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 § 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) further in view of Weinstock (US 5592086)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 (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) and configured to cause the display to 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.
Schumann discloses all of the limitations of the claim except includes a frequency between 11 kHz and 20 kHz. Weinstock teaches at least a portion of the complex pulse waveform having a frequency or frequency range includes a frequency between 11 kHz and 20 kHz (col. 4, lines 55-62). Therefore, it would have been obvious at the time of the invention to one of ordinary skill in the art to broaden the frequency range used by Schumann to include 11-20 kHz as taught by Weinstock for the purpose of more easily detecting irregularities in a patient with a broader frequency range to allow for a better diagnosis.
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 arguments in view of the newly recited frequency range have been considered but are moot in view of the new rejection.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, 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).
In response to applicant’s arguments regarding Schumann not teaching an interface, applicant themselves admit that Schumann discloses an interface in paragraphs 0037, 0045 which is configured to “control actuators actuate controls suitable for controlling parameters of the electrical output and other interface of the electronic pain treatment device of the present invention” (paragraph 0037). Furthermore, paragraphs 0031-0032 teach the display displaying (a) status information, including an indication relating to the complex pulse waveform being applied to the body; (c) an indication of pain relief of the treatment by the apparatus as noted… “impedance readings are used to determine the state of the tissue under test and/or treatment. A reduction in impedance (increase in conductivity) during or after treatment indicates the treatment is reducing the level of pain perceived by the patient under treatment…in another embodiment, identification of the shape of the waveform allows identification of the transition of a first portion of the waveform from a square like wave having two peaks to a triangle like wave having a single peak which signals the end of treatment”. Eror also teaches in paragraph 0100 “for example, the screen 112 may display a visual anatomical schematic having a highlighted interrogation point overlay that helps the device operator identify and place the interrogation prove 120. The screen image desirably changes as required to inform the operator of the desired interrogation point for each point of interest during data acquisition series”.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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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