DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Specification
The disclosure is objected to because of the following informalities: the status of the ‘967 application listed in par. 0001 must be updated.
Appropriate correction is required.
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 17 and 18 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. The combination of the touchscreen for selecting icons by touching the screen, and the button or toggle button for selecting defined waveforms was not originally not disclosed. Paragraph 0081 indicates that one may select pulse shapes by activating a button, or alternatively, if the display has touchscreen capabilities, the pulse shape can be selected by touching the screen.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2, 3, 9, 12, 17-20 and 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,589,099 in view of Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented claims, except where noted below. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
The use of a touchscreen as a user interface to select waveforms by allowing a user to touch the screen would have been considered an obvious design expediency by those of ordinary skill in the art. Clearly the use of touchscreens as user interfaces is ubiquitous in the computer arts as discussed by Gerber (see par. 0062). Those of ordinary skill in the art would have considered any known manner of distinguishing between waveforms to have been an obvious matter of design, including the use of text and icons (such a feature is considered admitted prior art as indicated below in the rejection under §103; also see the above reference article proving that such formatting is old and well-known in computer interfaces). Clearly icons and text are common tools associated with computer displays to inform the user as to the characteristics associated with any given selection. To use different icons to distinguish between different shapes, as cited in claim 3, would have further been considered an obvious design expediency to ensure that the icon matched the pulse shape, thus eliminating potential confusion as to which icon to press for any desired pulse shape.
Regarding claims 9 and 19, allowing a user to select additional waveforms, including a second defined waveform, would have been considered a matter of obvious design to those of ordinary skill in the art, as such a feature allows one to adjust stimulation as needed to best suit the needs of the patient.
Concerning claims 17 and 18, the use of a ubiquitous button including a toggle button to allow selection of options on a computer (or any system allowing a user to select desired options, for that matter) is well-known and would have been considered a matter of obvious design by those of ordinary skill in the art looking to provide a form of control over the selection process.
Regarding claims 26, 27, 30 and 31, while the ‘099 patent does not explicitly recite peripheral or functional nerve stimulation, those of ordinary skill in the art would have reasonably recognized that the ‘099 neurostimulation invention would have been suitable for use in any therapeutic neurostimulation application where optimization of the pulse waveform would enhance the therapeutic effect, and thus not limited solely to deep brain and/or spinal cord stimulation.
Claims 10, 11, 22 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 10,589,099 in view of Herbst (Pub. No. 2002/0143365), Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Application of the Herbst reference to claims 10, 11, 22 and 23 parallels the art rejection given below, with the application of Gerber and the historical paper already elaborated above. It would have been obvious to modify the ‘099 invention in the recited manner because such modification allows one to more effectively apply stimulation according to the prevailing conditions. Electrical impedance has long been detected in medical stimulators for this reason as evidenced by Herbst.
Claims 2, 3, 9, 12, 17-20 and 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,376,435 in view of Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented spinal cord stimulation claims, with the exception of the limitations already discussed above. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
The rationale for rejecting claims 2, 3, 9, 12, 17-20, 25-27 and 29-31 are substantially identical to those already given above and will not be repeated for the sake of brevity.
Claims 10, 11, 22 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11,376,435 in view of Herbst (Pub. No. 2002/0143365), Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
The rationales for rejecting claims 10, 11, 22 and 23 are identical to those already given above and will not be repeated for the sake of brevity.
Claims 2, 3, 9, 12, 17-20 and 24-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9,849,285 in view of Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Although the claims at issue are not identical, they are not patentably distinct from each other because the present invention's claims are merely broader in scope than the patented claims, except where noted below. Once the applicant has received a patent for a species or a more specific embodiment, he is not entitled to a patent for the generic or broader invention (see In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993)).
The rationale for rejecting claims 3, 9, 12, 17-20 are identical to those already given above and will not be repeated for the sake of brevity.
Regarding claims 24-31, while the ‘285 invention does not elaborate on the particular type of stimulation therapy, but more broadly covers electrical stimulation in general, those of ordinary skill in the art would have considered any specific form of therapy where pulse shape is a therapeutic consideration, to be reasonably applicable to the ‘285 invention. As pulse shape is an important consideration in deep brain, spinal, peripheral and functional nerve stimulation, it would have been reasonable to conclude that similar optimization benefits could be obtained by enabling pulse shape selection in these applications as well.
Claims 10, 11, 22 and 23 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 9,849,285 in view of Herbst (Pub. No. 2002/0143365), Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
The rationale for rejecting claims 10, 11, 22 and 23 are identical to those already given above and will not be repeated for the sake of brevity.
Claims 2, 3, 9-12, 17-20 and 22-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 9,238,138 in view of Herbst (Pub. No. 2002/0143365), Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Given that the ‘138 invention accepts user input specifying the shape of the waveform from at least two defined waveforms, to provide a user interface presenting the available selection choices to the user would have been considered a matter of obvious routine design because it’s old and well-known in computer controlled systems to present a user with the available choices for selection on an interface as a matter of convenience. Herbst, for example, shows a related system wherein a user interface is employed to present selectable options to the user. See the rejection below for more details on the application of Herbst with regards to claims 10, 11, 22 and 23.
The rationale for rejecting claims 3, 9, 12, 17-20 and 24-31 are identical to those already given above where appropriate and will not be repeated for the sake of brevity.
Claims 2, 3, 9-12, 17-20 and 22-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 8,036,754 in view of Herbst (Pub. No. 2002/0143365), Gerber et al. (Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Given that the ‘754 invention accepts user input specifying the shape of the waveform from at least two defined waveforms, to provide a user interface presenting the available selection choices to the user would have been considered a matter of obvious routine design because it’s old and well-known in computer-controlled systems to present a user with the available choices for selection on an interface as a matter of convenience. Herbst, for example, shows a related system wherein a user interface is employed to present selectable options to the user. See the rejection below for more details on the application of Herbst with regards to claims 10, 11, 22 and 23.
The rationale for rejecting claims 3, 9, 12, 17-20 and 24-31 are identical to those already given above where appropriate and will not be repeated for the sake of brevity.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 2, 3, 9-12, 17-20 and 22-31 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Herbst in view of Brink (Pat. No. 5,725,560), Gerber et al. (Gerber: Pub. No. 2006/0190051) and the article entitled “A Brief History of the Origin of the Computer Icon.”
Regarding claim 2, Herbst discloses a method, comprising: presenting at least two defined waveforms on a user interface (requisite feature in order to allow a user to choose the particular signal or waveform appropriate to the intended electrical stimulation application; see Fig. 1, elements 13-17 showing user selectable waveform shape options), wherein the at least two defined waveforms are available for user selection (par. 0066) and have different defined waveform shape characteristics other than different pulse amplitudes, pulse widths or pulse rates (par. 0030; Fig. 1, ES signal stage); using the user interface to select a defined waveform from the at least two defined waveforms presented on the user interface (par. 0066); and delivering neurostimulation (par. 0007; electrical stimulation to effect nerve regeneration) to one or more electrical terminals in accordance with the defined waveform (par. 0018; electrical stimulation).
Herbst does not explicitly discuss the use of a touchscreen using both icons and text, and concomitantly does not disclose detecting when one of the defined waveforms presented on the touchscreen is touched. Herbst, however, discloses that a user may use a dial, switches, or software communicating with the device to choose the particular signal or waveform appropriate for the intended stimulation application (par. 0066).
Brink, in a related medical waveform selection system, discloses that a user interface may be included which includes dials, switches and graphical representations of stored waveforms that the user may select on the screen (text abridging cols. 3 and 4; Figs. 5A, 5B and 6). A graphical representation of a waveform is considered an icon. Clearly the use of icons to aid a user in recognizing and selecting an appropriate option on a computer screen was old and well-known at the time of the present invention. Images and symbols have long been used to represent selections on computer interfaces because such symbols or icons help to improve visual clarity and simplicity, may save screen space, are often universally recognized regardless of the user’s native language, and may be more aesthetically pleasing to the eye. Lacking any criticality in using an icon to present data to a user vs. presentation of descriptive text or any other suitable manner of distinguishing between selections, those of ordinary skill in the art would have considered the use of icons to be transparently obvious.
Brink discloses that in the embodiment shown in Fig. 6, waveforms may be selected by clicking a mouse button or performing some other type of action (col. 4, lines 1-3). Brink further teaches, “[t]hose skilled in the art will appreciate that these interfaces are exemplary of a wide variety of possible user interfaces that could be used and still fall within the spirit and scope of the invention,” (col. 3, lines 45-49). Touchscreens are ubiquitous and widely used in user interfaces of all types as they allow a convenient and intuitive way to select displayed screen options and control device operation. Gerber, for example, discloses a neurostimulator device wherein pulse parameters may be selected from a user input programmer that may include buttons, a key pad, a touchscreen, soft buttons on a display, or other input media (par. 0062). Touchscreens are thus an art-recognized equivalent to buttons and/or dials. The applicant gives no criticality to this feature, and in fact, discloses that buttons or alternatively a touchscreen may be used (par. 0081). Once it has been established that a touchscreen may be used to enact control of pulse shape characteristics, it would be inherently necessary to detect when one of the defined waveforms presented on the touchscreen display is touched in order to allow the system to recognize the user’s selection.
Regarding the use of both icons and text, the examiner took Official Notice in the previous Office Action that it was old and well-known at the time of the invention to utilize both icons and text to distinguish between various user selectable options on computer screens, and gave specific examples (e.g., Apple’s Lisa computer with GUI developed in the ‘80s). It was logically reasoned that the use of text in addition to the use of an icon may help ensure that the proper symbol is being selected by the user, and that text may also help to further distinguish between similar waveforms that may have subtle distinctions difficult to see on a small symbol or difficult to characterize with a symbol, thus providing a beneficial advantage. The applicant has failed to adequately traverse this Notice. As MPEP section 2144.03, C clearly states:
To adequately traverse a finding based on official notice, an applicant must [emphasis added] specifically point out the supposed errors in the examiner’s action, which would include stating why the noticed fact is not considered to be common knowledge or well-known in the art. A mere request by the applicant that the examiner provide documentary evidence in support of an officially-noticed fact is not a proper traversal [emphasis added]. See 37 CFR 1.111(b). See also Chevenard, 139 F.2d at 713, 60 USPQ at 241. A general allegation that the claims define a patentable invention without any reference to the examiner’s assertion of official notice would be inadequate.
The applicant simply states that none of the cited references show this feature, thus amounting to a mere request by the applicant that the examiner provide documentary evidence. Lacking any adequate traversal, this feature is now considered admitted prior art. Nonetheless, the examiner has additionally provided a reference detailing the history of the computer icon, proving that the use of both icons and text have been standard practice in the computer interface arts for half a century. Lacking any criticality in one presentation format over the other, those of ordinary skill in the art would have considered it blatantly obvious to utilize text with the icons of Brink in order to take advantage of benefits discussed above.
Related comments apply to patentably indistinct claims 12 and 20. Specifically regarding the use of a non-transitory machine-readable medium (claim 20), such a feature would inherently be required in the programmable and software-controllable system of Herbst.
Regarding claims 9 and 19, given that the device of Herbst is intended to allow a user to selectively adjust stimulation appropriate to the application, the feature of allowing a user to select additional waveforms, including a second defined waveform, is considered an inherent quality of the Herbst invention. Clearly one would not design the Herbst system to only allow a single waveform choice and lock out additional changes, as such a design would defeat the entire purpose of the invention to provide a multi-functional system appropriate for whatever biological or biomedical application is of concern to the user, and to allow testing of different types of electrical stimuli in accordance with patient need (pars. 0010, 0011 and 0015).
Regarding claims 10, 11, 22 and 23, Herbst discloses that a measuring stage may be used which contains various sensors which may sense the electrical parameters of the subject being treated along with prevailing conditions (par. 0029), including the electrical property of impedance (par. 0067). The use of such sensors allows one to manually or automatically modify stimulation based on the detected parameter by way of feedback (par. 0018), thus improving the effectiveness of treatment.
Regarding claims 17 and 18, note the rejection of said claims above under §112, 1st paragraph. Herbst does not explicitly refer to the use of a button or toggle button. Herbst does, however, teach that the user may use a mechanical dial or switch, or software to control waveform selection (par. 0066). Official Notice was taken that buttons are old and well-known switching mechanisms to provide user control over selection in electronic devices with user interfaces (see also Brinks Fig. 5B who shows the use of buttons). The use of buttons provides a simple, cost-effective mechanism by which users can control device operation (e.g., a standard computer keyboard, or software created keyboard). Those with visual impairments or who lack coordination, may find physical buttons easier to use than a touchscreen display. Additionally, toggle buttons have the known advantage of visually indicating their state so as to effectively appraise the user of selected conditions, and are old and well-known in the computer software arts. Lacking any criticality in one input mechanism over the other, those of ordinary skill in the art would have considered it transparently obvious to utilize the well-known button, toggle button, or any other recognized selection switch equivalent, for waveform selection purposes. The applicant has failed to traverse this Official Notice. The features are now considered admitted prior art.
Regarding claims 24-31 and the particular form of neurostimulation, Herbst discloses that their invention generally relates to electrical stimulation devices, and more particularly, a multi-functional system capable of selectively applying stimulation signals for a broad spectrum of different biological and bio-medical applications (par. 0004). Clearly a fair reading of Herbst would not limit the invention to any one particular format. Any application requiring testing of stimulus or user selection of pulse characteristics to determine the most effective and appropriate stimulation parameters, would benefit from the control afforded by Herbst. Common sense requires any medical stimulator device to be tested, fitted and adjusted to best meet the needs of the patient through the course of their treatment. Providing such a capability on spinal cord, deep brain, peripheral nerve, or functional nerve stimulators is no exception as proper management of stimulation parameters is critical. It would have therefore been considered obvious to anyone of ordinary skill in the medical arts to include the ability to adjust stimulation shape parameters on any neurostimulation system including spinal cord, deep brain, peripheral nerve and functional nerve stimulation applications, in order to optimize stimulation effects. The applicant, in fact, states that it is to be understood that the invention is not limited to any one type of stimulator, but may be used with a wide variety of stimulators including stimulators for adaptively controlling pulse parameters in order to prevent urinary incontinence such as disclosed by Gerber.
Response to Arguments
Applicant's arguments filed January 27, 2026 have been fully considered but they are not persuasive.
The amendment has not removed the obviousness-type double patenting rejections as indicated above.
Regarding the rejection of claims on prior art, the applicant argues that neither Herbst nor Brink use a touchscreen. The use of a touchscreen is considered an obvious equivalent to the use of buttons or a mouse (see Gerber reference) as argued in detail above.
The applicant additionally argues that Herbst only discloses multi-functional electrical stimulation and Brink refers to a defibrillation waveform. It is argued that neither include neurostimulation. This is not convincing because as indicated in the rejection above, Herbst discloses delivering neurostimulation (par. 0007; electrical stimulation to effect nerve regeneration) to one or more electrical terminals in accordance with the defined waveform (par. 0018; electrical stimulation). Herbst further suggests that direct cortical stimulators may benefit (par. 0009). Furthermore, the applicant discloses that the invention is not limited to any one application, and that neurostimulation systems include in its broadest sense defibrillation (pars. 0003 and 0040). It is also noted that Gerber discloses a neurostimulator for preventing urinary incontinence and which allows for pulse parameter adjustment. The applicant discloses that urinary incontinence devices are to be considered neurostimulators (par. 0040). Clearly those of ordinary skill in the art would have regarded the teachings of Herbst to apply to any electrical stimulation system including neurostimulators, as control of pulse parameters in these devices is no less critical to optimizing therapy effectiveness.
Regarding the presentation of both icons and text, such a limitation is considered admitted prior art as the applicant has not adequately traversed the Official Notice as required by MPEP 2144.03, C (see rejection and MPEP section quoted above). In any event, the examiner has provided a reference discussing the history of the icon, where both icons and text have been used for the past half century in computerized user interfaces. The use of both icons and text to present at least two defined waveforms would have been considered blatantly obvious by any artisan of ordinary skill.
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 KENNEDY SCHAETZLE whose telephone number is (571)272-4954. The examiner can normally be reached 2nd Monday of the biweek and W-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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/KENNEDY SCHAETZLE/Primary Examiner, Art Unit 3796
KJS
June 5, 2026
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