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.
Claim 1, 2, 4, 7, 8, 10-15, 17, 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCaprio et al. (US 2014/0276618 A1) in view of Anderson et al. (US 2013/0197483 A1).
With regard to claim 1 and 11, DiCaprio discloses A catheter (Fig. 2b-21b) comprising:(a) a distal tube (14) comprising a tubular wall and a tube lumen (36) defined within the tube by the tubular wall; and (c) a proximal shaft (16) attached to a proximal portion of the distal tube, the proximal shaft comprising: (i) at least one first elongate member (84a, 54a, see also embodiments of Fig. 16F-16L); and a first sheath segment (80) disposed around a first length of the first and second at least one elongate member such that the first length of the at least one elongate member is disposed within the first sheath segment (see Fig. 13a and 14).
However, DiCaprio does not disclose a support membrane.
Anderson teaches a catheter having a distal tube (26, Fig. 3) and a proximal shaft (16); and further including a support membrane (20) disposed around a portion of the distal tube (see fig. 3, where element 20 extends into the proximal end of the distal tube.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effectivefiling date of the claimed invention to modify the device of DiCaprio with the support membrane as taughtby Anderson for the purpose of increasing the push force, and torque control of the tubing ([0044]).
With regard to claim 2, DiCaprio discloses wherein the proximal shaft further comprises (a) a shaft lumen defined by the first sheath segment (80, sheath segment is a tubing wrapped around the proximal shaft and therefore would inherently have a lumen) and (b) wherein the proximal shaft comprises at least one unsheathed segment (see Fig .13, distal of 48a and 48b that is not within sheath 80) wherein a length of the first and second elongate members is not disposed within the sheath.
With regard to claim 4, DiCaprio discloses wherein the proximal shaft further comprises a shaft lumen defined by the first sheath segment (80, sheath segment is a tubing wrapped around the proximal shaft and therefore would inherently have a lumen).
With regard to claim 7 DiCaprio discloses wherein the at least one elongate member comprises first (54a, 84a) and second (54b, 84b) elongate members, wherein the first and second elongate members are disposed in rolling contact and/or sliding contact with each other along the at least one unsheathed segment or within the at least one sheath segment (two elongate member 84a and 84b are disposed side by side and therefore can be considered in a rolling contact with each other).
With regard to claim 8 and 15, DiCaprio discloses the claimed invention except for the support membrane.
Anderson teaches the support membrane (20) being arcuate in shape therefore demonstrating a partial circumference membrane).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effectivefiling date of the claimed invention to modify the device of DiCaprio with the support membrane as taughtby Anderson for the purpose of increasing the push force, and torque control of the tubing ([0044]).
With regard to claim 10, DiCaprio discloses wherein the distal tube comprises a distal portion thathas a higher stiffness than a proximal portion ([0106], the reinforcing coil has a larger pitch at thetransition zone 40, which is equivalent to the proximal portion of the distal tube, such that there is lessreinforcement in this area compared to a more distal portion of the distal tube).
With regard to claim 12, DiCaprio discloses wherein the proximal shaft further comprises (a) a shaft lumen defined by the first sheath segment (80, sheath segment is a tubing wrapped around the proximal shaft and therefore would inherently have a lumen) and (b) wherein the proximal shaft comprises at least one unsheathed segment (see Fig .13, distal of 48a and 48b that is not within sheath 80) wherein a length of the first and second elongate members is not disposed within the sheath.
With regard to claim 13, DiCaprio discloses wherein the proximal shaft further comprises a shaft lumen defined by the first sheath segment (80, sheath segment is a tubing wrapped around the proximal shaft and therefore would inherently have a lumen).
With regard to claim 14, DiCaprio discloses wherein characteristics of the at least one sheath segment or the at least one unsheathed segment determine torsional compliance characteristics of the catheter (the term characteristics is broad, thus the material/thickness/size/location of the sheathed or unsheathed section could all determine the torsional compliance characteristics of the catheter as a whole).
With regard to claim 17, DiCaprio discloses A catheter (Fig. 2b-21b) comprising:(a) a distal tube (14) comprising a tubular wall and a tube lumen (36) defined within the tube by the tubular wall; and (c) a proximal shaft (16) attached to a proximal portion of the distal tube, the proximal shaft comprising: (i) at least one first elongate member (84a, 54a, see also embodiments of Fig. 16F-16L); and a first sheath segment (80) disposed around a first length of the first and second at least one elongate member such that the first length of the at least one elongate member is disposed within the first sheath segment (see Fig. 13a and 14) a shaft lumen defined by at least one sheath segment (80, sheath segment is a tubing wrapped around the proximal shaft and therefore would inherently have a lumen) and (b) wherein the proximal shaft comprises at least one unsheathed segment (see Fig .13, distal of 48a and 48b that is not within sheath 80) wherein a length of the first and second elongate members is not disposed within the sheath..
However, DiCaprio does not disclose a support membrane.
Anderson teaches a catheter having a distal tube (26, Fig. 3) and a proximal shaft (16); and further including a support membrane (20) disposed around a portion of the distal tube (see fig. 3, where element 20 extends into the proximal end of the distal tube.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effectivefiling date of the claimed invention to modify the device of DiCaprio with the support membrane as taughtby Anderson for the purpose of increasing the push force, and torque control of the tubing ([0044]).
With regard to claim 19, DiCaprio discloses wherein characteristics of the at least one sheath segment or the at least one unsheathed segment determine torsional compliance characteristics of the catheter (the term characteristics is broad, thus the material/thickness/size/location of the sheathed or unsheathed section could all determine the torsional compliance characteristics of the catheter as a whole).
With regard to claim 20, DiCaprio discloses wherein the at least one elongate member comprises first (54a, 84a) and second (54b, 84b) elongate members, wherein the first and second elongate members are disposed in rolling contact and/or sliding contact with each other along the at least one unsheathed segment or within the at least one sheath segment (two elongate member 84a and 84b are disposed side by side and therefore can be considered in a rolling contact with each other).
Claim 3, 5-6, 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCaprio et al. (US 2014/0276618 A1) in view of Anderson et al. (US 2013/0197483 A1) and in further view of Berg et al. (US 5,911,715).
With regard to claim 3, DiCaprio/Anderson teach the claimed invention except for an additional sheath segment.
Berg teaches wherein the proximal shaft comprises at least one additional sheath segment (11 isbroken into several different segments), wherein each of the at least one additional sheath segments is disposed around a different length of the first and second elongate members (see Fig. 2-5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effectivefiling date of the claimed invention to modify the device of DiCaprio/Anderson with the second sheathsegment as taught by Berg for the purpose of creating a catheter having sections of different rigidity forgreater control of the device when guiding into the body (Col 6, lines 41-50).
With regard to claim 5 and 18, DiCaprio/Anderson teach the claimed invention except for a filler material.
Berg teaches further comprising a filler material (18) disposed within at least a portion of the first sheath segment.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of DiCaprio/Anderson with the filler material as taught by Berg for the purpose of creating a catheter having sections of different rigidity for greater controlof the device when guiding into the body (Col 6, lines 41-50).
With regard to claim 6, DiCaprio discloses wherein characteristics of the at least one sheath segment or the at least one unsheathed segment determine torsional compliance characteristics of the catheter (the term characteristics is broad, thus the material/thickness/size/location of the sheathed or unsheathed section could all determine the torsional compliance characteristics of the catheter as a whole).
However, DiCaprio does not teach the second sheath segment.
Berg teaches wherein the proximal shaft comprises at least one additional sheath segment (11 isbroken into several different segments), wherein each of the at least one additional sheath segments is disposed around a different length of the first and second elongate members (see Fig. 2-5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effectivefiling date of the claimed invention to modify the device of DiCaprio/Anderson with the second sheathsegment as taught by Berg for the purpose of creating a catheter having sections of different rigidity forgreater control of the device when guiding into the body (Col 6, lines 41-50).
Claim 9 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over DiCaprio et al. (US 2014/0276618 A1) in view of Anderson et al. (US 2013/0197483 A1) and in further view of Minhara et al.(US 2004/0236215 A1).
With regard to claim 9 and 16 , DiCaprio/Anderson teaches the claimed invention except for a protective wrap.
Minhara teaches a distal tubing (8, Fig. 2) and a proximal shaft (2), wherein the distal tube further comprises a protective wrap (5) disposed around a portion of a proximal opening of the distal tube (as shown in Fig. 5).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of DiCaprio/Anderson with the protective wrap as taught by Minhara for the purpose of reinforcing and coupling the distal tube with the proximal shaft ([0062]).
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.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-34 of U.S. Patent No. 11,986,607 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because Claim 1 and 11 recite similar subject matter as claim 10 (which includes limitations of claim 1) such as the distal tube, the support membrane, a proximal shaft having at least one elongate member and a first sheath segment. The present claims are a broader version of the claims in U.S. Patent No. 11,986,607 B2 and therefore are taught by U.S. Patent No. 11,986,607 B2.
Conclusion
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/Lauren P Farrar/Primary Examiner, Art Unit 3783
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