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
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract should be in narrative form, within the range of 50 to 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 9 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 claims 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. Claims 9 and 18 recite "repeating administration of the electrical waveform at an interval not shorter than nine hours". The instant specification, regarding time intervals, recites “an interval sufficient to effect substantially immediate pain relief in the patient” ([0006], similarly in [0011], [0018], [0020]), and “The time interval may be about 10 minutes, but an interval may be selected by a magnitude sufficient to effect pain relief in the patient” ([0018], similarly in [0020]). No mention of the limitation of “an interval not shorter than nine hours” is made within the instant specification, thus there is a lack of written description support for the claims.
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 5, 10, 11 and 19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 term “administration of the electrical waveform results in a reduction of the phantom limb pain by at least 50%” in claims 5 and 19 is a relative term which renders the claim indefinite. The term “administration of the electrical waveform results in a reduction of the phantom limb pain by at least 50%” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Criteria is not given to quantify a reduction in phantom limb pain.
The term “administering the electrical waveform is more effective at relieving the phantom limb pain compared to pain medication” in claim 10 is a relative term which renders the claim indefinite. The term “administering the electrical waveform is more effective at relieving the phantom limb pain compared to pain medication” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Criteria is not given to determine the effectiveness of administering an electrical waveform versus pain medication to relieve phantom limb pain.
The term “administering the electrical waveform is more effective at relieving the phantom limb pain than spinal cord stimulation (SCS) and/or peripheral nerve stimulation (PNS)” in claim 11 is a relative term which renders the claim indefinite. The term “administering the electrical waveform is more effective at relieving the phantom limb pain than spinal cord stimulation (SCS) and/or peripheral nerve stimulation (PNS)” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Criteria is not given to determine the effectiveness of administering an electrical waveform versus than spinal cord stimulation (SCS) and/or peripheral nerve stimulation (PNS) to relieve phantom limb pain.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-8, 10-17, and 19-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kilgore et al. (US 2010/0241190).
Regarding independent claim 1, Kilgore discloses a method of blocking signal transmission through a nerve with reduced onset activity includes applying an HFAC to an axon of a nerve to block the transmission of signals through the axon. Kilgore further discloses a method of treating phantom limb pain in a patient ([0007]: “This application concerns apparatus, systems, and methods for blocking signal transmission through a nerve without generating activity in the nerve outside of the system.”), the method comprising:
administering an electrical waveform ([0025], Figs. 5-10 disclose a “HFAC waveform” or “high-frequency alternating current” waveform.) to the patient’s nerve for an interval sufficient to relieve the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”), the electrical waveform configured to block conduction of an action potential in the nerve and not generate an action potential in the nerve ([0044]: “FIG. 10 illustrates another waveform 1010 for producing a nerve block. …An HFAC waveform is started after a period where the ramped direct current is applied. The HFAC waveform has its amplitude increased until it reaches a block threshold. At this point, the DC offset is ramped down until the whole waveform is charge-balanced, thus allowing the HFAC block to be established without onset action potentials.”), wherein the electrical waveform is characterized as having a frequency between 5 kHz to 50 kHz ([0031]: “"High-frequency", as used herein with reference to alternating current (e.g., HFAC), refers to frequencies above approximately 1 kiloHertz. In some examples, high-frequency refers more specifically to 5 to 50 kiloHertz.”), and wherein the electrical waveform has a voltage between 4 V peak-to-peak (Vpp) to 20 Vpp ([0029]: “Eliminating the undesired onset entirely involves eliminating both phases of the onset response. The repetitive phase can be reduced by adjusting amplitude and frequency. For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”; [0050]: “In one example, the first amplitude and the third amplitude are in the range of 4 volts peak-to-peak to 10 volts peak-to-peak.”) or a current between 4 mA peak-to-peak (mApp) to 26 mApp.
Regarding claim 2, Kilgore discloses that the electrical waveform is applied to the patient’s nerve at a site proximal to a neuroma ([0034]: “The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”; see Fig. 2 below, showing treatment to a “missing” or “damaged” appendage.).
PNG
media_image1.png
383
449
media_image1.png
Greyscale
Regarding claim 3, Kilgore discloses that the electrical waveform is applied to the patient’s sciatic or tibial nerve ([0032]: “Examples described herein may have application in areas including motor nerve block, sensory nerve block, and autonomic block.”; Note that the sciatic and tibial nerve(s) are motor and sensory nerves, thus a motor nerve block or sensory nerve block would affect these nerves.).
Regarding claim 4, Kilgore discloses that the electrical waveform is administered by an electrode implanted in the patient (blocking electrode 32 in Fig. 2; [0034]: “Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”).
Regarding claim 5, Kilgore discloses that administration of the electrical waveform results in a reduction of the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”); [0050]; [0054]: “…method 1200 provides a combination of the DC and the HFAC in an order that reduces an onset activity that is observed in the nerve either proximally or distally to the blocking electrode or electrodes.”) by at least 50%.
Regarding claim 6, Kilgore discloses that the electrical waveform is a sinusoidal waveform ([0029]: “For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”).
Regarding claim 7, Kilgore discloses that the electrical waveform is applied to the patient’s nerve via a plurality of electrodes ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 8, Kilgore discloses the plurality of electrodes are part of a nerve cuff wrapped around the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 10, Kilgore discloses that administering the electrical waveform is more effective at relieving the phantom limb pain compared to pain medication ([0005]: “…drug treatments may have produced unwanted side-effects, may have acted globally on the body rather than specifically on a specific nerve, and may have been neither quick acting nor quickly reversible.”).
Regarding claim 11, Kilgore discloses that administering the electrical waveform is more effective at relieving the phantom limb pain than spinal cord stimulation (SCS) and/or peripheral nerve stimulation (PNS) ([0005]).
Regarding independent claim 12, Kilgore discloses a method for treating phantom limb pain in a patient ([0007]: “This application concerns apparatus, systems, and methods for blocking signal transmission through a nerve without generating activity in the nerve outside of the system.”), the method comprising:
administering an electrical waveform ([0025], Figs. 5-10 disclose a “HFAC waveform” or “high-frequency alternating current” waveform.) to the patient’s nerve for an interval sufficient to relieve the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”), the electrical waveform applied via an electrode that is in contact with the patient’s nerve (blocking electrode 32 in Fig. 2; [0034]: “Apparatus 30 comprises an HFAC blocking electrode 32 and an implantable controller 34. The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”), wherein the electrical waveform is configured to block conduction of an action potential in the nerve and not generate an action potential in the nerve ([0044]: “FIG. 10 illustrates another waveform 1010 for producing a nerve block. …An HFAC waveform is started after a period where the ramped direct current is applied. The HFAC waveform has its amplitude increased until it reaches a block threshold. At this point, the DC offset is ramped down until the whole waveform is charge-balanced, thus allowing the HFAC block to be established without onset action potentials.”), wherein the electrical waveform is characterized as having a frequency between 5 kHz to 50 kHz ([0031]: “"High-frequency", as used herein with reference to alternating current (e.g., HFAC), refers to frequencies above approximately 1 kiloHertz. In some examples, high-frequency refers more specifically to 5 to 50 kiloHertz.”), and wherein the electrical waveform has a voltage between 4 V peak-to-peak (Vpp) to 20 Vpp ([0029]: “Eliminating the undesired onset entirely involves eliminating both phases of the onset response. The repetitive phase can be reduced by adjusting amplitude and frequency. For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”; [0050]: “In one example, the first amplitude and the third amplitude are in the range of 4 volts peak-to-peak to 10 volts peak-to-peak.”) or a current between 4 mA peak-to-peak (mApp) to 26 mApp.
Regarding claim 13, Kilgore discloses that the electrical waveform is applied to the patient’s sciatic or tibial nerve ([0032]: “Examples described herein may have application in areas including motor nerve block, sensory nerve block, and autonomic block.”; Note that the sciatic and tibial nerve(s) are motor and sensory nerves, thus a motor nerve block or sensory nerve block would affect these nerves.).
Regarding claim 14, Kilgore discloses that the electrical waveform is applied to a neuroma ([0034]: “The blocking electrode 32 may be positioned adjacent to a nerve proximal to a neuroma.”; Fig. 2).
Regarding claim 15, Kilgore discloses that the electrode is a cuff electrode that is wrapped around the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 16, Kilgore discloses that the electrode has multiple conductive contact points that contact the patient’s nerve ([0039]: “…in one example the DC electrodes and the HFAC electrodes may be combined into a single five-pole nerve cuff electrode. This five-pole nerve cuff electrode may include two outer electrodes for direct current and three inner electrodes for HFAC. A further form of the electrode may utilize a three-pole nerve cuff electrode in which the DC and HFAC are superimposed on the outer electrodes.”).
Regarding claim 17, Kilgore discloses that the electrical waveform is generated by an external waveform generator ([0034]: “In this application, the nerve block can be delivered continuously, can be triggered using an external signal device 36, and so on.”).
Regarding claim 19, Kilgore discloses that administration of the electrical waveform results in a reduction of the phantom limb pain ([0034]: “FIG. 2 illustrates an apparatus 30 used, for example, to block neuroma pain, pain associated with a missing appendage, pain associated with a damaged appendage, and so on.”); [0050]; [0054]: “…method 1200 provides a combination of the DC and the HFAC in an order that reduces an onset activity that is observed in the nerve either proximally or distally to the blocking electrode or electrodes.”) by at least 50%.
Regarding claim 20, Kilgore discloses that the electrical waveform is a sinusoidal waveform ([0029]: “For example, a 30 kilohertz, 10 volts peak-to-peak sinusoidal waveform may eliminate the repetitive phase.”).
Claim Rejections - 35 USC § 103
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.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Kilgore in view of Donders et al. (US 2007/004300, hereinafter referred to as Donders).
Regarding claim 9, Kilgore is silent to repeating administration of the electrical waveform at an interval not shorter than nine hours.
However, Donders teaches an apparatus for applying a signal to a nerve for the treatment of a disorder. Donders further teaches repeating administration of the electrical waveform at an interval not shorter than nine hours ([0054]: “For example, duty cycle could be applied for a 12-hour period associated with daytime and be continually off with a 12-hour period associated with the evening or during sleep hours.”).
Donders teaches a similar pursuit to that of the instant application and Kilgore in applying a signal to a nerve for the treatment of a disorder. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Kilgore to include administering an electrical waveform at an interval not shorter than nine hours in order to sufficiently effect pain relief in the patient.
Regarding claim 18, in view of the Kilgore/Donders combination, Kilgore is silent to repeating administration of the electrical waveform at an interval not shorter than nine hours.
However, Donders teaches an apparatus for applying a signal to a nerve for the treatment of a disorder. Donders further teaches repeating administration of the electrical waveform at an interval not shorter than nine hours ([0054]: “For example, duty cycle could be applied for a 12-hour period associated with daytime and be continually off with a 12-hour period associated with the evening or during sleep hours.”).
Donders teaches a similar pursuit to that of the instant application and Kilgore in applying a signal to a nerve for the treatment of a disorder. Therefore, it would have been obvious to one having ordinary skill in the art at the effective filing date of the invention to modify the invention of Kilgore to include administering an electrical waveform at an interval not shorter than nine hours in order to sufficiently effect pain relief in the patient.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mrva et al. (US 2006/0030919);
Hoffer et al. (US 7,302,296);
Kilgore et al. (US 7,389,145); and
Boggs, II et al. (US 2010/0152809).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARY G SCHLUETER whose telephone number is (703)756-4601. The examiner can normally be reached M-F 9:00am-5:30pm EST.
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, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/M.G.S./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796