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 05/04/26 have been fully considered but they are not persuasive.
On pages 7-11, Applicant argues that since Landon and Spargias fail to disclose each element of the claim individually, it would not be obvious to modify the distal end of the capsule of Landon because Spargias has a sheath that operates differently.
The Examiner respectfully disagrees, noting the operation of the sheath of Spargias does not appear to have anything to do with the shape of the distal end, which only assists in smooth insertion, making this argument unclear.
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.
Claims 1, 6-8, 10, 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon et al. (US 20190008639 A1) hereinafter known as Landon in view of Spargias (US 20170333186 A1).
Regarding claim 1 Landon discloses a capsule (Figures 18-19 item 106) of a delivery apparatus configured to deliver a prosthetic medical device to a target implantation site (The applicant is advised that, while the features of an apparatus may be recited either structurally or functionally, claims directed to an apparatus must be distinguished from the prior art in terms of structure rather than function. In addition, it has been held by the courts that apparatus claims cover what a device is, not what a device does. See MPEP 2144 (I). In this case, the patented apparatus of Landon discloses (as detailed above) all the structural limitations required to perform the recited functional language, therefore was considered to anticipate the claimed apparatus. See, for example [0008]), the capsule comprising:
a distal end portion (Figures 18-19 item 107) comprising a plurality of wings spaced circumferentially apart around the distal end portion by slots (Figure 18-19 shows the axial slots extending lengthwise to form wings to a transition to the middle section/diameter), wherein the wings, in a radially compressed configuration, have outer diameter of a middle portion of the capsule and an outer diameter at a distal end of the distal portion, the distal end spaced away from the middle portion of the capsule, and wherein the wings are radially expandable to an expanded configuration upon deployment of the medical device from the distal end of the capsule (Figures 18-19) such that the distal expands to the wider outer diameter (Figures 18-19),
but is silent with regards to the wings tapering from the middle portion of the capsule to a narrower outer diameter at the distal end.
However, regarding claim 1 Spargias teaches a capsule that includes a distal end portion that narrows in diameter from a wider outer diameter of a middle portion to a first narrower outer diameter at a distal end of the distal end portion, (Figure 13 shows capsule 35 with a tapered distal end (see also [0097]). Landon and Spargias are involved in the same field of endeavor, namely delivery capsules. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the capsule of Landon so that its distal end is tapered as is taught by Spargias in order to allow smooth tracking forward and backwards during delivery of the medical device. When Landon is modified in light of Spargias, the Examiner understands the wings of the distal end to adopt this geometry as well, which inherently results in the wings where they join to the middle of the capsule to be wider before they begin to taper to form the nosecone at the distal end of the distal portion.
Regarding claim 6 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein Landon further discloses each slot extends from the distal end of the distal end portion and extending in an axial direction from the end of the distal portion to a portion of the capsule that transitions from the distal end portion to the middle portion (Figure 18-19 shows the axial slots extending lengthwise to form wings to a transition to the middle section/diameter).
Regarding claim 7 the Landon Spargias Combination teaches the capsule of claim 6 substantially as is claimed,
wherein Landon further discloses each wing is formed between two adjacent slots (Figures 18-19),
and wherein the Combination further teaches, in the radially compressed configuration, each wing angles radially inward from a wider proximal end of the wing to a narrower distal end of the wing, the distal ends of the wings forming the distal end of the distal end portion of the capsule that is spaced from the middle portion of the capsule (when Landon is modified for its distal end to have a conical shape, the notches would obviously angle radially inward from a wider proximal end of the wing towards a narrow distal end of the wing in order to fit the conical shape of the Combination).
Regarding claim 8 the Landon Spargias Combination teaches the capsule of claim 6 substantially as is claimed,
wherein Landon further discloses each slot includes an elongate end portion extending from the distal end of the distal end portion to the portion of the capsule that transitions, and a bulbous end arranged at the portion of the capsule that transitions (Figures 18-19 show a circular proximal end to the elongate notches).
Regarding claim 10 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein the Combination further teaches the capsule is configured to cover and enclose the medical device in a radially compressed configuration and wherein the medical device in a compressed configuration comprises a tapered end that the distal end portion is configured to surround (this does not appear to materially change the structure of the claimed capsule, which the Examiner understands to be capable of enclosing such as a medical device, if desired).
Regarding claim 21 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein the Combination further teaches the narrower outer diameter of the distal end portion is a first narrower outer diameter (see the explanation/modification of Landon in view of Spargias’s conical shape, above),
and wherein Spargias further teaches a capsule can comprise a proximal end portion that narrows in diameter from the wider outer diameter to a second narrower diameter at its proximal end (Figure 13 shows capsule 35 with a tapered proximal end as well as a tapered distal end; see also [0097]). As above, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the capsule of Landon so that its proximal end is tapered as is taught by Spargias in order to allow smooth tracking forward and backwards during delivery of the medical device.
Regarding claim 22 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein the Combination further teaches in the expanded configuration, the distal end portion has a constant outer diameter (the Examiner notes that while Landon shows (Figures 18-19) that the outer diameter can expand in a flared configuration, in order to get to that diameter, there is at least one intermediate configuration in which the distal end portion has a straight cylindrical profile during the deployment of the non-claimed medical device. This intermediate configuration, where the diameter is constant and cylindrical, is now considered to be the “expanded configuration” of the claims.).
Claim 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon and Spargias as is applied above in view of Racchini et al. (US 20170196690 A1) hereinafter known as Racchini.
Regarding claim 9 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein Landon further discloses the wings comprise an elastic, self-expanding material that is shape set ([0141]),
but is silent with regards to whether the wings are shape set into the compressed configuration.
However, regarding claim 9 Racchini teaches that delivery catheters can have a capsule that is shape-set in a compressed configuration (Racchini claim 4). Landon and Racchini are involved in the same field of endeavor, namely delivery device capsules. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the capsule of the Landon Spargias Combination so that the capsule is shape-set into either the delivery or the expanded configurations, as is taught by Racchini, 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).
Claim 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Landon and Spargias as is applied above, as is evidenced by Voelkl (US 20100185207 A1), or in the alternative, as being unpatentable over Landon, Spargias, and Voelkl.
Regarding claim 23 the Landon Spargias Combination teaches the capsule of claim 1 substantially as is claimed,
wherein the Combination further teaches the plurality of wings comprises a plastically deformable material ([0141] stainless steel). While the Combination is silent with regards to whether the wings are plastically deformed to the compressed configuration, Voelkl teaches that when a stainless steel compressible element is compressed radially, it results in plastic deformation ([0047]). Accordingly, the inherency of the Combination’s stainless steel wings being compressed radially into the compressed configuration via a plastic deformation is considered to be evidenced by, or in the alternative, obvious over Voeklel.
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 05/03/26
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