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, all the limitations of claims 1, 14, 19, and the elements of claim 26 including “the light guide”, “a radiating source”, “a-laser-radiation-emitting distal portion”, “a needle”, and the location of the device 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 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 6, 9, 11, 26-28, 30-33, 36-46, and 50 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.
Claim 6 recites the limitation "through the spinous processes" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "through a spinous processes" and suggests amending.
Claim 9 recites the limitation "from the thoracolumbar fascia" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "from a thoracolumbar fascia" and suggests amending.
Claim 11 recites the limitation "both sides of the midsagittal plane" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "both sides of a midsagittal plane" and suggests amending.
Claim 26 recites the limitation "the power of laser radiation" in line 14. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "a power of laser radiation" and suggests amending.
Claim 27 is rejected based on its dependency on claim 26.
Claim 28 recites the broad limitation “a power of 1.5 to 150 mW per light guide” in line 2. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). Claim 26 recites “1 to 100 mW” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such broader language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 30-32 are rejected based on their dependency on claim 28.
Claim 33 recites the limitation "through the spinous processes" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "through a spinous processes" and suggests amending.
Claim 36 recites the limitation "from the thoracolumbar fascia" in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "from a thoracolumbar fascia" and suggests amending.
Claims 37-46 are rejected based on their dependency on claim 28.
Claim 50 recites the limitation "into the nucleus pulposus" in line 5. There is insufficient antecedent basis for this limitation in the claim. Examiner will interpret as "into a nucleus pulposus" and suggests amending.
Allowable Subject Matter
Claims 1-5, 10, 12-14, 16-19, 21-25, and 48-49 are allowed.
Claim 26 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 6, 9, 11, 27-28, 30-33, 36-46, and 50 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Reason for Indicating Allowable Subject Matter
The following is an examiner’s statement of reasons for allowance:
Examiner has found reference US 2012/0158099 Lee to disclose a method and apparatus of treating a hernia of an intervertebral disc in a patient (Para 7-8 and 46); this included a light guide inserted into the patient (Para 49-50, 59, and Figure 2B; treatment energy, i.e. light, is introduced through catheter 20), surrounding the hernia (Para 49 and 46; into the intervertebral disc; to treat a herniated disc), and laser radiation (Para 49-50, 59, and Figure 2B, element 20), the laser radiation having a specific wavelength and power. Examiner has also found supporting references RU 2277393 MAGOMAEV and RU 2368401 OLEJNIKOV to disclose some dependent claims that recited irradiation time and location. Lee, among many other references, treats a herniated disc by inserting the light guide into the nucleus pulposus as can be seen in Figure 1D, the light emission is meant to be into the disc itself. Lee discloses in Para 10 that the tissue surrounding the intervertebral disc is irradiated, however, does not disclose “positioning a laser-radiation-emitting distal portion of at least one light guide within dorsal paravertebral muscle tissue at a spinal level” and “the laser-radiation-emitting distal portion remains positioned within the dorsal paravertebral muscle tissue, irradiating the dorsal paravertebral muscle tissue with laser radiation emitted from the distal portion”. Examiner wasn’t able to find the stated limitations. Applicant’s specification discloses the desirability of introducing the laser into the specific location in the muscle versus into the disc itself and provides advantage to that configuration. Lee teaches away from that. Examiner was also unable to find “performing indirect intravascular laser blood irradiation by irradiating a carrier solution with second laser radiation while introducing the irradiated carrier solution into a vascular system of the patient” and “performing direct intravascular laser blood irradiation by directly irradiating blood of the patient within a vascular system of the patient with third laser radiation”. For this reason, claims 1-5, 10, 12-14, 16-19, 21-25, and 48-49 are allowed and claims 6, 9, 11, 26-28, 30-33, 36-46, and 50 are objected to as allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Response to Arguments
Applicant’s arguments have been fully considered but are moot because the new ground of rejection.
Refer to U.S.C. 112(b) rejections above and allowable subject matter.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AYA ZIAD BAKKAR whose telephone number is (313)446-6659. The examiner can normally be reached on 7:30 am - 5:00 pm M-Th.
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, Benjamin Klein can be reached (571) 270-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AYA ZIAD BAKKAR/
Examiner, Art Unit 3796
/Benjamin J Klein/ Supervisory Patent Examiner, Art Unit 3792
