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 II in the reply filed on 12/18/25 is acknowledged.
Claims 1-13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected group, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/18/25. Claims 21-33 are newly added.
Information Disclosure Statement
Applicant should note that the large number of references in the attached IDS have been considered by the examiner in the same manner as other documents in Office search files are considered by the examiner while conducting a search of the prior art in a proper field of search. See MPEP 609.05(b). Applicant is requested to point out any particular references in the IDS which they believe may be of particular relevance to the instant claimed invention in response to this office action.
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) 14-16, 20, 21, 22, 26-28 and 30-33 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. US 7959603 in view of Kohler et al. US 2005/0101903 in view of Brenneman et al. US 2010/0268316.
Regarding claim 14, Wahr et al. discloses a method comprising: delivering a stagnation device 136 and a medical implant 194 to a blood flow pathway of a heart (column 1, lines 17-23, coronary vessels of the heart) via a sheath 160 (figures 6A-6F); delivering the medical implant 194 beyond the sheath and proximate to a tissue wall of the heart (delivered beyond the sheath 160 within the coronary vessels, figure 6H); injecting a contrast solution into the blood flow pathway (for example, column 3, lines 27-37, column 13, lines 23-34, column 8, lines 29-33).
Wahr et al. discloses expansion once distal of the sheath 160 (figure 6C) at least partial inhibition of blood flow within the blood flow pathway (with sealing balloon 136 to stop blood flow, figure 6C) and compression of the stagnation device (deflated for removal and establishing normal flow, figure 6I, column 14, lines 55-59), but fails to disclose retracting the sheath to cause expansion of the stagnation device; and extending the sheath to compress the stagnation device.
Kohler et al. teaches a method for delivering a self-expanding stagnation device 102 and an implant 30 via a sheath 108 in the coronary vessel 38 and heart wall tissue 32 (figure 11), providing the stagnation device to be collapsed within the outer sheath and retracting the sheath to cause expansion of the stagnation device, without additional influence, when the sheath is retracted (paragraphs 0014, 0035, sheath is retracted permit basket to expand), exposing the stagnation device causes the stagnation device to expand (self-expanding basket, paragraph 0003).
Brenneman et al. discloses a method for delivering a stagnation device 30 and an implant 8 into the heart (paragraphs 0075, 0146) via a sheath 24 (figure 10), retracting the sheath to cause expansion of the implant (paragraph 0104) and extending the sheath to compress the stagnation device (paragraph 0105, one or more members may be recaptured at least partially re-sheathed to allow for removal or repositioning).
Therefore, it would have been obvious to one having ordinary skill in the art to retract the sheath to allow for expansion of the stagnation device, as taught by Kohler et al., to allow for expansion without additional influence, and to re-sheath and collapse the stagnation device, as taught by Brenneman et al. as known method to remove or reposition an expandable member within a procedure.
Regarding claim 15, Wahr et al. further comprising extending an actuating rod 193 to attach the medical implant to the tissue wall (figure 6E), wherein the actuating rod is attached to the medical implant 194 while the contrast solution is injected into the blood flow pathway (column 3, lines 27-37; injecting contrast dye while blood flow is stopped, figure 6C, delivery rod 193 still attached).
Regarding claim 16, Wahr et al. discloses further comprising detaching the actuating rod from the medical implant following injection of the contrast solution (column 3, lines 27-37, contrast solution is injected when flow is stopped, once positioned stent is expanded against the vessel wall and the stent is deployed by the delivery balloon from the delivery system 193, and flow is reestablished).
Regarding claim 20, Wahr et al. discloses wherein the stagnation device comprises an inflatable balloon (sealing balloon 136).
Regarding claims 21, 27, 28, 30 and 33, Wahr et al. discloses a method of delivering one or more implants comprising: delivering a stagnation device 136 and a medical implant 194 to a blood flow pathway of a heart (column 1, lines 17-23, coronary vessels of the heart) via an outer sheath 160 (figures 6A-6F); further comprising delivering an inner sheath 100 via the outer sheath (figure 6B, evacuation sheath assembly 100) the stagnation device extends from an outer surface of the inner sheath (figure 6C, stagnation device 136 on exterior of sheath 100), delivering the medical implant 194 beyond the sheath and proximate to a tissue wall of the heart (delivered beyond the sheath 160 within the coronary vessels, figure 6H); anchoring the medical implant (anchored by expanding delivery balloon against the vessel wall (column 14, lines 27-29), extending an actuating rod 193 to anchor the medical implant to the proximal portion (figure 6E), wherein the actuating rod is attached to the medical implant 194 following anchoring of the medical implant (prior to releasing stent from rod 193 delivery balloon will anchor the stent by expansion at both a proximal and distal end, Examiner notes the method of anchoring is not claimed, and may be interpreted broadly such as expanding the stent along the vessel wall to anchor within), injecting a contrast solution into the blood flow pathway (for example, column 3, lines 27-37, column 13, lines 23-34, column 8, lines 29-33), detaching the actuating rod from the medical implant (balloon is deflated and removed with rod 193, column 14, lines 34-36).
Wahr et al. discloses expansion once distal of the sheath 160 (figure 6C) at least partial inhibition of blood flow within the blood flow pathway (with sealing balloon 136 to stop blood flow, figure 6C) and compression of the stagnation device (deflated for removal and establishing normal flow, figure 6I, column 14, lines 55-59), but fails to disclose delivering the implant through an opening in a tissue of the heart and anchoring to a distal side or proximal side of the tissue wall, retracting the sheath to at least partially expose the stagnation device and cause at least partial inhibition of blood flow within the blood flow pathway; and extending the sheath to compress the stagnation device.
Kohler et al. teaches a method for delivering a self-expanding stagnation device 102 and an implant 30 via a sheath 108 in the coronary artery and through an opening in a tissue of the heart (figure 11, through heart wall 32 and extending into the vessel 38) and being anchored at a proximal end (within heart tissue 32) and distal end (within vessel 38), providing the stagnation device to be collapsed within the outer sheath and retracting the sheath to cause expansion of the stagnation device, without additional influence, when the sheath is retracted (paragraphs 0014, 0035, sheath is retracted permit basket to expand), exposing the stagnation device causes the stagnation device to expand (self-expanding basket, paragraph 0003).
Brenneman et al. discloses a method for delivering a stagnation device 30 and delivering an implant 8 through an opening in a tissue of the heart (paragraphs 0075, 0146, through walls of the aorta and vena cava, 31, 32) via a sheath 24 (figure 10), anchoring the medical implant to a distal side of the tissue wall (figures 7-8, anchored to 32), extending an actuating rod (shaft 25, paragraph 0074) to anchor the medical implant to a proximal side of the tissue wall and maintain contact with the medical implant following anchoring of the medical implant (anchoring to side 31, paragraph 0074-0077, distal and proximal clinch members are released while shaft 25 is extended and connected to implant 30, proximal clinch members may be released after expansion of the central section and distal clinch members, figures 7-10) the stagnation device expanding once exposed from the sheath (figure 10) and retracting the sheath to cause expansion of the implant (paragraph 0104) and extending the sheath to compress the stagnation device (paragraph 0105, one or more members may be recaptured at least partially re-sheathed to allow for removal or repositioning).
Therefore, it would have been obvious to one having ordinary skill in the art to retract the sheath to allow for expansion of the stagnation device, as taught by Kohler et al., to allow for expansion without additional influence, and delivering the implant through an opening in a tissue of the heart and anchoring to a distal side or proximal side of the tissue wall or to re-sheath and collapse the stagnation device, as taught by Brenneman et al. as known method for placing and anchoring a proximal and distal end of an implant on a proximal and distal side of tissue within the heart to provide a passageway therethrough, or to remove or reposition an expandable member within a procedure as necessary.
Regarding claim 22, Wahr et al. discloses further comprising detaching the actuating rod from the medical implant following injection of the contrast solution (column 3, lines 27-37, contrast solution is injected when flow is stopped, once positioned stent is expanded against the vessel wall and the stent is deployed by the delivery balloon from the delivery system 193, and flow is reestablished).
Regarding claim 26, Wahr et al. discloses wherein the stagnation device comprises an inflatable balloon (sealing balloon 136).
Regarding claim 31, Wahr et al. further comprising extending an actuating rod 193 to attach the medical implant to the tissue wall (figure 6E), wherein the actuating rod is attached to the medical implant 194 while the contrast solution is injected into the blood flow pathway (column 3, lines 27-37; injecting contrast dye while blood flow is stopped, figure 6C, delivery rod 193 still attached).
Regarding claim 32, Wahr et al. discloses further comprising detaching the actuating rod from the medical implant following injection of the contrast solution (column 3, lines 27-37, contrast solution is injected when flow is stopped, once positioned stent is expanded against the vessel wall and the stent is deployed by the delivery balloon from the delivery system 193, and flow is reestablished).
Claim(s) 17-19 and 23-25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. US 7959603 in view of Kohler et al. US 2005/0101903 in view of Brenneman et al. US 2010/0268316, and further in view of Gilson et al. US 2002/0002384.
Regarding claims 17-19 and 23-25, Wahr et al. discloses the method essentially as claimed as discussed above, but fails to disclose the stagnation device comprising a network of wires, wherein the stagnation device comprises a covering extending between the wires, wherein the covering is porous.
Gilson et al. teaches a method for occluding a bloodflow pathway comprising a stagnation device that may be expanded from a delivery sheath for deployment into a target vessel, the stagnation device comprising a network of wires 30 (figures 11-15), wherein the stagnation device comprises a covering 31 extending between the wires (figures 11-15), wherein the covering is porous (paragraph 0141, covering may be a porous fabric or mesh).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to modify Wahr et al. with a stagnation device comprising a network of wires and a porous covering to be delivered and expanded from within a sheath, as taught by Gilson et al, as a known substitute in the art to provide a collapsable and expandable arrangement to form an occluding screen allowing for controlled porosity.
Claim(s) 29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wahr et al. US 7959603 in view of Kohler et al. US 2005/0101903 in view of Brenneman et al. US 2010/0268316, and further in view of Hart et al. US 6183492.
Regarding claim 29, Wahr et al. in combination discloses the method essentially as claimed as discussed above, but fails to disclose the stagnation device being a tubular sheath having one or more expandable petals at and end portion of the tubular sheath.
Hart et al. teaches a stagnation device comprising a tubular sheath having one or more expandable petals at and end portion of the tubular sheath (figure 19, tubular sheath or sleeve 511 comprising a plurality of fingers or petals 525 at an end portion of the tubular sheath) to move from a low profile to an expanded profile (figures 18, 19, column 6, lines 26-43). It would have been an obvious matter of design choice to modify the Wahr et al., to have a stagnation device comprising a tubular sheath having one or more expandable petals at and end portion of the tubular sheath, since applicant has not disclosed that having this shape solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with either designs that have a collapsed or expanded configuration to be deployed with a sheath.
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
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