DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 21-24, 26-35 and 37-39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Leanna et al. US 2007/0270931 in view of Gabbay US 2007/0162100 in view of in view of Morales US 5893852.
Regarding claims 21-24, 26, 29, 30, 31, 32, 33, 34, 37, 38 and 39, Leanna et al. discloses a method for loading a prosthetic medical device 20 having a self-expanding support frame for catheter delivery (paragraph 0003, may be self-expanding variety), comprising:(a) providing a loading apparatus assembly including: a delivery catheter (paragraph 0005, 0018, figure 1) including an outer tubular member and a distal tip member (figure 1), the outer tubular member including a sheath having a sheath lumen extending to a distally facing sheath opening (figure 1, lumen within 60 and opening for receiving distal tip member), the distal tip member including an elongate cannula 50 and a distal tip body 40; wherein a distal region of the sheath is receivable in the passageway of the body to position the distally facing opening of the sheath in communication with the second chamber (figure 3, distal end of 60 within the body until transition step 36, paragraph 0026), a loading apparatus including a body 30 defining a passageway (figure 2), the passageway including a first, transition chamber 35 having an axial length and an inner diameter (figure 2), the inner diameter of the transition chamber varying over the axial length of the transition chamber (figure 2), the passageway further including a second chamber 38 proximal of the transition chamber; a length of the sheath received in the passageway of the body with the distally facing opening of the sheath in communication with the second chamber of the passageway of the body (figure 3, distal end of 60 within the second chamber 38); a proximal end of the prosthetic medical device 20 received in the second chamber of the passageway of the body (figure 4) and positioned distal of the distally facing opening of the sheath (device 20 is moved from the transition chamber 35 into the proximal chamber 38, when the proximal end of device 20 is at least partially or initially in the second chamber 38, it will be distal of the sheath 60); the loading apparatus in a position surrounding the distal tip member with the elongate cannula disposed in the passageway of the body and extending through the prosthetic valve medical device (figure 3), after the providing, disposing the proximal end of the prosthetic medical device into the distally facing opening of the sheath and into and along the sheath lumen (figure 4, device 20 extending within opening of 60, paragraph 0036) ; (c) after the disposing, disrupting the loading apparatus to enable removal of the loading apparatus from the position surrounding the distal tip member (paragraph 0029, loading apparatus may be formed of separate elements such as being split or hinged) and (d) after the disrupting, removing the loading apparatus from the position surrounding the distal tip member (paragraph 0029, 0041, loading apparatus body 30 removed from assembly).
Leanna et al. discloses loading apparatus may be formed of separate elements such as being split or hinged for loading or having outer shapes for ease for loading a stent member, or mounting engagement means (paragraphs 0029, 0042), but fails to explicitly disclose disrupting for removal of the loading apparatus from the stent member assembly, wherein the disrupting comprises disrupting a separable connection of the loading apparatus, such as a threaded or clamped connection.
However, it would have been obvious to one having ordinary skill in the art to utilize the separate elements for ease of removal of the loading apparatus or enabling the elements to be split for removal as alternative shapes are anticipated to provide additional ergonomic features, handles, or engagement surfaces for tools or simply ease of manufacture and may be understood alternative outer surfaces may be realized (paragraph 0029, 0042), or wherein the loading apparatus is wherein the disrupting comprises disrupting a separable connection of the loading apparatus, such as a threaded or clamped connection (paragraph 0029, 0042, for example, hinged connection or screw-thread or other known means of engagement). It would have been an obvious matter of design choice to provide an engagement being threaded or clamped or otherwise since applicant has not disclosed that providing such a connection solves any stated problem or is for any particular purpose and it appears that the invention would perform equally well with a threaded, clamped, hinged, or alternative means of releasably engagement.
Leanna et al. fails to disclose a prosthetic medical device stent being a prosthetic valve medical device, and wherein the prosthetic valve medical device includes at least one section of tissue or tissue-derived material.
Gabbay teaches a storage and loading system for implantable medical devices, the medical devices may be a stent or heart valve devices (paragraphs 0001, 0002, implantable stents or other implantable heart valve prosthesis), the wherein the prosthetic valve medical device includes at least one section of tissue or tissue-derived material or mechanical or biomechanical valves as desired (paragraph 0002).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Leanna et al. with a prosthetic valve medical device formed of at least one section of tissue or tissue-derived material, as taught by Gabbay as is known in the art to provide a loading apparatus for stent or valve medical prosthetic devices depending on the necessary procedure and of a tissue derived material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Leanna et al. fails to further comprise positioning a stiffening mandrel in the elongate cannula disposed in the passageway of the body.
Morales teaches a prosthesis compression loading device (column 1, lines 5-7) and positioning a stiffening mandrel in the elongate cannula so as to provide column strength to support the elongate cannula against compressive forces (column 3, lines 57-65, mandrel is inserted or slidable within the catheter to help maintain shape of the cannula or catheter and helps prevent damage).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Leanna et al. with a stiffening mandrel, as taught by Morales, to provide strength to support the elongate cannula against compressive forces.
Regarding claims 27 and 28, Leanna et al. discloses wherein the passageway of the body also defines a third chamber 32, the third chamber distal of the transition chamber (figure 2), wherein the third chamber has a uniform diameter (figure 2).
Regarding claim 35, Leanna et al. discloses the device essentially as disclosed as discussed above, but fails to disclose a pusher having a plurality of pushing arms configured to contact and push the prosthetic valve medical device.
However, Gabbay teaches pushing a prosthetic valve medical device 59 axially (figures 4-7, prosthetic pushed into tapered chamber), wherein the pushing comprises pushing on the prosthetic valve medical device with a plurality of pushing arms of a pusher (figure 6, arms 104, 106 of pusher 100, paragraph 0043).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Leanna et al. with a pusher, as taught by Gabbay, to further push the medical device or valve into the transition chamber and through the loading apparatus.
Claim 25, 36 and 40 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Leanna et al. US 2007/0270931 in view of Gabbay US 2007/0162100 in view of in view of Morales US 5893852 as discussed above, and further in view of Duffy et al. US 2011/0208296.
Regarding claim 25, 36, and 40, Leanna et al. in combination discloses a method essentially as claimed as discussed above, but fails to disclose wherein the loading apparatus includes a sleeve in a position surrounding the elongate cannula of the distal tip member, and wherein the disrupting comprises disrupting the sleeve lengthwise along a length of the sleeve, wherein the disrupting comprises cutting, or wherein the disrupting is other than by cutting.
Duffy et al. teaches wherein the loading apparatus includes a sleeve 1602 in a position surrounding the elongate cannula of the distal tip member (figure 16, sleeve 1602 over shaft of distal tip assembly 104), and wherein the disrupting comprises disrupting the sleeve lengthwise along a length of the sleeve (paragraph 0058, two halves split for removal) wherein the disrupting comprises cutting (paragraph 0058, two halves may be manually cut), or wherein the disrupting is other than by cutting (paragraph 0058, two halves attached with a collar) to provide a capture sleeve for compressing and placing the prosthesis over the prosthesis retainer that may be removed after placement (paragraph 0058).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify Leanna et al. in combination with a loading apparatus having a sleeve in a position surrounding the elongate cannula of the distal tip member, and wherein the disrupting comprises disrupting the sleeve lengthwise along a length of the sleeve, wherein the disrupting comprises cutting, or wherein the disrupting is other than by cutting, as taught by Duffy et al. to provide a capture sleeve for compressing and placing the prosthesis over the prosthesis retainer prior to removal.
Conclusion
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/CHRISTINA C LAUER/Examiner, Art Unit 3771