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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 8-10 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the memory as recited in claim 8 is not set forth as being non-transitory.
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 1-10 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 1, and all dependent claims thereof, recites the limitation “obtaining a period length of a second preset pulse, and dividing the first pulse train into N of the second pulse trains according to the period length of the second preset pulse,” where “the second pulse trains” lacks antecedent basis in the claims and it is unclear what element this might be referring to.
Claim 4 recites the limitation “wherein a number of pulse widths of the N of the second preset trains is identical with a number of pulse widths within a first pulse train period.” The meaning of this limitation is unclear. It is not clear what “a number of pulse widths” is referring to (e.g. is “a number of pulse widths” the same as a number of pulses, or does “a number of pulse width” refer to the value of the pulse widths?). It is further unclear what “a number of pulse widths within a first pulse train period” refers to since it seems to be distinct from “a number of pulse widths of the N of the second preset trains,” where “second preset trains” lacks antecedent basis in the claims and it is not clear what element this might be referring to. For the purposes of further examination this claim will be interpreted to mean that the pulses comprising the second pulse trains have an equal or fixed pulse width.
Claims 7 and 9, and all dependent claims thereof, recite the limitations “controlling a treatment tip to vibrate slightly along a direction parallel with a skin surface” and “control the treatment tip to vibrate slightly along a direction parallel with a skin surface” (respectively). The term “slightly” in claims 7 and 9 is a relative term which renders the claim indefinite. The term “slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich (US 20160001096 A1, Jan. 7, 2016) (hereinafter “Mishelevich”).
Regarding claim 1: Mishelevich discloses a modulation method for ultrasonic output pulses, comprising: obtaining an output frequency of a first preset pulse, and modulating a to-be-modulated pulse according to the output frequency of the first preset pulse to obtain a first pulse train ([0118] - base ultrasound carrier and superimposed pulse trains; fig. 38, [0583]; “first pulse train” comprises bursts 3810, 3820, 3830 superimposed on baseline carrier 3800); where the pulses (3840) represent a second set of pulse trains and “any pulse train pattern can be contained within a burst” ([0583]).
Mishelevich further discloses multiple pulse train patterns such as fixed, Fibonacci, and random that, if included within the first set of pulse trains, would require dividing the first pulse train according to the period length of the second pulse trains (claims 1-6, [0579]-[0581], see e.g. fig. 38 where pulses 3840 represent a second pulse train pattern that can be any pulse train pattern). It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the burst-mode pattern of Mishelevich (comprising first pulse trains 3810, 3820, and 3830 and second pulse trains comprising pulses 3840) using any of the disclosed pulse train patterns including fixed, random, or Fibonacci in view of the explicit suggestion of Mishelevich that the second pulse trains can be any pulse train pattern and because it has been held that combining two embodiments disclosed adjacent to each other in a prior art patent does not require a leap of inventiveness and involves only routine skill in the art, Boston Scientific v. Cordis Fed. Cir. 2009.
Further regarding claim 1: Mishelevich discloses controlling a transducer to sequentially output the N of the second pulse trains ([0605]).
Regarding claim 2: Mishelevich discloses the modulation method for ultrasonic output pulses according to claim 1, wherein the obtaining the period length of the second preset pulse, and dividing the first pulse train into N of the second pulse trains according to the period length of the second preset pulse further comprises: obtaining a pulse width of a period of the second preset pulse and an Off time of the period of the second preset pulse ([0154]-[0156], [0158] [0579]-[0581], [0583] - each of these pulse train patterns has a known pulse width and either a known or calculated inter-pulse interval or “Off time of the period”); and determining the period length of the second preset pulse according to the pulse width of the period of the second preset pulse and the Off time of the period of the second preset pulse ([0154]-[0156], [0158] [0579]-[0581], [0583] - each of these pulse train patterns has a known pulse width and either a known or calculated inter-pulse interval or “Off time of the period” where the period length is simply the combination of the pulse width and the inter-pulse interval which is either known or calculated).
Regarding claim 3: Mishelevich discloses the modulation method for ultrasonic output pulses according to claim 2, wherein the pulse width of the period of the second preset pulse is 0.2ms ([0580]-[0581], 0.2 ms). This is less than a constant time for human pain perception as defined at paragraph [0053] of the instant disclosure.
Regarding claim 4, as best understood based on limitations which are indefinite: Mishelevich discloses he modulation method for ultrasonic output pulses according to claim 2, wherein a number of pulse widths of the N of the second preset trains is identical with a number of pulse widths within a first pulse train period (the pulse width disclosed for the pulse trains of claim 2 are all the same at 0.2 ms - [0156], [0580]-[0581], [0583]).
Regarding claim 5: Mishelevich discloses the modulation method for ultrasonic output pulses according to claim 1, further comprising: adjusting a duty ratio (duty cycle) of each of the pulse trains and/or a voltage amplitude of each of the pulse trains to control an output power of each of the pulse trains ([0163]-[0164], [0166], [0588]-[0589]).
Regarding claim 6: Mishelevich discloses the modulation method for ultrasonic output pulses according to claim 5, wherein the adjusting the duty ratio (duty cycle) of each of the pulse trains further comprises: adjusting the pulse width and/or an Off time of each of the pulse trains to control the duty ratio (duty cycle) of each of the pulse trains ([0163]-[0164], [0166], [0588]-[0589]).
Regarding claim 7: Mishelevich discloses the modulation method for ultrasonic output pulses according to claim 1, wherein the controlling the transducer to sequentially output the N of the second pulse trains further comprises: controlling a treatment tip to vibrate slightly along a direction parallel with a skin surface while controlling the transducer to sequentially output the N of the second pulse trains ([0547]-[0548]).
Regarding claim 8: Mishelevich discloses a controller, comprising a memory and a processor, wherein the memory stores a control program for ultrasonic output pulses, and the modulation method for ultrasonic output pulses according to claim 1 is implemented when the control program for ultrasonic output pulses is executed by the processor ([0637]-[0640]).
Regarding claim 9: Mishelevich discloses an ultrasonic treatment apparatus, comprising: a treatment tip provided with a transducer inside (fig. 57, [0636]); an ultrasonic generating unit for modulating ultrasonic pulses outputted by the transducer (fig. 57, [0637]-[0638]); wherein the controller is further configured to control the treatment tip to vibrate slightly along a direction parallel with a skin surface, and control the transducer to output the pulse trains ([0522]-[0524], [0547]-[0548], [0641]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mishelevich as applied to claim 9 above, and further in view of Johnson et al. (US 2005/0143638 A1, Jun. 30, 2005) (hereinafter “Johnson”).
Regarding claim 10: Mishelevich discloses the ultrasonic treatment apparatus according to claim 9, further comprising: an ultrasonic handpiece, wherein the treatment tip is provided at the ultrasonic handpiece (ultrasound transducer - [0067], [0077], [0079], [0082], [0518]; while Mishelevich does not use the word “handpiece”, there is no structural difference provided in the claim between an “ultrasonic handpiece” and the ultrasound transducer of Mishelevich); the ultrasonic handpiece comprises a point-type handpiece and a linear-type handpiece ([0085]-[0086] - cup-shaped and elongated); the linear-type handpiece is configured to apply multiple focuses of the ultrasonic energy in line at one shot (figs. 17A-B, [0534]), and the point-type handpiece is configured to apply one focus of the ultrasonic energy at one shot (fig. 8, [0491], [0520]), where the ultrasound transducer(s) (“ultrasonic handpiece”) are capable of moving along the skin surface of the treatment area ([0067] - “Ultrasound transducers are positioned by spinning them around the head on a track”, [0082] - “Ultrasound transducers are positioned by spinning them around the head on a track”; [0518]). However Mishelevich is silent on the transducers being capable of discretely moving at a preset interval along a skin surface of the treatment area and being capable of continuously sliding and overlapping for a preset time along the skin surface of the treatment area.
Johnson, in the analogous art of ultrasound imaging, discloses ultrasound transducers mounted to rotate about a target body part in continuous motion or discrete, stepwise motion along the skin surface of the target area ([0046]).
It would have been prima facie obvious for one having ordinary skill in the art prior to the effective filing date of the claimed invention to implement the motion of the ultrasound transducer(s) of Mishelevich as either continuous or discrete as disclosed by Johnson in order to cover the entire desired target area and because a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product [was] not of innovation but of ordinary skill and common sense (KSR, 550 U.S. at 421, 82 USPQ2d at 139).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Barthe et al. (US 2016/0296769 A1, Oct. 13, 2016) discloses a treatment probe that generates pulse trains and is capable of being moved continuously or discretely to apply treatment.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN A PEHLKE whose telephone number is (571)270-3484. The examiner can normally be reached 9:00am - 5:00pm (Central Time), Monday - Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chris Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CAROLYN A PEHLKE/Primary Examiner, Art Unit 3799
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