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
Claims 1-13 have priority to their filing date: 06/30/21 since the parent applications fail to have support for the independent claim, including:
an earpiece comprising a speaker, an ear canal microphone, an ambient sound microphone, a stent configured to receive an eartip, and a memory and processor being part of the earpiece.
Claim Objections
Claims 1-3 are objected to because of the following informalities:
Claims 1-2 are objected to for claiming the “first element contracts or expands bending the stent”, but it appears there is both punctuation and a word missing between “expand” and “bending”.
Claim 3 is objected to for referring to “the distance” and “a stent” with improper antecedent basis.
Appropriate correction is required.
Drawings
The drawings are objected to because item “1750” is used in the figures but not mentioned in the specification. “1740” is used to represent both the second microphone and the third microphone.
Item 13 is used to designate the tubular structure, accommodating structure, structure, and accommodating conduit.
Item 15 is used to designate both “bend” and “curvature profile”
Item 17 is used to designate both tubular structure and accommodating conduit
item 14 is used to designate both device and accommodating structure
Item 23 is used to designate both accommodating structure and external auditory canal.
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.
Specification
The disclosure is objected to because of the following informalities: Paragraph [0036] refers to “an Analysis & Data Storage” but it isn’t clear why this is capitalized.
The specification refers to “Electro activated polymer” but this is grammatically incorrect, as it is believed this should read “electroactive polymers”.
Appropriate correction is required.
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 1-13 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 pre-AIA the applicant regards as the invention.
Claim 1 is indefinite for claiming “a stent configured to accept an eartip”, when it is unclear whether or not the “eartip” is intended to be positively claimed. It appears from claim 1 that it is not positively claimed, but since claim 11 further refers to the eartip, it appears this may have been the intention.
Remaining claims are indefinite for depending on an indefinite claim.
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 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 1-7 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Usher et al. (US 20190278556 A1) hereinafter known as Usher in view of Couvillion (US 20030236445 A1).
Regarding claim 1 Usher discloses an earpiece ([0037]) comprising;
a speaker ([0037], [0032]),
an ear canal microphone ([0037]),
an ambient sound microphone ([0037]),
a stent ([0046]) configured to accept an eartip (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Usher discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus of “accepting an eartip. See, for example Figure 9),
but is silent with regards to the stent including two contraction/expansion elements embedded therein, and a memory and processor that signal the first element to contract/expand to bend the stent.
However, regarding claim 1 Couvillion teaches that medical devices can include a contraction/expansion first element and a contraction/expansion second element (Figure 1 item 12 (Fig 6a-e items 610, 612) indicate the presence of at least one electroactive polymer (EAP) in the active member within each actuator; and also indicate there can be many actuators) which are embedded in the device (Figures 6a-e; [0057]-[0058] the actuators are embedded within the device),
and a memory that stores instructions ([0008]), with a processor ([0014]) that executes the instructions to send a signal to the first element so that the first element contracts or expands bending the device (Abstract; [0036], [0038]). Usher and Couvillion are involved in the same field of endeavor, namely medical devices which traverse tortuous lumens. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the earpiece of Usher so that it’s stent includes contraction/expansion elements which enable the stent to bend such as is taught by Couvillion in order to provide the stent a way to traverse tortuous lumens into which it is implanted, such as an ear canal.
Regarding claim 2 the Usher Couvillion Combination teaches the earpiece of claim 1 substantially as is claimed,
wherein Usher further teaches the instructions include sending a signal to the second element so it contracts or expands bending the device [stent] ([0008]; Abstract).
Regarding claim 3 the Usher Couvillion Combination teaches the earpiece of claim 2 substantially as is claimed,
wherein Couvillion further teaches a sensor coupled to the [device] ([0083]), wherein the sensor is configured to determine a distance of the stent from a wall of a tubular structure when inserted therein (this is stated as a functional limitation of the sensor (see the explanation above). See also [0082]-[0087]).
Regarding claim 4 the Usher Couvillion Combination teaches the earpiece of claim 3 substantially as is claimed,
wherein Usher further discloses the tubular structure is an ear canal of a user (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2111.02 (II). In this case, the patented structure of Usher was considered capable of performing the cited intended use. See, for example Figure 11 which shows the stent within the ear canal).
Regarding claim 5 the Usher Couvillion Combination teaches the earpiece of claim 4 substantially as is claimed,
wherein Usher further discloses the instructions include receiving a microphone signal ([0078]).
Regarding claim 6 the Usher Couvillion Combination teaches the earpiece of claim 5 substantially as is claimed,
wherein Usher further discloses the instructions include sending an audio signal to the speaker ([0082]).
Regarding claim 7 the Usher Couvillion Combination teaches the earpiece of claim 6 substantially as is claimed,
wherein Usher further teaches their earphones can include a second ambient sound microphone ([0103]). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the earphone of the Usher Couvillion Combination to include a second ASM as is taught by Usher since it has been held that mere duplication of essential working parts of a device involves only routine skill in the art. See MPEP 2144.04(VI)(B).
Regarding claim 11 the Usher Couvillion Combination teaches the earpiece of claim 7 substantially as is claimed,
wherein Usher further discloses the eartip is capable of sealing the ear canal when the earpiece is inserted into the ear canal (this is stated as a functional limitation of the eartip, which is also not positively claimed. (However, see also [0047]).).
Claims 8-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Usher and Couvillion as is applied above, further in view of Applicant’s Admitted Prior Art ("Artificial Muscles from Fishing Line and Sewing Thread", Carter S. Haines et al., Science 343, 868 (2014)), hereinafter known as AAPA.
Regarding claim 8 the Usher Couvillion Combination teaches the earpiece of claim 7 substantially as is claimed,
wherein Couvillion further teaches the first element is composed of polymer ([0034]),
but is silent with regards to the polymer being twisted and the expansion/contraction being controlled by heating.
However, regarding claim 8 AAPA teaches expanding/contracting elements which can be twisted polymer which is controlled by heating (page 869 column 1; twisted/coiled fibers; page 870 column 2 electrothermically driven muscles with an electrical heating element). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the expansion/contraction element material as is taught by AAPA it has been held by the courts that selection of a prior art material on the basis of its suitability for its intended purpose is within the level of ordinary skill. See MPEP 2144.07. Further, the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). The Examiner understands any actuatable material obvious to try.
Regarding claim 9 the Usher Couvillion Combination teaches the earpiece of claim 8 substantially as is claimed,
wherein AAPA further teaches the twisted first element is further composed of conductive thread (page 870 column 2 electrical heating element with metal-coated sewing thread).
Regarding claim 10 the Usher Couvillion Combination teaches the earpiece of claim 9 substantially as is claimed,
wherein Couvillion further teaches the first element’s expansion and contraction are controlled by the processor sending current through the [actuator] ([0036], [0038]).
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Usher and Couvillion as is applied above, further in view of Miller et al. (US 20230071306 A1) hereinafter known as Miller.
Regarding claim 12 the Usher Couvillion Combination teaches the earpiece of claim 7 substantially as is claimed,
but is silent with regards to the sensor being an infrared sensor.
However, regarding claim 13 Miller teaches that position tracking sensors can be infrared ([0106]). Usher and Miller are involved in the same field of endeavor, namely medical devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the type of sensor used in the Usher Couvillion Combination so it is an infrared sensor as is taught by Miller since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Claim 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Usher and Couvillion as is applied above, further in view of Lloyd (US 5938602 A).
Regarding claim 13 the Usher Couvillion Combination teaches the earpiece of claim 7 substantially as is claimed,
but is silent with regards to the sensor being an acoustic sensor.
However, regarding claim 13 Lloyd teaches that position tracking sensors can be acoustic (Column 3 lines 57-58, Column 4 lines 13-15). Usher and Lloyd are involved in the same field of endeavor, namely implantable medical devices. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the type of sensor used in the Usher Couvillion Combination so it is an acoustic sensor as is taught by Lloyd since the courts have held that the simple substitution of one known element for another to obtain predictable results in a prima facie case of obviousness. See MPEP 2143 (I)(B).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 04/04/25