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.
Claims 24, 27-32, and 34-38 are rejected under 35 U.S.C. 103 as unpatentable over U.S. Patent Application Publication No. 2009/0192463 (Nardeo) in view of U.S. Patent Application Publication No. 2017/0216506 (Jeevanandam).
Regarding claim 24, Nardeo discloses a system for inserting a medical device (catheter, see Abstract) into a blood vessel of a patient comprising: an introducer assembly (10) comprising: an elongate sheath (12) sized for insertion into a blood vessel of a patient (see paragraphs [0003]-[0009] and [0028]), the elongate sheath having a longitudinal axis (along the length of the sheath 12); a hub (16) coupled to a proximal portion of the elongate sheath, the hub comprising: a first hub portion (40/46; see also 60/70) having a first notch (42 or 48); and a second hub portion (22) partially surrounding the first hub portion, and wherein the second hub portion comprises: two wings (20); and an opening (30; see also central opening in hub portion 22) disposed above the first notch; and wherein the first hub portion comprises a first material (proximal end 40 comprises sheath tube material, such as polytetrafluroethylene, see Abstract and paragraphs [0007], [0011], and [0036]; see also second material for liner 46 that is different from third material for component 22 molded around proximal end, see paragraph [0010]) and the second hub portion comprises a second material (polyethylene, see Abstract and paragraphs [0007], [0011], and [0036]; see also third material for component 22 molded around proximal end, see paragraph [0010]), the first material differing from the second material.
Further regarding claim 24, Nardeo is silent on the system including a blood pump for insertion into a blood vessel. However, Jeevanandam discloses a system for introducing a blood pump into a blood vessel that includes a blood pump and introducer assembly for introducing the blood pump into the blood vessel (see paragraph [0009]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the introducer assembly of Nardeo to introduce a blood pump into a blood vessel, as Jeevanandam suggests a blood pump is suitable for being introduced into a blood vessel by an introducer assembly to facilitate implantation of a cardiac assist device (see Jeevanandam, see paragraphs [0003]-[0006]). Thus, the introducer assembly of Nardeo and the blood pump of Jeevanandam are known prior art elements that one of ordinary skill int the art could have been predictably combined as claimed into one system, and each element merely performs the same function as it does separately. See MPEP 2143(I)(A).
Regarding claim 27, Nardeo discloses wherein the first notch (48) is oriented parallel to the longitudinal axis of the elongate sheath (see Figs. 7-10; to facilitate splitting along longitudinal axis of sheath).
Regarding claim 28, Nardeo discloses wherein the hub (16) is configured to break at the first notch (48) along a direction of the longitudinal axis of the elongate sheath (see paragraph [0030] and Figs. 7-10).
Regarding claim 29, Nardeo discloses wherein the elongate sheath (12) further comprises a longitudinal scoring parallel to the longitudinal axis of the elongate sheath (see paragraph [0013]).
Regarding claim 30, Nardeo discloses wherein the elongate sheath (12) is configured to tear along the longitudinal scoring parallel to the longitudinal axis of the elongate sheath (see paragraph [0013]).
Regarding claim 31, Nardeo discloses wherein the first hub portion and the elongate sheath form a hemostatic bond wherein the hemostatic bond is configured to prevent blood from flowing between the first hub portions and the elongate sheath (see Figs. 9 and 10 and paragraphs [0010], [0013], [0014], [0031], and [0032]; additionally, first hub portion 40/60 is shown integrally formed with elongate sheath 12 such that blood cannot flow between the first hub portion and elongate sheath).
Regarding claim 32, Nardeo discloses wherein the wings (20) each comprise a wide face (face with ridges, see Figs. 1-6) and a narrow face, and the wide face is normal to the longitudinal axis of the elongate sheath (see Fig. 6, e.g.).
Regarding claim 34, Nardeo discloses wherein the first hub portion (40/46; see also 60/70) comprises a second notch (first and second notches 48, see Fig. 7; see also first and second notches 42, see Fig. 7).
Regarding claims 35 and 36, Nardeo fails to explicitly disclose wherein the first material has a hardness of about 45 Shore D, and wherein the second material has a hardness in the range of about 68-72 Shore D. However, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide the first and second materials with the claimed hardness ranges as 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 37, Nardeo fails to explicitly disclose wherein the hub has a minimum diameter of about 9 Fr. However, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide the hub with the claimed minimum diameter as 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 38, Nardeo fails to explicitly disclose wherein the first hub portion has a minimum thickness of 0.1 mm at the first notch. However, it would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to provide the first hub portion with the claimed minimum thickness at the first notch as 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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.
Claims 25, 26, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Nardeo in view of Jeevanandam, and further in view of U.S. Patent No. 5,489,273 (Whitney).
Regarding claims 25 and 26, Nardeo appears to disclose wherein the first material has a first ultimate strength and the second material has a second ultimate strength, the second ultimate strength being greater than the first ultimate strength (polytetrafluroethylene vs. polyethylene, see Abstract and paragraphs [0007], [0011], and [0036]), and wherein the first material has a first stiffness and the second material has a second stiffness, the second stiffness being greater than the first stiffness (polytetrafluroethylene vs. polyethylene, see Abstract and paragraphs [0007], [0011], and [0036]). Alternatively, Whitney discloses an infusion apparatus including a winged hub portion (22) and a catheter sheath (20), wherein the hub is made of a relatively stiffer and stronger material than the catheter sheath (tetrafluoroethylene vs. polyethylene, see col. 5, lines 13-28 and lines 36-37). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the second hub material to be stiffer and stronger than the first hub material to facilitate gripping and manipulating of the introducer assembly via the second hub portion and allow for flexible positioning and easy splitting of the first hub portion.
Regarding claim 33, Nardeo fails to disclose wherein the wings each comprise a wide face and a narrow face such that the narrow face is normal to the longitudinal axis of the elongate sheath. However, Whitney discloses an introducer device including wings (18/20), wherein the wings each comprise a wide face and a narrow face such that the narrow face is normal to the longitudinal axis of an elongate sheath (see Figs. 1-4). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to configure the assembly such that the narrow face is normal to the longitudinal axis as suggested by Whitney as such a modification merely involves substituting one known wing orientation and technique for splitting a catheter sheath from a known introducer device for another known wing orientation and technique for splitting a catheter sheath from another known introducer device without any unpredictable results.
Claims 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Nardeo in view of Jeevanandam, and further in view of U.S. Patent No. 6,887,417 (Gawreluk).
Regarding claims 39-42, Nardeo fails to disclose wherein the first hub portion has a thickness at the first notch that is variable along a length of the first notch (claim 39), and wherein the thickness of the first hub portion at the first notch is greatest at a proximal end portion of the first hub portion (claim 40), wherein the thickness of the first hub portion at the first notch is between about 0.01 inches and 0.012 inches at the proximal end portion of the first hub portion (claim 41), and wherein the thickness of the first hub portion at the first notch is between about 0.004 inches and 0.006 inches at a distal end portion of the first hub portion (claim 42). However, Gawreluk discloses a catheter-sleeve assembly including a hub portion (16) including a notch (50/52), wherein the thickness of the hub portion at the notch is variable along a length of the notch (see col. 8, lines 10-19). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to make the thickness of the hub portion at the notch variable along the length of the notch as suggested by Gawreluk in order to obtain a desired force versus splitting characteristic for the hub (see col. 8, lines 10-19). Additionally, it would have been obvious to make the thickness of the first hub portion at the first notch greatest at a proximal end portion of the first hub portion in order to provide a stronger “initiation force” required for splitting of the hub in order to prevent against unintentional tearing of the hub portion, followed by decreasing force needed to continue splitting of the hub once the initiation force has commenced. Additionally, it would have been prima facie obvious to make the thickness of the first hub portion at the first notch be between about 0.01 inches and 0.012 inches at the proximal end portion of the first hub portion, and the thickness of the first hub portion at the first notch be between about 0.004 inches and 0.006 inches at a distal end portion of the first hub portion as 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. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
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 24-30, 32-37, and 39-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-18 of U.S. Patent No. 12,310,621 B2 (Murphy ‘621) in view of Jeevanandam.
Claim 1 of Murphy ‘621 recites all of the subject matter of claim 24 of the present application except that the introducer assembly is part of a system for inserting a blood pump into a blood vessel of a patient that includes a blood pump. However, Jeevanandam discloses a system for introducing a blood pump into a blood vessel of a patient that includes a blood pump and introducer assembly for introducing the blood pump into the blood vessel (see paragraph [0009]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the introducer assembly of claim 1 of Murphy ‘621 to introduce a blood pump into a blood vessel, as Jeevanandam suggests a blood pump is suitable for being introduced into a blood vessel by an introducer assembly to facilitate implantation of a cardiac assist device (see Jeevanandam, see paragraphs [0003]-[0006]). Thus, the introducer assembly of claim 1 of Murphy ‘621 and the blood pump of Jeevanandam are known prior art elements that one of ordinary skill int the art could have been predictably combined as claimed into one system, and each element merely performs the same function as it does separately. See MPEP 2143(I)(A).
Further, claims 2-7 and 9-18 of Murphy ‘621 disclose the subject matter of claims 25-30, 32-37, and 39-42 of the present application, respectively.
Claims 24-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,369,413 B2 (Murphy ‘413) in view of Jeevanandam.
Claim 1 of Murphy ‘413 recites all of the subject matter of claim 24 of the present application except that the introducer assembly is part of a system for inserting a blood pump into a blood vessel of a patient that includes a blood pump. However, Jeevanandam discloses a system for introducing a blood pump into a blood vessel of a patient that includes a blood pump and introducer assembly for introducing the blood pump into the blood vessel (see paragraph [0009]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the introducer assembly of claim 1 of Murphy ‘413 to introduce a blood pump into a blood vessel, as Jeevanandam suggests a blood pump is suitable for being introduced into a blood vessel by an introducer assembly to facilitate implantation of a cardiac assist device (see Jeevanandam, see paragraphs [0003]-[0006]). Thus, the introducer assembly of claim 1 of Murphy ‘413 and the blood pump of Jeevanandam are known prior art elements that one of ordinary skill int the art could have been predictably combined as claimed into one system, and each element merely performs the same function as it does separately. See MPEP 2143(I)(A).
Further, claims 2-19 of Murphy ‘413 disclose the subject matter of claims 25-42 of the present application, respectively.
Claims 24-42 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-20 of U.S. Patent No. 10,709,476 B2 (Murphy ‘476) in view of Jeevanandam.
Claim 1 of Murphy ‘476 recites all of the subject matter of claim 24 of the present application except that the introducer assembly is part of a system for inserting a blood pump into a blood vessel of a patient that includes a blood pump. However, Jeevanandam discloses a system for introducing a blood pump into a blood vessel of a patient that includes a blood pump and introducer assembly for introducing the blood pump into the blood vessel (see paragraph [0009]). It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention to use the introducer assembly of claim 1 of Murphy ‘476 to introduce a blood pump into a blood vessel, as Jeevanandam suggests a blood pump is suitable for being introduced into a blood vessel by an introducer assembly to facilitate implantation of a cardiac assist device (see Jeevanandam, see paragraphs [0003]-[0006]). Thus, the introducer assembly of claim 1 of Murphy ‘476 and the blood pump of Jeevanandam are known prior art elements that one of ordinary skill int the art could have been predictably combined as claimed into one system, and each element merely performs the same function as it does separately. See MPEP 2143(I)(A).
Further, claims 2-7 and 9-20 of Murphy ‘476 disclose the subject matter of claims 25-42 of the present application, respectively.
Conclusion
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/NICHOLAS J PLIONIS/Primary Examiner, Art Unit 3773