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 .
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)(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.
Claims 10-12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Rogers et al (US 20220401111 A1).
Regarding claims 10-12, Rogers discloses a sheath 705 for use with a sheath delivery system, in figures 8a-11f, the sheath 705 [0082-0093] comprising:
an elongated lumen with a distal tip 710 and an open proximal end (fig 11c);
a curved section located proximal the distal tip such that the curved section does not advance past an entry point into a patient (figs 11c-11d);[0086-0088];
a plurality of suture wings located along the curved section ([0091] wherein a suture wing is configured to receive a suture that fastens the sheath to a skin surface adjacent to the entry point into the patient, such that the curved section of the sheath directs a wire exiting the sheath from the open proximal end away from the patient. The curved section comprises a two- dimensional curve in an x-y plane as in figures 11c-11d. The curved section also comprises a three-dimensional curve along a z-axis as seen in figure 11f.
Allowable Subject Matter
Claims 1-9 and 13-15 are allowed.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 1, the art of record does not teach or render obvious a sheath delivery system, comprising a footplate having an axis point about which the footplate pivots, the footplate configured to pivot within the lumen between an initial state that generally lies along the lumen and a rotated state, the footplate anchoring the access device within a blood vessel when the footplate is in the rotated state; a first wire port through which a first wire enters the lumen and advances past the footplate into the blood vessel, so that the first wire advances through the blood vessel in a first direction; and a second wire port configured to guide a second wire into the lumen so that the second wire passes through the lumen such that the second wire advances through the blood vessel in a second direction, in combination with the elements set forth in the claim.
Regarding claim 13, the art of record does not teach or render obvious a method of using a sheath delivery system, the method comprising
inserting an access device into the blood vessel over the first wire, the access device having a footplate and a depth indicator;
receiving an indication from the depth indicator that the access device is sufficiently inserted in the blood vessel to engage the footplate;
advancing the first wire through the blood vessel in a first direction;
pivoting the footplate so that the footplate is aligned with an antegrade/retrograde axis within the blood vessel, thereby anchoring the access device in the blood vessel; and
advancing a second wire through the access device and through a bore in the footplate into the blood vessel in a second direction, in combination with the elements set forth in the claim.
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..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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