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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 04/13/2026. As directed by the amendment: claims 1 have been amended; claims 5-6, 10, 30-50 have been canceled; and no new claims have been added. Thus, claims 1-4, 7-9 are presently pending in this application.
Claim Objections
Claim(s) is/are objected to because of the following informalities:
Claim 1, line 3, “the hub”. It should be amended as “the connection hub”.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 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) 1-2, 4, 7-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agro et al. (WO 98/10821) in view of Trocke et al. (US 2018/0078744).
Regarding claim 1, Agro discloses
A needle (34, fig. 1) for accessing a vasculature of a patient (line 16 page 8 to line 7 page 12, figs. 1-1C), comprising:
a sharp tip at a distal end (see fig. 1 for the tapered distal end 46);
a connection hub (32, fig. 1) at a proximal end (40), the hub (32) configured for connection to a syringe (Examiner notes: the limitation “configured for connection to a syringe” is interpreted as functional limitation, and the limitation “a syringe” is not positively recited in claim 1. See lines 28-37 page 8 for connection hub 32);
a cannula (38, fig. 1) extending from the distal end (46) to the proximal end (40), the cannula (38) comprising a fluid lumen (56 or 58, figs. 1A-1C and lines 1-14 page 10) extending from the distal end (46) to the proximal end (40);
a guideway lumen (60, figs. 1A-1B) extending proximally away from the distal end (46), wherein the guideway lumen (60) comprises a guideway slot (42/52/54) extending along a length of the guideway lumen (see fig. 1), and wherein the guideway lumen (60) is configured for placement of a guidewire therein (Examiner notes: “the limitation “is configured for placement of a guidewire therein” is interpreted as functional limitation, and the limitation “a guidewire” is not positively recited in claim 1. See fig. 1 and lines 21-37 page 9 for lumen 60 with slot 42/52/54); and
a sheath (110, figs. 4-5) disposed over the cannula (38) along a length of the cannula (see fig. 5) extending away from the distal end (46, fig. 5), the sheath (110) configured to retain the guidewire within the guideway lumen (Examiner notes: the limitation “configured to retain the guidewire within the guideway lumen” is interpreted as functional limitation, and the limitation “the guidewire” is not positively recited in claim 5. See fig 5 for the position of sheath 110 with respect to cannula 38), wherein: the sheath (110) includes a sheath wall (wall of 110) having a separable portion (118) extending from a distal end of the sheath to a proximal end of the sheath (see fig. 4 and line 24 page 13 to line 9 page 14), and the separable portion (118) includes a longitudinal section of a weakened structure (see figs. 4A-4C)
Agro discloses different embodiments of the sheath (see fig. 4B for sheath 110 with separable portion 118 and see fig. 4C for sheath 130 with separable portion 136 for a guide wire radial movement into and out of the sheath), but Agro is silent about the separable portion including a thin section
However, Trocke teaches a sheath (100, fig. 1) including a sheath wall (130/132) having a separable portion with a thin section (150, fig. 2 and pars. 0040-0042).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Agro’s sheath to include a thin section, as taught by Trocke, for the purpose of facilitating the separation of the sheath when force is applied to the sheath (par. 0039 of Trocke).
Regarding claim 2, Agro in view of Trocke discloses the needle according to claim 1,
Agro further discloses wherein the guideway slot (42/52/54, fig. 1) extends radially (Examiner notes: see figs. 1 and 1C, and lines 21-37 page 9 for 42/52/54 extending radially to allow guidewire 36 to be inserted into) through a guideway-lumen wall (wall of 60, see fig. 1).
Regarding claim 4, Agro in view of Trocke discloses the needle according to claim 1,
Agro further discloses wherein a width of the guideway slot (width of 42/52/54) is substantially equal to or less than (see fig. 1) a diameter of the guideway lumen (diameter of 60).
Regarding claim 7, Agro in view of Trocke discloses the needle according to claim 1,
Agro further discloses wherein: the sheath (110) is rotatable about the cannula (38) between a first angular position and a second angular position, the separable portion (118) is disposed adjacent the guideway slot (42/52/54) in the first position (see figs. 5 and 6), and the separable portion is disposed away from the guideway slot in the second position (Examiner notes: the diameter of 34 is smaller than the diameter of 110 as shown in fig. 6; 34 is positioned within 110; and 34 is capable of being rotated within 110 or 110 is capable being rotated with respect to 34. Therefore, when 110 is rotated with respect to 34, 110 is in a position where 118 is disposed away from 42/52/54).
Regarding claim 8, Agro in view of Trocke discloses the needle according to claim 1,
Agro further discloses wherein separable portion (118) is configured for passage of the guidewire therethrough (Examiner notes: the limitation “is configured for passage of the guidewire therethrough” is interpreted as functional limitation, and the limitation “the guidewire” is not positively recited in claim 8. See figs. 4-6 and line 30 page 13 to line 9 page 14 for element 118).
Regarding claim 9, Agro in view of Trocke discloses the needle according to claim 1,
Agro further discloses wherein separable portion (118) is configured for passage of the cannula therethrough (Examiner notes: the limitation “is configured for passage of the cannula therethrough” is interpreted as functional limitation. See figs. 4-6 and line 30 page 13 to line 9 page 14 for 118 allowing a guidewire (not shown) to be radially slid into or out of sheath 110; and 118 with a continuous slit for guide wire radial movement into and out of sheath 110. Therefore, 118 is capable of being widened to allow the passage of the cannula under an applied force from a user).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agro et al. (WO 98/10821) in view of Trocke et al. (US 2018/0078744) in further view of Khanicheh et al. (US 2019/0022353).
Regarding claim 3, Agro in view of Trocke discloses the needle according to claim 1, wherein the guideway slot (42/52/54, fig. 1) extends along (see fig. 1) the guideway lumen (60)
Agro is silent about the guideway slot extending to the distal end.
However, Khanicheh teaches about a guidewire lumen including a slit extending along the length thereof (see fig. 2A and par. 0035).
It would have been obvious to one having ordinary skill in the art before the effective filling date of the claimed invention to modify Agro’s guidewire slot to extending along the length of the guidewire lumen, as taught by Khanicheh, for the purpose of providing sufficient structure to allow greater ease and precision of placement of the guidewire.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO 892 form.
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/DUNG T ULSH/Examiner, Art Unit 3783
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