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 .
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 6 and 14 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.
Claims 6 and 14 recite “a second rotary joint,” and claim 6 additionally recites “a second axis.” However, there is no first rotary joint or first axis claimed. So, one the one hand, only one actual joint and one actual axis is claimed, but on the other hand, the reference to them as a “second” axis and “second” joint implies the existence of a first of each of them. As such, it is unclear whether these claims require one or two joints and/or axes. This renders the scope of the claim unclear and indefinite.
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.
(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.
Claims 7-9, 12, and 14-16 are rejected under 35 U.S.C. 102(a)(2) as being clearly anticipated by US 2015/0360030 A1 to Cartledge et al. (hereinafter “Cartledge”).
Regarding Claim 7, Cartledge teaches an earphone assembly adapted for transcutaneous peripheral nerve stimulation, the earphone assembly comprising:
a listening unit (e.g. 4310 in FIG. 43) including a speaker configured to receive a sound signal and emit audio according to the sound signal (see e.g. Paras. 346, 351, 361, 364, 384);
a stimulator (see e.g. Para. 271: “Helix Cuff 1610, 2700, 2900, 3200, 3600”) removably coupled to the listening unit (see e.g. FIG. 43 and Para. 271) and including a probe unit having at least one electrode contact (see e.g. FIGS. 36-57 showing various configurations);
a body coupled to the probe unit, the body including an interface protrusion (4300 in FIG. 43) for receiving the listening unit (4310), wherein the interface protrusion extends from the body and is shaped to complementarity receive a portion of the listening unit to be removably coupled (see FIG. 43); and
wherein the stimulator is configured to apply, as audio is emitted from the speaker, an amplified electrical signal (see Para. 384) from an amplifier to transcutaneously electrically stimulate a peripheral nerve of a subject (see e.g. Paras. 346, 351, 361, 364, 384); and
wherein the amplified electrical signal is generated from the sound signal (see e.g. Paras. 346, 351, 361, 364, 384); and
wherein the interface protrusion is configured as a plurality of gripping arms configured to grip the listening unit (see 4300 interfacing with 4310 in FIG. 43 via gripping arms).
Regarding Claim 8, Cartledge teaches wherein the probe unit includes a probe arm having the at least one electrode contact at a distal end thereof, the probe arm including a bendable portion configured for adjustably positioning the at least one electrode contact (see e.g. Paras. 263, 269 along with FIGS. 27-41 and 44-45 teaching various aspects of bendability of the probe arm).
Regarding Claim 9, Cartledge teaches wherein the listening unit is an earbud configured to be received in an ear canal of a subject (see earbud 4310 in FIG. 43).
Regarding Claim 12, Cartledge teaches wherein the at least one electrode contact is a first electrode contact and a second electrode contact; and wherein the probe unit includes a probe arm branching into first and second prongs separated by a gap, wherein the first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm (see e.g. FIGS. 36-57 showing various configurations; see particularly FIGS. 44-45 showing first and second electrode contacts 4432 which each extend from respective prongs of a probe arm).
Regarding Claim 14, Cartledge teaches wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate (see e.g. FIGS. 36-57 showing various configurations; see particularly FIGS. 44-45 showing rotary joint formed from slots 4442 which allows prongs 4434 to rotate together).
Regarding Claim 15, Cartledge teaches a method for adapting earbuds for transcutaneous peripheral nerve stimulation (see e.g. Para. 271: “any standard set of earbuds can be used at the same time”), the method comprising::
providing a stimulator configured for removably coupling to an earbud (see e.g. FIG. 43 and Para. 271);
receiving a sound signal from a sound source (see e.g. Paras. 346, 351, 361, 364, 384);
amplifying the sound signal using an amplifier to generate an amplified electrical signal (see Para. 384);
emitting audio according to the sound signal using a speaker in the earbud (see e.g. Paras. 346, 351, 361, 364, 384); and
as audio is emitted from the earbud, transcutaneously electrically stimulating a peripheral nerve of a subject by applying the amplified electrical signal using the stimulator (see e.g. Paras. 346, 351, 361, 364, 384).
Regarding Claim 16, Cartledge further teaches wherein the stimulator includes a body having an interface protrusion (4300 in FIG. 43) extending therefrom, the interface protrusion configured for receiving the earbud (4310), wherein the interface protrusion is shaped to complementarity receive a portion of the earbud to be removably coupled (see 4300 interfacing with 4310 in FIG. 43), and wherein the interface protrusion includes a plurality of gripping arms configured to grip the earbud (see 4300 interfacing with 4310 in FIG. 43 via gripping arms).
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.
Claims 1-6, 10-11 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Cartledge in view of US 2013/0274848 A1 to Beck et al. (hereinafter “Beck”).
Regarding Claims 1 and 13, Cartledge teaches a transcutaneous peripheral nerve stimulation system comprising:
a stimulator (see e.g. Para. 271: “Helix Cuff 1610, 2700, 2900, 3200, 3600”) including an input configured to receive a stimulation signal based on a sound signal from a sound source (see e.g. Paras. 346, 351, 361, 364, 384) and a probe arm configured to be removably coupled to an earbud (see FIG. 43 and Para. 271);
at least one electrode contact located at a distal end of the probe arm, wherein, when the stimulator is coupled to the earbud and the earbud is engaged with a person to hear the sound signal through the earbud, the at least one electrode contact is arranged to engage the person to deliver the stimulation signal to transcutaneously stimulate a peripheral nerve (see e.g. FIGS. 36-57 showing various configurations);
a body (see e.g. FIG. 43)
an earbud interface (4300 in FIG. 43 and Para. 271) for receiving the earbud (4310), wherein the earbud interface includes a plurality of gripping arms configured to grip the earbud (see 4300 interfacing with 4310 in FIG. 43 via gripping arms).
Cartledge fails to specifically teach a body “having an opening for receiving the probe arm” and [from claim 13] “wherein the probe arm is slidably adjustable relative to the body.” However, another reference, Beck, teaches a similar device for transcutaneous nerve stimulation (see e.g. Para. 50: “a transcutaneous electrical nerve stimulation can be conducted concretely upon a surface area of the ear”) including a pair of electrodes (4, 5) which branch from a probe arm (8) which is received in an opening (9) of a body (3 and/or 7) in a slidingly adjustable manner (see e.g. Para. 52: “it is essentially that the holding element 3 is able to shift the holding bar 8 linearly into the direction of the longitudinal axis L by the linear guide 7” and Para. 57: “the holding bar 8 including the lateral extension 13 can move in longitudinal direction L in the linear guide 7”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Cartledge to provide a body having an opening for receiving the probe arm such that the probe arm is slidably adjustable relative to the body, as seen in Beck, because this would advantageously allow a further degree of adjustability of the position of the electrodes, thereby allowing for a greater variety of user ear shapes and sizes to be accommodated and treated properly.
Regarding Claim 2, Cartledge teaches wherein the earbud interface (4300) extends from the body and is sized to complementarity receive and grip the earbud (4310; see FIG. 43).
Regarding Claim 3, Cartledge teaches various adjustment mechanisms for adjusting grip tightness (see e.g. the mechanisms in FIGS. 32-35, 40-41, 44-47 and Para. 283). Although these are not specifically disclosed for the interface grips in FIG. 43, one skilled in the art would have understood how to provide adjustable tightness for the grip of the earbud, as providing such adjustability would be a trivial engineering matter. Adjustability in general is not a patentable advance where needed. See MPEP § 2144.04(V)(D). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Cartledge to have the body include an adjusting mechanism for adjusting how tightly the earbud interface grips the earbud because it would predictably and advantageously provide increased adjustability and versatility for attachment to a wider range of earbud sizes and shapes.
Regarding Claim 5, wherein the at least one electrode contact is a first electrode contact and a second electrode contact; and wherein the probe arm branches into first and second prongs at a distal end thereof, wherein the first and second electrode contacts extend from the first and second prongs, respectively, of the probe arm (see e.g. FIGS. 36-57 showing various configurations; see particularly FIGS. 44-45 showing first and second electrode contacts 4432 which each extend from respective prongs of a probe arm).
Regarding Claim 6, Cartledge teaches wherein the probe arm is slidably adjustable relative to the body at the opening (see rejection of claim 1 above); and wherein the first and second prongs are coupled to the probe arm at a second rotary joint such that the first and second prongs together rotate about a second axis. (see e.g. FIGS. 36-57 showing various configurations; see particularly FIGS. 44-45 showing rotary joint formed from slots 4442 which allows prongs 4434 to rotate together).
Regarding Claims 4 and 11, Beck teaches the use of elastomer materials for various parts of the device including pieces of the electrode arrangement, particularly since such a material would be known to be soft and biocompatible and is thus appropriate for this application (see e.g. Paras. 28 and 32 of Beck). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Cartledge to form the holding arms from an elastomeric material since one skilled in the art would recognize it as among the known suitable material choices for such an application, with such a selection yielding nothing more than predictable results since the behavior of elastomeric materials in such devices is well understood and predictable.
Regarding Claim 10, Cartledge fails to specify the rigidity of the interface protrusion. However, Cartledge generally envisions various rigid materials for use with the helix cuff, and also teaches that rigidity and flexibility are both possible alternatives (see e.g. Paras. 265, 269). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Cartledge to make the interface protrusion rigid because doing so would yield well know and predictable outcomes, specifically yielding predictable pros and cons compared to selecting a flexible material, and furthermore because experimenting with materials having various degree of rigidity and flexibility is a routine type of design experimentation that one skilled in the art would find obvious to perform.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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