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
Applicant’s arguments have been considered but are moot because the present rejection constitutes a new ground of rejection and does not rely on any reference applied in the prior rejection of record for the specific teaching or matter challenged by Applicant. Zaver does not expressly disclose that element 74 is wound about a bracing strut or secured to the proximal markers. However, Zaver does disclose, in another embodiment, a radiopaque element 34 is wound about the annular structure and secured to proximal marker 38a. Accordingly, it would have been obvious to one of ordinary skill in the art to incorporate element 34 and proximal marker 38a into Monstadt’s tubular structure so that the radiopaque element is wound about Monstadt’s annular structure and secured to proximal marker 38a for visualization purposes. Because Monstadt’s annular structure is formed by the bracing strut (9) and connecting struts (5, 5′) defining the proximal annular structure, the radiopaque element would necessarily be positioned around those struts and secured to the proximal marker as claimed.
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.
Claim 1 is indefinite under 35 U.S.C. § 112(b) because it contains conflicting and/or unclear recitations regarding the ring marker. The claim first recites broadly that “the annular structure (6) comprises a ring marker (12) with a radiopaque material for visualizing the spatial position of the annular structure (6),” but later recites that “the ring marker is wound in a loop-like fashion around the entire circumference of the annular structure with the ends of the ring marker secured on the proximal marker.”
It is unclear why “for visualizing the spatial position of the annular structure” but the ring marker is wound around an entire circumference of the annular structure. whether the later language is intended to further define the ring marker, merely describe an example, or impose an additional required structural limitation. As drafted, the claim does not clearly set forth the metes and bounds of the claimed invention.
Claim 3 is indefinite under 35 U.S.C. § 112(b) for the same reasons. Claim 3 recites that “the ring marker (12) encompasses the annular structure (6) at least partially along its length,” while claim 1, from which it depends, also recites that “the ring marker is wound in a loop-like fashion around the entire circumference of the annular structure.”
The relationship between these recitations is unclear. It is not readily apparent whether claim 3 is intended to require a partial circumferential marker, a full circumferential marker, or both. Accordingly, the scope of claim 3 is not reasonably certain.
Claim 14 recites the limitation "the cylindrical structure" in line 3. There is insufficient antecedent basis for this limitation in the claim.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 4 is rejected under 35 U.S.C. § 112(d) or pre-AIA 35 U.S.C. § 112, fourth paragraph, because it fails to properly and distinctly further limit the subject matter of the claim upon which it depends.
Claim 4 recites that “the ring marker (12) encompasses the annular structure (6) along its entire length,” while claim 1 already recites that “the ring marker is wound in a loop-like fashion around the entire circumference of the annular structure.” It is unclear whether claim 4 adds a distinct further limitation or merely restates subject matter already recited in claim 1. As such, claim 4 is not in proper dependent form and does not clearly comply with the statutory requirements.
Applicant may cancel the claim, amend the claim to place it in proper dependent form, rewrite the claim in independent form, or provide a sufficient showing that the claim complies with the statutory requirements.
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.
15. Claim(s) 1-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monstadt et al. (US 10292803 B2) in view of Zaver et al. (US 20070233175 A1).
Claim 1: Monstadt et al. disclose a thrombectomy device comprising an essentially tubular structure (1) having a proximal end and a distal end and including a plurality of mesh cells (3, 4) composed of struts, including two connecting struts (5, 5′) arranged at proximal mesh cells at the proximal end of the tubular structure (1) and extending in the proximal direction, as well as a coupling member (11) arranged proximally of the tubular structure (1), the connecting struts (5, 5′) being attached to said coupling member, and the coupling member (11) being connected to a pusher wire (12). Monstadt et al. further disclose that the struts of the proximal mesh cells, the connecting struts (5, 5′), the coupling member (11), and the bracing struts (9) form a closed annular structure.
However, Monstadt et al. do not expressly disclose a distal marker, a proximal marker, or a ring marker wound in a loop-like fashion around the entire circumference of the annular structure with the ends of the ring marker secured on the proximal marker.
Zaver et al. disclose a vascular device, including an annular structure (31) at a proximal end of a mesh structure (32), distal marker (38b), proximal marker (38a), and a radiopaque ring marker (34) arranged around the entire circumference of the annular structure region for visualization. Zaver et al. further teach that the radiopaque ring marker may be formed in wire, spiral, tubular, or sleeve form, may extend around varying percentages of the perimeter of the annular opening, and may be provided along the device. Zaver et al. also disclose radiopaque materials such as gold-plated tungsten wire. Accordingly, Zaver et al. teach the use of a radiopaque marker associated with an annular vascular structure to facilitate fluoroscopic visualization.
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the annular proximal structure of Monstadt et al. in view of Zaver et al. by providing a radiopaque ring marker wound around the annular structure and secured on the proximal marker, in order to improve visualization of the annular structure and adjacent coupling region during delivery, deployment, tracking, and retrieval of the device.
Claim 2: Monstadt et al. disclose a thrombectomy device according to claim 1, wherein a slit (7) extends in a helical or coiled fashion over the circumferential surface of the tubular structure (1), with a bracing strut (9) spanning the slit (7) at the proximal end of the tubular structure (1).
Claim 3: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein the ring marker encompasses the annular structure at least partially along its length. However, Zaver et al. disclose the ring marker (34) encompasses the annular
Claim 4: Monstadt et al. do not disclose a thrombectomy device according to claim 3, wherein the ring marker encompasses the annular structure along its entire length.
Claim 5: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein the ring marker is wire-shaped or sleeve-shaped and wound or laid around the struts forming the annular structure.
Claim 6: Monstadt et al. do not disclose a thrombectomy device according to claim 5, wherein the wire-shaped ring marker is of one-piece design.
Claim 7: Monstadt et al. do not disclose a thrombectomy device according to claim 1, including a proximal marker (13) in the region of the coupling member (11).
Claim 8: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein the ends of the wire-shaped ring marker are secured in or to the proximal marker (13) or coupling member (11).
Claim 9: Monstadt et al. disclose a thrombectomy device according to claim 1, wherein the bracing strut (9) forms a camber, with the maximum of the camber pointing toward the distal end of the tubular structure (1).
Claim 10: Monstadt et al. do not disclose a thrombectomy device according to claim 1, including further distal or proximal markers made of radiopaque material.
Claim 11: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein the radiopaque material is selected from gold, tantalum, platinum, palladium, an alloy based on precious metals, or a combination thereof, such as platinum-iridium.
Claim 12: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein further markers are provided along the tubular structure (1), and the markers are provided in wire form, spiral form, tubular form, or sleeve form.
Claim 16: Monstadt et al. do not disclose a thrombectomy device according to claim 1, wherein the ring marker has a first end and a second end and an intermediate portion, the first end being wound about a first one of the two connecting struts, the second end being wound about the second one of the two connecting struts, and the intermediate portion being wound about a portion of the bracing strut extending between the first and second connecting struts.
The combination of Monstadt et al. and Zaver et al. would have yielded no more than predictable results. Monstadt et al. provide the thrombectomy device framework and annular proximal structure, while Zaver et al. teach the use of radiopaque marker elements associated with a vascular annular structure to improve fluoroscopic visibility. A person of ordinary skill in the art would have been motivated to incorporate Zaver’s radiopaque ring marker into the annular structure of Monstadt et al. to enhance visualization of the proximal end of the device, including the annular region and coupling member, during delivery, adjustment, and retrieval. Such a modification would merely apply a known imaging feature to a known vascular device to achieve the expected and predictable result of improved fluoroscopic tracking.
Accordingly, it would have been obvious to one of ordinary skill in the art to provide a radiopaque ring marker as claimed, including a marker wound around the annular structure and secured on the proximal marker, thereby satisfying the limitations of claims 1–12 and 16.
30. Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Monstadt et al. (US 10292803 B2) in view of Zaver et al. (US 20070233175 A1) further in view of Sargent (US 20100211094 A1).
As discussed above with respect to the rejection of claims 1–12, Monstadt et al. in view of Zaver et al. disclose the thrombectomy device structure, including the tubular structure, proximal end, distal end, mesh cells, connecting struts, coupling member, and annular structure, and further disclose radiopaque marker arrangements for visualizing portions of the device. However, Monstadt et al. in view of Zaver et al. do not expressly disclose that at least part of the tubular structure is provided with an additional marker formed by coating with radiopaque material.
Zaver et al. disclose, including in Fig. 9, additional radiopaque marker material (108) provided on portions of the device other than the annular structure at the proximal end, thereby teaching that radiopaque marking may be applied to additional regions of the device to facilitate visualization. Sargent further teaches that device portions may be rendered radiopaque by applying a radiopaque coating to a substrate. In particular, Sargent paragraph [0029] discloses that tip 20 and attachment points 40 may be made radiopaque either by employing a noble metal or by applying a radiopaque polymeric or ceramic coating by any suitable technique, including spraying or dipping. Sargent further identifies exemplary radiopaque materials such as gold, platinum, iridium, palladium, rhodium, or mixtures thereof, and explains that such radiopaque features improve fluoroscopic visibility during delivery, adjustment, and retrieval.
It would have been obvious to a person of ordinary skill in the art at the time the invention was made to modify the thrombectomy device of Monstadt et al., as taught by Zaver et al., by providing additional radiopaque coating on at least portions of the tubular structure, as suggested by Sargent, in order to enhance fluoroscopic visualization and facilitate tracking of the device during delivery, adjustment, and retrieval. The proposed modification merely applies a known radiopaque coating technique to a known vascular device to achieve the predictable result of improved imaging visibility.
Accordingly, claims 14 and 15 are unpatentable over the combined teachings of Monstadt et al., Zaver et al., and Sargent.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TAN-UYEN T HO/Supervisory Patent Examiner, Art Unit 3771
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