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 Rejections - 35 USC § 103
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 non-obviousness.
Claims 1, 2, 5-7 and 10-14 are rejected under 35 U.S.C. 103 as being unpatentable over Ortiz et al. (US 2004/0167620) in view of Keranen et al. (WO 2006/091163).
Regarding claim 1, Ortiz et al. disclose a method for replacement of a defective heart valve of a heart of a patient, said method comprising: introducing a distal loop-shaped element (lower coil of member 212 - Figure 28) of a medical device having a helical structure around the heart valve annulus (¶[0087]; Figure 28); positioning a first loop-shaped element (upper coil of member 212) of the helical structure on a first side of the heart valve oriented towards a cardiac chamber of the heart (the upper coil would be above an annulus as evident from Figure 28 and would be within an atrium- ¶[0069]); the first loop-shaped element having a smaller diameter than the distal loop-shaped element (e.g. see larger distal loop-shaped element diameter at 70b in Figure 8); rotationally inserting the helical structure around the valve (¶[0077], [0079]); and moving a prosthetic valve (210) along the medical device into position for attachment to the heart valve (¶[0087]; Figure 28).
Ortiz et al. fail to specifically disclose that the distal loop-shaped element is introduced in between the heart muscle wall and chordae of the heart.
Keranen et al. teach that a similar distal loop-shaped element (44; Figure 5) can be introduced in between the heart muscle wall and chordae of the heart (¶[0014]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Keranen et al. to have introduced the distal loop-shaped element of Ortiz et al. between the heart muscle wall and chordae of the heart in order to avoid interference with or damage to the chordae.
Ortiz et al. fail to disclose that the first loop-shaped element has a smaller diameter than the distal loop-shaped element.
Keranen et al. disclose a similar helical structure having a first loop-shaped element (42) of smaller diameter than a distal loop-shaped element (44; Figures 3 and 5) in order to prevent rupture of tissue between the loops (¶[0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the helical structure of Ortiz et al. with the larger distal loop-shaped element of Keranen et al. in order to prevent rupture of tissue between the loops.
Ortiz et al. fail to specifically disclose that the loop-shaped elements are arranged to reposition or circumflex the chordae towards a center of the heart valve upon rotational insertion of the helical structure in the heart valve. Ortiz et al. disclose that defective heart valves are often dilated in diameter (¶[0003]) and further discloses that it is known to position ring-shaped devices around an annulus to reduce the diameter of the annulus (¶[0004]).
Therefore, in view of the known prior art teachings above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have made the helical structure or ring-shaped device of Ortiz et al. of sufficient diameter such that it reduces the diameter of a dilated valve annulus upon insertion in order to reshape it to its normal diameter for receipt of the prosthetic valve. When the valve annulus is reduced in diameter, the chordae would be repositioned or circumflexed as claimed (noting that some chordae are located adjacent the annulus - see for example ¶[0073] of US 2021/0322170 or ¶[0036] of US 2015/0094800 as evidentiary support).
Regarding claim 2, the helical structure, being smaller in diameter than the dilated valve as explained above, would circumflex the chordae as the helical structure is inserted (which can be regarded as a continuous circumflexing over some period of time).
Regarding claim 5, Ortiz et al. fail to disclose passing the medical device through a commissure at the heart valve upon introducing the distal loop-shaped element.
However, Keranen et al. teach inserting the above distal loop-shaped element by passing it through a commissure of a heart valve upon introducing the distal loop-shaped element (¶[0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention and in view of Keranen et al. to have introduced the distal loop-shaped element of Ortiz et al. by passing it through a commissure of the heart valve in order to avoid having to make a hole through the valve or valve annulus.
Regarding claim 6, the prosthetic valve is attached to the medical device (¶[0087] of Ortiz et al.).
Regarding claim 7, the prosthetic valve is inserted along a center axis of the helical structure to place the prosthetic valve into position at the heart valve (evident from Figures 27 and 28 of Ortiz et al.).
Regarding claim 10, the medical device is formed from a shape-memory material and is configured to be compressible for delivery in a catheter (claims 7 and 8 of Ortiz et al.).
Regarding claim 11, the medical device comprises a connection interface (220b of Ortiz et al.) for releasably attaching a delivery device at a proximal end thereof.
Regarding claim 12, the helical structure comprises a portion (70a; Figure 8 of Ortiz et al.) extending in parallel to a center axis of the helical structure.
Regarding claim 13, the portion extending in parallel to the center axis is arranged as part of a proximal portion of the helical structure (see member 70a on upper coil in Figure 8 of Ortiz et al.).
Regarding claim 14, the medical device includes sections of differing flexibility (the fabric 216 or sutures - Figure 28 of Ortiz et al., would have a different flexibility than the loop-shaped elements).
Allowable Subject Matter
Claims 3, 4, 8 and 9 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/THOMAS MCEVOY/Primary Examiner, Art Unit 3771
