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 Objections
Claim 1 is objected to because of the following informalities: Claim 1 recites “the proximal end” in line 9 which should read “the proximal end of the reconstraining member” for consistency purposes. Appropriate correction is required.
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.
Claim(s) 1-9, 11 and 13-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kitaoka (WO 2014/109003 A1).
Regarding claim 1, Kitaoka discloses a stent delivery system (stent delivery device 10; Fig. 1), comprising: an inner shaft (shaft 14); a deployment sheath (outer sheath 16) disposed about the inner shaft (Fig. 1); a stent (stent 12) disposed radially between the inner shaft (14) and the deployment sheath (16; Fig. 1); and a reconstraining member (inner sheath 18 which includes expansion restricting portion 34 and inner sheath body 36) extending over the stent (12) and under the deployment sheath (16) and having a distal end (distal end of 34) and a proximal end (proximal end of 36) both free from attachment to the deployment sheath (as 34 i.e., 18 moves relative to 16; Figs. 1-2, 5-7; page 3, paragraph 4 of the English translation), wherein when the deployment sheath (16) is in a first configuration (distal position; Fig. 1) extending completely over the stent, the distal end of the reconstraining member (34) extends distally beyond a distal end of the stent (12), and the proximal end extends proximally beyond a proximal end of the stent (Fig. 1).
Regarding claim 2, Kitaoka discloses wherein the proximal end of the reconstraining member (18) includes a first handle (operation pin 42; Fig. 1).
Regarding claim 3, Kitaoka discloses wherein a proximal end of the deployment sheath (16) includes a second handle (operation pin 40).
Regarding claim 4, Kitaoka discloses wherein when the deployment sheath (16) is in the first configuration (Fig. 1), the second handle (40) is distal of the first handle (42; Fig. 1).
Regarding claim 5, Kitaoka discloses wherein the reconstraining member (18) is configured to cover an entirety of the stent (12) while the deployment sheath (16) is proximally withdrawn from a distal portion of the stent (Fig. 5).
Regarding claim 6, Kitaoka discloses wherein axial movement of the reconstraining member (18) and the deployment sheath (16) are independent of one another (via sliding operation pins 40, 42; page 4, paragraph 1 of the English translation).
Regarding claim 7, Kitaoka discloses wherein the reconstraining member (18) is free from any attachment to the stent (as 18 is moved off of stent; Figs. 5-7).
Regarding claim 8, The claimed phrase “laser cut” is being treated as a product by process limitation; that is the process of making the stent. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113. In the instant case, the stent (12) of Kitaoka is a metallic stent (formed of a Ti-Ni alloy, which is metal; page 2, paragraph 6 of the English translation); therefore, the stent is structurally substantially the same as that claimed and found to meet the claimed limitation.
Regarding claim 9, Kitaoka discloses wherein the stent (12) is a self-expanding stent (stent 12 has a self-expanding function; page 2, paragraph 6 of the English translation).
Regarding claim 11, Kitaoka discloses wherein the reconstraining member (18) is longer than the deployment sheath (16; when handles 40 and 42 are adjacent one another, 18 extends distally past 16; Fig. 5).
Regarding claim 13, Kitaoka discloses a stent delivery system (stent delivery device 10; Fig. 1), comprising: an inner shaft (shaft 14); a deployment sheath (outer sheath 16) disposed about the inner shaft (Fig. 1); a stent (stent 12) disposed radially between the inner shaft (14) and the deployment sheath (16); and a reconstraining member (inner sheath 18 which includes expansion restricting portion 34 and inner sheath body 36) extending over the stent (12) and under the deployment sheath (16) and having a distal end (distal end of 34) and a proximal end (proximal end of 36) both free from attachment to the deployment sheath (as 34 i.e., 18 moves relative to 16; Figs. 1-2, 5-7; page 3, paragraph 4 of the English translation), wherein axial movement of the reconstraining member (18) and the deployment sheath (16) are independent of one another (via sliding operation pins 40, 42; page 4, paragraph 1 of the English translation).
Regarding claim 14, Kitaoka discloses wherein the proximal end of the reconstraining member (18) includes a first handle (operation pin 42).
Regarding claim 15, Kitaoka discloses wherein a proximal end of the deployment sheath (16) includes a second handle (operation pin 40).
Regarding claim 16, Kitaoka discloses wherein when the deployment sheath (16) is in the first configuration extending completely over the stent (Fig. 1), the second handle (40) is distal of the first handle (42; Fig. 1).
Regarding claim 17, Kitaoka discloses wherein the reconstraining member (18) is configured to cover an entirety of the stent (12) while the deployment sheath (16) is proximally withdrawn from a distal portion of the stent (Fig. 5).
Regarding claim 18, Kitaoka discloses wherein the reconstraining member (18) is free from any attachment to the stent (as 18 is moved off of stent; Figs. 5-7).
Regarding claim 19, Kitaoka discloses wherein the reconstraining member (18) is longer than the deployment sheath (16; when handles 40 and 42 are adjacent one another, 18 extends distally past 16; Fig. 5).
Regarding claim 20, Kitaoka discloses a method for delivering a stent (stent 12; Figs. 1-7), the method comprising: advancing a stent delivery system (stent delivery device 10; Fig. 1) through a body lumen (blood vessel 100) to a position adjacent to a target (Fig. 5); wherein the stent delivery system (10) comprises: an inner shaft (shaft 14); a deployment sheath (outer sheath 16) disposed about the inner shaft (Fig. 1); the stent (12) disposed radially between the inner shaft (14) and the deployment sheath (16; Fig. 1); and a reconstraining member (inner sheath 18 which includes expansion restricting portion 34 and inner sheath body 36) extending over the stent (12) and under the deployment sheath (16) and having distal (distal end of 34) and proximal (proximal end 36) ends both free from attachment to the deployment sheath (as 34 i.e., 18 moves relative to 16; Figs. 1-2, 5-7; page 3, paragraph 4 of the English translation), wherein axial movement of the reconstraining member (18) and the deployment sheath (16) are independent of one another (via sliding operation pins 40, 42; page 4, paragraph 1 of the English translation); proximally retracting the deployment sheath (16) to deploy the stent (12; Figs. 1, 5); and proximally retracting the reconstraining member (18; Figs. 5-7).
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) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitaoka (WO 2014/109003 A1) in view of Bigus et al. (US 2003/004561 A1).
Regarding claim 10, Kitaoka fails to disclose wherein the stent includes a coating.
However, Bigus teaches a stent delivery system (system 10; Figs. 1-2) with an inner shaft (shaft 24), a deployment sheath (tubular member 48), a stent (stent 36), and a reconstraining member (retention member 42), the stent (36) including a coating comprised of a drug/polymer/or active substance ([0028]). Bigus further teaches a lubricant may be applied between the deployment sheath (48) and the reconstraining member (42) to reduce friction therebetween so as to not damage the stent coating.
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 stent of Kitaoka to include a coating and to include a lubricant between the deployment sheath and reconstraining member as taught by Bigus in order to further treat the target site with therapeutic agents to improve the healing process without damaging the stent coating.
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kitaoka (WO 2014/109003 A1) in view of Wübbeling et al. (US 2012/0143304 A1).
Regarding claim 12, Kitaoka discloses wherein the reconstraining member (18) includes a tubular sheath (34, 36) extending over an entirety of the stent (12; Fig. 1), wherein a proximal end of the tubular sheath includes a handle (operation pin 42), but fails to disclose a pull wire extending proximally from the tubular sheath, wherein a proximal end of the pull wire includes a handle.
However, Wübbeling teaches a tubular sheath (sheath 12) extending over an entirety of a stent (stent 10; Fig. 1) that is pulled back proximally using a pulling force on a pulling device (16; [0017]), wherein the pulling device (16) may be a pull tube, similar to that of Kitaoka, or alternatively, wherein the pulling device (16) may be a pull wire that runs all the way back to the hand unit ([0017]). Thus, pull tubes and pull wires were known equivalents in the prior art.
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 18 proximal of the stent 12 (i.e., the tubular sheath of the reconstraining member) of Kitaoka to include a pull wire extending proximally to the handle (42) of Kitaoka, rather than the tubular sheath. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of a pulling device that retracts the reconstraining member by user manipulation.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kitaoka (US 2015/0265444 A1), Lim (US 9,724,222 B2), Grad et al. (US 2012/0316638 A1), Austin (US 2006/0184226 A1), and Styre (US 2009/0299449 A1) are noted for teaching reconstraining members.
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.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached 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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/SARAH A LONG/Primary Examiner, Art Unit 3771
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