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 .
Response to Arguments
The previous rejection of claim(s) 4-5 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 4 on 10/20/2025.
Applicant's arguments filed 10/20/2025 have been fully considered but they are not persuasive. With respect to claims 1 and 10, applicant argues that Dorn et al. (US 2011/0137396) in view of Glazier et al. (US 2014/0005767) fails to disclose wherein a shape of the distal tip from a distal end to the proximal end consists of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip because the alleged convex shape transition of annotated Fig. 1A of Glazier is not clear enough to clearly teach a “convex shaped transition”. The examiner respectfully disagrees.
The term “convex” is not found in applicant’s specification; therefore, a general definition is given and “convex” is defined as “curving or bulging outwards” (https://www.collinsdictionary.com/us/dictionary/english/convex). The examiner maintains that the shoulder of the distal tip 10 of Glazier (as pointed to in annotated Fig. 1A of Glazier below and on page 9 of applicant’s arguments) curves outward from a distal-most tip that inclines and tapers away from the longitudinal axis of the distal tip to a constant diameter portion. If applicant is arguing that the shoulder does not curve outward and is instead two lines that meet at an angle, then the two lines would at least meet so that the angle bulges outwards, thereby meeting the definition of “convex”. It is clear that the shoulder of Glazier bulges outwards as shown in annotated Fig. 1A; therefore, Glazier clearly teaches “a convex shaped transition” as claimed.
Further, “convex” may be defined as “(of a polygon) containing no interior angle greater than 180 degrees” (https://www.collinsdictionary.com/us/dictionary/english/convex) and assuming again that applicant is arguing that the shoulder does not curve outward and is instead two lines that meet at an angle, the polygon shape of the distal tip as shown below does not contain an interior angle greater than 180 degrees (see annotated Fig. 1A below); thus, the polygon is considered convex in shape, including at the shoulder.
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Accordingly, applicant’s arguments over Glazier are not found persuasive.
The rejection of claims 10 and 12-15 under 35 U.S.C. 103 as being obvious over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005797 A1) in view of Botros (US 2017/0335152 A1) has been withdrawn in light of applicant’s amendment made 10/20/2025. Specifically, Dorn in view of Glazier in view of Botros does not teach the inner sheath is a polyether block amide.
Applicant’s arguments with respect to claims 10 and 12-15 have been considered but are moot because the new ground of rejection does not rely on any reference in the prior art rejection of record for any teaching or matter specifically challenged in the argument. However, as discussed below, the newly added reference Green et al. (US 2013/0304181 A1) teaches said limitation.
Claim Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the distal end to the shoulder” in line 19 which should read “the distal end of the distal tip to the shoulder”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 10 recites “the distal tip” in lines 11, 18, 19 and 22 which should read “the delivery tip”. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: Claim 1 recites “the distal end to the shoulder” in lines 19-20 which should read “the distal end of the delivery tip to the shoulder”. Appropriate correction is required.
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.
Claim(s) 1 and 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005767 A1).
Regarding claim 1, Dorn discloses a prosthesis delivery catheter assembly (system 1; Fig. 1), comprising: an outer sheath (outer sheath 2); an inner sheath (inner catheter 3) disposed within the outer sheath (Fig. 1), the inner sheath (3) comprising a first outer diameter (outer diameter of 3); and a distal tip (tip member 6) disposed at a distal end of the inner sheath (Fig. 1), the distal tip (6) comprising: a distal portion (see annotated Fig. 1 below); a proximal portion (see annotated Fig. 1 below); a lumen (lumen of 6; Fig. 6) with a constant diameter that extends from the distal portion to the proximal portion (wherein the inner catheter 3 fixedly secured to the tip member 6 causes the tip member 6 to have a constant diameter lumen; Fig. 1); and a shoulder disposed between the distal portion and the proximal portion (see annotated Fig. 1 below) with a convex shaped transition reducing an outer diameter of the distal tip from the distal portion to the proximal portion (see annotated Fig. 1 below with the outer sheath omitted), wherein the proximal portion comprises: a shaft (see annotated Fig. 1 below) comprising a second outer diameter (outer diameter of shaft; Fig. 1) larger than the first outer diameter (Fig. 1); and a proximal end comprising a proximally facing transition from the first outer diameter to the second outer diameter (see annotated Fig. 1 below).
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Dorn fails to disclose wherein a shape of the distal tip from a distal end to the proximal end consists of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip because of the constant diameter portion found at the shoulder.
However, Glazier teaches a distal tip (distal tip 12; Fig. 1A) comprising: a distal portion; a proximal portion; and a shoulder disposed between the distal portion and the proximal portion with a concave convex shaped transition reducing an outer diameter of the distal tip from the distal portion to the proximal portion (see annotated Fig. 1A below), wherein the proximal portion comprises: a shaft (see annotated Fig. 1A) comprising a second outer diameter larger (constant diameter of shaft) than a first outer diameter (outer diameter of inner shaft 24); and a proximal end comprising a proximally facing transition (at 32) from the first outer diameter to the second outer diameter (Fig. 1A), wherein a shape of the distal tip from a distal end to the proximal end consists of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip (see annotated Fig. 1A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the distal tip of Dorn to consist of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip because of the constant diameter portion found at the shoulder i.e., eliminating the constant diameter portion found at the shoulder as taught by Glazier, since the shape of the distal tip is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed distal tip is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, the modification in shape would reduce the overall length of the distal tip protruding from the outer sheath, thereby reducing trauma to surrounding tissue during delivery.
Regarding claim 4, Dorn modified discloses the invention as claimed above, and Dorn further discloses wherein the outer sheath (2) comprises a lumen (in which stent device 4 resides; Fig. 1), and wherein the shaft (cylindrical portion of proximal portion) is disposable within the lumen of the outer sheath (Fig. 1).
Regarding claim 5, Dorn modified discloses the invention as claimed above, and Dorn further discloses the lumen (lumen through 6; Fig. 1) of the distal tip is in communication with a lumen (lumen through 3) of the inner sheath (Fig. 1).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005767 A1), as applied to claim 1 above, and further in view of Sheldon et al. (US 2008/0097572 A1).
Regarding claims 7-8, Dorn modified fails to disclose wherein the distal tip comprises a nylon material and wherein the nylon material is a polyether block amide.
However, Sheldon teaches a prosthesis delivery catheter (Fig. 4) comprising: an outer sheath (outer sheath 20); an inner sheath (inner sleeve 61) disposed within the outer sheath (Fig. 4); and a distal tip (nosecone 150) disposed at the distal end of the inner sheath (Fig. 4), the distal tip comprising a nylon material that is a polyether block amide (as nosecone 150 may be made from a polyether block amide such as PEBAX.RTM; [0051]). Sheldon teaches polyether block amides are suitable commercially-available, medical-grade materials for distal tips of prosthesis delivery catheters ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the distal tip of modified Dorn to be made from a nylon material that is a polyether block amide as taught by Sheldon, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005767 A1), as applied to claim 1 above, and further in view of Neglen et al. (US 2016/0310302 A1).
Regarding claim 9, Dorn modified fails to disclose wherein the inner sheath and the distal tip comprise a unibody construct. Instead, the inner sheath (3) is attached to the distal tip (6; [0079]).
However, Neglen teaches a prosthesis delivery catheter (abstract) comprising an inner sheath (inner member/sheath; Fig. 5) that is coupled with a distal tip (nose cone; Fig. 5), wherein the inner sheath and the distal tip may be coupled together with an adhesive or other suitable coupling substance or member, similar to that of Dorn, or wherein the distal tip and the inner sheath may be formed as a single integrally piece formed in a unitary design ([0058]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner sheath and the distal tip of the modified Dorn to be a unibody construct as taught by Neglen, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Claim(s) 10 and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005797 A1) in view of Botros (US 2017/0335152 A1) in view of Green et al. (US 2013/0304181 A1).
Regarding claim 10, Dorn discloses a prosthesis deployment device (Fig. 1), comprising a prosthesis delivery catheter assembly (system 1; Fig. 1) comprising: an outer sheath (outer sheath 2); an inner sheath (inner catheter 3) disposed within the outer sheath (Fig. 1), the inner sheath (3) comprising a first outer diameter (outer diameter of 3); and a delivery tip (tip member 6) disposed at a distal end of the inner sheath (Fig. 1), the delivery tip comprising: a distal portion (see annotated Fig. 1 below); a proximal portion (see annotated Fig. 1 below); and a shoulder (see annotated Fig. 1 below) disposed between the distal portion and the proximal portion and reducing an outer diameter of the distal tip from the distal portion to the proximal portion (see concave shaped transition reducing portion between the shoulder and the shaft of the tip; Fig. 1), wherein the proximal portion comprises: a shaft (see annotated Fig. 1 below) comprising a second outer diameter larger than the first outer diameter (see annotated Fig. 1 below); and a proximal end comprising a proximally facing transition from the first outer diameter to the second outer diameter (see annotated Fig. 1 below); a pliant member (stent bed 5 which is made of rubber, silicone glue, PEBAX, etc. which are pliant materials as they are soft materials that can bend or flex without breaking; [0084]) surrounding a portion of an exterior surface of the inner sheath (Fig. 1), the pliant member (5) configured to engage a constrained prosthesis (stent device 4); and an actuator (pull member 7) operably coupled to the outer sheath (2; Fig. 2) and configured to proximally translate the outer sheath relative to the constrained prosthesis (4) to deploy the constrained prosthesis (as the operatory pulls 7 to retract the outer sheath 2 as desired; [0078]; [0087]).
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Dorn fails to disclose wherein a shape of the distal tip from a distal end to the proximal end consists of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip because of the constant diameter portion found at the shoulder.
However, Glazier teaches a distal tip (distal tip 12; Fig. 1A) comprising: a distal portion; a proximal portion; and a shoulder disposed between the distal portion and the proximal portion with a concave convex shaped transition reducing an outer diameter of the distal tip from the distal portion to the proximal portion (see annotated Fig. 1A below), wherein the proximal portion comprises: a shaft (see annotated Fig. 1A) comprising a second outer diameter larger (constant diameter of shaft) than a first outer diameter (outer diameter of inner shaft 24); and a proximal end comprising a proximally facing transition (at 32) from the first outer diameter to the second outer diameter (Fig. 1A), wherein a shape of the distal tip from a distal end to the proximal end consists of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip (see annotated Fig. 1A below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the shape of the distal tip of Dorn to consist of an inclined taper away from a longitudinal axis of the distal tip from the distal end to the shoulder, the convex shaped transition to the shaft of the proximal portion, a constant diameter portion, and an inclined taper toward the longitudinal axis to the proximal end of the distal tip because of the constant diameter portion found at the shoulder i.e., eliminating the constant diameter portion found at the shoulder as taught by Glazier, since the shape of the distal tip is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed distal tip is significant. In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). Further, the modification in shape would reduce the overall length of the distal tip protruding from the outer sheath, thereby reducing trauma to surrounding tissue during delivery.
Dorn discloses wherein the pliant member (5) comprises a thermoplastic elastomer (as PEBAX is a thermoplastic elastomer; [0084]) but fails to disclose wherein the pliant member extends longitudinally along an entire length of the constrained prosthesis and wherein the pliant member comprises an inner layer configured to couple to the inner sheath and an outer layer configured to imprint with the constrained prosthesis, wherein the inner layer of the pliant member comprises a grafted polyolefin, and wherein the outer layer of the pliant member comprises a thermoplastic elastomer, and the inner sheath is a polyether block amide. Instead, the pliant member (5) is a single continuous layer coupled to the inner sheath (3) and configured to imprint with the constrained prosthesis (via the deformability of the stent bed 5 such that the stent device 4 is partially embedded into the outer surface of the PEBAX stent bed 5; [0084]) as the single layer is a thermoplastic elastomer (PEBAX; [0084]).
However, Glazier teaches a prosthesis delivery catheter (Fig. 3E) comprising an outer sheath (distal sheath 22); an inner sheath (inner shaft 24), a distal tip (distal tip 12); a pliant member (elastomeric element 40/40’, while 40’ is directed to in order to show the elastomeric element extends the entire length of the compartment 28, additional structure of 40’ is found equivalent to 40; [0066]) surrounding a portion of an exterior surface of the inner sheath (Fig. 3E), the pliant member configured to engage a constrained prosthesis ([0066]). Glazier teaches wherein the pliant member (40’) can extend longitudinally along an entire length of the constrained prosthesis (Fig. 3E; [0066]) or in other embodiments, a plurality of smaller elements of varying diameter may be used ([0066]). Glazier further teaches the pliant member may be glued to the inner sheath ([0065]); thus, the pliant member may be made of an outer thermoplastic elastomer layer including PEBAX ([0066]), similar to that of Dorn, and an inner layer comprising glue.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the single thermoplastic elastomer layer of the pliant member of modified Dorn to extend longitudinally along an entire length of the constrained prosthesis and to be glued to the inner sheath such that the pliant member includes an inner layer as taught by Glazier. Extending the pliant member along an entire length of the constrained prosthesis assists in the radial expansion and/or release of the prosthesis ([0066] of Glazier) and gluing a thermoplastic elastomer to an inner shaft is a know technique for affixing a thermoplastic elastomer to an inner shaft. Thus, using the known technique of gluing for permanently attaching the pliant member to the inner sheath of modified Dorn to provide the desired affixation would have been obvious to one of ordinary skill in the art.
Modified Dorn fails to disclose wherein the glue i.e., the inner layer comprises a grafted polyolefin.
However, Botros teaches grafted polyolefin is an adhesive composition ([0019]; [0057]) useful in applications for conventional polymeric compositions in medical tubing ([0093]) and as a tie-layer in multi-layer films ([0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the glue i.e., inner layer of the pliant member of modified Dorn to comprise a grafted polyolefin in light of the teachings of Botros, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Modified Dorn fails to disclose wherein the inner sheath is a polyether block amide.
However, Green teaches a prosthesis deployment device (Figs. 4A-4D) comprising an inner sheath (inner tubular member 110) and an outer sheath (outer tubular member 120) configured to engage a constrained prosthesis (stent 2; Fig. 4A) wherein the inner sheath (inner tubular member) can be made of any suitable material including but not limited to PEBAX, which is a polyether block amide ([0100]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the inner sheath of modified Dorn to be a polyether block amide since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 12, Dorn modified discloses the invention as claimed above, and Dorn further discloses wherein the proximally facing transition comprises an inclined surface (inclined surface from inner catheter 3 to shaft; see annotated Fig. 1 above).
Regarding claim 13, Dorn modified discloses the invention as claimed above, and Dorn further discloses wherein the outer sheath (2) comprises a lumen (in which stent device 4 resides; Fig. 1), and wherein the shaft (cylindrical portion of proximal portion) is disposable within the lumen (Fig. 1).
Regarding claim 14, Dorn modified discloses the invention as claimed above, and Dorn further discloses wherein the inner sheath (3) comprises a lumen (lumen through 3; Fig. 1), and wherein the delivery tip (6) comprises a lumen in communication with the lumen of the inner sheath (Fig. 1).
Regarding claim 15, Dorn modified discloses the invention as claimed above, and Dorn further discloses wherein the distal portion (see annotated Fig. 1 above) comprises a radially inward taper extending from the shoulder to a distal end of the distal portion (distal tapered tip; see annotated Fig. 1 above).
Claim(s) 16-17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dorn et al. (US 2011/0137396 A1) in view of Glazier et al. (US 2014/0005797 A1) in view of Botros (US 2017/0335152 A1) in view of Green et al. (US 2013/0304181 A1), as applied to claim 10 above, and further in view of Sheldon et al. (US 2008/0097572 A1).
Regarding claims 16-17, Dorn modified fails to disclose wherein the delivery tip comprises a nylon material and wherein the nylon material is a polyether block amide.
However, Sheldon teaches a prosthesis delivery catheter (Fig. 4) comprising: an outer sheath (outer sheath 20); an inner sheath (inner sleeve 61) disposed within the outer sheath (Fig. 4); and a delivery tip (nosecone 150) disposed at the distal end of the inner sheath (Fig. 4), the delivery tip comprising a nylon material that is a polyether block amide (as nosecone 150 may be made from a polyether block amide such as PEBAX.RTM; [0051]). Sheldon teaches polyether block amides are suitable commercially-available, medical-grade materials for delivery tips of prosthesis delivery catheters ([0051]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the delivery tip of modified Dorn to be made from a nylon material that is a polyether block amide as taught by Sheldon, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Geiser et al. (US 2005/0113902) is noted for teaching a distal tip consisting of the shape claimed (Fig. 9), clearly showing “a convex shaped transition”.
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 SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
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, Elizabeth Houston can be reached on (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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/SARAH A LONG/Primary Examiner, Art Unit 3771