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. Therefore, the “thermoelectric unit” of claim 1 and “negative pressure unit” of claim 6 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 1-8 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 1 recites the limitation “has one side that comes into contact with a patient’s skin to form a lesion based on vibration below a skin surface of the patient so as to improve the skin”. Examine notes that the limitation positively recites the patient’s skin as a part of the claimed invention thus encompasses a human organism. Examiner recommends amending the claims to define the configuration of the handpiece/one side thereof (e.g. has one side that is configured to/adapted to come into contact with…. Or similar) in order to advance prosecution.
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.
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:
The limitation “transfer unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“to move the main body”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function. Examiner notes that the limitation “transfer” is merely a functional modifier which does not denote sufficient structure to the claimed “unit”.
A review of the specification shows that at least a wheel or the like ([0080]) appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “thermoelectric unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “thermoelectric” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“cools the at least one of the base unit and the plurality of transducers”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that there appears to be no corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “control unit” in claim 1 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“determines an intensity of the vibration energy and emits the vibration energy”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a processor configured for performing functions as disclosed in at least [0030] appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
The limitation “negative pressure unit” in claim 6 meets all 3 prongs of the analysis set forth in MPEP § 2181 (I). The limitation meets prong (A) because “unit” is a generic placeholder for “means”. The limitation meets prong (B) because the generic placeholder (the “unit”) is modified by functional language (“forms a lower pressure than atmospheric pressure in the suction hole to suction the patient’s skin”). The limitation meets prong (C) because this claim element is not further modified by sufficient structure or material for performing the claimed function.
A review of the specification shows that a compressor ([00150]) appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation.
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.
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(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 recites the limitation “thermoelectric unit”. Examiner notes the limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph and lacks written description because the specification fails to disclose sufficient corresponding structure that performs the entire claimed function of “cools the at least one of the base unit and the plurality of transducers”. For at least these reasons, a person having ordinary skill in the art would not have recognized the inventor had possession of the claimed invention at the original time of filing.
Claim Rejections - 35 USC § 112(b)
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 1-8 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 limitation “thermoelectric element” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. It is unclear what constitutes a thermoelectric element which would cool the at least one of the base unit and the plurality of transducers. For examination purposes, it has been interpreted to mean any element which can perform cooling of other elements. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 1 is rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik et al. (US 20220008112 A1), hereinafter Sverdlik in view of NPL Kassanos (“Bioimpedance Sensors: A Tutorial”), hereinafter Kassanos.
Regarding claim 1,
Sverdlik teaches a medical skin treatment device (at least fig. 7 (1100) and corresponding disclosure in at least [0261]. See also at least fig. 8 (2302) and corresponding disclosure in at least [0311] and at least fig. 1 and corresponding disclosure in at least [0139]) comprising:
a main body (at least fig. 7 (1104) and corresponding disclosure in at least [0261]. See also at least fig. 8 (2304) and corresponding disclosure in at least [0311] and at least fig. 1 (106) and corresponding disclosure in at least [0142]) including a control unit (at least fig. 1 (108) and corresponding disclosure in at least [0142]) configured to control an operation of the skin treatment device ([0142] which discloses controller 108 is configured to control operation of the system, for example controlling emission of ultrasound energy by applicator 102) and a power source unit (at least fig. 1 (110) and corresponding disclosure in at least [0143]) configured to supply power to the medical skin treatment device;
a transfer unit (at least fig. 8 (2314) and corresponding disclosure in at least [0320]. See also at least [0143] which discloses console is portable for example placed on a cart (i.e. transfer unit)) configured to move the main body ([0320] which discloses wheels configured to allow easy movement of the console further a cart is configured to make the console portable (i.e. to move the main body));
and a handpiece (at least fig. 7 (1102) and corresponding disclosure in at least [0261]. See also at least fig. 8 (2306) and corresponding disclosure in at least [0317]) that receives power from the power source unit of the main body, is controlled by the control unit ([0142] which discloses controller 108 is configured to control operation of the system, for example controlling emission of ultrasound energy by applicator 102), and has one side that comes into contact with a patient's skin to form a lesion based on vibration energy below a skin surface ([0110] which discloses unfocused ultrasound energy is applied to produce multiple spaced apart thermal damage lesions for example in the reticular dermis layer of the skin. See also [0151]) of the patient so as to improve skin ([0110] which discloses A potential advantage of forming spaced-apart lesions may include that non-damaged tissue between lesions may promote healing by generating growth of elastin and/or collagen fibers and [0109] which discloses treating skin to cause tightening of the skin ,
wherein the handpiece (2306/1102) includes:
a base unit (at least fig. 7 (1108) and corresponding disclosure in at least [0262]. See also at least fig. 4 (700) and corresponding disclosure in at least [0216]) and coupled to the one side of the handpiece (see at least fig. 7);
a plurality of transducers (at least fig. 4 (702) and corresponding disclosure in at least [0216]) that are formed on one side of the base unit (see at least fig. 4 and [0216] which discloses transducers are mounted on base 704. Optionally each transducer is mounted on a distally extending branch 706 of base 704. Optionally transducers 702 are attached to base 704 by a thin layer of glue) at positions excluding a center of the base unit (see at least fig. 4 in which the transducers are not in a center of the base unit) and vibrate at a predetermined therapeutic frequency to transmit the vibration energy to the patient's skin;
a thermoelectric element (at least fig. 7 (1112) and corresponding disclosure in at least [0262]. See also at least fig. 4 (710) and corresponding disclosure in at least [0225]) that is formed inside at least one of the base unit and the plurality of transducers (see at least fig. 7 and 4) and cools the at least one of the base unit and the plurality of transducers to prevent burning of the skin surface of the patient in contact with the one side of the handpiece ([0100] which discloses the transducers and/or tissue surface contacting the applicator are actively cooled, for example by a thermo electric cooler (TEC) element used in conjunction with a heat exchange, [0011] which discloses said cooling comprises cooling said external surface to maintain a temperature of the epidermis between 5-40 degrees Celsius and [0096] which discloses cooling at least a portion of the tissue to reduce thermal damage to the tissue surface and/or other tissue layers);
and an electrode unit ([0241] which discloses applicator comprises one or more RF electrodes) that is formed on the one side of the base unit ([0241] which discloses the RF electrodes are coupled to a coating of the base), includes at least two electrodes (RF electrodes) and measures an impedance of the patient's skin ([0241] which discloses the RF electrodes are used for measuring bio-impedance of the tissue. Optionally, bio-impedance measurements are performed to assess contact of the transducers with the tissue and/or as a measure of the tissue condition in response to treatment),
and the control unit determines an intensity of the vibration energy ([0143] which discloses controller selects (i.e. determines) one or more of: treatment parameters, a tissue layer to be targeted, a number of treatments, timing of treatments and/or treatment duration according to the inserted input [0113] which discloses treatment parameters are selected for obtaining a desired effect. In an example of parameter selection, an intensity of the emitted ultrasound is selected to be between 8-40 W/cm, between 12-22 W/cm, between 10-17 W/cm, between 14-18 W/cm to produce thermal damage in the dermis yet avoid damage to the epidermis, or for example, above 22 W/cm to produce thermal damage in the dermis and the epidermis) corresponding to the impedance of the patient's skin (examiner notes that the limitation is broad and the vibration energy is considered to correspond to the impedance of the patient’s skin) based on a predetermined function ([0128] which discloses values of at least one treatment parameter are changed according to collected information. In some areas, the treatment parameter comprises at least one of energy intensity, [0199] which discloses one or more treatment parameters are modified, for example energy parameters (e.g. frequency, intensity); a temperature profile of the transducer(s); a treatment duration; a shape and/or size of the applicator, [0340] which discloses values of at least one treatment parameter (comprising ultrasonic waves intensity) are adjusted to a selected treatment region and/or per a specific selected subject at block 2410, [0366] which discloses values of the treatment parameter, is adjusted according to information collected at one or more blocks 2424, 2426, 2428 and 2430. In some embodiments, the at least one treatment parameter comprises energy intensity emitted from at least one ultrasound transducer, overall energy per treatment region in a selected time period, overall energy per a selected time period, duration of each energy pulse, overall energy per a treatment session and optionally additionally per treatment region. Examine notes that such selection/modification of the energy intensity is necessarily based on a predetermined function (i.e. a function of the energy with respect to any of the information collected). See also [0399] which discloses the ultrasound system 2486 is configured to transmit information to the remote device during and/or following treatment delivery. In some embodiments, the information transmitted to the remote device includes feedback information, for example evaluation data, on the treatment delivered to the subject. In some embodiments, the received feedback data is used to update at least one protocol stored in the remote device and/or parameters thereof. Alternatively, the received feedback data is used to generate at least one new protocol, and/or to provide suggestions to the user 2488 how to modify the treatment. See also [0321]) and emits the vibration energy from the plurality of transducers based on the intensity of the vibration energy (see at least claim 13 regarding the control circuitry signaling the ultrasound transducers to generate and deliver one or more pulses of ultrasonic energy).
Sverdlik fails to explicitly teach wherein the electrodes include at least one positive electrode and at least one negative electrode.
Nonetheless, Kassanos teaches it is known for a bioimpedance sensor to include at least one positive electrode and at least one negative electrode (see at least fig. fig. 4(a) depiecting a biopolar (i.e. one positive electrode (A or B) and one negative (A or B). See also pg. 22199 disclosing the simplest way to measure electrical impedance is to use two electrodes as in fig. 4(a) the second electrode should be 180 degrees out of phase of the one applied at the other electrode).
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sverdlik to include at least one positive electrode and at least one negative electrode in order measure the impedance of the skin accordingly. Such a modification amounts to merely a simple substitution of one set of electrodes for another yielding predictable results with respect to bioimpedance measurement thereby rendering the claim obvious (MPEP 2143).
Claims 2-5 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik and Kassanos, as applied to claim 1 above, and further in view of Pearson et al. (US 20030130711 A1), hereinafter Pearson.
Regarding claim 2,
Sverdlik, as modified, teaches the elements of claim 1 as previously stated. Sverdlik fails to explicitly teach wherein, in a coordinate system in which a horizontal axis represents the impedance and the vertical axis represents the intensity of the vibration energy, the predetermined function is represented by a logarithmic function.
Pearson, in a similar field of endeavor involving tissue treatment, teaches wherein, in a coordinate system in which a horizontal axis represents impedance and a vertical axis represents the intensity of treatment, a predetermined function is represented as a logarithmic function (see at least fig. 23d and corresponding disclosure in at least [0148])
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sverdlik to include a predetermined function as taught by Pearson in order to allow delivered power to the target site to be controlled by controlling local impedance. Such a modification would provide the benefit of minimizing damage to surrounding healthy tissue near the end of treatment (Pearson [0148]).
Regarding claim 3,
Sverdlik, as modified, teaches the elements of claim 2 as previously stated. Sverdlik, as modified, further teaches wherein the control unit is configured to measure the impedance of the patient’s skin, determine the intensity of the vibration energy to be increased as the impedance increases based on the predetermined function ([0354] which discloses when heating a tissue layer located at a depth of at least 1.5 mm from the external surface of the skin with ultrasonic energy of 15 W/cm.sup.2 the tissue layer is unaffected. In some embodiments, when gradually increasing the ultrasonic energy, for example to 20 W/cm.sup.2, the tissue layer is affected and optionally a necrotic region is formed. In some embodiments, increasing the ultrasonic energy to levels higher than 25 W/cm.sup.2, increases the volume and/or the size of the necrotic region. Optionally, the effect of energy levels higher than 15 W/cm.sup.2 on the tissue, for example the increase in size and/or volume of the necrotic region is exponential. Examiner notes that the system functions to determine the intensity of the vibration energy such that it increase and examiner notes that a corresponding tissue impedance would also increase. Additionally/alternatively see fig. 23d of Pearson)
Kassanos, as applied to claim 1 above, further teaches wherein a control unit is configured to:
Cause an electrode unit to flow a predetermined test current from at least one positive electrode to at least one negative electrode (at least fig. 3 (I) and 4A (I));
Measure a test voltage between the at least one positive electrode and the at least one negative electrode (at least figs. 3 (V0)and 4A (delta V));
And measure the impedance of the patient’s skin based on the test current and the test voltage (pg. 22212 which discloses In addition to the above, digitization following voltage measurement and amplification can be used to process the signal and obtain the impedance in the digital domain. Digital implementations of synchronous detection can be implemented, using e.g. microcontrollers [219]. See also pg. 22191 which discloses the impedance is equal tot th e complex ratio of the ac voltage (V) over the current (I));
Regarding claim 4,
Sverdlik, as modified, teaches the elements of claim 2 as previously stated.
Sverdlik, as modified, further teaches wherein the control unit is configured to measure the impedance of the patient’s skin, determine the intensity of the vibration energy to be increased as the impedance increases based on the predetermined function ([0354] which discloses when heating a tissue layer located at a depth of at least 1.5 mm from the external surface of the skin with ultrasonic energy of 15 W/cm.sup.2 the tissue layer is unaffected. In some embodiments, when gradually increasing the ultrasonic energy, for example to 20 W/cm.sup.2, the tissue layer is affected and optionally a necrotic region is formed. In some embodiments, increasing the ultrasonic energy to levels higher than 25 W/cm.sup.2, increases the volume and/or the size of the necrotic region. Optionally, the effect of energy levels higher than 15 W/cm.sup.2 on the tissue, for example the increase in size and/or volume of the necrotic region is exponential. Examiner notes that the system functions to determine the intensity of the vibration energy such that it increase and examiner notes that a corresponding tissue impedance would also increase. Additionally/alternatively see fig. 23d of Pearson)
Kassanos, as applied to claim 1 above, further teaches wherein a control unit is configured to:
Cause the electrode unit to flow a test voltage between at least one positive electrode and at least one negative electrode ((at least figs. 3 (V0)and 4A (delta V). Examiner notes that application of the current would necessarily cause changes in the voltage and would therefore cause the electrode unit to flow a voltage (V) between the electrodes);
Measure a test current between the at least one positive electrode and the at least one negative electrode ((at least fig. 3 (I) and 4A (I)));
And measure the impedance of the patient’s skin based on the test current and the test voltage (pg. 22212 which discloses In addition to the above, digitization following voltage measurement and amplification can be used to process the signal and obtain the impedance in the digital domain. Digital implementations of synchronous detection can be implemented, using e.g. microcontrollers [219]. See also pg. 22191 which discloses the impedance is equal tot th e complex ratio of the ac voltage (V) over the current (I)));
Regarding claim 5,
Sverdlik further teaches wherein the predetermined therapeutic frequency of the vibration energy is 250 kHz or more and 20 MHz or less ([0106] which discloses one or more transducers are excited at treatment frequencies (e.g. between 9-22 MHz) where frequencies between 9-20 MHz fall within the claimed range. See also [0202] which discloses one or more transducers 502 are activated at a frequency suitable for thermally damaging deep tissue, for example a frequency between 8-22 MHz, 10-20 MHz, such as 11 MHz, 15 MHz, 18 MHz).
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sverdlik, Kassanos, and Pearson, as applied to claim 5 above, and further in view of Spooner et al. (US 20080195000 A1), hereinafter Spooner.
Regarding claim 6,
Sverdlik, as modified, teaches the elements of claim 5 as previously stated. Sverdlik further teaches wherein a suctioning hole for suctioning the patient’s skin is formed in the base unit ([0183] which discloses designated holes forming in the transducer surface. Examiner notes that for suctioning the patient’s skin is considered an intended use of the hole where limitations directed towards intended use must result in a structural difference between the claimed invention and the prior art. In this case it is noted that the holes formed in the transducer surface are capable of being used for suctioning the patient’s skin, thus read on the claimed limitation).
Sverdlik fails to explicitly teach a negative pressure unit included in at least one of the handpiece or the main body forms a lower pressure than atmospheric pressure in the suction hole to suction the patient’s skin.
Spooner, in a similar field of endeavor involving ultrasound treatment of the skin, teaches a suction hole for suctioning a patient’s skin is formed in a base unit [0023] which disclose vacuum ports within the cup 24 are coupled to a vacuum source, such that application of suction via the ports 30 will draw a patient’s skin into contact with the tissue contact plate), and a negative pressure unit (at least fig. 5 (62) and corresponding disclosure in at least [0036] or at least fig. 4 (50) and corresponding disclosure in at least [0027]) in at least one of a handpiece (at least fig. 1 (14) and corresponding disclosure in at least [0020]) or a main body (see at least fig. 1 (12 or the console on which the touchscreen 18 exists) and corresponding disclosure in at least [0020]) forms a lower pressure than atmospheric pressure in the suction hole to suction the patient’s skin.
It would have been obvious to a person having ordinary skill in the art before the effective filing date to have modified Sverdlik, as currently modified, to include a negative pressure unit as taught by Spooner in order to optimize ultrasound coupling [0023] and further to provide for suctioning the skin which would allow for beneficial uses in dermatological treatment using ultrasound (Spooner [0018]-[0020])
Regarding claim 7,
Sverdlik, as modified, teaches the elements of claim 6 as previously stated. Spooner, as applied to claim 6 above, further teaches wherein a distance between the one side of the handpiece and the patient's bone is measured based on the plurality of transducers included in the handpiece ([0048] which discloses because bone tissue can be heated very rapidly by ultrasound energy, some embodiments might include features that notify the user when the handpiece is positioned less than a predetermined distance from an underlying bone),
when the measured distance is included in a threshold range and the pressure formed the suction hole is less than a threshold pressure, the control unit controls the plurality of transducers to emit the vibration energy ([0047] which discloses throughout the treatment cycle, pressure sensors are used to generate feedback corresponding to the vacuum pressure of the system and the patient. If the pressure sensors detect that the cup 24 is not well sealed against the tissue, the treatment cycle will end and/or the console 12 will provide an auditory and/or visual alarm notifying the user that there may be inadequate contact between the handpiece and the skin [0048] which discloses bone tissue can be heated very rapidly by ultrasound energy, some embodiments might include features that notify the user when the handpiece is positioned less than a predetermined distance from an underlying bone),
and when the measured distance is not included in the threshold range or the pressure formed in the suction hole is higher than or equal to the threshold pressure, the control unit controls the plurality of transducers not to emit the vibration energy ([0047] which discloses in such embodiments, feedback that the handpiece is near an underlying bone can cause an auditory and/or visual alarm, and/or it may lockout the system against application of ultrasound until the handpiece is repositioned and/or the lock is overridden by the user. [0048] which discloses in such embodiments, feedback that the handpiece is near an underlying bone can cause an auditory and/or visual alarm, and/or it may lockout the system against application of ultrasound until the handpiece is repositioned and/or the lock is overridden by the user).
Regarding claim 8,
Sverdlik, as modified, teaches the elements of claim 7 as previously stated. Sverdlik, as modified, further teaches wherein at least one of the threshold range and the threshold pressure is determined based on the measured impedance (Examiner notes that based on the measured impedance is broadly recited and merely requires that the measured impedance exists in the procedure and furthermore, it is noted that the claim is directed towards a system and no system component is recited as performing any such determination. Thus it is noted that in the modified system the at least one of the range or pressure taught by Spooner is considered determined based on the measured impedance as the measured impedance is a part of the procedure of Sverdlik, therefore any determinations included in the procedure are considered to be based thereon in its broadest reasonable interpretation).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BROOKE L KLEIN whose telephone number is (571)270-5204. The examiner can normally be reached Mon-Fri 7:30-4.
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, Anne Kozak can be reached at 5712700552. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BROOKE LYN KLEIN/Primary Examiner, Art Unit 3797
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