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 07/25/2023 in which claims 21, 22, 24 and 27-34 have been cancelled; thus, claims 1-20, 23, 25 and 26 are presently pending in this application, and currently examined in the Office Action.
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 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 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 Objections
Claim 13 is objected to because of the following informalities: lines 1-2 sets forth the parameter of “a second anchor configured to placed on an outside surface of the vessel”; however this parameter is found to be grammatically incorrect. In order to overcome this issue, it is suggested the word “be” be added between the words “to” and “placed”. Appropriate correction is required.
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 5, 6, 12-15, 18-20, 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 5, which sets forth the parameter of “the first anchor includes a footplate”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by “a footplate”. Specifically, it is not clear what exact structure would be needed in order to read on the first anchor including a footplate; and the originally filed disclosure does not aid in explaining or clarifying what exact structure “a footplate” entails. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 6, which sets forth the parameter of “the first anchor includes a nitinol braid and/or polymer configured to flare” (emphasis added); however, this parameter is found to be confusing since it is not clear how exactly the first anchor can include/be a nitinol braid and a polymer configured to flare ; and the originally filed disclosure does not aid in explaining or clarifying such a structure, in fact it is completely silent regarding such a structure. Thus, one having ordinary skill in the art would not reasonable be 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”; this parameter is found to be confusing since it is not clear what exact structure his intended by this 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 who exactly the two structures are related to/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 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.
Regarding claim 13, which sets forth the limitations of “a first anchor”, on line 2, and “a second anchor”, on line 2; are these first and second anchors (on line 2) the same structure as the first anchor, which was first set forth on line 3 of claim 1 from which claim 13 depends, and the second anchor, which was first set forth on line 1 of claim 13, or are they separate and completely different first and second anchors (thereby having two sets of first and second anchors). If these first and second anchors (on line 2) are the same structure as the first and second anchors, as set forth on line 3 of claim 1 and line 1 of claim 13, respectively, (as they seem to be) it is suggested the limitations on line 2 be amended to state “the first anchor” and “the second anchor”. However, if these first and second anchors (on line 2) are different, separate and distinct structures from the first and second anchors, as set forth on line 3 of claim 1 and line 1 of claim 13, respectively, then it is further unclear what exactly these structures are/entail and/or how they relate to the final structure of the claimed device.
Regarding claim 14, which sets forth the parameter of “the second anchor includes a suture pad”; however, this parameter is found to be confusing since it is not clear what exactly, structurally, is meant by “a suture pad”. Specifically, it is not clear what exact structure would be needed in order to read on the second anchor, which cooperates with the first anchor to hold the tubular member to the vessel (as set forth in claim 13 from which claim 14 depends) including a suture pad; and the originally filed disclosure does not aid in explaining or clarifying what exact structure “a suture pad” entails. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim 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 “an expandable tip”. Specifically, it is not clear what exact structure would read on the second anchor, which cooperates with the first anchor to hold the tubular member to the vessel (as set forth in claim 13 from which claim 15 depends) including an expandable tip. Is this expandable tip part of the second anchor, or is it a separate, distinct, structure coupled/joined to the second anchor, for example for delivery, or something else completely different; and the originally filed disclosure does not aid in explaining or clarifying what exact structure “an expandable tip” is, and/or how it 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.
Regarding claims 18 and 19, which set forth the parameters of the first and second anchors included the same (claim 18)/different (claim 19) “features”; however, these parameters are found to be confusing since it is not clear what exactly, structurally, is meant by the term “features”, and the originally filed disclosure does not aid in explaining or clarifying the term. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 20, the last three lines of the claim set forth the parameter of “the anchor includes: a proximal anchor portion configured to engage with subcutaneous tissue; and a distal anchor portion configured to appose an inner wall of the vessel”; however, this parameter is found to be confusing since it is not clear if the distal and proximal anchor portions are merely portions/sections of one distinct anchor structure, of if the distal and proximal anchor portions are meant to be two, separate and distinct, anchor structures. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 23, which recites the limitation “the distal anchor”, on line 1; there is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear what exactly, structurally, this “distal anchor” is and/or how it relates to the final structure of the claimed device. For example, is this distal anchor the same structure as the “distal anchor portion”, first set forth on the last line of claim 20 from which claim 23 depends, or is it another separate and distinct structure from the “distal anchor portion”, of claim 20. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Regarding claim 25, which recites the limitation(s) “the distal and proximal anchors”, on line 1; there is insufficient antecedent basis for this limitation in the claim. Furthermore, it is unclear if these “distal and proximal anchors” are separate, distinct, structures from the distal and proximal anchor portions (as set forth the last two lines of claim 20 from which claim 25 depends), in order for each to include “an atraumatic disk” (as set forth in claim 25); or if these “distal and proximal anchors” are intended to be the same structure as the distal and proximal anchor portions, set forth in claim 20, and if so, how exactly can portions of a structure include “an atraumatic disk”, as set forth in claim 25. Thus, one having ordinary skill in the art would not reasonable be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight, and intended use/functional language is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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 1-14, 15, 17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Williams et al. (US PG Pub. 2007/0203517), hereinafter Williams.
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]).
Regarding claim 2, Williams discloses the device of claim 1, wherein 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 ([0059] & [0060]).
Regarding claim 3, Williams discloses the device of claim 1, wherein the first anchor (20c/d) includes a plurality of fingers (34), illustrated in Figure 6 ([0048]).
Regarding claim 5, Williams discloses the device of claim 1, wherein the first anchor (20c/d) includes a footplate (30), illustrated in Figure 6 ([0048]).
Regarding claims 6 and 16, Williams discloses the device of claims 1 and 13, wherein the first and second anchors (20b&20a) include polymer configured to flare into a deployed configuration, illustrated in Figure 1 ([0046], Lines 5-6).
Regarding claims 7 and 8, Williams discloses the device of claim 1, wherein the first anchor (20b) includes an inflatable balloon which is operably coupled, via port (23) to a fluid source ([0042], Lines 9-10 & [0044], Lines 9-13).
Regarding claim 9, Williams discloses the device of claim 1, further comprising 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 ([0042]).
Regarding claim 11, Williams discloses the device of claim 1, wherein, in a deployed configuration, the first anchor (20b) is configured to be oriented perpendicular to a central axis of the tubular member (10), illustrated in Figures 1 and 13H.
Regarding claim 14, Williams discloses the device of claim 13, wherein the second anchor (10c/d) includes a suture pad (36), illustrated in Figure 6 ([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 discloses the device of claim 13, wherein the first and second anchors (20b&20a) include the same features, illustrated in Figures 1 and 13H.
Claims 1, 13 and 19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Thompson et al. (US PG Pub. 2012/0184893), hereinafter Thompson.
Regarding claims 1, 13 and 19, Thompson discloses a device, illustrated in Figures 1, 5 and 6, comprising a tubular member (138) configured to extend at least partially into a vessel of a patient; a first anchor (144) coupled to the tubular member (138) and configured to hold a position of the tubular member relative to, and appose an inner wall of, the vessel; and a second anchor (143) configured to be placed on an outside surface of the vessel, wherein the first and second anchors (144&143) cooperate to hold the tubular member (138) to the vessel, and the first and second anchors (144&143) include different features, illustrated in Figures 5 and 6 ([0144], Last 2 Lines [0145] & [0148], Lines 4-6 - to clarify, the first anchor 144 is has a disk-like shape and the second anchor 143 has an open-ended cylindrical shape, thereby the first and second anchors include different features).
Claims 20, 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray et al. (US PG Pub. 2018/0361127), hereinafter Gray.
Regarding claims 20, 23 and 25, Gray discloses a device (100), illustrated in Figure1, comprising an anchor (114) configured to hold a position of a tubular member (110) to a vessel, the anchor (114) being positionable within the vessel, wherein the anchor (114) includes a proximal anchor portion (P) configured to engage with subcutaneous tissue; and a distal anchor portion (D) configured to appose an inner wall of the vessel, wherein the distal anchor portion (D) includes one or more barbs (132), and each of the distal and proximal anchor portions (D&P) include an atraumatic disk, illustrated in Figure 1 ([0025]).
Claim 26 is rejected under 35 U.S.C. 102(a)(1) as being anticipated Gittings et al. (US PG Pub. 2007/0055344), as disclosed in the IDS dated 11/08/2023, hereinafter Gittings.
Regarding claim 26, Gittings discloses a method comprising inserting a tubular member (260) into a lumen (42) of a vessel/coronary vessel/LAD of a patient through an access site/opening, the tubular member (260) extending at least partially into the vessel/coronary vessel/LAD; and holding a position of the tubular member (260) to the vessel/coronary vessel/LAD via a first anchor (268), which is configured to appose an inner wall of the vessel/coronary vessel/LAD, illustrated in Figures 19A-19C ([0076] & [0077]).
Conclusion
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