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
Amended Drawings submitted 09/18/2025 are accepted.
Specification
Amendments to the Specification submitted 09/18/2025 are accepted.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1, 3, 4, 11-17, 21, 24, 25, 42, 50-53, 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.
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.
Claim(s) 1, 50 and 53 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Palasis et al. (US 2014/0100644)
Palasis discloses an implantable device, comprising: a tube comprising a plurality of biodegradable biometallic wires (110, 120 [0016]) braided together ([0015]), the tube being coated with a flexible conformal biodegradable polymer (410, Fig 3) in an expanded state such that, upon compression and release of compression, the flexible conformal biodegradable polymer-coated tube self-expands back to the expanded state ([0021]), wherein the flexible conformal biodegradable polymer binds the braided wires of the tube together at a plurality of wire crossover points to inhibit sliding movement between the wires (since the prior art has the claimed structure it is therefore capable of performing the same function), and wherein the flexible conformal biodegradable polymer comprises a plasticizer ([0030])
50. wherein the flexible conformal biodegradable polymer further comprises at least one of: poly(L-lactide) (PLLA); poly (DL-Lactide) (PLA); poly(L-lactide-co-D, L-lactide); polyglycolide (PGA); poly(D, L- lactide-co-glycolide); or poly(caprolactone) ([0022]).
53. wherein the flexible conformal biodegradable polymer further comprises an antiproliferative drug or an antiproliferative drug-containing coating (0032]).
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.
Claim(s) 42 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644)
Palasis discloses that the wires complete a full revolution (see Fig. 1a) but does not disclose that the tube is cut into at least two segments.
However, it would have been obvious to one having ordinary skill in the art at the time the invention was made to provide two stents, since it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Claim(s) 3, 11, 12, 14, is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) as applied to claim 1 in view of Gong (US 2018/0153676)
Palasis discloses the implantable device as claimed in claim 1 as noted above. Palasis does not disclose the tube comprises one or more radiopaque wires.
However, Gong discloses
Claim 3: a braided stent wherein at least one of the wires is radiopaque wherein at least one of the one or more radiopaque wires comprises a composite wire (Fig 6 [0021], [0070]).
Claim 11: wherein the one or more radiopaque wires comprises one or more non-degradable radiopaque wires (for example wire core is nickle titanium [0023]).
Claim 12: wherein the one or more non-degradable radiopaque wires comprises a biocompatible radiopaque metal [0023] materials listed are biocompatible.
Claim 14: wherein the biocompatible radiopaque metal includes at least one of gold, platinum, tantalum, iridium, iron, or tungsten [0023].
It would have been obvious to one of skill in the art before the effective filing date to incorporate radiopaque wires into the braided stent of Schaffer as a way to provide enhanced imaging of the stent [0006].
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) in view of Gong (US 2018/0153676) as applied to claim 3 above and further in view of Zheng (US 2013/0331927).
Modified Palasis discloses the invention as stated above but does not disclose at least one of the one or more radiopaque wires comprises a magnesium-alloy radiopaque composite wire.
However, Zheng discloses that magnesium alloy is a known option for radiopaque material [0722].
It would have been obvious to one of ordinary skill in the art before the effective filing date to choose magnesium alloy as the radiopaque material as taught by Zheng as t has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin,125 USPQ 416.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) in view of Gong (US 2018/0153676) as applied to claim 12 above and further in view of Zhao (US 2024/0058144).
Modified Palasis disclose claimed invention as noted above but does not disclose the one or more non-degradable radiopaque wires is smaller than a diameter of each of the plurality of biodegradable biometallic wires.
However, Zhao disclose a wire stent that includes radiopaque wires where the radiopaque wires can have a different diameter than the other wires [0073]. Providing wires made of a different material and/or with a different size can reduce the cost of the stent and enables it to be applied in more scenarios and a wider range of applications.
It would have obvious to one of ordinary skill in the art as of the effective filing date to modify the stent such that the radiopaque wires have different diameter than the other wires for the purposes stated above.
Regarding the diameter of the radiopaque wires being 25-40% smaller than the other wires. It would have been obvious to one of ordinary skill in the art as of the effective filing date to modify the stent of modified Schaffer to fall within the claimed dimensions. In Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Claim(s) 15 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) in view of Gong (US 2018/0153676) as applied to claim 14 above and further in view of Fulkerson (US 2005/0288722).
Modified Palasis discloses the invention as noted above but does not disclose the composite radiopaque wire is coated with a permanent polymer that is a dielectric material.
However, Fulkerson teaches an implantable device that also uses radiopaque material to enhance visibility in the body [0076]. Fulkerson further teaches that covering the radiopaque material with an electrically insulating coating to galvanic corrosion between dissimilar metals or from exposure to blood or other bodily fluid.
Thus, it would be obvious to coat the radiopaque wires in the modified Schaffer stent to have an insulating coating for the purpose of avoiding galvanic corrosion.
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) in view of Gong (US 2018/0153676) and Fulkerson (US 2005/0288722) as applied to claim 16 above and further in view of Helmus (US 2006/0089709)
Modified Palasis disclose the device as noted above having a radiopaque wire coated with insulating material that is parylene but does not disclose the material is polyimide or fluoropolymer.
However, Helmus teaches that polyimide is a material that is known to be used for its insulating properties [0069].
It would have been obvious to one of ordinary skill in the art before the effective filing date to choose polyimide as the insulating material as taught by Helmus. It has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin,125 USPQ 416.
Claim(s) 21, 24 and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) as applied to claim 1 above and further in view of Schaffer (US 2011/0319978)
Palasis discloses the device as noted and further that the biodegradable wires can comprise a list of metals, but does not disclose the biodegradable wires comprise at least 80% magnesium alloy.
However, Schafer discloses a bioabsorbable stent frame made from magnesium including compositions of 80% magnesium and 90% magnesium; that zinc [0055] or calcium [0021] or manganese [0021] can be used in combination with magnesium; and that that the bioabsorbable metal can be a rare earth metal [0019].
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the claimed materials in the modified stent of Schafer based on the teachings of Schaffer since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin,125 USPQ 416.
Claim(s) 51 and 52 is/are rejected under 35 U.S.C. 103 as being unpatentable over Palasis et al. (US 2014/0100644) as applied to claim 1 above in view of Ganatra (US 2016/0166727).
Palasis discloses the claimed invention as noted above but does not disclose the specific composition of materials as claimed.
However, Ganatra teaches resorbable filaments can be made of a conformal polymer comprising poly (D, L-lactide-co- glycolide) and acetyl tri-n-butyl citrate (ATBC) plasticizer ([003] and [0091]).
It would have been obvious to one of ordinary skill in the art before the effective filing date to use the claimed materials in the modified stent of Schafer based on the teachings of Ganatra since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin,125 USPQ 416.
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 ELIZABETH HOUSTON whose telephone number is (571)272-7134. The examiner can normally be reached generally M-F 8:00-4:30.
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/ELIZABETH HOUSTON/Supervisory Patent Examiner, Art Unit 3771
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