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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-12, and 20 in the reply filed on 03/20/2026 is acknowledged.
Thus, claims 1-12, and 20 are presenting pending in this application.
Claim Objections
Claims 1-12, and 20 are objected to because of the following informalities:
Claim 1 recites, “at a selected frequency and amplitude” in ln 13 which Examiner suggest amending to read --at a selected frequency and a selected amplitude-- for consistency with claims 4-5.
Claims 2-12 and 20 are objected by virtue of dependency to claim 1
Claim 3 recites, “a respective one” in ln 3 which Examiner suggest amending to read --the respective one-- as it is introduced in ln 2.
Claim 5 recites, “the support” in ln 1 which Examiner suggest amending to read --the at least one support-- for consistency with claim 1.
Claims 10-11 recites, “comprising” in ln 1 which Examiner suggest amending to read --the actuator further comprising-- for clarity as the actuator of claim 1 is further defined via claim 9.
Claim 12 recites, “each of three actuators” in ln 2-3 which Examiner suggest amending to read --each of the three actuators-- for consistency with claim 1 and clarity as the actuator is provided for each vibration unit serving the mandible areas and sternum area and avoid confusion with “three actuators” which seems to be newly introduced vs the actuator of vibration units.
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.
Claim 20 is 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 20 recites, “Use of the system of claim 1” which renders claim indefinite. It is unclear whether the use of the system would fall under the method or the process of using the system. Further, claim renders the scope of the claim unclear since the claim does not set forth any steps. Thus, the claim is indefinite where it merely recites a use without any active, positive steps delimiting how this use is actually practiced or setting forth any steps involved in the process. See MPEP 2173.05(q).
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.
Claim 20 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim does not fall within at least one of the four categories of patent eligible subject matter because "Use" claims that do not purport to claim a process, machine, manufacture, or composition of matter. See MPEP 2173.05(q)
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 1-2, and 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Ehrenreich et al. (US 20150305974 A1).
Regarding claim 1, Ehrenreich et al. discloses, a system for mitigating temporomandibular joint disorders (therapy devices 100 of Fig 1 which Examiner notes that the devices are capable of mitigating temporomandibular joint disorder via vibration energy as described in ¶111), comprising:
at least one support adapted to be worn by a wearer (the support are worn as shown in Fig 12, “some embodiments in combination with a CPAP mask assemble” and Fig 19H, “the housing configured to be embodied as multiple pieces”);
an array of vibration units mounted to the at least one support and spaced apart from each other (¶0196, implies that each therapy device has a driver assembly which is a mechanical vibratory device), each of the vibration units including an actuator (¶0196 and 0205, a vibrating mechanism of the driver assembly) and a vibrating pad (¶0197, the engaging portion of the driver assembly) in driving engagement with the actuator (¶0197 and ¶0199-0205),
the vibration units including a right mandible-engaging unit, a left mandible-engaging unit (200 as shown in Fig 12; ¶0207, “the system may comprise at least two therapy providing devices…”; ¶0213, “…configured to be received or engage or is integrated into the headgear arrangement…. engage the patient's jawbone or skull”), and the right mandible-engaging unit including a right mandible- engaging vibrating pad for engaging a right side of a mandible of the wearer, the left mandible- engaging unit including a left mandible-engaging vibrating pad for engaging a left side of the mandible of the wearer (200 of Fig 12; ¶0141,0207,0213,0411)
a controller (a computing device 300, Figs 21A and 21B) in communication with the actuators of each of the vibration units (¶0369, “The computing device 300 includes a processor, memory, energy source (such as a battery), and a display 310. The computing device may be a custom manufactured device for use with the therapy device 200 as described above”), the controller configured to activate one or more of the actuators (¶0371-0398, implies that the computing device controls the driver assembly via the software/program in terms of vibration, frequency, amplitude in form of vibration or waveform therapy/acoustic vibration) in order to induce vibration of the vibrating pad of the respective vibration unit at a selected frequency (¶0385, “the driver assembly to vibrate at a frequency or sweep through a range of frequencies between about 40 Hz and 150 Hz” and a selected amplitude (¶0394, “the amplitude of the signal can be adjusted to adjust the sound pressure generated by the driver assembly 220”; ¶0396, “measurement of a sound pressure level is related to the displacement of a portion of the driver 220. The portion of the driver 220 may be displaced between: 0 mm and 20 mm… 0.05 mm to 0.005mm”).
While Ehrenreich et al. discloses, a single therapy providing device may be disposed on the sternum to provide therapy or two therapy providing devices maybe disposed on the sternum in order to provide the therapy (¶0401), Ehrenreich et al. does not specifically discloses a sternum-engaging unit and the sternum-engaging unit including a sternum-engaging vibrating pad for engaging a sternum of the wearer while vibration units comprising the right mandible-engaging unit, and the left mandible-engaging unit.
However, Ehrenreich et al. teaches that the one of the ordinary skills in the art would have make and use the disclosure, describes several embodiments, adaptations, variations, alternatives, and uses of the disclosure (¶0137) and the therapy device can be placed at other locations on the user such as the sternum, jaw, and other areas in order to lower blood pressure (¶0411). Thus, the different combination of the therapy devices is a result effective variable for the purpose of lowering the blood pressure.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Ehrenreich et al. to include a sternum-engaging unit and the sternum-engaging unit including a sternum-engaging vibrating pad for engaging a sternum of the wearer as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). See MPEP 2144.05.II.A.
Regarding claim 2, Ehrenreich et al. discloses the system of claim 1 as discussed above.
Ehrenreich et al. further discloses, wherein the actuators of each of the vibration units is an acoustic actuator (¶0411, “When activated, the driver assembly 220 of the therapy providing device 200 generates a frequency in the form of a sound wave… transmitted in the form of vibration”; ¶0432, “utilization of the devices in accordance with the methods…utilizes acoustic vibration of specific frequencies applied at specific time intervals”).
Regarding claim 4, Ehrenreich et al. discloses the system of claim 1 as discussed above.
Ehrenreich et al. further discloses, wherein the selected frequency of the vibrations ranges from 100 Hz to 300 Hz (¶0394).
Regarding claim 5, Ehrenreich et al. discloses the system of claim 1 as discussed above.
Ehrenreich et al. further discloses, wherein the selected amplitude of the vibrations ranges from 1 mm to 5 mm (¶0394; ¶0396).
Allowable Subject Matter
Claims 3 and 6-12 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding the subject matters of claims 3, 6, and 9, no other prior arts have been found that teach or suggest all the claimed features such as wherein the acoustic actuator includes a housing, an acoustic vibrator engaged to a respective one of the pads, the acoustic vibrator mounted within the housing, actuation of the acoustic vibrator induces a reciprocating motion of a respective one of the pads; wherein the support is a harness, the left mandible-engaging unit, the right mandible-engaging unit, and the sternum-engaging unit are secured to the harness; and wherein the actuator includes: a housing; an electric motor mounted within the housing; a cam drivingly engaged by the electric motor; and a cam follower engaged by the cam; wherein actuation of the electric motor induces rotation of the cam about a cam axis and a reciprocating motion of the cam follower about a follower axis while the vibrating units comprises the left mandible-engaging unit, the right mandible-engaging unit, and the sternum-engaging unit as recited in claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAEICK JANG whose telephone number is (703)756-4569. The examiner can normally be reached M-F 8:30 - 4:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kendra D Carter can be reached at (571) 272-9034. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.J./Examiner, Art Unit 3785
/JOSEPH D. BOECKER/Primary Examiner, Art Unit 3785