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
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) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Grace(US 20180008348 A1) in view of Aggerholm(US 20150367098 A1).
Regarding claim 1, Grace discloses method for improving the compliance of a blood vessel within a subject, the method comprising: locating a calcified portion in the media of the blood vessel of the subject; positioning a laser catheter within the vasculature of the subject, the catheter comprising a proximal end a distal end, and at least one emitter disposed adjacent the distal end; positioning a sheath over the laser catheter within the vasculature of the subject, wherein the sheath comprises a proximal end and a distal end, wherein the sheath comprises a first layer forming a lumen, a plurality of pairs of attenuating members and intermediate layers radially exterior the first layer(A method for improving the compliance of a blood vessel within a subject, the method comprising locating a calcified portion in the media of the blood vessel of the subject, positioning a laser catheter within the vasculature of the subject, the catheter comprising a proximal end, a distal end, and at least one emitter disposed at the distal end, positioning a sheath over the laser catheter within the vasculature of the subject, wherein the sheath comprises a proximal end, a distal end and a attenuating member disposed adjacent the distal end[0128]), positioning the sheath within the vasculature such that the attenuating member is disposed adjacent a portion of the calcified portion in the media of the blood vessel; positioning the laser catheter within the vasculature such that the at least one emitter is positioned within the attenuating member and adjacent the portion of the calcified portion in the media of the blood vessel; introducing a liquid medium into the sheath and to the at least one emitter; and emitting a plurality of pulses of light energy from the at least one emitter into the liquid medium, wherein the plurality of pulses of light energy react with the liquid medium and generate a plurality of propagating laser-induced pressure waves that disrupt the calcified portion of media, thereby improving the compliance of the blood vessel(positioning the laser catheter within the vasculature such that the at least one emitter is positioned within the attenuating member and adjacent the portion of the calcified portion, introducing a liquid medium into the outer sheath and to the at least one emitter; activating the at least one emitter to transmit pulses of light energy into the liquid medium; emitting one or more pulses of light energy from the at least one emitter, wherein the one or more pulses of light energy reacts with the liquid medium and generates a plurality of propagating laser-induced pressure waves that disrupt the calcified portion of the media, thereby improving the compliance of the blood vessel[0128]); wherein the plurality of pairs of attenuating members and intermediate layers are configured to increase an amplitude of the pressure waves as the pressure waves transmit through the sheath(Regarding the ability of the attenuating member 1124″ to redirect at least a portion of the laser-induced pressure waves toward the guidewire lumen 1618 and/or guidewire 1620 to excite and/or vibrate the guidewire 1620, the pressure waves or portion of the pressure wave(s) that do not pass through the attenuating member 1124″ may be redirected by the attenuating member 1124″ toward the guidewire lumen 1618 and/or guidewire 1620 to excite and/or vibrate the guidewire 1620. The sizes of the openings 1126″ of the attenuating member 1124″ (see FIG. 18) may be selected to control the amplitude or direction of the laser-induced pressure waves that are reflected toward the guidewire lumen 1618, guidewire 1620 and/or targeted tissue[0443]. Also, similar to the discussion included above with respect to FIG. 18 the attenuating member 1124″ depicted in FIGS. 20″ and 20′″ is shown at the distal end of the sheath 1614′. The attenuating member 1124″, however, may alternatively and/or additionally as be disposed at the proximal end of the sheath 1614′, the central portion of the sheath 1614′, any location or multiple locations between the proximal end and distal end of the sheath 1614′, or in the entire length or substantially the entire length of the sheath 1614′. Therefore, as the catheter 1612 or 1612′ translates within the sheath 1614′, the guidewire 1620 will continue to excite and/or vibrate[0444]).
Grace fails to disclose the wherein the attenuating members are constructed of a first material having a first thickness and first durometer, and the intermediate layers are constructed of a second material having a second thickness and a second durometer, wherein the first durometer is greater than the second durometer, wherein the first thickness and the second thickness are different. However, Aggerholm teaches “Referring first to FIG. 1, there is shown in schematic form and in longitudinal cross-section a preferred embodiment of sheath 10. The sheath 10 has a wall 12 formed of a plurality of layers 14 described below, and an internal lumen 16 through which medical devices and medical tools, for example, can be made to pass. The sheath 10 may constructed in a variety of diameters from several tenths of a French to one or just a few French (a French being 0.3 mm). It may even be constructed to have a much larger diameter[0029]. The wall 12 of the sheath 10 includes a first or inner layer 20 made of a relatively hard and low friction material, for instance a polymer material. An example of a suitable material is polytetrafluoroethylene (PTFE) such as Teflon™[0031]. A second or intermediate layer 22 overlies the inner layer 20 and includes a strengthening member 24 disposed, in the preferred embodiment, in direct contact with, that is in abutment with, the outer surface of the inner layer 20[0034]. The third or outer layer 30 provides a smooth outer surface to the sheath 10, in particular as this is curved or bent, whereupon the differences in compressibility of the strengthening member 24 and interstitial material 28 would otherwise create edges in the outer surface of the sheath 10 were the outer layer 30 to be omitted. Furthermore, the outer layer 30 is able to provide a harder and more slippery outer surface to the sheath 10, which optimizes its trackability in a patient's vasculature and reduces the risk of damage to the vessel walls[0044]”
It would have been obvious to one of ordinary skill at or before the effective filing date to have configured the catheter sheath system of Grace with the catheter or sheath assembly of Aggerholm. Doing so would specify the materials selected for the sheath member in the system to include multiple layers of varying thicknesses and hardness to allow light to be emitted in certain sections.
Regarding claim 2, Grace in view of Aggerholm teaches the method of claim 1, further comprising the step of re- positioning the sheath such that the attenuating member is adjacent another calcified portion of the media(Grace - further comprising the step of re-positioning the sheath such that the attenuating member is adjacent another calcified portion of the media.[0129]).
Regarding claim 3, Grace in view of Aggerholm teaches the method of claim 1, further comprising the step of re- positioning the laser catheter within the sheath such that the one or more emitters is adjacent another calcified portion of the media(Grace - Fig. 28C, Fig. 28D, Fig. 29, Step 3840 includes positioning within the vasculature the sheath and the liquid light guide catheter 3126 (and optionally the guidewire) such that a attenuating member within the sheath is adjacent the portion of vasculature having the calcified media, and the distal end of the liquid light guide catheter is disposed within the attenuating member adjacent the vasculature that includes the calcified portion(s) in the media. For example, a clinician may slide the liquid light guide catheter 3126 adjacent the guidewire and into the vasculature such that the emitter(s) of the liquid light guide catheter 3126 are positioned adjacent to the vasculature that has the calcified media, as shown in FIG. 37C. A sheath 1120 of the present disclosure is then slid over the liquid light guide catheter 3126 to a position within the vasculature such that the attenuating member is adjacent the vasculature that includes the calcified portion(s) in the media. Accordingly, the emitter may be disposed within the portion of the sheath comprising the attenuating member[0520]).
Regarding claim 4, Grace in view of Aggerholm teaches the method of claim 3, wherein the laser catheter is re-positioned within the attenuating member(Grace - wherein the within the laser catheter is re-positioned within the attenuating member[0131]).
Regarding claim 5, Grace in view of Aggerholm teaches the method of claim 1, further comprising the step of re- positioning the laser catheter within sheath(Grace - further comprising the step of re-positioning the laser catheter within sheath[0130]).
Regarding claim 6, Grace in view of Aggerholm teaches the method of claim 5, wherein the laser catheter is re-positioned within the attenuating member(Grace - wherein the within the laser catheter is re-positioned within the attenuating member[0131]).
Regarding claim 7, Grace in view of Aggerholm teaches the method of claim 1, further comprising the steps of removing the laser catheter from the vasculature and removing the sheath from the vasculature(Grace - further comprising the steps of removing the laser catheter from the vasculature and removing the outer sheath from the vasculature[0132]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-7 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant argues that Grace(US 20180008348 A1) in view of Laudenslager(US 20150105714 A1) cannot be naturally combined to disclose the layers of the sheath claimed. However new art Aggerholm(US 20150367098 A1) teaches the composition of a sheath with multiple layers, each layer comprising a different material with different thickness and durometer. Aggerholm can be naturally combined with Grace and therefore, the 103 rejections of claims 1-7 stand.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA CATHERINE ANTHONY whose telephone number is (703)756-4514. The examiner can normally be reached 7:30 am - 4:30 pm, EST, M-F.
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/MARIA CATHERINE ANTHONY/Examiner, Art Unit 3796
/Benjamin J Klein/Supervisory Patent Examiner, Art Unit 3792
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