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 .
Response to Arguments
Applicant’s arguments with respect to claim(s) 17,33,36 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. The rejection relies on the new teaching of Cox and while Holzer was used in the new rejection, it was not disputed for the teaching of a balloon catheter which Cox was silent on this delivery system and did mention in the background they are known, thus a prima facie case of obviousness has been established.
Additionally the new reference to Cox was combined with DE 202014102615 for the teaching of the balloon catheter with two channels of which was not disputed. Thus, a 103 rejection establishing a prima facie case of obviousness has been made.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 23 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 23 recites “pores of the covering with a size of at least 15 µm2 over an area of 100000 µm2….” and is broadening the scope of claim 17 from which it depends since it recited “pores have a size of at least 30 µm2”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 17,23,25-31 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2008/151204) in view of Holzer et al. (2018/0338847). Cox et al. disclose (abstract) a medical system for the treatment of stenosis in intracranial blood vessels. Cox further discloses (page 6, lines 29,30) a compressible and self-expandable implant for covering the stenosis. Fig. 16 shows the implant 100 having a mesh structure at least a section of which is provided with a covering 108 produced from an electrospun fabric (page 32, lines 1-4,6) having pores of different sizes (Fig. 6,page 13, lines 32-34, page 14, lines 1-4). Fig. 4 shows the covering includes at least 10 pores 24 with a size of at least 30 µm2 over an area of 100000 µm2 (page 16, lines 13-28, pore size range from 10 µm to 500 µm, which are circular(round) and thus have an area of πr2, which is, respectively 78.54 µm2 to 196,350 µm2, thus all pores have a size of at least 30 µm2 over any area, which includes 100000 µm2) and thus illustrated pore arrangements are applicable for use with the mesh and covering shown in Fig. 6. It is noted Cox et al. did disclose balloon catheters are known (page 3, lines 9-15), however Cox was silent a balloon catheter was used for dilating the stenosis and for delivering the implant into the blood vessel. Holzer et al. teach (Fig. 8) a balloon catheter 802 to deliver a porous covering 104 to a vessel. Holzer et al. further teach (paragraph 146) a balloon catheter is used to deliver an implant having a mesh and covering to a vessel and dilate and deliver the implant. It would have been obvious to one of ordinary skill in the art to use a balloon catheter as taught by Holzer et al. with the implant of Cox et al. such that it provides the surgeon the ability to expand manually the section of placement in a vessel and be appropriately dilated or open to have the correct lumen dimension flow path. Regarding claims 23, 25 Cox discloses values for the pores to be of a diameter at least 4 µm (above) and also pores can be at most 750 µm2 falls within range (page 16, lines 13-28, pore size range from 10 µm to 500 µm, which are circular(round) and thus have an area of πr2, which is, respectively 78.54 µm2 to 196,350 µm2). Regarding claims 26,27, Cox discloses (page 32, lines 6-8) the covering is securely connected to the mesh structure via mechanical means or chemical means and the mesh structure is sheathed with a bonding agent at least one of in parts or in sections, and wherein the bonding agent forms a mechanical interlock between the covering and the mesh structure. With respect to claim 28, Cox et al. disclose (page 21) the covering is produced from a plastic material. Regarding claim 29, Cox shows (Fig. 12) the covering formed from filaments oriented and disposed in a network-like manner. It is also noted that Cox et al. also disclose (page 18, lines 13-20) the filament thickness can be within a range of 50nm to 50,000 nm or alternatively 0.05 µm to 50 µm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cox such that the filament thickness is between 0.1 µm and 3 µm, since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Regarding claims 30,31 Cox discloses (page 19, lines 32-34) the covering has a biocompatible coating and it can contain heparin.
Claim(s) 17,19-23,25-31,33-36 are rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2008/151204) in view of (DE 202014102615). Cox et al. disclose (abstract) a medical system for the treatment of stenosis in intracranial blood vessels. Cox further discloses (page 6, lines 29,30) a compressible and self-expandable implant for covering the stenosis. Fig. 16 shows the implant 100 having a mesh structure at least a section of which is provided with a covering 108 produced from an electrospun fabric (page 32, lines 1-4,6) having pores of different sizes (Fig. 6,page 13, lines 32-34, page 14, lines 1-4). Fig. 4 shows the covering includes at least 10 pores 24 with a size of at least 15 µm2 (claim 33) or 30 µm2 (claims 17,36) over an area of 100000 µm2 (page 16, lines 13-28, pore size range from 10 µm to 500 µm, which are circular(round) and thus have an area of πr2, which is, respectively 78.54 µm2 to 196,350 µm2, thus all pores have a size of at least 15 µm2 or 30 µm2 over any area since the value is above both minimums, which includes 100000 µm2) and thus illustrated pore arrangements are applicable for use with the mesh and covering shown in Fig. 6. It is noted Cox et al. did disclose balloon catheters are known (page 3, lines 9-15), however Cox was silent a balloon catheter was used for dilating the stenosis and for delivering the implant into the blood vessel. DE ‘615 teach (Fig. 4) a balloon catheter 12 to deliver a self-expanding device 21 to a vessel. DE ‘615 further teach (abstract) a balloon catheter is used to deliver an implant with two channels to provide the surgeon control of the balloon and self-expanding device individually. It would have been obvious to one of ordinary skill in the art to use a balloon catheter as taught by DE ‘615 with the implant of Cox et al. such that it provides the surgeon the ability to expand manually the section of placement in a vessel and be appropriately dilated or open to have the correct lumen dimension flow path. With respect to claims 19,34 Cox et al. did not disclose a catheter of which is a balloon catheter having at least two channels and a balloon, wherein an inflation channel of the at least two channels is in fluid communication with the balloon, and a delivery channel of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening and a distal outlet opening for deploying the implant. (DE 202014102615) teach (Figs. 2-5) a balloon catheter with at least two channels (10,11) and a balloon 12. DE '615 teach an inflation channel 10 of the at least two channels is in fluid communication with the balloon, and a delivery channel 11 of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening 13 and a distal outlet opening for deploying the implant. It would have been obvious to one of ordinary skill in the art to use a balloon catheter with at least two channels and a balloon, wherein an inflation channel of the at least two channels is in fluid communication with the balloon, and a delivery channel of the at least two channels extends through the balloon, and wherein the delivery channel has a proximal inlet opening and a distal outlet opening for deploying the implant as taught by DE 202014102615 in the stent delivery system of Cox et al. such that it can be easily controlled and provide a low profile system for protection of the vessel. Regarding claim 36, Cox discloses the claimed invention except for the specific balloon catheter. The same teachings explained above for claim 19 and motivation is used for the same obviousness rejection. Regarding claim 20, abstract of DE '615 can be understood to consider the self-expandable stent to be compressed if placed within the working channel and have it passed therethrough. With respect to claims 21,35 DE '615 teaches (page 2 of translation) the balloon catheter comprises three X-ray markers, wherein a first X-ray marker is disposed in a region of 3 the distal outlet opening of the delivery channel, a second X-ray marker is disposed in a region of a distal balloon end, and a third X-ray marker is disposed in a region of a proximal balloon end. Regarding claim 22, DE '615 teaches (page 2 of translation) the delivery channel has a friction-reducing inner coating for a translational movement of the implant in the delivery channel.
Regarding claims 23, 25 Cox discloses values for the pores to be of a diameter at least 4 µm (above) and also pores can be at most 750 µm2 falls within range (page 16, lines 13-28, pore size range from 10 µm to 500 µm, which are circular(round) and thus have an area of πr2, which is, respectively 78.54 µm2 to 196,350 µm2). Regarding claims 26,27, Cox discloses (page 32, lines 6-8) the covering is securely connected to the mesh structure via mechanical means or chemical means and the mesh structure is sheathed with a bonding agent at least one of in parts or in sections, and wherein the bonding agent forms a mechanical interlock between the covering and the mesh structure. With respect to claim 28, Cox et al. disclose (page 21) the covering is produced from a plastic material. Regarding claim 29, Cox shows (Fig. 12) the covering formed from filaments oriented and disposed in a network-like manner. It is also noted that Cox et al. also disclose (page 18, lines 13-20) the filament thickness can be within a range of 50nm to 50,000 nm or alternatively 0.05 µm to 50 µm. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Cox such that the filament thickness is between 0.1 µm and 3 µm, since it has been held that in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). Regarding claims 30,31 Cox discloses (page 19, lines 32-34) the covering has a biocompatible coating and it can contain heparin.
Claim(s) 32 is rejected under 35 U.S.C. 103 as being unpatentable over Cox et al. (WO 2008/151204) in view of Holzer et al. (2018/0338847) as applied to claim 31 above, and further in view of Dinh et al. (5554182). Cox et al. in view of Holzer et al. is explained supra. However, Cox et al. as modified by Holzer et al. did not explicitly disclose the heparin is one of covalently bonded to the fibrin or incorporated into the fibrin. Dinh et al. teach (col. 8, lines 30-37) a stent having a coating of heparin incorporated into fibrin. It would have been obvious to one of ordinary skill in the art to have the heparin incorporated in the fibrin coating as taught by Dinh et al. on the stent of Cox et al. as modified with Holzer such that it provides a stable fibrin coating to assist with clotting control and stability, col. 2, lines 25-31 of Dinh.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799