DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 5/9/2025, 7/9/2025, 12/8/2025 and 4/10/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “robot-assisted surgical device” recited in claim 14 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 3-6 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation “wherein the blade has at least two through holes” before reciting "the other end of the through hole passing through the flank face" and “the through hole allowing the flank face to form a chip ejection portion” and it is unclear which of the “at least two through holes” these subsequent limitations are referring to/further modifying (i.e., do both/all through holes pass through the flank face or does only one through hole pass through the flank face).
Claim 4 recites the limitation “the other end of the through hole passes through a part of the flank face close to the second end face” and it is unclear which of the “at least two through holes” recited in claim 3, from which claim 4 depends, this limitation is in reference to (i.e., do all through holes pass through a part of the flank face or does just one through hole pass through a part of the flank face).
Claim 5 is rendered indefinite due to its dependency from and further modification of claim 3.
Claim 6 recites the limitation “wherein a junction of the through hole and the flank face forms a scraping portion” and it is unclear which of the “at least two through holes” this limitation is in reference to. Claim 3, from which claim 6 depends, introduces “at least two through holes” and thus the limitations of claim 6 are unclear as the Examiner cannot determine which of the “at least two through holes” are being modified by the cited limitations.
Claim Rejections – 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 and 8-13 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Heavey (US 2021/0275208 A1).
Regarding claim 1, Heavey discloses:
A medical ultrasonic scalpel (see Fig. 1), comprising:
a blade (tip 16, see Figs. 1 and 5) having a first end face (distal-outwardly face of the tip shown in Fig. 5; the face extends along distal ends 38 of teeth 34) and a cutting groove (distal aperture through tip 16 shown in Fig. 5 that connects to lumen 24 passing through the length of the device; see also Fig. 3 and Para. [0030]);
wherein the cutting groove passes through the first end face (see Figs. 3 and 5; lumen 24 passes through the entire length of the device), and the cutting groove allows the first end face to form at least one annular cutting face (see Fig. 5 showing an annular cutting face comprising cutting teeth 34 extending around the distal aperture).
Regarding claim 2, Heavey discloses the invention of claim 1, Heavey further discloses wherein the blade also has a second end face (proximally-facing surface of angled transition portion 30, see Examiner’s Diagram of Fig. 5 below) and a flank face (surface of contacting portion 32, see Examiner’s Diagram of Fig. 5 below), the first end face being opposite the second end face (see Examiner’s Diagram of Fig. 5 showing the “first end face” and “second end face” on opposing sides of the tip 16), the flank face connecting the first end face and the second end face (see Examiner’s Diagram of Fig. 5 below showing wherein the surface of the contacting portion 32 extends between and connects the terminal ends of the tip 16), and the cutting groove being a through hole (see Figs. 2-5 showing wherein the aperture of the tip 16 connects to a lumen 24 extending through and along the length of the device), with one end of which passes through the first end face and the other end of which passes through one of the second end face and the flank face (see Figs. 2-5 showing wherein lumen 24 extends through the entire length of the device, passing entirely through the tip 16).
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Examiner’s Diagram of Fig. 5
Regarding claim 8, Heavey discloses the invention of claim 2, Heavey further discloses wherein the blade has one through hole (see Fig. 5 showing a single through hole at the distal end of the tip), the other end of which passes through the second end face (see Figs. 2-5 showing wherein the distal aperture of the tip connects to lumen 24 passing entirely through the tip portion).
Regarding claim 9, Heavey discloses the invention of claim 1, Heavey further discloses wherein the cutting face is serrated (see Fig. 5 showing a plurality of teeth 34 forming serrations along the periphery of the distal aperture).
Regarding claim 10, Heavey discloses the invention of claim 1, Heavey further discloses wherein an orthographic projection of the cutting groove on the first end face comprises at least one of a circle, an ellipse or a rectangle and a rounded rectangle (see Fig. 5 showing wherein the distal aperture is in the form of a circle).
Regarding claim 11, Heavey discloses the invention of claim 10, Heavey further discloses wherein the medical ultrasonic scalpel further comprises a bit bar (shaft 12, see Fig. 1) connected to an end of the blade away from the first end face (see Figs. 1 and 5).
Regarding claim 12, Heavey discloses the invention of claim 11, Heavey further discloses wherein the medical ultrasonic scalpel further comprises: a bit body (distal portion 22, see Fig. 2), the bit body connecting the bit bar (see Figs. 1-2 showing the distal portion 22 connecting to more proximal shaft portion 12) and the blade (see Fig. 2), and in a direction parallel to the first end face (see Fig. 2), the bit body having a cross-sectional area smaller than the area of the first end face (see Figs. 2 and 5 showing wherein the cross-sectional area of the distal portion 22 is smaller than the distal portion of the tip 16 due to the angled transition surface 30 extending radially outward from the distal portion to form an enlarged distal tip; see also Para. [0033]).
Regarding claim 13, Heavey discloses:
A medical ultrasonic scalpel system (see Fig. 1) comprising:
a vibration source (ultrasonic oscillation mechanism 14, see Fig. 1 and Para. [0032]; and
a medical scalpel of claim 1 (see Fig. 1);
wherein the vibration source is connected to a blade of the medical ultrasonic scalpel, and is configured to generate vibration (see Para. [0032] and [0039]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim(s) 3-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heavey (US 2021/0275208 A1) in view of Hu (CN 115054313 A).
Regarding claim 3, Heavey discloses all of the limitations of the invention of claim 2.
However, Heavey does not expressly disclose wherein the blade has at least two through holes, the other end of the through hole passing through the flank face, and the through hole allowing the flank face to form a chip ejection portion.
In the same field of endeavor, namely ultrasonic non-rotational cutting devices, Hu teaches an ultrasonic scalpel (see Fig. 1) comprising blade (working head 1, see Figs. 1-2) having a distal cutting face (see Fig. 2 showing a distal-outwardly face of the working head constituting a “distal face” having teeth 101 extending therefrom) and a flank face (side surfaces of the working head, see Fig. 2); wherein the distal face comprises a through hole passing through the length of the blade (see Fig. 2); and wherein the blade further comprises a second through hole passing through the flank face (opening 103, see Fig. 2), allowing the flank face to form a chip ejection portion configured to flush away debris from the cutting site during a cutting operation (see Para. [0023] and [0031]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the contacting portion of the device of Heavey to comprise a through hole therein as taught and suggested by Hu to, in this case, provide a flush port configured to eject debris away from the cutting site during operation (see Hu Para. [0023] and [0031]).
Regarding claim 4, the combination of Heavey and Hu discloses the invention of claim 3, Heavey, as modified by Hu, further discloses wherein the first end face has an area larger than the area of the second end face (see Examiner’s Diagram of Heavey Fig. 5 above showing the distal, first end face having a surface area larger than the second end face due to the tapered shape of the transition surface; see also Para. [0033]), and the other end of the through hole passes through a part of the flank face close to the second end face (see Hu Fig. 2 showing wherein ejection opening 103, as incorporated into the contacting portion of Heavey, is disposed along the sidewall of the “flank face” close to the proximal, “second end face” of the blade portion).
Regarding claim 5, the combination of Heavey and Hu disclose the invention of claim 3, Heavey further discloses wherein in a direction (X) from the first end face to the second end face, a distance L1 between axes of any two through holes remains the same at first and then gradually increases (see Examiner’s Diagram of Fig. 5_Reference below showing wherein a distance between the distal aperture of the blade tip and ejection port, as incorporated from the teachings of Hu, increases along the longitudinal axis between two reference points along the ejection port and a reference point along the distal aperture; each reference point comprising a unique axis extending therethrough in a direction transverse to the longitudinal axis).
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Examiner’s Diagram of Fig. 5_Reference
Regarding claim 6, the combination of Heavey and Hu disclose the invention of claim 3, Heavey, as modified by Hu, further discloses wherein a junction of the through hole and the flank face forms a scraping portion (see Hu Fig. 2 showing wherein the sidewalls along the periphery of the ejection port 103, as incorporated into the contacting portion of Heavey, may constitute a scraping portion).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heavey (US 2021/0275208 A1) in view of Hu (CN 115054313 A), further in view of Lauchner (US 2014/0277030 A1).
Regarding claim 7, the combination of Heavey and Hu disclose all of the limitations of the invention of claim 6.
However, Hu does not expressly disclose wherein the scraping portion is serrated; or the scraping portion has a chamfer.
In the same field of endeavor, namely ultrasonic cutter devices, Lauchner teaches an ultrasonic cutter (see Fig. 1) comprising a blade (distal end 18, see Fig. 1) having an opening along the sidewall of a flank face of the blade structure (opening 38, see Figs. 1-2); wherein the flank face opening comprises serrations along a peripheral edge thereof (cutting edges 52, see Figs. 1-2) to facilitate cutting tissue cutting ultrasonic vibrations (see Para. [0042] and [0044]) in contact therewith.
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified at least one peripheral surface of the ejection port of Hu, as incorporated into the contacting portion of Heavey, to comprise serrations as taught and suggested by Lauchner to, in this case, facilitate cutting tissue either in contact with the ejection port or to facilitate further cutting of tissue being ejected from the port (i.e., to better cut and reduce the size of debris exiting the ejection port).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heavey (US 2021/0275208 A1) in view of Cao (US 2021/0030435 A1).
Regarding claim 14, Heavey discloses:
A robot-assisted ultrasonic scalpel system comprising:
A medical ultrasonic scalpel of claim 13 (see Figs. 1-5);
However, Heavey does not expressly disclose a robot-assisted surgical device connected to the medical scalpel of the medical ultrasonic scalpel system configured to control movement of the medical ultrasonic scalpel.
In the same field of endeavor, namely ultrasonic bone cutting devices, Cao teaches an ultrasonic scalpel (see Fig. 1) comprising a distal blade (blade portion 16, see Fig. 1); wherein the ultrasonic scalpel is configured to be controlled by a robotic-assisted surgical device (see Fig. 12 and Para. [0059]) which provides increased accuracy, speed and force control when performing surgical cutting operations (see Para. [0044] and [0058]-[0059]).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the ultrasonic scalpel of Heavey to be configured to use with a robot-assisted controller as taught and suggested by Cao to, in this case, provide an alternative controller system having increased accuracy, speed and force control compared to a traditional hand-held system (see Cao Para. [0044] and [0058]-[0059]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s
disclosure. See the attached PTO-892 Notice of References Cited. Specifically, US 11446051 B2 to Fujisaki, US 11540854 B2 to Fujisaki, US 9358017 B2 to Rad, US 11779366 B2 to Sun, US 12226116 B2 to Gras, US 20190298571 A1 to McDonell, US 20200129330 A1 Master and US 20180103976 A1 to Heavey all disclose ultrasonic surgical cutting devices comprising a blade tip having at least one through hole pertaining to the limitations of claim 1.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MITCHELL B HOAG whose telephone number is (571)272-0983. The examiner can normally be reached 7:30 - 5:00 M-F.
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, Darwin Erezo can be reached at 5712724695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.B.H./Examiner, Art Unit 3771
/DARWIN P EREZO/Supervisory Patent Examiner, Art Unit 3771
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