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 filed 09/11/26 have been fully considered but they are not persuasive.
On page 8 regarding claim objections Applicant argues amendments overcomes the objections of record.
The Examiner respectfully agrees and withdraws the outstanding objections.
On pages 8-9 regarding drawing and specification objections Applicant argues amendments overcome the objections of record.
The Examiner respectfully agrees and withdraws drawing and specification objections.
On pages 9-12 regarding 112 rejections Applicant argues amendments overcome the rejections of record.
On page 10 regarding prior art, Applicant argues item 730 of Drasler is not an inflow edge of the leaflets, but instead is an inflow edge of the frame, since [0308] refers to this as the upstream end of the frame 192 (Fig 34a). Applicant argues [0310] states the
The Examiner respectfully points out the rejection of record points to the leaflets being item 270, and only points to the inflow edge of the leaflets to be at, or near item 730, since the inflow end of the frame and leaflets are around the same location – the leaflets simply didn’t have a number in Drasler for their inflow end: “at 730” was used for convenience’s sake since it did not have its own number.
On pages 10-11 Applicant argues Drasler also states specifically that the leaflets are directly attached to the frame of the device in [0310], seen in figure 34a.
The Examiner respectfully points out this argument is drawn towards another embodiment of Drasler, and is not related to any of the embodiments referenced by the rejection of record which makes this unpersuasive.
The Examiner further notes that while claim 13 is marked as “original” it should be marked as “withdrawn” in accordance with the MPEP. If proper status identifiers are not included in the future, a non-compliant will be mailed to Applicant.
Claim Rejections - 35 USC § 102
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) 1-4, 6, 8-11, 14-19 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Drasler et al. (US 20190209320 A1) hereinafter known as Drasler.
Regarding claim 1 Drasler discloses a device for treating a diseased native valve in a patient comprising:
a frame structure (Figure 34C, 34G item 865) having an unexpanded configuration and an expanded configuration ([0309] the securement band 865 can be expanded), and
a valve segment (190) coupled to the frame and comprising:
a plurality a leaflets (270), wherein an inflow edge of the leaflets (near element 730/280) is not directly supported by the frame (Figure 34C, 34G shows the inflow edge near 730/280 not supported by frame 865),
a seal attached to the inflow edge of the leaflets (285) and positioned radially between the frame and the leaflets (Figure 34G, 34C; [0319] the covering can be attached adjacent and radially outwards of the leaflet and attached to the stent-valve frame), and
a seal support (920) attached to or within the seal which provides axial rigidity to the seal (Figure 34C, 34G; [0319]).
Regarding claim 2 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the inflow edge of the leaflets (near 730/280) is spaced radially inward from an inflow edge of the frame when the frame is expanded (Figure 34c shows band 865 extending radially outward further than the inflow edge near 730 of leaflets 270).
Regarding claim 3 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses a nadir support skirt extending between the seal (Figure 34c item 285) and an inflow edge of the frame (730) ([0297] the covering 285 can include a skirt-shaped portion as is seen in Figure 34G).
Regarding claim 4 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses a portion of the inflow edge of the leaflets (near 730/280) extends axially beyond an inflow edge of the frame (Figure 34c item 865) such that the portion of the inflow edge of the leaflets extends further in an inflow direction than the inflow edge of the frame (Figure 34c).
Regarding claim 6 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal (285) comprises polyurethane ([0016]).
Regarding claim 8 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) comprises an undulating wireform (Figure 34c shows the support 920 undulating; [0380] the frames can comprise Nitinol wire in a zig-zag shape ([0315] the seal support 920 is described as a “frame surface”)).
Regarding claim 9 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends proximate to the inflow edge of the leaflets (Figure 34c).
Regarding claim 10 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends closer to an inflow edge (near 730) of the seal than an outflow edge (740) of the seal (285) (Figure 34G shows how the outflow edge 740 is occupied by a nadir support skirt 285 instead of the seal 285 seen in figure 34c.).
Regarding claim 11 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) is configured to pretension the seal (285) ([0037] self-expansion pre-tensions the seal to an expanded configuration).
Regarding claim 14 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the frame (865) has a longitudinal length (Figure 34d item 942) of less than 35 mm in its expanded configuration ([0331] 1-10 mm).
Regarding claim 15 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the frame (865) comprises a flared inflow section, a central annular section, and a flared outflow section (Figure 34G shows frame 865 with an hourglass shape).
Regarding claim 16 Drasler discloses the device of claim 15 substantially as is claimed,
wherein Drasler further discloses the seal (285) is attached to the central annular section (Figure 34G).
Regarding claim 17 Drasler discloses the device of claim 15 substantially self- as is claimed,
wherein Drasler further discloses the flared inflow and outflow sections are configured to engage an exterior anchor therebetween when the frame is expanded (This is stated as an “intended use” of the claimed device. The applicant is advised that a recitation of the intended use of an 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. See MPEP 2111.02 (II). In this case, the patented structure of Drasler was considered capable of performing the cited intended use.).
Regarding claim 18 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the leaflets (270) are attached to the frame (865) only at commissures of the leaflets (see Figures 34f, 34g item 312).
Regarding claim 19 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses at least a portion of the inflow edge of the leaflets (near 730/280) extends axially beyond the frame structure (865) while an entire outflow edge of the leaflets (740) is positioned within the frame (Figure 34G).
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 5 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler as is applied above in view of Bonyuet et al. (US 10045846 B2) hereinafter known as Bonyuet.
Regarding claim 5 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) is bonded to the seal ([0312]),
but is silent with regards to the seal support being laminated within the seal.
However, regarding claim 5 Bonyuet teaches that support (frames) can be laminated within coverings (Column 2 lines 10-15). Drasler and Bonyuet are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Drasler by having the seal support laminated within the seal as is taught by Bonyuet since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known attachment method of the support to the seal would have been obvious to try.
Regarding claim 7 Drasler discloses the device of claim 1 substantially as is claimed,
wherein Drasler further discloses the seal support (920) extends annularly with the seal (285) (Figure 34c),
but is silent with regards to the seal support extending within the seal.
However, regarding claim 7 Bonyuet teaches that support (frames) can be laminated within coverings (Column 2 lines 10-15). Drasler and Bonyuet are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Drasler by having the seal support extend within the seal as is taught by Bonyuet since the courts have held that choosing from a finite number of identified, predictable solutions with a reasonable expectation of success results in a prima facie case of obviousness. See MPEP 2143 (I)(E). In this case, the use of any known attachment method of the support to the seal would have been obvious to try.
Claim 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drasler as is applied above in view of Oba et al. (US 20160310268 A1) hereinafter known as Oba.
Regarding claim 12 Drasler discloses the device of claim 1 substantially as is claimed,
but is silent with whether or not the seal support (920) is not directly connected to the frame (865).
However, regarding claim 12 Oba teaches that heart valve frames can have frame portions that are not directly connected from one another (Figure 1 item 11 show connections between frame portions 302, 304 only thorugh a sleeve 306). Drasler and Oba are involved in the same field of endeavor, namely heart valves. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the device of Drasler so that the support 920 and frame 865 are not directly connected to one another as is taught by Oba in order to allow adjusting the flexibility of the frame as a whole, which might be desirable based on the geometry and ailments of a particular patient.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 Jacqueline Woznicki whose telephone number is (571)270-5603. The examiner can normally be reached M-Th 10am-6pm EST.
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, Jerrah Edwards can be reached on 408-918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Jacqueline Woznicki/Primary Examiner, Art Unit 3774
