Prosecution Insights
Last updated: October 27, 2026
Application No. 19/021,801

MEDICAL DEVICES AND RELATED METHODS

Non-Final OA §103
Filed
Jan 15, 2025
Priority
Aug 24, 2018 — divisional of 11/224,480 +1 more
Examiner
LANCASTER, LINDSAY REGAN
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Boston Scientific Scimed Inc.
OA Round
1 (Non-Final)
53%
Grant Probability
Moderate
1-2
OA Rounds
2y 1m
Est. Remaining
75%
With Interview

Examiner Intelligence

Grants 53% of resolved cases
53%
Career Allowance Rate
56 granted / 105 resolved
-16.7% vs TC avg
Strong +22% interview lift
Without
With
+21.5%
Interview Lift
resolved cases with interview
Typical timeline
3y 11m
Avg Prosecution
34 currently pending
Career history
162
Total Applications
across all art units

Statute-Specific Performance

§101
2.3%
-37.7% vs TC avg
§103
69.3%
+29.3% vs TC avg
§102
20.7%
-19.3% vs TC avg
§112
5.0%
-35.0% vs TC avg
Black line = Tech Center average estimate • Based on career data from 105 resolved cases

Office Action

§103
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 . 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. Status of the Claims The current office action is made responsive to claims filed 01/15/2025. Claims 1-20 are pending. A complete action on the merits appears below. Claim Rejections - 35 USC § 103 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. Claims 1-2, 4-10, and 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1). Regarding claim 1, Livneh teaches a medical device (Fig. 37; surgical instrument 50) comprising: a shaft (Fig. 37-40; housing 58), wherein a distal portion of the shaft includes one or more arms (Fig. 7 & 37-40; fingers 120; [0082] teaches the electrode as being connected in a similar fashion as the first embodiment), and wherein the one or more arms are movable relative to the distal portion of the shaft ([0070] teaches the fingers as each including a stem which allows the fingers to flare apart when not compressed); and an electrode (Fig. 37-40; electrode 158), wherein a proximal end of the electrode and the one or more arms form a coupling configured to releasably couple the electrode with the shaft ([0081]). However, Livneh fails to teach the shaft including a shaft lumen configured to direct a flow of fluid through the shaft, the electrode including an electrode lumen configured to direct a flow of fluid through the electrode, and wherein, when the electrode is coupled to the shaft, fluid delivered through the shaft lumen is delivered through the electrode lumen and emitted from the electrode. Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]). Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Regarding claim 2, Livneh teaches the medical device of claim 1, wherein each of the one or more arms includes a protrusion (Fig. 7; tip 124). Regarding claim 4, Livneh teaches the medical device of claim 1, wherein the electrode includes one or more receivers configured to receive the one or more arms (Fig. 37-40; the widest portion of ball shaped end 166 s shown as contacting fingers 120). Regarding claim 5, Livneh teaches the medical device of claim 4, wherein each of the one or more receivers is radially wider than a portion of the electrode distal to the one or more receivers ([0081]) or than a portion of the electrode proximal to the one or more receivers. Regarding claim 6, Klein teaches the medical device of claim 1, further including one or more seals configured to form a fluid tight seal between the electrode and the shaft ([0033], [0040]- [0043]). Regarding claim 7, Klein teaches the medical device of claim 6, wherein, with the electrode coupled to the shaft, the one or more seals sealingly engage surfaces of the electrode and the shaft to direct fluid from the shaft lumen to the electrode lumen such that the shaft lumen and the electrode lumen form a fluid flowpath ([0033], [0040]- [0043]). In accordance with the above rejection of claim 1, Livneh further teaches the electrode being coupled to the shaft with the one or more arms ([0081]). Regarding claim 8, Livneh teaches the medical device of claim 1, wherein each of the one or more arms is biased to move radially outwardly, and wherein each of the one or more arms is longitudinally movable within the distal portion of the shaft ([0063], [0071]- [0072], [0082]). Regarding claim 9, Livneh teaches the medical device of claim 8, wherein the one or more arms includes a plurality of arms (Fig. 7; fingers 120). Regarding claim 10, Livneh teaches the medical device of claim 9, further including at least one biasing member configured to bias the plurality of arms distally within the distal portion of the shaft (Fig. 7; stems 122). Regarding claim 16, Livneh teaches a medical device kit (Abstract), comprising: a medical device (Fig. 1; surgical instrument 50) including a handle (Fig. 1; handles 64, 66), and a shaft (Fig. 37-40; housing 58) extending distally from the handle, wherein the shaft includes a shaft lumen ([0059]); and an electrode (Fig. 37-40; electrode 158), wherein the shaft includes a distal portion ([0059]) having a mechanism therein that is configured for securing the electrode to the distal portion of the shaft ([0069]), releasing the electrode from the distal portion of the shaft ([0062]- [0063]), and securing another tool to the distal portion of the shaft ([0062]). However, Livneh fails to teach the electrode as being a plurality of electrodes and therefore the other tool as being another electrode. While Livneh does not explicitly teach the tools which are selected for attachment and detachment as being a plurality of electrodes, there is no evidence that more than one electrode makes a meaningful difference to the function of the device compared to the currently taught plurality of tools which teaches at least one of the tools as being an electrode which is attachable and detachable to the shaft distal portion. Specifically in view of Livneh which teaches the detachable tool assembly as being easily separable from the shaft and housing to allow a user of the surgical instrument to quickly change the desired tool, wherein the at least one desired tool which is discussed as being changed between is taught as being at least one electrode ([0062], [0079], [0083]) and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)). Livneh further fails to teach the electrode including (1) one or more insulator on a distal portion of the respective electrode, or (2) an electrode lumen configured to be fluidly connected to the shaft lumen. Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]). Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Regarding claim 17, Livneh teaches the medical device kit of claim 16, wherein movement of a portion of the handle controls movement of the coupled electrode ([0063]), and electrical energy delivered through the shaft is delivered to tissue through the coupled electrode ([0084]). Further, in accordance with the above rejection of claim 16, Klein teaches the medical device kit of claim 16, wherein at least two electrodes of the plurality of electrodes differ in structure ([0035]), wherein coupling different electrodes of the plurality of electrodes to the shaft changes a fluid flowpath of the medical device ([0035]- [0037]), and wherein, when one of the at least two electrodes is coupled to the distal portion of the shaft, fluid delivered through the shaft lumen is delivered through the coupled electrode ([0035]). Claims 3, 11, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1) further in view of King (US 20180098771 A1). Regarding claim 3, Livneh teaches the medical device of claim 2. However, Livneh fails to teach the medical device of claim 2 wherein each of the one or more arms further includes at least one of an angled portion at a proximal end of the protrusion and an angled portion at a distal end of the protrusion, wherein each of the angled portion at the proximal end of the protrusion and the angled portion at the distal end of the protrusion is angled relative to a central longitudinal axis of the distal end of the shaft. King teaches a system having a distal treatment portion which is loadable onto a proximal applicator prior to insertion into a living body for treating target tissue (Abstract, [0023]). This distal treatment portion is taught as being loaded onto the proximal applicator by a yoke having opposed portions which are permitted to spread to receive an enlarged end of a control member, which upon longitudinal movement of the control member, controls the longitudinal movement of the distal end for treating tissue ([0023]). King further teaches the opposed portions of the yoke which are permitted to spread to receive the enlarged end as having a tapered portion which has a larger diameter opening closer to the enlarged end of the control member and a smaller portion which has a portion which protrudes (Fig. 1; shoulder 142) from the longitudinal axis and opens to a widened portion which is sized and shaped to receive the enlarged end, so as to prevent the undesirable movement of the enlarged end, which has a widened portion which is larger than the portions which are distal and proximal to said wider portion, out of the constraint of the opposed portions of the yoke ([0028]- [0029]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the widened and narrowed portions of the enlarged end and the opposed portions, as is taught by King, into the ball-end of the connection rod and tip of the arms, as is taught by Livneh, to produce the predictable result of preventing the undesirable movement of the enlarged end out of the yoke, as is taught by King, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Regarding claim 11, Livneh teaches the medical device of claim 10, wherein the distal portion of the shaft includes a central passage with an angled portion that narrows, and wherein the angled portion is configured to force the plurality of arms radially inwardly as the plurality of arms move within the distal portion of the shaft ([0071]- [0072]. However, Livneh fails to teach the angled portion as narrowing distally and the arms as moving distally to force the arms radially inwardly. King teaches a system having a distal treatment portion which is loadable onto a proximal applicator prior to insertion into a living body for treating target tissue (Abstract, [0023]). This distal treatment portion is taught as being loaded onto the proximal applicator by a yoke having opposed portions which are permitted to spread to receive an enlarged end of a control member, which upon longitudinal movement of the control member, controls the longitudinal movement of the distal end for treating tissue ([0023]). King further teaches the distal end as being the portion of the device which contains expandable elements, also referred to as the opposed portions, which are permitted to spread and receive an enlarged distal end of a control member of the applicator, such that that longitudinal movement of the control member relative to the outer portion of the applicator, provides for an attachment between the inner proximal member and the expandable elements of the distal end ([0023], [0028]- [0029]). Therefore, while Livneh does not explicitly teach the angled portion as narrowing distally and the arms as moving distally to force the arms radially inwardly, there is no evidence that the direction which causes this inward and outward movement of the arms as making a meaningful difference to the function of the device and/or producing an unexpected result and it has been held that the reversal of parts is an obvious modification (MPEP 2144.04(VI)(A)). For this reason, it would have been obvious to a person having ordinary skill in the art before the effective filing date to have reversed any functional elements of the shaft which produce the arms coupling and uncoupling the distal end effector of King into the portion of Livneh which causes the arms to couple and uncouple the electrode as long as each functional element retains its ability to function in a desired and/or predictable manner. Regarding claim 18, Livneh as modified teaches the medical device kit of claim 17, wherein the distal portion of the shaft includes one or more arms each including a protrusion ([0081]), wherein each of the plurality of electrodes includes a receiver portion that is radially wider than a portion of the electrode distal to the receiver portion ([0081]), and wherein the protrusion engages the receiver portion ([0081]). However, Livneh fails to teach the arms including an angled portion proximal to the protrusion, and an angled portion distal to the protrusion and a receiver portion that is radially wider than a portion of the electrode proximal to the receiver portion. King teaches a system having a distal treatment portion which is loadable onto a proximal applicator prior to insertion into a living body for treating target tissue (Abstract, [0023]). This distal treatment portion is taught as being loaded onto the proximal applicator by a yoke having opposed portions which are permitted to spread to receive an enlarged end of a control member, which upon longitudinal movement of the control member, controls the longitudinal movement of the distal end for treating tissue ([0023]). King further teaches the opposed portions of the yoke which are permitted to spread to receive the enlarged end as having a tapered portion which has a larger diameter opening closer to the enlarged end of the control member and a smaller portion which has a portion which protrudes (Fig. 1; shoulder 142) from the longitudinal axis and opens to a widened portion which is sized and shaped to receive the enlarged end, so as to prevent the undesirable movement of the enlarged end, which has a widened portion which is larger than the portions which are distal and proximal to said wider portion, out of the constraint of the opposed portions of the yoke ([0028]- [0029]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the widened and narrowed portions of the enlarged end and the opposed portions, as is taught by King, into the ball-end of the connection rod and tip of the arms, as is taught by Livneh, to produce the predictable result of preventing the undesirable movement of the enlarged end out of the yoke, as is taught by King, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Regarding claim 20, Livneh teaches the medical device kit of claim 19, wherein, when one of the electrodes is coupled to the distal end of the shaft, movement of a portion of the handle controls movement of the coupled electrode, and electrical energy delivered through the shaft is delivered to tissue through the coupled electrode ([0063], [0084]). However, Livneh fails to teach the medical device kit, wherein coupling different electrodes of the plurality of electrodes to the shaft changes a fluid flowpath or an insulation pattern of the medical device, wherein, when one of the electrodes is coupled to the distal end of the shaft, fluid delivered through the shaft lumen is delivered through the coupled electrode. Klein teaches an applicator for providing water-jet surgery comprising a handle, a pressure conduit, a nozzle, and an electrode, wherein the distal portion, referred to as a molded part, can be connected detachably to the handle based on the necessity for the operating step being performed (Abstract, [0042], [0043]). Klein further teaches the molded part as being able to be constructed with different lengths and being able to be bent into various lengths and shapes ([0035]- 0037]). These size and shape distinctions are provided so as to allow for a shape which is suitable based on the momentary operating step and the alteration based on this step is performed simply by changing to another molded part during the operation ([0007]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the surgical device having detachable distal elements for use in performing surgical procedure with an electrode as having a variety of sizes and shape for delivering fluid, as is taught by Klein, into the surgical instrument having a detachable tool assembly as is taught by Livneh as modified, to produce the predictable result of providing the desired fluid delivery based on the current operating step, as is taught by Klein, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1) further in view of Deutmeyer (US 20080188848 A1). Regarding claim 12, Livneh teaches the medical device of claim 1, wherein the shaft includes a coupling tube (Fig. 7, 37-40; cavity 128) with a distal coupling portion configured for securing to the proximal end of the electrode ([0074]), and wherein the distal coupling portion comprises a material configured to couple the coupling tube to the electrode ([0074], [0084]). In accordance with the above rejection of claim 1, Klein further teaches a seal between coupling tube and the electrode that facilitates fluid flow from the electrode lumen ([0033], [0035]- [0037]). However, Livneh as modified fails to teach the material as being an elastomeric polymer which forms a seal. Deutmeyer teaches a tool having an electrode which can have fluid moving through a drive shaft of said electrode ([0068]- [0069]). Deutmeyer further teaches an annular seal at the proximal end of the electrode, where the seal is constructed of a resilient elastomeric material ([0050]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the known use of an elastomeric material to form a seal of a device having an electrode with a lumen for receiving fluid, as is taught by Deutmeyer, into the system having an electrode with a lumen for receiving fluid flow as is taught by Livneh as currently modified, to produce the predictable result of using a known material to form a seal, as is taught by Deutmeyer, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1) further in view of Stockert (US 6592580 B1) and Goble (US 6015406 A). Regarding claim 13, Livneh as modified teaches the medical device of claim 1. However, Livneh as modified fails to teach the medical device wherein the electrode includes an insulator that only partially covers a distal end face of the electrode, wherein the electrode includes an outlet in the distal end face. Stockert teaches a high-frequency treatment of body tissue comprising a head which is provided with at least one HF electrode which can be brought into contact with tissue to be treated and electrically activated (Abstract). The at least one HF electrode including several HF electrodes which are separated by an insulator (Col. 5, Lines 7-20). Stockert further teaches the several HF electrodes at the distal end of the head containing several electrodes which are separated by as insulator as being separated so as to be controlled individually or in combination (Col. 3, Lines 35-55). This allows only the HF electrodes which are actually positioned with respect to the tissue to be treated in such a manner that the energy emitted by then has the desired effect, while those electrodes which would cause an undesired heating are not activated (Col. 3, Lines 35-55). Additionally, the undesired heating is controlling by the electrodes containing openings for delivering a cooling liquid to patient tissue so as to not exceed certain temperatures (Col. 1, Line 50- Col. 2, Line 15). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the conductive members as being electrically separated by an insulator and containing at least one opening for delivering a cooling liquid, as is taught by Stockert, into the conductive members as is taught by Livneh as modified, to produce the predictable result of providing energy to only the desired portion of the device and cooling patient tissue, to reduce undesired heating in the form of heating undesirable tissue and the tissue exceeding certain temperatures, as is taught by Stockert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Livneh as modified by Stockert further fails to teach the insulator including a plurality of protrusions projecting from the distal end face about the outlet. Goble teaches an electrode assembly having a distal active electrode for tissue contact and an insulation sleeve surrounding the active electrode (Col. 16, Lines 45-68). Goble further teaches the insulation sleeve as being formed with a pair of diametrically opposed forwardly-extending wings which project beyond the active electrode so as to trap the desired tissue against the active electrode and prevent unnecessary exposure of the active electrode to adjacent structures surrounding the desired tissue which may undesirable damage said structures (Col. 16, Lines 45-68). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the insulating portions as projecting beyond the active electrode, as is taught by Goble, into the distal electrode portion having an insulator as is taught by Livneh as modified by Stockert, to produce the predictable result of contact desirable tissue with the active electrode and preventing undesirable contact with the active electrode, as is taught by Goble, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1) further in view of Stockert (US 6592580 B1). Regarding claim 14, Livneh teaches the medical device of claim 1, wherein the electrode includes at least one conductive member ([0080]), and wherein the medical device includes a conductor that is longitudinally movable to contact and deliver energy to the first conductive member ([0084]). However, Livneh fails to teach the at least one conductive member as including a first conductive member and a second conductive member. While Livneh does not explicitly teach the conductive member as being plural first and second conductive members, there is no evidence that more than one conductive makes a meaningful difference to the function of the device compared to the currently taught conductive member and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)). Livneh further fails to teach wherein the first conductive member and the second conductive member are electrically separated by an insulating member. Stockert teaches a high-frequency treatment of body tissue comprising a head which is provided with at least one HF electrode which can be brough into contact with tissue to be treated and electrically activated (Abstract). The at least one HF electrode including several HF electrodes which are separated by an insulator (Col. 5, Lines 7-20). Stockert further teaches the several HF electrodes at the distal end of the head containing several electrodes which are separated by as insulator as being separated so as to be controlled individually or in combination (Col. 3, Lines 35-55). This allows only the HF electrodes which are actually positioned with respect to the tissue to be treated in such a manner that the energy emitted by then has the desired effect, while those electrodes which would cause an undesired heating are not activated (Col. 3, Lines 35-55). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the conductive members as being electrically separated by an insulator, as is taught by Stockert, into the conductive members as is taught by Livneh as modified, to produce the predictable result of providing energy to only the desired portion of the device, as is taught by Stockert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of Klein (US 20080243157 A1) further in view of Geistert (US 20110257649 A1). Regarding claim 15, Livneh teaches the medical device of claim 1. In accordance with the above rejection of claim 1, Klein teaches electrode as including at least one outlet in a distal portion of the electrode ([0042]). However, Livneh as modified fails to teach the medical device wherein the electrode includes two or more outlets in a distal portion of the electrode proximal of a distal end face of the electrode, and wherein the electrode includes a channel with angled portions fluidly connecting the electrode lumen to the two or more outlets. Geistert teaches an electrode for an ablation catheter including an electrode body extending along a longitudinal axis and an irrigation lumen extending parallel to the longitudinal axis through which a fluid is provided (Abstract). Geistert further teaches the electrode as comprising a plurality of passages which provide flow of the fluid out of the electrode, wherein the plurality of passages are situated at an angle to the longitudinal axis ([0011], [0016], [0021]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the positioning of passages for providing fluid out of an electrode, as is taught by Geistert, into the electrode having a fluid lumen, as is taught by Livneh as modified, to produce the predictable result of providing fluid out of an electrode, as is taught by Geistert, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Livneh (US 20080004656 A1) in view of King (US 20180098771 A1). Regarding claim 19, Livneh teaches a medical device kit (Abstract), comprising: a medical device (Fig. 1; surgical instrument 50) including a handle (Fig. 1; handles 64, 66), and a shaft (Fig. 37-40; housing 58) extending distally from the handle, wherein the shaft includes a shaft lumen ([0059]); and at least one electrode (Fig. 37-40; electrode 158), including at least a first electrode and a second tool ([0062]- [0063]), wherein the second tool differs in structure from the first electrode ([0062]- [0063], [0082], [0085]), and wherein each of the first electrode and the second tool includes a receiver portion (Fig. 37-40; the widest portion of ball shaped end 166 s shown as contacting fingers 120) that is radially wider than a portion of the electrode distal to the receiver portion ([0081]), wherein the shaft includes a distal end having one or more movable arms, wherein each of the one or more movable arms (Fig. 7; arms 120) includes a protrusion (Fig. 7; tip 124), and wherein each of the one or more movable arms is configured for securing the first electrode to the distal end of the shaft ([0059], [0069]), releasing the first electrode from the distal end of the shaft ([0062]- [0063]), and securing the second tool to the distal end of the shaft ([0062]). However, Livneh fails to teach the at least one electrode as being a plurality of electrodes and there the other tool as being a second electrode. While Livneh does not explicitly teach the tools which are selected for attachment and detachment as being a plurality of electrodes, there is no evidence that more than one electrode makes a meaningful difference to the function of the device compared to the currently taught plurality of tools which teaches at least one of the tools as being an electrode which is attachable and detachable to the shaft distal portion. Specifically in view of Livneh which teaches the detachable tool assembly as being easily separable from the shaft and housing to allow a user of the surgical instrument to quickly change the desired tool, wherein the at least one desired tool which is discussed as being changed between is taught as being at least one electrode ([0062], [0079], [0083]) and it has been held that a duplication of parts is an obvious modification, as the mere duplication of parts has no patentable significance unless a new and unexpected result is produced (MPEP 2144.04(VI)(B)). Livneh further fails to teach the receiver portion as being radially wider than a portion of the electrode proximal to the receiver portion and the arms including an angled portion proximal to the protrusion, and an angled portion distal to the protrusion. King teaches a system having a distal treatment portion which is loadable onto a proximal applicator prior to insertion into a living body for treating target tissue (Abstract, [0023]). This distal treatment portion is taught as being loaded onto the proximal applicator by a yoke having opposed portions which are permitted to spread to receive an enlarged end of a control member, which upon longitudinal movement of the control member, controls the longitudinal movement of the distal end for treating tissue ([0023]). King further teaches the opposed portions of the yoke which are permitted to spread to receive the enlarged end as having a tapered portion which has a larger diameter opening closer to the enlarged end of the control member and a smaller portion which has a portion which protrudes (Fig. 1; shoulder 142) from the longitudinal axis and opens to a widened portion which is sized and shaped to receive the enlarged end, so as to prevent the undesirable movement of the enlarged end, which has a widened portion which is larger than the portions which are distal and proximal to said wider portion, out of the constraint of the opposed portions of the yoke ([0028]- [0029]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the widened and narrowed portions of the enlarged end and the opposed portions, as is taught by King, into the ball-end of the connection rod and tip of the arms, as is taught by Livneh, to produce the predictable result of preventing the undesirable movement of the enlarged end out of the yoke, as is taught by King, as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to LINDSAY REGAN LANCASTER whose telephone number is (571)272-7259. The examiner can normally be reached Monday-Thursday 8-4 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, Joseph Stoklosa can be reached on 571-272-1213. 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. /L.R.L./Examiner, Art Unit 3794 /JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
Read full office action

Prosecution Timeline

Jan 15, 2025
Application Filed
Oct 01, 2026
Non-Final Rejection mailed — §103 (current)

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6y 6m to grant Granted Jul 07, 2026
Patent 12594112
Cryogenic Applicator
5y 0m to grant Granted Apr 07, 2026
Patent 12594118
SYSTEMS, DEVICES, AND ASSOCIATED METHODS FOR NEUROMODULATION WITH ENHANCED NERVE TARGETING
2y 5m to grant Granted Apr 07, 2026
Patent 12575878
MAPPING AND ABLATION CATHETER WITH MULTIPLE LOOP SEGMENTS
4y 4m to grant Granted Mar 17, 2026
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
53%
Grant Probability
75%
With Interview (+21.5%)
3y 11m (~2y 1m remaining)
Median Time to Grant
Low
PTA Risk
Based on 105 resolved cases by this examiner. Grant probability derived from career allowance rate.

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