DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. 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
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/02/2026 (“02/02/26 Amendment") has been entered, and fully considered.
Response to Amendment
3. In the 01/05/26 Amendment, claims 1-3, 18, 26, & 27 were amended, and claim 30 was newly added. No claims were cancelled (claims 7, 8, 14, 16, 17, 19, 21, & 28 were previously cancelled). Therefore, claims 1-6, 9-13, 15, 18, 20, 22-27, 29, & 30 are now pending in the application.
4. The 01/05/26 Amendment has overcome the claim objection, and the rejections under § 112(b) previously set forth in the Final Office Action mailed 10/02/25 (“10/02/25 Action”).
5. The prior rejection of independent claim 1 under § 102 has been updated to address the amendment, and maintained. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
6. A new claim objection, and new grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
Claim Objections
7. Claim 30 is objected to because of the following informalities:
In claim 30, line 8, the recitation of reference character “(120)” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
8. 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.
9. Claims 1, 2, 4, 9, 15, & 26 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2014/0276774 to Raybin et al. (“Raybin”).
10. Regarding claim 1, Raybin discloses an excision apparatus for removing cellular tissue, said excision apparatus comprising:
a housing [elongate member (4) - ¶’s [0027], [0028]; FIG. 2] having a longitudinal direction [extending along the longitudinal axis of elongate member (4) - FIG. 2] and provided with a fixation portion [distal cap (2) - ¶’s [0027], [0031], [0033]; FIG. 2], wherein the fixation portion [(2)] is configured to be arranged on cellular tissue [e.g., ¶’s [0024], [0033]] such that a closed space [cavity (9) - ¶[0033]; FIG. 2] is formed by the cellular tissue and an inner surface [an inner surface of cap (2) that defines cavity (9) - FIG. 2] of the fixation portion [(2)];
said fixation portion [(2)] being further configured to fixedly retain the cellular tissue near the inner surface by removal of air from the closed space [(9)] via one or more air grooves [see “NOTE” below] near the inner surface of the fixation portion [(2)] which are connected to an air evacuating channel [a lumen (5) of the elongate member (4) which extends into distal cap (2) - see ¶’s [0029], [0033], claim 5; FIG. 2] [NOTE: as broadly as claimed, the “air grooves” comprise grooves formed between “longitudinal ridges” extending from an inner surface of cavity (9) to opening (10) of cap (2) (see ¶[0039]); further, because they extend along the inner surface of the cavity (9) defined by distal cap (2), they are “connected to” (or part of, e.g., in fluid communication with) the air evacuating channel defined by the portion of the lumen (5) that extends into distal cap (2); as such, Raybin satisfies the structural limitations of the claim];
a cutting element [tool (8) - ¶’s [0030], [0040], [0041]; FIG. 2] moveably arranged in the housing [(4)] [see ¶[0042]] such that the cutting element [(8)] is movable between a retracted position and an extended position with respect to the fixation portion [(2)] [see ¶[0042] (“In certain other embodiments, tool 8 may be movably disposed within lumen 5 of elongate member 4 and cavity 9 of distal cap 2. For example, tool 8 may be coupled to a suitable actuation member (not shown) on handle 3 that may be configured to advance and retract tool 8 relative to lumen 5 of elongate member 4”)], wherein the cutting element [(8)] comprises an electrode [tip (11) of tool (8) - ¶’s [0041], [0042]; FIG. 2] arranged at a distal end of the cutting element [¶[0030] (“…tool 8 may include any suitable electrically-conductive device configured to dissect and/or cut tissue, including, as examples, a wire, a needle, a blade, a knife, or a needle knife. It should be appreciated, however, that tool 8 is not limited to tissue dissection and/or cutting devices, and may include any other suitable instrument or tool for any medical procedure”); ¶[0041] (“Tip 11 may pierce the drawn tissue when tool 8 (and thus tip 11) is electrically-activated”); and ¶[0042] (“Tip 11 may then dissect tissue by moving tip 11 relative to the tissue. As tip 11 cuts through the tissue, a dissection path along the tissue may be formed”)] and configured for cutting a section of the cellular tissue retained by the fixation portion [(2)] when the cutting element [(8)] is in the extended position [e.g., ¶’s [0040]-[0042], claim 5].
11. Regarding claim 2, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein the cutting element [(8)] is translatable along an axis with respect to the housing [(4)] [¶[0042]], wherein the axis is oriented according to the longitudinal direction of the housing [(4)] [as clearly shown in FIG. 2, tool (8) extends along the longitudinal axis of housing (4)].
12. Regarding claim 4, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein the fixation portion is cup-shaped [see ¶[0035] (“In certain other embodiments, a cylindrical distal cap 2 may define a circular or oval shaped opening 10”); NOTE: as broadly as claimed, distal cap (2) defines a cavity (9) and has an opening (10), and is therefore “cup-shaped”].
13. Regarding claim 9, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein at least the fixation portion [(2)] is manufactured from a transparent material [see ¶[0037] (“Distal cap 2 and/or elongate member 4 may also be optically clear, allowing an operator to visualize tool 8 and tissue positioned within and/or around distal cap 2”)].
14. Regarding claim 15, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein the housing [(4)] comprises an elongate intermediate portion [as broadly as claimed, a portion extending between handle (3) and distal cap (2) - FIG. 2], and wherein the fixation portion [(2)] is arranged at a distal end [(7)] of said elongate intermediate portion and is operably connected to said elongate intermediate portion [see ¶[0031] (“Distal cap 2 may be coupled to distal end 7 of elongate member 4”); FIG. 2] such that air is removable from the closed space [(9)] via the air evacuating channel through the intermediate portion [lumen (5) of the elongate member (4) - see ¶’s [0029], [0033]; FIG. 2]; and/or [the following limitation is an optional alternative limitation that is not required] wherein the air evacuating channel is formed by the elongate intermediate portion being spaced apart from and around the cutting element such that an air removal channel is formed and wherein the intermediate portion comprises an air evacuation interface being connectable to an air pump; and/or [the following limitation is an optional alternative limitation that is not required] wherein one or more further air removal channels are formed by the elongate intermediate portion.
15. Regarding claim 26, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein the fixation portion [(2)] is configured to be releasably attachable to a distal end [(7)] of the housing [(4)] [see ¶[0031] (“Distal cap 2 may be coupled to distal end 7 of elongate member 4 by any suitable means. In one embodiment, for example, distal cap 2 may be detachably coupled to distal end 7 by any suitable coupling technique, such as, for example, a snap-fit, a luer-lock, screw threading, and the like”)].
Claim Rejections - 35 USC § 103
16. 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.
17. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
18. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Raybin.
19. Regarding claim 3, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses wherein the fixation portion [distal cap (2)] comprises at least one standing wall [wall defining the cavity (9)] extending in the longitudinal direction of the housing [the cavity (9) (including the walls that define it) extends in the longitudinal direction of the housing - FIG. 2] and an opening [opening (10)] …, and having an edge [shown in the annotated excerpt of FIG. 2 of Raybin below] configured to come into contact with the cellular tissue and wherein in the extended position the cutting element [(8)] does not extend beyond the edge of the fixation portion [(2)] [see ¶[0041] (“In some embodiments, tip 11 may extend through opening 10 and may include a portion external distal cap 2. In other embodiments, an entirety of tip 11 may be contained within cavity 9 at all times and may extend up to but not through opening 10”)].
PNG
media_image1.png
248
370
media_image1.png
Greyscale
ANNOTATED EXCERPT OF FIG. 2 OF RAYBIN
As seen above, the opening (10) in distal cap (2) extends in a direction substantially parallel to the longitudinal direction of the housing [(4)].
Raybin alternatively teaches that the opening (10) in distal cap (2) may be substantially perpendicular to the longitudinal axis of distal cap (2) to define a distally-facing opening (10) [see ¶[0034] (“opening 10 may be substantially perpendicular to the longitudinal axis of distal cap 2 to define a distally-facing opening 10. Still in further embodiments, opening 10 may be substantially parallel to the longitudinal axis of distal cap 2. Moreover, it should be appreciated that opening 10 may extend any suitable distance along the length of distal cap 2”)]. However, in such a configuration, given that the axis of distal cap (2) is slightly angled relative to the longitudinal direction of the housing (4), the plane of the opening will not be perfectly perpendicular to the longitudinal direction of the housing [(4)].
As such, Raybin does not explicitly disclose:
wherein the fixation portion [distal cap (2)] comprises an opening [opening (10)] oriented perpendicular to the longitudinal direction of the housing [(4)].
Raybin does, however, teach that the slant angle of opening (10) may vary depending on, e.g., the organ or the procedure [see Raybin, e.g., ¶’s [0034]-[0035]].
Accordingly, in the configuration of Raybin wherein the opening (10) in distal cap (2) is substantially perpendicular to the longitudinal axis of distal cap (2) to define a distally-facing opening (10), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Raybin such that the slant angle of opening (10) also be varied/adjusted (as expressly taught by Raybin) in a variety of positions including, e.g., one that results in the opening extending perpendicular to the longitudinal direction of the housing, depending on, e.g., an optimal position needed for contacting a given organ, or for a given procedure, as changing the slant angle of the opening (10) based on need would have been an example of a common practice requiring only ordinary skill in the art, and would hence be considered a routine expedient (especially given Raybin’s explicit contemplation of such a change in slant angle).
20. Claims 5, 6, 18, 20, 22-24, & 30 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin in view of U.S. Patent Application Publication No. 2016/0346037 to Truckai et al. ("Truckai").
21. Regarding claim 5, Raybin discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Raybin disclsoes that the cutting element [tool (8)] may include any suitable electrically-conductive device configured to dissect and/or cut tissue [¶[0030]], and that tip (11) of tool (8) may extend through opening (10) and may include a portion external to distal cap (2) [¶0041]].
While Raybin discloses that the cutting element [(8)] is translatable [¶[0042], Raybin is silent as to the translatable distance, and therefore does not explicitly disclose:
wherein the cutting element is translatable over a distance measured along the axis of at least 3 mm.
Truckai, in a similar field of endeavor, teaches an electrosurgical device adapted for cutting and extracting tissue in an endoscopic procedure [¶[0003]]. More particularly, Truckai teaches an electrosurgical probe (100) that includes a handle portion (104), an elongate shaft (105), and a distal working end (110) having an opening (140) [¶[0040]; FIG. 1]. Truckai further teaches an electrode (120) having an elongated medial portion (142) that extends through a passageway (or channel) in shaft (105) to an actuator mechanism (146) in the handle (104). The electrode (120) terminates in an electrically conductive portion having a hook portion for the electrosurgical cutting of tissue [¶[0041]; FIG. 1A]. Truckai teaches that any suitable actuator mechanism known in the art can be used to move electrode (120) axially and rotationally relative to longitudinal axis (108) [¶’s [0041], [0048]], including axially beyond opening (140) [see, e.g., FIGS. 2A-2C].
Truckai additionally teaches that it was known in the art for a cutting element [electrode (120)] to be translatable over a distance measured along the axis of at least 3 mm. For example, with reference to FIGS. 1B & 1C, Truckai teaches that the hook portion of electrode (120) will typically have a length (L) in the range from 3 mm to 10 mm [see ¶[0044]]. FIG. 2A depicts the hook portion as being within window (140), while FIG. 2B depicts the substantial length of hook portion as being outside of window (140). Therefore, it is the Examiner’s position that the hook portion in Truckai is translatable over a distance that corresponds at least to its length (at least 3 mm to 10 mm).
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that translatable cutting element (8) be translatable any suitable, art-recognized distance including, e.g., a distance measured along the axis of at least 3 mm, as taught by Truckai, based on desired clinical goals/objectives (e.g., size/depth of tissue to be excised).
22. Regarding claim 6, Raybin discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
While Raybin discloses that the cutting element [(8)] is translatable [¶[0042], Raybin does not disclose:
wherein the cutting element is rotatable along the axis of the housing; and/or [the following limitation is an optional alternative limitation that is not required] wherein the cutting element is rotatable between a plurality of indicated cutting positions, wherein each indicated cutting position corresponds with a respective section of the cellular tissue; and/or [the following limitation is an optional alternative limitation that is not required] wherein the plurality of indicated cutting positions comprises four quadrants.
Truckai, in a similar field of endeavor, teaches an electrosurgical device adapted for cutting and extracting tissue in an endoscopic procedure [¶[0003]]. More particularly, Truckai teaches an electrosurgical probe (100) that includes a handle portion (104), an elongate shaft (105), and a distal working end (110) having an opening (140) [¶[0040]; FIG. 1]. Truckai further teaches an electrode (120) having an elongated medial portion (142) that extends through a passageway (or channel) in shaft (105) to an actuator mechanism (146) in the handle (104). The electrode (120) terminates in an electrically conductive portion having a hook portion for the electrosurgical cutting of tissue [¶[0041]; FIG. 1A].
Truckai teaches that any suitable actuator mechanism known in the art can be used to move electrode (120) axially and rotationally relative to longitudinal axis (108) [¶’s [0041], [0048]] [compare FIG. 2B & FIG. 2C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that the cutting element is (additionally) rotatable along the axis of the housing, as taught by Truckai, since such a modification would allow for greater maneuverability of the distal end of the tip (11) of tool (8) of Raybin relative to the portion of tissue to be excised, thereby facilitating the procedure for a physician.
23. Regarding claim 18, Raybin discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses an actuating element [actuation member - ¶[0042]] being connected to the cutting element [(8)], wherein the actuating element is arranged at the proximal end of the housing [(4)] and is configured for moving the cutting element [(8)] between the retracted position and the extended position [see ¶[0042] (“In certain other embodiments, tool 8 may be movably disposed within lumen 5 of elongate member 4 and cavity 9 of distal cap 2. For example, tool 8 may be coupled to a suitable actuation member (not shown) on handle 3 that may be configured to advance and retract tool 8 relative to lumen 5 of elongate member 4”)]…
and/or [the following limitation is an optional alternative limitation that is not required] wherein the actuating element is arranged in an actuator housing section comprising an actuator housing wall, wherein the actuator housing wall comprises a plurality of position protrusions which are configured to be engaged by a position limiting element of the actuating element.
Raybin does not, however, disclose:
[the actuating element is configured for] rotating the cutting element along the axis.
Truckai, in a similar field of endeavor, teaches an electrosurgical device adapted for cutting and extracting tissue in an endoscopic procedure [¶[0003]]. More particularly, Truckai teaches an electrosurgical probe (100) that includes a handle portion (104), an elongate shaft (105), and a distal working end (110) having an opening (140) [¶[0040]; FIG. 1]. Truckai further teaches an electrode (120) having an elongated medial portion (142) that extends through a passageway (or channel) in shaft (105) to an actuator mechanism (146) in the handle (104). The electrode (120) terminates in an electrically conductive portion having a hook portion for the electrosurgical cutting of tissue [¶[0041]; FIG. 1A].
Truckai teaches that any suitable actuator mechanism known in the art can be used to move electrode (120) axially and rotationally relative to longitudinal axis (108) [¶’s [0041], [0048]] [compare FIG. 2B & FIG. 2C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that the actuating element be additionally configured for rotating the cutting element along the axis, as taught by Truckai, since such a modification would allow for greater maneuverability of the distal end of the tip (11) of tool (8) of Raybin relative to the portion of tissue to be excised, thereby facilitating the procedure for a physician.
24. Claims 20 & 22, which each ultimately depend from claim 18, further narrow optional limitations that are only recited in the alternative in claim 18, and are not required. For example, claims 20 & 22 never positively recite that the system further comprises a plurality of position protrusions, a position limiting element, or actuator housing wall.
25. Regarding claims 23 & 24, the combination of Raybin and Truckai teaches all of the limitations of claim 18 for the reasons set forth in detail (above) in the Office Action.
Raybin discloses that tool (8) may be coupled to a suitable actuation member (not shown) on handle (3) that may be configured to advance and retract tool (8) [see ¶[0042]].
Raybin does not explicitly disclose:
[claim 23] wherein an actuator housing section is provided at the proximal end of the housing and comprises a plurality of slots arranged side by side in a longitudinal direction along the axis;
wherein the excision apparatus further comprises a position abutting element configured to prevent the cutting element from moving beyond the position abutting element, and
wherein the position abutting element is arrangeable in a slot of the plurality of slots; nor
[claim 24] wherein each slot of the plurality of slots forms a through hole and the position abutting element comprises an abutment which is configured to extend through the slot when the position abutting element is arranged on the actuator housing section and is configured to prevent the cutting element from moving beyond the abutment.
Truckai, in a similar field of endeavor, teaches an electrosurgical device adapted for cutting and extracting tissue in an endoscopic procedure [¶[0003]]. More particularly, Truckai teaches an electrosurgical probe (100) that includes a handle portion (104), an elongate shaft (105), and a distal working end (110) having an opening (140) [¶[0040]; FIG. 1]. Truckai further teaches an electrode (120) having an elongated medial portion (142) that extends through a passageway (or channel) in shaft (105) to an actuator mechanism (146) in the handle (104). The electrode (120) terminates in an electrically conductive portion having a hook portion for the electrosurgical cutting of tissue [¶[0041]; FIG. 1A].
With reference to FIG. 1A, Truckai further teaches that actuator mechanism (146) in the handle (104) is adapted to slide from position A to position B to position C to thereby move the electrode (120) from the non-extended position of FIG. 2A to the extended position of FIG. 2B, and then to the extended and rotated position of FIG. 2C [¶[0041]]. Truckai teaches that any suitable actuator mechanism known in the art can be used to move the electrode (120) axially and rotationally [¶[0041]].
As one example, Truckai teaches that the moveable actuator (146) can be configured with detents that engages a portion of handle (104) to releasably maintain the electrode (120) in one of the selected positions of FIGS. 2A-2C [¶[0041]].
Accordingly, as broadly as claimed, Truckai teaches an actuator housing section provided at the proximal end of the housing [handle portion (104)] that comprises a plurality of slots [detent depressions/notches] arranged side by side in a longitudinal direction along the axis [corresponding to positions “A,” “B,” & “C” in FIG. 1A]; wherein the excision apparatus further comprises a position abutting element [a detent component (often a small ball) designed to engage the detent notches, as would be appreciated by one of ordinary skill in the art] configured to prevent the cutting element from moving beyond the position abutting element [until enough force is applied to disengage the detent component from the detent notch, as would be appreciated by one of ordinary skill in the art], and wherein the position abutting element is arrangeable in a slot of the plurality of slots [again, a detent component designed to engage the detent notches];
wherein each slot of the plurality of slots form a through hole [notches receive the detent component] and the position abutting element comprises an abutment which is configured to extend through the slot when the position abutting element is arranged on the actuator housing section and is configured to prevent the cutting element from moving beyond the abutment [detent component is designed to engage the detent notches to hold the cutting element in a desired position until enough force is applied to disengage the detent component from the detent notch, as would be appreciated by one of ordinary skill in the art].
In view of Raybin’s disclosure (noted above) that the tool may be coupled to a suitable actuation member (not shown) on the handle to advance and retract the tool, it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Raybin and Truckai such that an actuator housing section is provided at the proximal end of the housing and comprises a plurality of slots arranged side by side in a longitudinal direction along the axis, wherein the excision apparatus further comprises a position abutting element configured to prevent the cutting element from moving beyond the position abutting element, wherein the position abutting element is arrangeable in a slot of the plurality of slots, wherein each of the plurality of slots forms a through hole and the position abutting element comprises an abutment which is configured to extend through the slot when the position abutting element is arranged on the actuator housing section and is configured to prevent the cutting element from moving beyond the abutment, all as taught by Truckai, since such a known actuator mechanism was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Truckai), and one of ordinary skill in the art would have been capable of applying this known actuator mechanism to the known device of Raybin/Truckai, and the results [the axial advancement and retraction of tool (8) through discrete, desired positions along the longitudinal axis of the device] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
26. Regarding claim 30, Raybin teaches an excision apparatus for removing cellular tissue, said excision apparatus comprising:
an elongated housing [elongate member (4) - ¶’s [0027], [0028]; FIG. 2] having a longitudinal direction [extending along the longitudinal axis of elongate member (4) - FIG. 2] and provided with a fixation portion [distal cap (2) - ¶’s [0027], [0031], [0033]; FIG. 2], wherein the fixation portion [(2)] has an opening [opening (10)]…, wherein the opening [(10)] is surrounded by an edge [shown in the annotated excerpt of FIG. 2 of Raybin below] which is configured to be arranged on cellular tissue [e.g., ¶’s [0024], [0033]] such that cellular tissue closes the opening [(10)] such that a closed space [cavity (9) - ¶[0033]; FIG. 2] is formed by the cellular tissue and an inner surface [an inner surface of cap (2) that defines cavity (9) - FIG. 2] of the fixation portion [(120)]; said fixation portion [(2)] being further configured to fixedly retain the cellular tissue near the inner surface by removal of air from the closed space [(9)] via an air evacuating channel [a lumen (5) of the elongate member (4) which extends into distal cap (2) - see ¶’s [0029], [0033], claim 5; FIG. 2];
PNG
media_image1.png
248
370
media_image1.png
Greyscale
ANNOTATED EXCERPT OF FIG. 2 OF RAYBIN
a cutting element [tool (8) - ¶’s [0030], [0040], [0041]; FIG. 2] moveably arranged in the housing [(4)] [see ¶[0042]] such that the cutting element [(8)] is movable along an axis in the longitudinal direction between a retracted position and an extended position with respect to the fixation portion [(2)] [see ¶[0042] (“In certain other embodiments, tool 8 may be movably disposed within lumen 5 of elongate member 4 and cavity 9 of distal cap 2. For example, tool 8 may be coupled to a suitable actuation member (not shown) on handle 3 that may be configured to advance and retract tool 8 relative to lumen 5 of elongate member 4”)]…,
wherein the cutting element [(8)] comprises an electrode [tip (11) of tool (8) - ¶’s [0041], [0042]; FIG. 2] arranged at a distal end of the cutting element [¶[0030] (“…tool 8 may include any suitable electrically-conductive device configured to dissect and/or cut tissue, including, as examples, a wire, a needle, a blade, a knife, or a needle knife. It should be appreciated, however, that tool 8 is not limited to tissue dissection and/or cutting devices, and may include any other suitable instrument or tool for any medical procedure”); ¶[0041] (“Tip 11 may pierce the drawn tissue when tool 8 (and thus tip 11) is electrically-activated”); and ¶[0042] (“Tip 11 may then dissect tissue by moving tip 11 relative to the tissue. As tip 11 cuts through the tissue, a dissection path along the tissue may be formed”)] and configured for cutting a section of the cellular tissue retained by the fixation portion [(2)] when the cutting element [(8)] is in the extended position [e.g., ¶’s [0040]-[0042], claim 5], wherein in the extended position the cutting element does not extend beyond the edge surrounding the opening of the fixation portion [(2)] [see ¶[0041] (“In some embodiments, tip 11 may extend through opening 10 and may include a portion external distal cap 2. In other embodiments, an entirety of tip 11 may be contained within cavity 9 at all times and may extend up to but not through opening 10”)].
A. Perpendicular Opening
As seen above [in FIG. 2], the opening (10) in distal cap (2) extends in a direction substantially parallel to the longitudinal direction of the housing [(4)].
Raybin alternatively teaches that the opening (10) in distal cap (2) may be substantially perpendicular to the longitudinal axis of distal cap (2) to define a distally-facing opening (10) [see ¶[0034] (“opening 10 may be substantially perpendicular to the longitudinal axis of distal cap 2 to define a distally-facing opening 10. Still in further embodiments, opening 10 may be substantially parallel to the longitudinal axis of distal cap 2. Moreover, it should be appreciated that opening 10 may extend any suitable distance along the length of distal cap 2”)]. However, in such a configuration, given that the axis of distal cap (2) is slightly angled relative to the longitudinal direction of the housing (4), the plane of the opening will not be perfectly perpendicular to the longitudinal direction of the housing [(4)].
As such, Raybin does not explicitly teach:
wherein the fixation portion [distal cap (2)] has an opening [opening (10)] perpendicular to the longitudinal direction.
Raybin does, however, teach that the slant angle of opening (10) may vary depending on, e.g., the organ or the procedure [see Raybin, e.g., ¶’s [0034]-[0035]].
Accordingly, in the configuration of Raybin wherein the opening (10) in distal cap (2) is substantially perpendicular to the longitudinal axis of distal cap (2) to define a distally-facing opening (10), it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify Raybin such that the slant angle of opening (10) also be varied/adjusted (as expressly taught by Raybin) in a variety of positions including, e.g., one that results in the opening extending perpendicular to the longitudinal direction of the housing, depending on, e.g., an optimal position needed for contacting a given organ, or for a given procedure, as changing the slant angle of the opening (10) based on need would have been an example of a common practice requiring only ordinary skill in the art, and would hence be considered a routine expedient (especially given Raybin’s explicit contemplation of such a change in slant angle).
B. Rotatable Cutting Element
Finally, Raybin teaches an actuating element [actuation member - ¶[0042]] connected to the cutting element [(8)] and configured for moving the cutting element [(8)] between the retracted position and the extended position [see ¶[0042] (“In certain other embodiments, tool 8 may be movably disposed within lumen 5 of elongate member 4 and cavity 9 of distal cap 2. For example, tool 8 may be coupled to a suitable actuation member (not shown) on handle 3 that may be configured to advance and retract tool 8 relative to lumen 5 of elongate member 4”)].
Raybin does not, however, teach:
wherein the cutting element is rotatable along the axis.
Truckai, in a similar field of endeavor, teaches an electrosurgical device adapted for cutting and extracting tissue in an endoscopic procedure [¶[0003]].
More particularly, Truckai teaches an electrosurgical probe (100) that includes a handle portion (104), an elongate shaft (105), and a distal working end (110) having an opening (140) [¶[0040]; FIG. 1]. Truckai further teaches an electrode (120) having an elongated medial portion (142) that extends through a passageway (or channel) in shaft (105) to an actuator mechanism (146) in the handle (104). The electrode (120) terminates in an electrically conductive portion having a hook portion for the electrosurgical cutting of tissue [¶[0041]; FIG. 1A].
Truckai teaches that any suitable actuator mechanism known in the art can be used to move electrode (120) axially and rotationally relative to longitudinal axis (108) [¶’s [0041], [0048]] [compare FIG. 2B & FIG. 2C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that the cutting element be rotatable along the axis, as taught by Truckai, since such a modification would allow for greater maneuverability of the distal end of the tip (11) of tool (8) of Raybin relative to the portion of tissue to be excised, thereby facilitating the procedure for a physician.
27. Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Raybin and Truckai, as applied to claim 23 above, and further in view of U.S. Patent Application Publication No. 2005/0119680 to Dykes ("Dykes").
28. Regarding claim 25, the combination of Raybin and Truckai teaches all of the limitations of claim 23 for the reasons set forth in detail (above) in the Office Action.
The combination of Raybin and Truckai does not explicitly teach:
wherein the position abutting element [a detent component (often a small ball) designed to engage the detent notches] is clippable on the housing, using a flexible or spring-loaded clip configured to engage the housing.
Dykes, in a similar field of endeavor, teaches that it was known to utilize spring-loaded detents to clip/click detents into matching grooves/notches in a housing to lock a slidable member in position [see ¶[0044] (“…as would be understood by those skilled in the art, the locking mechanism may include two or more grooves formed on the interior of guard 20 that lock guard 20 open or closed by interaction with matching spring-loaded balls. In a similar manner, other types of spring-loaded (coiled spring or leaf spring) detents may be employed to "click" into grooves or notches in order to lock guard 20 into one of its two positions. Other examples not shown would include a bowed leaf spring attached at both ends of a reduced diameter portion, with a rounded projection on their upper-most portion to serve as a spring-loaded detent. In addition, a snap ring arrangement could be used as a detent to "click" into grooves to lock guard 20 into position”)].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Raybin and Truckai such that the position abutting element is clippable on the housing, using a flexible or spring-loaded clip configured to engage the housing, as taught by Dykes, since such a known detent/notch engagement configuration was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Dykes), and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Raybin/Truckai, and the results [engaging detents with corresponding notches] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
29. Claims 10 & 29 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin in view of U.S. Patent Application Publication No. 2005/0113854 to Uckele ("Uckele").
30. Regarding claim 10, Raybin discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Raybin discloses the introduction of various medical devices through one or more device channels, that the dimensions of the channels may vary, that the device may be a device used for, e.g., dissection and resection [¶[0025]], and that the tool may include any suitable instrument or tool for any medical procedure [¶[0030]].
Raybin does not, however, disclose:
a guiding rod extending outwardly along the axis, in the direction of a distal end of the housing, and configured to be inserted in a body cavity for aligning the excision apparatus with walls of the body cavity.
Uckele, in a similar field of endeavor, teaches a surgical instrument for the removal of a conical section of cervical tissue [¶[0003]]. Uckele further teaches the use of an outwardly extending stabilization rod (20) to attach to a patient’s cervical tissue to prevent the cervical tissue from moving away during a procedure [¶[0031]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin to include an outwardly extending stabilization rod so as to provide the benefit/advantage of keeping the device of Raybin attached to (and therefore aligned with) the tissue of interest to be excised during a procedure, thereby facilitating the procedure for a physician.
31. Regarding claim 29, the combination of Raybin and Uckele teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
Uckele further teaches wherein the body cavity is a cervix of a female patient [e.g., Abstract, ¶[0003]].
32. Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Raybin and Uckele, as applied to claim 10 above, and further in view of U.S. Patent Application Publication No. 2020/0000513 to Motai ("Motai").
33. Regarding claim 12, the combination of Raybin and Uckele teaches all of the limitations of claim 10 for the reasons set forth in detail (above) in the Office Action.
Raybin teaches that the tool (8) may include any suitable electrically-conductive device configured to dissect and/or cut tissue, including, for example, a wire [¶[0030]].
The combination of Raybin and Uckele does not teach:
wherein the electrode forms the a subelectrode and wherein the guiding rod forms a second subelectrode.
However, a bipolar configuration in which an extendable/retractable wire serves as an active electrode while a rod/shaft provides a return electrode was well known in the art, before the effective filing date of the claimed invention.
As one example, Motai, in a similar field of endeavor, teaches a high-frequency snare (6) provided with a bipolar electrode (14) formed of a ring-shaped wire, which can tightly bind and cut tissue by causing a high-frequency current to flow therein [¶[0032]; FIG. 1]. Motai teaches that the ring-shaped wire serves as an active electrode, and a return electrode is provided in a portion of a shaft (13) [¶[0034]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the combination of Raybin and Uckele such that the electrode forms a first subelectrode [active electrode] and wherein the guiding rod forms a second subelectrode [return electrode], since such a known energy conduction configuration was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Motai), and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Raybin/Uckele, and the results [energy path in a bipolar electrode configuration] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
34. Claims 11 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Raybin in view of U.S. Patent Application Publication No. 2007/0208339 to Arts et al. ("Arts").
35. Regarding claims 11 & 13, Raybin discloses all of the limitations of claim 2 for the reasons set forth in detail (above) in the Office Action.
Raybin discloses that the tool (8) may include any suitable electrically-conductive device configured to dissect and/or cut tissue, including, for example, a wire [¶[0030]].
Raybin does not, however, disclose:
[claim 11] wherein the electrode is a bipolar electrode comprising a first and a second subelectrode; nor
[claim 13] wherein the electrode is a loop electrode; and/or [the following limitation is an optional alternative limitation that is not required] wherein the loop electrode extends radially, in a projection on the axis, over a distance of at least 3 mm.
Arts, in a similar field of endeavor, teaches an electrode in the form of a wire snare loop (24) [FIG. 2]. In a bipolar configuration, one of two sides (40, 42) of electrode (24) serves as an active electrode [as broadly as claimed, a first subelectrode], while the other serves as a return electrode [as broadly as claimed, a second subelectrode] being separated by an insulative material (e.g., ceramic tip) [¶0029; FIG. 2].
Given Raybin’s disclosure (noted above) that the tool (8) may include any suitable electrically-conductive device configured to dissect and/or cut tissue, including, for example, a wire [¶[0030]], it would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that the electrode comprises a bipolar loop electrode comprising a first and a second subelectrode, as taught by Arts, since such a modification amounts merely to the substitution of one known electrode configuration for another, yielding predictable results [provision of an electrically-conductive device configured to dissect and/or cut tissue] to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
36. Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Raybin in view of WO 2012/087506 A2 to Chomas et al. ("Chomas").
37. Regarding claim 27, Raybin discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Raybin further discloses:
wherein the one or more air grooves extend over the inner surface [see ¶[0039] - as well as the rejection of claim 1 set forth above]; and
wherein the fixation portion [(2)] is provided with a plurality of graduation indicators [radiopaque or sono-reflective markings - ¶[0038]], wherein the plurality of graduation indicators are… on the fixation portion [(2)] [see ¶[0038] (“Furthermore, suitable markings, such as, for example, radiopaque or sono-reflective markings (not shown), may be applied to the outer surface of distal cap 2. These markings may facilitate the detection of a position and/or orientation of distal cap 2 within the patient's body, and an operator, with the aid of suitable imaging equipment, may track the path of distal cap 2 and avoid potential damage to sensitive tissues. In some embodiments, a portion or a substantial entirety of the periphery of opening 10 may include a radiopaque or sono-reflective marking”)].
Raybin does not, however, explicitly teach:
wherein the plurality of graduation indicators are evenly distributed along a circular arc on the fixation portion.
Chomas, in a similar field of endeavor, teaches a skin treatment device comprising a handpiece and a cutting tool that is inserted through a conduit and percutaneously inserted into a tissue disposed within a recessed area of the handpiece [Abstract]. Chomas teaches that it was known to provide reference markings (used to indicate depth settings) that are evenly distributed seen along a circular arc [see, e.g., pg. 32, ll. 3-19; FIG. 14A].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Raybin such that that the shape, number, and/or spacing of the radiopaque or sono-reflective markings applied to the fixation portion (2) be selected from among known, art-recognized position/orientation indicator configurations deemed desirable or expedient such as, e.g., being evenly distributed seen along a circular arc, as taught by Chomas, since such a known position/orientation indicator configuration was recognized as part of the ordinary capabilities of one skilled in the art (as demonstrated by Chomas), and one of ordinary skill in the art would have been capable of applying this known configuration to the known device of Raybin, and the results [facilitating the detection of a position and/or orientation of distal cap within the patient's body] would have been entirely predictable to one of ordinary skill in the art. KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398 (2007).
Response to Arguments
38. As noted above, the 01/05/26 Amendment has overcome the claim objection, and the rejections under § 112(b) previously set forth in the 10/02/25 Action.
39. A new claim objection, and new grounds of rejection under § 103 are set forth herein, necessitated by Applicant’s Amendment.
40. The prior rejection of independent claim 1 under § 102 based on Raybin has been updated, and maintained.
41. Independent Claim 1
Applicant’s arguments concerning the alleged deficiencies of Raybin have been fully considered, but they are not persuasive.
Fixation Portion/Closed Space
As it concerns the rejection of independent claim 1 under § 102 based on Raybin, Applicant continues to argue that Raybin fails to disclose the limitation “wherein the fixation portion is configured to be arranged on cellular tissue such that a closed space is formed by the cellular tissue and an inner surface of the fixation portion:”
Applicant notes that Raybin' s disclosure of "upon application of a suction force through the lumen 5, target tissue may be drawn through opening 10 and into cavity 9", is different from the required configuration in claim 1 as amended. Drawing tissue into a cavity upon application of suction is not the same as being positioned on tissue and forming a closed space wherein a part of the space is bordered by the tissue and another part is bordered by the fixation portion.
02/02/26 Amendment, pgs. 10-11.
***
Applicant further notes that claim 1 requires a certain positioning (such that a closed space is formed) in addition to the application of suction or the removal of air. This additional feature of positioning is completely absent in Raybin and Applicant believes the Office Action incorrectly concludes that such positioning and the resulting closed space is disclosed by Raybin.
02/02/26 Amendment, pg. 11.
These arguments are not persuasive. When the fixation portion (2) of Raybin is placed on the surface of cellular tissue, a closed space is formed between, and defined by, the tissue surface (on the bottom), and the interior of cap (2) [i.e., the inner surface of cap (2) that defines cavity (9)]. If such a closed space were not formed in Raybin to begin with, as Applicant alleges, it is not clear how the application of suction would even be able to draw tissue into the opening (10). Stated another way, in the absence of a closed space, suction would have no effect as air would simply continue to be drawn in through whatever alleged opening existed between the fixation portion of Raybin and the surface of the cellular tissue.
b. Air Grooves
Independent Claim 1 was amended to include the limitation concerning “air grooves” taken from dependent claim 27:
said fixation portion being further configured to fixedly retain the cellular tissue near the inner surface by removal of air from the closed space via one or more air grooves near the inner surface of the fixation portion which are connected to an air evacuating channel;
Concerning this limitation, Applicant argues as follows:
Thus, claim 1 has been amended to clarify that the removal of air is performed via "one or more air grooves near the inner surface of the fixation portion" which are connected to an air evacuating channel. As noted in the Specification, these air grooves improve the function of the fixation portion and allow for the tissue to be more evenly retained therein when suction is applied. (See Specification, page 5, lines 18-21, and on page 20, lines 6 - 17.)
None of the cited references disclose or suggest the provision of one or more air grooves to improve the fixation of tissue before cutting.
02/02/26 Amendment, pgs. 9-10, emphasis added.
***
In rejecting claim 27 on file (which included the feature of one or more air grooves which is now present in claim 1), the Office Action cites to paragraph [0039] of Raybin as allegedly disclosing the claimed air grooves. Applicant disagrees. Claim 1 as amended requires "one or more air grooves" which are "near the inner surface of the fixation portion" and which are "connected to an air evacuating channel". These air grooves near the inner surface, which are connected to the air evacuating channel serve the purpose of enhancing the applied vacuum within the fixation portion and thereby improve fixation at the inner surface of the fixation portion of the tissue before cutting. Paragraph [0039] of Raybin, by contrast, suggests the provision of a grate with ridges which extend away from the inner surface of cavity 9, which is contrary to the function of the claimed air grooves. The ridges of the grate serve to control the depth of the cavity and thereby the volume of tissue to be drawn into the cavity. Effectively the tissue is thereby kept further away from the inner surface of the cavity 9, whereas the claimed air grooves allow for a closer contact between the inner surface of the fixation portion and the tissue. Applicant thus believes that paragraph [0039] of Raybin cannot be considered as disclosing the claimed air grooves, since air grooves are both structurally and functionally clearly different from the grate with ridges.
02/02/26 Amendment, pg. 12, emphasis added.
Applicant’s arguments are not persuasive, as Applicant’s focus on the “function” served by the grooves ignores the fact that Raybin clearly discloses the claimed structure. As set forth in the updated rejection of claim 1 herein, the “air grooves” in Raybin comprise grooves formed between “longitudinal ridges” extending from an inner surface of cavity (9) to opening (10) of cap (2) (see ¶[0039]). As broadly as claimed, because the longitudinal ridges (forming the grooves therebetween) extend along the inner surface of the cavity (9) defined by distal cap (2), they are “connected to” (or part of, e.g., in fluid communication with) the air evacuating channel which is defined by the portion of the lumen (5) that extends into distal cap (2). For these reasons, Raybin satisfies the structural limitations of the claim.
42. For the foregoing reasons, the rejection of independent claim 1 under § 102 has been maintained.
43. Dependent Claim 3
44. The rejection of claim 3 has been updated herein to address amended claim 3.
45. Dependent Claim 6 & 18
46. Concerning dependent claims 6 & 18, Applicant argues as follows:
Paragraph 24 of the Office Action identifies paragraphs [0041], [0048] and FIGS. 2B and 2C of Truckai as disclosing, in combination with Raybin, all features of dependent claim 6.
Applicant disagrees, because Raybin and Truckai disclose mutually different cutting configurations. The cutting tool of Raybin is completely internal (inside the cavity), and has no freedom (or even physical space) to rotate, whereas the cutting tool of Truckai operates externally (outside the cavity). It is therefore submitted that the disclosures of Raybin and Truckai cannot reasonably be combined, and that the Office Action's combination of these documents is based on an impermissible hindsight reconstruction.
The same reasoning is applicable to the subject-matter of claim 18 in view of the claimed rotating of the cutting element along the axis.
02/02/26 Amendment, pg. 14.
This argument is not persuasive. The current claim language does not require 360° rotation. Modifying Raybin so that the cutting element is rotatable along the axis of the housing, even, e.g., along a small angle of rotation to allow for a side-to-side or sweeping movement would allow for greater maneuverability of the distal end of the tip (11) of tool (8) of Raybin relative to the portion of tissue to be excised, thereby facilitating the procedure for a physician.
47. New Claim 30
Newly added claim 30 has been rejected herein (above) based on the combination of Raybin and Truckai.
Conclusion
48. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Bradford C. Blaise/Examiner, Art Unit 3794