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 .
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.
Claim(s) 2-4, 6-7, 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 8956374 to Hawkins et al. (Hawkins) in view of US 6210400 to Hebert et al. (Hebert).
Hawkins teaches:
Claim 2: A method for generating shock waves to treat calcified lesions in the body of a patient comprising:
introducing a shock wave device (Fig. 2) of a shock wave system into vasculature of a patient, and the shock wave device comprises:
an elongate member (balloon catheter 20, Fig. 2);
a tubular member (balloon 26, Fig. 2) connected to the elongate member (20) and configured to be filled with a fluid (for inflating the balloon), the tubular member having a closed distal end (Fig. 2);
a support member (21, Fig. 2)positioned at least partially within the tubular member; and
a plurality of shock wave generators (22, 24, Fig. 2) that extend along the elongate member (20) and into the tubular member (26, Fig. 2);
advancing the shock wave device to a region within the vasculature having calcified deposits (for treating the calcified lesions);
filling the tubular member with a fluid (Fig. 2); and
activating the shockwave generators to generate shock waves, wherein the shock waves pass through the tubular member to treat the calcified deposits external to the tubular member (Col. 4, ll. 42-59).
Claim 7: The fluid within the tubular member comprises saline (Col. 1, ll. 64-65).
Hawkins fails to teach:
Claim 2: The shock wave system comprises a laser generator, a plurality of shock wave generators, each shock wave generator includes an optical fiber for propagating laser pulses, wherein at least one of the optical fibers has a different length than at least one other of the optical fibers.
Claim 3: Each optical fiber is configured to emit laser pulses for absorption by tissue.
Claim 4: Each optical fiber is configured to emit laser pulses for microablation of tissue subsequent to absorption.
Claim 6: The optical fibers are configured to propagate laser pulses into the fluid within the tubular member to form vapor bubbles.
Claim 10: The optical fibers are configured to propagate laser energy into pigmented tissue to generate a shock wave.
Claim 11: Each optical fiber of the plurality of shock wave generators is coupled to the laser generator.
Claim 12: The optical fibers are configured to propagate laser energy into the fluid within the tubular member to generate a shock wave.
Hebert teaches:
Claim 2: In the same field as endeavor, flexible flow apparatus and method for disruption of occlusions comprises a laser generator (Col. 4, ll. 7-9), plurality of shock wave generators (431, 433, 435, Fig. 11B) includes an optical fiber for propagating laser pulses, wherein at least one of the optical fibers has a different length than at least one other of the optical fibers (Fig. 11B).
Claim 3: Each optical fiber (431, 433, 435, Fig. 11B) is configured to emit laser pulses for absorption by tissue (Functional limitation, Col. 2, ll. 5-12).
Claim 4: Each optical fiber (431, 433, 435, Fig. 11B) is configured to emit laser pulses for microablation of tissue subsequent to absorption (Functional limitation, the laser in Hebert is also creating laser pulse and is capable of doing such).
Claim 6: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser pulses into the fluid within the tubular member to form vapor bubbles (functional limitation, the laser in Hebert is creating expansion and collapsing of the bubbles, abstract, would create vapor bubbles).
Claim 10: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser energy into pigmented tissue to generate a shock wave (functional limitation).
Claim 11: Each optical fiber of the plurality of shock wave generators (431, 433, 435, Fig. 11B) is coupled to the laser generator.
Claim 12: The optical fibers (431, 433, 435, Fig. 11B) are configured to propagate laser energy into the fluid within the tubular member to generate a shock wave (Fig. 11B) (Col. 10, II. 50-65, Col. 11, II. 1-14).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to modify optical fibers as taught by Hebert into Hawkins as a know substitution of one known device for another that would yield predictable result of generating shock wave for disruption of occlusions.
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hawkins in view of Hebert and further in view of US 2016/0184022 to Grace et al. (Grace).
Hawkins in view of Hebert teaches:
The method of claim 2 (see rejection of claim 2 above).
Hawkins in view of Hebert fails to teach:
Claim 5: The laser generator is an excimer laser.
Grace teaches:
Claim 5: In the same field as endeavor, an ablation system (100, Fig. 1) comprises using excimer laser (130, para. 0224).
It would have been obvious to one of ordinary skill in the art at the time of the invention was filed to employ excimer laser as taught by Grace into Hawkins in order to create pressure waves with sufficient force to treat a vascular obstruction in a subject (para. 0278).
Allowable Subject Matter
Claims 8-9 objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claim 8, the prior art fails to disclose the tubular member has a loop portion and one or more shock wave generators are positioned within the loop portion. Prior art Hebert discloses the tubular member with shock wave generators within the tubular member but fails to disclose the loop portion as claimed. Claim 9 also objected for depending on objected claim 8.
Response to Arguments
Applicant’s arguments with respect to claim(s) 06/05/2026 have been considered but are moot because of the new ground of rejection. Further, Hebert discloses that the optical fibers are at different lengths within the balloon for its purpose of multiple inlets and outlets for fluid flow. The applicant argued that since Hawkins only discloses a single shockwave generator, there is no reason to modify the plurality of shockwave generator of Hebert into Hawkins. This is not persuasive. As shown in figure 5 of Hawkins, the electrodes are disposed at both the same length and different lengths within the balloon in different embodiments. Providing multiple shockwave generators at different lengths within the balloon can provide different shockwaves at different locations to enhance breaking up occlusions within the body.
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 PHONG SON DANG whose telephone number is (571)270-5809. The examiner can normally be reached Mon-Fri 8-5.
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/PHONG SON H DANG/Primary Examiner, Art Unit 3771
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