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 .
Status of Claims
THIS ACTION IS FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claims 1-13, 15, 17 are pending in this application. Claims 14 and 16 are cancelled, Claims 1-13, 15 and 17 have been amended and Claims 1-13, 15 and 17 have been examined on the merits.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “10” has been used to designate both a longitudinal stem and a titanium cannula. 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. 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.
The drawings are objected to because it is unclear what reference character 1 and 2 are pointing to in Figure 21, as they appear to just point outside of the figure. It is also unclear why reference character 10 is used in Figure 13, as it points to a person, when the Specifications denote the reference character as either a titanium cannula or a longitudinal stem.
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Figure 13 of the Instant Application
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 Objections
Claim 8 objected to because of the following informalities:
“the adipocytes” should be “adipocytes” in Claim 8, line 4.
Appropriate correction is required.
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 1, 12-13 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ariza (US 20190380728 A1) in view of Yamaha (US 20080194999 A1), and in further view of Araki et al. (US20210330342A1).
Regarding Claim 1,
Ariza teaches an ultrasonic surface optimizer for fragmenting or emulsifying soft tissue in a patient ("ultrasonic devices to assist with emulsification and removal of fat tissue during surgical procedures” [0001]),
the optimizer powered by an ultrasonic vibratory energy source (“probe is intended to be used as a device that may be inserted into an incision and thereafter be movably and/or removably positioned at an intended location. As such, the inventive probe is structured to transmit ultrasonic energy to an intended location within a surgical site” [0006]) said optimizer comprising:
an elongated body (i.e. a longitudinal handle) having a proximal and distal end (corresponding disclosure in at least 0007] and fig. 1 below), a longitudinal stem which is configured to join the proximal end and the distal end;
an axis of the longitudinal stem aligned with the center of the longitudinal stem and passing through the proximal end and the distal end (corresponding disclosure in at least [0007], where “the probe according to the present invention generally comprises, an elongated body having a sidewall that extends between a proximal end and a distal end of the probe”);
a connection at the proximal end of the probe of the longitudinal stem for connecting the longitudinal stem to the ultrasonic vibratory source (corresponding disclosure in at least [0011] where there is a connecting structure on the proximal end (longitudinal stem), which can be used to connect the probe to an exterior ultrasonic device or generator);
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Figure 1.
a tip at the distal end of the longitudinal stem(corresponding disclosure in at least [0029], where there is a distal tip (202) comprising an apex (a point) coincident at the distal end.
Ariza does not teach the plurality of grooves at the end of the probe, the grooves being i) generally transverse to an axis of the longitudinal stem,(i)along the axis of the longitudinal stem, and ij) substantially circumscribing the axis of the longitudinal stem thereby reducing a tissue contact surface area along and around sides of the tip, and iii) providing an additional tissue fragmentation surface area of the tip in planes generally perpendicular to the axis of the longitudinal stem; and wherein the grooves and rings and a rough finish located around the grooves, the rings, and the tip, wherein the rough finish is configured to fragment or emulsify subcutaneous soft tissues in such a way that a greater surface area is covered in different angular and longitudinal orientations and not only a frontal one.
Yamaha, in a similar field of endeavor, teaches a similar concept (ultrasound for emulsification) of a probe that includes a plurality of grooves at the end of the probe, the grooves being i) generally transverse to an axis of the longitudinal stem,(i)along the axis of the longitudinal stem, and ij) substantially circumscribing the axis of the longitudinal stem thereby reducing a tissue contact surface area along and around sides of the tip (corresponding disclosure in at least Figure 2 and [0051], where there is a probe with a plurality of groves at the end/tip of the probe, which is circumscribing the axis “ groove 64 as a recess extends over all circumference of the probe 42 on the side of the distal end portion of the probe 42. A plurality of such groove 64 is arranged side by side in the central axial direction of the probe 42”)
and iii) providing an additional tissue fragmentation surface area of the tip in planes generally perpendicular to the axis of the longitudinal stem; and wherein the grooves and rings and a rough finish located around the grooves, the rings, and the tip, wherein the rough finish is configured to fragment or emulsify subcutaneous soft tissues in such a way that a greater surface area is covered in different angular and longitudinal orientations and not only a frontal one (corresponding disclosure in at least Figure 2 and[0054], where there is a rough finish at the tip of the probe, as denoted in Figure 2, and the rough finish is configured for emulsification “A living tissue emulsified and fractured by the cavitation generated in each groove 64 is sucked into the suction path 46 through the suction opening”).
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Figure 2. of Yamaha
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the grooves and rough finish at the tip of the probe as taught by Yamaha. One of the ordinary skill in the art would have been motivated to incorporate this because the grooves are used during emulsification and fracturing tissue as they go into the grooves.
As can be clearly and factually seen above, Yamaha teaches all the claimed limitations. Yet, in any case or in any interpretation, if one argues that the Yamaha does not teach analytical steps as claimed (i.e., the plurality of grooves at the end of the probe, the grooves being i) generally transverse to an axis of the longitudinal stem,(i)along the axis of the longitudinal stem, and ij) substantially circumscribing the axis of the longitudinal stem thereby reducing a tissue contact surface area along and around sides of the tip, and iii) providing an additional tissue fragmentation surface area of the tip in planes generally perpendicular to the axis of the longitudinal stem; and wherein the grooves and rings and a rough finish located around the grooves, the rings, and the tip, wherein the rough finish is configured to fragment or emulsify subcutaneous soft tissues in such a way that a greater surface area is covered in different angular and longitudinal orientations and not only a frontal one.) which the office does not concede, Araki reference (US20210330342A1) is brought in to also show that these steps are further taught in an effort to provide compact prosecution.
In the same field of endeavor, Araki teaches a similar concept (surgical instruments using mechanical vibrations), of a probe that includes a plurality of grooves at the end of the probe, the grooves being i) generally transverse to an axis of the longitudinal stem,(i)along the axis of the longitudinal stem, and ij) substantially circumscribing the axis of the longitudinal stem thereby reducing a tissue contact surface area along and around sides of the tip (corresponding disclosure in at least [0041] and Figure 17, where there are a plurality of grooves transverse to the stem “a cutting surface 15 a [a first main cutting surface] that is made of a corrugated surface having a crosshatch pattern due to a plurality of U-shaped grooves is formed on the lower principal surface”).
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Figure 17 of Araki
and iii) providing an additional tissue fragmentation surface area of the tip in planes generally perpendicular to the axis of the longitudinal stem; and wherein the grooves and rings and a rough finish located around the grooves, the rings, and the tip, wherein the rough finish is configured to fragment or emulsify subcutaneous soft tissues in such a way that a greater surface area is covered in different angular and longitudinal orientations and not only a frontal one (corresponding disclosure in at least [0069] and Figure 17, where there is a rough finish around the grooves, which can be shown in the figure “ a cutting surface 26 a that is made of a corrugated surface having a crosshatch pattern due to a plurality of U-shaped grooves 28 is formed on the lower principal surface”).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have included grooves and rough finish around the probe at the end of the tip, as taught by Araki. One of ordinary skill in the art would have been motivated to incorporate this because the grooves are used for increasing the surface area of the probe and the rough finish is used in assisting in the cutting or breaking down of the tissue.
Regarding Claim 12, the combination noted teaches all the claimed limitations.
Specifically, Yamaha further teaches that the plurality of grooves each has a bottom, where each bottom, in a cross section that contains the axis of the longitudinal stem, which is substantially flat and substantially parallel to the longitudinal axis (corresponding disclosure in at least [0034] and Figure 3, where the distal end portion of the probe including a plurality of grooves, the grooves having a bottom, which is substantially flat and being parallel to the longitudinal axis).
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Figure 3
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have a plurality of grooves. One of the ordinary skill in the art would have been motivated to incorporate this because cavitation is promoted with this configuration (corresponding disclosure from the present application in at least [0051]).
Regarding Claim 13, the combination noted teaches all the claimed limitations.
Specifically, Yahama teaches the that each bottom of the plurality of grooves is U-shaped ((see fig. 3), which have a U-shape when cut across the grey-dotted lines (Figure 4)).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have included a plurality of grooves. One of the ordinary skill in the art would have been motivated to incorporate this because cavitation is promoted with this configuration (corresponding disclosure from the present application in at least [0051]).
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Figure 4.
Regarding Claim 17, the combination noted teaches all the claimed limitations.
Specifically, Ariza further teaches wherein that the tip at the distal end of the longitudinal stem has a blunt or bullet-shaped shape (corresponding disclosure in at least [0008], where the distal tip of the probe (optimizer) comprising an apex having a substantially rounded, blunt configuration).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have this blunt configuration. One of the ordinary skill in the art would have been motivated to incorporate this because it helps facilitate entry of the probe within the surgical site (corresponding disclosure in at least [0008]).
Claims 2-7, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Ariza (US 20190380728 A1) in view of Yamaha et al. (US 20080194999 A1) as applied to Claim 1 above and further in view of Britva et al. (US 20110213279 A1, hereinafter Britva).
Regarding Claim 2, the combination noted teaches all the claimed limitations.
Specifically, Britva teaches an ultrasonic surface optimizer (i.e. energy delivery surface), wherein the surface comprises different orientations with a texture in the direction or pattern perpendicular to the direction of the grooves, according to the bisector of the angles formed by the directions of the grooves, in any direction, radial or normal to a radius (corresponding disclosure in at least [0068], where the surface “includes at least one of i) multiple discontinuous surfaces; ii) plurality of protrusions positioned on the energy delivery surface; iii) plurality of vertical ridges positioned on the energy delivery surface; and iv) a plurality of concentric circular ridges positioned on the energy”).
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Regarding Claim 3, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches that the rough finish due to its nature and its number of micro surfaces at different angles (corresponding disclosure in at least [0038] and fig. 6, where there are a plurality of protrusions and/or indentions or depressions positioned on the distal surface and the distal portion is shown to have a ridged surface with a plurality of protrusions in the figure) serve to extend the active or output area of the sonotrode, in order to optimize the longitudinal surfaces that are not used in a smooth model or raised only with grooves.
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
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Figure 6
Regarding Claim 4, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches another surface of the sonotrode, characterized in that the use of the rough finish is comprised of a series of peaks and valleys (corresponding disclosure in at least [0038] and fig. 6, where there are a plurality of protrusions and/or indentions or depressions positioned on the distal surface, which form peaks
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Regarding Claim 5, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches that the ultrasonic surface optimizer, wherein that the use of the rough finish has an area with micro cross-sectional surfaces (corresponding disclosure in at least [0336], where the undulating membrane deformation increases membrane surface area by at least 20%) that generate a very large active area upon longitudinal movement that optimizes the ultrasound output.
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Regarding Claim 6,
the combination above does not teach all the claimed limitations.
Britva further teaches wherein that the use of the rough finish offers a greater surface area at different length scales (corresponding disclosure in at least [0068], where the surface includes multiple delivery surface configurations, including “i) multiple discontinuous surfaces; ii) plurality of protrusions positioned on the energy delivery surface; iii) plurality of vertical ridges positioned on the energy delivery surface; and iv) a plurality of concentric circular ridges positioned on the energy”)
It is known in the art that when there are different protrusions geometries, each protrusion or peak will have different lengths, and irregularities on the surface would add extra surface area.
Regarding Claim 7, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches that the rough finish increases the efficiency of the ultrasound output by means of its corresponding scales, since the deviations or alterations of the undulation and roughness are in different orientations (corresponding disclosure in at least [0336], where the undulating membrane geometry deformation (fig. 6) increases the surface area (efficiency of ultrasound output) by at least 20%).
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Regarding Claim 9, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches the use of the rough finish consumes less energy, because the transverse surfaces to the longitudinal movement of the cannula are greater than any smooth surface, it is more stable and uniform (corresponding disclosure in at least [0336], [0126], and [0135], where the use of the protrusions facilitate scattering of transverse mechanical waves into the tissue for more effectiveness [0138]).
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Regarding Claim 11, the combination noted teaches all the claimed limitations.
Specifically, Britva further teaches the use of the rough finish reduces the thermal impact on the tissue of the human body, that is, its application reduces the risks of burns and complications in patients undergoing this procedure (corresponding disclosure in at least [0068], where there are a plurality of protrusions (rough surface) and other configurations to the surface).
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ariza (US 20190380728 A1) in view of Yamaha et al. (US 20080194999 A1) as applied to Claim 1 above and further in view of Aljure (US 20230028334 A1) and Britva (US 20110213279 A1).
Regarding Claim 8, the combination noted teaches all the claimed limitations.
Specifically, Aljure teaches where the rough finish is configured to provide an optimization of a surface of the optimizer and is configured to assist the tapping zone helps to break down the adipocytes (corresponding disclosure in at least [0033] and fig. 7, where a commercial probe with grooves that are used to fracture and emulsify adipocytes using back and forth strokes).
Aljure discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
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Figure 7
Aljure does not teach that the rough finish provides optimization of the surface.
However, in the same field of endeavor, Britva teaches multiple delivery surface configurations, including “i) multiple discontinuous surfaces; ii) plurality of protrusions positioned on the energy delivery surface; iii) plurality of vertical ridges positioned on the energy delivery surface; and iv) a plurality of concentric circular ridges positioned on the energy” (corresponding disclosure in at least [0068]).
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Ariza (US 20190380728 A1in view of Yamaha et al. (US 20080194999 A1) as applied to Claim 1 above and further in view of Britva et al. (US 20110213279 A1, hereinafter Britva) and Zhou et al. (“The Effects of Low-Intensity Ultrasound on Fat Reduction of Rat Model”, Biomed Rest Int., 2017, pg. 1).
Regarding Claim 10, the combination noted above does not teach wherein the rough finish requires less power for optimal operation, therefore, the sonotrode has less energy dissipation and less temperature radiation.
However, Britva teaches that the use of the rough finish requires less power for optimal operation, therefore, the sonotrode has less energy dissipation and less temperature radiation (corresponding disclosure in at least [0068] and [0087], where the protrusions on the surface use a power density for the ultrasound waves of at least 3 watts/cm2). Zhou discloses that for such procedure, low intensity power is 17.5 W/cm2 , which is greater than the reference. Thus, the reference provides a sonotrodes with less power consumption, which would have less energy dissipation and less temperature radiation.
Britva discloses the claimed invention except for characterizations to be on grooves. It would have been an obvious matter of design choice to provide those protrusions on the grooves, because it appears that the invention would perform equally well and would be within the level of ordinary skill in the art since the reference discloses the protrusion on the probe.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Ariza (US 20190380728 A1) in view of Yamaha et al. (US 20080194999 A1) as applied to Claim 1 above and further in view of Aljure (US 20230028334 A1, hereinafter Aljure).
Regarding Claim 15,
Aljure further teaches an ultrasonic surface optimizer (i.e., ultrasonic frequency vibration apparatus), wherein the longitudinal stem includes an open lumen along its length, such that the open lumen is configured to be aligned with the axis of the longitudinal stem, and generally located in the center of the longitudinal stem (corresponding disclosure in at least [0058] and fig. 8, where the lumen (122, 120) is centered and appears open along the length longitudinally).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have the lumen centered and aligned with the axis of the longitudinal stem. One of the ordinary skill in the art would have been motivated to incorporate this because centering the lumen along the length allows for space for the removal of emulsified or fractured tissue (corresponding disclosure in at least [0051]).
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Figure 8
Response to Arguments
In regards to the Drawing objections, the updated Drawings sheet dated 06/28/2025 and the amended Specifications (06/28/2025) have been considered, but are rejected due to the reasons listed in the office action above.
Applicant’s arguments filed 06/28/2025 with respect to the rejections under 35.U.S.C. 103 have been fully considered but they are not persuasive.
With respect to the rejection regarding Claim 1, applicant’s arguments have been considered but are moot because a new ground of rejection has been applied to the amended claims. The rough finish, as taught by Yamaha, is further noted in Figure 2, shown in the office action. Further, per the amendments, the Araki reference was introduced to meet the limitations of the rough finish located around the grooves, the rings, and the tip.
With respect to Applicant’s arguments to the remaining claims, see pages 14-16, regarding claims 2-13, 15, and 17, these claims are not allowable based on their dependence to the independent claim 1 for at least the reasonings provided above.
Conclusion
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
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/K.E.K./Examiner, Art Unit 3797
/SERKAN AKAR/Primary Examiner, Art Unit 3797