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 .
Response to Amendment
This office action is responsive to the amendment filed on 11/13/2025. As directed by the amendment: claims 1, 7-9 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, 11-29 are presently pending in this application.
Response to Arguments
Applicant’s argument pages 8-9 of the remarks filed 11/13/2025 that Argo does not disclose “the separable portion includes a longitudinal section of a weakened structure having a thin section or a perforation” since the slit 118 of Argo cannot be interpreted as a thin section or a perforation. Applicant’s argument has been fully considered and are not persuasive. Perforation is defined in Dictionary.com (see attached NPL file for the definition of perforation) as a hole made or passing through a thing. Figure 4 and line 30 page 13 to line 9 page 14 disclose 118 being a slit, allowing a guide wire (not shown) to be radially slid into or out of sheath assembly 110 and aligning with slits 126 and 128 to provide a continuous slit for guide wire radial movement into and out of the sheath assembly 110. Therefore, 118 reads on the limitation of being a separable portion including a longitudinal section of a weakened structure having a perforation.
Applicant’s argument page 9 of the remarks filed 11/13/2025 that sheath 130 fails to teach the “separable portion is configured for passage of the cannula therethrough”. Applicant’s argument has been fully considered and are persuasive. However, upon further consideration, Argo sheath 110 reads on this limitation, see the rejection below.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2, 4, 7-9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Agro et al. (WO 98/10821).
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 and 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); and
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, fig. 1) 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, fig. 4) 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 (118) of a weakened structure having a thin section or a perforation (Examiner notes: see line 24 page 13 to line 9 for 118 being a slit, which is a weakened structure having a perforation).
Regarding claim 2, Agro discloses
The needle according to claim 1, 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 discloses
The needle according to claim 1, 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 discloses
The needle according to claim 1, 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 discloses
The needle according to claim 1, 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 discloses
The needle according to claim 1, 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 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) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Agro et al. (WO 98/10821) in view of Khanicheh et al. (US 2019/0022353).
Regarding claim 3, Agro 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DUNG T ULSH whose telephone number is (571)272-9894. The examiner can normally be reached Monday-Friday 9am-6pm.
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/DUNG T ULSH/Primary Examiner, Art Unit 3783
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