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 .
Election/Restrictions
Applicant’s election without traverse of Group III: claims 17-20 in the reply filed on 5/1/26 is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 17 recites “the stabilization device including an outer surface and an opening within the outer surface between a distal end and a proximal end of the stabilization device” and “directing the implant out of the opening” but there is no particular structure defining the stabilization or exactly how the implant is arranged on the catheter such that it is permitted to be released out from the stabilization device.
Dependent claims do not provide any further clarifying limitations to establish a clear understanding of how the stabilization device is cooperatively arranged on the outer catheter when the implant was recited on the inner catheter in claim 17.
Claim 29 recites the limitation "the valve" in line 1 of the claim. There is insufficient antecedent basis for this limitation in the claim. It makes no sense that the valve recited in claim 17 (natural valve annulus) is to be sheathed. Thus, is the implant a valve prosthesis?
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.
Claim(s) 17-19,21-27,29 are rejected under 35 U.S.C. 103 as being unpatentable over Jenson et al. (2015/0238729) in view of Valdez et al. (WO 2021/096766). Jenson et al. disclose (paragraph 29) a method comprising: providing a system including a delivery device having an outer catheter and an inner catheter (paragraph 74) supporting an implant, paragraph 36. Fig. 1B shows the delivery device 10 further having a stabilization device 26 positioned at least partially over the outer catheter 32. Please note claims are given their broadest reasonable interpretation, of which stabilization element 26 has openings as seen in Fig. 1B. However, further it can be said in giving the broadest reasonable interpretation, the stabilization device includes elements (40,26,28) of which has an outer surface and an opening 22 within the outer surface between a distal end and a proximal end of the stabilization device. Jenson et al. further disclose delivering the delivery device to an atrium of a heart (paragraph 36) such that the stabilization device 26 engages an inferior vena cava (paragraph 63). Jenson et al. does disclose directing the implant (paragraph 37) to a valve annulus such that deployment of the implant is into the valve annulus. However, Jenson did not explicitly state the implant is directed out the opening to deliver to the annulus. Valdez et al. teach (paragraph 13) that a medical implant catheter can be passed through a side opening 214 of a stabilization device 200 to place an implant at a target site, see Figs. 14,15. It would have been obvious to one of ordinary skill in the art to utilize the side opening in the stabilization device and pass the implant out the stabilization device side opening as taught by Valdez et al. with the method of treating a heart and placement at an annulus the implant such that one can easily access the location via the path enabled by the delivery system. Regarding claim 18, as best understood and giving the broadest reasonable interpretation, Jenson shows (Fig. 2A) the stabilization device includes a first support on the outer surface, the first support 26 having a delivery arrangement and an expanded arrangement; further wherein a maximum outer diameter of the first support is greater in the expanded arrangement as compared to the delivery arrangement (paragraph 57); further wherein the first support is transitioned to the delivery arrangement at the inferior vena cava. Regarding claim 19, as mentioned already claims are given their broadest reasonable interpretation and it can be construed in Fig. 2A of Jenson there is a distal end (of the stabilization element 26) secured to the outer catheter and a portion of the proximal end extends away from the outer catheter to engage the inferior vena cava 52. With respect to claim 21, again broadest reasonable interpretation is being given to the claim and with no boundaries in the claim to define exact structural parameters or specific location, it can be construed Fig. 3A of Jenson shows the stabilization device with multiple elements or portions defining the structure that during the step of delivering the delivery device, the stabilization device element 40 further engages a superior vena cava 50. Per the modification with Valdez, it is noted that Jenson discloses (paragraph 83) the implant can be a valve device (replacement). Additionally Valdez teaches (paragraph 72) that a sheath or capsule covers an implant device. Regarding claim 22, Jenson discloses (paragraph 23) the first support is an inflatable balloon. Regarding claim 23, Jenson discloses (paragraph 23) the first support is made of mesh (stents, braided structure and see mesh form bulge in figures). Regarding claim 24, Jenson discloses (paragraph 58) the first support is biased to the expanded arrangement. Regarding claim 25, Jenson discloses (paragraph 58) the first support connected to an actuation shaft configured to transition the first support from the delivery arrangement to the expanded arrangement. Please note the claim 26 uses relative terminology “proximal” and Jenson shows Fig. 1B the first support 26 is positioned proximal to the opening 22. With respect to claim 27, Jenson shows (Fig. 1B) a second support 40 positioned on the outer surface distal to the opening (paragraph 61); wherein the second support has a compressed arrangement and an expanded arrangement (see Fig. 5E and paragraph 51 stating the support expands which thus is also compressed and can be on a catheter rod); wherein the second support has a greater outer diameter in the expanded arrangement as compared to the compressed arrangement. Regarding claim 29, Jenson et al. disclose (paragraph 59) a capsule or sheath is sheathing the valve (paragraph 36) during the step of delivering.
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson et al. (2015/0238729) in view of Valdez et al. (WO 2021/096766) as applied to claim 17 above, and further in view of Zhao et al. (WO 2020/046979). Jenson et al. in view of Valdez et al. is explained supra. However, Jenson et al. in view of Valdez et al. did not explicitly disclose one of the distal end and proximal ends of the stabilization device is fixed to the outer catheter and another of the distal and proximal ends is movable with respect to the distal end; the stabilization device configured to transition from a delivery arrangement in which the stabilization device is positioned against the outer catheter to a deployed arrangement in which the stabilization device bulges outwardly with respect to the outer catheter to engage the inferior vena cava. Zhao et al. teach (fig. 16) that one of the distal end 29a and proximal ends 29b of the stabilization device is fixed to the outer catheter and another of the distal and proximal ends is movable with respect to the distal end, see paragraph 127. Jenson shows (Fig. 3A) that the stabilization device 26 is positioned against the outer catheter 28 to a deployed arrangement in which the stabilization device bulges outwardly with respect to the outer catheter to engage the inferior vena cava 52. It would have been obvious to one of ordinary skill in the art to provide one of the distal end and proximal ends of the stabilization device is fixed to the outer catheter and another of the distal and proximal ends is movable with respect to the distal end per the teaching of Zhao et al. in the method of treating a heart in which the stabilization device configured to transition from a delivery arrangement in which the stabilization device is positioned against the outer catheter to a deployed arrangement in which the stabilization device bulges outwardly with respect to the outer catheter to engage the inferior vena cava per Jenson and also modified with Valdez such that it allows adjustability in location placement to meet the anatomy of the patient.
Claim(s) 28 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson et al. (2015/0238729) in view of Valdez et al. (WO 2021/096766) as applied to claim 17 above, and further in view of Kapadia (WO 2013/016618). Jenson et al. in view of Valdez et al. is explained supra. However, Jenson et al. in view of Valdez et al. did not explicitly disclose the stabilization device receives a guide wire that is anchored to a subclavian vein. Kapadia teaches (paragraphs 19,44) that the atrium, superior vena cava, and the subclavian vein communicate such that a guidewire can be passed through these vessels unimpeded. It would have been obvious to one of ordinary skill in the art to pass the guide wire into the subclavian vein per the teaching of Kapadia in the method of treating a heart in which a guidewire is passed out the side opening of the delivery device of Jenson and also modified with Valdez such that it prevents any unwanted reverse movement and the anchoring in the subclavian vein would stabilize it.
Claim(s) 30 is rejected under 35 U.S.C. 103 as being unpatentable over Jenson et al. (2015/0238729) in view of Valdez et al. (WO 2021/096766) as applied to claim 29 above, and further in view of Hanson (6432130). Jenson et al. in view of Valdez et al. is explained supra. However, Jenson et al. in view of Valdez et al. did not explicitly disclose the capsule includes a distal portion and a proximal portion, wherein the distal portion and the proximal portion are configured to separate to release the implant. Hanson teaches (Fig. 4) a capsule or sleeve 30 including a distal portion 60 and a proximal portion 62, wherein the distal portion and the proximal portion are configured to separate to release the implant, see claim 13. It would have been obvious to one of ordinary skill in the art to utilize a capsule that separates into a proximal and distal portion as taught by Hanson in the method of delivering an implant to the heart by Jenson as modified with Valdez such that it exposes the implant and does not impede the expansion in the area needed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN E PELLEGRINO whose telephone number is (571)272-4756. The examiner can normally be reached 8:30am-5:00pm M-F.
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/BRIAN E PELLEGRINO/Primary Examiner, Art Unit 3799
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