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
Applicant’s arguments, see pages 2-8 of remarks (pgs 6-12 response), filed 2/16/26, with respect to the rejection(s) of claim(s) 1,2,4,6-8,11-13,15-17,19 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of teachings to Hill et al. (8747462) and Carpentier et al. (4106129).
Applicant did not submit arguments pointing out disagreements with the examiner’s contentions on dependent claim limitations not being taught by the teaching references. Thus the references used in obviousness rejections under 35 U.S.C. 103 are maintained to teach the limitations not disputed. In response to applicant's argument that Hill ‘831 does not teach a radiopaque marker which “identifies the stent as being expandable”, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The Hill radiopaque marker is the same as claimed, Applicant argues a function which in fact could be a mental determination by the surgeon or radiologist discerning where a radiopaque marker has been positioned or moved thus providing knowledge to the practitioner. Thus Applicant’s argument is not persuasive.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1,6 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187). Please note the claims are to a product and not a method of use. The recitations of function are just that, intended uses of the apparatus in a suggested condition. Fig. 1 shows a surgical prosthetic heart valve 10 adapted for post-implant expansion and having an inflow end and an outflow end. Carpentier et al. disclose (col. 2, lines 66-68) a fabric-covered stent surrounding a flow axis. Fig. 2 shows the stent 16 with three upstanding commissure posts, 17-19 the stent defining a substantially circular base 21 at an inflow end of the commissure posts with an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use. It can also be seen the base 16 is a single substantially circular element with two free ends 22 connected. Fig. 1 also shows a plurality of flexible leaflets 13-15 supported by the stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve. However, Carpentier et al. did not disclose a suture used to connect the free ends of the base and to provide a single point of weakness configured to break to separate the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use. Hill et al. teach (Fig. 1) a heart valve device base 26 is a single substantially circular element with two free ends 44 connected by a suture wire 28. Hill et al. also teach (page 12, lines 2-5) that the suture wire 28 can be breakable (function under the right conditions) which would allow the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force. Thus, it would have been obvious to one of ordinary skill in the art that alternatively a suture wire can be used to connect free ends of a base element as taught by Hill et al. with the heart valve stent of Carpentier et al. such that it capable of being breakable to separate the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use. Regarding claim 6, Fig. 2 of Carpentier shows the single point of weakness is formed by the base free ends connected by the suture that is located circumferentially mid-way between two of the commissure posts.
Claim(s) 2,4 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) as applied to claim 1 above, and further in view of Locke et al. (WO 2012/018779). Carpentier et al. as modified by Hill et al. is explained supra. However, Carpentier in view of Hill did not explicitly disclose the stent is a single polymer band or the free ends overlap, one radially sliding inside the other. With respect to claim 2, Lock et al. teach (page 9,18) the stent can be a single band of polymer material. It would have been obvious to one of ordinary skill in the art to alternatively select a cross-sectional profile and material such as a polymer taught by Lock et al. for the stent of Carpentier et al. as modified with Hill et al. such that a biocompatible material is used and also not interfering with imaging due to the selection of a polymer. Regarding claim 4, Lock et al. show (Figs. 12,13) that free ends of base can overlap where one radially slides inside the other, see pages 20,21. It would have been obvious to one of ordinary skill in the art to alternatively arrange ends to overlap and have one radially slide in the other as taught by Lock et al. with the stent of Carpentier et al. as modified with Hill et al. in order to firmly connect the ends.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) as applied to claim 1 above, and further in view of Belhe et al. (2013/0030351). Carpentier et al. as modified by Hill et al. is explained supra. However, Carpentier in view of Hill did not explicitly disclose a pressure needed to break the suture. Belhe et al. teach (paragraph 165) that a pressure of between 2.25 to 3 atm is used to break a suture serving as temporary connection means. It would have been obvious to provide suture with a breaking pressure point within 2.25 to 3 atm as taught by Belhe et al. for the connection means of suture in the stent of Carpentier as modified by Hill such that it performs at the appropriate dimensions of placement of the valve at the site so it permits the expansion of the base to meet the dimensions of the annulus.
Claim(s) 8 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) as applied to claim 1 above, and further in view of Case et al. (2004/0167619). Carpentier et al. as modified by Hill et al. is explained supra. However, Carpentier in view of Hill did not explicitly disclose a radiopaque wire on the stent visible from outside the body after implant that identifies the stent as being expandable. Case et al. teach (Fig. 8) to provide a radiopaque wire 14 on the stent (20,21) visible from outside the body after implant that identifies the stent condition. It would have been obvious to one of ordinary skill in the art to alternatively use a radiopaque wire on the stent as taught by Case et al. with the prosthetic valve of Carpentier et al. as modified by Hill et al. such that the surgeon can discern is in the expanded condition or open sufficiently, see Case paragraph 43.
Claim(s) 11-13,16 are rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) and Hill et al. (WO 2006/135831). Please note the claims are to a product and not a method of use. The recitations of function are just that, intended uses of the apparatus in a suggested condition. Fig. 1 shows a surgical prosthetic heart valve 10 adapted for post-implant expansion and having an inflow end and an outflow end. Carpentier et al. disclose (col. 2, lines 66-68) a fabric-covered stent surrounding a flow axis. Fig. 2 shows the stent 16 with three upstanding commissure posts, 17-19 the stent defining a substantially circular base 21 at an inflow end of the commissure posts with an implant circumference that is substantially non-compressible from a first diameter prior to implant and in normal physiological use. It can also be seen the base 16 is a single element with two free ends 22 connected. Fig. 1 also shows a plurality of flexible leaflets 13-15 supported by the stent and configured to close toward the flow axis and ensure one-way blood flow through the heart valve. However, Carpentier et al. did not disclose a suture used to connect the free ends of the base and to provide a single point of weakness configured to break to separate the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use. Hill et al. teach (Fig. 1) a heart valve device base 26 is a single substantially circular element with two free ends 44 connected by a suture wire 28. Hill et al. also teach (page 12, lines 2-5) that the suture wire 28 can be breakable (function under the right conditions) which would allow the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force. Thus, it would have been obvious to one of ordinary skill in the art that alternatively a suture wire can be used to connect free ends of a base element as taught by Hill et al. with the heart valve stent of Carpentier et al. such that it capable of being breakable to separate the free ends and permit expansion of the base from the first diameter to a second diameter larger than the first diameter upon application of an outward dilatory force from within the stent substantially larger than forces associated with normal physiological use. However, Carpentier et al. also did not disclose a radiopaque marker on the base that identifies the stent as being expandable. Hill et al. teach (page 10) that a radiopaque marker can be provided around the base or circumference to identify expansion of the stent frame member. It would have been obvious to one of ordinary skill in the art to utilize a radiopaque marker on the base or circumference as taught by Hill et al. ‘831 with the prosthetic valve of Carpentier et al. as modified by Hill ‘187 such that the surgeon can accurately assure placement and functionality of the valve in the lumen. With respect to claim 12, Carpentier in view of Hill ‘187 did not explicitly disclose the stent is a single polymer band or the free ends overlap, one radially sliding inside the other. Hill et al. ‘831 teach (page 6, lines 5-8) the stent can be a single band of polymer material (page 9, lines 18,19). It would have been obvious to one of ordinary skill in the art to alternatively select a cross-sectional profile (rectangular can be a band type) and material such as a polymer taught by Hill et al. ‘831 for the stent of Carpentier et al. as modified with Hill et al. ‘187 such that a biocompatible material is used and also not interfering with imaging due to the selection of a polymer, while providing a supportive profile. Regarding claim 13, Fig. 1 of Hill ‘187 shows/teaches the base 26 includes free ends 44 connected by the suture 28. Regarding claim 16, Fig. 2 of Carpentier shows the single point of weakness is formed by the base free ends connected by the suture that is located circumferentially mid-way between two of the commissure posts.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) and Hill et al. (WO 2006/135831) as applied to claim 13 above, and further in view of Locke et al. (WO 2012/018779). Carpentier et al. as modified by Hill et al. ‘187 and Hill et al. ‘831 is explained supra. However, Carpentier in view of Hill ‘187 and Hill et al. ‘831 did not explicitly disclose the stent free ends overlap, one radially sliding inside the other. Lock et al. show (Figs. 12,13) that free ends of base can overlap where one radially slides inside the other, see pages 20,21. It would have been obvious to one of ordinary skill in the art to alternatively arrange ends to overlap and have one radially slide in the other as taught by Lock et al. with the stent of Carpentier et al. as modified with Hill et al. ‘187 and Hill et al. ‘831 in order to firmly connect the ends.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) and Hill et al. (WO 2006/135831) as applied to claim 11 above, and further in view of Belhe et al. (2013/0030351). Carpentier et al. as modified by Hill et al. ‘187 and Hill et al. ‘831 is explained supra. However, Carpentier in view of Hill ‘187 and Hill et al. ‘831 did not explicitly disclose a pressure needed to break the suture. Belhe et al. teach (paragraph 165) that a pressure of between 2.25 to 3 atm is used to break a suture serving as temporary connection means. It would have been obvious to provide suture with a breaking pressure point within 2.25 to 3 atm as taught by Belhe et al. for the connection means of suture in the stent of Carpentier as modified by Hill ‘187 and Hill et al. ‘831 such that it performs at the appropriate dimensions of placement of the valve at the site so it permits the expansion of the base to meet the dimensions of the annulus.
Claim(s) 19 is rejected under 35 U.S.C. 103 as being unpatentable over Carpentier et al. (4106129) in view of Hill et al. (WO 2012/158187) and Hill et al. (WO 2006/135831) as applied to claim 11 above, and further in view of Case et al. (2004/0167619). Carpentier et al. as modified by Hill et al. ‘187 and Hill et al. ‘831 is explained supra. It is noted that Hill ‘831 did state the radiopaque marker could be a sleeve on a stent, 1st paragraph of page 10. However, Carpentier in view of Hill ‘187 and Hill et al. ‘831 did not explicitly disclose a radiopaque wire as the marker. Case et al. teach (Fig. 8) to provide a radiopaque wire 14 wrapped on the stent (20,21) in the form of a sleeve visible from outside the body after implant that identifies the stent condition. It would have been obvious to one of ordinary skill in the art to alternatively utilize a radiopaque wire as a sleeve type marker on the stent as taught by Case et al. with the prosthetic valve of Carpentier et al. as modified by Hill ‘187 and Hill et al. ‘831 such that the surgeon can discern is in the expanded condition or open sufficiently, see Case paragraph 43.
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 BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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