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 § 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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 12 is rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claims recite part of the human body in combination with the device, e.g. (Claim 12, states “comprising the subject’s saliva”). It has been held that a claim directed to or including within its scope, a human being will not be considered to be patentable subject matter under 35 U.S.C. 101. The grant of limited, but exclusive property right in a human being is prohibited by the constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970). For examination purposes, all claims will be considered as if such limitations involving the combination with a human were not present.
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 5 and 7 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 5, line 5 states “element; optionally wherein” the term “optionally” renders the claim indefinite since the metes and bound cannot be determined it is unclear if the device further comprises bristles or a fluid-delivering nozzle.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation less than or equal to 90%, and the claim also recites preferably less than or equal to 50% which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipate by Kim (US 2021/0307500).
Kim a personal oral care device (100) for at-home use by a subject-in their own home, the oral care device comprising a control arrangement (400) configured to provide an electrical signal; and a pair of electrodes (121,122) for contacting an aqueous solution, the pair of electrodes being connected to the control arrangement, the electrical signal and the pair of electrodes being configured such that at least one of the electrodes (Fig. 3, 10; paragraph 119), responsive to said electrical signal, generates hydrogen ions from water in the aqueous solution to deliver within a subject's oral cavity (paragraph 54 and 119), a variation of the electrical signal controlling said generation of hydrogen ions, wherein the electrical signal is a pulsed electrical signal (Fig. 10).
Regarding claim 2, the variation of the electrical signal limits a rate of change of generation of the hydrogen ions and/or promotes hydrogen ion neutralization (i.e. a variation of current will result in a rate of change; paragraph 17).
Regarding claim 3, comprising an actuator (340) configured to move in accordance with the electrical signal (paragraph 104; vibration motor).
Regarding claim 4, wherein the control arrangement (400) is configured to generate an actuator control signal to control the movement of the actuator (340), the actuator control signal being in phase with the electrical signal, or a phase difference being defined between the actuator control signal and the electrical signal (same circuit controls the motor and electrodes).
Regarding claim 5, comprising at least one cleaning element (112; bristles) for mechanically or fluidically cleaning inside the subject's oral cavity, said at least one cleaning element being arranged such that said movement of the actuator respectively causes movement of or fluid delivery from the at least one cleaning element; optionally wherein the at least one cleaning element comprises bristles or a fluid-delivering nozzle for cleaning surfaces inside the subject's oral cavity (paragraph 47).
Regarding claim 6, wherein said electrical signal comprises a periodic variation in at least one of amplitude, polarity and frequency (paragraph 128-132).
Regarding claim 7, wherein a duty cycle of the pulsed electrical signal is less than or equal to 90% (Fig. 11A; paragraphs 128-132)
Regarding claim 8, wherein the electrical signal comprises a bidirectional waveform supplied to the electrodes (Fig. 11A; bidirectional waveform).
Regarding claim 9, wherein a positive peak amplitude of the bidirectional waveform is different from a negative peak amplitude of the bidirectional waveform (Fig. 11C; paragraph 131-133).
Regarding claim 10, wherein one of the positive and negative peak amplitudes is at least 1.1 times the other of the positive and negative peak amplitudes (Fig. 11C paragraph 131-133).
Regarding claim 11, wherein the control arrangement (400) is configured to provide the electrical signal to the pair of electrodes (121,122) for a predetermined time period before terminating the provision of the electrical signal to the pair of electrodes (121, 122).
Regarding claim 12, wherein the pair of electrodes (121,122) are insertable into the subject's oral cavity, said aqueous solution comprising the subject's saliva and/or one or more oral care agents (i.e. used in user’s mouth).
Regarding claim 13, comprising a cleaning unit (bristles) for inserting into the subject's oral cavity, said cleaning unit having a recess in which one or both of the pair of electrodes (121,122) is or are mounted.
Regarding claim 14, wherein the pair of electrodes (121, 122) are arranged with one of the electrodes defining an outer electrode which at least partially surrounds the other of the electrodes that defines an inner electrode and/or wherein the pair of electrodes are interdigitated (Fig. 12B).
Regarding claim 15, wherein the personal oral care device is a toothbrush, a mouthpiece or an irrigator (Fig. 1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RACHEL RUNNING STEITZ whose telephone number is (571)272-1917. The examiner can normally be reached Monday-Friday 8:00am-4:30pm EST.
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/RACHEL R STEITZ/Primary Examiner, Art Unit 3772
8/31/2026
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