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 sub-species 1A, Figures 9 and 11 in the reply filed on 07/16/2026 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2025 in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
In re claim 1, the limitation “and being transmitting the current to the individual”, should read “and transmitting the current to the individual".
In re claim 12, the limitation “a method for applying to the electrical stimulation generating device for improving sleep disorders as claim 1” should read “a method for applying the electrical stimulation generating device for improving sleep disorders as in claim 1”.
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 1-12 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 re claim 1, the limitations “gradually increasing frequency group” and “a gradually decreasing frequency group” are unclear. The term “gradually” is a relative term which renders the claim indefinite. The term “gradually” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
In re claim 1, it is unclear as to whether each one of the frequency groups of the gradually increasing group, constant frequency group, and gradually decreasing group are required. Specifically, the limitation “wherein the current generated by the signal generator has an electrical stimulation pulse with a frequency of 1 to 30 Hz, and includes a gradually increasing frequency group, a constant frequency group, or a gradually decreasing frequency group” requires the current include only one of a gradually increasing frequency group, a constant frequency group, or a gradually decreasing group, while the limitation “the gradually increasing frequency group, the constant frequency group, and the gradually decreasing frequency group are each composed of a plurality of single-phase pulse groups” provides requirements for all of the groups, suggesting that each one is required by the claim. For purposes of examination, this is interpreted under broadest reasonable interpretation in light of the specification as only requiring one of the gradually increasing frequency group, the constant frequency group, or the gradually decreasing frequency group.
In re claim 1, the limitation “the single-phase pulse group” is unclear. It is unclear if this is referring to the duty cycles of each of the plurality of single-phase pulse groups or just one of them. For purposes of examination, the limitation will be interpreted as best understood in light of the specification to mean “a duty cycle of the single-phase pulse groups is more than 60%”.
Claims 2-5 also recite “gradually increasing frequency” and “gradually decreasing frequency”, see above 35 U.S.C. 112(b) Rejection, In re claim 1.
Claims 2-5 place further requirements for each of the optional groups of the gradually increasing decreasing group, constant frequency group, and gradually decreasing group, see 35 U.S.C. 112(b) Rejection, In re claim 1 regarding optional or required frequency groups as these claims are unclear for the same reason. These claims will be interpreted in the same way as claim 1 as just requiring one of the gradually increasing frequency group, the constant frequency group, or the gradually decreasing frequency group.
In re claim 3, the limitation “the output time” has insufficient antecedent basis for this limitation in this claim.
In re claim 7, the limitation “wherein the single-phase pulse groups are composed of a plurality of single-phase pulses with the duty cycle of 40% to 60%” is unclear. Under broadest reasonable interpretation, the single-phase pulse groups could have a duty cycle of 40% to 60%, which would not be possible in light of claim 1, or the plurality of single-phase pulses could have a duty cycle of 40% to 60%. For purposes of examination, this limitation is interpreted as best understood in light of the specification to mean wherein the single-phase pulse groups are composed of a plurality of single-phase pulses, wherein the plurality of single-phase pulses has a duty cycle of 40% to 60%.
In re claim 12, refers to the electrical stimulation generating device for improving sleep disorders as in claim 1, and therefore has the same 112(b) rejections as above 35 U.S.C. 112(b), In re claim 1.
In re claim 12, the limitation “the electrical stimulation generating device for improving sleep disorders as claimed in any claims of claims 1 to 11 claim 1” lacks antecedent basis and should read “an electrical stimulation generating device for improving sleep disorders as claimed in any claims of claims 1 to 11 claim 1”.
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 11 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In re claim 11, the limitation “wherein the electrode structure contacts the abdominal skin of the individual” recites a human organism as a part of the structure of the device as a part of the device interacts with a human organism through its structure. In this case the abdomen of an individual (human), is contacted by the electrodes and is therefore part of the claimed invention. Examiner suggests revising the claim so that it reads “wherein the electrode structure is configured to contact the abdominal skin of the individual”.
Claim Rejections - 35 USC § 103
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (TWI833616).
In re claim 1, Chang discloses an electrical stimulation generating device (Fig. 1: 1000) for improving sleep disorders*, comprising:
a host machine (1);
a signal generator (3; pg. 3, ln. 39: “command signal generated by the interface module 3”) being disposed within the host machine (Fig. 1: 3 is disposed within 1) for generating a current (Pg. 3, ln. 19-22: “the electrical stimulation pulse combination generated by the electrical stimulation generator 1”);
at least one signal transmission module (Pg. 3, ln. 19-21: “signal transmission line”; Fig. 1: lines connecting 3 and 2),
wherein one end of which is electrically connected to the signal generator (Fig 1: lines are connected to 1);
at least one electrode structure (one of 2)
being electrically connected to the other end of the signal transmission module (Fig. 1: lines connect to 2), and
having a contact surface (Fig. 1: surface of electrodes facing user) for
contacting the skin of an individual (Pg. 3, ln. 48-51: “the contact position of the contact surface is the skin of the user's individual”) and
being transmitting the current to the individual (Pg. 3, ln. 19-22: “transmits the electrical stimulation pulse combination generated by the electrical stimulation generator 1 to the individual”);
wherein the current generated by the signal generator
has an electrical stimulation pulse with a frequency of 1 to 30 Hz (Pg. 3, ln. 56-58: “the frequency range of the second frequency group is preferably 1 to 30 Hz, more preferably 1 to 28 Hz, and the frequency range of the third frequency group is preferably 5 to 30 Hz, more preferably 6 to 26 Hz”), and
includes a
gradually increasing frequency group,
a constant frequency group (Pg. 3, ln. 56-58: second and/or third frequency group), or
a gradually decreasing frequency group,
the gradually increasing frequency group, the constant frequency group, and the gradually decreasing frequency group are each composed of a plurality of single-phase pulse groups (Pg. 4, ln. 42-54: each frequency group is composed of a plurality of single-phase pulse groups), and
a duty cycle of the single-phase pulse group is greater than or equal to 50% (Pg. 3, ln. 36).
Chang lacks:
a duty cycle of the single-phase pulse group is more than 60%.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the duty cycle of Chang with a duty cycle of the single-phase pulse group is more than 60%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Chang discloses wherein duty cycle of the single-phase pulse group is greater than or equal to 50%, which overlaps with the claimed range of more than 60%. Further, there appears to be no criticality regarding the claimed range (Instant Spec.: pg. 16, ln. 1-5) appears to be referring to the duty cycle of the single-phase pulses; the experimental results (Instant Spec.: pg. 32, ln. 14-17 and pg. 33, ln. 1-4) do not isolate duty cycle to show criticality).
*Regarding the limitations " for improving sleep disorders", this is a recitation of intended use. Specifically, a recitation of the intended use of the claimed 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. As the device disclosed by Chang is the same as the device in claim 1, it can be assumed the device will inherently perform the intended use of improving sleep disorders. See MPEP § 2111.02 (II) and § 2112.01 (I).
In re claim 2, Chang discloses wherein
the frequency of the gradually increasing frequency group and the gradually decreasing frequency group range from 5 to 30 Hz, and
the frequency of the constant frequency group ranges from 4 to 8 Hz (Pg. 2, ln. 1-2: frequencies range between 1 and 30 Hz; pg. 4: 47-52: the 54th to 59th frequency groups are at frequencies of 5, 6, 7, and 8).
In re claim 3, Chang discloses wherein
the output time of the gradually increasing frequency group is between 350 and 470 seconds,
the output time of the gradually decreasing frequency group is between 170 and 250 seconds, and
the output time of the constant frequency group is between 900 and 1000 seconds and 320 and 400 seconds (Pg. 3, ln. 58-60 and pg. 4, ln. 1-4).
Chang lacks:
the output time of the constant frequency group is between 1750 and 1850 seconds.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the duty cycle of wherein the output time of the constant frequency group is between 1750 and 1850 seconds, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Further, there appears to be no criticality regarding the claimed range, as the output time of the frequencies can be adjusted according to actual needs (Pg. 22, ln. 4-5).
In re claim 4, Chang discloses wherein
the gradually increasing frequency group sequentially includes a first gradually increasing frequency, a second gradually increasing frequency, and a third gradually increasing frequency,
the constant frequency group sequentially includes a first constant frequency, a second constant frequency, a third constant frequency, a fourth constant frequency, and a fifth constant frequency (Pg. 4, ln. 42-54: there are five single-phase pulse groups in the second and third frequency groups; note: this could be, for example, the fifty-fourth through the fifty-eighth single-phase pulse groups), and
the gradually decreasing frequency group sequentially includes a first gradually decreasing frequency, a second gradually decreasing frequency, and a third gradually decreasing frequency.
In re claim 5, Chang discloses wherein each of the first gradually increasing frequency to the third gradually increasing frequency, the first constant frequency to the fifth constant frequency, and the first gradually decreasing frequency to the third gradually decreasing frequency have their respective frequency ranges and output times (Pg. 4, ln. 42-54: each pulse group has a respective frequency and output time).
In re claim 6, Chang discloses wherein the duty cycles of the single-phase pulse groups are greater than or equal to 50% (see 35 U.S.C. 103 Rejection, In re claim 1).
Chang lacks:
wherein the duty cycles of the single-phase pulse groups are 70% or 100%.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the duty cycle of Chang wherein the duty cycles of the single-phase pulse groups are 70% or 100%. since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Chang discloses wherein duty cycle of the single-phase pulse group is greater than or equal to 50%, which overlaps with the claimed values of 70% or 100%. Further, there appears to be no criticality regarding the claimed range (Instant Spec.: pg. 16, ln. 1-5) appears to be referring to the duty cycle of the single-phase pulses; the experimental results (Instant Spec.: pg. 32, ln. 14-17 and pg. 33, ln. 1-4) do not isolate duty cycle to show criticality).
In re claim 7, Chang discloses wherein the single-phase pulse groups are composed of a plurality of single-phase pulses (inherent: single-phase pulse groups would comprise multiple pulses to have a frequency value) with a duty cycle (inherent: a plurality of single-phase pulses will have a duty cycle).
Chang lacks:
wherein the single-phase pulse groups are composed of a plurality of single-phase pulses with the duty cycle of 40% to 60%.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the duty cycle of Chang wherein the single-phase pulse groups are composed of a plurality of single-phase pulses with the duty cycle of 40% to 60%, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. Chang discloses wherein duty cycle of the single-phase pulse groups is greater than or equal to 50%, but is silent to the duty cycle of the single-phase pulses. Further, there appears to be no criticality regarding the claimed range (Instant Spec.: pg. 16, ln. 1-5 appears to be referring to the duty cycle of the single-phase pulses in combination with the varying frequencies).
In re claim 8, Chang discloses wherein the waveform of the electrical stimulation pulse is
a square wave (Pg. 1, ln. 56-57: “the waveform of the single-phase pulse group is square”),
a sine wave (optional),
a triangle wave (optional), or
a sawtooth wave (optional).
In re claim 9, Chang discloses wherein a potential difference of the current is less than 10 Vpp (Pg. 2, ln. 11-12).
In re claim 10, Chang discloses wherein the signal transmission module is a signal transmission wire (Pg. 3, ln. 19-21: “signal transmission line”) or a combination of the signal transmission wire and a magnetic clasp (optional).
In re claim 11, Chang discloses wherein the electrode structure contacts the abdominal skin of the individual Pg. 2; ln. 14-15).
In re claim 12, Changs discloses a method for applying to the electrical stimulation generating device for improving sleep disorders** as claim 1 (See 35 U.S.C. 103 Rejection, In re claim 1).
**Regarding the limitation “for improving sleep disorders” see MPEP 211.02(I): “Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process”. As the device disclosed by Chang is the same as the device in the specification for carrying out the method of claim 12, it can be assumed the device will inherently perform the claimed process.
Conclusion
The following prior art is made of record and not relied upon is considered pertinent to applicant's disclosure:
Yamaguchi et al. (WO 2007015368) discloses a sleep disorder treating device comprising electrode pads to be wrapped around the abdomen of a user and supply a pulse voltage to prevent urinary sensation at night.
Contact
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HALLE M WELCH whose telephone number is (571)272-0168. The examiner can normally be reached Mon-Fri, 8:30 am to 5:00 pm..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/HALLE MARGARET WELCH/Examiner, Art Unit 3796
/DAVID HAMAOUI/SPE, Art Unit 3796
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