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 .
Preliminary Amendment
Applicant’s preliminary amendment, filed September 27, 2023, has been entered.
Election/Restrictions
Applicant’s election without traverse of Invention I (claims 1-14 and 17) in the reply filed on December 1, 2025 is acknowledged. Accordingly, claims 15, 16, 18 and 19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claim 10 is 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.
Claim 10 recites “and/or” at two instances. This recitation renders the claim vague and indefinite as the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-5, 8, 10-12, 14 and 17 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Heath (U.S. Patent No. 7,101,392).
In regard to claims 1-5, 8, 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 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 14, Heath teaches that the filament 11 may be a draw-form member (see col. 8, line 3).
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) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heath (U.S. Patent No. 7,101,392).
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.
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 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.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 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).
The applied reference has a common inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
In regard to claim 9, Heath is silent as to utilizing any of the materials listed in claim 9 for the core 8. However, Cai et al. teach a composite wire for medical applications comprised of a core 107 and a shell 109 (see Fig. 2B). A titanium alloy may be used for core 107 (see col. 8, lines 13-30). Cai et al. thus demonstrate that is it well known and desirable in the medical arts to utilize a titanium alloy to form the core on an implanted medical device. 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 titanium alloy taught by Cai et al. as the material for the core 8 of Heath, as an alternative material choice.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 8, 10-14 and 17 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7 and 8 of copending Application No. 19/041,225 in view of Heath (U.S. Patent No. 7,101,392).
Claims 1-3, 7 and 8 of copending application No. 19/041,225 recite all of the features of claims 1-5, 8, 10-12, 14 and 17 except for the core being formed from a non-metallic powder material, differences between the mechanical properties of the outer member alone and the composite material, the radiopacity of the core material and the galvanic couple. However, as noted in the above rejection for claims 1-5, 8, 10-12, 14 and 17, Heath teaches these features.
This is a provisional nonstatutory double patenting rejection.
Claims 6 and 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7 and 8 of copending Application No. 19/041,225 in view of Chan et al. (U.S. Patent No. 11,191,272).
Claims 1-3, 7 and 8 of copending application No. 19/041,225 recite all of the features of claims 6 and 7 except for the outer member being formed from a bioabsorbable material and either magnesium or a magnesium alloy. However, as noted in the above rejection for claims 5 and 6, Chan et al. teaches these features.
This is a provisional nonstatutory double patenting rejection.
Claims 9 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 7 and 8 of copending Application No. 19/041,225 in view of Cai et al. (U.S. Patent No. 11,111,571).
Claims 1-3, 7 and 8 of copending application No. 19/041,225 recite all of the features of claim 9 specific material makeup of the core. However, as noted in the above rejection for claims 5 and 6, Cai et al. teaches these features.
This is a provisional nonstatutory double patenting rejection.
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