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 not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. 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.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
Pursuant to 37 C.F.R. 1.84(b)(1), the drawings appear to be photocopies of photographs which are not ordinarily permitted unless the only practicable medium. The Examiner notes that at any rate, because the drawings appear to be photocopies of photographs, the drawings are not of sufficient clarity so that the text and elements are legible.
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 “adjacent to a nerve trunk” renders the claims indefinite because its unclear how “adjacent” to the nerve trunk the catheter must be in order to infringe on the claims. The Applicant substitutes one relative term “proximate” with another “adjacent” without providing any meaningful discussion as to how close the catheter must be to the nerve trunk to infringe the claims. In fact, the specification appears to be devoid of any and all discussion of how adjacent the catheter must be and therefore, an ordinary skilled worker would not understand how close to the nerve the catheter can be without infringing the claim scope.
Regarding claim 73, the limitation “persistent” renders the claim indefinite because its unclear how persistent 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, 63-64, 66-67, 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 12, 3 at a first location, shown in fig. 3, such that a distal end of the first catheter is adjacent 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, and 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.
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 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. With regard to the dosing of .5-30 ml, Theile states that the combination of .5% QX-314 and 2% lidocaine administered near the sciatic nerve produced 1h of non-selective sensory and motor block followed by more than 9h of pain selective block. See page. 6. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In order to properly support a rejection on the basis that an invention is the result of “routine optimization”, the examiner must make findings of relevant facts, and present the underpinning reasoning in sufficient detail. The articulated rationale must include an explanation of why it would have been routine optimization to arrive at the claimed invention and why a person of ordinary skill in the art would have had a reasonable expectation of success to formulate the claimed range. See In re Stepan, 868 F.3d 1342, 1346, 123 USPQ2d 1838, 1841 (Fed. Cir. 2017). See also In re Van Os, 844 F.3d 1359,1361,121 USPQ2d 1209, 1211 (Fed. Cir. 2017). Here, Theile teaches the dosing of the medication affects the sensory and pain block. See Theile page 6. Thus, Theile teaches that the dosing is a result effective variable which controls the duration of pain and sensory blocking. Thus an ordinary skilled worker would have found it obvious to optimize the dosing of the sodium channel blocker to provide the appropriate sensory and pain block.
Response to Arguments
Applicant's arguments filed 7/8/2026 have been fully considered but they are not persuasive.
With regard to the drawings objections, the Applicant argues that no color photos appear in the application. The Examiner notes that the drawings appear to be photocopies of color photographs given the grayscale present in the drawings. Photocopies of the drawings would not be acceptable pursuant to Rule 1.84(b)(1). The drawings are because they appear to be photographs. Nevertheless, the material thrust of the objection is that the drawings are insufficient for examination since the subject matter contained in the drawings is not legible. Though the Applicant may be correct that the drawings are not color photographs and thus the basis for objection is incorrect, the material thrust of the objection remains and the Applicant is obligated to provide legible drawings for examination. Thus, the basis for objection is altered above; however, the objection remains.
With regard to the rejections under 35 U.S.C. 112, the Applicant argues that the amendment altering “proximate” to “adjacent” renders the rejection moot. The Examiner disagrees. The issue presented herein is whether it is sufficiently clear to an ordinary skilled worker how close the catheter must be to the nerve to infringe on the claim scope. The specification provides no details on what is required by the term “adjacent” or how close an ordinary skilled worker may place the first catheter to the nerve trunk in order to infringe the claim limitation. Is it one inch? Two inches? Etc.? The Applicant’s rebuttal should include some indication of how close the catheter must be to infringe the claims. The limitation is otherwise rejected in view of the absence of such rebuttal.
The Applicant argues that the prior art Meyer does not disclose that a single element satisfies both limitations of having at least one electrode and delivering a substance. The Applicant appears to distinguish the prior art by identifying the needle as a separate element from the catheter. The Examiner disagrees. The claim states that a first catheter includes at least one electrode and is configured to deliver an amount of substance. The Applicant does not recite that the catheter only includes a flexible tubing and not the needle. In fact, claim 63 expressly recites the first catheter a removable needle. Thus, the needle is interpreted as a part of the catheter consistent with the Applicant’s own usage. Furthermore, the broadest reasonable interpretation of a catheter includes at least a needle since the term catheter means “a tubular medical device for insertion into canals, vessels, passageways, or body cavities usually to permit injection or withdrawal of fluids or to keep a passage open.” See Merriam-Webster. Such an interpretation appears to be substantially supported on the record as discussed in Luther US 5,531,701 showing a needle-catheter combination. Furthermore, the Examiner notes that no recitation appears to require the recited functional elements be contained to a single piece. While the recitations are recited to be in the catheter, the claims do not limit elements where the catheter is rigid, as in Meyer fig. 1 or composed of several elements as shown in Meyer fig. 3.
Additionally, the Applicant argues that Meyer’s pulsed electricity is for nerve location and not for therapeutic purposes. The Examiner notes that no claim limitation even recites the term “therapeutic”. Furthermore, arguably, locating the nerve via electric pulse in order to deliver pain blocking substances or anesthesia is a therapeutic purpose.
For these reasons, the rejections above are maintained.
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 GERALD LUTHER SUNG whose telephone number is (571)270-3765. The examiner can normally be reached 9-5 PST.
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, Devon Kramer can be reached at (571)272-7118. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GERALD L SUNG/Primary Examiner, Art Unit 3741
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