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 .
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 4/24/2026 has been received and made of record. Note the acknowledged form PTO-1449 enclosed herewith.
Response to Arguments
This Office action is in response to the applicant’s communication filed on 6/30/2026. Each argument and/or amendment directed towards a maintained rejection is addressed below. Rejections/objections not repeated herein have been withdrawn.
Applicant’s arguments, see page 8, with respect to Applicant’s claim amendments made in view of the previous claim objections have been fully considered and are persuasive. The previous claim objections have been withdrawn.
Applicant’s arguments, see pages 8-9, with respect to Applicant’s claim amendments made in view of the previous 112 rejections have been fully considered and are persuasive. The previous 112 rejections have been withdrawn.
Applicant’s arguments, see pages 9-10, with respect to the deficiencies of Goldberg in view of the present claim amendments to the respective independent claims have been fully considered and are persuasive. Therefore, the previous prior art rejections made under Goldberg alone have been withdrawn. However, upon further consideration, a new ground(s) of rejection is made under Goldberg in view of Utas et al. (US 2018/0001055), as set forth below.
Claim Rejections - 35 USC § 103
Claim(s) 1-3, 6-8, 10-18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Goldberg et al. (US 2019/0307589) in view of Utas et al. (US 2018/0001055).
Goldberg discloses (see Figs. 2-7 and 24) an expandable sheath and a method of making comprising the following claim limitations:
(claim 1) An expandable sheath (100, Fig. 1) for deploying a medical device (as shown in Fig. 1; [0066]-[0068]), the expandable sheath (100) comprising: an inner liner (i.e., a lubricious liner expressly disposed on the inner surface of inner layer 102; see Fig. 7; [0073]) comprising one or more polymer layers ([0073]; at least one layer of lubricious material disclosed); wherein the inner liner has a first surface and an opposite second surface, wherein the first surface of the inner liner defines an inner surface of the expandable sheath (100) (as shown in Fig. 7; [0073]; [0091]-[0093]; inner liner on the inner surface of inner layer 102; and layer 120 removed during sheath formation to expose the inner liner); a first polymeric layer (102, Fig. 7; [0089]) surrounding radially outward of the inner liner, such that it is positioned at the second surface of the inner liner and wherein the first polymeric layer (102) comprises one or more sublayers (as shown in Fig. 7, first polymeric layer 102 comprises at least one sublayer); a braided layer (104, Fig. 7; [0089]) disposed radially outward of the first polymeric layer (102) (as shown in Fig. 7); a second polymeric layer (106, Fig. 7; [0089]) surrounding radially outward of the braided layer (104) (as shown in Fig. 7), wherein the second polymeric layer (106) comprises one or more sublayers (as shown in Fig. 7, second polymeric layer 106 comprises at least one sublayer); an outer liner (108; Fig. 7; [0089]; [0092]) comprising one or more polymer layers ([0089]; at least one layer of material disclosed); wherein the outer liner has a first surface and an opposite second surface, wherein the first surface of the outer liner overlies the second polymeric layer (106), and wherein the second surface of the outer liner defines an outer surface of the expandable sheath (100) (as shown in Fig. 7; [0091]-[0092]; layer 122 removed during sheath formation to expose the outer liner 108 of the sheath 100); wherein the inner liner, the first polymeric layer, the second polymeric layer, and the outer liner form a laminate structure (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers); and wherein, when a medical device (e.g., prosthesis 12 of Fig. 1) is passed through the sheath (100), a diameter of the sheath (100) locally expands from a first unexpended diameter (D1, Fig. 6) around the medical device (shown at 132, Fig. 6) to a second expanded diameter (D2, Fig. 6), while the first and second polymeric layers resist axial elongation of the sheath (100) such that a length of the sheath (100) remains substantially constant (see claims 1, 7 and 43; [0006]; [0009]; [0019]; [0079]; [0081]; [0087]); and wherein the sheath (100) resiliently returns to a third diameter after the passage of the medical device (as shown in Fig. 6; [0088]);
(claim 2) wherein the inner liner comprises two or more polymer layers, wherein each of the polymer layers has a thickness from about 0.5 microns to about 40 microns, and wherein the two or more polymer layers are laminated together and/or (i.e., claimed in the alternative, using “or”) wherein the outer liner (108) comprises two or more polymer layers ([0073]; combinations of multiple polymeric materials disclosed for composing the outer liner 108), and wherein the two or more polymer layers are laminated together (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers);
(claim 3) wherein the first polymeric layer (102) comprises two or more polymer sublayers ([0073]; combinations of multiple polymeric materials disclosed for composing the first polymeric layer 102), and wherein the two or more polymer sublayers are laminated together (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers) and/or (i.e., claimed in the alternative, using “or”) wherein the second polymeric layer comprises two or more polymer sublayers, wherein each of the polymeric layers has a thickness from about 0.5 microns to about 40 microns, and wherein the two or more polymer sublayers are laminated together;
(claim 6) wherein the one or more polymer layers of the inner liner and/or outer liner (108) comprises an ultra-high-molecular-weight polyethylene (UHMWP) polymer layer ([0073]; outer liner 108 expressly may comprise ultra-high-molecular-weight polyethylene (UHMWP));
(claim 7) wherein the first polymeric layer (102) comprises at least one sublayer comprising a polyolefin or a polyurethane, and/or (i.e., claimed in the alternative, using “or”) wherein the second polymeric layer (106) comprises at least one sublayer comprising a polyolefin or a polyurethane ([0078]; second polymeric layer 106 expressly may comprise a polyolefin or a polyurethane);
(claim 8) wherein the polyolefin comprises a polypropylene comprising a bi-oriented polypropylene, a cast polypropylene, or a combination thereof and/or wherein the polyolefin comprises a polyethylene comprising a low-density polyethylene (LDPE), a high density polyethylene (HDPE), or a combination thereof (i.e., as claim 8 depends from claim 7 and Goldberg discloses a polyurethane, the subject matter of claim 8 is interpreted as being optional since a polyolefin is one option of a list of materials claimed in the alternative);
(claim 10) wherein the sheath (100) comprises a plurality of longitudinally extending pleats (126/128, Figs. 3 and 6), wherein the plurality of pleats (126/128) extend around at least a portion of a circumference of the sheath (100) (as shown in Figs. 3 and 6) ([0071]), and wherein each of the plurality of pleats (126/128) comprises at least a portion of the inner liner ([0073]), at least a portion of the first polymeric layer (102), at least a portion of the second polymeric layer (106), and at least a portion of the outer liner (108) (as shown in Figs. 3 and 6; [0071]; [0079]; [0082]-[0083]; [0092]; inner and outer layers expressly comprise folds/pleats, with the interior layers encapsulating the braided layer wherein the braided layer buckle to assist in forming the folds/pleats throughout the entire wall thickness of the sheath);
(claim 11) wherein the plurality of pleats form a plurality of circumferentially spaced ridges (126, Figs. 3 and 6) and a plurality of circumferentially spaced valleys (128, Figs. 3 and 6), and wherein, as the medical device is passed through the sheath, the ridges (126) and valleys (128) at least partially level out to allow a sheath wall to radially expand (see claims 4 and 50; [0007]; [0020]; [0071]);
(claim 12) wherein the first polymeric layer (102) is bonded or adhered to at least a portion of the second surface of the inner liner ([0073]; [0091]-[0093]; inner liner applied to and bonded to the first polymeric layer 102, and the sheath formation further includes compression and heating to bond the laminated layers together), and the second polymeric layer (106) is bonded or adhered to at least a portion of the first surface of the outer liner (108) ([0080]; [0089]; [0091]-[0093]; second polymeric layer 106 applied to and bonded to the outer liner 108, and the sheath formation further includes compression and heating to bond the laminated layers together);
(claim 13) wherein at least one of the following is true: (a) the one or more polymer layers of the inner liner comprises a porous film, at least a portion of the first polymeric layer extends within at least a portion of the porous film of the inner liner; (b) when the one or more polymer layers of the outer liner (108) comprises a porous film ([0073]; ePTFE is a well-known highly porous substrate), at least a portion of the second polymeric layer (106) extends within at least a portion of the porous film of the outer liner (108) (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers, as the layers are heated sufficiently to become soft and tacky (i.e., reflowed or melted) and encroach into open/void spaces of adjacent layers);
(claim 14) wherein the braided layer (104) comprises a plurality of helical multifilar filaments (110, Figs. 5A-5B) braided together (as shown in Figs. 5A-5B; [0075]-[0076]), and wherein the braided layer (104) has a proximal end and a distal end ([0076]; braided layer comprises a length), wherein the braided layer (104) comprises a plurality of closed loops at the distal end of the braided layer (104) (as shown in Fig. 24; [0116]), and wherein the proximal end of the braided layer is positioned along a proximal end of the sheath (100) ([0076]; braided layer 104 may extend along the entire length L of the sheath or only a long a portion of the length of the sheath; wherein for the entire length, the braided layer would be positioned at the proximal end of the sheath 100);
(claim 15) wherein the braided layer (104) has a length extending from the proximal end of the braided layer (104) to the distal end of the braided layer (104) and wherein the braided layer length is shorter than a length of the sheath (100) measured from a proximal end of the sheath (100) to the distal end of the sheath (100) ([0076]; braided layer 104 may extend along only a portion of the length of the sheath);
(claim 16) wherein the filaments of the braided layer (104) are movable ([0009]; [0079]; [0081]; [0087]) between the first (102) and second (106) polymeric layers such that the braided layer (104) is configured to (i.e., capable of) radially expand as a medical device is passed through the sheath (100) while the length of the sheath (100) remains substantially constant (as shown in Fig. 6; see claims 1, 7 and 43; [0006]; [0009]; [0019]; [0079]; [0081]; [0087]); and/or (i.e., claimed in the alternative, using “or”) wherein the filaments of the braided layer are resiliently buckled when the sheath is in a collapsed configuration, and the first and second polymeric layers are attached to each other at a plurality of open spaces between the filaments of the braided layer;
(claim 17) A method of making an expandable sheath, the method comprising: forming an inner liner (i.e., a lubricious liner expressly disposed on the inner surface of inner layer 102; see Fig. 7; [0073]); wherein the inner liner comprises one or more polymer layers ([0073]; at least one layer of lubricious material disclosed) and wherein the inner liner has a first surface and an opposite second surface (as shown in Fig. 7; [0073]; inner liner disposed on the inner surface of inner layer 102); forming a first polymeric layer (102, Fig. 7; [0089]), wherein the first polymeric layer (102) is positioned radially outward of the inner liner ([0073]; [0089]); wherein the first polymeric layer (102) comprises one or more sublayers (as shown in Fig. 7, first polymeric layer 102 comprises at least one sublayer); and wherein the first polymeric layer (102) overlies the second surface of the inner liner (as shown in Fig. 7; [0073]; inner liner disposed on the inner surface of inner layer 102); positioning a braided layer (104, Fig. 7; [0089]) radially outward of a first polymeric layer (102) (as shown in Fig. 7; [0089]); forming a second polymeric layer (106, Fig. 7; [0089]) such that it is positioned radially outward of the braided layer (104) (as shown in Fig. 7; [0089]); wherein the second polymeric layer (106) comprises one or more sublayers (as shown in Fig. 7, second polymeric layer 106 comprises at least one sublayer); forming an outer liner (108; Fig. 7; [0089]; [0092]) radially outward of the second polymeric layer (106) (as shown in Fig. 7; [0089]); wherein the outer liner (108) comprises one or more polymer layers ([0089]; at least one layer of material disclosed), and wherein the outer liner (108) has a first surface and an opposite second surface (as shown in Fig. 7), and wherein the first surface of the outer liner (108) is in contact with at least a portion of the second polymeric layer (106) (as shown in Fig. 7; [0089]); heating the inner liner, the first polymeric layer, the braided layer, the second polymeric layer, and the outer liner to form a laminate structure (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers); and crimping the laminate structure to form a plurality of longitudinally-extending pleats (126/128, Figs. 3 and 6) ([0092]; crimping step after heating expressly disclosed to form folds 126/128), wherein the plurality of longitudinally-extending pleats (126/128) are configured to (i.e., capable of) expand upon passage of a medical device through the sheath (100) (as shown in Fig. 6; see claims 4 and 50; [0007]; [0020]; [0071]);
(claim 18) wherein i) the step of forming the inner liner comprises wrapping a first material around an initial mandrel; ii) the step of forming the first polymeric layer comprises wrapping a second material radially outward of the second surface of the inner liner, or the step of forming the first polymeric layer comprises coating of the second surface of the inner liner with one or more layers of a second material to form the one or more sublayers of the first polymeric layer; iii) the step of forming the second polymeric layer comprises wrapping a third material outward of the braided layer, or the step of forming the second polymeric layer comprises coating the braided layer with one or more layers of a third material to form the one or more sublayers of the first polymeric layer; and/or (i.e., steps i-iv claimed in the alternative, using “or”) iv) the step of forming the outer liner (108) comprises wrapping a fourth material radially outward of the second surface of the second polymeric layer (106) (as shown in Fig. 7; [0089]; [0092]; wrapping outer liner polymeric material about the second polymeric layer 106 is expressly disclosed); and
(claim 20) wherein the step of heating comprises at least partially encapsulating the braided layer (104) within the inner liner ([0073]), the first polymeric layer (102), the second polymer layer (106), and the outer liner (108) (as show in Fig. 7; [0091]-[0092]; layered sheath formed from heating and compression of the layers, wherein layers 102/108 bond to each other through the open spaces of the braided layer 104 thereby expressly encapsulating the braided layer 104) and/or (i.e., claimed in the alternative, using “or”) wherein the step of heating comprises the second material at least partially penetrating a porous first material.
Goldberg, as applied above, discloses an expandable sheath and a method of making comprising all the limitations of the claim except for a third polymeric layer disposed on at least a portion of a proximal end of the sheath, wherein an outer surface of the third polymeric layer has a lower roughness than the second surface of the outer liner, and the specifically claimed thicknesses of claims 2-3.
However, Utas teaches a similar catheter/sheath comprising a third/outer polymeric layer disposed on at least a portion of a proximal end of the sheath ([0031]; [0048]; outer catheter surface polymer layer expressly disclosed), wherein an outer surface of the third polymeric layer has a lower roughness than the second surface of the outer liner ([0031]; outer layer having greater smoothness and less surface roughness compared to other internal layers expressly disclosed) in order to beneficially provide an outer surface of a catheter/sheath having less friction, being smoother with less surface roughness, being easier to coat or the like along the entire outer surface ([0031]; [0120]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the device/method of Goldberg to have a third polymeric layer disposed on at least a portion of a proximal end of the sheath, wherein an outer surface of the third polymeric layer has a lower roughness than the second surface of the outer liner in order to beneficially provide an outer surface of a catheter/sheath having less friction, being smoother with less surface roughness, being easier to coat or the like along the entire outer surface, as taught by Utas.
Regarding claims 2-3, Goldberg in view of Utas discloses the outer liner and/or first polymeric layer 102 expressly may comprising a relatively thin layer of polymeric material having a total thickness of 0.01 mm to 0.5 mm (i.e., 10 microns to 500 microns) ([0072]). However, Goldberg in view of Utas does not explicitly disclose wherein each of the polymer layers has a thickness from about 0.5 microns to about 40 microns. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the thickness of each of the polymer layers of either the outer liner and/or the first polymeric layer to be between about 0.5 microns to about 40 microns and since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists.” In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Further, applicant appears to have placed no criticality on the claimed ranges (see paragraph [0251] indicating respective thicknesses “can” be within quite a variety of various thickness ranges).
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Goldberg in view of Utas as applied to claim 17 above, and further in view of Chouinard (US 2004/0176740).
Goldberg in view of Utas, as applied above, discloses an expandable sheath and a method of making comprising all the limitations of the claim except for wherein after forming the laminate structure, the method further comprises forming a third polymeric layer at least a portion of a proximal end of the sheath, and wherein the step of forming the third polymeric layer comprises wrapping a fifth material radially outward of an outer surface of the outer liner, forming one or more polymer layers of the third polymeric layer.
However, Chouinard teaches a similar intravascular device and method of making wherein, after the device is formed, the method further comprises forming a third polymeric layer (10, Fig. 4) at least a portion of a proximal end of the sheath (2, Fig. 4), and wherein the step of forming the third polymeric layer (10) comprises wrapping a fifth material radially outward of an outer surface of the outer liner (at 6/9, Fig. 4), forming one or more polymer layers of the third polymeric layer (10) ([0034]; outer polymeric layer 10 expressly may comprise an extruded layer that is wrapped around the outer surface of a sheath 2 and heated to conform to the sheath 2) in order to beneficially provide for enhanced biocompatibility of the device exterior surface as well as other beneficial material characteristics, as needed ([0034]). Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the method of Goldberg in view of Utas to have the method further comprises forming a third polymeric layer at least a portion of a proximal end of the sheath, and wherein the step of forming the third polymeric layer comprises wrapping a fifth material radially outward of an outer surface of the outer liner, forming one or more polymer layers of the third polymeric layer in order to beneficially provide for enhanced biocompatibility of the device exterior surface as well as other beneficial material characteristics, as needed, as taught by Chouinard.
Allowable Subject Matter
Claims 4-5 and 9 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.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Robert Lynch whose telephone number is (571)270-3952. The examiner can normally be reached on Monday-Friday (9:00AM-6:00PM, with alternate Fridays off).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Elizabeth Houston, at (571) 272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT A LYNCH/Primary Examiner, Art Unit 3771
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