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, 9-11 and 16-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 18-20 of U.S. Patent No. US 12,257,399 in view of DiCaprio et al. US 2014/0276618.
Claims 1-7, 17 and 19 are rejected over claim 18 of US Patent No. 12,257,399 including overlapping subject matter such as a catheter comprising: an elongate body comprising: a proximal portion including a proximal end of the elongate body; and a distal tip portion, wherein the distal tip portion comprises: an inner liner; a reinforcement member surrounding the inner liner; at least one marker band surrounding the inner liner, each marker band of the at least one marker band extending from a respective marker band proximal end to a respective marker band distal end; an outer jacket surrounding a first portion of the inner liner and ending proximal of a proximal-most marker band proximal end; and a tip outer jacket surrounding a second portion of the inner liner and the at least one marker band, wherein the tip outer jacket extends distally past a distal-most marker band distal end; and an elongate push member comprising an elongate member and an anchor member positioned at a distal end of the elongate member, wherein the elongate push member is mechanically coupled to the proximal end of the elongate body, but fails to disclose the proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end, the elongate push member being mechanically coupled such that the distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member.
DiCaprio et al. disclose the proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end (entry port 30, figure 20B), the elongate push member 16 such that the distal end of the anchor member (58A, 58B, for example, figure 7B) is distal of the entry port distal end and proximal of the reinforcement member (reinforcing coil or mesh in tube 14, paragraph 0088, figure 7B, coil is distal of transition zone 40), wherein a proximal end of the anchor member is positioned distal to the entry port proximal end (figure 7B proximal end of 58B is distal to the proximal end of port 130), wherein a proximal end of the anchor member 58B is aligned with the entry port distal end, figure 7A, 7B; Examiner notes it does not disclose how it is specifically aligned or arranged with respect to one another), wherein the distal end of the elongated member is positioned distal to the entry port proximal end (figures 7A, 7B, extend into tube 14 past opening 130), wherein the distal end of the elongated member is positioned distal to the entry port distal end (figures 7A, 7B, distal end 58B is distal of the opening 130), wherein the tapered entry port tapers in a proximal direction from the entry port distal end to the entry port proximal end (figure 7B),
Therefore, it would have been obvious to modify US Patent No. 12,257,399 with a tapered entry port extending between an entry port proximal end and an entry port distal end, the elongate push member being mechanically coupled such that the distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member, as taught by DiCaprio et al. to provide an opening that can be tapered to provide an enlarged opening to facilitate movement of tools and device along the axes (paragraph 0122) and anchoring the anchor member of the elongate push member within the walls of the tube distal to or aligned with the entry port (figure 7B) for enhancing kink resistance of that portion of the tube and assist in transmitting a distal or proximal force in a more even fashion during use (paragraph 0101).
Claim 9 is rejected over claim 18 of US Patent No. 12,257,399 where the tip outer jacket surrounds proximal and distal ends of the at least one marker band.
Claim 10 is rejected over claim 18 of US Patent No. 12,257,399 is wherein the proximal end of the tip outer jacket laterally abuts or is laterally adjacent the distal end of the outer jacket.
Claim 11 is rejected over claim 18 of US Patent No. 12,257,399 wherein the tip outer jacket exhibits a different durometer than the outer jacket.
Claims 16, 18 and 20 are rejected over claims 19 and 20 of US Patent No. 12,257,399 wherein the anchor member and a portion of the elongate push member are positioned between the inner liner and the outer jacket.
Claims 1-7, 9-12, 17 and 19 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 18 of U.S. Patent No. US 11,911,573 in view of DiCaprio et al. US 2014/0276618.
Claims 1-7, 17 and 19 are rejected over claims 1 and 18 of US Patent No. 11,911,573 including overlapping subject matter such as a catheter comprising: an elongate body comprising: a proximal portion including a proximal end of the elongate body; and a distal tip portion, wherein the distal tip portion comprises: an inner liner; a reinforcement member surrounding the inner liner; at least one marker band surrounding the inner liner, each marker band of the at least one marker band extending from a respective marker band proximal end to a respective marker band distal end; an outer jacket surrounding a first portion of the inner liner and ending proximal of a proximal-most marker band proximal end; and a tip outer jacket surrounding a second portion of the inner liner and the at least one marker band, wherein the tip outer jacket extends distally past a distal-most marker band distal end; and an elongate push member comprising an elongate member and an anchor member positioned at a distal end of the elongate member, wherein the elongate push member is mechanically coupled to the proximal end of the elongate body, but fails to disclose the proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end, the elongate push member being mechanically coupled such that the distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member.
DiCaprio et al. disclose the proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end (entry port 30, figure 20B), the elongate push member 16 such that the distal end of the anchor member (58A, 58B, for example, figure 7B) is distal of the entry port distal end and proximal of the reinforcement member (reinforcing coil or mesh in tube 14, paragraph 0088, figure 7B, coil is distal of transition zone 40), wherein a proximal end of the anchor member is positioned distal to the entry port proximal end (figure 7B proximal end of 58B is distal to the proximal end of port 130), wherein a proximal end of the anchor member 58B is aligned with the entry port distal end, figure 7A, 7B; Examiner notes it does not disclose how it is specifically aligned or arranged with respect to one another), wherein the distal end of the elongated member is positioned distal to the entry port proximal end (figures 7A, 7B, extend into tube 14 past opening 130), wherein the distal end of the elongated member is positioned distal to the entry port distal end (figures 7A, 7B, distal end 58B is distal of the opening 130), wherein the tapered entry port tapers in a proximal direction from the entry port distal end to the entry port proximal end (figure 7B).
Therefore, it would have been obvious to modify US Patent No. 11,911,573 with a tapered entry port extending between an entry port proximal end and an entry port distal end, the elongate push member being mechanically coupled such that the distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member, as taught by DiCaprio et al. to provide an opening that can be tapered to provide an enlarged opening to facilitate movement of tools and device along the axes (paragraph 0122) and anchoring the anchor member of the elongate push member within the walls of the tube distal to or aligned with the entry port (figure 7B) for enhancing kink resistance of that portion of the tube and assist in transmitting a distal or proximal force in a more even fashion during use (paragraph 0101).
Claim 9 is rejected over claims 1 and 18 of US Patent No. 11,911,573 where the tip outer jacket surrounds proximal and distal ends of the at least one marker band.
Claim 10 is rejected over claims 1 and 18 of US Patent No. 11,911,573 is wherein the proximal end of the tip outer jacket laterally abuts or is laterally adjacent the distal end of the outer jacket.
Claims 11 and 12 are rejected over claim 1 and 18 of US Patent No. 11,911,573 wherein the tip outer jacket exhibits a different or lower durometer than the outer jacket.
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) 1-14 and 16-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. US 2019/0336149 in view of DiCaprio US 2014/0276618.
Regarding claims 1-9, 16-20, Yang et al. discloses a catheter (figure 31A, 31B) comprising: an elongate body 3000 comprising: a proximal portion including a proximal end of the elongate body (figure 31A, portion 3002), and a distal portion located distally of the proximal portion (figure 31A, portion 3004), wherein the distal portion comprises: an inner liner 3014; a reinforcement member 3024 surrounding the inner liner (paragraph 0226, coil or reinforcement 3024 wrapped around liner 3014); at least one marker band surrounding the inner liner (annular marker 3040 is around or surrounding the inner liner on the device), each marker band of the at least one marker band extending from a respective marker band proximal end to a respective marker band distal end (each proximal and distal side of the marker band); an outer jacket 3020 surrounding a first portion of the inner liner (paragraph 0228, 0229; outer jacket applied over catheter body and inner liner, figure 31A) and ending proximal of the marker band proximal end of a proximal-most marker band of the at least one marker band (outer jacket segments 3020, 3022 for example, ends prior to the marker band 3040; figure 31A); and a tip outer jacket surrounding a second portion of the inner liner and the at least one marker band (figure 31A, inner liner 3014 extends throughout; portion 3038 of the tip outer jacket extends and surrounds both ends of marker band 3040), wherein the tip outer jacket extends distally past the marker band distal end of a distal-most marker band of the at least one marker band (figure 31A, tip 3038 extends to end of catheter); and an elongate push member 42 comprising an elongate member (for example, shown with a different embodiment catheter 10, push member 42 coupled with catheter body 34, figure 3B, Examiner notes catheter 3000 would be configured to be used with a push member, such as depicted with catheter 10 and include features of catheter 3000, paragraph 0217; any catheter or shaft or sections may comprise multi-layer constructs), a portion push member being positioned between the inner liner and the outer jacket (for example, paragraph 0091, overlap portion for connecting the elongate push member may comprising a tightly sliding fit between the multi-layer constructs, or integrated into catheter, paragraph 0093) extending only partially around an outer perimeter of the inner liner (for example, figure 3B, extends around at least a part of the outer perimeter of the portion 34 and may be positioned around as being positioned with the device, Examiner notes “around” does not require to be positioned around an exterior in a circumference, but may be considered to be “around” as being defined by “on all or various sides: in every or any direction” -Merriam Webster.com).
Yang et al. fails to disclose the proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end the elongate push member comprising an anchor member positioned at a distal end of the elongate member, the elongate push member being mechanically coupled to the elongate body such that a distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member, the entry port proximal end to the entry port distal end is 2 cm to 10 cm.
DiCaprio et al. disclose a catheter having an elongate body proximal portion defining a tapered entry port extending between an entry port proximal end and an entry port distal end (entry port 30, figure 20B, for facilitating movement of tools and devices, paragraph 0122), the elongate push member 16 being mechanically coupled to the elongate body such that the distal end of the anchor member (58A, 58B, for example, figure 7B, paragraph 0101) is distal of the entry port distal end and proximal of the reinforcement member (reinforcing coil or mesh in tube 14, paragraph 0088, figure 7B, coil is distal of transition zone 40), wherein a proximal end of the anchor member is positioned distal to the entry port proximal end (figure 7B proximal end of 58B is distal to the proximal end of port 130), wherein a proximal end of the anchor member 58B is aligned with the entry port distal end, figure 7A, 7B; Examiner notes it does not disclose how it is specifically aligned or arranged with respect to one another), wherein the distal end of the elongated member is positioned distal to the entry port proximal end (figures 7A, 7B, extend into tube 14 past opening 130), wherein the distal end of the elongated member is positioned distal to the entry port distal end (figures 7A, 7B, distal end 58B is distal of the opening 130), wherein the tapered entry port tapers in a proximal direction from the entry port distal end to the entry port proximal end (figure 7B), wherein the anchor member extends only partially around an outer perimeter of the inner liner (for example, figure 7B, anchor member extends within elongate member, and may be considered to extend partially around an outer perimeter as it is inserted around or within the same area of the inner liner, Examiner notes “around” does not require to be positioned around an exterior in a circumference, but may be considered to be “around” as being defined by “on all or various sides: in every or any direction” -Merriam Webster.com), the elongate member and anchor 58A, 58B being located between an inner and outer portions (figure 3A, within tube of transition area 40, Examiner notes in combination with an inner liner, the anchor being within the outer tube portion would result in the claimed configuration).
DiCaprio et al. discloses the transition segment 40may be of different lengths according to design considerations (paragraph 0089) and the opening or entry port 130 be tapered or extended opening for facilitating movement or tools along the catheter. It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide an entry port between 2cm and 10cm for receiving the desired tools, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Therefore, it would have been obvious to modify Yang et al. with a tapered entry port extending between an entry port proximal end and an entry port distal end, the elongate push member being mechanically coupled such that the distal end of the anchor member is distal of the entry port distal end and proximal of the reinforcement member, as taught by DiCaprio et al. to provide an opening that can be tapered to provide an enlarged opening to facilitate movement of tools and device along the axes (paragraph 0122) and anchoring the anchor member of the elongate push member within the walls of the tube distal to or aligned with the entry port (figure 7B) for enhancing kink resistance of that portion of the tube and assist in transmitting a distal or proximal force in a more even fashion during use (paragraph 0101).
Regarding claim 10-12, Yang et al. discloses wherein the proximal end of the tip outer jacket laterally abuts the distal end of the outer jacket (figure 31A, tip distal end 3038 is adjacent and abuts distal end portion 3036, or may consider any of portions therebetween, for example, 3026, 3038, 3030, 3032, 3034, 3036 to abut the neighboring portion), the tip outer jacket exhibits a different or lower durometer than the outer jacket (paragraph 0230, durometer of the segments may decrease in the distal direction, such as 3022 and 3026 may have a higher diameter than successive segments in the distal direction or the tip outer jacket portion).
Regarding claim 13, Yang et al. discloses wherein the reinforcement member (paragraph 0226, coil or reinforcement 3024 wrapped around liner 3014) does not extend distally past the marker band 3040 of the distal most marker band (figure 31A).
Regarding claim 14, Yang et al. disclose the catheter essentially as claimed comprising a reinforcement member comprising a coil (paragraph 0226, coil 3024), but fails to disclose wherein a distal end of the reinforcement member overlaps the at least one marker band.
DiCaprio et al. discloses a catheter comprising an elongate body comprising a reinforcement member (coil 62 or tube 14, figure 11, paragraph 0106) extending the length of the tube 14 (paragraph 106), the tube comprising one or more marker bands (for example, bands 26, 28, 24, figure 3C, paragraph 0090), the reinforcement coil resulting in overlapping the at least one marker band 28 as it extends along the tube 14 for viewing or locating portions of the elongate member or tube (paragraph 0090).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective time of the invention to modify the catheter to have a reinforcement coil extending over a marker band and the length of the elongate member, as taught by DiCaprio et al. to provide marker bands along various portions of the elongate member or tube to assist in locating, while the tube also being reinforced by the coil.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. US 2019/0336149 in view of DiCaprio US 2014/0276618 as discussed above, and further in view of Saitou et al. US 2002/0022825.
Regarding claim 15, Yang et al. discloses a catheter essentially as claimed as discussed above, but fails to disclose the reinforcement comprising a coil defining a first pitch in the proximal portion of the elongate body, wherein the coil defines a second pitch in the distal portion of the elongate body, and wherein the second pitch is greater than the first pitch.
Saitou et al. teaches a catheter assembly having an inner layer 8 and an outer layer 8, comprising a reinforcement member 3 between the inner and outer layer (paragraph 0022, reinforcing coil), the coil defining a first pitch in the proximal portion of the elongate body 2 (first pitch in proximal region), wherein the coil defines a second pitch in the distal portion of the elongate body (first pitch in distal region), and wherein the second pitch is greater than the first pitch (paragraph 0202; pitch may be selected and varied in each region of the catheter to provide the necessary flexibility and bendability).
Therefore, it would have been obvious to one having ordinary skill in the art to provide a coil having a proximal pitch and distal pitch along the elongate body, wherein the second pitch is greater than the first pitch, as taught by Saitou et al. to vary the coil pitches along selected segments to provide the necessary flexibility and bendability along the body.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/ Examiner, Art Unit 3771
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