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 .
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1-17), Species I (Fig. 1-4) of Group A, and Species IV (Fig. 5) of Group B in the reply filed on 06/24/2026 is acknowledged.
Applicant acknowledges in the reply that claims 18-20 are directed to a non-elected invention. Accordingly, claims 18-20 have been withdrawn.
It is the Examiner’s position that claim 13, which claims a first medical device including “a curved distal section formed of shape memory material”, is specific to Species II (Fig. 9-12) of Group A.
Therefore, claims 13 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
Claims 1-12 and 14-17 are currently under examination.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12 and 14 are rejected under 35 U.S.C. 102(a)(1) as being unpatentable over Lindekugel et al. (US 2023/0128853 A1).
Regarding claim 1, Lindekugel discloses a system (10, see Fig. 1A) for accessing a target site within the body of a patient, said system comprising: a first tubular medical device (sheath 70, see Fig. 2A) having a distal end, a proximal end, and a lumen defined therethrough between the distal end and the proximal end, said lumen configured to accept a guidewire to advance said first tubular medical device over the guidewire to the target site (sheath 70 has a lumen configured to receive a guidewire 30, see Fig. 2A and [0047]); and a second medical device (RICC catheter 50, see Fig. 1A) advanceable alongside said first tubular medical device over the guidewire said first tubular medical device is advanced over, the guidewire extending through said lumen defined through said first tubular medical device and a lumen defined through said second medical device (RICC catheter 50 is advanceable over the same guidewire 30 that the sheath 70 is advanced over, see Fig. 1A).
Regarding claim 2, Lindekugel discloses the system of claim 1, wherein: said first tubular medical device includes a tubular elongate body extending between the proximal end and the distal end of said first tubular medical device and a wall defining said lumen (sheath 70 has a tubular body defining a wall of the lumen, see Fig. 2A); said tubular elongate body defines a distal opening at the distal end of said first tubular medical device (the needle 20 extends through the distal opening of the sheath 70, see Fig. 2A); said tubular elongate body defines a side opening (74) through said wall thereof; and a guidewire (30) is extendable into the distal opening of said tubular elongate body, through a distal portion of said lumen therein, and out the side opening through said wall of said tubular elongate body to be accessible for extending into the lumen defined through said second medical device (see Fig. 2A).
Regarding claim 3, Lindekugel discloses the system of claim 2, wherein said side opening is selected from one of the group consisting of a slot, a slit, a skive, a hole, or an aperture (aperture 74 can be considered a slot, slit, skive, hole or aperture, see Fig. 2A).
Regarding claim 4, Lindekugel discloses the system of claim 2, wherein said second medical device (50, see Fig. 1A) has a proximal end (towards hub 60) and a distal end (54), and includes a tubular elongate body extending between the proximal end and the distal end thereof having a wall defining a lumen configured to accept the portion of the guidewire extending out the side opening of said first tubular medical device (the body of catheter 50 defines a lumen configured to receive a guidewire extending out of the side opening of the sheath 70, see Fig. 1A).
Regarding claim 5, Lindekugel discloses the system of claim 4, wherein said tubular elongate body of said second medical device defines a distal opening at the distal end of said second medical device, said guidewire being extendable therethrough into the lumen defined through said second medical device (there is an opening in the distal end of catheter 50 for receiving the guidewire 30, see Fig. 1A and [0042]).
Regarding claim 6, Lindekugel discloses the system of claim 5, wherein said second medical device is configured to allow the proximal end of the guidewire inserted therethrough to exit said system through the proximal end of said second medical device (catheter 50 is configured so that guidewire 30 can extend proximally of the catheter, see Fig. 1A).
Regarding claim 7, Lindekugel discloses the system of claim 2, further comprising a cannula (needle 20 can be considered a cannula, see Fig. 2A) having a distal end and a proximal end (see Fig. 2B), wherein: said cannula is configured to be insertable through said lumen defined through said first tubular medical device (needle 20 is insertable through sheath 70, see Fig. 2A); said cannula has a wall defining a lumen (22) therethrough extending between the distal end and the proximal end of said cannula; a distal opening is defined in the distal end of said cannula in communication with said lumen through said cannula; a side opening (24) is defined in said cannula wall in communication with said lumen of said cannula; and the distance between the distal opening and the side opening of said tubular elongate body of said first tubular medical device is substantially the same as the distance between the distal opening and the side opening of said cannula (apertures 74 and 24 of the sheath and needle are aligned so that guidewire can pass through each, see Fig. 2A and [0047]).
Regarding claim 8, Lindekugel discloses the system of claim 1, wherein said first tubular medical device (sheath 70, see Fig. 2A) is a sheath.
Regarding claim 9, Lindekugel discloses the system of claim 8, further comprising a cannula insertable through said lumen defined through said first tubular medical device (needle 20 can be considered a cannula and is insertable into the sheath 70, see Fig. 2A).
Regarding claim 10, Lindekugel discloses the system of claim 9, further comprising a stylet insertable through a lumen defined through said cannula (guidewire 30 can be considered a stylet since it is an elongated medical probe and is insertable through the needle 20, see Fig. 2A).
Regarding claim 11, Lindekugel discloses the system of claim 7, further comprising a stylet insertable through said lumen defined through said first tubular medical device (guidewire 30 can be considered a stylet since it is an elongated medical probe and is insertable through the needle 20, see Fig. 2A).
Regarding claim 12, Lindekugel discloses the system of claim 1, wherein said second medical device comprises a device selected from the group consisting of: a scope, a flexible scope, a steerable catheter, a guide catheter, a non-steerable catheter, a sheath, or an access sheath (RICC catheter 50 can be considered a steerable catheter, guide catheter, a sheath or an access sheath).
Regarding claim 14, Lindekugel discloses the system of claim 1, wherein said second medical device is steerable and capable of steering said first tubular medical device when said second medical device and said first tubular medical device are extended over a common guidewire (when sheath 70, needle 20 and RICC catheter 50 are arranged as in Fig. 1A, force can be applied to the needle-sheath assembly via catheter 50 to guide the needle-sheath assembly).
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 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Lindekugel.
Regarding claim 15, Lindekugel discloses a system for accessing a target site within the body of a patient: a guidewire (30); a first tubular medical device (sheath 70, see Fig. 2A) having a distal end, a proximal end, and a lumen defined therethrough between the distal end and the proximal end, the lumen configured to accept said guidewire and to be advanced over said guidewire to the target site (sheath 70 has a lumen configured to receive a guidewire 30, see Fig. 2A and [0047]); and a second medical device (RICC catheter 50, see Fig. 1A) advanceable over said guidewire alongside said first tubular medical device with said guidewire extending through the lumen defined through said first tubular medical device and a lumen defined through said second medical device (RICC catheter 50 is advanceable over the same guidewire 30 that the sheath 70 is advanced over, see Fig. 1A).
While Lindekugel does not expressly disclose providing the components of the system as a kit, the Examiner takes official notice that combining usable parts together in a kit is old and well known and does not provide any unexpected results. Thus, it would have been obvious to one having ordinary skill in the art at the time of the invention to provide all the components usable together in a kit to enhance the ease of use for the user.
Regarding claim 16, Lindekugel discloses the kit of claim 15, wherein: said first tubular medical device includes a tubular elongate body extending between the proximal end and the distal end of said first tubular medical device and a wall defining said lumen (sheath 70 has a tubular body defining a wall of the lumen, see Fig. 2A); said tubular elongate body defines a distal opening at the distal end of said first tubular medical device (the needle 20 extends through the distal opening of the sheath 70, see Fig. 2A); said tubular elongate body defines a side opening (74) through said wall thereof; and a guidewire (30) is extendable into the distal opening of said tubular elongate body, through a distal portion of said lumen therein, and out the side opening through said wall of said tubular elongate body to be accessible for extending into the lumen defined through said second medical device (see Fig. 2A).
Regarding claim 17, Lindekugel discloses the kit of claim 15, wherein said second medical device comprises a device selected from the group consisting of: a scope, a steerable catheter, a guide catheter, a non-steerable catheter, a sheath, or an access sheath (RICC catheter 50 can be considered a steerable catheter, guide catheter, a sheath or an access sheath).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mitchell et al. (US 20160220786 A1), Kurrus et al. (US 20120157854 A1), McQueen et al. (US 8123739 B2), and Chou et al. (US 20180207399 A1) teach related catheter systems formed of two medical devices tracked over a shared guidewire.
Howell (US 2021/0085927 A1) and Massey et al. (US 2003/0135230 A1) teach catheter systems provided as a kit.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SERENITY MILLER whose telephone number is (571)272-1155. The examiner can normally be reached Monday-Friday 8:00am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SERENITY A MILLER/Examiner, Art Unit 3771
/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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