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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the rectifiers discussed in claim 28 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 40 is objected to because of the following informalities: the word “treats” on line 2 should be changed to the word “treat.” 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.
Claim 33 is 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 recited result of providing OD-ENB without production of irreversible Faradaic reaction products at the neural tissue is not adequately described in the disclosure. The applicant states that using a DC waveform can be used to prevent the reaction via manipulation of the DC waveform (par. 0035), but does not elaborate on what the manipulation of the DC waveform entails. It is noted that the applicant describes the types of materials that may be used to prevent the reaction (par. 0045), but not the type of DC waveform manipulation. If the applicant is ascribing the desired result to the use of the materials cited in claim 32, then the claim fails to further limit claim 32 (see rejections below).
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.
Claim 33 is 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.
The scope of claim 33 is unclear. Claim 33 merely indicates a desired result to be achieved by the invention. Presumably, the desired feature expressed in claim 33 is the result of the electrode material used and recited in claim 32. If so, then the claim fails to further limit claim 32. If not, then it is unclear what structural feature is being relied upon to bring about this desired result.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 25 and 33 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 25, claim 1 already requires a wireless connection between the capsule and the external power source, with the powering/communication component configured to receive a power signal via communication with the external power source. It is therefore unclear what further distinction is being presented in claim 25 which states that the powering/communication component is configured to receive the power signal from the external power source wirelessly. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Regarding claim 33, note the comments made in the rejection of said claim under 112(b).
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,617,884. Although the claims at issue are not identical, they are not patentably distinct from each other because, except as specifically indicated below, the present invention's claims are merely broader in scope than the patented claims. 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)).
Regarding claim 28, while the use of a power transfer rectifier or a shunt rectifier is not recited in the ‘884 invention, Official Notice is taken that power transfer or shunt rectifiers are old and well-known in the art of wireless power transfer. Such means allow for AC signals such as those suitable for wireless communication, to be converted into DC signals, thus enabling the converted signal to be directly applied in any application requiring DC current. To utilize such rectifiers to provide the requisite DC blocking signal in the wireless, battery-less neuromodulation device of the ‘884 invention would have been obvious to those of ordinary skill in the art.
Regarding claims 29, 30, 36 and 37, while the ‘884 patent does not recite the use of DC set points controlled by a controller, it would have been obvious to one of ordinary skill in the art to control DC set points in order to precisely and safely control stimulation in a consistent, medically appropriate manner.
Regarding claim 34, although it is not explicitly stated that the applied nerve blocking signal of the ‘884 invention is used to treat pain, Official Notice is taken that it is old and well-known to use nerve blocking signals to block pain in the neurostimulation art. Clearly preventing a sensory nerve from transmitting its signal to the brain by using a blocking signal would prevent or reduce any sensations of pain in the brain. Treating pain by blocking sensory nerve transmissions would have therefore been considered obvious by those of ordinary skill in the art.
Regarding claim 38, while the ‘884 invention does not discuss treatment times, those of ordinary skill in the art would have considered the exact time of treatment to depend upon the condition of the patient, the severity of pain, the type of nerve stimulated, the location of the nerve and the expertise of the physician under whose care the patient resides. Routine clinical experimentation would dictate the necessary stimulation times for optimal treatment.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 12,246,174. Although the claims at issue are not identical, they are not patentably distinct from each other because, except as specifically indicated below, the present invention's claims are merely broader in scope than the patented claims. 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)).
Regarding claim 28, while the use of a power transfer rectifier or a shunt rectifier is not recited in the ‘174 invention, Official Notice is taken that power transfer or shunt rectifiers are old and well-known in the art of wireless power transfer. Such means allow for AC signals such as those suitable for wireless communication, to be converted into DC signals, thus enabling the converted signal to be directly applied in any application requiring DC current. To utilize such rectifiers to provide the requisite DC blocking signal in the wireless, battery-less neuromodulation device of the ‘174 invention would have been obvious to those of ordinary skill in the art.
Regarding claims 29, 30, 36 and 37, while the ‘174 patent does not recite the use of DC set points controlled by a controller, it would have been obvious to one of ordinary skill in the art to control DC set points in order to precisely and safely control stimulation in a consistent, medically appropriate manner.
Regarding claim 31, while the ‘174 patent indicates that the device is powered from an external power source, it does not explicitly state that the capsule comprises no internal power source. Given that power can be provided by an external source on demand, those of ordinary skill in the art would have understood that an internal power source was optional as it is not necessary to power the device. Further, incentive to make the implantable capsule unobtrusive in size would have led artisans to the obvious conclusion that elimination of any internal power source would be desirable in the pursuit of this art-recognized general goal.
Regarding claim 38, while the ‘174 invention does not discuss treatment times, those of ordinary skill in the art would have considered the exact time of treatment to depend upon the condition of the patient, the severity of pain, the type of nerve stimulated, the location of the nerve and the expertise and experience of the physician under whose care the patient resides. Routine clinical experimentation would ultimately dictate the necessary stimulation times for optimal treatment.
Claim Rejections - 35 USC § 102
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 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) 21-25, 27-31, 34, 36, 37 and 40 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by O’Handley et al. (O’Handley: Pub. No. 2009/0062886).
Regarding claim 21 (with related comments applying to similarly worded and patentably indistinct method claim 35), O’Handley discloses a system comprising: an external power source 81; and an implantable capsule (pars. 0020 and 0022, encapsulated implanted ME sensor/transducer with stimulation capabilities in the form of a pellet) located proximal to neural tissue and wirelessly coupled to the external power source (see for example pars. 0017-0020, 0024), the implantable capsule comprising: at least one blocking electrode (any of the opposing electrodes of the system across which the voltage 87 or like voltage is applied and capable of providing the blocking discussed in pars. 0181, 0182); and a powering/communication component (sensor/transducer 86 or the like) configured to communicate with the external power source to receive a power signal to power at least a portion of the implantable capsule (see at least pars. 0012, 0018 and 0022), wherein, when powered, the implantable capsule is configured to deliver a direct current (DC) to at least a portion of the neural tissue (see pars. 0011, 0145) to provide an on- demand electrical nerve block (OD-ENB) to at least partially block a neural signal transmitted through the nervous tissue (stimulation may be provided on an “as need” basis for immediate use without the need for storage batteries, see pars. 0020, 0024, 0147).
Regarding claim 22, see par. 0022. The implantable electrodes used to conduct the stimulation currents used by the invention are considered to inherently comprise a conducting material.
Regarding claim 23, note the comments above regarding nerve blocking and the use of conductive materials. Any stimulation signal applied via the electrodes as described, is considered to constitute a “blocking electrode contact” that is conductive.
Regarding claim 24, a closed loop is required in order for the required stimulation current to be generated. It is therefore inherent that one of the two disclosed electrodes comprise a return electrode.
Regarding claim 25, see at least par. 0018.
Regarding claim 27, note par. 0018 and the use of a magnetostrictive-electroactive (ME) magnetic field element used to wirelessly receive power for generation of DC (see pars. 0011, 0145).
Regarding claim 28, rectifier 72 is considered a power transfer rectifier or a shunt rectifier.
Regarding claims 29, 30, 36 and 37, O’Handley discloses that a controller may be employed to control the various stimulation parameters including current density (which may include DC as discussed above) and thus the power in order to provide stimulation that is safe and efficacious with minimal discomfort to the patient (pars. 0019, 0021 and 0023). Any control feature allowing setting or adjusting of the parameters of the stimulation signal is considered to contain a “set point.”
Regarding claim 31, note par. 0147 wherein the O’Handley system does not require batteries (i.e., an internal power source).
Regarding claim 34, see at least pars. 0024 and 0182.
Regarding claim 40, see the rejection of related claim 34.
Claim(s) 21-30, 32, 33, 35-37 and 39 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Schulman et al. (Schulman: Pat. No. 5,193,539).
Regarding claim 21 (with related comments applying to patentably indistinct method claim 35), Schulman discloses a system comprising: an external power source (element 61 or equivalent structure); and an implantable capsule (see at least Fig. 8) located proximal to neural tissue (col. 4, lines 20-31) and wirelessly coupled to the external power source (see at least Fig. 10), the implantable capsule comprising: at least one blocking electrode (either of electrode 14 or 15; see also text abridging cols. 9 and 10); and a powering/communication component (inductively coupled coil 11 and associated circuitry) configured to communicate with the external power source to receive a power signal to power at least a portion of the implantable capsule (see Figs. 1, 2, 10), wherein, when powered, the implantable capsule is configured to deliver a direct current (DC) (see col. 2, lines 54-65 and the discussion of Fig. 3, with the rectified signal representing a DC signal) to at least a portion of the neural tissue to provide an on-demand electrical nerve block (OD-ENB) to at least partially block a neural signal transmitted through the nervous tissue (see col. 1, line 64- col. 2, line 19 with the stimulation provided through external control and allowing the patient the ability to suppress their disorders or symptoms immediately with no systemic side effects other than inactivation/blocking of the targeted nerve, and the text abridging cols. 9 and 10 with reference to nerve blocking).
Regarding claim 22, see at least Fig. 8 which shows an implantable capsule with external biocompatible shell portion (implantable housing 72 inherently required to be biocompatible), and a conducting portion comprising conductive material (i.e., electrodes).
Regarding claim 23, given that the Schulman device is designed to achieve anodal block of nerve axons using DC as discussed above, any electrode applying the stimulation is considered a blocking electrode.
Regarding claim 24, for a current to be generated as disclosed, one of electrodes 14 or 15 located on either side of the housing must receive a return current.
Regarding claims 25, 26 and 39, see Figs. 2 and 10.
Regarding claims 27 and 28, see the discussion of power rectification associated with the circuit of Fig. 3.
Regarding claims 29, 30, 36 and 37, the device of Schulman may receive “DC set points” via an external controller as discussed in col. 2, lines 5-19, and col. 4, lines 12-35, where the set points are used to dictate stimulation parameters such as amplitude, pulse duration, pulse width, etc.
Regarding claim 32, Schulman discloses that the electrodes by their structure form a capacitor (see Fig. 2; element 20 and associated text). The electrodes are therefore considered to comprise a high charge capacity material.
Regarding claim 33, note the rejection of said claim above under §112. The high charge capacity electrodes of Schulman are considered to avoid irreversible Faradaic reaction products. It is further noted that Schulman teaches that the system is charge balanced and does not cause anodic or cathodic deterioration of the electrodes or damage to body tissue (see col. 2, lines 20-25). Charge balancing is considered to prevent production of irreversible Faradaic reaction products at body tissue locations when implanted.
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 following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over O’Handley ‘886.
Regarding method claim 38, O’Handley teaches that due to the efficiency of the stimulator, the device may provide continuous stimulation for 2 minutes or more (par. 0193). While such a time period is discussed in relation to bone growth stimulation, artisans of ordinary skill in the art would have reasonably considered the efficiency of the stimulator’s power system to also apply when performing nerve blocking. Clearly the exact length of treatment time would, as already discussed above, depend upon the condition of the patient, the severity of pain, the type of nerve stimulated, the location of the nerve and the expertise and experience of the physician under whose care the patient resides. Routine clinical experimentation would ultimately dictate the necessary stimulation times for optimal treatment. The applicant only references 2 minutes or more as a non-limiting example, along with 5 or more minutes and 10 or more minutes (see par. 0038 of the present specification). The open-ended limitations would include time periods of days, weeks or months –all well-within the capabilities of the O’Handley system (see for example pars. 0113 and 0185 which provides for therapy on an as-needed basis). Those of ordinary skill in the art would have therefore considered the time of 2 minutes or more in nerve blocking applications to be a matter of obvious design.
Conclusion
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.
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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
August 22, 2026
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