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 statement (IDS) submitted on 10/30/2025 has been considered by the examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The pixelation of the words of the specification are such as to make reading difficult. New application papers with unpixellated words are required.
The incorporation of essential material in the specification by reference to an unpublished U.S. application, foreign application or patent, or to a publication is improper. Applicant is required to amend the disclosure to include the material incorporated by reference, if the material is relied upon to overcome any objection, rejection, or other requirement imposed by the Office. The amendment must be accompanied by a statement executed by the applicant, or a practitioner representing the applicant, stating that the material being inserted is the material previously incorporated by reference and that the amendment contains no new matter. 37 CFR 1.57(g).
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “ultrasonic transducer units” and “rotary motor unit” in claim 1, “power supply protruding terminal units” in claim 7, “ultrasonic transducer moving unit” in claim 12.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The ultrasound transducer units are ultrasound transducers (see para. 96). The rotary motor unit is a rotary shaft mounted on the rotary mount (see para. 19 and claim 2). The power supply protruding terminal units are terminals (see para. 134). The ultrasonic transducer moving unit includes rotary mount and mounting arm member (Fig. 7; see para. 151).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 2-13 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.
For claim 2, the limitation “wherein the rotary motor unit comprises a rotary shaft mounted on the rotary mount and connected to the rotary motor unit” is indefinite. It is unclear how a rotary motor unit is connected to the rotary motor unit (i.e., if two rotary motor units are somehow connected together via a rotary mount, or rotary mount is connected something else). For the purpose of advancing prosecution, the examiner assumes to read the limitation as “wherein the rotary motor unit comprises a rotary shaft mounted on the rotary mount”.
Claims 3-13 are dependent of claim 2, and therefore rejected under this 112(b) rejection as well.
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.
Claims 1-6 and 12-14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Slayton et al. (US 20160332006 A1, published November 17, 2016), hereinafter referred to as Slayton.
Regarding claim 1, Slayton teaches an ultrasonic wave generating device having a plurality of ultrasonic transducers, the ultrasonic wave generating device comprising:
a cartridge housing having, on a bottom thereof, a window configured to come into contact with a skin and allow ultrasonic waves to pass through (Fig. 6; see para. 0037 – “Transducer module 3 can comprise a coupling surface configured to acoustically couple a transducer within transducer module 3 to a region of interest of a subject, such as, for example, subcutaneous tissue of a patient. One or more of the transducer can be configured to focus a conformal distribution of ultrasound energy into region of interest comprising subcutaneous tissue.”; see para. 0054 – “Transducer module 301 can comprise a housing 353, which may comprise an acoustic window 352 and an opening.”);
a plurality of ultrasonic transducer units disposed in the cartridge housing and configured to generate ultrasonic waves (Fig. 7; see para. 0037 – “One or more of the transducer can be configured to focus a conformal distribution of ultrasound energy into region of interest comprising subcutaneous tissue.”; see para. 0058 – “Transducer assembly 404 can comprise a plurality of transducers. In an example, transducer assembly 404 comprises first transducer 10, a second transducer 11, of three transducer 12, and a fourth transducer 13.”);
a rotary mount on which the plurality of ultrasonic transducer units are mounted and which is rotatably disposed in the cartridge housing (Fig. 6; see para. 0044 – “Control module 4 can comprise a motor and be configured to control the motor, which can be coupled to a motion mechanism [rotary mount] within transducer module 3 [within housing 353].”); and
a rotary motor unit configured to rotate the rotary mount (Fig. 6; see para. 0044 – “Control module 4 can comprise a motor and be configured to control the motor, which can be coupled to a motion mechanism [rotary mount] within transducer module 3.”).
Furthermore, regarding claim 2, Slayton further teaches wherein the rotary motor unit comprises a rotary shaft mounted on the rotary mount and connected to the rotary motor unit (Fig. 4; see para. 0055 – “Rotational movement (indicated by arrow 50) can spin arm 363, which is engaged with, slide 360. Arm 363 rotates around a pivot point 330, which can be at the end of the transducer shaft 70.”), and
the plurality of ultrasonic transducer units are mounted on the rotary mount at positions spaced apart from and eccentric to a rotation center of the rotary mount (Fig. 7; see para. 0058 – “Transducer module 302 comprises transducer assembly 404 which can have a rotational movement (indicated by arrow 50). Transducer assembly 404 can comprise a plurality of transducers.”).
Furthermore, regarding claim 3, Slayton further teaches wherein the rotary mount comprises a plurality of mounting arm members disposed radially from a rotation center to which the rotary shaft is connected (Fig. 4; see para. 0055 – “Rotational movement (indicated by arrow 50) can spin arm 363, which is engaged with, slide 360. Arm 363 rotates around a pivot point 330, which can be at the end of the transducer shaft 70.”).
Furthermore, regarding claim 4, Slayton further teaches wherein all of the plurality of ultrasonic transducer units have structures that position focal points of ultrasonic waves at the same depth, or at least any one of the plurality of ultrasonic transducer units has a structure that positions the focal point of an ultrasonic wave at a different depth (see para. 0034 – “The plurality of ultrasound transducers can be configured to have different focal depths of the ultrasound energy.”).
Furthermore, regarding claim 5, Slayton further teaches wherein the plurality of ultrasonic transducer units are all disposed to be spaced apart from the rotation center of the rotary mount by the same distance, or at least any one of the plurality of ultrasonic transducer units is disposed to be spaced apart from the rotation center of the rotary mount by a different distance (Fig. 7; see para. 0094 – “If using two or more ultrasound sources, each source can be located at the same distance from the rotational axis (thereby producing a single circle when not moving linearly) or at different distances from the rotational axis (thereby producing concentric circles with not moving linearly).”).
Furthermore, regarding claim 6, Slayton further teaches wherein the ultrasonic transducer unit is rotated around the rotary shaft while an ultrasonic generation surface is positioned horizontally, thereby moving a focal point of the ultrasonic wave generated from the ultrasonic transducer unit along a circular path in the same plane (see para. 0070 – “In a non-limiting example, FIG. 17 illustrates a top view of a region of interest with an example of a circular pattern of treatment, according to various embodiments of the present invention. Circular path 725 can be produce by, for example, a treatment system illustrated in FIGS. 6-8. As system moves along path 705, circular path 715 can produce a matrix of evenly spaced lesions 700.”).
Furthermore, regarding claim 12, Slayton further teaches an ultrasonic transducer moving unit disposed under the rotary mount and configured to adjust the distance between the rotation center of the rotary mount and the ultrasonic transducer units by linearly moving the ultrasonic transducer units (Fig. 4; see para. 0055 – “Rotational movement (indicated by arrow 50) can spin arm 363, which is engaged with, slide 360. Arm 363 rotates around a pivot point 330, which can be at the end of the transducer shaft 70. Movement of slide 360 linearly along rail 350 is generated by movement of arm 363 around pivot point 330.”).
Furthermore, regarding claim 13, Slayton further teaches wherein the mounting arm members include:
a first arm member connected to the rotary shaft (Fig. 4-5, transducer shaft 70 (first arm member) connected to motor shaft 60 (rotary shaft));
a second arm member rotatably hinged to the first arm member and on which the ultrasound transducer units are mounted (Fig. 4-5, arm 363 (second arm member) rotatably hinged to transducer shaft 70 (first arm member), transducer 10 mounted on arm 363 (second arm member); see para. 0055 – “Arm 363 rotates around a pivot point 330, which can be at the end of the transducer shaft 70.”); and
an arm rotation motor (motor 200) configured to rotate the second arm member in a plane about the hinge (see para. 0055 – “Rotational movement (indicated by arrow 50) can spin arm 363, which is engaged with, slide 360.”).
Furthermore, regarding claim 14, Slayton further teaches a therapeutic ultrasonic wave generating device comprising:
a body housing connected to a control body through a handpiece cable assembly (see para. 0044 – “Control module 4 can be located with a housing, which can be in a hand-held format.”); and
an ultrasound generating device detachably coupled to the body housing (see para. 0037 – “Referring to FIG 1, a treatment system 1 can comprise a control module 4 and a transducer module 3. Transducer module 3 can be self-contained and can be removably attached to control module 4.”), wherein the therapeutic ultrasonic wave generating device is the ultrasonic wave generating device having a plurality of ultrasonic transducers of claim 1 (see claim 1 above).
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 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 7-11 are rejected under 35 U.S.C. 103 as being unpatentable over Slayton in view of Mumaw et al. (US 20160121143 A1, published May 5, 2016), hereinafter referred to as Mumaw.
Regarding claim 7, Slayton teaches all of the elements disclosed in claim 2 above.
Slayton teaches a plurality of ultrasound transducers mounted on a rotary motor unit and connected to a power supply (see para. 0072 – “Power supply can supply power to transducer module comprising the ultrasound transducer, and at least a portion of the motion mechanism.”), but does not explicitly teach wires providing power to the ultrasound transducers via a power supply board within the housing.
Whereas, Mumaw, in an analogous field of endeavor, teaches a plurality of power supply protruding terminal units (Fig. 36, conductive traces 2112) protruding upward from the rotary mount (rotation drum 2120) and configured to supply power to the plurality of ultrasonic transducer units (Fig. 36; see para. 0151 – “…PC board (2110) is operable to transmit power from brush contact (2170) to transducer (2190)…”; see para. 0151 – “Conductive traces (2112) may be formed on PC board (2110) by chemical etching, printing of conductive ink, as a part of a molded interconnect device, and/or otherwise. Conductive traces (2112) of the present example comprise circular paths of conductive material (e.g., gold, copper, etc.) such that a brush contact (2170) (shown in FIGS. 35-36) is operable to electrically couple to conductive traces (2112) even when PC board (2110) is rotated through 360 degrees.”); and
a power supply board (Fig. 6, PC board 2110) spaced above the rotary mount (rotation drum 2120) in the cartridge housing and to which the plurality of power supply protruding terminal units are connected (see para. 0151 – “Conductive traces (2112) may be formed on PC board (2110) by chemical etching, printing of conductive ink, as a part of a molded interconnect device, and/or otherwise. Conductive traces (2112) of the present example comprise circular paths of conductive material (e.g., gold, copper, etc.) such that a brush contact (2170) (shown in FIGS. 35-36) is operable to electrically couple to conductive traces (2112) even when PC board (2110) is rotated through 360 degrees.”).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified a plurality of ultrasound transducers mounted on a rotary motor unit and connected to a power supply, as disclosed in Slayton, by also having wires providing power to the ultrasound transducers via a power supply board within the housing, as disclosed in Mumaw. One of ordinary skill in the art would have been motivated to make this modification in order for only a single temperature sensor may be needed to monitor both the temperature of transducer the electronic components, and by including the electronic components within the casing of transducer, thicker wires may be used for the electrical couplings due to the short run distances and the reduced need for flexibility, and these thicker wires may help mitigate heat generated within the surgical instrument, as taught in Mumaw (see para 0167).
Furthermore, regarding claim 8, Mumaw further teaches wherein a ring-shaped electrode pattern connected through a power cable to receive power is disposed on a bottom of the power supply board (Fig. 36, PC board 2110 as power supply board; see para. 0151 – “Wire (2192) is then electrically coupled to one or more electrodes (not shown) of transducer (2190).”; see para. 0155 – “Transfer casing (2150) further includes openings (2154) through which brush contacts (2170) may be coupled to one or more wires (not shown) from a cable (not shown) configured to provide power to transducer (2190).”), and the
power supply protruding terminal units (wire 2192) move along a circular path along the ring-shaped pattern while elastically in contact with the ring-shaped electrode pattern (see para. 0151 – “Wire (2192) is then electrically coupled to one or more electrodes (not shown) of transducer (2190)…PC board (2110) is operable to transmit power from brush contact (2170) to transducer (2190) even when transducer (2190) and PC board (2110) are rotated relative to brush contact (2170).”).
Furthermore, regarding claim 9, Slayton further teaches wherein the cartridge housing has a sealed internal structure and is filled with an ultrasonic transmission medium, and the ultrasonic transmission medium is an insulating liquid (see para. 0085 – “A coupling liquid can be sealed within transducer module 3.”).
Furthermore, regarding claim 10, Mumaw further teaches:
a board position-fixing board (Fig. 35-36, transfer casing 2150) disposed between a top of the cartridge housing and the power supply board (PC board 2110) and configured to support the position of the power supply board (see para. 0154 – “Referring now to FIGS. 35-36, a transfer casing (2150) is configured to encase the assembled rotation drum (2120) and PC board (2110) therein. In the example shown, transfer casing (2150) comprises a two-piece hollow cylinder having an annular channel (2152) configured to receive and retain PC board (2110) therein when transfer casing (2150) is assembled about rotation drum (2120) and PC board (2110).”);
a plurality of first board fixing portions (Fig. 35-36, brush contacts 2170) having both ends fixed to the top of the cartridge housing and the board position-fixing board (transfer casing 2150) and configured to support the position of the board position-fixing board; and a plurality of second board fixing portions (brush contacts 2170) having both ends fixed to the board position- fixing board and the power supply board and configured to support the position of the power supply board (see para. 0155 – “Transfer casing (2150) further includes openings (2154) through which brush contacts (2170) may be coupled to one or more wires (not shown) from a cable (not shown) configured to provide power to transducer (2190).”).
Furthermore, regarding claim 11, Mumaw further teaches wherein the plurality of first board fixing portions and the plurality of second board fixing portions are formed in a hollow tubular shape (Fig. 35-36, transfer casing 2150, which includes brush contacts 2170, has a hollow tube shape; see para. 0155 – “Transfer casing (2150) further includes openings (2154) through which brush contacts (2170) may be coupled to one or more wires (not shown) from a cable (not shown) configured to provide power to transducer (2190).”), and
power cables connecting the ring-shaped electrode pattern and a first main power supply terminal protruding upward from the cartridge housing are disposed inside the first and second board fixing portions (see para. 0151 – “Wire (2192) is then electrically coupled to one or more electrodes (not shown) of transducer (2190).”).
The motivation for claims 8 and 10-11 was shown previously in claim 7.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Crunkilton (US 20080243035 A1, published October 2, 2008) discloses using either the standard PCB or the slip ring PCB, the transducer may have a trace ring around the circumference of the transducer so the transducer may also be assembled to the bottom section without concern for orientation and placement of the electrical pins to the transducer.
Shelton, IV et al. (US 20170202607 A1, published July 20, 2017) discloses the strategically stacked circuit boards, the low thermal conductivity path from the circuit boards to the multi-lead battery terminal assembly, and a flex circuit are features that assist in preventing heat from reaching the exterior surface of the device.
Ha (US 20210220677 A1, published July 22, 2021) discloses a cable electrically connected to the PCB is connected to a transducer moving mechanism device located inside the housing.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nyrobi Celestine whose telephone number is 571-272-0129. The examiner can normally be reached on Monday - Thursday, 7:00AM - 5:00PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Pascal Bui-Pho can be reached on 571-272-2714. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.C./Examiner, Art Unit 3798
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