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
Color photographs and color drawings are not accepted in utility applications unless a petition filed under 37 CFR 1.84(a)(2) is granted. Any such petition must be accompanied by the appropriate fee set forth in 37 CFR 1.17(h), one set of color drawings or color photographs, as appropriate, if submitted via the USPTO patent electronic filing system or three sets of color drawings or color photographs, as appropriate, if not submitted via the via USPTO patent electronic filing system, and, unless already present, an amendment to include the following language as the first paragraph of the brief description of the drawings section of the specification:
The patent or application file contains at least one drawing executed in color. Copies of this patent or patent application publication with color drawing(s) will be provided by the Office upon request and payment of the necessary fee.
Color photographs will be accepted if the conditions for accepting color drawings and black and white photographs have been satisfied. See 37 CFR 1.84(b)(2).
Claim Objections
Claim 67, the limitation “the amount of the at least one of the sodium channel blocker and the anesthetic amount” should be “the amount of the substance comprising at least one of the sodium channel blocker and an anesthetic”.
Claim 72 is objected to because of the following informalities: the limitation “upper extremity” should be “the upper extremity”; “thigh, knee, leg, ankle and foot” should be “the thigh, the knee, the leg, the ankle, and the foot”; “neck, chest wall and abdominal wall” should be “the neck, the chest wall and the abdominal wall”; “thoracic, lumbar, and sacral regions” should be “the thoracic, the lumbar, and the sacral regions” for consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 60-74 are 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.
Regarding claim 60, the limitation “proximate a nerve trunk” renders the claims indefinite because its unclear how “proximate” to the nerve trunk the catheter must be in order to infringe on the claims.
Regarding claim 60, the limitation “at least one or more electrodes” at line 9 renders the claim indefinite because its unclear whether this is the electrodes at line 5 or not.
Regarding claim 60, the limitation “an amount of substance” at lines 9-10 renders the claim indefinite because its unclear if this is the amount substance referred to at line 7 or not.
Regarding claim 62, the limitation “the at least one electrode” renders the claim indefinite because its unclear which electrode is being referred to. Claim 60 refers to “at least one or more electrodes” at two separate locations and its unclear which electrodes are being referred to and how many.
Regarding claim 64, the limitation “one of the electrodes” renders the claim indefinite because its unclear if this is one of the previous electrodes claimed or not and how many electrodes are being claimed. The two previous recitations recite at least one or more electrodes where it is unclear how many electrodes are being required. Additionally, the recitation “(tip)” renders the claim indefinite because its unclear whether the distal end is required to be a tip or not.
Regarding claim 65, the limitation “the delivery of the amount of substance” renders the claim indefinite because its unclear whether the step is being positively recited or not. Claim 60 recites a method where a catheter is implanted adjacent to a nerve trunk and the catheter is configured to deliver an amount of substance, but the substance is not positively recited as being delivered. Claim 65 recites the step of deliver where its unclear the step actually exists.
Regarding claim 71, the limitation “(innervation)” renders the claim indefinite because its unclear whether the limitation is being recited and what is being required from the term.
Regarding claim 73, the limitation “persistent” and “chronic” renders the claim indefinite because its unclear how persistent or chronic the pain must be to infringe the limitation.
Claims dependent thereon are rejected for the same reasons.
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) 60-61, 63-67, 71-73 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Meyer US 6,298,256.
Regarding claim 60, Meyer discloses an apparatus, the normal operation of which yields a pain management method comprising: implanting a first catheter 3 at a first location, shown in fig. 3, such that a distal end of the first catheter is proximate a nerve trunk of a patient, the distal end 12 is adjacent to the nerve P as claimed; wherein the first catheter: includes at least one or more electrodes 12a configured to provide a pulsed electrical current to and/or around the nerve trunk, see col. 5, line 62-col. 6, line 3, the electrode is configured to supply electrical current to the electrode 12a and thus is capable of providing pulsed electrical current to and/or around the nerve trunk, is configured to deliver an amount of a substance to and/or around the nerve trunk, see col. 6, lines 23-33 stating that the injection 2 is configured to supply a local anesthetic, and includes at least one or more electrodes 12a configured to deliver an amount of substance to and/or around the nerve trunk, id.
Regarding claim 61, Meyer discloses the first catheter is configured to deliver an anesthetic to and/or around the nerve trunk. Id.
Regarding claim 63, Meyer discloses the first catheter includes a removable needle 1 with a lumen, see fig. 2 the lumen has an opening in which catheter 3 remains.
Regarding claim 64, Meyer discloses one of the electrodes comprises the distal end (tip) of the needle. See fig. 2, element 12a.
Regarding claim 65, Meyer discloses a catheter that is capable of delivering an amount of substant that can close the molecular gate of the sodium channel in the axonal membrane of the nerve trunk. The catheter is configured to deliver an anesthetic and thus is capable of delivering any substance including a sodium channel blocker.
Regarding claim 66, Meyer discloses the substance comprises at least one of a sodium channel blocker and an anesthetic. See col. 6, lines 23-33 stating the substance is an anesthetic.
Regarding claim 67, Meyer discloses an apparatus that is capable of delivering an amount of the at least one of the sodium channel blocker and the anesthetic amount of the anesthetic between 0.5-30 ml. Meyer disclose an catheter that can be used to deliver any amount of anesthetic of sodium channel blocker. The needle can dose as many ml as necessary if remaining in sufficient duration.
Regarding claim 71, Meyer discloses the nerve trunk contains the nerve pathway (innervation) for a body part of the patient. See col. 1, lines 12-18 stating that the surgical procedures are for upper and lower extremities.
Regarding claim 72, Meyer discloses the body part is selected from the group consisting of: upper extremity including the shoulder, the arm, the elbow, the forearm, the wrist and the hand and the lower extremity including the hip, thigh, knee, leg, ankle and foot and the spine (including the cervical, thoracic, lumbar and sacral regions of the spine) and the head and neck, chest wall and abdominal wall. Meyers discloses the body part is the upper and lower extremities. Id.
Regarding claim 73, Meyer discloses the method is performed for pain control after a surgical procedure and/or persistent pain after surgical procedure and chronic pain. Id stating the invention is drawn toward pain therapy, i.e. chronic pain.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 62, 68-70, 74 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Griffith US 5,853,373.
Regarding claim 62, Meyer discloses all elements except for the at least one electrode comprises at least a pair of electrodes.
Griffith teaches a bipolar needle comprising two electrodes 20, 36 to produce an appropriate charge pulse. See col. 6, lines 47-65.
It would have been obvious to an ordinary skilled worker to provide at least a pair of electrodes to the needle of Meyer, as taught by Griffith, in order to provide an appropriate charge pulse. Id. The charge pulse would facilitate location of a nerve. See col. 3, lines 36-49.
Regarding claim 68-70, 74, Meyer discloses all elements but does not disclose any details of the electrical current applied and thus does not teach the delivery of the pulsed electrical current is configured to close the synaptic gate in the dorsal horn of the spinal cord; the pulsed electrical current comprises a current of between 0.1 and 20 milliamps; the pulsed electrical current includes pulses of between 0.1 and 1.0 millisecond; the pulsed electrical current is supplied via a pulse generator.
Griffith teaches an electrical charge for nerve location and blocking similar to Meyer should be applied in pulses by a pulse generator 53, see fig. 5, where the current should be applied at about .5 mA and pulses of 0.1-0.2 ms. See col. 3, lines 12-35. The preferred electric current application allows for location of the targeted nerve. See col. 3, lines 36-49.
It would have been obvious to an ordinary skilled worker to provide a pulse generator configured to apply a current as claimed in the apparatus of Meyer, as taught by Griffith, in order to locate a targeted nerve. Id. With regard to the limitation that the electrical current is configured to close the synaptic gate in the dorsal horn of the spinal cord, Meyer, in view of Griffith, discloses a current within the range of the claimed current and therefore is interpreted as capable of closing the synaptic gate.
Claim(s) 65-67 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meyer in view of Theile “Recent developments regarding voltage gated sodium channel blockers for the treatment of inherited and acquired neuropathic pain syndromes”.
Regarding claims 65-67, Meyer discloses all elements except for a sodium channel blocker. Meyer only generally refers to the use of an anesthetic.
Theile teaches a novel strategy for localized anesthesia via selective inhibition of nociceptive fibers and the use of lidocaine, i.e. a sodium channel blocker and QX-314, i.e. another sodium channel blocker produces long lasting differential nerve block better than lidocaine alone and without initial irritation induced by capsaicin administration. See page 6.
It would have been obvious to an ordinary skilled worker to provide a sodium channel blocker as the anesthetic of Meyer, as taught by Theile, in order to provide long lasting differential nerve block. Id. The use of the sodium channel blocker is interpreted as being configured to close the molecular gate of the sodium channel in the axonal membrane of the nerve trunk and would be capable of delivering 0.5-30 ml of lidocaine and QX-314.
Conclusion
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/GERALD L SUNG/Primary Examiner, Art Unit 3741