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 .
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1, 7, 8, 14, 15 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 3 and 10 of U.S. Patent No. 12,296,114.
Although the claims at issue are not identical, they are not patentably distinct from each other because they disclose overlapping subject matter as discussed below. Examiner notes the delivery catheter and method using the delivery catheter would be obvious and overlapping subject matter.
Claims of application 19/190,524
Rejected over claims of U.S. Patent No. 12,296,114
Overlapping subject matter
1, 7, 15, 20
3
A delivery catheter or method, comprising a guide sheath including: a tubular body having a lumen and a distal end, a sleeve extending distally and secured on the distal end, a liner layer mounted or supported loosely on the sleeve, a catheter shaft extending through the lumen from a handle to a docking cap, and a suture securing the liner layer to the sleeve, the liner layer includes a rounded end, wherein the liner layer has a backward fold at the rounded end.
8, 14
10
A biostimulator system comprising: a delivery catheter comprising a guide sheath including a tubular body and having a lumen and a distal end, a sleeve extending distally from the distal end, a liner layer supported loosely on the sleeve, a catheter shaft extending through the lumen from a handle to a docking cap, a biostimulator, and a suture securing the liner layer to the sleeve, the liner layer includes a rounded end, wherein the liner layer has a backward fold at the rounded end.
Claims 1-6, 8-12, 14-16 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 10,653,859 in view of Reydel et al. US 2001/0044595.
Claims of application 19/190,524
Rejected over claims of U.S. Patent No. 10,653,859
Overlapping subject matter
1, 3-5, 15
1
A delivery catheter or method, comprising a guide sheath including: a tubular body having a lumen and a distal end, a sleeve or atraumatic sheath extending distally and secured on the distal end, the sleeve includes a braided construction, a liner layer mounted or supported loosely on the sleeve, a catheter shaft extending through the lumen from a handle to a docking cap.
2, 6, 16
1
a sleeve or atraumatic sheath including a braided construction, or a dual-wall construction
8, 10-12
17
A biostimulator system comprising: a delivery catheter comprising a guide sheath including a tubular body and having a lumen and a distal end, a sleeve including a braided construction extending distally from the distal end, a liner layer supported loosely on the sleeve, a catheter shaft extending through the lumen from a handle to a docking cap is coupled to or configured to receive a biostimulator, and a suture securing the liner layer to the sleeve.
9, 14, 19
17
a sleeve or atraumatic sheath including a braided construction, or a dual-wall construction
U.S. Patent No. 10,653,859 fails to explicitly disclose a suture securing the liner layer to the sleeve, the suture secures a distal portion of the liner layer to the sleeve, wherein the suture attaches the liner layer to the braid at a plurality of securement locations around a circumference of the sleeve, the plurality of securement locations are diametrically opposed to each other.
Reydel et al. teaches an introducer member 12, or tubular body, having a sleeve 13 or liner, the tubular body and liner achieving an attachment 14 by a variety of well-known methods including wrapping with a thread or suture material, heat shrink wrap or tubing, adhesive, or a combination thereof (paragraph 0050), the suture securing the liner to the sleeve (paragraph 0050), the suture secures a distal portion of the liner layer to the sleeve (for example, figure 16, attachment suture 14), wherein the suture attaches the liner layer to the braid or sleeve at a plurality of securement locations around a circumference of the sleeve (for example, may have more than one attachment point thus forming an arrangement of unitary construction, paragraph 0050), the plurality of securement locations are diametrically opposed to each other (paragraph 0050, for example, figure 18 attachment points 110 diametrically opposed).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify U.S. Patent No. 10,653,859 with a suture attaching the liner layer to the sleeve, as taught by Reydel et al., in order to form an attachment between a tubular member and a liner by a well-known means in the art and resulting in an arrangement of unitary construction.
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.
Claim 18 is 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 18 recites the limitation "the braid" in line 1. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-5 and 8-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright, JR. et al. US 2005/0080430 in view of Foltz et al. US 2004/0116955 in view of Marnfeldt et al. US 2005/0267555 and in view of Reydel et al. US 2001/0044595.
Regarding claims 1-5 and 8-12, Wright, JR. et al. discloses a delivery catheter (paragraph 0002), comprising: a guide sheath including a tubular body 10 having a lumen and a distal end 12 (figure 1 lumen through tubular body 10), a sleeve 40 extending distally from the distal end (figure 2a), and a liner layer supported on the sleeve (paragraph 0030, heat shrink sealing layer or other elastomeric layer may be used on the outside surface); and a catheter shaft extending through the lumen from a handle (paragraph 0027, instrument for delivering a medical device are inserted through the proximal end 18, figure 1), wherein the sleeve includes a braided construction at a distal end (paragraph 0011).
Wright, JR. et al. fails to disclose wherein the sleeve comprises wherein the liner layer is supported loosely on the sleeve, a suture securing the liner layer or a distal portion of the liner layer to the sleeve, the suture securing the liner to the sleeve, or attaches the liner layer to the braid of the sleeve, the suture secures a distal portion of the liner layer to the sleeve, wherein the suture attaches the liner layer to the braid at a plurality of securement locations around a circumference of the sleeve, the plurality of securement locations are diametrically opposed to each other, or wherein the catheter shaft extending through the lumen from a handle to a docking cap, a biostimulator coupled to the docking cap.
Foltz et al. teaches a dilator and catheter assembly comprising a liner layer 80 being supported loosely conforming over the assembly body and tip (paragraph 0052, figure 1B) in order to cover the assembly shaft and provide an exterior layer with a lubricating material for easy rapid insertion (paragraph 0052), and may be an alternative to a shrink wrapped liner as known in the art to position around the exterior of a shaft (paragraph 0052, may be a shrink wrap or loosely supported liner layer on the exterior).
Marnfeldt et al. teaches a catheter carrying an implantable medical device 200, a docking cap coupled to the distal portion of a connection shaft 210 (distal end of shaft, the docking cap including a slot configured to receive the attachment feature to dock the implantable device against the catheter (figures 10-12, 14, 17, for example, show various docking caps), wherein the docking cap includes a slot configured to receive an attachment feature of a biostimulator to dock a biostimulator against the delivery catheter (the implantable medical device may include, but is not limited to, a stimulator, microstimulator, catheter, lead, electrode, stent, pacemaker, bone fixation device, pump, defibrillator, or any other device or component that is implanted within the patient).
Reydel et al. teaches an introducer member 12, or tubular body, having a sleeve 13 or liner, the tubular body and liner achieving an attachment 14 by a variety of well-known methods including wrapping with a thread or suture material, heat shrink wrap or tubing, adhesive, or a combination thereof (paragraph 0050), the suture securing the liner to the sleeve (paragraph 0050), the suture secures a distal portion of the liner layer to the sleeve (for example, figure 16, attachment suture 14), wherein the suture attaches the liner layer to the braid or sleeve at a plurality of securement locations around a circumference of the sleeve (for example, may have more than one attachment point thus forming an arrangement of unitary construction, paragraph 0050), the plurality of securement locations are diametrically opposed to each other (paragraph 0050, for example, figure 18 attachment points 110 diametrically opposed). Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wright, JR. et al. with a loosely supported liner with a rounded end on the exterior of the sheath, as taught by Foltz et al. to provide a sheath that may be used for positioning and easy insertion of a catheter or assembly tip, as it is also known to provide a loose liner as a substitute for a shrink wrapped liner, and a handle and docking cap and attachment feature, as taught by Marnfeldt et al. for docking the medical implant or biostimulator to be implanted with the catheter, and a suture attaching the liner layer to the sleeve at a distal end, to the braid, at a plurality of securement locations around a circumference of the sleeve, as taught by Reydel et al., in order to form an attachment between a tubular member and a liner by a well-known means in the art and resulting in an arrangement of unitary construction.
Claim(s) 6 and 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright, JR. et al. US 2005/0080430 in view of Foltz et al. US 2004/0116955 in view of Marnfeldt et al. US 2005/0267555 and in view of Reydel et al. US 2001/0044595, as discussed above, and further in view of Buehlmann et al. US 6994677.
Regarding claims 6 and 13, Wright, JR. et al. in combination discloses the sleeve essentially as claimed as discussed above, but fails to disclose wherein the sleeve comprises a dual-wall construction.
Buehlmann et al. teaches a catheter having an atraumatic distal end (figures 40-45), the distal end being a braided woven, or mesh construction (braided material 244, figures 40-45) including folding or rolling a cylindrical wall of a tube back on itself to form the dual-wall construction (figure 42, column 12, lines 20-53) extending distally from the distal end (column 12, lines 53-54, mounted on tube 43 and secured with heat shrink tubing 252) to provide a folded over two layered braided element forming smooth ends to protect tissue (figures 40-45; column 13, lines 13-17; folded over itself to form a smooth end).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wright, JR. et al. with a folded dual-wall construction being secured to the distal end of a tubular body, as taught by Buehlmann et al., to provide an atraumatic distal end for the catheter to avoid unnecessary trauma to surrounding tissues.
Claim(s) 15-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright, JR. et al. US 2005/0080430 in view of Foltz et al. US 2004/0116955 in view of Reydel et al. US 2001/0044595.
Regarding claims 15-18, Wright, JR. et al. discloses a method comprising: securing a sleeve 40 to a distal end of a tubular body 10 (figure 1), wherein the tubular body has a lumen and a distal end 12 (figure 1, lumen through tubular body 10), and wherein the sleeve extends distally from the distal end (figure 2, sleeve 40 at distal end of catheter); mounting a liner layer over the sleeve such that the liner layer is supported on the sleeve (paragraph 0030, heat shrink sealing layer or other elastomeric layer may be used on the outside surface), wherein the sleeve includes a braided construction (paragraph 0011), but fails to disclose mounting a liner layer over the sleeve such that the liner layer is supported loosely on the sleeve and securing the liner layer to the sleeve with a suture.
Wright, JR. et al. fails to disclose wherein mounting the liner layer over the sleeve comprises wherein the liner layer is supported loosely on the sleeve, securing the liner layer to the sleeve with a suture, the suture attaches the liner layer to a distal portion of the liner layer to the sleeve, the suture securing the liner to the sleeve, or the suture attaches the liner layer to the braid of the sleeve, the suture secures a distal portion of the liner layer to the sleeve, wherein the suture attaches the liner layer to the braid at a plurality of securement locations around a circumference of the sleeve, the plurality of securement locations are diametrically opposed to each other, or wherein the catheter shaft extending through the lumen from a handle to a docking cap, a biostimulator coupled to the docking cap.
Foltz et al. teaches a dilator and catheter assembly comprising a liner layer 80 being supported loosely conforming over the assembly body and tip (paragraph 0052, figure 1B) in order to cover the assembly shaft and provide an exterior layer with a lubricating material for easy rapid insertion (paragraph 0052), and may be an alternative to a shrink wrapped liner as known in the art to position around the exterior of a shaft (paragraph 0052, may be a shrink wrap or loosely supported liner layer on the exterior).
Reydel et al. teaches an introducer member 12, or tubular body, having a sleeve 13 or liner, the tubular body and liner achieving an attachment 14 by a variety of well-known methods including wrapping with a thread or suture material, heat shrink wrap or tubing, adhesive, or a combination thereof (paragraph 0050), the suture securing the liner to the sleeve (paragraph 0050), the suture secures a distal portion of the liner layer to the sleeve (for example, figure 16, attachment suture 14), wherein the suture attaches the liner layer to the braid or sleeve at a plurality of securement locations around a circumference of the sleeve (for example, may have more than one attachment point thus forming an arrangement of unitary construction, paragraph 0050), the plurality of securement locations are diametrically opposed to each other (paragraph 0050, for example, figure 18 attachment points 110 diametrically opposed).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wright, JR. et al. with a loosely supported liner with a rounded end on the exterior of the sheath, as taught by Foltz et al. to provide a sheath that may be used for positioning and easy insertion of a catheter or assembly tip, as it is also known to provide a loose liner as a substitute for a shrink wrapped liner, and a handle and docking cap and attachment feature, as taught by Marnfeldt et al. for docking the medical implant or biostimulator to be implanted with the catheter.
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wright, JR. et al. US 2005/0080430 in view of Foltz et al. US 2004/0116955 in view of Reydel et al. US 2001/0044595, as discussed above, and further in view of Buehlmann et al. US 6994677.
Regarding claim 19, Wright, JR. et al. in combination discloses the sleeve essentially as claimed as discussed above, but fails to disclose wherein the sleeve comprises a dual-wall construction.
Buehlmann et al. teaches a catheter having an atraumatic distal end (figures 40-45), the distal end being a braided woven, or mesh construction (braided material 244, figures 40-45) including folding or rolling a cylindrical wall of a tube back on itself to form the dual-wall construction (figure 42, column 12, lines 20-53) extending distally from the distal end (column 12, lines 53-54, mounted on tube 43 and secured with heat shrink tubing 252) to provide a folded over two layered braided element forming smooth ends to protect tissue (figures 40-45; column 13, lines 13-17; folded over itself to form a smooth end).
Therefore it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Wright, JR. et al. with a folded dual-wall construction being secured to the distal end of a tubular body, as taught by Buehlmann et al., to provide an atraumatic distal end for the catheter to avoid unnecessary trauma to surrounding tissues.
Allowable Subject Matter
Claims 7, 14 and 20 are rejected on the ground of nonstatutory double patenting as being unpatentable over the claims of U.S. Patent No. 12,296,114 as discussed above in more detail, but would be allowable if a proper terminal disclaimer is filed and the claims are rewritten to include 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:
Wright, JR. et al. discloses a delivery sheath including a sleeve includes a braided construction and a liner layer, fails to disclose wherein the loosely supported liner layer includes a rounded end, wherein the liner layer has a backward fold at the rounded end.
Buehlmann et al. teaches a catheter having an atraumatic distal end (figures 40-45), the distal end being a braided woven, or mesh construction (braided material 244, figures 40-45) including folding or rolling a cylindrical wall of a tube back on itself to form the dual-wall construction (figure 42, column 12, lines 20-53) and teaches a shrink wrap or liner tubing on the exterior of the catheter. Buehlmann et al. fails to disclose the liner tubing layer being loosely supported on the exterior of the sheath and including a rounded end, the liner layer having a backward fold at the rounded end.
Foltz et al. teaches a dilator and catheter assembly comprising a liner layer 80 being supported loosely conforming over the assembly body and tip (paragraph 0052, figure 1B) in order to cover the assembly shaft and provide an exterior layer with a lubricating material for easy rapid insertion (paragraph 0052), wherein the liner layer includes a rounded end (figure 1B, liner 80 rounded at the distal end as it is loosely conforming to the distal end member 40, distal end member being an oblate spheroid, paragraph 0043, therefore, providing the liner 80 with a rounded surface as it is tapering and conforming to the rounded shape of member 40). Foltz et al. fails to disclose wherein the liner layer has a backward fold at the rounded end.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771
