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 .
Specification
The disclosure is objected to because of the following informalities: Paragraph [0001] recites related applications that have matured into patents the paragraph should be updated with the issued patent number. Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2006/0004423 to Boveja et al. (Boveja).
In reference to at least claim 1
Boveja discloses a system for providing electrical stimulation to biological tissue to treat one or more medical conditions (e.g. Fig. 6) comprising: one or more leads configured to be positioned in contact with or proximate to biological tissue that is proximate one or more occipital or peripheral nerves (e.g. electrode array placed proximate the occipital nerve, Figs. 5A-9B, 23, 32); an implantable pulse generator configured to deliver electrical stimulation to the biological tissue via the one or more leads (e.g. implantable pulse generator, Figs. 22-23, paragraphs [0121]-[0124]); a power source configured to operatively connect and supply power to the implantable pulse generator (e.g. power source may be external, implantable or a combination device, paragraph [0116]); and one or more processors configured to operate the implantable pulse generator to deliver the electrical stimulation via a stimulation waveform (e.g. logic/control unit and microprocessor, 100/102, 398, paragraphs [0165], [0175]) wherein stimulation waveform comprises a series of stimulation pulses that vary over time to reduce an effect of neural accommodation or adaptation (e.g. rectangular and/or complex electrical pulses, Figs. 34B-34N).
In reference to at least claim 2
Boveja discloses wherein at least one of an inter-pulse frequency, a pulse amplitude, or a pulse width of the series of stimulation pulses increases over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N; paragraph [0145]).
In reference to at least claim 3
Boveja discloses wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses increases linearly over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 4
Boveja discloses wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses increases exponentially over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 5
Boveja discloses wherein at least one of an inter-pulse frequency, a pulse amplitude, or a pulse width of the series of stimulation pulses decreases over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 6
Boveja discloses wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses decreases linearly over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 7
Boveja discloses wherein the at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses decreases exponentially over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 8
Boveja discloses wherein at least one of an inter-pulse frequency, a pulse amplitude, or a pulse width of the series of stimulation pulses increases over the time, and wherein a different one of the at least one at least one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses decreases over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 9
Boveja discloses wherein the time comprises a first time period and a second time period, wherein the series of stimulation pulses is a first series of stimulation pulses over the first time period, and wherein the stimulation waveform comprises a second series of stimulation pulses over the second time period (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 10
Boveja discloses wherein a pattern of the second series of stimulation pulses matches a pattern of the first series of stimulation pulses (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 11
Boveja discloses wherein a pattern of the second series of stimulation pulses comprises an inverted pattern of a pattern of the first series of stimulation pulses (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 12
Boveja discloses wherein the stimulation waveform comprises one or more relaxation pauses between at least some of the plurality of pulses (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 13
Boveja discloses wherein the one or more processor is further configured to adjust the stimulation waveform based at least in part on at least one of user input, a time of day, a user activity level, a physiological parameter, or a predetermined pattern (e.g. “The predetermined programs stored in the external stimulator are capable of being modified through the use of a separate programming station” the programming station providing the claimed user input, paragraph [0141], physician or authorized user can make alterations to the actual parameters [0263]).
In reference to at least claim 14
Boveja discloses a method for providing electrical stimulation to biological tissue to treat medical conditions, the method comprising: selecting, using one or more processors (e.g. logic/control unit and microprocessor, 100/102, 398, paragraphs [0165], [0175]), a stimulation waveform of a plurality of stimulation waveforms that reduce an effect of neural adaption, wherein each of the plurality of stimulation waveforms comprises a series of stimulation pulses (e.g. rectangular and/or complex electrical pulses, Figs. 34B-34N); and operating, using the one or more processors (e.g. logic/control unit and microprocessor, 100/102, 398, paragraphs [0165], [0175]), an implantable pulse generator to deliver electrical stimulation to biological tissue that is proximate one or more occipital nerves (e.g. implantable pulse generator, Figs. 22-23, paragraphs [0121]-[0124]); wherein to deliver the electrical stimulation, the one or more processors (e.g. logic/control unit and microprocessor, 100/102, 398, paragraphs [0165], [0175]), causes the implantable pulse generator to apply the selected stimulation waveform via one or more leads positioned in contact with or proximate to the biological tissue (e.g. implantable pulse generator, Figs. 22-23, “implantable pulse generator (IPG)”, para. [0121]-[0124]).
In reference to at least claim 15
Boveja discloses wherein at least one of an inter-pulse frequency, a pulse amplitude, or a pulse width of the series of stimulation pulses of the selected stimulation waveform increases or decreases over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 16
Boveja discloses wherein at least one of an inter-pulse frequency, a pulse amplitude, or a pulse width of the series of stimulation pulses of the selected stimulation waveform increases over the time, and wherein a different one of the inter-pulse frequency, the pulse amplitude, or the pulse width of the series of stimulation pulses of the selected stimulation waveform decreases over the time (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 17
Boveja discloses wherein the time comprises a first time period and a second time period, wherein the series of stimulation pulses is a first series of stimulation pulses over the first time period, and wherein the selected stimulation waveform comprises a second series of stimulation pulses over the second time period (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 18
Boveja discloses wherein a pattern corresponding to the first second series of stimulation pulses matches a pattern corresponding to the second series of stimulation pulses (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 19
Boveja discloses wherein the selected stimulation waveform comprises one or more relaxation pauses between at least some of the plurality of pulses (e.g. rectangular and/or complex electrical pulses, Figs. 15A-15B, 34B-34N and associated paragraphs [0144]- [0145], [0201]-[0209]).
In reference to at least claim 20
Boveja discloses wherein the selection is based at least in part on at least one of a user input, a time of day, a user activity level, a physiological parameter, or a predetermined pattern (e.g. “The predetermined programs stored in the external stimulator are capable of being modified through the use of a separate programming station” the programming station providing the claimed user input, paragraph [0141], physician or authorized user can make alterations to the actual parameters [0263]).
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 1-11,13-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11,13 and 16-18 of U.S. Patent No. 11,779,755. Although the claims at issue are not identical, they are not patentably distinct from each other because both the claims in the instant application and U.S. Patent No. 11,779,755 recite almost identical system and method claims for providing electrical stimulation to biological tissue proximate one or more occipital or peripheral nerves. The claims in the instant application are more generic, e.g. do not require a motion sensor or the one or more processors being configured to identify major variations and minor variations in the raw patient signal corresponding to one or more forces to which the body is exposed, wherein the major variations correspond to a signal of interest portion including physiologically significant information from the raw patient signal, and wherein the minor variations correspond to minute physiologically least significant information of an unwanted or left over signal portion of the raw patient signal, periodically capture and extract insignificant data from minor variations that correspond to minute physiologically least significant information of the unwanted or left over signal portion of the raw patient signal unrelated to physiologically significant major variations of the signal of interest portion, wherein the insignificant data is limited to being extracted from portions corresponding to the minor variations, wherein the insignificant data is used to generate a stimulation signal by tuning a stimulation waveform according to the minor variations in the raw patient signal and utilizing the insignificant data to generate a stimulation signal by tuning a stimulation waveform according to the minor variations in the raw patient signal, than the species claims within U.S. Patent No. 11,779,755. The generic claims recited in the instant application fall within the scope of the species claims within U.S. Patent No. 11,779,755 and therefore are fully anticipated by the species claims within U.S. Patent No. 11,779,755, therefore a patent to the genus, i.e. any grant of patent in the instant application, would improperly extend the right to exclude granted by U.S. Patent No. 11,779,755, i.e. patent to the species, should the genus issues as a patent after the species, see MPEP 804.
Instant Application
US Patent No 11,779,755
Analysis
Claim 1
Claim 1
Claim 1 of the instant application is fully anticipated by claim 1 within U.S. Patent No. 11,779,755. The only difference being that claim 1 within U.S. Patent No. 11,779,755 recites a motion sensor and the one or more processors being configured to identify major variations and minor variations that correspond to one or more forces to which the body is exposed and utilizing that information to tune a stimulation waveform (see further details above) and is therefore more specific than generic claim 1 of the instant application. Therefore, the scope of claim 1 within the instant application falls within the scope of claim 1 of U.S. Patent No. 11,779,755 and is fully anticipated by claim 1 of U.S. Patent No. 11,779,755.
Claim 2
Claim 2
See analysis above regarding claim 1 of the instant application. The limitations within claim 2 are fully disclosed within claim 2 of U.S. Patent No. 11,779,755.
Claim 3
Claim 3
See analysis above regarding claim 2 of the instant application. The limitations within claim 3 are fully disclosed within claim 3 of U.S. Patent No. 11,779,755.
Claim 4
Claim 4
See analysis above regarding claim 2 of the instant application. The limitations within claim 4 are fully disclosed within claim 4 of U.S. Patent No. 11,779,755.
Claim 5
Claim 5
See analysis above regarding claim 1 of the instant application. The limitations within claim 5 are fully disclosed within claim 5 of U.S. Patent No. 11,779,755.
Claim 6
Claim 6
See analysis above regarding claim 5 of the instant application. The limitations within claim 6 are fully disclosed within claim 6 of U.S. Patent No. 11,779,755.
Claim 7
Claim 7
See analysis above regarding claim 5 of the instant application. The limitations within claim 7 are fully disclosed within claim 7 of U.S. Patent No. 11,779,755.
Claim 8
Claim 8
See analysis above regarding claim 1 of the instant application. The limitations within claim 8 are fully disclosed within claim 8 of U.S. Patent No. 11,779,755.
Claim 9
Claim 9
See analysis above regarding claim 1 of the instant application. The limitations within claim 9 are fully disclosed within claim 9 of U.S. Patent No. 11,779,755.
Claim 10
Claim 10
See analysis above regarding claim 9 of the instant application. The limitations within claim 10 are fully disclosed within claim 10 of U.S. Patent No. 11,779,755.
Claim 11
Claim 11
See analysis above regarding claim 9 of the instant application. The limitations within claim 11 are fully disclosed within claim 11 of U.S. Patent No. 11,779,755.
Claim 13
Claim 13
See analysis above regarding claim 1 of the instant application. The limitations within claim 13 are fully disclosed within claim 13 of U.S. Patent No. 11,779,755.
Claim 14
Claim 16
Claim 14 of the instant application is fully anticipated by claim 16 within U.S. Patent No. 11,779,755. The only difference being that claim 16 within U.S. Patent No. 11,779,755 recites a motion sensor and the one or more processors being configured to identify major variations and minor variations that correspond to one or more forces to which the body is exposed and utilizing that information to tune a stimulation waveform (see further details above) and is therefore more specific than generic claim 14 of the instant application. Therefore, the scope of claim 14 within the instant application falls within the scope of claim 16 of U.S. Patent No. 11,779,755 and is fully anticipated by claim 16 of U.S. Patent No. 11,779,755.
Claim 15
Claim 17
See analysis above regarding claim 14 of the instant application. The limitations within claim 15 are fully disclosed within claim 17 of U.S. Patent No. 11,779,755.
Claim 16
Claim 17
See analysis above regarding claim 14 of the instant application. The limitations within claim 16 are fully disclosed within claim 17 of U.S. Patent No. 11,779,755.
Claim 19
Claim 18
See analysis above regarding claim 14 of the instant application. The limitations within claim 19 are fully disclosed within claim 18 of U.S. Patent No. 11,779,755.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2005/0102006 to Whitehurst et al. which teaches a skull-mounted electrical stimulation system. US 2005/0216070 to Boveja et al. which teaches a method and system for providing therapy for migraine/chronic headache by providing electrical pulses to vagus nerve(s). US 2006/0206165 to Jaax et al. which teaches occipital nerve stimulation to treat headaches and other conditions. US 2008/0027505 to Levin et al. which teaches a system and method for treatment of headaches.
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