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 .
Response to Amendment
2. Applicant’s Amendment filed December 19, 2025 (hereinafter “12/19/25 Amendment") has been entered, and fully considered. In the 12/19/25 Amendment, claims 1, 2, 4-7, 9, 11, 12, 15, 18-21, & 23 were amended, and claim 3 was cancelled. No claims were newly added. Therefore, claims 1, 2, & 4-23 are now pending in the application.
3. The 12/19/25 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the Non-Final Office Action mailed 08/12/25 (“08/12/25 Action”).
4. New claim objections, and updated rejections under §§ 102 & 103 are set forth herein, necessitated by Applicant’s Amendment.
5. Applicant's arguments are addressed in detail below in the “Response to Arguments” section.
Claim Objections
6. Claims 1, 6, 7, 9, 11, 18, 20, 21, & 23 are objected to because of the following informalities:
a. In claim 1, line 16, the recitation of “the opposing jaw” should instead recite --the opposing jaw member-- to be consistent with prior recitations in the claim.
b. In claim 6, lines 1-2, the recitation of “the at least the first segment” should instead recite --the first segment-- to be consistent with the recitation in amended claim 1.
c. In claim 6, lines 2-3, the recitation of “the at least the second segment” should instead recite --the second segment-- to be consistent with the recitation in amended claim 1.
d. In claim 7, line 4, the recitation of “the at least the first segment” should instead recite --the first segment-- to be consistent with the recitation in amended claim 1.
e. In claim 7, line 5, the recitation of “the opposing jaw” should instead recite --the opposing jaw member--.
f. In claim 9, line 4, the recitation of “such that the at least the first segment” should instead recite --such that the first segment--.
g. In claim 9, line 5, the recitation of “the opposing jaw” should instead recite --the opposing jaw member--.
h. In claim 11, lines 3-4, the recitation of “such that the at least the first segment” should instead recite --such that the first segment--.
i. In claim 11, line 4, the recitation of “the opposing jaw” should instead recite --the opposing jaw member--.
j. In claim 11, line 5, the recitation of “the opposing jaw” should instead recite --the opposing jaw member--.
k. In claim 18, line 1, the recitation of “the first compressible segment” should instead recite --the first segment-- to be consistent with the recitation in amended independent claim 15.
l. In claim 18, line 2, the recitation of “the second compressible segment” should instead recite --the second segment-- to be consistent with the recitation in amended independent claim 15.
m. In claim 20, lines 4-6, the recitation of “in response to the first tensile force exceeding a specified first threshold force, deforming at least a portion of a first segment of the plurality of individually deformable segments in a direction away from an opposing jaw member” should instead recite --in response to the first tensile force exceeding the specified first threshold force, deforming at least a portion of the first segment of the plurality of individually deformable segments in a direction away from an opposing jaw member of the first jaw member or the second jaw member-- to be consistent with the amendments made to independent claim 19.
n. In claim 21, lines 4-6, the recitation of “in response to the second tensile force exceeding a specified second threshold force, deforming at least a portion of a second segment of the plurality of individually deformable segments in a direction away from an opposing jaw member” should instead recite --in response to the second tensile force exceeding the specified second threshold force, deforming at least a portion of the second segment of the plurality of individually deformable segments in a direction away from the opposing jaw member-- to be consistent with the amendments made to independent claim 19.
o. In claim 23, line 6, the recitation of “an opposing jaw” should instead recite --the opposing jaw member--.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
7. 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.
8. Claims 1, 4, 7, 8, & 14-21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2021/0196346 to Leuck et al. (“Leuck”).
9. Regarding claim 1, and with reference to FIG. 39 (reproduced below), Leuck discloses an end effector assembly [end effector (2380) - ¶[0244]; FIG. 39] of a medical device, the end effector assembly [(2380)] comprising a jaw assembly comprising:
a first jaw member [broadly, ultrasonic blade (2382) - ¶[0244]; FIG. 39];
a second jaw member [clamp jaw (2385) - ¶[0244]; FIG. 39] pivotably coupled to the first jaw member [(2382)] at a fulcrum [a pivot axis; see ¶[0146] which generally describes pivotal movement of a clamp arm relative to the ultrasonic blade] wherein the jaw assembly is movable between a first position [open position] in which the first [(2382)] and second [(2385)] jaw members are opposing and spaced apart from each other and a second position [closed position] in which the first [(2382)] and second [(2385)] jaw members are positioned closer to each other than in the first position [e.g., when clamping and compressing tissue under treatment - e.g., ¶[0144] (“Tissue under treatment is clamped and compressed between the clamp arm 1000 and the ultrasonic blade”)]; and
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FIG. 39 of LEUCK
an electrode [electrode (2386) - ¶[0244]; FIG. 39] arranged on an inner surface of the first jaw member or the second jaw member [electrode (2386) is arranged on an inner/upward-facing surface of the second jaw member (2385) via springs (2388a, 2388b, 2388c); FIG. 39], the electrode [(2386)] including a plurality of segments [segments (2386a, 2386b, 2386c) - ¶[0244]; FIG. 39] extending outward [distally] in a row [segments (2386a, 2386b, 2386c) are arranged in a straight line (longitudinally in a row)] away from the fulcrum [away from the pivot axis; FIG. 39];
the plurality of segments including:
a first segment [e.g., proximal-most segment (2386c)] configured to deform or move in a direction away from an opposing member of the first jaw member or the second jaw member [movable in a downward direction, away from first jaw member (2382)], when a tensile force exceeding a specified first threshold force is present at the first segment [see ¶[0244] (“Three springs 2388a, 2388b, 2388c are positioned between each of the electrode segments 2386a, 2386b, 2386c and the clamp jaw 2385 to apply distal, medial, and proximal bias to the electrode segments 2386a, 2386b, 2386c, respectively”); see also ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw”); & ¶’s [0240]-[0242]; the force needed to overcome the bias of spring (2388c) and its selected spring rate comprises a specified first threshold force]; and
a second segment [e.g., distal segment (2386a) - ¶[0244]; FIG. 39] configured to deform or move, discretely [“independently” (addressed in greater detail below)] from the deformation or moving of the first segment [proximal-most segment (2386c)] and in a direction away from the opposing jaw [movable in a downward direction, away from first jaw member (2382)], when a tensile force exceeding a specified second threshold force is present at the second segment [see ¶’s [0239]-[0242]; & [0244]; the force needed to overcome the bias of spring (2388a) and its selected spring rate comprises a specified second threshold force]. NOTE: Leuck clearly and unambiguously discloses that each segment is capable of independent deflection [see ¶[0239] (“In one aspect, a segmented electrode configuration comprises independently deflectable portions. Each segment of the segmented electrode is capable of deflecting independently. In one aspect, the segmented electrode comprises independently deflectable electrodes for use in a combination ultrasonic/bipolar RF energy device. Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”)]. This limitation is described in greater detail below in the “Response to Arguments” section.
10. Regarding claim 4, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the second segment [(2386a)] is longitudinally spaced apart from the first segment [(2386c)] [as broadly as claimed, second segment (2386a) is longitudinally spaced apart (in a longitudinal direction along the jaw member) from the first segment (2386c), with the medial segment (2386b) disposed therebetween - ¶[0244]; FIG. 39].
11. Regarding claim 7, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the first segment [(2386c)] includes a first compression feature [spring element (2388c) - ¶[0244]; FIG. 39] configured such that a strain from the tensile force localizes within the first segment [(2386c)] at or near the first compression feature [resistance is controlled by (and therefore at) spring element (2388c) - ¶[0241]] such that the at least the first segment [(2386c)] deforms in a direction away from the opposing jaw [movable in a downward direction, away from first jaw member (2382)] [see ¶’s [0239]-[0242], [0244]].
12. Regarding claim 8, Leuck discloses all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the compression feature includes at least one of: a necking feature; a serration; an opening; a spring [spring element (2388c) - ¶[0244]; FIG. 39]; or a tapered region.
13. Regarding claim 14, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses an electrically conductive layer covering the plurality of segments [e.g., ¶[0198] (“Another technique comprises making the surface of the clamp arm pad conductive, providing wear-through electrodes, 3D printing, thermal spraying, cold spraying, coatings/paints/epoxies, sheet/foil/wire/film wrapping or laminating, vacuum metalizing, printing/transferring, among other techniques”)].
14. Regarding claim 15, and with reference to FIG. 39 (reproduced below), Leuck discloses a forceps comprising:
an end effector assembly [end effector (2380) - ¶[0244]; FIG. 39] comprising:
a first jaw [clamp jaw (2385) - ¶[0244]; FIG. 39] having a tissue sealing surface [surface of electrode (2386) - ¶[0244]; FIG. 39]; and
a second jaw [broadly, ultrasonic blade (2382) - ¶[0244]; FIG. 39] having a tissue sealing surface [the ultrasonic blade contacts tissue (e.g., ¶’s [0133], [0135]), and the end effector assembly is used to seal tissue (¶’s [0002], [0133], [0135]); as such the ultrasonic blade is considered to have a tissue sealing surface],
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FIG. 39 of LEUCK
wherein the first jaw [(2385)] and the second jaw [(2382)] move between an open position and a closed position [the first jaw and the second jaw move between and open and closed position when clamping and compressing tissue under treatment - e.g., ¶[0144] (“Tissue under treatment is clamped and compressed between the clamp arm 1000 and the ultrasonic blade”)],
wherein the tissue sealing surface of at least one of the first jaw and the second jaw includes an electrode [the first jaw (2385) includes electrode (2386) - ¶[0244]; FIG. 39] having a plurality of individually separately compressible segments [segments (2386a, 2386b, 2386c) - ¶’s [0239], [0244]; FIG. 39].
wherein the individually separately compressible segments [segments (2386a, 2386b, 2386c)] include:
a first segment [e.g., proximal-most segment (2386c)] configured to deform or move when a tensile force exceeding a specified first threshold force is present at the first segment [see ¶[0244] (“Three springs 2388a, 2388b, 2388c are positioned between each of the electrode segments 2386a, 2386b, 2386c and the clamp jaw 2385 to apply distal, medial, and proximal bias to the electrode segments 2386a, 2386b, 2386c, respectively”); see also ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw”); & ¶’s [0240]-[0242]; the force needed to overcome the bias of spring (2388c) and its selected spring rate comprises a specified first threshold force]; and
a second segment [e.g., distal segment (2386a) - ¶[0244]; FIG. 39] configured to deform or move, discretely [“independently” (addressed in greater detail below)] from the deformation or moving of the first segment [proximal-most segment (2386c)], when a tensile force exceeding a specified second threshold force is present at the second segment [see ¶’s [0239]-[0242]; & [0244]; the force needed to overcome the bias of spring (2388a) and its selected spring rate comprises a specified second threshold force]. NOTE: Leuck clearly and unambiguously discloses that each segment is capable of independent deflection [see ¶[0239] (“In one aspect, a segmented electrode configuration comprises independently deflectable portions. Each segment of the segmented electrode is capable of deflecting independently. In one aspect, the segmented electrode comprises independently deflectable electrodes for use in a combination ultrasonic/bipolar RF energy device. Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”)]. This limitation is described in greater detail below in the “Response to Arguments” section.
15. Regarding claim 16, Leuck discloses all of the limitations of claim 15 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the first jaw (2385) includes a body extending from a proximal end to a distal end of the first jaw [jaw (2385) comprises a body extending from a proximal end to a distal end - FIG. 39] and the electrode [(2386)] includes an electrode sealing surface [surface of electrode (2386) - ¶[0244]; FIG. 39] spaced apart from the body via at least one deformable member [any of springs (2388a, 2388b, 2388c) are deformable members that respectively separate the electrode segments (2386a, 2386b, 2386c) from the body of the jaw (2385) - ¶[0244]; FIG. 39].
16. Regarding claim 17, Leuck discloses all of the limitations of claim 16 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the electrode sealing surface is spaced apart from the body via at least two deformable members [any two of springs (2388a, 2388b, 2388c); FIG. 39].
17. Regarding claim 18, Leuck discloses all of the limitations of claim 15 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein a first compressible segment of the plurality of compressible segments is moveable with respect to a second compressible segment of the plurality of compressible segments on a same one of the first or second jaw [the first jaw (2385)] [see ¶[0239] (“In one aspect, a segmented electrode configuration comprises independently deflectable portions. Each segment of the segmented electrode is capable of deflecting independently. In one aspect, the segmented electrode comprises independently deflectable electrodes for use in a combination ultrasonic/bipolar RF energy device. Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates. In other aspects, this configuration may enable only a portion of the electrode to be deflectable”); see also ¶’s [0240]-[0242]].
18. Regarding claim 19, and with reference to FIG. 39 (reproduced below), Leuck discloses a method for applying a target pressure [“desired pressure profile” - e.g., ¶’s [0241], [0242]] to a tissue [e.g., ¶[0239]] via a medical device [¶[0010] (“a surgical instrument comprising an end effector”)], the method comprising:
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FIG. 39 of LEUCK
articulating an end effector assembly [end effector (2380) - ¶[0244]; FIG. 39] of a medical device [¶[0010] (“a surgical instrument comprising an end effector”)] between:
a first position [open position] wherein first [broadly, ultrasonic blade (2382) - ¶[0244]; FIG. 39] and second [clamp jaw (2385) - ¶[0244]; FIG. 39] jaw members of the assembly [(2380)] are spaced apart from each other; and
a second position [closed position] wherein the first [(2382)] and second [(2385)] jaw members are positioned closer to each other than in the first position [e.g., when clamping and compressing tissue under treatment - e.g., ¶[0144] (“Tissue under treatment is clamped and compressed between the clamp arm 1000 and the ultrasonic blade”)]; and
compressing the tissue between the first [(2382)] and second [(2385)] jaw members of the end effector assembly [(2380)], wherein the compressed tissue contacts a plurality of individually deformable segments [segments (2386a, 2386b, 2386c) - ¶’s [0239]-[0244]; FIG. 39] located on the first jaw member or the second jaw member [on the second jaw member (2385) - ¶’s [0239]-[0244]; FIG. 39][;]
wherein the individually deformable segments [segments (2386a, 2386b, 2386c)] include:
a first segment [e.g., proximal-most segment (2386c)] configured to deform or move when a tensile force exceeding a specified first threshold force is present at the first segment [see ¶[0244] (“Three springs 2388a, 2388b, 2388c are positioned between each of the electrode segments 2386a, 2386b, 2386c and the clamp jaw 2385 to apply distal, medial, and proximal bias to the electrode segments 2386a, 2386b, 2386c, respectively”); see also ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw”); & ¶’s [0240]-[0242]; the force needed to overcome the bias of spring (2388c) and its selected spring rate comprises a specified first threshold force]; and
a second segment [e.g., distal segment (2386a) - ¶[0244]; FIG. 39] configured to deform or move, discretely [“independently” (addressed in greater detail below)] from the deformation or moving of the first segment [proximal-most segment (2386c)], when a tensile force exceeding a specified second threshold force is present at the second segment [see ¶’s [0239]-[0242]; & [0244]; the force needed to overcome the bias of spring (2388a) and its selected spring rate comprises a specified second threshold force]. NOTE: Leuck clearly and unambiguously discloses that each segment is capable of independent deflection [see ¶[0239] (“In one aspect, a segmented electrode configuration comprises independently deflectable portions. Each segment of the segmented electrode is capable of deflecting independently. In one aspect, the segmented electrode comprises independently deflectable electrodes for use in a combination ultrasonic/bipolar RF energy device. Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”)]. This limitation is described in greater detail below in the “Response to Arguments” section.
19. Regarding claim 20, Leuck discloses all of the limitations of claim 19 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses:
receiving or applying, at the first segment [e.g., proximal-most segment (2386c)] of the plurality of individually deformable segments, a first tensile force [associated with (or resulting from) the clamping of tissue - ¶[0239]]; and
in response to the first tensile force exceeding a specified first threshold force, deforming at least a portion of a first segment [(2386c)] of the plurality of individually deformable segments in a direction away from an opposing jaw member [movable in a downward direction, away from first jaw member (2382)] [see ¶’s [0239]-[0244]].
20. Regarding claim 21, Leuck discloses all of the limitations of claim 20 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses:
receiving or applying, at the second segment [e.g., medial segment (2386b)] of the plurality of individually deformable segments, a second tensile force [associated with (or resulting from) the clamping of tissue - ¶[0239]]; and
in response to the second tensile force exceeding a specified second threshold force, deforming at least a portion of a second segment [(2386b)] of the plurality of individually deformable segments in a direction away from an opposing jaw member [movable in a downward direction, away from first jaw member (2382)] [see ¶’s [0239]-[0244]].
Claim Rejections - 35 USC § 103
21. 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.
22. 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.
23. Claims 5, 6, 22, & 23 are rejected under 35 U.S.C. 103 as being unpatentable over Leuck.
24. Regarding claim 5, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 5 recites the limitation “wherein the specified first threshold force at the first segment is greater than the specified second threshold force at the second segment.”
While Leuck does not explicitly disclose the foregoing limitation, Leuck does disclose variations in the number of segments, as well as in spring/compression rates along the length of the clamp arm jaw depending on a desired pressure profile [see, e.g., ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”); ¶[0241] (“In one aspect, the deflectable electrode may comprise three elements although three or more elements may be employed depending on the desired pressure profile”); and ¶[0242] (“springs could be designed and tuned to apply the exact desired pressure profile”)].
As such, it is the Examiner’s position that the foregoing teachings of Leuck would have plainly suggested to one of ordinary skill in the art that it would have been obvious, before the effective filing date of the claimed invention, to configure the spring rates of the individual segments in a variety of different arrangements including, e.g., one wherein the specified first threshold force [the force needed to overcome the bias of spring (2388c) and its selected spring rate] at the first segment [(2386c)] is greater than the specified second threshold force [the force needed to overcome the bias of spring (2388a) and its selected spring rate] at the second segment [(2386a)], depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.). Those skilled in the art will readily appreciate that electrode segments having different spring rates will require different threshold forces to deform.
25. Regarding claim 6, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Claim 6 recites the limitation “wherein the at least the first segment is configured to deform more than at least the second segment upon being subject to a same tensile force.”
While Leuck does not explicitly disclose the foregoing limitation, Leuck does disclose variations in the number of segments, as well as in spring/compression rates along the length of the clamp arm jaw depending on a desired pressure profile [see, e.g., ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”); ¶[0241] (“In one aspect, the deflectable electrode may comprise three elements although three or more elements may be employed depending on the desired pressure profile”); and ¶[0242] (“springs could be designed and tuned to apply the exact desired pressure profile”)].
As such, it is the Examiner’s position that the foregoing teachings of Leuck would have plainly suggested to one of ordinary skill in the art that it would have been obvious, before the effective filing date of the claimed invention, to configure the spring rates of the individual segments in a variety of different arrangements including, e.g., one wherein the at least the first segment [(2386c)] is configured to deform more than at least the second segment [(2386a)] upon being subject to a same tensile force, depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.). Those skilled in the art will readily appreciate that electrode segments having different spring rates will deform differently responsive to application of the same tensile force.
26. Regarding claim 22, Leuck discloses all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Claim 22 recites the limitation “wherein the specified first threshold force at the first segment is greater than the specified second threshold force at the second segment.”
While Leuck does not explicitly disclose the foregoing limitation, Leuck does disclose variations in the number of segments, as well as in spring/compression rates along the length of the clamp arm jaw depending on a desired pressure profile [see, e.g., ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”); ¶[0241] (“In one aspect, the deflectable electrode may comprise three elements although three or more elements may be employed depending on the desired pressure profile”); and ¶[0242] (“springs could be designed and tuned to apply the exact desired pressure profile”)].
As such, it is the Examiner’s position that the foregoing teachings of Leuck would have plainly suggested to one of ordinary skill in the art that it would have been obvious, before the effective filing date of the claimed invention, to configure the spring rates of the individual segments in a variety of different arrangements including, e.g., one wherein the specified first threshold force [the force needed to overcome the bias of spring (2388c) and its selected spring rate] at the first segment [(2386c)] is greater than the specified second threshold force [the force needed to overcome the bias of spring (2388a) and its selected spring rate] at the second segment [(2386a)], depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.). Those skilled in the art will readily appreciate that electrode segments having different spring rates will require different threshold forces to deform.
27. Regarding claim 23, Leuck discloses all of the limitations of claim 21 for the reasons set forth in detail (above) in the Office Action.
Claim 23 recites the limitation: “receiving or applying, at the second segment of the plurality of individually deformable segments, a third tensile force; and in response to the third tensile force exceeding the specified first threshold force, withstanding deformation of the second segment of the plurality of individually deformable segments in a direction away from an opposing jaw concurrent with deformation at the first segment.”
While Leuck does not explicitly disclose the foregoing limitation, Leuck does disclose variations in the number of segments, as well as in spring/compression rates along the length of the clamp arm jaw depending on a desired pressure profile [see, e.g., ¶[0239] (“Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”); ¶[0241] (“In one aspect, the deflectable electrode may comprise three elements although three or more elements may be employed depending on the desired pressure profile”); and ¶[0242] (“springs could be designed and tuned to apply the exact desired pressure profile”)].
As such, it is the Examiner’s position that the foregoing teachings of Leuck would have plainly suggested to one of ordinary skill in the art that it would have been obvious, before the effective filing date of the claimed invention, to configure the spring rates of the individual segments in a variety of different arrangements including, e.g., one wherein the second segment withstands a tensile force that causes the first segment to deform or, more particularly, to include receiving or applying, at the second segment of the plurality of individually deformable segments, a third tensile force; and in response to the third tensile force exceeding the specified first threshold force, withstanding deformation of the second segment of the plurality of individually deformable segments in a direction away from an opposing jaw concurrent with deformation at the first segment depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.). Those skilled in the art will readily appreciate that electrode segments having different spring rates will deform differently responsive to application of the same tensile force.
28. Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Leuck in view of U.S. Patent Application Publication No. 2007/0213711 to Eder et al. ("Eder").
29. Regarding claim 2, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Leuck further discloses wherein the first segment [proximal-most segment (2386c)] includes a first compression feature [spring element (2388c) - ¶[0244]; FIG. 39].
Leuck also discloses an electrosurgical energy source for providing energy to the end effector [e.g., a generator for providing power to the end effector - see ¶[0319]; FIG. 48], but appears silent as to the particulars of the elements used to convey the energy.
As such, Leuck does not disclose the following emphasized limitations:
wherein the first segment includes a first compression feature configured to transmit energy received from an electrosurgical energy source to at least one of the plurality of segments.
Eder, in a similar field of endeavor, teaches a surgical electrocautery method and apparatus, comprising a pair of jaws (21, 22) that utilizes electrodes with respective springs (25 or 26) to effect compliance of the electrodes to tissue [e.g., ¶[0024]; FIG. 2].
Eder further teaches that it was known to utilize springs as conductors [e.g., ¶’s [0008], [0011]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Leuck such that that the first compression feature [spring element (2388c)] serve as a conductor for transmitting energy to corresponding segment (2386c), since such an energy transmission technique (use of a spring as a conductive element) was recognized as part of the ordinary capabilities of one skilled in the art, as clearly demonstrated by Eder, and one of ordinary skill in the art would have been capable of applying this known technique to the known device of Leuck, and the results (transmission of energy to an electrode segment) 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).
30. Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Leuck in view of U.S. Patent Application Publication No. 2021/0196307 to Shelton, IV ("Shelton").
31. Regarding claim 9, Leuck discloses all of the limitations of claim 7 for the reasons set forth in detail (above) in the Office Action.
While Leuck discloses that the electrode may comprise a plurality of independently deflecting segments, each with its own compression feature (spring), to create a desired pressure profile [Leuck, ¶’s [0239]-[0244]; FIG. 39], Leuck does not explicitly disclose that each segment includes multiple compression features.
As such, Leuck does not disclose:
wherein the first segment includes a second compression feature configured such that a strain from the tensile force localizes disproportionately within the first segment at or near the second compression feature such that the at least the first segment deforms in a direction away from the opposing jaw.
Shelton, in a similar field of endeavor, teaches an end effector assembly (1830) comprising an ultrasonic blade (1838) and a clamp arm (1832) having an electrode (1834) disposed thereon [¶[0186]; FIG. 22 (reproduced below)].
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FIG. 22 of SHELTON
FIG. 25 of SHELTON
With reference to FIG. 25, Shelton teaches that sections/segments of electrode (1834) may be supported by multiple compression features [multiple springs (1836)] [¶[0186]].
Shelton further teaches that the springs may vary in thickness, spring force, and distribution density to create “zones” [e.g., zones 1-4] of variable spring bias [¶’s [0186]-[0187]], which affects energy distribution density [e.g., ¶[0189]].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Leuck to include multiple compression features [springs] supporting each of the electrode segments 2386a, 2386b, 2386c, and distributed across the width of the clamp arm, since such a modification would provide for greater support/stability of each electrode segment on the clamp arm [i.e., each segment being supported by multiple springs rather than one individual spring], while also providing for greater control over a desired pressure profile.
As modified, and given Leuck’s explicit teaching that spring/compression rates may vary along the length of the clamp arm jaw depending on a desired pressure profile [¶’s [0239], [0241], [0242]], it is the Examiner’s position that it would have additionally been obvious, before the effective filing date of the claimed invention, to further modify the combination of Leuck and Shelton to configure the spring rates of the multiple springs [compression features] of individual segments in a variety of different arrangements including, e.g., one wherein the tensile force localizes disproportionately within the first segment at or near the second compression feature such that the at least the first segment deforms in a direction away from the opposing jaw, depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.).
32. Regarding claim 10, the combination of Leuck and Shelton teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Leuck was previously modified above (in the rejection of claim 9) to include multiple compression features, as taught by Shelton.
Shelton further teaches wherein the first compression feature is located laterally outward of the second compression feature [as clearly seen in FIG. 25, the compression features (1836) are distributed across the width of the clamp arm (1832), with compression features [springs] situated along the edges of the clamp arm being located “laterally outward” of those positioned in the center of the clamp arm.
33. Regarding claim 11, the combination of Leuck and Shelton teaches all of the limitations of claim 9 for the reasons set forth in detail (above) in the Office Action.
Leuck was previously modified above (in the rejection of claim 9) to include multiple compression features, as taught by Shelton.
As modified, and given Leuck’s explicit teaching that spring/compression rates may vary along the length of the clamp arm jaw depending on a desired pressure profile [¶’s [0239], [0241], [0242]], it is the Examiner’s position that it would have additionally been obvious, before the effective filing date of the claimed invention, to further modify the combination of Leuck and Shelton to configure the spring rates of the multiple springs [compression features] of individual segments in a variety of different arrangements including, e.g., one wherein the first and second compression features are each configured such that a strain from the tensile force localizes at both the first and second compression features equally, such that the at least the first segment deforms in a direction away from the opposing jaw and maintains a substantially parallel orientation with respect to an inner face of the opposing jaw upon deformation, depending on a desired pressure profile needed to achieve a desired clinical outcome (which may, of course, be dependent on various factors including, e.g., tissue type, tissue thickness, etc.).
34. Claims 12 & 13 are rejected under 35 U.S.C. 103 as being unpatentable over Leuck in view of U.S. Patent Application Publication No. 2005/0021027 to Shields et al. ("Shields").
35. Regarding claim 12, Leuck discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Leuck does not disclose:
wherein the first jaw member includes an electrically nonconductive standoff element configured to impede the first jaw member from contacting the second jaw member when the first and second jaw members are moved towards the second position.
Shields, in a similar field of endeavor, teaches that it was known to utilize electrically nonconductive standoff elements [stop elements (150)] in either or both jaw members of an electrosurgical instrument (e.g., forceps) to impede a first jaw member from contacting a second jaw member when the first and second jaw members are moved towards a second (or closed) position (when grasping/clamping tissue) [e.g., ¶’s [0040], [0041]; FIG. 1C]. The stop elements (150) in Shields extend through a cut-out in the sealing surface of the jaw(s) [e.g., ¶[0043]; FIG. 1C].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Leuck such that the clamp arm includes an electrically nonconductive standoff element (or plural standoff elements) configured to impede the first jaw member from contacting the second jaw member when the first and second jaw members are moved towards the second position, as taught by Shields, in order to yield a consistent and accurate gap distance between sealing surfaces during sealing [Shields, ¶[0040]]. NOTE: it is the Examiner’s position that the use of the terms “first” and “second” merely differentiates between jaw members. Whether the clamp arm (that is being modified) is considered the first jaw member or the second jaw member is only a matter of naming convention, as the instant rejection proposes modifying the clamp arm of Leuck (and not the ultrasonic blade) to include the stop elements extending from the electrode segments.
36. Regarding claim 13, the combination of Leuck and Shields teaches all of the limitations of claim 12 for the reasons set forth in detail (above) in the Office Action.
Leuck was modified above (in the rejection of claim 12) to include the nonconductive standoff(s) [stop element(s) (150)] of Shields, which Shields teaches extend through cutouts in the first segment [the stop elements (150) in Shields extend through cut-outs in the sealing surface of the jaw(s) [e.g., ¶[0043]; FIG. 1C]].
Response to Arguments
37. As noted above, the 12/19/25 Amendment has overcome the claim objections, and the rejections under § 112(b) previously set forth in the 08/12/25 Action.
38. New claim objections, and updated rejections under §§ 102 & 103 are set forth herein, necessitated by Applicant’s Amendment.
39. In the 12/19/25 Amendment, independent claim 1 was amended to include aspects of the limitations of original claim 3 (now cancelled), and to further specify that the second segment is configured to deform or move discretely from the deformation or moving of the first jaw:
… a second segment configured to deform or move, discretely from the deformation or moving of the first segment and in a direction away from the opposing jaw, when a tensile force exceeding a specified second threshold force is present at the second segment.
Emphasis added.
Independent claims 15 & 19 were each amended to include similar, new limitations.
In the “Remarks,” Applicant argues that Leuck fails to disclose “discrete” deformation or movement among the first and second segments because the plurality of segments in Leuck are linked by pins:
As described in Leuck para. [00214], alleged “plurality of segments” (i.e., segments 2386a, 2386b, and 2386c) are physically linked to one another by pins 2387a and 2387b. Thus, any movement of an individual segment 2386a, 2386b, or 2386c will be translated to the others via a respective pin. Thus, Leuck fails to teach or suggest discrete movement/deformation of segments, extending outward in a row away from the fulcrum, as required by independent claim 1.
12/19/25 Amendment, pg. 9.
This argument is not persuasive. The issue presented by Applicant’s amendment concerns interpretation of the term “discretely,” and what it requires in terms of deformation or movement of the first segment relative to that of the second segment.
“[T]he ordinary and customary meaning of a claim term is the meaning that the term would have to a person of ordinary skill in the art in question at the time of the invention, i.e., as of the effective filing date of the patent application.” Phillips v. AWH Corp.,415 F.3d 1303, 1313, 75 USPQ2d 1321, 1326 (Fed. Cir. 2005) (en banc). The ordinary and customary meaning of a term may be evidenced by a variety of sources, including the words of the claims themselves, the specification, drawings, and prior art. However, the best source for determining the meaning of a claim term is the specification – the greatest clarity is obtained when the specification serves as a glossary for the claim terms. See, e.g., In re Abbott Diabetes Care Inc., 696 F.3d 1142, 1149-50, 104 USPQ2d 1337, 1342-43 (Fed. Cir. 2012)
In the instant case, neither Applicant’s Specification nor the priority application use the term “discretely” when describing deformation or movement of the electrode segments vis-à-vis one another. Applicant does, however, explicitly equate the term “discretely” with the word “independently” in the Remarks:
Applicant's device as claimed in claim 1… requires that a second segment be configured to deform or move discretely from a deformation or moving of a first segment, i.e., that the two segments may deform or move independently of each other.
12/19/25 Amendment, pg. 8., emphasis in original, emphasis added.
By Applicant’s own admission, Leuck satisfies the claim limitation at issue since, as noted in the body of the rejection above, Leuck clearly and unambiguously discloses that each segment is capable of independent deflection [see ¶[0239] (“In one aspect, a segmented electrode configuration comprises independently deflectable portions. Each segment of the segmented electrode is capable of deflecting independently. In one aspect, the segmented electrode comprises independently deflectable electrodes for use in a combination ultrasonic/bipolar RF energy device. Each segment of the segmented electrode may have a separate spring rate along the length of the clamp arm jaw. This configuration may provide variable spring/compression rates”)].
For this reason, as currently claimed, there is no evidence of record establishing that the “independent” deflection of the segments of Leuck should be construed any differently than the claimed discrete (or independent) movement of Applicant’s claimed segments.
To advance prosecution, Examiner suggests clarifying structural distinctions between the claimed segments and those of Leuck (e.g., that the claimed segments are “un-tethered,” etc.) rather than focusing on resulting movements of the segments, which are highly variable depending on selected spring rates, applied forces, tissue thickness, etc.
Finally, Applicant concludes by arguing that:
Leuck's approach to jaw segmentation does not satisfy the elements of Applicant's amended claim 1, and in operation would likely fail to achieve a range of variable closure force required by the operation and provided by Applicant's end effector assembly, as claimed.
12/19/25 Amendment, pg. 9.
This argument, concerning what Leuck would “likely fail to achieve,” constitutes an unsupported, conclusory assertion. The arguments of counsel cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 116 F.3d 1465, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”).
For each of the foregoing reasons, the rejections under §§ 102 & 103 based on Leuck have been updated and maintained.
Conclusion
40. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
41. 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.
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/Bradford C. Blaise/Examiner, Art Unit 3794