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 with traverse of Group I, claims 1-3, 17-18 in the reply filed on 01/13/2026 is acknowledged. The traversal is on the ground(s) that there is an undue search burden in examining all of the claims together, as it is likely that art discussing a vascular insertion system and introducer tool would discuss a method of using the system as well as the introducer tool itself. Applicant respectfully requests the restriction between Groups I, II, and III be withdrawn and all of the pending claims be examined together.
The examiner agrees. Therefore, the restriction requirement is withdrawn, and
claims 1-21 are examined on the merits.
Drawings
The drawings are objected to because they fail to meet requirements in
MPEP 608.02 (V) Drawing Standards. See 37 CFR 1.84 (p)(3), (u)(2), (l), and (m).
(p)(3): Numbers, letters, and reference characters must measure at least .32 cm. (1/8 inch) in height.
(u)(2): Numbers and letters identifying the views must be larger than the numbers used for reference characters.
(l): Character of lines, numbers, and letters. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. The weight of all lines and letters must be heavy enough to permit adequate reproduction. This requirement applies to all lines however fine, to shading, and to lines representing cut surfaces in sectional views. Lines and strokes of different thicknesses may be used in the same drawing where different thicknesses have a different meaning.
(m) Shading. The use of shading in views is encouraged if it aids in understanding the invention and if it does not reduce legibility. Shading is used to indicate the surface or shape of spherical, cylindrical, and conical elements of an object. Flat parts may also be lightly shaded. Such shading is preferred in the case of parts shown in perspective, but not for cross sections. See paragraph (h)(3) of this section. Spaced lines for shading are preferred. These lines must be thin, as few in number as practicable, and they must contrast with the rest of the drawings. As a substitute for shading, heavy lines on the shade side of objects can be used except where they superimpose on each other or obscure reference characters. Light should come from the upper left corner at an angle of 45°. Surface delineations should preferably be shown by proper shading. Solid black shading areas are not permitted, except when used to represent bar graphs or color.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 4, and 10 are objected to because of the following informalities:
In claims 1, 4, and 10, “a tapered guide sheath lure” should be amended with “a tapered guide sheath luer”. Appropriate correction is required.
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.
(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 16, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by AL-RASHDAN et al. (US 20140236088 A1).
Regarding claim 16, AL-RASHDAN discloses a vascular introducer tool (sheath 40; figs 1-5c) comprising:
a shaft (44,46,42) having an outer wall extending from a proximal end to an opposite distal end with a lumen extending in a longitudinal direction defined therethrough; and disposed between the proximal and distal ends the shaft including an intermediate transition section 44,46 having a tapered inner diameter and a tapered outer diameter (in [0026] states that the sheath has different transitions that adapt to the tapering of the obturator (fig 2). Therefore, the inner and outer diameter are tapered).
Regarding claim 19, AL-RASHDAN discloses the outer wall of the shaft includes a semi-split section (50; fig 5a-5c) extending in a longitudinal direction from a proximal end of the lumen and terminating proximally of the distal end of the introducer tool defining distally thereof an unsplit distal section (fig 5b).
Regarding claim 20, AL-RASHDAN discloses wherein a proximal section of the outer wall of the shaft is splitable (figs 5a-5c) in the longitudinal direction into multiple proximal divided sections separated away from one another relative to a longitudinal axis through the vascular introducer tool forming respective tabs.
Allowable Subject Matter
Claims 2-3, 5-9, 11-15, and 17-18 are allowed.
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Chelsea Stinson can be reached at 571-270-1744. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783