DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/19/2025 has been entered.
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 1-11, 13-19, 21-23 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 recites the limitation "the same time", “the same screen”, “the illustrated portion”. There is insufficient antecedent basis for this limitation in the claim.
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 factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 1-11, 13-19, 21-23 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schumann (US 20070106342) in view of Eror (US 20090124924)1. An apparatus configured to deliver electrical pulses to a body during a treatment (ABSTRACT), the apparatus comprising:
a generator circuit (202) configured to output, from among a plurality of pulse train configurations for different treatments, an electrical pulse train configuration of the plurality of pulse train configurations (paragraph 0020…. “the electronic pain treatment device of the present invention 100 administers therapeutic electrical energy, of specific and predetermined waveforms, generated by the device, to trigger points associated with pain”) including a complex pulse waveform (PARAGRAPH 0016) (“a second circuit operable to generate electrical waveforms of variable frequency and variable amplitude…”, claim 1) having an amplitude of less than 190 Volts (paragraph 0073), at least a portion of the complex pulse waveform having a frequency or frequency range that includes a frequency between 4 kHz and 20 kHz (paragraph 0026, 0047);
a conductor (206a/b and/or 110a/b) electrically coupled to the generator circuit to receive therefrom the complex pulse waveform of a selected one of the plurality of electrical pulse train configurations and to apply the complex pulse waveform to a region of interest of the body (PARAGRAPH 0016-0017, 0020-0021);
an intensity adjustment circuit (215/216) configured to adjust an intensity of the complex pulse waveform in response to an intensity input (PARAGRAPH 0025-0026), the intensity input being selected from one of a plurality of different waveforms (“the electrical output of the electronic pain treatment device of the present invention 100 comprises specific electric wave shapes of variable amplitude”, paragraph 0026) or from the plurality of electrical pulse train configurations (in an embodiment, the wave shape is akin to a pulse whose shape changes as a function of the impedance of the skin or other tissue under treatment…paragraph 0026);
an interface (paragraph 0031, 0037, 0045) coupled to a display (504 and/or “output display on the main console 102”) (paragraph 0020, and 0031) to cause the display to display at the same time or at different times on the same screen of the display (a) status information, including an indication relating to the complex pulse waveform being applied to the body (PARAGRAPH 0031-0033); (c) an indication of pain relief of the treatment by the apparatus (paragraph 0022… “treatment progress is monitored via a conductivity indication such as from a meter or conductivity indicating device 212…increased conductivity is a consistent marker for immediate reductions in perceived pain.”) (paragraph 0031-0032); and
a controller configured to instruct the generator circuit to end delivery of the complex pulse waveform, wherein the amplitude and/or the frequency of the complex pulse waveform is variable as the complex pulse waveform is being applied to the region of interest of the body (PARAGRAPH 0037-0046, 0074).
Schumann discloses all of limitations of the claim except (b) an anatomical illustration of at least a portion of the body and an indication of at least one of a plurality of locations on the illustrated portion of the body, each of the plurality of locations representing a different area for treatment by the apparatus.
Eror teaches an interface coupled to a display…an anatomical illustration of at least a portion of the body and an indication of at least one of a plurality of locations on the illustrated portion of the body, each of the plurality of locations representing a different area for treatment by the apparatus (paragraph 0100).
Therefore, it would have been obvious at the time of the invention to one of ordinary skill in the art to utilize Schumann’s screen to include a visual anatomical schematic as taught by Eror for the purpose of assisting the operator during treatment by allowing the operator to identify and accurately place the probe.
2. The apparatus of claim 1, the display being further configured to display real-time information about the treatment (PARAGRAPH 0031-0032, 0035).
3. The apparatus of claim 1, the display being further configured to display patient-specific data (PARAGRAPH 0036).
4. The apparatus of claim 1, wherein the display is an external display (502/504 and/or “output display on the main console 102”) (paragraph 0020, and 0031).
5. The apparatus of claim 4, wherein the external display includes graphics (PARAGRAPH 0031).
6. The apparatus of claim 4, wherein the external display includes an indication of the intensity (PARAGRAPH 0031-0032).
7. The apparatus of claim 1, wherein the display is configured to display guided, malady- specific, treatment starting points (PARAGRAPH 0022).
8. The apparatus of claim 1, wherein the display includes a duration of time (PARAGRAPH 0034-0035).
9. The apparatus of claim 1, wherein the intensity adjustment circuit is configured to adjust the intensity by adjusting a pulse width or a carrier current (PARAGRAPH 0025-0026).
10. The apparatus of claim 1, wherein the intensity input is provided via an intensity knob or dial (paragraph 0037).
11. The apparatus of claim 1, Schumann discloses wherein the controller is configured to receive an input from a plus-minus control (paragraph 0037). Schumann does not explicitly teach wherein the plus-minus provided via a touchscreen. However, the Examiner takes official notice that touch screens are well known and common knowledge in the art at the time of the invention. The Examiner denotes this for claims 13 as well.
14. The apparatus of claim 1, wherein the region of interest of the body includes a nervous system trigger point or a point to provide nerve stimulation, or wherein the region of interest of the body is a wound (PARAGRAPH 0016-0017, claim 17).
15. The apparatus of claim 1, wherein the conductor constitutes a probe that is manipulable (PARAGRAPH 0020).
16. The apparatus of claim 1, used to treat a condition including neuralgia or neuropathy or a disease affecting the body's nervous system (PARAGRAPH 0016-0017, 0019).
17. The apparatus of claim 1, used to treat a pain condition (PARAGRAPH 0016-0017).
18. The apparatus of claim 1, wherein the conductor is placed directly against a skin of the body (PARAGRAPH 0026).
19. The apparatus of claim 1, further comprising a memory storage device (“computer”) to store data about the treatment (PARAGRAPH 0031, 0036).
21. The apparatus of claim 1, wherein the plurality of different waveforms includes a square wave, a filtered waveform, a drift-compensated waveform, or a uni-polar waveform (paragraph 0026-0027).
22. The apparatus of claim 1, wherein the interface is further configured to cause the display to display a real-time improvement field as the complex pulse waveform is being outputted (paragraph 0031-0033, 0045, 0053).
23. The apparatus of claim 1, wherein the controller is further configured to output voice audio feedback or audio suggestions through a speaker (paragraph 0031, 0041-0042).
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are not persuasive.
Applicant argues that Schumann does not teach the different electrical pulse train configurations. However, Schumann discloses in paragraph 0020 “the electronic pain treatment device of the present invention 100 administers therapeutic electrical energy, of specific and predetermined waveforms, generated by the device, to trigger points associated with pain”.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “targeted pain reduction by selecting among different pulse train configurations and being able to guide where to place the conductor on the body and to display indication of pain relief where the conductor is delivered the selected electrical pulse train to the body”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Schumann discloses a display which provides an indication of pain relief of the treatment by the apparatus as noted in the rejection above. The claim does not require that the anatomical illustration etc and the indication of pain relief of the treatment by the apparatus be displayed in the argued manner.
Conclusion
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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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791