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
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group 2, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 10, 2025.
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.
Claims 1-14 are 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). Claim 1, lines 2-3 recite “a stationary electrode in contact with a patient's skin within a physical manipulation target region of a patient's body.” This is positively reciting the patient’s skin. It is suggested to claim the device “configured to contact” or other similar language.
Similar issues exist in claim 8.
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 1-14 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1, lines 4-7 recite the phrase “a first electrode for application to the patient's skin by a practitioner during an electrotherapy-assisted physical manipulation treatment an identified tissue type, as determined based on the practitioner's observance of or the patient's reporting of the rhythmic contraction of the patient's muscle.” This phrase is unclear, as it is not known how the phrase “an identified tissue type” fits into the claim. Applicant is required to clearly state how the “an identified tissue type” is related to the physical manipulation treatment.
Claim 1, lines 8-9 recites “to the mobile electrode”. There is insufficient antecedent basis for this term. It is unclear if this is referencing the “first electrode” of line 4 or a separate electrode not previously mentioned.
Claim 1, lines 12-15, recites the phrase “the first MDMC pulsed current frequency causing rhythmic contraction of the patient's muscle within the physical manipulation target region at a contraction pulse frequency that is lower than the tissue treatment pulse frequency.” This phrase is unclear, as it is not clear how it is known that the first MDMC pulsed current frequency causes the desired contractions of the patient’s muscle. Additionally, since the “first MDMC pulsed current frequency is mixed with an alternating current (AC) current frequency component,” it would be unclear whether the MDMC pulse current is causing the contractions, or the AC current frequency component added to the signal. Similar issues exist in claim 8.
Claim 1, lines 14-16 recite the phrase, “wherein the first MDMC pulsed current frequency has a direct macro-current portion equal to or greater than one milliampere (mA).” This phrase is unclear, as it is not known what a “direct macro-current portion” is referring to. It is also unclear how a “direct macro-current portion” is measured, and how a “direct macro-current portion” can be “greater than one milliampere (mA).” Similar issues exist in claim 8.
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.
Claims 1, 3, 6, 8, 10-11, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Clock (US 2017/0266446).
Examiner wishes to note that the term “mixed direct macro-current electrotherapy” is not well known in the art, and thus the broadest reasonable interpretation of the term has been used.
Regarding claim 1, as best the claim can be understood, O’Clock discloses the claimed electrotherapy system comprising:
a stationary electrode in contact with a patient's skin within a physical manipulation target region of a patient's body (e.g. counter electrode 16);
a first electrode for application to the patient's skin by a practitioner during an electrotherapy-assisted physical manipulation treatment an identified tissue type, as determined based on the practitioner's observance of or the patient's reporting of the rhythmic contraction of the patient's muscle (e.g. electrode 14a);
an MDMC electrotherapy pulsed frequency generator operably connected to the mobile electrode and the stationary electrode to deliver a first MDMC pulsed current frequency having a tissue treatment pulse frequency corresponding to the identified tissue type to the patient's skin (e.g. electrotherapeutic device 10 comprising signal generator 12),
wherein the first MDMC pulsed current frequency is mixed with an alternating current (AC) current frequency component (e.g. pulsed current missed with AC current as shown in Figure 2E); and
the first MDMC pulsed current frequency causing rhythmic contraction of the patient's muscle within the physical manipulation target region at a contraction pulse frequency that is lower than the tissue treatment pulse frequency, wherein the first MDMC pulsed current frequency has a direct macro-current portion equal to or greater than one milliampere (mA) (e.g. microcurrents that are in the range of 100 microamps to 1000 microamps, that includes equal to one milliampere; see [0005]).
Regarding claim 3, as best the claim can be understood, O’Clock additionally discloses wherein the tissue type to be treated is identified by the practitioner as a type of tissue located within the physical manipulation target region, and the tissue treatment pulse frequency is one of a plurality of frequencies associated with the tissue type to be treated (e.g. treatment of eye tissue; see [0003]).
Regarding claim 6, as best the claim can be understood, O’Clock discloses a tissue treatment pulse frequency is equal to or greater than 10 Hz (e.g. as disclosed in [0014]).
Regarding claim 8, as best the claim can be understood, O’Clock discloses mixed direct macro-current (MDMC) electrotherapy system comprising:
a stationary electrode in contact with a patient's skin within a physical manipulation target region of a patient's body (e.g. counter electrode 16);
a mobile electrode for application to the patient's skin by a practitioner during an electrotherapy-assisted physical manipulation treatment of an identified condition affecting an identified tissue type, as determined based on the practitioner's observance of or the patient's reporting of the rhythmic contraction of the patient's muscle (e.g. electrode 14a);;
an MDMC electrotherapy pulsed frequency generator operably connected to the mobile electrode via an electrically conductive interface to deliver a first MDMC pulsed current frequency having a condition treatment pulse frequency corresponding to the identified condition to the patient's skin (e.g. electrotherapeutic device 10 comprising signal generator 12),
where the first MDMC pulsed current frequency is mixed with an alternating current (AC) current frequency component (e.g. pulsed current missed with AC current as shown in Figure 2E); and
the first MDMC pulsed current frequency causing rhythmic contraction of the patient's muscle within the physical manipulation target region at a contraction pulse frequency that is lower than the condition treatment pulse frequency, where the first MDMC pulsed current frequency has a direct macro-current portion equal to or greater than one milliampere (mA) (e.g. microcurrents that are in the range of 100 microamps to 1000 microamps, that includes equal to one milliampere; see [0005]).
Regarding claim 10, as best the claim can be understood, O’Clock additionally discloses wherein the tissue type to be treated is identified by the practitioner as a type of tissue located within the physical manipulation target region, and the tissue treatment pulse frequency is one of a plurality of frequencies associated with the tissue type to be treated (e.g. treatment of eye tissue; see [0003]).
Regarding claim 11, as best the claim can be understood, O’Clock additionally discloses wherein the identified condition is identified by the practitioner as a condition capable of causing one or more symptoms within the physical manipulation target region, as reported by the patient, and the condition treatment pulse frequency is one of a plurality of frequencies associated with the identified condition (e.g. treatment of eye tissue; see [0003]).
Regarding claim 13, as best the claim can be understood, O’Clock additionally discloses the condition treatment pulse frequency are equal to or greater than 10 Hz (e.g. as disclosed in [0014] and [0069]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amanda K Hulbert whose telephone number is (571)270-1912. The examiner can normally be reached Monday - Friday 9:00-5:00.
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/Amanda K Hulbert/Primary Examiner, Art Unit 3792