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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 33 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 33 discloses “whereupon the pushing arms impart a compressive force onto the prosthetic valve medical device to cause advancement thereof through the passageway, during which tension is applied to a portion of the prosthetic valve medical device”. However, paragraph 0072 of the instant specification discloses the pushing arms applying a compressive force onto the medical device or by an application of tension, but does not disclose the application of tension during or in addition to the compressive force, but is disclosed as either a compressive force or a tension being applied.
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 21-25, 29, 30-33, 37, 38, 39, 40, 44, 45 and 46 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.
Regarding claim 21-25, 29, 37, 38, 39, 40, 44 and 45 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: providing a delivery catheter (paragraph 0005, 0018, figure 1) including an outer tubular member 60 and a distal tip member (figure 1), the outer tubular member defining a sheath lumen extending to a sheath opening (figure 1, lumen within 60 and opening for receiving distal tip member), the distal tip member comprising an elongate cannula 50 and a distal tip body 40; providing a loading apparatus including a body 30 defining a passageway extending from a first opening to a second opening (figure 2), the passageway including a first chamber 32, a second, transition chamber 35, and a third chamber 38, the transition chamber located between the first chamber and the third chamber (figure 2), the first chamber having a first chamber axial length and a first chamber maximum inner diameter (figure 2), the third chamber having a third chamber axial length and a third chamber maximum inner diameter (figure 2), wherein the first chamber maximum inner diameter is larger than the third chamber maximum inner diameter (figure 2, tapers from larger diameter in distal end 32 to smaller diameter in proximal end 38), the transition chamber having a transition chamber axial length and a transition chamber inner diameter that decreases over the transition chamber axial length in a direction from the first chamber to the third chamber (figure 2); introducing the prosthetic medical device into the first chamber (figure 3, medical device 20); positioning the distal tip member of the delivery catheter through the prosthetic valve medical device with the elongate cannula of the distal tip member extending through the prosthetic valve medical device (figure 3, cannula 50 extends through); first transitioning the prosthetic medical device to a radially-compressed first configuration (figure 3, starts within portion 32), the first transitioning including moving the prosthetic medical device along passageway surfaces of the transition chamber of the loading apparatus (although not shown, prosthetic medical device moves from the first chamber 32 into the transition chamber 35, paragraph 0027, 34), after the first transitioning, second transitioning the prosthetic medical device to a radially compressed second configuration that differs from the radially compressed first configuration (figure 4, paragraph 0036, prosthetic transitions into the third chamber), the second transitioning including moving the prosthetic valve medical device along passageway surfaces of the third chamber of the loading apparatus (paragraph 0036); after the second transitioning, disposing a first end of the prosthetic valve medical device 20 into the sheath opening (extend within opening of 60) and into and along the sheath lumen (paragraph 0036); and after the disposing, disrupting the loading apparatus (paragraph 0029, , loading apparatus may be formed of separate elements such as being split or hinged) after the disrupting, removing the loading apparatus from the position surrounding the elongate cannula of the distal tip member (paragraph 0029, 0041, loading apparatus body 30 removed from assembly), wherein the loading apparatus includes a sleeve.
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.
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 the 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.
Regarding claim 30-33, and 46, Leanna et al. discloses the device essentially as disclosed as discussed above wherein tension is applied to a portion of the prosthetic valve medical device (sutures 92, 98 configured to apply tension to the stent, figure 3, paragraph 0031), but fails to disclose wherein the first transitioning and second transitioning comprise pushing the prosthetic valve medical device axially along the transition chamber and the third chamber, wherein the pushing comprises pushing on the prosthetic valve medical device with a plurality of pushing arms of a pusher, the pushing arms extending into the passageway and contacting the prosthetic valve medical device, wherein the pushing arms contact an intermediate portion of the prosthetic valve medical device occurring between the first end of the prosthetic valve medical device and a second end of the prosthetic valve medical device, wherein the pushing comprises moving the pusher axially relative to the body, whereupon the pushing arms impart a compressive force onto the prosthetic valve medical device to cause advancement thereof through the passageway, during which tension is applied to a portion of the prosthetic valve medical device, also comprising a pusher having a plurality of pushing arms extendable into the passageway to contact the prosthetic valve medical device.
However, Gabbay teaches wherein the first transitioning and second transitioning comprise pushing the prosthetic valve medical device 59 axially along the transition chamber and the third chamber (figures 4-7, prosthetic pushed into tapered chamber from a first to third chamber portion), 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), the pushing arms extending into the passageway and contacting the prosthetic valve medical device (figure 5, 7, paragraph 0043, engage with prosthesis 59), wherein the pushing arms contact an intermediate portion of the prosthetic valve medical device occurring between the first end of the prosthetic valve medical device and a second end of the prosthetic valve medical device (arms contact the prosthesis, paragraph 0042, 0043, may be manually deflected inward for contacting an intermediate portion of the prosthesis, additionally or alternatively, the arms may be considered to contact the intermediate portion of the stent even if indirectly to push the prosthetic device), wherein the pushing comprises moving the pusher axially relative to the body (figures 4-7, in direction of arrow), whereupon the pushing arms impart a compressive force onto the prosthetic valve medical device to cause advancement thereof through the passageway (for example, figure 7, compressed into the smaller chamber 26, figure 3), also comprising a pusher having a plurality of pushing arms 104, 106 extendable into the passageway (within guide 12, figures 3, 7) to contact the prosthetic valve medical device (figures 6, 7)
Regarding claim 34, Leanna et al. in combination discloses wherein the sheath opening has a diameter (opening at end of 60, figure 3), the method also comprising further compressing a lead-in portion of the prosthetic valve medical device to a diameter less than the diameter of the sheath opening with a segment of the passageway surfaces of the third chamber (figure 4, prosthesis 20 is compressed into the chamber 30 and into the sheath 60).
Claims 25-27, 41 and 42 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 as discussed above, and further in view of Duffy et al. US 2011/0208296.
Regarding claims 25-27, 41 and 42 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.
Regarding claims 35, 36, 47 and 48, 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 having a first end defining a first end opening, a second end defining a second end opening, and a sleeve passageway between the first end opening and the second end opening, the sleeve passageway providing the passageway surfaces of the third chamber for compressing the prosthetic valve medical device, and wherein the segment of the passageway surfaces is proximate the second end opening of the sleeve, wherein the sheath opening is not within the sleeve passageway during the disposing, wherein the loading apparatus includes a sleeve having a first end defining a first end opening, a second end defining a second end opening, and a sleeve passageway between the first end opening and the second end opening, the sleeve passageway providing passageway surfaces of the third chamber for compressing the prosthetic valve medical device, wherein the sheath opening has a diameter, and wherein the sleeve has a segment proximate the second end opening of the sleeve configured to further compress a lead-in portion of the prosthetic valve medical device to a diameter less than the diameter of the sheath opening.
Duffy et al. teaches wherein the loading apparatus includes a sleeve 1602 having a first end defining a first end opening, a second end defining a second end opening (figure 16, each end of 1602, opening for 132 to be placed within lumen), and a sleeve passageway between the first end opening and the second end opening (for receiving shaft 132, figure 16), the sleeve passageway providing the passageway surfaces of the third chamber for compressing the prosthetic valve medical device (figure 16, sleeve placed around prosthesis for being compressed within funnel 302), and wherein the segment of the passageway surfaces is proximate the second end opening of the sleeve (figure 16, located proximate as they are within the same device), wherein the sheath opening is not within the sleeve passageway during the disposing (figure 16, at least partially not within the sleeve during this step), wherein the sheath opening has a diameter, and wherein the sleeve has a segment proximate the second end opening of the sleeve configured to further compress a lead-in portion of the prosthetic valve medical device to a diameter less than the diameter of the sheath opening (lead-in portion proximate the funnel 302 configured to compress the prosthetic when transitioned).
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 having a first end defining a first end opening, a second end defining a second end opening, and a sleeve passageway between the first end opening and the second end opening, the sleeve passageway providing the passageway surfaces of the third chamber for compressing the prosthetic valve medical device, and wherein the segment of the passageway surfaces is proximate the second end opening of the sleeve, wherein the sheath opening is not within the sleeve passageway during the disposing, wherein the sheath opening has a diameter, and wherein the sleeve has a segment proximate the second end opening of the sleeve configured to further compress a lead-in portion of the prosthetic valve medical device to a diameter less than the diameter of the sheath opening, as taught by Duffy et al. to provide a capture sleeve for maintaining or protecting the prosthesis within the funnel during transition or compression of the prosthesis.
Claim 28 and 43 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 Morales US 5893852.
Regarding claim 28, Leanna et al. in combination discloses a system and method essentially as claimed as discussed above, but fails to further comprise positioning a stiffening mandrel in the elongate cannula so as to provide column strength to support the elongate cannula against compressive forces,
the stiffening mandrel slidably receivable in the elongate cannula so as to provide column strength to support the elongate cannula against compressive forces.
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, the stiffening mandrel slidably receivable 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTINA C LAUER whose telephone number is (571)270-5418. The examiner can normally be reached Monday-Thursday 7:00 AM-4:00 PM.
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/CHRISTINA C LAUER/Examiner, Art Unit 3771