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 filed May 21, 2024 has been entered and the references cited therein have been considered by the examiner.
Drawings
Figures 1A, 1B and 2 should be designated by a legend such as --Prior Art-- because only that which is old is illustrated. See MPEP § 608.02(g). Corrected drawings in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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 § 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.
In claim 1, the phrase “the short-wave diathermy driver” lacks proper antecedent basis in claim 1. In claim 4, the phrase “wherein the diathermy driver operates is capable” is vague and indefinite.
As claims 2, 3 and 5-10 depend from claim 1 they are likewise rejected.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 2 recites “a short-wave diathermy driver” that is already recited in independent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 5, 9, 11-13 and 16 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Dimino et al. (U.S. Patent Application Publication No. 2020/0094068).
In regard to claims 1, 2, 11, Dimino et al. teach a therapeutic device that delivers a pulsed radio frequency (PRF) signal for deep tissue healing (see para. 0022). Dimino et al. specifically reference a PRF derived from both a continuous and a pulsed a 27.12 MHz sine wave, which is a known frequency used for diathermy (see paras. 0022 and 0024). Dimino et al. teach a miniature control circuit 300 (diathermy driver) that produces waveforms that drive a generating device such as coupling device 400 (see para. 0335). The miniature control circuit 300 has a switching power supply 302 that controls voltage to a micro-controller 303 and to storage capacitors 304 (see para. 0335). The micro-controller 303 also controls a pulse shaper 305 and a pulse phase timing control 306 that determine pulse shape, burst width, burst envelope shape and burst repetition rate (see para. 0335). Thus, Dimino et al. provide the structure such that the control circuit 300 can act as a short-wave diathermy driver. Dimino et al. also teach a coupling device 400 that is an electric coil 401 wound with multistrand flexible magnetic wire 402 (see Figs. 4A and 4B and para. 0336). The coil 401 (diathermy array) comprises about 10 to about 50 turns (loops) of about 0.01 mm to 0.1 mm diameter multistrand wire (see Figs. 4A and 4B and para. 0336). In regard to claim 5, Figures 4A and 4B show that the wire 402 as well as the coil 401 are circular in shape. In regard to claims 9 and 16 Dimino et al teach that the coupling device is incorporated into a positioning device (see para. 0338) that can be an inflatable, fluid, visco-elastic or air fluidized bed, cushion or mattress (see paras. 0073-0076). See also paras. 0370-0372. With further respect to claims 11 and 16 and in regard to claims 12 and 13, see, e.g., para. 0374 describing a method of use which includes placing the device on the patient in a manner to initiate the therapy.
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.
Claim(s) 3, 4, 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dimino et al. (U.S. Patent Application Publication No. 2020/0094068) in view of Encore Medical Catalog, Chattanooga Intelect SWD 100, 2009 (hereinafter “Encore Catalog”).
In regard to claims 3, 4, 14 and 15, as noted above, Dimino et al. specifically reference a PRF derived from both a continuous and a pulsed a 27.12 MHz sine wave, which is a known frequency used for diathermy (see paras. 0022 and 0024). However, Dimino et al. are silent as to the pulse width, pulse frequency, peak power and maximum average power used. Encore Catalog teaches the Intelect SWD 100 system which lists technical specifications of output frequency of 27.12 MHz, pulse width of 20-400 µsec, pulse rate or frequency of 10-800 Hz and peak power of 200 W. A maximum average power is not listed but if peak power is 200 W, the device is capable of average power of 64 W. It is also noted that in the specification of the instant application, at para. 0017, applicant states that the Intelect SWD 100 has the exact specification as recited in claims 3, 4, 14 and 15. Since Dimino et al. teach using the therapeutic device with the parameters required for diathermy, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to operate the device of Dimino et al. within the technical parameters disclosed by Encore Catalog in order to properly equip the device for use in diathermy and to thereby achieve an effective therapeutic result.
Claim(s) 6, 7, 10 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dimino et al. (U.S. Patent Application Publication No. 2020/0094068) in view of Wong et al. (U.S. Patent Application Publication No. 2023/0158319).
In regard to claims 6 and 7, Dimino et al. are silent as to either the wire 402 as well as the coil 401 being polygonal or square in shape. However, Wong et al. teach a similar apparatus 10 to deliver energy to tissues in a patient comprised of a coil 20 driver by a power source 25 to generate electromagnetic fields (see Fig. 1 and para. 0100). The coil 20 has a number of windings 20A that may have cross sections that are round, elliptical or others (see para. 0106). Wong et al. thus teach that different shapes for the windings of a coil for generating electromagnetic fields to deliver energy to a patient are well known in the art. Furthermore, it is well settled that a change in shape of a prior art device is a design consideration within the skill of the art. See In reDailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to make the coil 401 or wire 402 of Dimino et al. in either a square or polygonal shape, in the manner disclosed by Wong et al., as an obvious matter of design choice. In regard to claim 10, Dimino et al. are silent as to a temperature sensor monitor. However, Wong et al. teach a temperature monitor 23 that monitors temperatures at one or more points 23A (see para. 0102) to apply feedback control to the power source (see para. 0029). It would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to equip the device of Dimino et al. with the temperature monitor 23 disclosed by Wong et al. in order to provide feedback control to the control circuit 300. In regard to claim 18, Dimino et al. are silent as to electromagnetic shielding. However, Wong et al. teach providing shielding to shield certain parts of the patient from RF radiation (see paras. 0168-0169). Wong et al. thus demonstrate that it was well known in the art to provide electromagnetic shielding to shield certain parts of the patient from RF radiation. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Dimino et al. with the shielding disclosed by Wong et al. in order to shield certain parts of the patient from RF radiation.
Claim(s) 8 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dimino et al. (U.S. Patent Application Publication No. 2020/0094068) in view of Chornenky et al. (PCT Publication No. WO 2012/033932).
In regard to claims 8 and 17, Dimino et al. are silent as to adjacent sections of the coil turns 401 having current flowing in opposite directions. However, Chornenky et al. teach a therapeutic device with coils 1401, 1402 that have opposite windings resulting in the opposite flow of current (see page 34, lines 11-28 and Figure 14). Chornenky et al. thus demonstrate that using opposite windings of coils in a therapeutic device is well known in the art to provide for consistent current flow. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to place the windings of the coil 401 of Dimino et al. in opposite directions in order to provide for consistent current flow.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794