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 and Amendment Filed
Applicant’s response and amendment, filed May 12, 2026, has been entered and made of record.
Information Disclosure Statement
The information disclosure statement filed May 12, 2026 has been entered and the references cited therein have been considered by the examiner.
Previously Set Forth Rejections
The status of the rejections set forth in the previous Office action (mailed January 15, 2026) is as follows:
The 35 USC 112(b) rejection of claim 10 has been overcome by amendments to claim 10.
The 35 USC 102(a)(2) rejection of claims 1-5, 8, 10-12, 14 and 17 as being anticipated by Heath (U.S. Patent No. 7,101,392) is hereby withdrawn.
The 35 USC 103 rejection of claim 13 as being unpatentable over Heath (U.S. Patent No. 7,101,392) is hereby withdrawn.
The 35 USC 103 rejection of claims 6 and 7 as being unpatentable over Heath (U.S. Patent No. 7,101,392) in view of Chan et al. (U.S. Patent No. 11,191,272) is hereby withdrawn.
The 35 USC 103 rejection of claim 9 as being unpatentable over Heath (U.S. Patent No. 7,101,392) in view of Cai et al. (U.S. Patent No. 11,111,571) is hereby withdrawn.
The double patenting rejections of claims 1-14 and 20 are hereby withdrawn.
The following new grounds of rejection are set forth:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claim(s) 1-5, 8-14 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heath (U.S. Patent No. 7,101,392) in view of Christensen et al. (U.S. Patent Application Publication No. 2019/0388355).
In regard to claims 1-5, 8, 9, 12 and 17, Heath teaches an endoprosthesis stent 1 that is formed of an elastic filament 11 knitted into a mesh cylinder 12 (see Figs. 1 and 1a). The filament 11 is a wire-form member that includes a longitudinal outer member 4 concentrically disposed about a central core 8 which extends along an axis 6 (see Figs. 2 and 2a). The longitudinal member 4 is formed of a metal, such as nitinol, and the core 8 can be tantalum with a density greater than the longitudinal member 4 to enhance the radiopacity of the filament 11 and thus the stent 1 (see col. 4, lines 52-60). Figure 2 shows that the longitudinal member 4 has an outer diameter and a hollow cavity that defines an inner diameter and that the core 8 is received in the hollow cavity and defines an outer diameter equal to the inner diameter of the longitudinal member 4. Heath also teaches that the core 8 is in intimate contact with and bonded to the interior portions of the outer member 4 and shows that the core 8 is centered in the hollow cavity that is created in the outer member 4 (Fig. 2 and see col. 4, line 65 to col. 5, line 1). Heath further teaches that the outer member 4 is formed of a continuous solid mass of a highly elastic biocompatible material (medical-grade), such as nitinol (see col. 7, lines 5-36). Heath also teaches that the core 8 may be in a power form and is formed from tantalum with a consistent density (see col. 7, lines 37-42). Heath does not specifically state that the powder is non-metallic. However, Christensen et al. teach a core/shell composite with a core that can be formed from a neutral metal oxide such as silicia, zirconia, titania and alumina (see para. 0035). Christensen et al. thus demonstrate that the use of non-metallic materials for the core of a core/shell composite was well known in the art. Furthermore, it is well settled that the selection of a known material based on its suitability for its intended use is within the skill of the art. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 227 F.2d 197, 125 USPQ 416 (CCPA 1960). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the neutral metal oxide (non-metallic) taught by Christensen et al. as the powder core 8 of Heath as the neutral metal oxide is shown by Christensen et al. to be sitable for a core/shell composite. Heath also states that the characteristics of the filament 11 and the selection of the outer member and core metals is based on the stent application, thus indicating that medical-grade materials are used (see col. 5, lines 30-32). In regard to claim 10, Heath teaches that the core 8 is somewhat stiffer than the outer member 4 (see col. 7, lines 46-47) and that the core 8 has a greater density than the outer member 4 (see col. 3, lines 8-10). Heath also teaches that the materials selected for the outer member 4 and the core 8 may be based on desired overall mechanical properties, such as density, modulus of elasticity, biocompatibility, flexural stiffness, durability, tensile and compression strength and the required radiopacity and resolution (see col. 6, lines 42-67). Accordingly, Heath teaches that the mechanical properties of the outer member 4 alone are less than 5% different (as evidenced by the term “somewhat”) than the mechanical properties of the composite outer member 4 and core 8 (forming filament 11). In regard to claim 11, Heath teaches that the diameter of the core 8 is less than about 50% of the outer diameter of the filament 11, ideally between 25% and 40% (see col. 5, lines 45-49). In regard to claim 13, Heath is silent as to the voltage of a galvanic couple formed between the outer member 4 and the core 8. However, given that the filament 11 is intended to be implanted into a human patient, and that the materials for the outer member 4 and the core 8 are specifically selected for this use, it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that the materials used in the outer member 4 and the core 8 of Heath would form a galvanic couple defining a voltage of less than 0.5V. In regard to claim 14, Heath teaches that the filament 11 may be a draw-form member (see col. 8, line 3).
Claim(s) 6 and 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heath (U.S. Patent No. 7,101,392) in view of Christensen et al. (U.S. Patent Application Publication No. 2019/0388355) and further in view of Chan et al. (U.S. Patent No. 11,191,272).
In regard to claims 6 and 7, Heath is silent as to the outer member 4 being formed from a bioabsorbable material or from magnesium or a magnesium alloy. However, Chan et al. teach an occluder 110 that is formed from at least one absorbable filament 102 made from a bioabsorbable material such as magnesium and magnesium alloys (see Fig. 1 and col. 22, lines 11-14). Chan et al. thus demonstrate that is it well known in the medical arts to utilize magnesium or a magnesium alloy on an implanted stent or occlude when bioabsorbability is desired. Furthermore, it is well settled that the selection of a known material based on its suitability for its intended use is a design choice within the skill of the art. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945); In re Leshin, 277 F.2d 197, 125 USPQ 416 (CCAP 1960). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the magnesium or magnesium alloy taught by Chan et al. as the material for the outer member 4 of Heath, in order to provide the desired bioabsorbability.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 and 17 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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