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.
Examiner's Note
Applicant's amendments and arguments filed 14 August 2026 are acknowledged and have been fully considered. The Examiner has re-weighed all the evidence of record. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application. In the Applicant's response, filed 14 August 2026, it is noted that claims 1, 5, 11, 14-15, and 17-19 have been amended and claims 20-24 newly added. Support can be found throughout the specification. No new matter has been added.
Newly submitted claims 21-22 directed to an invention that is independent or distinct from the invention originally claimed for the following reasons: Claims 21-22 depend from previously withdrawn claims.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 21-22 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Status of the Claims
Claims 1, 3-5, 9-16, and 17-24 are pending.
Claims 14-15, 17-19, and 21-22 are withdrawn.
Claims 1, 3-5, 9-13, 20 and 23-24 are rejected.
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, 3-4, 10, 12, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Park et al. (J Adv Prosthodont 2013;5:402-8) 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 nor does it teach calcium in the coating.
Park further teaches that a combination calcium phosphate coating formed on a magnesium-coated substrate surface enhances osteoblast viability by enhancing cell attachment and proliferation (pg 407, ¶4).
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. It would have been further obvious to include calcium in the coating to enhance cell proliferation and adhesion, as taught by Park. 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 and calcium 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 the inclusion of calcium with magnesium in the film, the prior art does not teach the amount of calcium to include. However, since it is taught that calcium included in the coating improves cell adhesion and proliferation, it would have been obvious to optimize the amounts thereof. That being said and in lieu of objective evidence of unexpected results, the concentration of calcium can be viewed as a variable which achieves the recognized result of improving cell proliferation and adhesion. The optimum or workable range of calcium can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of calcium nonobvious.
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, 3-4, 10, 12, and 23-24 are accordingly rejected as obvious over the prior art.
Claims 1, 3-5, 10, 12, and 23-24 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 Park et al. (J Adv Prosthodont 2013;5:402-8)in view of Cheng et al. (US 2008/0153944).
Avellanet, Park, 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 along with calcium, 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, 3-5, 10, 12, and 23-24 are accordingly rejected as obvious over the prior art.
Claims 1, 3-4, 10-12, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Park et al. (J Adv Prosthodont 2013;5:402-8)in view of Tobing et al. (US 6,608,134) in view of Yang et al. (US 2008/0208315).
Avellanet, Park, 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 with calcium, 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, 3-4, 10-12, and 23-24 are accordingly rejected as obvious over the prior art.
Claims 1, 3-4, 9-10, 12, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Avellanet (US 2010/0161032) in view of Park et al. (J Adv Prosthodont 2013;5:402-8) in view of Tobing et al. (US 6,608,134) in view of Stromme et al. (US 2015/0298984).
Avellanet, Park, 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 with calcium, 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, 3-4, 9-10, 12, and 23-24 are accordingly rejected as obvious over the prior art.
Claims 1, 3-5, 10-13, 20 and 23-24 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 further teaches that a combination calcium phosphate coating formed on a magnesium-coated substrate surface enhances osteoblast viability by enhancing cell attachment and proliferation (pg 407, ¶4).
Park does not teach wherein titanium surface is hydrophilic. Park does not teach the concentration of calcium.
Parisi teaches titanium implants shaped like 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. Calcium can also be included in the coating based on the teaching that it improves cell adhesion and proliferation. 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 and less than 50º. 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 the inclusion of calcium with magnesium in the film, the prior art does not teach the amount of calcium to include. However, since it is taught that calcium included in the coating improves cell adhesion and proliferation, it would have been obvious to optimize the amounts thereof. That being said and in lieu of objective evidence of unexpected results, the concentration of calcium can be viewed as a variable which achieves the recognized result of improving cell proliferation and adhesion. The optimum or workable range of calcium can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Appellants provide no evidence of any secondary consideration such as unexpected results that would render the optimized amounts of calcium nonobvious.
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)).
Regarding the water droplet angle, a water droplet contact angle of 54.2º is reasonably close to 50º or less. Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (See MPEP 2131.03 (III)).
Claims 1, 3-5, 10-13, 20 and 23-24 are accordingly rejected as obvious over the prior art.
Response to Arguments
Applicant's arguments filed 14 August 2026 have been fully considered but they are not persuasive. The Applicant, in general, argues that the prior art does not teach a coating layer or film consisting of calcium and magnesium.
In response, Park, above, teaches that by further including calcium in the magnesium coating, the implant has enhanced cell adhesion and proliferation. The benefit realized by further including calcium would have been motivation to the skilled artisan to modify Park and Avellanet to further comprise calcium in their coating compositions.
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, 3-5, 9-13, 20, and 23-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 4, 9, and 14-17, 22, and 24 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, 3-5, 9-13, 20, and 23-24.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant's arguments filed 14 August 2026 have been fully considered but they are not persuasive. The Applicant argues that the rejection does not recite any specific differences between the instant claims and the ‘561 claims.
In response, the above rejection recites how the ‘561 claims render obvious the instant claims. Despite some differences, the ‘561 claims teach all the required limitations of the instant claims.
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 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Brian Kwon can be reached at 571-272-0581. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANDREW S ROSENTHAL/Primary Examiner, Art Unit 1613
