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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8/19/2026 has been entered.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8 have been considered, but are moot in view of the new grounds of rejection.
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) 1-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bonutti et al. (Pub. No.: US 2014/0142509 A1; hereinafter “Bonutti”) in view of JP 2005537856 A (hereinafter “the ‘856 reference”).
Bonutti teaches 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 (para. 0081), the sheath comprising: an elongated inner member (204) (e.g., Figs. 33-43) movable between an unexpanded and an expanded configuration (paras. 0081-0082), the inner member including a first circumferential portion (portion of element 204 located closer to cylindrical elements 112, 114, as shown in Fig. 13) adjacent a proximal end of the inner member (e.g., Figs. 33-43) and a second circumferential portion (portion of element 204 located closer to the nose cone of elements 112, 114, as shown in Fig. 13) extending in a distal direction from the first circumferential portion (e.g., Figs. 33-43), the second circumferential portion is helically coiled around a longitudinal axis (central axis of element 204) of the inner member (e.g., Figs. 33-43) and forming a central lumen (central opening) therethrough, at least the second circumferential portion of the inner member including first (please see the example in annotated Figure A, below) and second (e.g., Figure A) longitudinal edges, where in the unexpanded configuration the first and second longitudinal edges overlap (e.g., Figure A), and movement of the inner member toward the expanded configuration causes an outer surface of an underlying portion (outer surfaces of the helical coil) of the inner member to slide along an inner surface of a corresponding overlying portion of the inner member and reduces the circumferential overlap of the first and second longitudinal edges (e.g., Figs. 33-43; paras. 0003-0006, 0081-0084); wherein a longitudinally extending edge (Figure A) of the first circumferential portion is offset from the first longitudinal edge of the second circumferential portion in a circumferential direction (Figure A); an outer member (sleeve/band) extending over the inner member (para. 0066); and a hub (112, 114) provided at a proximal end of the sheath (Fig. 13), where a proximal end of the inner member and outer member are coupled to the hub (Fig. 13).
Regarding claims 1 and 6-8, Bonutti teaches the limitations of the claimed invention, as described above. It does not explicitly recite that the sleeve/band outer member is elastomeric. The ‘856 reference teaches that it is well known in the art that an outer sheath member comprises a continuous cylindrical layer and an elastomeric material (Figs. 1-8; pgs. 2-3 of the provided translation), for the purpose of allowing the user to more easily insert devices into a patient by utilizing the material’s elasticity and physical properties to accommodate the vasculature and the other devices. The device is placed in a lumen formed by the elastomeric outer member, and positioned in contact with an inner surface of the lumen of the elastomeric outer member (Figs. 1-8). The elastomeric outer member exerts a compressive force onto the inner member to bias the inner member toward the unexpanded configuration (pgs. 2-4, when the device is in its contracted configuration, the physical presence of the outer member provides a compressive force). It would have been obvious to one having ordinary skill in the art to modify the outer member of Bonutti to comprise an elastomer and have the claimed configuration, as taught by the ‘856 reference, in order to utilize the material’s elasticity and physical properties to accommodate the vasculature and the other inserted devices. 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 sheath material for another, is generally considered to be within the level of ordinary skill in the art.
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Figure A.
Bonutti teaches the following regarding claim 2: the sheath of claim 1, wherein, movement of the inner member between the unexpanded and expanded configurations, changes a circumferential spacing between the first and second longitudinal edges along at least a portion of a length of the inner member (e.g., Figs. 33-43; paras. 0081-0084, as the inner member expands, the first and second longitudinal edges unwind and move further apart, creating a larger circumferential spacing).
Bonutti teaches the following regarding claim 3: the sheath of claim 1, wherein an opening is formed along a portion of the inner member when the inner member is in the expanded configuration, the portion extends from a distal end of the inner member in a direction toward a proximal end of the inner member (para. 0098).
Bonutti teaches 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 (Figs. 33-43).
Bonutti teaches the following regarding claim 5: the sheath of claim 1, wherein the inner member is composed of a relatively stiff polymeric material such that the inner member is composed of a material having a greater stiffness than the outer member (para. 0068; and pgs. 2-3 of the ‘856 reference).
Bonutti teaches the following regarding claim 6: the sheath of claim 1, wherein the first circumferential portion is cylindrical (e.g., Figs. 20-24, 33-43).
Bonutti teaches 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, and positioned in contact with an inner surface of the lumen of the elastomeric outer member (para. 0066).
Bonutti teaches the following regarding claim 8: the sheath of claim 1, wherein the second circumferential portion is helically coiled in a single circumferential direction (e.g., Figs. 33-43).
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.
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/ANN HU/Primary Examiner, Art Unit 3774
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