees.
However, Zhang teaches a device (Figure 4: delivery device 200a) wherein the central lumen (Figure 4: proximal enclosure 210 and first core member 220) expands conically (Figure 4: first core member 220 expands conically to proximal enclosure 210) from a smaller diameter to a larger diameter at a transition angle of 25-30 degrees ([0139]: “a ramp angle of approximately 45 degrees, or may range from between about 10 degrees to about 80 degrees, from between about 20 degrees to about 70 degrees, from between about 30 degrees to about 60 degrees,”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the shape of the central lumen disclosed by Brucker so that it expands conically from a smaller diameter to a larger diameter as taught by Zhang to minimize the retraction force required to retract the central lumen from the target tissue (Zhang [0139]), which increases the longevity of the device.
Regarding claim 2, Brucker in view of Zhang discloses the device of claim 1, and Zhang further discloses a device (Figure 4: delivery device 200a) wherein an apex of a cone is directed towards the central lumen (Figure 4: proximal enclosure 210 and first core member 220) in a proximal direction (Figure 4: the apex of the cone is directed towards first core member 220 in a proximal direction).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Brucker so that the apex of a cone is directed towards the central lumen in a proximal direction as taught by Zhang to minimize the retraction force required to retract the central lumen from the target tissue (Zhang [0139]), which increases the longevity of the device.
Regarding claim 3, Brucker in view of Zhang discloses the device of claim 1, and Zhang further discloses a device (Figure 4: delivery device 200a) wherein the central lumen (Figure 4: proximal enclosure 210 and first core member 220) transitions from the smaller diameter (Figure 4: first core member 220) to the larger diameter (Figure 4: proximal enclosure 210) between the proximal end of the body and the mid-portion of the body (Figure 4: the transition between diameters occurs between the proximal end and the mid-portion of the body).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the shape of the central lumen disclosed by Brucker so that it transitions from a smaller diameter to a larger diameter between the proximal end of the body and the mid-portion of the body as taught by Zhang to minimize the retraction force required to retract the central lumen from the target tissue (Zhang [0139]), which increases the longevity of the device.
Regarding claim 7, Brucker in view of Zhang discloses the device of claim 1, with Brucker further disclosing a device wherein each flow distribution lumen extends distally within the body parallel to the longitudinal axis (Figure 11A: passageways 1182) and then transitions along a radial wall of the body that is perpendicular to the longitudinal axis to a corresponding aperture (Figure 11A: passageways 1183).
Regarding claim 15, Brucker discloses a device for a radial spray catheter (Figures 1 and 11A), comprising: an elongate member (Figure 1: catheter assembly 190) having a longitudinal axis (Figure 1: shaft 110), an open proximal end (Figure 1: handle 120), a distal end (Figure 1: irrigated ablation electrode assembly 170 and Figure 11A), a central lumen (Figure 11A: fluid passageway 1186) expanding from a smaller diameter to a larger diameter (Figure 11A: diameter of fluid plenum 1184 expands from the smaller diameter of the shaft to the larger diameter of shell 1120), wherein the central lumen extends at the larger diameter through the distal end of the elongate member (Figure 11A: the distal end of the shell 1120 is the larger diameter), and a plurality of fluid distribution lumens (Figure 11A: passageways 1182) extending through the distal end of the elongate member to a plurality of apertures distributed about an exterior radial surface of the elongate member (Figure 11A: apertures 1108 and [0232]), wherein each flow distribution lumen is distal to the open proximal end of the elongate member (Figure 11A: passageways 1182 are distal to passageway 1186), wherein each flow distribution lumen is in fluid communication with the central lumen ([0232]) and extends to at least one aperture of the plurality of apertures ([0232]), wherein the fluid distribution lumens are concentrically arranged about the longitudinal axis (Figure 11A: passageways 1182 are arranged concentrically about the longitudinal axis), and wherein the device is configured to move fluid through the plurality of fluid distribution lumens and the plurality of apertures to spray a body lumen of a patient ([0232]: “Fluid passes into fluid plenum 1084 and then into passageways 1082 and exits the electrode assembly through apertures 1080 providing active cooling of the exterior surfaces of shell 1010.” And [0119]). Brucker does not explicitly disclose a device wherein the central lumen expands conically from a smaller diameter to a larger diameter at a transition angle of 25-30 degrees.
However, Zhang teaches a device (Figure 4: delivery device 200a) wherein the central lumen (Figure 4: proximal enclosure 210 and first core member 220) expands conically (Figure 4: first core member 220 expands conically to proximal enclosure 210) from a smaller diameter to a larger diameter at a transition angle of 25-30 degrees ([0139]: “a ramp angle of approximately 45 degrees, or may range from between about 10 degrees to about 80 degrees, from between about 20 degrees to about 70 degrees, from between about 30 degrees to about 60 degrees,”).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the shape of the central lumen disclosed by Brucker so that it expands conically from a smaller diameter to a larger diameter at a transition angle of 25-30 degrees as taught by Zhang to minimize the retraction force required to retract the central lumen from the target tissue (Zhang [0139]), which increases the longevity of the device.
Regarding claims 21 and 28, Brucker in view of Zhang teaches the device of claim 7 and the device of claim 15, respectively, with Brucker further disclosing a device wherein each flow distribution lumen of the plurality of flow distribution lumens corresponds to a row of apertures of the plurality of apertures (Figure 11A: each passageway 1182 is connected to at least two apertures 1108 as shown in Figure 11A, Figure 10B shows six apertures per passageway).
Regarding claim 24, Brucker in view of Zhang discloses the device of claim 15, and Brucker further discloses a device wherein the central lumen (Figure 11A: fluid passageway 1186) extends through the distal end of the elongate member (Figure 11A is the distal end of the elongate member, so fluid passageway 1186 extends through it).
Regarding claim 25, Brucker in view of Zhang discloses the device of claim 15, and Zhang further discloses a device (Figure 4: delivery device 200a) wherein the central lumen (Figure 4: proximal enclosure 210 and first core member 220) transitions from the smaller diameter (Figure 4: first core member 220) to the larger diameter (Figure 4: proximal enclosure 210) between the proximal end of the elongate member and a mid-portion of the elongate member (Figure 4: the transition between diameters occurs between the proximal end and the mid-portion of the elongated member).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the shape of the central lumen disclosed by Brucker so that it transitions from a smaller diameter to a larger diameter between the proximal end of the body and the mid-portion of the body as taught by Zhang to minimize the retraction force required to retract the central lumen from the target tissue (Zhang [0139]), which increases the longevity of the device.
Regarding claim 27, Brucker in view of Zhang discloses the device of claim 1, with Brucker further disclosing a device wherein each flow distribution lumen of the plurality of flow distribution lumens extends distally within the elongate member parallel to the longitudinal axis (Figure 11A: passageways 1182) and then transitions along a radial wall of the elongate member that is perpendicular to the longitudinal axis to a corresponding aperture (Figure 11A: passageways 1183).
Regarding claims 31 and 35, Brucker in view of Zhang teaches the device of claim 21 and the device of claim 28, respectively, and Brucker further teaches a device wherein each flow distribution lumen of the plurality of flow distribution lumens comprises an annular channel (Figure 11A: passageways 1182 comprise an annular channel) that extends to the row of apertures (Figure 11A: apertures 1108 and also see Figure 10B).
Regarding claims 32 and 36, Brucker in view of Zhang teaches the device of claim 31 and the device of claim 35, respectively, and Brucker further teaches a device wherein the annular channel of a first flow distribution lumen of the plurality of flow distribution lumens extends to a proximal row of apertures of the plurality of apertures (Figure 11A: passageway 1182 that is closest for shell 1120) and the annular channel of a second flow distribution lumen of the plurality of flow distribution lumens extends to a distal row of apertures of the plurality of apertures (Figure 11A: the longest passageway 1182), and wherein the annular channel of the second flow distribution lumen is positioned nearer to the longitudinal axis of the body relative to the annular channel of the first flow distribution lumen (Figure 11A: the longest passageway 1182 is near to the longitudinal axis relative to the shortest passageway 1182).
Regarding claim 34, Brucker in view of Zhang discloses the device of claim 1, with Brucker further disclosing a device wherein each flow distribution lumen (Figure 11A: passageways 1182 and 1183) is directly connected to at least one aperture of the plurality of apertures (Figure 11A: apertures 1108).
Regarding claim 38, Brucker in view of Zhang discloses the device of claim 15, with Brucker further disclosing a device wherein each flow distribution lumen (Figure 11A: passageways 1182) is directly connected to at least one aperture of the plurality of apertures (Figure 11A: each passageway 1182 is connected to at least one aperture 1108)
Claims 4 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Brucker in view of Zhang, further in view of Groves et al., US 20130110100, herein referred to as “Groves”.
Regarding claim 4, Brucker in view of Zhang discloses the device of claim 1, but does not explicitly disclose a device wherein the proximal end of the body is configured to be mated with the distal end of the catheter.
However, Groves teaches a device (Figure 1) wherein the proximal end of the body (Figure 1: proximal portion 18 of elongate body 16) is configured to be mated with the distal end of the catheter (Figure 1: handle 94 and [0055]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Brucker so that the proximal end of the body is configured to be mated with the distal end of the catheter as taught by Groves to allow the device to monitor the fluid pressure and/or flow rate (Groves [0055]).
Regarding claim 26, Brucker in view of Zhang discloses the device of claim 15, but does not explicitly disclose a device wherein the open proximal end of the elongated member is configured to be mated with the distal end of the catheter.
However, Groves discloses a device (Figure 1) wherein the open proximal end of the elongate member (Figure 1: proximal portion 18 of elongate body 16) is configured to be mated with the distal end of the catheter (Figure 1: handle 94 and [0055]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Brucker so that the open proximal end of the elongated member is configured to be mated with the distal end of the catheter as taught by Groves to allow the device to monitor the fluid pressure and/or flow rate (Groves [0055]).
Claims 33 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Embodiment A of Brucker (Figure 11A) in view of Zhang, further in view of Embodiment B of Brucker (Figure 9C)
Regarding claims 33 and 37, Embodiment A of Brucker in view of Zhang teaches the device of claim 31 and the device of claim 35, respectively, but does not explicitly disclose a device wherein the plurality of flow distribution lumens comprises six flow distribution lumens, and wherein the plurality of apertures comprises six rows of apertures.
However, Embodiment B of Brucker teaches a device wherein the plurality of flow distribution lumens comprises six flow distribution lumens (Figure 9C: there are six rows of passageways 982 and [0224]: “FIG. 9C shows an arrangement of raised bars with fluid passageways aligned axially (parallel to the central longitudinal axis of the insert).”), and wherein the plurality of apertures comprises six rows of apertures (Figure 9C: there are six rows of apertures).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Embodiment A of Brucker so that the plurality of flow distribution lumens comprises six flow distribution lumens and the plurality of apertures comprises six rows of apertures as taught by Embodiment B of Brucker since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794