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 Amendment
Claims 1-20 are pending in the application. Claims 17-20 have been withdrawn from consideration. Claims 1 and 8 have been amended.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Greenberg (US 2008/0039881 A1).
Regarding claim 1, Greenberg discloses (Figures 1, 2, 12-19) a device for tissue resection from within a body, the device comprising: an elongate body (210) defining a cavity therein; a sheath (see Figure 15 annotated below) extendable from or retractable into the cavity of said elongate body (210); and a tissue retractor (see Figure 15 annotated below) coupled to said sheath; wherein: said tissue retractor includes a mechanism (232) configured to be expandable radially outwardly from said sheath (Figure 15), and retractable radially inwardly toward said sheath (Figure 16); and said mechanism (232), when in the radially retracted configuration (Figure 16), is configured to capture tissue (118) between said mechanism and said sheath and is axially retractable into the cavity of said elongate body (210) with tissue (118) captured between said mechanism (232) and said sheath to draw the captured tissue into the cavity of said elongate body (Figure 19; paragraphs 0089-0090); and wherein said sheath is capable of advancing said mechanism through selected tissue (106, paragraph 0083) for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue distal from said cavity.
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Regarding claim 5, Greenberg discloses (Figure 19) said sheath is axially retractable toward the cavity of said elongate body (210) to draw the tissue (118) captured between said mechanism (232) and said sheath into the cavity of said elongate body (paragraphs 0089-0090).
Regarding claim 6, Greenberg discloses (Figures 12-19) a tissue resecting device (216; paragraph 0052).
Regarding claim 7, Greenberg discloses (Figures 1 and 3A-3F) that said tissue resecting device (216) comprises a shear proximal edge of a distal cap from which said mechanism (232) extends proximally.
Claims 1, 4-8, and 12-16 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Arevalos et al. (US 2019/0374254 A1) (“Arevalos”).
Regarding claim 1, Arevalos discloses (Figures 74A-74D) a device for tissue resection from within a body, the device comprising: an elongate body (7403) defining a cavity therein; a sheath (see Figure 74C annotated below) extendable from or retractable into the cavity of said elongate body (7403); and a tissue retractor coupled to said sheath; wherein: said tissue retractor includes a mechanism (7401) configured to be expandable radially outwardly from said sheath (Figures 74A and 74C), and retractable radially inwardly toward said sheath (Figures 74B and 74D); and said mechanism (7401), when in the radially retracted configuration (Figure 74D), is configured to capture tissue (7420) between said mechanism and said sheath and is axially retractable into the cavity of said elongate body (7403) with tissue (7420) captured between said mechanism (7401) and said sheath to draw the captured tissue into the cavity of said elongate body (Figure 74D; paragraph 0197); and wherein said sheath is capable of advancing said mechanism through selected tissue (7420) for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue distal from said cavity (Figure 74C).
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Regarding claim 4, Arevalos discloses that said mechanism has a first end (see Figure 74C annotated above) coupled to said sheath and a second end (see Figure 74C annotated above) expandable radially away from said sheath (Figure 74C) and radially retractable toward said sheath (Figure 74D) and positioned to move axially into the cavity of said elongate body (7403) prior to the first end of said mechanism moving into the cavity of said elongate body (paragraph 0197).
Regarding claim 5, Arevalos discloses (Figure 74D) said sheath is axially retractable toward the cavity of said elongate body (7403) to draw the tissue (7420) captured between said mechanism (7401) and said sheath into the cavity of said elongate body (paragraph 0197).
Regarding claim 6, Arevalos discloses a tissue resecting device (paragraph 0197).
Regarding claim 7, Arevalos discloses an expanded cutter which would follow in the next coaxial catheter (paragraph 0197). Arevalos discloses (Figures 15A-15D) that an expanded cutter (1508) expands to provide a shear edge around the cavity of the elongate body (1510; paragraph 0190).
Regarding claim 8, Arevalos discloses (Figures 74A-74D) a system for tissue resection from within a body, said system comprising: a lumen (see Figure 74C annotated below) extendable into a patient, said lumen including one or more working channels for delivering accessories (guidewire) to selected tissue for resection; and a tissue resection device deliverable over said lumen, said tissue resection device comprising: an elongate body (7403) defining a cavity therein; a sheath (see Figure 74C annotated below) extendable from or retractable into the cavity of said elongate body; and a tissue retractor coupled to said sheath and having a mechanism (7401) configured to be expandable radially outwardly (Figures 74A and 74C) from said sheath, and retractable radially inwardly toward said sheath (Figures 74B and 74D); wherein: said mechanism, when in the radially retracted configuration, is configured to capture tissue (7420) between said mechanism and said sheath and is axially retractable into the cavity of said elongate body with tissue captured between said mechanism and said sheath to draw the captured tissue into the cavity of said elongate body (paragraph 0197); and wherein said sheath is configured to advance said mechanism through selected tissue (7420) for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue distal from said cavity (Figure 74C).
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Regarding claim 12, Arevalos discloses that said mechanism has a first end (see Figure 74C annotated above) coupled to said sheath and a second end (see Figure 74C annotated above) expandable radially away from said sheath (Figure 74C) and radially retractable toward said sheath (Figure 74D) and positioned to move axially into the cavity of said elongate body (7403) prior to the first end of said mechanism moving into the cavity of said elongate body (paragraph 0197).
Regarding claim 13, Arevalos discloses (Figure 74D) that said sheath is retractable toward the cavity of said elongate body (7403) to draw the tissue (7420) captured between said mechanism and said sheath into the cavity of said elongate body (paragraph 0197).
Regarding claim 14, Arevalos discloses a tissue resecting device (paragraph 0197).
Regarding claim 15, Arevalos discloses an expanded cutter which would follow in the next coaxial catheter (paragraph 0197). Arevalos discloses (Figures 15A-15D) that an expanded cutter (1508) expands to provide a shear edge around the cavity of the elongate body (1510; paragraph 0190).
Regarding claim 16, Arevalos discloses that an extended portion of the guidewire is pushed through an initial puncture site into the left atrium, followed by the penetrating tip of the first internal coaxial catheter to penetrate an interatrial septum from a right atrium into the left atrium of a heart of a mammal at approximately the fossa ovalis (paragraph 0352). Therefore, Arevalos discloses a tissue penetrating device extendable through said lumen to pierce through the selected tissue for resection before extending said tissue resection device through the selected tissue for resection.
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.
Claims 2, 3, and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Arevalos et al. (US 2019/0374254 A1) (“Arevalos”) in view of Smid et al. (US 6,709,386 B2) (“Smid”).
Regarding claim 2, Arevalos discloses (Figures 74A-74D) said comprises a plurality of arms (tines) extending around said sheath, each arm having a first end and a second end (see Figure 74C annotated above), each arm being extendable radially from a position extending along said sheath to a radially expanded position in which said second end is radially extended away from said sheath (Figures 74A, 74C); paragraph 0190).
However, Arevalos fails to disclose the first end being pivotably coupled with respect to said sheath so that each arm is independently extendable radially from the position extending along said sheath to the radially expanded position in which said second end is radially extended away from said sheath.
Smid teaches (Figure 5) an expansion mechanism comprising a plurality of arms (19a, 19b) extending around a cylindrical bar (6), each arm having a first end and a second end, the first end being pivotably coupled with respect to said bar (at 10) so that each arm is radially extendable from a position extending along said bar to a radially expanded position in which said second end is radially extended away from said bar (Figure 5). Smid teaches that each arm can be actuated individually or in a ganged manner via actuation rods (Column 5, lines 44-52).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the arms disclosed by Arevalos to be pivotably coupled at the first end and independently extendable radially from the sheath, as taught by Smid. This modification would allow actuation of expansion to be in an individual or also in ganged manner (Smid, Column 5, lines 44-52).
Regarding claim 3, Arevalos as modified by Smid teaches that the tines further comprise barbs to engage and stabilize the septum tissue prior to and following engagement with the cutter (Arevalos, paragraph 0004). Therefore, the combined teaching teaches said second ends of said plurality of arms have a tip comprising an anchor configured to be engaged with selected tissue for resection.
Regarding claims 9 and 11, Arevalos discloses (Figures 74A-74B) said mechanism comprises a plurality of arms (tines) extending around said sheath, each arm having a first end and a second end (see Figure 74C annotated above), each arm being extendable from a position extending along said sheath (Figures 74B, 74D) to a radially expanded position (Figures 74A, 74C) in which said second end is radially extended away from said sheath (Figure 15B; paragraph 0190).
However, Arevalos fails to disclose the first end being pivotably coupled with respect to said sheath so that each arm is independently extendable from the position extending along said sheath to the radially expanded position in which said second end is radially extended away from said sheath. Arevalos fails to disclose said mechanism further comprising a distal cap, the first ends of said plurality of arms being pivotably coupled to a hub disposed within said distal cap, said arms being radially outwardly expandable with respect to said distal cap.
Smid teaches (Figure 5) an expansion mechanism comprising a plurality of arms (19a, 19b) extending around a cylindrical bar (6), each arm having a first end and a second end, the first end being pivotably coupled with respect to said bar (at 10) so that each arm is extendable from a position extending along said bar to a radially expanded position in which said second end is radially extended away from said bar (Figure 5). Smid teaches that each arm can be actuated individually or in a ganged manner via actuation rods (Column 5, lines 44-52). Smid teaches said expansion mechanism further comprises a distal cap (15), the first ends of said plurality of arms (19a, 19b) being pivotably coupled to a hub (10) within said distal cap, said arms being radially outwardly expandable with respect to the distal cap.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the mechanism disclosed by Arevalos to comprise a distal cap and a hub, and the arms be pivotably coupled at the first end to the hub and independently extendable from the sheath, as taught by Smid. This modification would allow actuation of expansion to be in an individual or also in ganged manner (Smid, Column 5, lines 44-52).
Regarding claim 10, Arevalos as modified by Smid teaches that the tines further comprise barbs to engage and stabilize the septum tissue prior to and following engagement with the cutter (Arevalos, paragraph 0004). Therefore, the combined teaching teaches said second ends of said plurality of arms have a tip comprising an anchor configured to be engaged with selected tissue for resection.
Response to Arguments
Applicant's arguments filed 4/7/26 have been fully considered but they are not persuasive.
Regarding the rejections citing the Greenberg reference, the Applicant has argued that Greenberg fails to disclose the new claim limitation “said sheath is configured to advance said mechanism through selected tissue for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue distal from the cavity. The Applicant argues that this limitation requires transmural architecture in which the sheath drives the mechanism fully through the selected tissue, such that the mechanism expands on the far (exterior) surface of that tissue. The Applicant argues that Greenberg operates entirely within the vessel lumen and the mechanism of Greenberg does not advance through and beyond a tissue wall to expand on an exterior surface on a distal side from the cavity. The Examiner respectfully disagrees with these arguments for a number of reasons.
First, what the Applicant is arguing, is not actually claimed. The independent claims as amended require “said sheath is configured to advance said mechanism through selected tissue for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue distal from the cavity.” There is no recitation about advancing the mechanism beyond a tissue wall to expand on an exterior surface on a distal side from the cavity. In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which Applicant relies (i.e., advancing the mechanism beyond a tissue wall to expand on an exterior surface on a distal side from the cavity) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Second, the new claim limitation is a functional limitation. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The new claim limitation does not provide any structural limitations that differentiate the claimed apparatus from the Greenberg reference.
Third, Greenberg discloses that the surgeon may advance at least a portion of the first catheter assembly through the cardiac valve (the selected tissue). Thus, the Greenberg reference discloses the structure recited in the claims and would be capable of performing the function claimed.
Regarding the rejection citing the Arevalos reference, the Applicant has similarly argued that the mechanism engages the tissue from within a cardiac chamber and that it does not show a sheath advancing a mechanism through tissue to an exterior surface of a side distal form the device cavity. The Examiner disagrees with these arguments for the same reasons provided above regarding the rejections citing the Greenberg reference. In Arevalos (Figures 74A-74D) the “selected tissue” is the septum (70). Figure 74C shows that the mechanism through selected tissue (the septum 7420) for resection such that said mechanism is expandable radially outwardly from said sheath on a side of the selected tissue (right side of the septum in Figure 74C) distal from said cavity (positioned on the left side of the septum in Figure 74C).
The Applicant has also argued that the Advisory Action mailed 8/28/25 concedes that the fundamental claim architecture is patentably distinct from Arevalos. The Examiner respectfully disagrees. The previous rejections cited a different embodiment of the Arevalos reference. The previous amendments overcame the specific embodiment of the Arevalos reference cited in the previous Office Action. The Advisory Action states that the amendments “appear to overcome the rejections under 35 U.S.C. § 102 and § 103 from the previous Office Action.” The Advisory Action does not state that the amendments overcome the entirety of the disclosure of the Arevalos reference.
For these reasons, the claims as currently written do not distinguish over the prior art of record.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/C.D.K/Examiner, Art Unit 3771
/DIANE D YABUT/Primary Examiner, Art Unit 3771
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