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 .
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.
Claim 11 requires a helical groove or protrusion on the conical section. In the drawings the helical grooves (400/410) are shown on the handle portion and not the conical section 500.
Therefore, the claim limitations 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 12-17 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 12 is a system that seems to be depending off claim 1 to include the scalpel of claim 1. However, it also copies and pastes all the limitations that are already in claim 1. It seems that in line 2, “of claim 1” could be deleted. Otherwise, line 2 could be modified to say “the medical ultrasonic scalpel of claim 1” and delete all the limitations of the scalpel and the last 2 lines need to be modified to “the first end of the handle” so that the vibration source is positively recited.
Claim 13 needs to say “the medical ultrasonic scalpel system of claim 12” in line 2.
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.
Claim(s) 1-12 and 14-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young (US 2008/0188878), in view of Pretorious et al. (US 2019/0223899; “Pretorious”).
Claim 1, Young discloses a medical ultrasonic scalpel (Fig. 4), comprising: a handle (2) having a handle longitudinal central axis (axis running through part 3 and the rest of the device), a first end (proximal end) of the handle being configured to be connected to a vibration source (Fig. 4; paragraph [0052]) to receive a vibration generated by the vibration source (paragraph [0052]); a shank (Fig. 4; 5) having a shank longitudinal central axis (same axis as noted above), a first end (proximal end of 5) of the shank being connected to a second end (distal end of 2) of the handle opposite to the first end of the handle (Fig. 4); a blade (4) having a blade longitudinal central axis (same axis as above), a first end (proximal end of 4 near where 6 points) of the blade being connected to a second end (distal end of 5 near where 6 points) of the shank opposite to the first end of the shank (Fig. 4), and a second end of the blade (distal of 4) being provided with a cutting portion (33 and 10) for cutting a tissue to be cut (Fig. 4); and a composite vibration pattern generating portion (the shape of 2, 5, and 6) provided on at least one of the handle and the shank and configured to convert the vibration received from the vibration source into a composite vibration of the cutting portion of the blade (Fig. 4; paragraph [0052]), the composite vibration comprising a longitudinal vibration parallel to at least one of the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis (paragraphs [0058] and [0070]-[0074]).
However, Young does not disclose the composite vibrations having at least two of the vibrations required by claim 1.
Pretorious teaches the composite vibration comprising at least two of the following vibrations: a longitudinal vibration parallel to at least one of the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis (paragraph [0039]); a torsional vibration with at least one of the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis as a torsional central axis (paragraph [0039]); and a bending vibration laterally offset from at least one of the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis (paragraph [0054]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine the helical grooves of Pretorious to the scalpel of Young, in order to help create a particular type of vibrations to cut material (paragraph [0039]).
Claim 2, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 1, Young discloses wherein the handle longitudinal central axis and the shank longitudinal central axis coincide with each other, and the blade longitudinal central axis is offset by a predetermined distance from, or at a predetermined angle with respect to, the handle longitudinal central axis and the shank longitudinal central axis; or the handle longitudinal central axis and the blade longitudinal central axis coincide with each other, and the shank longitudinal central axis is offset by a predetermined distance from, or at a predetermined angle with respect to, the handle longitudinal central axis and the blade longitudinal central axis; or the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis coincide with one another (Fig. 4; all the portions lie on the same axis).
Claim 3, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 1, the combination results in wherein the composite vibration pattern generating portion comprises a first composite vibration pattern generating portion provided in the handle and configured to convert a longitudinal vibration component of the vibration source into the torsional vibration (the helical grooves that cause this to occur in Applicant’s device are part of the combination, so the same results would result).
Claim 4, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 3, Pretorious teaches wherein the first composite vibration pattern generating portion is at least one inclined groove and/or helical groove (Fig. 3; 78) provided on an outer periphery of the handle at a first predetermined included angle with respect to the handle longitudinal central axis (Fig. 3); or the first composite vibration pattern generating portion is at least one strip-like protrusion and/or helical protrusion provided on the outer periphery of the handle at the first predetermined included angle with respect to the handle longitudinal central axis.
Claim 5, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 4, Pretorious teaches wherein the at least one inclined groove and/or helical groove comprises two or more inclined grooves and/or helical grooves evenly distributed along the outer periphery of the handle (Fig. 3; 78).
Claim 6, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 1, Pretorious teaches wherein the composite vibration pattern generating portion further comprises a second composite vibration pattern generating portion provided in the handle or the shank and configured to convert a longitudinal vibration component of the vibration source into the bending vibration (paragraph [0046]).
Claim 7, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 6, Pretorious teaches wherein the second composite vibration pattern generating portion is formed by at least one lateral cutout of the handle or the shank (Fig. 3; 78; the lateral grooves/cutouts in the handle help to vibrate the tool as described in paragraph [0046] with bending); or the second composite vibration pattern generating portion is formed by at least one lateral projection of the handle or the shank.
Claim 8, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 1, Young discloses wherein the vibration source comprises an ultrasonic transducer capable of generating a longitudinal vibration and/or a torsional vibration (paragraphs [0052], [0054], and [0058]).
Claim 9, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 3, Young discloses wherein a transverse dimension of the handle is greater than a transverse dimension of the shank (Figs. 1 and 4), and the second end of the handle is connected to the first end of the shank via a conical transition section (Figs. 1 and 4).
The view of Young does not give a fully clear view of how 5 attaches to 2 even though you can see the taper. Pretorious clearly shows a conical taper between each section of the tool (Figs. 3 and 4).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to taper each section of Young, in the same manner shown by Pretorious, in order to start out with a stronger resilient base and then have a smaller tip that can enter the worksite for precision (Figs. 3 and 4).
Claim 10, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 9, the combination results in wherein the composite vibration pattern generating portion further comprises a third composite vibration pattern generating portion provided in the conical transition section and configured to convert a longitudinal vibration component of the vibration source into the torsional vibration (Pretorious – Figs. 3 and 4; the structure of the upper portion is the same as the Applicant’s so the same type of vibrations are expected).
Claim 11, Young in view of Pretorious disclose the medical ultrasonic scalpel according to claim 10.
However, they do not disclose the grooves on the conical transition section.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to relocate and or add the grooves to different parts of the device, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art and rearranging parts of an invention involves only routine skill in the art.
Claim 12, Young in view of Pretorious disclose a medical ultrasonic scalpel system, comprising a vibration source (Young paragraphs [0052], [0054], and [0058]) and the medical ultrasonic scalpel of claim 1, the vibration source being connected a first end of the handle of the medical ultrasonic scalpel and configured to generate a vibration (Young - paragraphs [0052], [0054], and [0058]).
Claim 14, Young in view of Pretorious disclose the medical ultrasonic scalpel system according to claim 12, Young discloses wherein the handle longitudinal central axis and the shank longitudinal central axis coincide with each other, and the blade longitudinal central axis is offset by a predetermined distance from, or at a predetermined angle with respect to, the handle longitudinal central axis and the shank longitudinal central axis; or the handle longitudinal central axis and the blade longitudinal central axis coincide with each other, and the shank longitudinal central axis is offset by a predetermined distance from, or at a predetermined angle with respect to, the handle longitudinal central axis and the blade longitudinal central axis; or the handle longitudinal central axis, the shank longitudinal central axis and the blade longitudinal central axis coincide with one another (Fig. 4; all the portions lie on the same axis).
Claim 15, Young in view of Pretorious disclose the medical ultrasonic scalpel system according to claim 12, the combination results in wherein the composite vibration pattern generating portion comprises a first composite vibration pattern generating portion provided in the handle and configured to convert a longitudinal vibration component of the vibration source into the torsional vibration (the helical grooves that cause this to occur in Applicant’s device are part of the combination, so the same results would result).
Claim 16, Young in view of Pretorious disclose the medical ultrasonic scalpel system according to claim 12, Pretorious teaches wherein the composite vibration pattern generating portion further comprises a second composite vibration pattern generating portion provided in the handle or the shank and configured to convert a longitudinal vibration component of the vibration source into the bending vibration (paragraph [0046]).
Claim 17, Young in view of Pretorious disclose the medical ultrasonic scalpel system according to claim 12, Young discloses wherein the vibration source comprises an ultrasonic transducer capable of generating a longitudinal vibration and/or a torsional vibration (paragraphs [0052], [0054], and [0058]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Young (US 2008/0188878), in view of Pretorious et al. (US 2019/0223899; “Pretorious”), in further view of Houser et al. (US 2005/0234484; “Houser”).
Claim 13, Young in view of Pretorious disclose the medical ultrasonic scalpel of claim 12.
However, they do not disclose it comprising a robot.
Houser teaches a robotic-assisted ultrasonic scalpel system (paragraphs [0011] and [0028]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to use a robot, as taught by Houser, to control the scalpel system of Young in view of Pretorious, since it is well-known to utilize robots in surgery since they can be more precise and do not fatigue like a human surgeon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Zade Coley/Primary Examiner, Art Unit 3775