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 .
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 endoprosthesis comprising a plurality of anchoring legs extending axially away from the first end of the framework, wherein the anchoring legs includes a plurality of paddles and each paddle is disposed opposite the first end of the expandable frame work (claim 6) 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 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 and 17 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 6, which depends from claim 5 which depends from claim 1, which set forth that the endoprosthesis comprises a plurality of anchoring legs extending axially away from the first end of the framework and that the anchoring legs includes a plurality of paddles; and claim 6 further sets forth that “each paddle of the plurality of paddles is disposed opposite the first end of the expandable framework”; however, this parameter if found to be confusing since it's not clear how the anchoring legs axially extend from the first end of the framework, but also have the paddles, which are included as part of the anchoring legs, being disposed opposite the first end of the expandable framework. 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 17, which sets forth the parameter of “the expandable framework is sized and configured to prevent external compression of the vein at the treatment site”; however, this parameter is found to be confusing since it is not clear how exactly the framework is/would be configured to “prevent external compression of the vein”. Specifically, it is not clear what additional structure, and/or deployment location/positioning, of the framework would be required to meet the claimed limitation of prevent external compression of the vein; and the originally filed disclosure does not aid in explaining or clarifying said parameter. 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, such as claims 1-14, 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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Longo et al. (US PG Pub. 2017/0281375), as disclosed in the IDS dated 12/11/2023, hereinafter Longo.
Regarding claims 1-4, Longo discloses an endoprosthesis for preventing collapse of a vein, illustrated in Figures 22A and 22B, comprising an expandable framework configured to shift between a radially collapsed configuration and a radially expanded configuration, the expandable framework having a first/proximal end and a second/distal end opposite the first/proximal end; and a plurality of anchoring legs/anchors extending axially away from the first/proximal end of the expandable framework, the plurality of anchoring legs/anchors being configured to shift between a delivery configuration and a deployed configuration; wherein, in the deployed configuration, the plurality of anchoring legs/anchors are configured to extend radially outward of the expandable framework in the radially expanded configuration; wherein the expandable framework and the plurality of anchoring legs/anchors are self-biased toward the deployed, radially expanded, configuration, illustrated in Figures 22A and 22B ([0090] & [0091]); and further comprising a plurality of anchoring barbs, i.e. curved tip portions, extending radially outward from the plurality of anchoring legs/anchors, illustrated in Figures 23D-23F ([0094]).
Regarding claims 1-3 and 5-8, Longo discloses an endoprosthesis for preventing collapse of a vein, illustrated in Figures 22C and 22D, comprising an expandable framework configured to shift between a radially collapsed configuration and a radially expanded configuration, the expandable framework having a first/distal end and a second/proximal end opposite the first/distal end; and a plurality of anchoring legs/flared distal end (AL) extending axially away from the first/distal end of the expandable framework, the plurality of anchoring legs (AL) being configured to shift between a delivery configuration and a deployed configuration; wherein, in the deployed configuration, the plurality of anchoring legs (AL) are configured to extend radially outward of the expandable framework in the radially expanded configuration; wherein the expandable framework and the plurality of anchoring legs (AL) are self-biased toward the deployed, radially expanded, configuration; and wherein the plurality of anchoring legs (AL) includes a plurality of paddles (P), each disposed opposite the first/distal end of the expandable framework, and configured to engage a wall of the vein, wherein each paddle (P) includes at least one aperture formed therein and at least one radiopaque marker, illustrated in Figures 22C, 22D and modified figure 22C, below ([0090]; [0091], Last 5 Lines [0095] & [0096]).
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Claims 15-17 and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McGuckin Jr. et al. (US PG Pub. 2002/0055772), as disclosed in the IDS dated 12/11/2023, hereinafter McGuckin.
Regarding claims 15, 16 and 19, McGuckin discloses a method of preventing collapse of a vein comprising, advancing a delivery catheter, having a lumen extending therethrough, into the vein at a location upstream of a treatment site within the vein, followed by positioning a distal end of the delivery catheter adjacent the treatment site and deploying an endoprosthesis (100) at the treatment site, illustrated in Figure 12 ([0125]); the endoprosthesis (100) including an expandable framework configured to shift between the radially collapsed configuration, illustrated in Figures 10 and 11 ([0038]; [0039] & [0117]) and a radially expanded configuration, illustrated in Figures 8 and 9B ([0035] & [0037]), the expandable framework comprising a plurality of closed cells (122), a first end and a second end opposite the first end, and a plurality of anchoring legs (AL) extending axially away from the first end of the expandable framework, the plurality of anchoring legs (AL) being configured to shift between a delivery configuration and a deployed configuration, wherein the plurality of anchoring legs (AL) are configured to extend radially outward of the expandable framework in the radially expanded configuration; wherein after deploying the endoprosthesis at the treatment site, the plurality of anchoring legs (AL) extends upstream from the expandable framework within the vein, illustrated in Figures 8, 9B, 10, 11 and modified figure 9B, below ([0121] & [0122]).
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Regarding claim 17, McGuckin discloses the method of claim 15, wherein the expandable framework is sized and configured to prevent external compression of the vein at the treatment site while simultaneously avoiding radial stretching of the vein at the treatment site ([0132] – to clarify, since the device is placed within the vein, there would be no external compression of the vein).
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 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Longo.
Regarding claims 9 and 10, Longo discloses the endoprosthesis of claim 5, wherein when unconstrained, the plurality of paddles (P) defines a radial extent greater than a radial extent of the expandable framework, illustrated in Figures 22C, 22D and modified figure 22C, above ([0095]); and though it is not specifically disclosed the radial extent of the plurality of paddles is at least 20% greater than the radial extent of the expandable framework, this parameter is deemed to be a mere matter of normal design choice not involving a novel, inventive, step. As disclosed by Longo, the radial extent of the anchoring legs/flared distal end (AL), and thereby also the plurality of paddles, is controlled by radius “r”. Thus, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate radius/radial extent for the anchoring legs/flared distal end, and thereby also the plurality of paddles, including being at least 20% greater than the radial extent of the expandable framework, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art (see MPEP 2144.05). Furthermore, it is to be noted that neither the claims, nor the originally filed specification, gave any reason/benefit for, or criticality to the parameter of the radial extent of the plurality of paddles being at least 10%, and further at least 20%, greater than the radial extent of the expandable framework, as opposed to any other amount greater.
Claims 11-14 are rejected under 35 U.S.C. 103 as being unpatentable over Savage et al. (US PG Pub. 2011/0264196), hereinafter Savage, in view of Oba et al. (US PG Pub. 2018/0055629), hereinafter Oba.
Regarding claims 11-14, Savage discloses a system for preventing collapse of a vein, illustrated in Figures 1-5, comprising a delivery catheter (106) having a lumen extending therethrough with an endoprosthesis (110/10) disposable within a distal portion of the lumen in a radially collapsed configuration, illustrated in Figure 5 ([0034], Lines 1-4), the endoprosthesis/stent including an expandable framework configured to shift between the radially collapsed configuration and a radially expanded configuration ([0019]), the expandable framework having a first end and a second end opposite (14) the first end; and a plurality of anchoring legs (30/32/34/36) extending axially away from the first end of the expandable framework, the plurality of anchoring legs (30/32/34/36) being configured to shift between a delivery configuration, illustrated in Figure 5, and a deployed configuration, illustrated in Figures 1-4; wherein, in the deployed configuration, the plurality of anchoring legs (30/32/34/36) is configured to extend radially outward of the expandable framework in the radially expanded configuration, wherein the plurality of anchoring legs (30/32/34/36) extends proximally from the expandable framework; a plurality of anchoring barbs (50) extending radially outward from the plurality of anchoring legs, wherein the plurality of anchoring legs (30/32) includes a plurality of paddles (16), configured to engage a wall of the vein, and attached to a portion, and extending within the lumen, of the delivery device/catheter to aid in delivery, including changing an angle of the plurality of anchoring barbs relative to a central longitudinal axis of the expandable framework, illustrated in Figures 1-5 ([0022]; [0028] & [0031]); but does not specifically disclose the portion of the delivery device/catheter, attached to the paddles, is at least one filament.
However, Oba teaches that it is well known in the art for a delivery system to comprise at least one filament/tether attached to a paddle/eyelet (232c) of an endoprosthesis, illustrated in Figure 6; wherein the filament/tether aid in delivery and/or recapturing/repositioning of the endoprosthesis ([0187]).
In view of the teachings of Oba, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the paddle attachment portion, of the system of Savage, to comprise at least one filament/tether, in order to not only aid in delivery of the endoprosthesis but also aid in recapturing/repositioning of the endoprosthesis, as taught by Oba.
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over McGuckin as applied to claim 15 above, and in view of Newell et al. (US Patent No. 9,308,110), hereinafter Newell.
Regarding claim 18, McGuckin discloses the method of claim 15, but does not specifically disclose recapturing the endoprosthesis within the lumen of the delivery catheter and repositioning the endoprosthesis at and/or adjacent to the treatment site.
However, Newell teaches that it is well known in the art for a delivery device to recapture a stent/endoprosthesis within a lumen a catheter and reposition it, in order to allow for improved/proper placement of the stent/endoprosthesis (Column , Lines 25-39).
In view of the teachings of Newell, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention for the method of McGuckin to further comprise disclose recapturing the endoprosthesis within the lumen of the delivery catheter and repositioning the endoprosthesis at and/or adjacent to the treatment site, in order to improve/find a proper placement for the endoprosthesis, as taught by Newell.
Allowable Subject Matter
Claim 20 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: no prior art, by itself, or in combination with other art, could be found that discloses or fairly teaches a method of preventing collapse of a vein at a treatment site, specifically a non-thrombotic iliac vein lesion site, including all the structural limitations set forth in the claim 20. The closest related art found was of McGuckin and Longo, as disclosed above. McGuckin teaches a method of preventing collapse of a vein comprising positioning a delivery catheter adjacent a treatment site within the vein, the delivery catheter having an endoprosthesis within a lumen of the delivery catheter, and deploying the endoprosthesis at the treatment site within a vein, wherein the endoprosthesis includes all the structural limitations set forth in independent claim 15, including that the plurality of anchoring legs extend upstream from the expandable framework within the vein. However, McGuckin does not teach the treatment site being a non-thrombotic iliac vein lesion. Furthermore, Longo teaches a method of preventing collapse of a vein comprising positioning a delivery catheter adjacent a treatment site within the vein, wherein the treatment site being a non-thrombotic iliac vein lesion, the delivery catheter having an endoprosthesis within a lumen of the delivery catheter, and deploying the endoprosthesis at the treatment site/non-thrombotic iliac vein lesion; but does not teach all the structural limitations of the endoprosthesis as set forth in independent claim 15, specifically, that the plurality of anchoring legs extend upstream from the expandable framework within the vein.
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 01/30/2026