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 .
Status of Claims
This office action is responsive to the amendment filed on 04/27/2026. As directed by the amendment: claims 1, 5, 13, 14, 18-20 and 26 have been amended, no additional claims have been cancelled and no new claims have been added. Thus, claims 1-20, 23, 25 and 26 are presently pending in this application, and currently examined in the Office Action.
Response to Amendments
The amendments to the Drawings and Specification, filed 04/27/2026, will not be entered since they add new matter and/or do not follow/detail the structure disclosed in the originally filed disclosure. For example, Figure 19A and paragraph [0070] were amended to add reference numeral 1901 to show “a suture pad”, however it is not clear where exactly reference numeral 1901 is pointing and, what actual structure is even being shown in the figure, since there are no other reference numbers in Figure 19A, and paragraph [0092] which discusses Figures 19A-19C sets forth multiple devices including a dilator, a mechanical circulatory support device, i.e. a percutaneous pump etc. and does not mention a suture pad, and/or how the second anchor could/does include such a structure, and/or what said structure of a suture pad is.
However, it is to be noted that the amendments to Figure 15B and paragraphs [0065] and [0083] would be accepted if submitted by themselves, and would overcome the drawing objection directed towards claims 7 and 8.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the device comprising a first anchor coupled to a tubular member, wherein the first anchor includes an inflatable balloon (claim 7), the device comprising a first anchor coupled to a tubular member, wherein the first anchor includes an inflatable balloon which is operably coupled to a fluid source (claim 8), the device comprising a first anchor coupled to a tubular member, wherein the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member and the first anchor is also configured to be oriented perpendicular to a central axis of the tubular member (claim 11), the device comprising a first anchor coupled to a tubular member, wherein the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member, and a second anchor which cooperates with the first anchor to hold the tubular member to a vessel, wherein the second anchor includes a suture pad (claim 14), and the device comprising a first anchor coupled to a tubular member, wherein the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member, and a second anchor which cooperates with the first anchor to hold the tubular member to a vessel, wherein the second anchor includes an expandable tip (claim 15) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 11, 13-20, 23 and 25 are 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.
Regarding claim 11, which depends form claim 1 which sets forth “the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member”, and claim 11 further sets forth the parameter of “the first anchor is configured to be oriented perpendicular to a central axis of the tubular member”; however this parameter was never mentioned in the originally filed disclosure. Specifically, neither the originally filed specification, nor the figures, mentioned, suggested or illustrated a device wherein the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member, and is also oriented perpendicular to a central axis of the tubular member.
Regarding claim 13, which depends form claim 1 which sets forth “the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member”, and claim 13 further sets forth the parameter of “second anchor configured to be placed on an outside surface of the vessel, wherein the first anchor and the second anchor cooperate to hold the tubular member to the vessel”; however this parameter was never mentioned in the originally filed disclosure. Specifically, the originally filed specification never mentions a device comprising a first anchor which is oriented at a 30-60 degree angle relative to a central axis of the tubular member and also having a second anchor which cooperates with the first anchor to hold the tubular member to the vessel.
Regarding claim 18, which sets forth the parameter of “the first and second anchors are identical” (emphasis added); however, this parameter was never mentioned in the originally filed disclosure.
Regarding claim 20, which sets forth the parameters of “the anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member”, and that the anchor includes a proximal anchor and a distal anchor; however, these parameters were never disclosed together in the same embodiment in the originally filed disclosure. Specifically, the originally filed specification never mentions a device comprising an anchor which is oriented at a 30-60 degree angle relative to a central axis of the tubular member, and also includes a proximal anchor and a distal anchor.
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 11, 12, 15, 20, 23 and 25 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.
Regarding claim 11, which depends form claim 1 which sets forth “the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member”, and claim 11 further sets forth the parameter of “the first anchor is configured to be oriented perpendicular to a central axis of the tubular member”; however this parameter is found to be confusing since it is not clear how the first anchor can be oriented at a 30-60 degree angle relative to a central axis of the tubular member, and also be oriented perpendicular to a central axis of the tubular member. Thus, one having ordinary skill in the art would not reasonable by apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 12, which sets forth the parameter of “the tubular member includes a cannula or sheath”; however, this parameter is found to be confusing since it is not clear what exact structure is intended by said parameter. Specifically, does the parameter intend from there to be two separate and distinct, structures, i.e. the tubular member and a cannula/sheath, in which case it is further found to be confusing since it is not clear how exactly the two structures are related/located in reference to one another and/or how both structures are part of the final structure of the claimed device; or does the parameter intend to mean the tubular member comprises, i.e. is, a cannula/sheath, in which case it is further found to be unclear what additional structural limitation(s) the parameter/claim imparts on the structure of the final device, instead of merely seeming to recite intended use/functional language without including any additional structure needed to meet the function/intended use. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite. (It is to be noted that in the reply dated 04/27/2026 Applicant argues that “one skilled in the art would understand and recognize the distinction in the claims between a catheter and a sheath” and goes on to give definitions of a catheter versus a sheath; however, this does not address, or clarify, the issues set forth above causing claim 12 to be indefinite).
Regarding claim 15, which sets forth the parameter of “the second anchor includes an expandable tip”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by the parameter. Specifically, it is not clear if the expandable tip is/is part of the second anchor, i.e. the second anchor comprises an expandable tip; or is the expandable tip is a separate, distinct, structure coupled to, and/or adjacent to, the second anchor, for example for delivery of the second anchor; or is the expandable tip some other completely different structure. The originally filed disclosure does not aid in explaining or clarifying what exactly is meant by the above mentioned parameter, and/or how the expandable tip is part of/relates to the structure of the second anchor. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite. (It is to be noted that in the reply dated 04/27/2026 Applicant argues that “one skilled in the art would understand and recognize the term “expandable tip” – it is a tip capable of expanding in at least one direction”; however, this does not aid in explaining/clarifying the issues set forth above causing claim 15 to be indefinite).
Regarding claim 20, which sets forth the parameters of “the anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member”, and that the anchor includes a proximal anchor and a distal anchor; however, these parameters are found to be confusing since it is not clear what structure the 30-60 degree orientation is directed towards. Specifically, is the distal anchor oriented at a 30-60 degree angle relative to a central axis, or is the proximal anchor oriented at a 30-60 degree angle relative to a central axis, or are both proximal and distal anchors oriented at a 30-60 degree angle relative to a central axis. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
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.
Claims 1-6, 10, 12-20 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thompson et al. (US PG Pub. 2012/0184893), as previously disclosed, hereinafter Thompson.
Regarding claims 1, 10, 13 and 17, Thompson discloses a device, illustrated in Figures 5, 6, 18 and 19, comprising a tubular member (138/227) configured to extend at least partially into a vessel of a patient; a first anchor (144/226) coupled to the tubular member (138/227), configured for atraumatic apposition to an inner wall of, and hold a position of the tubular member relative to, the vessel; a second anchor (143/225) configured to be placed on an outside surface of the vessel, wherein the first anchor (144/226) and the second anchor (143/225) pinch/sandwich the vessel to hold the tubular member (138/227) to the vessel; and wherein the first anchor (144/226) is oriented at a 30-60 degree angle relative to a central axis of the tubular member (138/227), illustrated in Figures 5, 6, 18 and 19 ([0143] – [0145]; [0148]; [0166], Last 9 Lines & [0167]).
Regarding claim 2, Thompson discloses the device of claim 1, wherein the first anchor (144/226) includes a delivery configuration and a deployed configuration, wherein, in the deployed configuration, the first anchor (144/226) has a diameter greater than an opening of the vessel through which the tubular member (138/227) extends into the vessel, illustrated in Figures 5, 6, 18 and 19 ([0144]).
Regarding claim 3, Thompson discloses the device of claim 1, wherein the first anchor (144/226) includes a plurality of fingers/spring arms (228), illustrated in Figures 5, 6 and 18 ([0144], Last 2 Lines & [0166], Lines 11-15).
Regarding claim 4, Thompson discloses the device of claim 1, wherein the first anchor (144/226) is attached at or near a distal end of the tubular member (138/227), illustrated in Figures 5, 6, 18 and 19.
Regarding claim 5, Thompson discloses the device of claim 1, wherein the first anchor (144/226) includes a footplate comprising one or more mechanical features/spring arms (228) that are configured to move into a deployed configuration to create across-section larger than an arteriotomy once in the vessel, illustrated in Figures 5, 6 and 18 ([0144], Last 2 Lines & [0166], Lines 11-15).
Regarding claims 6 and 16, Thompson discloses the device of claim 1, wherein the first anchor (144/226) includes a polymer configured to flare into a deployed configuration, and the second anchor (143/225) includes a polymer, illustrated in Figures 5, 6, 18 and 19 ([0146]).
Regarding claim 12, Thompson discloses the device of claim 1, wherein the tubular member (138/227) includes a cannula/sheath, illustrated in Figures 5, 6, 18 and 19.
Regarding claim 14, Thompson discloses the device of claim 13, wherein the second anchor (143/225) includes a suture pad/polymer covering configured to be secured to a patient via sutures, illustrated in Figure 11 ([0143], Lines 8-14 – to clarify, the polymer covering is considered a suture pad since it is configured to, i.e. has the physical/structural ability to be secured to a patient via sutures, and neither the claim, nor the originally filed disclosure disclose any other structure/material needed to meet the limitation of “a suture pad”).
Regarding claim 15, Thompson discloses the device of claim 13, wherein the second anchor (143/225) includes an expandable tip ([0144], Lines 5-11 – to clarify, the second anchor 143/225 is considered to include an expandable tip since it has the capability to be compressed in diameter for delivery and the expands once delivered).
Regarding claim 18, Thompson discloses the device of claim 13, wherein the first and second anchors (226&225) are identical, illustrated in Figures 18 and 19.
Regarding claim 19, Thompson discloses the device of claim 13, wherein the first and second anchors (144&143) are not identical, illustrated in Figures 5 and 6.
Regarding claims 20 and 25, Thompson discloses a device (224), illustrated in Figures 18 and 19, comprising an anchor (225/226) configured to hold a position of a tubular member (227) to a vessel, the anchor (225/226) being positionable within the vessel, wherein the (225/226) is oriented at a 30-60 degree angle relative to a central axis of the tubular member (227), and wherein the anchor includes a proximal anchor (225), including an atraumatic disk, configured to engage with subcutaneous tissue; and a distal anchor (226), including an atraumatic disk, configured to appose an inner wall of the vessel, illustrated in Figures 18 and 19 ([0166], Last 9 Lines & [0167]).
Claims 20 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Carson et al. (US PG Pub. 2005/0192604), hereinafter Carson.
Regarding claims 20 and 25, Carson discloses a device (60), illustrated in Figures 5A and 5B, comprising an anchor (64/62) configured to hold a position of a tubular member (66/70) to a vessel (TV), the anchor (62) being positionable within the vessel (TV), wherein the anchor (64) is oriented at a 30-60 degree angle relative to a central axis of the tubular member (66), and wherein the anchor (64/62) includes a proximal anchor (64), including an atraumatic disk, configured to engage with subcutaneous tissue; and a distal anchor (62), including an atraumatic disk, configured to appose an inner wall of the vessel (TV), illustrated in Figures 5A and 5B ([0076]).
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kirsch et al. (US PG Pub. 2003/0065344), hereinafter Kirsch.
Regarding claim 26, Kirsch discloses a method comprising inserting a tubular member (216) into a vessel (262) of a patient through an access site (264), the tubular member (216) extending at least partially into the vessel (262); and holding a position of the tubular member (216) to the vessel via a first anchor (230), which is configured to appose an inner wall (266) of the vessel (262) and is oriented at a 30-60 degree angle relative to a central axis of the tubular member (216), illustrated in Figure 9 ([0040]; [0057] & [0066]).
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 1-10, 12-14 and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US PG Pub. 2007/0203517), as previously disclosed, hereinafter Williams, in view of Carson.
Regarding claims 1, 4, 10, 12, 13 and 17, Williams discloses a device comprising a tubular member/cannula (10) configured to extend at least partially into a vessel of a patient; a first anchor (20b) attached at or near a distal end (12) of the tubular member/cannula (10) and configured to hold a position of the tubular member relative to, and for atraumatic apposition to an inner wall of, the vessel; and a second anchor (20a) configured to be placed on an outside surface of the vessel, wherein the first and second anchors (20b&20a) pinch/sandwich the vessel to hold the tubular member (10) to the vessel, illustrated in Figures 1 and 13H ([0042]; [0058] & [0060]); but does not specifically disclose the first anchor is oriented at a 30-60 degree angle relative to a central axis of the tubular member.
However, Carson discloses a device (60), in the same field of endeavor, comprising a first anchor (64) coupled to a tubular member (66), wherein the first anchor (64) is oriented at a 30-60 degree angle relative to a central axis of the tubular member (66), illustrated in Figures 5A and 5B; the first anchor being at a desired angled such that the tubular member assumes a desired orientation with a respect to a target vessel ([0076]).
In view of the teachings of Carson, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the first anchor, of the device of Williams, to be oriented at a 30-60 degree angle relative to a central axis of the tubular member, such that the tubular member can assume a desired orientation with a respect to the target vessel, as taught by Carson.
Regarding claim 2, Williams in view of Carson disclose the device of claim 1, wherein Williams further teaches the first anchor (20b) includes a delivery configuration, illustrated in Figures 13A-13B and a deployed configuration wherein the first anchor (20b) has a diameter greater than an opening (I) of the vessel through which the tubular member (10) extends into the vessel, illustrated in Figures 13E-13H (Williams: [0059] & [0060]).
Regarding claim 3, Williams in view of Carson disclose the device of claim 1, wherein Williams further teaches the first anchor (20c/d) includes a plurality of fingers (34), illustrated in Figure 6 (Williams: [0048]).
Regarding claim 5, Williams in view of Carson disclose the device of claim 1, wherein Williams further teaches the first anchor (20c/d) includes a footplate comprising one or more mechanical features (30) configured to move into a deployed configuration to create a cross-section larger than an arteriotomy once in the vessel, illustrated in Figure 6 (Williams: [0048]).
Regarding claims 6 and 16, Williams in view of Carson disclose the device of claims 1 and 13, wherein Williams further teaches the first and second anchors (20b&20a) include polymer configured to flare into a deployed configuration, illustrated in Figure 1 (Williams: [0046], Lines 5-6).
Regarding claims 7 and 8, Williams in view of Carson disclose the device of claim 1, wherein Williams further teaches the first anchor (20b) includes an inflatable balloon which is operably coupled, via port (23) to a fluid source (Williams: [0042], Lines 9-10 & [0044], Lines 9-13).
Regarding claim 9, Williams in view of Carson disclose the device of claim 1, wherein Williams further teaches a second tubular member (23) disposed along the tubular member (10), wherein the second tubular member (23) is operably coupled to the first anchor (20b) to move the first anchor from a delivery configuration to a deployed configuration, illustrated in Figure 3 (Williams: [0042]).
Regarding claim 14, Williams in view of Carson disclose the device of claim 13, wherein Williams further teaches the second anchor (10c/d) includes a suture pad (36), illustrated in Figure 6 (Williams: [0048] – to clarify, the term “suture pad” has been interpreted as a pad/material which is capable of being, i.e. has the physical/structural ability to be, sutured).
Regarding claim 18, Williams in view of Carson disclose the device of claim 13, wherein Williams further teaches the first and second anchors (20b&20a) are identical, illustrated in Figures 1 and 13H.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Thompson.
Regarding claim 23, Thompson discloses the device of claim 20, wherein the distal anchor includes one or more barbs (554), illustrated for example in Figure 86, the barbs provide for tissue penetration and additional anchoring ([0232]); thus, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the distal anchor (226), of the embodiment of Figures 18 and 19, to include one or more barbs in order to provide for tissue penetration and additional anchoring, as taught by Thompson.
Response to Arguments
Applicant’s arguments with respect to the claims have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, in response to Applicant’s amendment, Examiner now rejects: independent claim 1, and those claims that depend from it, as being unpatentable over Williams in view of Carson or unpatentable over Thompson; independent claim 20, and those claims that depend from it, as being unpatentable over Carson or unpatentable over Thompson; and independent claim 26 as being unpatentable over Kirsch.
Furthermore, Applicant's arguments regarding the prior art of Thompson have been fully considered but they are not persuasive. Specifically, Applicant argues that Thompson “does not teach or suggest use of anchors at 30-60 degree angles relative to a central axis of the tubular member. Examiner respectfully disagrees with Applicant’s assertion. Thompson clearly states, in paragraph [0166], “expandable disks extend away from the longitudinal axis at an angle of between about 45 and about 135 degrees”. Additionally, while referencing Figure 19, Thompson also states “the disks 225 and 226 extend radially outward at an angle of between about 10 and about 30 degrees from perpendicular” ([0167], Last 2 Lines); 30 degrees from perpendicular equates to 60 degrees. Thus, Thompson clearly teaches the parameter of the first anchor being oriented at a 30-60 degree angle.
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 DINAH BARIA whose telephone number is (571)270-1973. The examiner can normally be reached Monday - Friday 10am - 5pm.
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/DINAH BARIA/Primary Examiner, Art Unit 3774 06/18/2026
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