DETAILED ACTION
This action is in response to preliminary amendments received on 07/11/2025. It is acknowledged that all of the originally filed claims 1-20 have been canceled and new claims 21-40 added. A complete action on the merits of claims 21-40 follows below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
Claim Objections
Claims 23, 31, 33, 37 and 39 are objected to because of the following informalities:
“oat least one” in claim 23 should be amended to --at least one--.
“the the first and second sweeping flat surfaces” in line 15 going to line 16 of claim 31 should be amended to recite --the first sweeping flat surface and the second sweeping flat surface-- or alternatively remove the second “the”.
“the first and second sweeping flat surfaces” in claims 31, 33 and 37 should be amended to recite --the first sweeping flat surface and the second sweeping flat surface--.
“at least one nodal support element” in claim 39 should be amended to recite --at least one nodal support element of the plurality of nodal support elements--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 23-24 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 23 recites the limitation at “least one elongate cutout at lateral edges of the proximal blade region, wherein each cutout is configured to provide clearance during movement of the clamp arm”. It is at most unclear how at least one (which can be a single one) cutout can be positioned at lateral edges of the proximal blade region. Based on the limitation of “each cutout”, it appears that the claim is directed to more than one cutouts; therefore, it is suggested to amend the claim to recite the at least one elongate cutout comprises a plurality of elongate cutout to thereby claim each to be positioned at lateral edges of the proximal blade region, wherein each cutout is configured to provide clearance during movement of the clamp arm. Clarification and appropriate correction is required.
Claim 24 recites the limitation “the at least one elongate cutout is positioned at longitudinal locations corresponding to the pin”. It is at most unclear how at least one (which can be a single one) cutout can be positioned at longitudinal locations corresponding to the pin. If more than one cutouts are intended for this limitation, it is suggested to amend the claim to recite the at least one elongate cutout comprises a plurality of elongate cutout to thereby claim them to be positioned at longitudinal locations corresponding to the pin. Clarification and appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 21-30 and 38-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Eichmann (US Pub. No. 2007/0191713).
Regarding Claim 21, Eichmann teaches a surgical instrument (Figs. 1 and 16A), comprising:
(a) a shaft assembly 72 extending along a longitudinal axis and having a distal shaft end portion ([0096] and Fig. 1);
(b) an ultrasonic blade 79 extending distally from the shaft assembly, the ultrasonic blade comprising:
(i) a proximal blade region (proximal end of the blade including cutout 82 and the stepped section in Figs. 3A-3B, see the annotated figure below) and a distal blade region, and
(ii) a planar upper surface 82 on the proximal blade region extending in a direction parallel to the longitudinal axis (see the annotated figure below); and
(c) a clamp arm 56 pivotably coupled to the distal shaft end portion, the clamp arm configured to move between an open position and a closed position relative to the ultrasonic blade ([0011], [0013] and [0017]) ,wherein the planar upper surface 82 is configured to provide dynamic clearance between the ultrasonic blade and the clamp arm during actuation of the clamp arm (there exist a space between the proximal end of the blade and the proximal end of the clamp as seen in Fig. 7A).
PNG
media_image1.png
163
384
media_image1.png
Greyscale
PNG
media_image2.png
187
491
media_image2.png
Greyscale
Regarding Claim 22, Eichmann teaches wherein the clamp arm is pivotably coupled to the distal shaft end portion by a pin (at least one of “camming members 94a and 94b” [0115] as shown in Fig. 14, also see [0114]).
Regarding Claim 23, Eichmann teaches wherein the ultrasonic blade further comprises oat least one elongate cutout 82 at lateral edges of the proximal blade region (see the annotated Fig. 6A above), wherein each cutout is configured to provide clearance during movement of the clamp arm (each cutout is configured to provide a clearance during movement of the clamp arm).
Regarding Claim 24, Eichmann teaches wherein the at least one elongate cutout 82 is positioned at longitudinal locations corresponding to the pin 94a/94b (see the annotated Fig. 6A above comprising a plurality of cutouts 82).
Regarding Claim 25, Eichmann teaches wherein the clamp arm 56 comprises a clamp pad 58 facing the ultrasonic blade 79 (Fig. 7A).
Regarding Claim 26, Eichmann teaches wherein the ultrasonic blade 79 is acoustically coupled to an ultrasonic transducer via a waveguide 80 positioned in the shaft assembly 72 ([0080]-[0083] and Fig. 1).
Regarding Claim 27, Eichmann teaches wherein the planar upper surface joins a rounded distal blade tip via a filleted edge (the step shown in the annotated figures above).
Regarding Claim 28, Eichmann teaches wherein the upper planar surface of the ultrasonic blade extends proximally beyond a longitudinal location of the clamp arm pivot (based on the positioning of the pivot as seen in Fig. 1 at least one of the upper planar surfaces 82 extends proximally beyond a longitudinal location of the clamp arm pivot).
Regarding Claim 29, Eichmann teaches wherein the ultrasonic blade 79 comprises a convexly rounded side edge that transitions laterally from the upper planar surface (the upper or lower rounded edges that that transitions laterally from the planar surfaces 82, Figs. 3A-3G and 6A).
Regarding Claim 30, Eichmann teaches wherein the upper planar surface has a narrower lateral width than a maximum lateral width of the ultrasonic blade (Fig. 3G shows a width of planar section 82 being narrower than at least a section of the more proximal end of the blade).
Regarding Claim 38, Eichmann teaches a surgical instrument (Figs. 1 and 16A), comprising:
(a) a shaft assembly 72 comprising an inner tube and an ultrasonic waveguide 80 ([0080]-[0083], [0096]) extending along a longitudinal axis (Fig. 1); and
(b) an ultrasonic blade 79 acoustically coupled to a distal end of the ultrasonic waveguide 80, the ultrasonic waveguide being supported within the inner tube by a plurality of nodal support elements (“distal-most node 84” [0096] and “aperture 66, which may be positioned at a node, is configured to receive a connector pin 27” [0082]) positioned at acoustic nodes along the ultrasonic waveguide.
Regarding Claim 39, Eichmann teaches wherein at least one nodal support element comprises an overmold member positioned at a distal acoustic node (“A seal 83 may be provided at the distal-most node 84, nearest the end-effector 81, to abate passage of tissue, blood, and other material in the region between the waveguide 80 and the distal shroud 76. Seal 83 may be of any known construction, such as an o-ring or silicon overmolded at node 84” [0096]).
Regarding Claim 40, Eichmann teaches wherein the ultrasonic waveguide 80 is secured within the shaft assembly by a retaining pin 27 extending transversely through the ultrasonic waveguide at a proximal acoustic node (“waveguide 80 may further include at least one radial hole or aperture 66 extending therethrough, substantially perpendicular to the longitudinal axis of the waveguide 80. The aperture 66, which may be positioned at a node, is configured to receive a connector pin 27, discussed below, which connects the waveguide 80, to the handle assembly 70” [0082]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries 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.
Claims 31-37 are rejected under 35 U.S.C. 103 as being unpatentable over Eichmann in view of Gee (US Pub. No. 2016/0367281).
Regarding Claim 31, Eichmann teaches a surgical instrument (Figs. 1 and 16A), comprising:
(a) a shaft assembly 72 extending distally along a longitudinal axis (Fig. 1); and
(b) an ultrasonic blade 79 extending from the shaft assembly (Fig. 1 and [0080], [0096]), the ultrasonic blade including:
(i) a linear blade region extending parallel to the longitudinal axis (Figs. 3A-3G showing a proximal end of the blade being linear),
(ii) a curved blade region extending distally from the linear blade region along a curved path that deflects laterally from the longitudinal axis, wherein the curved blade region tapers in width distally toward a distal blade tip (Figs. 3A-3G showing a distal end of the blade being curved and tapering in width distally toward a distal blade tip),
(iii) a primary treatment side (“rotational movement of the clamp arm 60 positioning the clamp pad in substantially parallel relationship to, and in contact with, blade 79, thereby defining a tissue treatment region” [0114]),
(iv) a cutting edge opposite the primary treatment side (“FIGS. 6B and 6D further illustrate a second expression of the blade 79. Illustrated is a radius cut 90 in blade 79 to provide two back cutting edges 92 and 92a” [0101]), and
Although in Figs. 3A-3G it appears that there are sweeping surfaces on the sides of the blade, neither the drawings show a clear picture nor the specification discloses it.
In the same field of invention Gee teaches an ultrasonic treatment instrument comprising a blade having a linear section, a curved section and first and second lateral sides 32, 34 extending between the primary treatment side (first face 16 including a tissue treatment surface 20 [0041]) and the cutting edge (second face 18 including a first tissue-cutting surface 26 [0042]), wherein the first and second lateral sides respectively include a first sweeping flat surface and a second sweeping flat surface, wherein the the first and second sweeping flat surfaces respectively define a first side edge and a second side edge of a transverse cross-section, wherein the first and second side edges are parallel to each other (“first intermediate wall 32 may extend, at least partially, between the first side wall 22 and the first tissue-cutting surface 26, as best illustrated in FIG. 1. A second intermediate wall 34 may extend, at least partially, between the second side wall 24 and the second tissue-cutting surface 28, as best illustrated in FIG. 4” [0042], Figs. 1-22).
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add lateral sweeping side surfaces to the blade of Eichmann in order to allow a smooth transition between the cutting edge and the treatment edge to eliminate concentration of energy on the sides during treatment.
Regarding Claim 32, Eichmann teaches wherein the curved blade region extends along an arc that is asymmetrical relative to the longitudinal axis (Figs. 3A-3G).
Regarding Claim 33, Eichmann in view of Gee teaches wherein the first and second sweeping flat surfaces extend through an entirety of the curved blade region (sections 32/34 as seen in Figs. 1-22 of Gee).
Regarding Claim 34, Eichmann teaches wherein the distal blade tip comprises filleted edges (Figs. 3A-G).
Regarding Claim 35, Eichmann teaches wherein the primary treatment side is convexly rounded (Figs. 3A-3G).
Regarding Claim 36, Eichmann teaches wherein the ultrasonic blade 79 defines a blade height and a blade width at each longitudinal position (blade width shown in Fig. 3F), and wherein the blade height is greater than the blade width throughout the curved blade region (blade height shown in the tilted configuration of Figs. 3E and 3G whereby the height appears to be greater than the width at least in the curved section).
Regarding Claim 37, Eichmann in view of Gee teaches wherein the first and second sweeping flat surfaces depend downwardly from the primary treatment side (Figs. 1-22 of Gee).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights