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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 13 June 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I drawn to a coated, biodegradable vaso-occlusive device in the reply filed on 8 April 2026 is acknowledged.
Claims 6-15, 17, and 19 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 April 2026.
Applicant’s election without traverse of a fatty amide-based polyurethane urea as the species of biodegradable coating and a species of coating comprising no additional ingredients in the reply filed on 8 April 2026 is acknowledged.
Claim 4-5 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 April 2026.
Claims 1-3, 16, 18, and 20 are examined on the merits herein.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-2, 16, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Murayama et al. (J Neurosurg, 2001, Vol. 94, 454-463) in view of Mangiardi (US 2016/0317718 cited on Applicant’s IDS filed 13 June 2024) and Li et al. (Bioact Mater, 2021, Vol. 11, 140-153).
Claim 1 is drawn to a coated, biodegradable vaso-occlusive device, comprising:
one or more endovascular coils composed of a magnesium alloy; and
a coating comprising one or more biodegradable polymer applied to a surface of the magnesium alloy.
Claim 16 is drawn to the device of claim 1, wherein the device is an aneurysm coil.
Murayama et al. teach aneurysm coils (Title) comprising platinum coated in a bioabsorbable polyglycolic/poly-L-lactic copolymer (Pg. 455 left column last paragraph).
As such, Murayama et al. teach a coated, vaso-occlusive device, comprising one or more endovascular coils and a coating comprising one or more biodegradable polymer applied to a surface of the coil, wherein the device is an aneurysm coil.
The device of Murayama et al. differs from the instantly claimed device in the following ways:
the device of Murayama et al. does not comprise a magnesium alloy.
Yet, as to 1: Mangiardi teaches biodegradable devices comprising a biodegradable metal scaffold and a biodegradable polymer coating (Abstract), including aneurysm sealing devices (Par. [0003]) wherein the biodegradable metal scaffold is made from a magnesium alloy (Pars. [0006-9]).
And as taught by Li et al., “Existing endovascular devices include coils, stents, flow diverters, and stent retrievers, which are mainly made of NiTi alloys, Co alloys or 316 L stainless steel, with good biomechanical compatibility for brain vessels and cytocompatibility for nerve cells. However, the constant presence of an inherent non-degradable metallic stent can impair vasomotor response and induce a prolonged inflammatory reaction and thrombosis” (Pg. 140 right column), further teaching “commercially available cerebrovascular stents are made of non-degradable metals, and their long-term existence may lead to acute thrombosis or late in-stent restenosis” (Pg. 143 left column third paragraph). Li et al. further teaches “Since magnesium (Mg) and its alloys have tunable mechanical strength, and proper biodegradability, which can be further regulated by surface coating techniques, they are considered a promising alternative to permanent biomedical materials” (Pg. 142 left column first paragraph) additionally teaching “biodegradable stents are proposed and designed to disappear after fulfilling their mission… the stent should degrade at an appropriate corrosion rate within 12-24 months without causing any side effects” (Pg. 143 left column second paragraph).
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murayama et al. to comprise a magnesium alloy. It would have been obvious to substitute one metal suitable for use in polymer coated aneurysm coils with another to obtain the predictable result of an aneurysm coil with improved vasomotor response and inflammatory reaction, with a reasonable expectation of success.
Based on all of the foregoing, claims 1 and 16 are rejected as prima facie obvious.
Claim 2 is drawn to the device of claim 1, wherein the one or more endovascular coils is in a shape selected from a group including coiled helical.
Murayama et al. further teach the device having a coil shape (Pg. 455 left column last paragraph, Fig. 1).
As such, claim 2 is rejected as prima facie obvious.
Claim 18 is drawn to the device of claim 16, wherein said coating protects the magnesium alloy from acute corrosion and supports moderate platelet deposition and cell-attachment and proliferation.
Murayama et al., Mangiardi, and Li et al. are silent as to the corrosion protection and support of platelet deposition, cell-attachment and proliferation of the coating.
However, as discussed in MPEP 2112.01, “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
As Murayama et al., Mangiardi, and Li et al. teach the instantly claimed device of claim 16, the instantly claimed corrosion protection and support of platelet deposition, cell-attachment and proliferation of the coating are necessarily present.
As such, claim 18 is rejected as prima facie obvious.
Claim 20 is drawn to the device of claim 16, wherein said device acutely occludes an aneurysm and generates tissue to fill the aneurysm.
Murayama et al. further teach the device completely occluding an aneurysm (Pg. 457 left column third paragraph) and generating tissue to fill the aneurysm (Pg. 458-459 bridging paragraph).
As such, claim 20 is rejected as prima facie obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Murayama et al., Mangiardi, and Li et al. as applied to claims 1-2, 16, 18, and 20 above, and further in view of Nachtkamp et al. (US 4,743,470 cited on Applicant’s IDS filed 13 June 2024) and Raval et al. (Reactive & Functional Polymers, 2006, Vol. 66, 315-321).
The teachings of Murayama et al., Mangiardi, and Li et al. have been set forth above.
Claim 3 is drawn to the device of claim 1, wherein the coating comprises a fatty amide-based polyurethane urea elastomer derived from a prepolymer comprising N,N-bis(2-hydroxyethyl) soybean oil fatty amide.
Murayama et al., Mangiardi, and Li et al. do not teach the elastomer derived from a prepolymer comprising N,N-bis(2-hydroxyethyl) soybean oil fatty amide.
However, Murayama et al. teach that many different bioabsorbable polymers are suitable for coating the device (Pg. 455 left column second paragraph).
Mangiardi also teaches many different polymers as suitable biodegradable polymer coatings for medical devices, including polyurethanes (Par. [84]).
Nachtkamp et al. teach polyurethane urea coatings based on N,N-bis(2-hydroxyethyl) amide (col. 23 lines 28-42) wherein the carboxylic acid to be reacted to form the amide is a fatty acid from natural materials including soybean oil (col. 5 lines 15-23).
Raval et al. teach N,N-bis(2-hydroxyethyl) fatty amide polymeric coatings as biocompatible and suitable for use in medical applications (Title, Abstract, Conclusions on pg. 320-321).
And as discussed in MPEP 2141(I), “[I]n Sakraida v. AG Pro, Inc., the Court derived . . . the conclusion that when a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious." Id. at 417, 82 USPQ2d at 1395-96.”
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Murayama et al. and Mangiardi to include a polyurethan urea elastomer based on N,N-bis(2-hydroxyethyl) soybean oil fatty amide as taught by Nachtkamp et al. It would have been obvious to substitute one coating taught to be suitable for medical devices for another to obtain the predictable result of a biodegradable polymer coated aneurysm coil, with a reasonable expectation of success.
As such, claim 3 is rejected as prima facie obvious.
Conclusion
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/PAUL HOERNER/Examiner, Art Unit 1611
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