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)(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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al (US 5968013 A).
Regarding claim 1, Smith discloses a perfusion sheath (figs 3, 5, 7) comprising: a sheath body 10,12 comprising an exterior surface and a lumen therethrough, the lumen extending from a distal end of the sheath body to a proximal end of the sheath body;
at least one perfusion aperture 104,82 in the sheath body positioned between the proximal end of the sheath body to the distal end of sheath body, the perfusion aperture providing for fluid communication through the exterior surface of the sheath body;
a removable perfusion aperture cover 40 positioned over the at least one aperture in the sheath body; and
a pull 76 attached to the removable perfusion aperture cover.
Regarding claim 2, Smith discloses when the sheath body is inserted into an arteriotomy, the pull has a length such that the pull will extend outside the arteriotomy (col. 3, line 30).
Regarding claim 3, Smith discloses the pull is selected from the group consisting of a wire 76.
Regarding claim 4, Smith discloses the pull 76 is a biocompatible material as well known in the medical art.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Smith (US 5968013 A).
Regarding claims 7-9, Smith fails to disclose the sheath is made of a flexible plastic being of a biocompatible polymer selected from the group consisting of thermoplastic polyurethane, nylon, polyether block amide, expanded polytetrafluoroethylene, and blends thereof.
Smith discloses that catheter structure 10 materials are well known in the art. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith sheath (catheter structure 10) by selecting a sheath material of one of a flexible plastic being of a biocompatible polymer selected from the group consisting of thermoplastic polyurethane, nylon, polyether block amide, expanded polytetrafluoroethylene, and blends thereof since selecting a well-known material for the intended use is old and well known in the art.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Smith in view of Bierman (US 20110218496 A1).
Regarding claim 17, Smith fails to disclose the pull is a colored pull.
Bierman teaches a dilator 24 having a white color to differentiate from the red color of the blood. Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify Smith with Bierman teaching of a colored dilator since adding color to Bierman’s wire 76 would help differentiate the wire from the blood/fluids inside the sheath 10.
Allowable Subject Matter
Claims 19-25 are allowed.
Claims 5, 6, 10-16, and 18 are 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.
The following is a statement of reasons for the indication of allowable subject matter: regarding claim 19, the art of record does not teach or render obvious a method for providing persistent distal limb perfusion, the method comprising:
the step of tensioning the pull corresponding to the determined perfusion aperture to peel away the perfusion aperture cover associated with the pull and open the determined perfusion aperture to provide the persistent distal limb perfusion, in combination with the steps and 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 Mon-Thur 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783