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 without traverse of Species A in the reply filed on 1/7/2026 is acknowledged. Claims 9-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species embodiments, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/7/2026. The requirement is deemed proper and is therefore made FINAL.
Specification
The disclosure is objected to because of the following informalities: a typographical error in paragraph [0001], which lists “U.S. Application No. 16/856,656.” The correct application number appears to be 16/865,656. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claim(s) 1-4 and 6-8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Furnish et al. (Pub. No.: US 2016/0074067 A1; hereinafter “Furnish”).
Furnish discloses the following regarding claim 1: an expandable sheath for protecting a surface of a blood vessel from the introduction of a medical device within the blood vessel, the sheath comprising: an elongated inner member (26) movable between an unexpanded (Fig. 7B) and an expanded (Fig. 7C) configuration (para. 0036), the inner member including a circumferential portion helically coiled (Figs. 7A-7C) around a longitudinal axis (A) of the inner member (Figs. 7A-7C) and forming a central lumen (central opening through element 26) therethrough, the inner member including first (left side edges) and second (right side edges) longitudinal edges, where in the unexpanded configuration the first and second longitudinal edges overlap (Fig. 7B; para. 0036), and movement of the inner member toward the unexpanded configuration reduces the circumferential overlap of the first and second longitudinal edges (Fig. 7C; para. 0036); an elastomeric outer member (10, 24) extending over the inner member (Fig. 7A; paras. 0029, 0033); a hub (20) provided at a proximal end of the sheath (Figs. 1-2), where a proximal end of the inner member and outer member are coupled to the hub (Figs. 1-2; para. 0028).
Furnish discloses the following regarding claim 2: the sheath of claim 1, wherein, when the inner member is in the expanded configuration, a gap is formed between the first and second longitudinal edges along at least a portion of a length of the inner member (Fig. 7C).
Furnish discloses the following regarding claim 3: the sheath of claim 1, wherein the portion (interpreted as the circumferential portion of claim 1) of the inner member extends from a distal end of the inner member in a direction toward a proximal end of the inner member (Figs. 7A-7C).
Furnish discloses the following regarding claim 4: the sheath of claim 1, wherein at least a portion of an outer diameter of the inner member steadily decreases in a direction toward a distal end of the inner member (para. 0031).
Furnish discloses the following regarding claim 6: the sheath of claim 1, wherein the elastomeric outer member forms a continuous cylindrical layer (Fig. 7A).
Furnish discloses the following regarding claim 7: the sheath of claim 1, wherein the inner member is positioned within a lumen formed by the elastomeric outer member (Fig. 7A; paras. 0035-0036), and positioned in contact with an inner surface (22) of the lumen of the elastomeric outer member (Fig. 7A; paras. 0035-0036).
Furnish discloses the following regarding claim 8: the sheath of claim 1, wherein the elastomeric outer member exerts a compressive force onto the inner member to bias the inner member toward the unexpanded configuration (paras. 0035-0036, when the device is in its contracted configuration, the physical presence of the outer member provides a compressive force).
Claim Rejections - 35 USC § 103
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) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Furnish in view of Aznoian et al. (Pub. No.: US 2004/0249436 A1; hereinafter “Aznoian”).
Furnish discloses the limitations of the claimed invention, as described above. It further recites that the inner member is composed of a relatively stiff material such that the inner member is composed of a material having a greater stiffness than the outer member (paras. 0029, 0033). However, it does not explicitly recite that the inner member is composed of a relatively stiff polymeric material. Aznoian teaches that it is well known in the art that helical vascular implants are made of relatively stiff thermoplastic polymer materials (paras. 0004-0005, 0014-0016), for the purpose of constructing the implant with the desired physical characteristics needed to suit the implantation site. It would have been obvious to one having ordinary skill in the art to modify the inner member of Furnish to comprise a polymer material, as taught by Aznoian, in order to provide the implant with the desired physical characteristics needed to suit the implantation site. Such a modification would be made with a reasonable expectation of success. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of implant material for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ANN HU/Primary Examiner, Art Unit 3774