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 .
DETAILED ACTION
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.
Claims 1-4, 8-10, 13-14 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (WO 2020/111831), in view of Alexander et al. (US 2019/0091490) and further in view of Steiner et al. (US 2004/0038598).
Addressing claim 1, Cho discloses a device suitable for treating subcutaneous tissue, comprising:
a. an ultrasonic transducer for generation of ultrasonic vibrations having a proximal face and a distal face (see Fig. 3; transducer 210);
b. a sonotrode with a sonotrode axis including: i. a proximal face in contact with, and acoustically-coupled to, said distal face of said ultrasonic transducer, ii. a conical portion having a proximal end and a distal end, wherein said conical portion is defined by a conical wall having an outer conical surface and an inner conical surface, the inner conical surface having a conical angle, which inner conical surface at least partially defines a hollow, and iii. a ring portion extending radially outwards from said distal end of said conical portion having a ring-shaped proximal face and a ring-shaped distal face which is a working face of sonotrode, a hole of said working face constituting an open end of said hollow, the proximal end of the conical portion having a proximal end radius and the distal end of the conical portion having a distal end radius, wherein the distal end radius is greater than the proximal end radius (see Figs. 1-3; sonotrode 102 inner surface/proximal surface in contact with transducer 210 distal surface; a conical opening treatment end with hollow inside; ring-shape treatment proximal surface; cone/conical shape: a cone shape is a 3D geometric figure with a flat, circular base that tapers smoothly to a single point called the apex or vertex, forming a curved surface; special type of cone does not has line segments for curve surface; a cone: a solid or hollow object which tapers from a circular or roughly circular base to a point; a cone does not require to have straight line segment; there are many definition of a cone and not just mathematical definition as see also the prior art made of record and not relied upon is considered pertinent to applicant's disclosure in the conclusion section (2018/0353988 discloses a curve cone (see Figs. 1, 3 and [0061]; curved coned)). There are unique shape cones).
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Cho does not disclose the ring portion having a ring portion distance from a center of the ring portion to an outer edge of the ring portion and the ring portion distance is greater than the distal end radius. Alexander discloses the ring portion having a ring portion distance from a center of the ring portion to an outer edge of the ring portion and the ring portion distance is greater than the distal end radius (see Fig. 3, ring 54). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cho to have the ring portion having a ring portion distance from a center of the ring portion to an outer edge of the ring portion and the ring portion distance is greater than the distal end radius as taught by Alexander because this improves longitudinal and efficient vibration (see [0101] and [0128]).
Cho does not disclose wherein at least a portion of the inner conical surface from the proximal end to the distal end of the conical portion is linear, wherein the conical angle along the at least a portion of the conical wall from the proximal end to the distal end of the conical portion is constant. This is just one type of cone shape and it only require routine skill in the art to use any type of cone shape. Steiner discloses wherein at least a portion of the inner conical surface from the proximal end to the distal end of the conical portion is linear, wherein the conical angle along the at least a portion of the conical wall from the proximal end to the distal end of the conical portion is constant (see [0019], Fig. 6 and claim 17; Steiner discloses a sonotrode with cone shape head surface). Examiner only relies on Steiner to explicitly disclose a type of cone that only require routine skill in the art. The court agreed that changes in shape was a matter of choice which a person of ordinary skill in the art would have found obvious (In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant).
Addressing claims 4 and 9-10, Cho discloses:
addressing claim 4, configured to apply suction to a skin-surface through said hole of said working face of said sonotrode (see Figs. 1-3; the cone shape provides suction/vacuum).
addressing claim 9, said sonotrode further comprising a stem, said stem having a proximal face that is said proximal face of said sonotrode and a distal end which is said proximal end of said conical wall (see Figs. 1-3).
addressing claim 10, said sonotrode comprising a proximal channel between said hollow and outside of said sonotrode near said transducer (see Fig. 3, 110).
Addressing claims 2-3, 13-14 and 22-24, Alexander discloses:
addressing claim 2, wherein said sonotrode is configured for a selected ultrasonic driving frequency, to act as an acoustic amplitude transformer for both longitudinal and transverse vibration (see abstract, [0005-0006], [0012], [0048], [0051], [0053] and Fig. 3; Alexander’s abstract, [0006] and [0012] disclose amplify transverse and longitudinal vibration);
addressing claim 3, wherein said configuration to act as an acoustic amplitude transformer for longitudinal vibration at said selected ultrasonic driving frequency is that the length of the sonotrode from the proximal face to the working face is: nλlongitudinal/2 where n is a positive integer; and λlongitudinal is the wavelength of ultrasonic longitudinal waves in the sonotrode (see abstract, [0005-0006], [0012], [0048], [0051], [0053] and Fig. 3; the length of the sonotrode is half wavelength; [0051] and [0053] disclose length of 55 mm and diameter 88 mm; this is within range of nλ/2 for selected frequency for longitudinal and transverse; the application specification discloses length of 50 mm and diameter of 90 mm (see [0155-0156]));
addressing claim 21, wherein said configuration to act as an acoustic amplitude transformer for transverse vibration at said selected ultrasonic driving frequency is that the diameter of the sonotrode from the proximal face to the working face is: nλtranserse/2 where n is a positive integer greater than 0; and λtransverse is the wavelength of ultrasonic transverse waves in the sonotrode (see abstract, [0005-0006], [0012], [0048], [0051], [0053] and Fig. 3; the length of the sonotrode is half wavelength; [0051] and [0053] disclose length of 55 mm and diameter 88 mm; this is within range of nλ/2 for selected frequency for longitudinal and transverse; the application specification discloses length of 50 mm and diameter of 90 mm (see [0155-0156]));
addressing claims 13 and 23-24wherein said ultrasonic transducer is configured to operate at a driving frequency of between 30 kHz and 200 kHz (see [0048]);
addressing claim 14, an ultrasound power supply to drive the ultrasonic transducer at a driving frequency of between 30 kHz and 200 kHz (see [0048]).
Addressing claim 8, Cho does not disclose wherein the diameter of said hole is between 10% and 70% of the diameter of said ring portion. However, this is just a designer choice that only require routine skill in the art. In Gardnerv.TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966) (The court held that the configuration of the claimed disposable plastic nursing container was a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed container was significant.).
Claims 5-7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Cho (WO 2020/111831), in view of Alexander et al. (US 2019/0091490), further in view of Steiner et al. (US 2004/0038598) and Ahn (KR 101721441).
Addressing claims 5-7 and 11-12, Cho does not disclose to irradiate a skin-surface apparent through said hole of said working face of said sonotrode with electromagnetic radiation; a prestressed Langevin-type transducer include an axial bolt wherein said axial bolt includes an axial passage between said distal end and said proximal end of said axial bolt; wherein said ultrasonic transducer is a prestressed Langevin- type transducer including an axial bolt having an axial passage between a distal end and a proximal end of said axial bolt, and said sonotrode comprising a bore for engaging said distal end of said axial bolt, so that said said proximal channel of said sonotrode and said axial passage of said axial bolt together provide communication between said hollow and said proximal end of said axial bolt; said sonotrode comprising a non-axial through-channel providing communication between said hollow and outside of said sonotrode through said conical wall. Using any type of transducer is just a designer choice. Ahn discloses irradiate a skin-surface apparent through said hole of said working face of said sonotrode with electromagnetic radiation; a prestressed Langevin-type transducer include an axial bolt wherein said axial bolt includes an axial passage between said distal end and said proximal end of said axial bolt; wherein said ultrasonic transducer is a prestressed Langevin- type transducer including an axial bolt having an axial passage between a distal end and a proximal end of said axial bolt, and said sonotrode comprising a bore for engaging said distal end of said axial bolt, so that said said proximal channel of said sonotrode and said axial passage of said axial bolt together provide communication between said hollow and said proximal end of said axial bolt; said sonotrode comprising a non-axial through-channel providing communication between said hollow and outside of said sonotrode through said conical wall (see Figs. 2, 4-7, [0052-0056]; Langevin-type transducer is just a transducer that is press between two masses; bolt 430 prestress the transducer 420; passage 401; proximal channel 120A-B; non-axial channel 300; laser is the electromagnetic radiation treatment; laser hole is a waveguide). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cho to irradiate a skin-surface apparent through said hole of said working face of said sonotrode with electromagnetic radiation; a prestressed Langevin-type transducer include an axial bolt wherein said axial bolt includes an axial passage between said distal end and said proximal end of said axial bolt; wherein said ultrasonic transducer is a prestressed Langevin- type transducer including an axial bolt having an axial passage between a distal end and a proximal end of said axial bolt, and said sonotrode comprising a bore for engaging said distal end of said axial bolt, so that said said proximal channel of said sonotrode and said axial passage of said axial bolt together provide communication between said hollow and said proximal end of said axial bolt; said sonotrode comprising a non-axial through-channel providing communication between said hollow and outside of said sonotrode through said conical wall as taught by Ahn because this is designer choice that securely integrate the transducer in the device; provide drug/solution treatment to the patient and laser treatment provide effective treatment to a certain treatment type (see [0048] and [0055]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 and 22-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2012/0330194 (see Fig. 3A and [0086]) and US 2018/0353988 (see Figs. 1, 3 and [0061]; curved coned) and US 5,490,810 (see Figs. 4 and 6, sonotrode 18 and 22 having truncated cone shape with ring at its larger base).
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 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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/HIEN N NGUYEN/
Primary Examiner
Art Unit 3797