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 .
Priority
The instant application is the national stage entry of PCT/JP2022/032506 filed 30 August 2022. Acknowledgement is made of the Applicant’s claim of foreign priority to application JP2021-140956 filed 31 August 2021.
Election/Restrictions
Claims 14-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 November 2025.
Status of the Claims
Claims 1-6 and 9-19 are pending.
Claims 14-19 are withdrawn.
Claims 1-6 and 9-13 are rejected.
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 5 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 5 recites the limitation "the hydrophilic property" which is not described in claims 1 or 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 6 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 1 recites a metal film which “comprises magnesium and optionally calcium.” Claim 6 recites the limitation wherein the metal film “comprises at least one metal selected from the group consisting of Mg, Ca, Zn and Fe.” Since claim 1 already requires the inclusion of magnesium, it is unclear if the metals in claim 6 are in addition the magnesium of claim 1. As such, the metes and bounds of claim 6 are indefinite.
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.
Claims 1-4, 6, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Tobing et al. (US 6,608,134).
Avellanet teaches stents, which are medical devices used to open and maintain blood flow through diseased blood vessels [0002]. The coated stent is implanted and left in place over time to allow drug to elute into the artery [0006]. The stent, which is tubular, is interpreted as having a cylindrical shape [0036]. The stent, which can be made of an inner stent made of cobalt-chromium and an outer stent made of stainless steel [0051], can further comprise a magnesium coating layer [0044]. After placement of the stent in the blood vessel, wherein the stent will necessarily come into contact with bodily fluids such as blood, the magnesium coating will dissolve and leave behind the metal stent as a permanent scaffold [0044].
Avellanet does not teach that the substrate has a hydrophilic surface.
Tobing teaches that stainless steel is a hydrophilic substrate (col 12, lns 25-28).
It would have been prima facie obvious to prepare the stent of Avellanet and coat it with a dissolvable magnesium coating, which is taught in the art. The stent can be made of stainless steel which is hydrophilic, as taught in Tobing, and as determined as being inherent based on the Applicant’s claims. It is noted that “products of identical chemical composition cannot have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (see MPEP 2112.01 (II)). The resulting cylindrical stainless steel stent would have a coating of magnesium that is taught as dissolving in the body (in blood, for example). While the source of magnesium is not taught in Avellanet, it is also not taught to include any Mg2Ca.
Regarding instant claim 4, HBSS already comprises magnesium, therefore it is known to solubilize the metal. The magnesium coating of Avellanet would necessarily be soluble in HBSS based on its inherent properties and the solubility of magnesium (see MPEP 2112.01 (II)). Claims 1-4, 6, 10, and 12 are accordingly rejected as obvious over the prior art.
Claims 1-6, 10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Tobing et al. (US 6,608,134) in view of Cheng et al. (US 2008/0153944).
Avellanet and Tobing, as applied supra, are herein applied in their entirety for the teachings of a magnesium coated stainless steel stent.
Avellanet does not teach the water droplet contact angle of the substrate.
Cheng teaches that untreated stainless steel has a contact angle of 84.69º [0055] (Fig. 3B).
It would have been prima facie obvious to prepare the stent of Avellanet and coat it with a dissolvable magnesium coating, which is taught in the art. The stent can be made of stainless steel which is hydrophilic, as taught in Tobing, and which inherently has a water droplet contact angle of less than 90º. Claims 1-6, 10, and 12 are accordingly rejected as obvious over the prior art.
Claims 1-4, 6, and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Tobing et al. (US 6,608,134) in view of Yang et al. (US 2008/0208315).
Avellanet and Tobing, as applied supra, are herein applied in their entirety for the teachings of a magnesium coated stainless steel stent.
Avellanet does not teach the surface roughness of the substrate.
Yang teaches that pure stainless steel (without surface modification) has a surface roughness of 8.16 nm (pg 5, Table 1). Even with surface modification using a hydrophilic hydroxyapatite, the surface roughness is from 14-38 nm (id).
It would have been prima facie obvious to prepare the stent of Avellanet and coat it with a dissolvable magnesium coating, which is taught in the art. The stent can be made of stainless steel which is hydrophilic, as taught in Tobing, and which inherently has a surface roughness of less than 50 mm. Claims 1-4, 6, and 10-12 are accordingly rejected as obvious over the prior art.
Claims 1-4, 6, 9-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Tobing et al. (US 6,608,134) in view of Stromme et al. (US 2015/0298984).
Avellanet and Tobing, as applied supra, are herein applied in their entirety for the teachings of a magnesium coated stainless steel stent.
Avellanet does not teach the film has an amorphous portion.
Stromme teaches an amorphous magnesium carbonate [0002] which can be used in dental formulations [0050]. The amorphous magnesium carbonate can be used as a surface coating on any substrate with the rationale that the amorphous magnesium carbonate improves or adds functionality to the product [0175].
It would have been prima facie obvious to prepare the stent of Avellanet and coat it with a dissolvable magnesium coating, which is taught in the art, wherein the magnesium coating is the amorphous magnesium carbonate coating of Stromme. Stromme teaches the coating can improve functionality thus providing motivation to select that magnesium source. Claims 1-4, 6, 9-10, and 12 are accordingly rejected as obvious over the prior art.
Claims 1-6 and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Park et al. (J Adv Prosthodont 2013;5:402-8) in view of Parisi et al. (Materials Science & Engineering C 117 (2020) 111307) in view of Hasegawa et al. (Int. J. Mol. Sci. 2020, 21, 783).
Park teaches a magnesium-coated titanium substrate in the shape of a disc (abstract; pg 403, ¶3). Titanium is used extensively in dental implants due to corrosion resistance, biocompatibility, machinability, and load bearing capability (pg 402, ¶1). Park further recognizes the ability of magnesium to degrade (i.e. dissolve) in body fluid and proposes an additional surface coating to reduce the drawbacks of magnesium (id). While dissolution of magnesium was slowed due to the additional coating, it was not ceased (pg 407, ¶9). A Ti-Mg substrate demonstrated full dissolution of the magnesium coating (id). The surface roughness of the uncoated titanium is taught as being 0.24 mm (pg 405, Table 1).
Park does not teach wherein titanium surface is hydrophilic.
Parisi teaches titanium implants shaped liked discs and used for dental purposes (abstract; Fig. 1). The titanium surface is taught as being hydrophilic, which is what contributes to the clinical success of the dental implant (abstract). The level of hydrophilicity can vary based on surface treatments and Parisi teaches that simple polished titanium (P) is hydrophilic with a water droplet contact angle of 54.2º and microrough surfaces (modSLA) have a contact angle of 9.0º (pg 3, sec 3.1; Fig. 1). The modSLA surfaces appear to be associated with improved cell differentiation over polished titanium (pg 8, ¶5).
Hasegawa teaches titanium implants for dental purposes (abstract) and further shows that roughness after treatment of the titanium surface typically ranges from about 0.2-2.0 mm (Fig. 2B).
It would have been prima facie obvious to prepare the titanium discs of Park to be used for dental implants wherein the disc (as shown in Fig. 1 of Parisi) has a cylindrical shape. The implant can be coated with magnesium which is known to dissolve in body fluids. Although additional protective coatings can be further included, these coatings only limit and do not prevent the ability of the magnesium to dissolve in body fluid. It would have been obvious to use modSLA titanium to achieve improved cell differentiation, wherein the droplet contact angle is less than 90º. Although Parisi does not teach the Ra value, based on Hasegawa the value is typically less then 2.0 mm and would thus be less than 50 mm as required in instant claim 11.
Regarding instant claim 4, HBSS already comprises magnesium, therefore it is known to solubilize the metal. The magnesium coating of Park would necessarily be soluble in HBSS based on its inherent properties and the solubility of magnesium (see MPEP 2112.01 (II)). Claims 1-6 and 10-13 are accordingly rejected as obvious over the prior art.
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 1-6 and 9-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, 9, and 14-17 of copending Application No. 18/034,561 in view of Avellanet (US 2010/0161032) and Tobing et al. (US 6,608,134) and Cheng et al. (US 2008/0153944).
The ‘561 claims are towards a substrate with a film disposed on the substrate wherein the film comprises magnesium and calcium and is free of Mg2Ca. Avellanet teaches stents, which are medical devices used to open and maintain blood flow through diseased blood vessels [0002], that are implanted and left in place over time to allow drug to elute into the artery [0006]. The stent, which is tubular, is interpreted as having a cylindrical shape [0036] can be made of stainless steel [0051] and can further comprise a magnesium coating layer [0044]. After placement of the stent in the blood vessel, wherein the stent will necessarily come into contact with bodily fluids such as blood, the magnesium coating will dissolve and leave behind the metal stent as a permanent scaffold [0044]. Tobing teaches that stainless steel is a hydrophilic substrate (col 12, lns 25-28). Cheng teaches that untreated stainless steel has a contact angle of 84.69º [0055] (Fig. 3B). It would have been obvious to prepare the substrate of ‘561 and substitute the magnesium coated stent of Avellanet. The resulting stainless steel stent coated with magnesium and comprising the roughness of ‘561 renders obvious instant claims 1-6 and 9-13
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREW S ROSENTHAL whose telephone number is (571)272-6276. The examiner can normally be reached M-F 8-5pm EST.
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/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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