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 Arguments
The previous objection of claims 3, 9, 11, 15 and 17-19 due to minor informalities has been withdrawn in light of applicant’s amendments made 1/16/2026.
Applicant’s arguments with respect to claim(s) 1-14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Scott et al. (US 2022/0273363 A1) is now relied upon for claims 1-14.
Applicant's arguments filed 1/16/2026 with respect to claim 15 have been fully considered but they are not persuasive. Applicant argues expandable members 54 do not inherently function as mechanical cutting blades as they require external ultrasonic energy to perform any cutting function. However, at least the first cutting blade (cutting tip 52) of the mechanical tissue-cutting assembly of Mueller is inherently a mechanical cutting blade as cutting tip 52 cuts or slices (column 10, lines 61-67) due to a sharp tip (Figs. 1, 4). Thus, Mueller discloses a mechanical tissue-cutting assembly and additional cutting blades would not necessarily need to be sharp to meet the claimed limitation because the cutting tip 52 itself makes the tissue-cutting assembly “mechanical”. Further, the expandable members 54 are also considered part of a mechanical tissue-cutting assembly as expandable members 54 are cutting blades because they allow for selective abrasion (column 11, lines 21-27) and the expandable members 54 do not need to emit energy in order to cut tissue. For example, the selective abrasion may be accomplished by ultrasonic means and ultrasonic means involves mechanically vibrating a blade to cut tissue i.e., a mechanical force. Applicant defines a mechanical tissue-cutting assembly as a blade, a cutting tip, and any equivalent thereof, etc. which may be substituted for an energy-emitting assembly 106, which selectively emits energy ([0027]). It is the examiner’s position that the ultrasonic blades 54 of Mueller do not emit energy on tissue to perform the action of cutting, they vibrate which is a mechanical force to perform cutting. Weitzner et al. (US 2018/0206864 A1) is also provided as an alternative even if the examiners arguments are not found persuasive.
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 3 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 3 recites, “the at least one mechanical tissue cutting device of the mechanical tissue-cutting assembly is configured to dilate a puncture hole formed through a biological wall”. Claim 3 depends from claim 1 which recites “at least one mechanical tissue cutting device positioned at the distal section of the expandable-and-collapsible support structure”. In other words, the sharp tip 300A, which is positioned at the distal section of the expandable-and-collapsible support structure (Figs. 1A, 3-4) creates the puncture. However, the sharp tip 300A does not dilate the puncture. Instead, devices 300B, 300C which are positioned at the proximal section of the expandable-and-collapsible support structure are configured to dilate the puncture hole and create a larger hole ([0024]; Fig. 6). Thus, applicant fails to provide support for the at least one mechanical tissue cutting device positioned at the distal section of the expandable-and-collapsible support structure configured to dilate a puncture hole as required by claim 3.
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 6-8 and 15-20 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.
Claims 6-7 recite “an expanded state” in line 3, respectively. It is unclear if this is the same or in addition to the “expanded state” recited in claim 1. For the purposes of examination, the limitation has been interpreted to read “the expanded state”.
Claim 8 recites “a distal section” in line 3. It is unclear if this is the same or in addition to the “distal section” recited in claim 1. For the purposes of examination, the limitation has been interpreted to read “the distal section”.
Claim 15 recites the limitation "the puncture" in line 12 and “the puncture hole” in lines 16-17. There is insufficient antecedent basis for these limitations in the claim.
Claims 16-20 are rejected based on their dependency on rejected claim 15.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 1-2 and 4-14 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Scott et al. (US 2022/0273363 A1).
Regarding claim 1, Scott discloses an apparatus (medical system 10; Fig. 1), comprising: an elongated medical sheath (shaft 20) comprising a distal end (distal end of 20) configured to be movable and positionable proximate to a biological feature (target tissue 70) of a patient (Figs. 2A-2C); and an expandable-and-collapsible support structure (end effector 30; Fig. 1) comprising a distal section (at probe tip 30a) and a proximal section (at expandable elements 38a, 38b) and configured to be selectively movable, at least in part, between a collapsed state (Fig. 2A) within an interior of the elongated medical sheath (20) when the distal end of the elongated medical sheath is advanced through a puncture of the biological feature of the patient (Fig. 2A) and an expanded state (Figs. 1, 2C) at an exterior of the elongated medical sheath (20) when the distal end of the elongated medical sheath is past the puncture of the biological feature of the patient (Fig. 2C); and a mechanical tissue-cutting assembly (probe tip 30a) being supported by the expandable-and-collapsible support structure (30; Fig. 1) and comprising at least one mechanical tissue cutting device (sharp distalmost surface of 30a; [0056]) positioned at the distal section of the expandable-and-collapsible support structure (30; Fig. 1) and being configured to create the puncture of the biological feature of the patient while the expandable-and-collapsible support structure is in the collapsed state (Fig. 2A).
Regarding claim 2, Scott discloses wherein: the at least one mechanical tissue cutting device (sharp distalmost surface of 30a) of the mechanical tissue-cutting assembly (30a) is configured to form a puncture hole through a biological wall (Fig. 2A).
Regarding claim 4, Scott discloses wherein the at least one mechanical tissue cutting device (sharp distalmost surface of 30a) comprises one or more sharp tips ([0056]).
Regarding claim 5, Scott discloses wherein the at least one mechanical tissue cutting device (sharp distalmost surface of 30a) comprises one or more cutting blades ([0056]).
Regarding claim 6, Scott discloses wherein: the expandable-and-collapsible support structure (30), once deployed from the interior of the elongated medical sheath (20), forms a tear drop shape in the expanded state (Fig. 1).
Regarding claim 7, Scott discloses wherein: the expandable-and-collapsible support structure (30) once deployed from the interior of the elongated medical sheath (20), forms a tapered proximal section in an expanded state (Fig. 1).
Regarding claim 8, Scott discloses wherein: the expandable-and-collapsible support structure (30), once deployed from the interior of the elongated medical sheath (20), is configured to expand radially at a distal section (Fig. 1).
Regarding claim 9, Scott discloses an apparatus (medical system 10; Fig. 1), comprising: an elongated medical sheath (shaft 20) comprising a distal end (distal end of 20) configured to be movable and positionable proximate to a biological feature (target tissue 70) of a patient (Fig. 2A); and an expandable-and-collapsible support structure (end effector 30) configured to be selectively movable, at least in part, between a collapsed state (Fig. 2A) within an interior of the elongated medical sheath (20) when the distal end of the elongated medical sheath is advanced through a puncture of the biological feature of the patient (Fig. 2A) and an expanded state (Figs. 1, 2C) at an exterior of the elongated medical sheath when the distal end of the elongated medical sheath is past the puncture of the biological feature of the patient (Fig. 2C), the expandable-and-collapsible support structure (30) including an expandable-and-collapsible cage structure (cage structure of 30; Fig. 1) having a distal section (at probe tip 30a) and a proximal section (at expandable elements 38a, 38b); and a mechanical tissue-cutting assembly (probe tip 30a) being supported by the expandable-and-collapsible support structure (Fig. 1), the mechanical tissue-cutting assembly includes: at least one sharp tip (sharp distalmost surface of 30a; [0056]) being positioned at the distal section of the expandable-and-collapsible cage structure (Fig. 1) and being configured to create the puncture of the biological feature of the patient while the expandable-and-collapsible cage structure is in a collapsed state (Fig. 2A).
Regarding claim 10, Scott discloses wherein the mechanical tissue-cutting assembly comprises at least one cutting blade (as expandable elements 38a, 38b are cutting blades as the ablate tissue; [0064]) positioned at the proximal section of the expandable-and-collapsible cage structure (cage structure of 30; Fig. 1). It is noted that “machinal tissue-cutting assembly” portion of the claim is met by the sharp tip 30a of Scott.
Regarding claim 11, Scott discloses wherein the at least one cutting blade (38a, 38b) is configured to dilate a puncture hole while the expandable-and-collapsible cage structure is in an expanded state (as the medical system 10 may be moved proximally by a user while elements 38a, 38b are ablating tissue).
Regarding claim 12, Scott discloses wherein: the expandable-and-collapsible cage structure (cage structure of 30), once deployed, forms a tear drop shape in an expanded state (Fig. 1).
Regarding claim 13, Scott discloses wherein: the expandable-and-collapsible cage structure (cage structure of 30), once deployed, forms a tapered proximal section in an expanded state (Fig. 1).
Regarding claim 14, Scott discloses wherein: the expandable-and-collapsible cage structure (cage structure of 30), once deployed, is configured to expand radially at the distal section of the expandable-and-collapsible cage structure (Fig. 1).
Claim(s) 15-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mueller (US 6,565,528 B1).
Regarding claim 15, Mueller discloses an apparatus (catheter assembly 12; Fig. 1), comprising: an elongated medical sheath (catheter accessing device 16) configured to be movable and positionable proximate to a biological feature of a patient (as catheter device 16 is steerable; column 6, lines 44-49); and an expandable-and-collapsible support structure (implement 48) configured to be selectively movable, at least in part, between a collapsed state (Fig. 1) within an interior of the elongated medical sheath and an expanded state (Fig. 4) at an exterior of the elongated medical sheath, the expandable-and-collapsible support structure including an expandable-and-collapsible cage structure (cage structure formed by 52, 54) having a distal section and a proximal section (Figs. 1, 4); and a mechanical tissue-cutting assembly (tip 52 and/or expandable members 54) being supported by the expandable-and-collapsible support structure, the mechanical tissue-cutting assembly includes: a first cutting blade (cutting tip 52) at the distal section of the expandable-and-collapsible cage structure and being configured to create a puncture of the biological feature of the patient (Fig. 4) while the expandable-and-collapsible cage structure is in a collapsed state (as the cutting tip 52 may extend out of the catheter accessing device 16 to an adjustable depth, i.e., wherein expandable members 54 are not fully extended out of the device 16; column 10, lines 61-63); and at least one second cutting blade (expandable member 54) positioned at the proximal section of the expandable-and-collapsible cage structure and being configured to dilate a puncture hole of a patient while the expandable-and-collapsible cage structure is in an expanded state (as expandable members 54 flex outwardly to form a three-dimensional support skeleton or cage within tissue; Fig. 4; column 10, lines 3-20; and expandable members 54 may be blades when an ultrasonic i.e. vibrating mechanical means is acted thereto; column 11, lines 21-27).
Regarding claim 16, Mueller discloses wherein the first cutting blade comprises at least one sharp tip (52) being positioned at the distal section of the expandable-and-collapsible cage structure (Figs. 1, 4).
Regarding claim 17, Mueller discloses wherein the at least one sharp tip (52) is configured to puncture the biological feature of the patient while the expandable-and-collapsible cage structure is in the collapsed state (as tip 52 may be introduced to puncture tissue without expanding the entirety of expandable members 54; see for example, Figs. 7A-7B).
Regarding claim 18, Mueller discloses wherein: the expandable-and-collapsible cage structure, once deployed, forms a tear drop shape in the expanded state (Fig. 4).
Regarding claim 19, Mueller discloses wherein: the expandable-and-collapsible cage structure, once deployed, forms a tapered proximal section in the expanded state (as the proximal ends of the expandable members 54 taper proximally towards actuation line 50; Figs. 1-4).
Regarding claim 20, Mueller discloses wherein: the expandable-and-collapsible cage structure, once deployed, is configured to expand radially at the distal section of the expandable-and-collapsible cage structure (at the distal section of expandable members 54; Fig. 4).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 15-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mueller (US 6,565,528 B1) in view of Weitzner et al. (US 2018/0206864 A1).
Regarding claim 15, Mueller discloses an apparatus (catheter assembly 12; Fig. 1), comprising: an elongated medical sheath (catheter accessing device 16) configured to be movable and positionable proximate to a biological feature of a patient (as catheter device 16 is steerable; column 6, lines 44-49); and an expandable-and-collapsible support structure (implement 48) configured to be selectively movable, at least in part, between a collapsed state (Fig. 1) within an interior of the elongated medical sheath and an expanded state (Fig. 4) at an exterior of the elongated medical sheath, the expandable-and-collapsible support structure including an expandable-and-collapsible cage structure (cage structure formed by 52, 54) having a distal section and a proximal section (Figs. 1, 4); and a mechanical tissue-cutting assembly (tip 52 and/or expandable members 54) being supported by the expandable-and-collapsible support structure, the mechanical tissue-cutting assembly includes: a first cutting blade (cutting tip 52) at the distal section of the expandable-and-collapsible cage structure and being configured to create a puncture of the biological feature of the patient (Fig. 4) while the expandable-and-collapsible cage structure is in a collapsed state (as the cutting tip 52 may extend out of the catheter accessing device 16 to an adjustable depth, i.e., wherein expandable members 54 are not fully extended out of the device 16; column 10, lines 61-63); and at least one second cutting blade (expandable member 54) positioned at the proximal section of the expandable-and-collapsible cage structure and being configured to dilate a puncture hole of a patient while the expandable-and-collapsible cage structure is in an expanded state (as expandable members 54 flex outwardly to form a three-dimensional support skeleton or cage within tissue; Fig. 4; column 10, lines 3-20; and expandable members 54 may be blades when an ultrasonic i.e. vibrating mechanical means is acted thereto; column 11, lines 21-27).
Mueller discloses wherein the second cutting blade (54) is configured to allow selective abrasion (column 11, lines 21-27) but fails to explicitly disclose wherein the blade itself is abrasive.
However, Weitzner teaches an apparatus (elongate member 710; Figs. 7A-7C) comprising an expandable-and-collapsible support structure (tissue disrupting element 140a) with one or more expandable cutting members (146a) positioned at a proximal section of the support structure (Fig. 7C), wherein the cutting members may include a variety of cross-sectional forms defining a cutting surface (e.g. sharpened edge, abrasive surface, serrations, teeth, etc.) configured to engage and disrupt debris ([0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the second cutting blade(s) of Mueller to include a sharpened edge, abrasive surface, serrations, and/or teeth as taught by Weitzner in order to engage and disrupt debris by selective abrasion. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of abrading tissue.
Regarding claim 16, Mueller modified discloses the invention as claimed above, and Mueller further discloses wherein the first cutting blade comprises at least one sharp tip (52) being positioned at the distal section of the expandable-and-collapsible cage structure (Figs. 1, 4).
Regarding claim 17, Mueller modified discloses the invention as claimed above, and Mueller further discloses wherein the at least one sharp tip (52) is configured to puncture the biological feature of the patient while the expandable-and-collapsible cage structure is in a collapsed state (as tip 52 may be introduced to puncture tissue without expanding the entirety of expandable members 54; see for example, Figs. 7A-7B).
Regarding claim 18, Mueller modified discloses the invention as claimed above, and Mueller further discloses wherein: the expandable-and-collapsible cage structure, once deployed, forms a tear drop shape in the expanded state (Fig. 4).
Regarding claim 19, Mueller modified discloses the invention as claimed above, and Mueller further discloses wherein: the expandable-and-collapsible cage structure, once deployed, forms a tapered proximal section in the expanded state (as the proximal ends of the expandable members 54 taper proximally towards actuation line 50; Figs. 1-4).
Regarding claim 20, Mueller modified discloses the invention as claimed above, and Mueller further discloses wherein: the expandable-and-collapsible cage structure, once deployed, is configured to expand radially at the distal section of the expandable-and-collapsible cage structure (at the distal section of expandable members 54; Fig. 4).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Scott et al. (US 2022/0273363 A1) in view of Weitzner et al. (US 2018/0206864 A1).
Regarding claims 10-11, Scott discloses wherein the mechanical tissue-cutting assembly comprises at least one cutting blade (as expandable elements 38a, 38b are cutting blades as the ablate tissue; [0064]) positioned at the proximal section of the expandable-and-collapsible cage structure (cage structure of 30; Fig. 1). It is noted that “machinal tissue-cutting assembly” portion of the claim is met by the sharp tip 30a of Scott. Scott discloses wherein the at least one cutting blade (38a, 38b) is configured to dilate a puncture hole while the expandable-and-collapsible cage structure is in an expanded state (as the medical system 10 may be moved proximally by a user while elements 38a, 38b are ablating tissue).
Scott fails to disclose the at least one cutting blade being a mechanical cutting blade.
However, Weitzner teaches an apparatus (elongate member 710; Figs. 7A-7C) comprising an expandable-and-collapsible support structure (tissue disrupting element 140a) with one or more expandable cutting members (146a) positioned at a proximal section of the support structure (Fig. 7C), wherein the cutting members may include a variety of cross-sectional forms defining a cutting surface (e.g. sharpened edge, abrasive surface, serrations, teeth, etc.) configured to engage and disrupt debris ([0044]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cutting blade(s) of Scott to include a sharpened edge, abrasive surface, serrations, and/or teeth as taught by Weitzner in order to engage and disrupt debris by selective abrasion. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded the predictable result of abrading tissue.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH A LONG whose telephone number is (571)270-3865. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached at (571)272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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