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 01/16/26 have been fully considered but they are not persuasive.
On pages 8-10 Applicant argues amendments overcome the objections and rejections of record. Regarding claim 2, Applicant argues Marmer does not teach the required working diameter “ranges”.
The Examiner respectfully refers to the rejection below regarding amended claims. However, regarding claim 2, the Examiner notes Armer does disclose the working diameter ranges meeting the limitations of the claim, since the docking frame expands from the unexpanded to the expanded diameter which creates a larger range than that of the valve frame, which does not expand as far.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 is objected to for referring to “a plurality of valve leaflets” and “an inner surface” when it is unclear how (if at all) these relate to the previously claimed “valve leaflets” and “inner surface”.
Additionally, there appears to be improper antecedent basis for “the respective valve frame”.
Appropriate correction is required.
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) 1-2, 6, 21, 25-26, 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armer et al. (US 20170231756 A1) hereinafter known as Armer in view of Brunett et al. (US 20150282931 A1) hereinafter known as Brunett.
Regarding claim 1 Armer discloses a prosthetic valve system comprising:
a mechanically expandable docking frame (Figure 22 item 10; Abstract both the docking frame and valve frame are expandable) configured to be implanted within a portion of a patient’s body (Figure 22),
a valve frame (Figure 22 item 29) having an outer surface and an inner surface (Figure 22 shows the valve outer surface engaging the docking frame 10 ([0197], and the inner surface where the lumen/leaflets are positioned) and the docking frame including openings (18), the openings being configured for the docking frame to be positioned within to dock the valve frame to the docking frame to support the valve frame within the portion of the patient’s body ([0197], Figure 22), and
a plurality of valve leaflets coupled to the valve frame which extend radially inward from the inner surface of the valve frame (Figure 22 shows three valve leaflets interior of the valve frame 29),
but is silent with regards to the valve frame including the openings so the openings dock the docking frame.
However, regarding claim 1 Brunett teaches that an inner valve frame (250) can include openings ([0085]) to receive a docking frame therein (300). Armer and Brunett 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 system of Armer by having the valve frame include openings to receive the docking frame as is taught by Brunett instead of the docking frame including openings to receive the valve frame (as is taught by Armer) 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, this is a simple male/female connection switch between connecting parts, which is considered obvious to one of ordinary skill.
Regarding claim 2 the Armer Brunett Combination teaches the system of claim 1 substantially as is claimed,
wherein Armer further discloses a working diameter range of the docking frame is greater than a working diameter range of the valve frame ([0198]; Figure 22 shows how the working range of the docking frame is larger than the diameter of the valve frame, which it surrounds).
Regarding claim 6 the Armer Brunett Combination teaches the system of claim 1 substantially as is claimed,
wherein Armer further discloses the valve frame is self-expanding to expand radially outward (Abstract; [0197], [0004] the valve frame is introduced over catheter and expands to engage the docking frame).
Regarding claim 21 the Armer Brunett Combination teaches the system of claim 1 substantially as is claimed,
wherein Brunett further teaches the openings are cut-outs in the outer surface of the valve frame (Figure 24 shows cut outs between struts 304).
Regarding claim 25 the Armer Brunett Combination teaches the system of claim 1 substantially as is claimed,
wherein Armer further discloses the docking frame is a mechanically expandable frame ([0007] expandable docking station; [0189] mechanically expandable).
Regarding claim 26 the Armer Brunett Combination teaches the system of claim 25 substantially as is claimed,
wherein Armer further discloses the mechanically expandable frame includes struts joined at hinges ([0177] the docking frame is made of a lattice of metal struts).
Regarding claim 28 the Armer Brunett Combination teaches the system of claim 25 substantially as is claimed,
wherein Armer further teaches the mechanically expandable (docking) frame has a cylindrical shape (see at least embodiments from Figures 4-5). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the shape of the outer frame to be any known shape 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). Any known shape is understood to be included within the number of predictable solutions.
Claim 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armer and Brunett as is applied above in view of Beith (US 20150320555 A1).
Regarding claim 3 the Armer Brunett Combination teaches the system of claim 1 substantially as is claimed,
but is silent with regards to there being a plurality of valve frames with a different greatest working diameter than one another.
However, regarding claim 3 Beith teaches that heart valve systems can include kits of a plurality of valve frames which each have a greatest working diameter different than each other ([0070]). Armer and Beith 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 system of the Armer Brunett Combination to include a kit of different sized valves as is taught by Beith in order to enable the surgeon implanting the valve frame to choose the size that is desirable for the anatomy and size of the patient being treated.
Claims 1 and 22-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armer as is applied above in view of Shaolian et al. (US 20160120642 A1) hereinafter known as Shaolian.
Regarding claim 1 Armer discloses a prosthetic valve system comprising:
a mechanically expandable docking frame (Figure 22 item 10; Abstract both the docking frame and valve frame are expandable) configured to be implanted within a portion of a patient’s body (Figure 22),
a valve frame (Figure 22 item 29) having an outer surface and an inner surface (Figure 22 shows the valve outer surface engaging the docking frame 10 ([0197], and the inner surface where the lumen/leaflets are positioned) and the docking frame including openings (18), the openings being configured for the docking frame to be positioned within to dock the valve frame to the docking frame to support the valve frame within the portion of the patient’s body ([0197], Figure 22), and
a plurality of valve leaflets coupled to the valve frame which extend radially inward from the inner surface of the valve frame (Figure 22 shows three valve leaflets interior of the valve frame 29),
but is silent with regards to the valve frame including the openings so the openings dock the docking frame.
However, regarding claim 1 Shaolian teaches that an inner valve frame (2410) can include openings (2420) to receive a docking frame therein (2430). Armer and Shaolian 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 system of Armer by having the valve frame include openings to receive the docking frame as is taught by Shaolian instead of the docking frame including openings to receive the valve frame (as is taught by Armer) 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, this is a simple male/female connection switch between connecting parts, which is considered obvious to one of ordinary skill.
Regarding claim 22 the Armer Shaolian Combination teaches the system of claim 1 substantially as is claimed,
wherein Shaolian further teaches the docking frame includes an upper edge and a lower edge (considered to be the upper extent and lower extent of the frame 2430 within the openings 2420), wherein the edges are both configured to be positioned within the openings (Figure 24b) and contact the valve frame (Figure 24b).
Regarding claim 23 the Armer Shaolian Combination teaches the system of claim 22 substantially as is claimed,
wherein Shaolian further teaches the valve frame is configured to expand radially outward such that the valve frame contacts the upper edge and the lower edge (Figure 24b; [0204] the valve frame is expandable).
Regarding claim 24 the Armer Shaolian Combination teaches the system of claim 23 substantially as is claimed,
wherein Armer further discloses a length of the valve frame reduces upon the valve frame expanding radially outward (see Figure 4c-d; the length of valve frame 29 is shorter in figure 4d (expanded configuration) than in figure 4c (delivery configuration); see also [0180] there is an inherent change in length when a stent expands from a compressed state to an expanded state).
Claim 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over Armer and Brunett as is applied above in view of Cartledge et al. (US 9913716 B2) hereinafter known as Cartledge.
Regarding claim 27 the Armer Brunett Combination teaches the system of claim 26 substantially as is claimed,
but is silent with regards to there being a mechanical drive with a plurality of drive rods for coupling with the docking frame for controlling expansion and contraction of the frame.
However, regarding claim 27 Armer discloses the frame can be mechanically expanding ([0189]) and Cartledge teaches that a mechanically expanding heart valve frame can include a mechanical drive (710) including a plurality of drive rods (740) for coupling with a mechanically expandable frame for controlling the expansion and contraction of the mechanically expandable frame (Column 15 lines 45-56). Armer and Cartledge 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 system of the Armer Brunett Combination so that the mechanics of the mechanically expanding frame of Cartledge are involved in the system of Armer 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 inclusion of any known mechanical expansion mechanism known in the art would have been obvious to try in Armer’s system.
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.
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/Jacqueline Woznicki/Primary Examiner, Art Unit 3774 02/25/26