DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 1 and 37 recites “a monitor device that is separate from the body impedance analysis circuit…”. Examiner notes the specification does not describe a monitor device that is separate from the body impedance analysis circuit.
Claims 19-30 are rejected under 112(a) as being dependent upon claim 1.
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, 37 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.
Claims 1 and 37 recites “a monitor device that is separate from the body impedance analysis circuit…”. Examiner notes the specification does not describe a monitor device that is separate from the body impedance analysis circuit. Examiner is unclear what “separate” is meant to define. Must they be physically separate, electrically separate, etc?
Claims 19-30 are rejected under 112(b) as being dependent upon claim 1.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 19-26, 28-31, 33-34, 37 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over by Schumann (US 20070106342) in view of Weinstock (US 20090270952)
The claims are rejected as follows:
1. Schumann discloses A patient treatment unit for analyzing and treating pain in human or animal tissues, (abstract) the patient treatment unit comprising:
a probe stimulus generator circuit (216) (paragraph 0025) that outputs a sequence of electrical pulses, the sequence of electrical pulses having a pulse width (paragraph 0023, “in an embodiment, time periods indicating the desired persistence of higher conductivity indications are typically in the range of about 5 to 20 seconds”; paragraph 0026, “the pulse duration is indicated by P”), a polarity (paragraph 0044), and a pulse frequency (paragraph 0026, 0038), the probe stimulus generator (216) controlling at least one of the pulse frequency, the polarity (209) (paragraph 0016, 0020), and the pulse width of the sequences of electrical pulses (Fig 2b) (paragraph 0025-0026);
a primary spherical probe (110a) and a secondary spherical probe (110b) for contacting a body of a patient and electrically coupled to the probe stimulus generator to receive the sequence of electrical pulses (Fig 2a) (paragraph 0025, 0054);
a body impedance analysis circuit (204) that senses voltage or current via the primary spherical probe (conductance/impedance/ amplifier) (paragraph 0025) and the secondary spherical probe (current) (paragraph 0025) in real-time as the sequence of electrical pulses are applied to the human or animal tissues to measure surface or tissue impedance (paragraph 0026) when the primary spherical and the secondary spherical probe are contacting the body of the patient (paragraph 0016, 0025);
a display device (“output display”/remote display 502) that displays the impedance measurement in real-time (paragraph 0031).
Schumann is silent regarding a monitor device that is separate from the body impedance analysis circuit that provides an indication of the sensed voltage or current as an impedance measurement in real- time as the sequence of electrical pulses are applied to the human or animal tissues. Weinstock teaches a monitor device (149) that is separate from the body impedance analysis circuit that provides an indication of the sensed voltage or current as an impedance measurement in real- time as the sequence of electrical pulses are applied to the human or animal tissues (paragraph 0046, see paragraph 0043-0044 for more details regarding overall system 108). Therefore, it would have been obvious at the time of invention to modify Schumann by Weinstock to include a monitor device that is separate from the body impedance analysis circuit for the purpose of enabling the medical technician to make real time adjustments during testing to easily increase patient safety and comfort.
19. Schumann discloses The patient treatment unit of claim 1, wherein the probe stimulus generator circuit is configured to output one of a plurality of electrical pulse train configurations, the sequence of electrical pulses being selected from one of the plurality of electrical pulse train configurations (paragraph 0026-0028).
20. Schumann discloses The patient treatment unit of claim 1, wherein the pulse width of the sequence of electrical pulses or a carrier current is varied to control an intensity of the sequence of electrical pulses (paragraph 0026).
21. Schumann discloses The patient treatment unit of claim 20, wherein the probe stimulus generator circuit is configured to alter the carrier current (paragraph 0028).
22. Schumann discloses The patient treatment unit of claim 19, wherein the plurality of electrical pulse train configurations include a square wave (paragraph 0027).
23. Schumann discloses The patient treatment unit of claim 19, wherein the plurality of electrical pulse train configurations include at least one waveform for treatment of a hand malady, a lower back pain in the patient, arthritis, a post-surgical pain, a post-surgical reduction of swelling, an inflammation, bruising, Osgood Schlater Disease, adhesive capsulitis, motor neuron disease, fibromyalgia, reflex sympathetic dystrophy, neuralgia, peripheral neuropathy, macular degeneration, wounds or scleroderma (paragraph 0026-0028).
24. Schumann discloses The patient treatment unit of claim 1, the treatment unit further comprising: an intensity adjustment circuit (amplitude/intensity adjustment) configured to adjust an intensity of the sequence of electrical pulses in response to an intensity input (paragraph 0039).
25. Schumann is silent regarding a treatment counter circuit configured to provide a signal indicative of a condition detectable by the probe stimulus generator. Weinstock teaches a treatment counter circuit configured to provide a signal indicative of a condition detectable by the probe stimulus generator (paragraph 0057-0069). Therefore, it would have been obvious at the time of the invention to one of the ordinary skill in the art to modify Schumann by Weinstock for the purpose of utilizing the measured waveforms which detects the abnormal tissue to provide effective therapy for an array of medical conditions.
26. Schumann is silent regarding the patient treatment unit of claim 25, wherein the sequence of electrical pulses is applied to the human or animal tissues based on the signal. Weinstock teaches wherein the sequence of electrical pulses is applied to the human or animal tissues based on the signal (paragraph 0057-0069). Therefore, it would have been obvious at the time of the invention to one of the ordinary skill in the art to modify Schumann by Weinstock for the purpose of utilizing the measured waveforms which detects the abnormal tissue to provide effective therapy for an array of medical conditions.
28. Schumann discloses The patient treatment unit of claim 25, wherein the probe stimulus generator circuit receives the signal from the treatment counter in a treatment mode (paragraph 0034-0035).
29. Schumann discloses The patient treatment unit of claim 19, wherein the plurality of electrical pulse train configurations includes a complex pulse waveform having a frequency of between 4 kHz and 20 kHz (paragraph 0026).
30. Schumann discloses The patient treatment unit of claim 1, the patient treatment unit further comprising a memory storage device to store data the treatment (paragraph 0036, 0058).
31. Schumann discloses A patient treatment unit for analyzing and treating pain in human or animal tissues, the patient treatment unit comprising:
a probe stimulus generator circuit (216) (paragraph 0025) that outputs a sequence of electrical pulses, the sequence of electrical pulses having a pulse width (paragraph 0023, “in an embodiment, time periods indicating the desired persistence of higher conductivity indications are typically in the range of about 5 to 20 seconds”; paragraph 0026, “the pulse duration is indicated by P”), a polarity (paragraph 0044), and a pulse frequency (paragraph 0026, 0038), the probe stimulus generator (216) controlling at least one of the pulse frequency, the polarity (209) (paragraph 0016, 0020), and the pulse width of the sequence of electrical pulses (Fig 2b) (paragraph 0025-0026);
a primary spherical probe (110a) and a secondary spherical probe (110b) for contacting a body of a patient and electrically coupled to the probe stimulus generator to receive the sequence of electrical pulses (Fig 2a) (paragraph 0025, 0054); and
a body impedance analysis circuit (204) that senses voltage or current via the primary spherical probe (conductance/impedance/ amplifier) (paragraph 0025) and the secondary spherical probe (current) (paragraph 0025) in real-time as the sequence of electrical pulses are applied to the human or animal tissues to measure surface or tissue impedance (paragraph 0026) when the probes are contacting the body of the patient (paragraph 0016, 0025);
Schumann is silent regarding a treatment counter circuit configured to provide a signal indicative of a condition detectable by the probe stimulus generator. Weinstock teaches a treatment counter circuit configured to provide a signal indicative of a condition detectable by the probe stimulus generator (paragraph 0057-0069). Therefore, it would have been obvious at the time of the invention to one of the ordinary skill in the art to modify Schumann by Weinstock for the purpose of utilizing the measured waveforms which detects the abnormal tissue to provide effective therapy for an array of medical conditions.
33. Schumann discloses The patient treatment unit of claim 31, wherein the pulse width of the sequence of electrical pulses or a carrier current is varied to control an intensity of the sequence of electrical pulses (paragraph 0026).
34. Schumann discloses The patient treatment unit of claim 33, wherein the probe stimulus generator circuit is configured to alter the carrier current (paragraph 0028).
37. Schumann discloses A patient treatment unit for analyzing and treating pain in human or animal tissues, the patient treatment unit comprising:
a probe stimulus generator circuit (216) (paragraph 0025) that outputs a sequence of electrical pulses, the sequence of electrical pulses having a pulse width (paragraph 0023, “in an embodiment, time periods indicating the desired persistence of higher conductivity indications are typically in the range of about 5 to 20 seconds”; paragraph 0026, “the pulse duration is indicated by P”) and a pulse frequency (paragraph 0026, 0038), the probe stimulus generator controlling the pulse frequency and the pulse width of the sequence of electrical pulses (Fig 2b) (paragraph 0025-0026);
a primary spherical probe and a secondary spherical probe for contacting a body of a patient and electrically coupled to the probe stimulus generator to receive the sequence of electrical pulses (Fig 2a) (paragraph 0025, 0054);
a body impedance analysis circuit (204) that senses voltage or current via the primary spherical probe (conductance/impedance/ amplifier) (paragraph 0025) and the secondary spherical probe (current) (paragraph 0025) in real-time as the sequence of electrical pulses are applied to the human or animal tissues to measure surface or tissue impedance (paragraph 0026) when the primary spherical probe and the secondary spherical probe are contacting the body of the patient (paragraph 0016, 0025); and
Schumann is silent regarding a monitor device that is separate from the body impedance analysis circuit that provides an indication of the sensed voltage or current as an impedance measurement in real- time as the sequence of electrical pulses are applied to the human or animal tissues. Weinstock teaches a monitor device (149) that is separate from the body impedance analysis circuit that provides an indication of the sensed voltage or current as an impedance measurement in real- time as the sequence of electrical pulses are applied to the human or animal tissues (paragraph 0046, see paragraph 0043-0044 for more details regarding overall system 108). Therefore, it would have been obvious at the time of invention to modify Schumann by Weinstock to include a monitor device that is separate from the body impedance analysis circuit for the purpose of enabling the medical technician to make real time adjustments during testing to easily increase patient safety and comfort.
Response to Arguments
Applicant's arguments filed 10/15/2025 have been fully considered but they are not persuasive.
In response to applicant’s note regarding claims 27 and 32 do not have an art rejection, however are rejected under 112a/112b. Applicant correctly notes that 35 should only be rejected under 112a/112b. The 103 rejection on claim 35 has been withdrawn.
In response to applicant’s arguments regarding the 112a rejection, examiner is unclear how the monitor device is separate from the body impedance analysis circuit but then also in paragraph 13 and claim 1 of the original specification, it is recited “a monitor device is electrically coupled to the body impedance analysis circuit”. If it is electrically coupled, then how is it separate? Therefore, the 112a rejection is maintained as is the 112b rejection, as the examiner is unclear if it is electrically coupled, in what way is it separate? Fig 1 is provided as support to show the monitor device 109 as separate and distinct from the body impedance analysis circuit, but once again it seems they are electrically coupled as noted above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning re Schumann in view of Weinstock, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Applicant recites that Schumann does not appear to teach the impedance or conductivity measurement circuit “Senses voltage or current via….are contacting the body of the patient”. Applicant does not explain how Schumann does not disclose this in paragraphs 0016, 0025.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Applicant argues that Weinstock does not teach a body impedance analysis circuit, however, Schumann discloses the body impedance analysis circuit. Schumann is silent regarding a monitor device. Weinstock is used to disclose a monitor device that is separate based on examiner’s 112a/112b rejection interpretations.
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both Schumann and Weinstock are systems for analyzing and treating tissue with electrical energy with dual probes.
In response to applicant's argument regarding “a treatment counter circuit configured to provide a signal indicative of a condition detectable by the probe stimulus generator”, 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. Weinstock teaches a signal indicative of a condition detectable by the probe stimulus generator (0057-0062).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached on 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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