DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Objections
Claims 7 and 16 are objected to because of the following informalities: claims 7 and 16 recite “forms a join” which should be “forms a joint”. Appropriate correction is required.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claims 1-3, 9-13, and 18-19 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Nobles et al. (US 20080058839 A1).
Regarding claim 1 Nobles discloses (fig. 6A-6C and 8-11) a system delivering a suture to a blood vessel, the system comprising:
a suture delivery device 44 having a distal end region (see fig. 6A);
a removable guidewire segment 14 (see [0051]) coupled to the distal end region (see fig. 6A, 10 and [0082]);
wherein the suture delivery device 44 is configured to deliver a suture to a wall of a blood vessel (see fig. 11 and [0084]); wherein the removable guidewire segment 14 is configured to be detached from the distal end region of the suture delivery device 44 (they are engaged but not permanently attached, see [0085]) and attached to a proximal guidewire segment 12 to form a guidewire 10 (14 is attached to segment 12 when the suture delivery device is attached); and
an access device 38 configured to be delivered to the blood vessel along the guidewire (see fig. 8 and [0072] and [0074]).
Regarding claim 11 Nobles discloses (fig. 6A-6C and 8-11) a medical device system comprising:
a suture delivery device 44 having a distal end region (see fig. 6A) configured to deliver a suture to a wall of a blood vessel (see fig. 11 and [0084]);
a removable distal guidewire segment 14 (see [0051]) detachably connected to the distal end region (see fig. 6A, 10 and [0082]);
a proximal guidewire segment 12 (see [0051]);
an access device 31/38 (see fig. 8 and [0074]);
wherein the removable distal guidewire segment 14 is configured to be detached from the distal end region of the suture delivery device 44 (they are engaged but not permanently attached, see [0085]) such that when the suture delivery device 44 is removed from the blood vessel, the removable distal guidewire segment can be attached to the proximal guidewire segment 12 to form a guidewire 10 (14 is attached to segment 12 when the suture delivery device is attached) that is configured to allow the access device 38 to be advanced thereover into the blood vessel (see fig. 8 and [0072] and [0074]).
Regarding claims 2 and 12 Nobles further discloses (fig. 6A-6C and 8-11) the suture delivery device 44 includes a body 20 comprising a suture capture rod 70 disposed within the body (see fig 18 and [0069]).
Regarding claims 3 and 13 Nobles further discloses (fig. 6A-6C and 8-11) the suture capture rod 70 is configured to pass the suture 52 through the wall of the blood vessel (see fig. 18 and [0098]).
Regarding claims 9 and 18 Nobles further discloses (fig. 6A-6C and 8-11) the access device includes an introducer 31 (see [0074]).
Regarding claims 10 and 19 Nobles further discloses (fig. 6A-6C and 8-11) the access device includes a dilator 38 (see fig. 8 and [0074]).
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 4-7, 14-16, and 20 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nobles in view of Melsheimer (US 20080051676 A1).
Regarding claims 4-7 and 14-16 Nobles discloses the claimed invention substantially as claimed, as set forth above for claim 1. Nobles is silent regarding the removable guidewire segment includes a proximal connector; the proximal connector includes a screw connector, a snap connector, or a spring coupler; the proximal guidewire segment includes a distal connector configured to engage the proximal connector; engagement of the proximal connector with the distal connector forms a join with smooth edges that are free of a step in diameter.
However Melsheimer, in the same filed of endeavor, teaches (fig. 2-5) a guidewire comprising a proximal segment 50 (see [0022]) and a removable guidewire segment 10 (see [0019]), wherein the removable guidewire segment 10 includes a proximal connector 20 (see fig. 4 and [0023]), the proximal connector 20 includes a screw connector (see fig. 4 and [0023]); the proximal guidewire segment 50 includes a distal connector 30 configured to engage the proximal connector 20 (see fig. 5 and [0025]); engagement of the proximal connector 30 with the distal connector forms a joint with smooth edges that are free of a step in diameter (see fig. 5).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify Nobles to have the removable guidewire segment includes a proximal connector; the proximal connector includes a screw connector, a snap connector, or a spring coupler; the proximal guidewire segment includes a distal connector configured to engage the proximal connector; engagement of the proximal connector with the distal connector forms a join with smooth edges that are free of a step in diameter as taught by Melsheimer, for the purpose of being able to attach a different tip to the guidewire in order to change the flexibility, torqueability, and pushability of the guidewire (see Melsheimer [0046]).
Regarding claim 20 Nobles discloses (fig. 6A-6C and 8-11) a medical device system comprising:
a suture delivery device 44 having a distal end region (see fig. 6A) wherein the suture delivery device 44 includes a body 20 comprising a suture capture rod 70 disposed within the body (see fig 18 and [0069]);
wherein the suture capture rod 70 is configured to pass the suture 52 through the wall of the blood vessel (see fig. 18 and [0098]);
a removable distal guidewire segment 14 (see [0051]) including a proximal connector (taper, see [0051]) detachably connected to the distal end region of the suture delivery device 44 (see fig. 6A, 10 and [0082]);
a proximal guidewire segment 12 (see [0051]);
an access device 38 (see fig. 8 and [0074]);
wherein the removable distal guidewire segment 14 is configured to be detached from the distal end region of the suture delivery device 44 (they are engaged but not permanently attached, see [0085]) such that when the suture delivery device 44 is removed from the blood vessel, the proximal connector (taper) of the removable distal guidewire segment 14 can be attached to the proximal guidewire segment to form a guidewire 10 (14 is attached to segment 12 when the suture delivery device is attached) that is configured to allow the access device 38 to be advanced thereover into the blood vessel. (see fig. 8 and [0072] and [0074]).
Nobles is silent regarding the proximal guidewire segment having a distal connector; the proximal connector of the removable distal guidewire segment can be attached to the distal connector of the proximal guidewire segment.
However Melsheimer, in the same filed of endeavor, teaches (fig. 2-5) a guidewire comprising a proximal segment 50 (see [0022]) and a removable distal guidewire segment 10 (see [0019]), wherein the removable guidewire segment 10 includes a proximal connector 20 (see fig. 4 and [0023]), the proximal guidewire segment 50 includes a distal connector 30 (see fig. 5 and [0025]); the proximal connector 20 of the removable distal guidewire segment 10 can be attached to the distal connector 30 of the proximal guidewire segment 50 (see fig. 5 and [0025]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify Nobles to have the proximal guidewire segment having a distal connector; the proximal connector of the removable distal guidewire segment can be attached to the distal connector of the proximal guidewire segment as taught by Melsheimer, for the purpose of being able to attach a different tip to the guidewire in order to change the flexibility, torqueability, and pushability of the guidewire (see Melsheimer [0046]).
Claims 8 and 17 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Nobles in view of Melsheimer and Kontos et al. (US 5,404,888).
Regarding claims 8 and 17 Nobles discloses the claimed invention substantially as claimed, as set forth above for claims 1 and 11.
Melsheimer, in the same filed of endeavor, teaches (fig. 2-5) a guidewire comprising a proximal segment 50 (see [0022]) and a removable distal guidewire segment 10 (see [0019]) removable connected to each other (see [0025]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify Nobles to have the proximal guidewire segment and removable distal guidewire segment removably connected to one another as taught by Melsheimer, for the purpose of being able to attach a different tip to the guidewire in order to change the flexibility, torqueability, and pushability of the guidewire (see Melsheimer [0046]).
Nobles is silent regarding an insertion tool for securing the removable distal guidewire segment to the proximal guidewire segment.
However Kontos, in the same filed of endeavor, teaches a guidewire comprising a distal segment and a proximal segment, wherein the distal section and a proximal section can be secured using an insertion tool for securing the removable distal guidewire segment to the proximal guidewire segment (see col. 3 ln. 61 – col. 4 ln. 2).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify Nobles as modified to have an insertion tool for securing the removable distal guidewire segment to the proximal guidewire segment as taught by Kontos, for the purpose of being able to facilitate alignment and connection of the sections (see Kontos [0046]).
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 1-7 of U.S. Patent No. 10,159,479 B2 in view of Nobles.
Regarding claim 1 U.S. Patent No. 10,159,479 claims in claim 1 a system delivering a suture to a blood vessel (col. 39 ln. 38-39), the system comprising:
a suture delivery device having a distal end region (col. 49 ln. 40 – col. 40 ln. 3);
a removable guidewire segment (col. 40 ln. 5) coupled to the distal end region (col. 40 ln. 8-11);
wherein the suture delivery device is configured to deliver a suture to a wall of a blood vessel (col. 40 ln. 20-22); wherein the removable guidewire segment is configured to be detached from the distal end region of the suture delivery device (col. 40 ln. 8-19) and attached to a proximal guidewire segment to form a guidewire (col. 40 ln. 8-19).
U.S. Patent No. 10,159,479 fails to claim an access device configured to be delivered to the blood vessel along the guidewire.
However Nobles, in the same filed of endeavor, teaches an access device 31/38 configured to be delivered to the blood vessel along the guidewire (see fig. 8 and [0072] and [0074]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify U.S. Patent No. 10,159,479 claim 1 to claim an access device configured to be delivered to the blood vessel along the guidewire as taught by Nobles, for the purpose of being able to introduce other devices to the vessel for treatment.
Regarding claim 11 U.S. Patent No. 10,159,479 claims in claim 1 a medical device system (col. 39 ln. 38-39) comprising:
a suture delivery device having a distal end region configured to deliver a suture to a wall of a blood vessel (col. 40 ln. 20-22);
a removable distal guidewire segment (col. 40 ln. 5) detachably connected to the distal end region (col. 40 ln. 8-10);
a proximal guidewire segment (col. 40 ln. 4);
wherein the removable distal guidewire segment is configured to be detached from the distal end region of the suture delivery device such that when the suture delivery device is removed from the blood vessel, the removable distal guidewire segment can be attached to the proximal guidewire segment to form a guidewire (col. 40 ln. 8-19) that is configured to allow the access device 38 to be advanced thereover into the blood vessel (the guidewire is capable of allowing an access device to be inserted thereover).
U.S. Patent No. 10,159,479 fails to claim an access device configured to be delivered to the blood vessel along the guidewire.
However Nobles, in the same filed of endeavor, teaches an access device 31/38 configured to be delivered to the blood vessel along the guidewire (see fig. 8 and [0072] and [0074]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify U.S. Patent No. 10,159,479 claim 1 to claim an access device configured to be delivered to the blood vessel along the guidewire as taught by Nobles, for the purpose of being able to introduce other devices to the vessel for treatment.
Regarding claims 2 and 12 U.S. Patent No. 10,159,479 claims in claim 1 the suture delivery device includes a body comprising a suture capture rod disposed within the body (col. 39 ln. 40 – col. 40 ln. 3).
Regarding claims 3 and 13 U.S. Patent No. 10,159,479 claims in claim 1 the suture capture rod is configured to pass the suture through the wall of the blood vessel (col. 39 ln. 40 – col. 40 ln. 3).
Regarding claims 4 and 14 U.S. Patent No. 10,159,479 claims in claim 1 the removable guidewire segment includes a proximal connector (coupling component, col. 40 ln. 8-19).
Regarding claim 5 U.S. Patent No. 10,159,479 claims in claim 5 the proximal connector includes a screw connector, a snap connector, or a spring coupler (col. 40 ln. 33-34).
Regarding claims 6 and 15 U.S. Patent No. 10,159,479 claims in claim 2 the proximal guidewire segment includes a distal connector configured to engage the proximal connector (col. 40 ln. 8-25).
Regarding claims 7 and 16 U.S. Patent No. 10,159,479 claims in claim 6 engagement of the proximal connector with the distal connector forms a joint with smooth edges that are free of a step in diameter (col. 40 ln. 8-19 and 35-36).
Regarding claims 8 and 17 U.S. Patent No. 10,159,479 claims in claim 7 an insertion tool for securing the removable guidewire segment to the proximal guidewire segment (col. 40 ln. 37-39).
Regarding claims 9 and 18 U.S. Patent No. 10,159,479 as modified claims the access device includes an introducer 31 (see Nobles [0074]).
Regarding claims 10 and 19 U.S. Patent No. 10,159,479 as modified claims the access device includes a dilator 38 (see fig. 8 and Nobles [0074]).
Regarding claim 20 U.S. Patent No. 10,159,479 claims in claim 1 a medical device system (col. 39 ln. 38-39), comprising: a suture delivery device having a distal end region (col. 39 ln. 40 – col. 40 ln. 3); wherein the suture delivery device includes a body comprising a suture capture rod disposed within the body ((col. 39 ln. 40 – col. 40 ln. 3)); wherein the suture capture rod is configured to pass a suture through a wall of a blood vessel (col. 39 ln. 40 – col. 40 ln. 3); a removable distal guidewire segment (col. 40 ln. 5) including a proximal connector detachably connected to the distal end region of the suture delivery device (col. 40 ln. 8-19); a proximal guidewire segment (col. 40 ln. 4) having a distal connector (col. 40 ln. 8-19); and wherein the removable distal guidewire segment is configured to be detached from the distal end region of the suture delivery device such that when the suture delivery device is removed from the blood vessel, the proximal connector of the removable distal guidewire segment can be attached to the distal connector of the proximal guidewire segment to form a guidewire (col. 40 ln. 8-19) that is configured to allow the access device to be advanced thereover into the blood vessel (the guidewire is capable of allowing an access device to be inserted thereover).
U.S. Patent No. 10,159,479 fails to claim an access device configured to be delivered to the blood vessel along the guidewire.
However Nobles, in the same filed of endeavor, teaches an access device 31/38 configured to be delivered to the blood vessel along the guidewire (see fig. 8 and [0072] and [0074]).
Therefore it would have been obvious to one of ordinary skill in the art, at the time the invention was made, to modify U.S. Patent No. 10,159,479 claim 1 to claim an access device configured to be delivered to the blood vessel along the guidewire as taught by Nobles, for the purpose of being able to introduce other devices to the vessel for treatment.
Conclusion
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/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
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