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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on May 5, 2026 has been entered.
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.
Claims 1, 3,5-10, and 13-16 are 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] vascular support implant comprising a magnesium alloy, the alloy including…less than 1 wt.% one or more micro-alloying elements selected from one or more of the elements Ag, Fe, Mn and Si wherein the magnesium alloy comprises Mg as the remainder and is free from rare earths apart from any and all unavoidable impurities including rare earth impurities”. The limits on the amounts of components are unclear. The disclosure does not mention unavoidable impurities. While the presence of some elemental impurities in magnesium alloys cannot be avoided and are therefore an inherent feature, generically, Sasaki et al. (previously cited) detail that magnesium alloys contain unavoidable impurities that include iron, nickel, cobalt, and copper (see paragraph 42). The applicant categorizes iron as a microalloying element that can be present at less than 1 wt% and iron can also be present as an unavoidable impurity, thus the permissible amount of iron is unclear. Further, this dual categorization also occurs via the explicit exclusion of rare earths from the alloy then, the subsequent recitation permitting rare earths as unavoidable impurities. Which rare earths count as unavoidable impurities in the instant invention is not clear, given that unavoidable impurities were not discussed in the disclosure.
Claim 16 recites “[a] vascular support implant comprising…magnesium alloy consisting of… less than 1 wt.% one or more micro-alloying elements selected from one or more of the elements Ag, Fe, Mn and Si; and Mg as the remainder including any and all unavoidable impurities”. This claim has a similar issue as claim 1 concerning the scope of unavoidable impurities.
Claim Interpretation
Claim 1 recites “[a] vascular support implant comprising a magnesium alloy, the alloy including between 1.5 wt.% and 20.0 wt.% Zn, 0 wt.% to 1 wt.%, Ca, and less than 1 wt.% one or more micro-alloying elements selected from one or more of the elements Ag, Fe, Mn and Si wherein the magnesium alloy comprises Mg as the remainder and is free from rare earths apart from any and all unavoidable impurities including rare earth impurities” [emphasis added]. The open language “including” and “comprises” employed to recite the components of the alloy permits the presence of components that are not recited and are not explicitly excluded. Thus elements such as zirconium, aluminum, and titanium are permitted in the alloy, based on the claim recitation with open claim language.
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.
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, 5, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Imwinkelried et al. (US PGPub No. 2017/0000925).
Winkelried et al. teach biodegradable implants composed of ultrapure magnesium alloy (see abstract). Various vascular implants, such as stents, as well as mesh shapes are envisioned (see paragraphs 50-51). They describe the alloy as consisting essentially of MgCaZn alloy, where calcium is present at 0.0005 to 1 wt%, zinc at 3 to 6 wt%, and 0.001 wt% other elements (see paragraph 10). They further envision “other elements” to include one or more of iron, copper, nickel, silicon, manganese, aluminum, zirconium, cobalt, and phosphorus (see paragraph 40). Rare earth elements are minimized and present at less than 0.05 ppm (see paragraph 45; instant claim 1). Winkelried et al. also teach a grain size of less than 10 mm for the alloy (see paragraph 19).
While a full example of each embodiment of the implants embraced by Winkelried et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow their guidance and make a stent with their MgCaZn alloy magnesium alloy. The grain size range embraces the instantly claimed grain size range, thereby rendering it obvious. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed.Cir. 1990)” (see MPEP 2144.05). Exclusion of rare earth metals would have been obvious as an idealized execution of their teaching to minimize their presence. Therefore claims 1 and 16 are obvious over Winkelried et al.
Claims 1, 5-9, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Winkelried et al. as applied to claims 1 and 16 above, and further in view of Paquin et al. (US PGPub No. 2019/0365957).
Winkelried et al. teach a stent that meets the limitations of instant claims 1, 5, and 16. A net structure and polymer coating for the stent are not explicitly detailed .
Paquin et al. teach a bioabsorbable stent made of materials envisioned to be magnesium and its alloys (see abstract). The struts of the stent are configured as a wire net that permits joining of the components without deleteriously impacting the mechanical or resorptive properties of the alloy (see paragraphs 2 and 5). They particularly envision alloys that include zinc as well as calcium that are free of rare earth metals (see paragraphs 32-33). Paquin et al. teach the thickness of the wire to be 50 to 150 microns (see paragraph 33; instant claim 7). They detail joining cuffs for the ends of the wire components to be tubular or cylindrical (see paragraph 43). They also envision the stent coated with a degradable polymer such as polylactic acid to extend the absorption time (see paragraph 39; instant claims 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ a wire net configuration for the stent of Winkelried et al. in light of Paquin et al. in order to preserve the properties of the magnesium alloy material. A cylindrical wire such that the taught wire thickness of Paquin et al. is a diameter would have been obvious based upon the joining cuffs of their wires being cylinders. It also oud have been obvious the apply a polylactic coating to the wire net struts as Paquin et al. also teach. These choices would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting range of wire diameters overlaps the instantly claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 5-9, and 16 are obvious over Winkelried et al. in view of Paquin et al.
Claims 1, 5-10, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Winkelried et al. in view of in view of Paquin et al. as applied to claims 1, 5-9, and 16 above, and further in view of Orlowski et al. (US PGPub No. 18/254312).
Winkelried et al. in view of Paquin et al. teach a stent that meets the limitations of instant claims 1, 5-9, and 16. The thickness of the polymer coating is not explicitly detailed.
Orlowski et al. teach a stent, a vascular implant, made of magnesium alloy which is provided with a polymer coating to permit added control and delay of its degradation (see abstract an paragraph 11). Their stents are composed of struts (net) (see paragraph 33; instant claim 6). Orlowski et al. envision the presence of zinc in the alloy at up 10 wt% along with other alloy components such as calcium (see paragraphs 25-26). The polymer is envisioned as several biodegradable varieties such as polylactide which is as exemplified (see paragraph 35 and example 2; instant claims 8-9). The coating layer of polymer is generally taught to be less than 200 nm thickness (see paragraph 34; instant claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the guidance of Orlowski et al. and add their biodegradable polymer coating with their taught thickness to the modified stent of Winkelried et al. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting range of coating thicknesses overlaps the instantly claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 5-10, and 16 are obvious over Winkelried et al. in view of Paquin et al. and Orlowski et al.
Claims 1, 5-10, and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Winkelried et al. in view of in view of Paquin et al. as applied to claims 1, 5-9, and 16 above, and further in view of Toner et al. (previously cited).
Winkelried et al. in view of Paquin et al. teach a stent that meets the limitations of instant claims 1, 5-9, and 16. The spacing between wire/struts composing the stent structure is not detailed.
Toner teaches that stent struts are commonly separated by a distance of 60-80 mm which also imparts an upper limit of about 30 mm on its polymer coatings (see paragraph 76; instant claims 10 and 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the spaces between wires/struts in the stent of Winkelried et al. in view of Paquin et al. and Orlowski et al. and their biodegradable polymer layer thickness as taught by Toner et al. because they were known to be common and suitable for stents. The ranges meet or overlaps that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 5-10, and 15-16 are obvious over Winkelried et al. in view of Paquin et al. and Toner et al.
Claims 1, 5-6, 8-10, 13-14, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Tong et al. (Journal of Alloys and Compounds 2019 785:410-421) in view of Paquin et al.
Tong et al. teach biodegradable magnesium alloy envisioned biomedical applications such as implants (see abstract and page 410 first column). They describe the alloy as being composed of zinc at 4.802 wt%, calcium at 0.514 wt%, manganese at 0.281 wt%, iron at 0.001 wt%, aluminum at 0.01 wt% and the balance magnesium (see table 1). Thus the total proportion of elements categorized as microalloying elements is 0.282 wt% (see instant claim 1). Tong et al. detail refining the grain size of the alloy via a pressing technique to improve its mechanical properties (see abstract). They teach a product of the pressing to have a grain size of 0.9 mm (see page 420 first column item 1; instant claims 5 and 13-14). Vascular support implants are not explicitly detailed.
Paquin et al. teach a bioabsorbable stent made of materials envisioned to be magnesium and its alloys (see abstract). The struts of the stent are configured as a wire net that permits joining of the components without deleteriously impacting the mechanical or resorptive properties of the alloy (see paragraphs 2 and 5). They particularly envision alloys that include zinc as well as calcium that are free of rare earth metals (see paragraphs 32-33). Paquin et al. teach the thickness of the wire to be 50 to 150 microns (see paragraph 33; instant claim 7). They detail joining cuffs for the ends of the wire components to be tubular or cylindrical (see paragraph 43). They also envision the stent coated with a degradable polymer such as polylactic acid to extend the absorption time (see paragraph 39; instant claims 8-9).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to employ the pressed alloy of Tong et al. in a stent with a design as detailed by Paquin et al. This choice would have been obvious as a particular known implant where magnesium alloys were known to be useful. It additionally would have been obvious to apply a biodegradable coating of Paquin et al. to the stent. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. A cylindrical wire such that the taught wire thickness of Paquin et al. is a diameter would have been obvious based upon the joining cuffs of their wires being cylinders. Therefore claims 1, 5-9, 13-14, and 16 are obvious over Tong et al. in view of Paquin et al.
Claims 1, 3, 5-6, 8-9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al.
Sasaki et al. teach a bioabsorbable stent comprising a magnesium alloy as the core component of its struts which are coated with a corrosion resistant material (see abstract). The magnesium alloy is free of rare earth elements and aluminum (see paragraph 12). In addition, the magnesium alloy is composed of 0.95 wt% to 2 wt% zinc and has a grain size of 1 to 3 mm (see paragraph 40; instant claims 1, 5, and 13-14). Manganese is present in the alloy at 0.05 to 0.4 wt% and calcium may be present at 0.05 to 0.2 wt% (see paragraphs 40 and 84; instant claims 1 and 3). Iron is present at less than 30 ppm, as an unavoidable impurity (see paragraph 86; instant claim 1). They detail the stent structure to be in accordance with figure 2 or 3 which depicts a wire/net configuration (see paragraphs 93-94; instant claim 6). Further Sasaki et al. teach that a biodegradable polymer layer may also be present on the stent and composed of various polymers such as polycaprolactone and poly(lactic acid-co-glycolic acid) (see paragraph 109; instant claims 8-9).
While a full example of each embodiment that follows from the teachings of Sasaki et al. is not detailed, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow their guidance and make a stent with magnesium alloy components in the range of proportions that they teach. The range for calcium, zinc, and grain size silicon overlap with those instantly recited, thereby rendering the claimed ranges obvious (see MPEP 2144.05). The application of a biodegradable polymer coating as they detail also would follow. Therefore claims 1, 3, 5-6, 8-9, and 13-14 are obvious over Sasaki et al.
Claims 1, 3, 5-9, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. as applied to claims 1, 3, 5-6, 8-9, and 13-14 above, and further in view of Hayashi et al (previously cited).
Sasaki et al. teach a stent that meets the limitations of instant claims 1, 3, 5-6, 8-9, and 13-14. The diameter of the wire composing the structure is not detailed.
Hayashi et al. teach stents composed of a magnesium alloy wire shaped as a mesh (net) (see paragraphs 7-9; instant claims 1 and 6). The wire diameter ranges from 5 to 100 mm (see paragraph 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the stent of Sasaki et al. as wires with sizes as taught by Hayashi et al. because it was known to be suitable and desirable for magnesium alloy stents. The range of wire diameters embraces that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-9, and 13-14 are obvious over Sasaki et al. in view of Hayashi et al.
Claims 1, 3, 5-6, 8-10, and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. as applied to claims 1, 3, 5-6, 8-9, and 13-14 above, and further in view of Orlowski et al.
Sasaki et al. teach a stent that meets the limitations of instant claims 1, 3, 5-6, 8-9, and 13-14. The thickness of the biodegradable polymer coating layer is not detailed.
Orlowski et al. teach a stent, a vascular implant, made of magnesium alloy which is provided with a polymer coating to permit added control and delay of its degradation (see abstract an paragraph 11). Their stents are composed of struts (net) (see paragraph 33; instant claim 6). Orlowski et al. envision the presence of zinc in the alloy at up 10 wt% along with other alloy components such as calcium (see paragraphs 25-26). The polymer is envisioned as several biodegradable varieties such as polylactide which is as exemplified (see paragraph 35 and example 2; instant claims 8-9). The coating layer of polymer is generally taught to less than 200 nm thickness (see paragraph 34; instant claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the guidance of Orlowski et al. concerning the thickness of a biodegradable polymer coating to employ on a magnesium alloy stent to inform the thickness employed for the same variety of coating on the stent of Sasaki et al. This choice would have been obvious because it was known to be suitable and desirable for magnesium alloy stents. The resulting range overlaps that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05; instant claim 10). Therefore claims 1, 3, 5-6, 8-10, and 13-14 are obvious over Sasaki et al. in view of Orlowski et al.
Claims 1, 3, 5-6, 8-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Sasaki et al. as applied to claims 1, 3, 5-6, 8-9, and 13-14 above, and further in view of Toner et al.
Sasaki et al. teach a stent that meets the limitations of instant claims 1, 3, 5-6, 8-9, and 13-14. The spacing between wire/struts composing the stent structure is not detailed.
Toner teaches that stent struts are commonly separated by a distance of 60-80 mm which also imparts an upper limit of about 30 mm on its polymer coatings (see paragraph 76; instant claims 10 and 15).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the spaces between struts in the stent of Sasaki et al. and their biodegradable polymer layer thickness as taught by Toner et al. because they were known to be common and suitable for stents. The ranges meet or overlaps that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-6, 8-10, and 13-15 are obvious over Sasaki et al. in view of Toner et al.
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, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a vascular support implant comprising a magnesium alloy. The patented claims recite the alloy to have 1.5 to 5.5 wt% zinc, as well as 0.5 to 2 wt% aluminum. These ranges meet or overlap with those instantly recited for the zinc and microalloying element, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Silicon, iron, and manganese may be present as microalloying components, however a maximum of 0.0063 wt% of such impurities is recited. Further, the patented claims recite the grain size to be less than 2.5 mm. Rare earth elements are not explicitly excluded.
Sasaki et al. teach that rare earth elements are a safety hazard to the human body and therefore detail their exclusion from magnesium alloys employed in stents (see paragraphs 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the guidance of the patented claims and employ its alloys in such a device because it is a recited particular variety of their implant. The range for element proportions overlap that instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). It also would have been obvious to exclude rare earth elements in light of Sasaki et al. as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3, 5, and 13-14 are obvious over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al.
Claims 1, 3, 5-7, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 5, and 13-14 of U.S. Patent No. 10,895,000 in view of Sasaki et al. as applied to claims 1, 3, 5, and 13-14 above, further in view of Hayashi et al.
Claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. render obvious the limitations of instant claims 1, 3, 5, and 13-14. The alloy as a wire and a polymer coating are not detailed.
Hayashi et al. teach stents composed of a magnesium alloy wire shaped as a mesh (net) (see paragraphs 7-9; instant claims 1 and 6). The wire diameter ranges from 5 to 100 mm (see paragraph 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the stent of the modified patented claims as wires with sizes as taught by Hayashi et al. because it was known to be suitable and desirable for magnesium alloy stents. The range of wire diameters embraces that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-7, and 13-14 are obvious over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. and Hayashi et al.
Claims 1, 3, 5-10, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 5-7, and 13-14 above, and further in view of Orlowski et al.
Claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 5-7, and 13-14. The presence of a polymer coating as instantly claimed is not detailed.
Orlowski et al. teach a stent, a vascular implant, made of magnesium alloy which is provided with a polymer coating to permit added control and delay of its degradation (see abstract an paragraph 11). Their stents are composed of struts (net) (see paragraph 33). Orlowski et al. envision the presence of zinc in the alloy at up 10 wt% along with other alloy components such as calcium (see paragraphs 25-26). The polymer is envisioned as several biodegradable varieties such as polylactide which is as exemplified (see paragraph 35 and example 2). The coating layer of polymer is generally taught to less than 200 nm thickness (see paragraph 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the guidance of Orlowski et al. and add their biodegradable polymer coating with their taught thickness to the modified stent of the patented claims. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting range of coating thicknesses overlaps the instantly claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-10, and 13-14 are obvious over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al., Hayashi et al., and Orlowski et al.
Claims 1, 3, 5-7, 10, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 5-7, and 13-14 above, and further in view of Toner et al.
Claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 5-7, and 13-14. The spacing between wire/struts composing the stent structure is not detailed.
Toner teaches that stent struts are commonly separated by a distance of 60-80 mm which also imparts an upper limit of about 30 mm on its polymer coatings (see paragraph 76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the spaces between struts in the stent of the modified patented claims and their biodegradable polymer layer thickness as taught by Toner et al. because they were known to be common and suitable for stents. The ranges meet or overlap those instantly recited, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-7, 10, and 13-15 are obvious over claims 1, 4, 7, 14, 16 and 19 of U.S. Patent No. 10,895,000 in view of Sasaki et al., Hayashi et al., and Toner et al.
Claims 1, 3, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a vascular support implant comprising a magnesium alloy. The patented claims recite the alloy to have 10 to 40 wt% zinc and 0 to 20 wt% of one or more of calcium, yttrium, silicone, aluminum, or lanthanide. They also recite 0.1 to 20 wt% of calcium in the alloys. These ranges meet or overlap with those instantly recited for the zinc and microalloying element, thereby rendering the claimed ranges obvious (see MPEP 2144.05). None of silver, iron, manganese, or silicon are required components. Rare earth elements are not explicitly excluded.
Sasaki et al. teach that rare earth elements are a safety hazard to the human body and therefore detail their exclusion from magnesium alloys employed in stents (see paragraphs 11-12).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the guidance of the patented claims and employ its alloys in such a device because it is a recited particular variety of their implant. The range for element proportions overlap that instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). It also would have been obvious to exclude rare earth elements in light of Sasaki et al. as the application of the same technique to a similar product in order to yield the same improvement. Therefore claims 1, 3, and 16 are obvious over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al.
Claims 1, 3, 6-7, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. as applied to claims 1, 3, and 16 above, further in view of Hayashi et al.
Claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. render obvious the limitations of instant claims 1, 3, and 16. The alloy as a wire and a polymer coating are not detailed.
Hayashi et al. teach stents, a vascular support implant, composed of a magnesium alloy wire shaped as a mesh (net) (see paragraphs 7-9; instant claims 1 and 6). The wire diameter ranges from 5 to 100 mm (see paragraph 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure a stent of the modified patented claims as wires with sizes as taught by Hayashi et al. because it was known to be suitable and desirable for magnesium alloy vascular implants and stents are known varieties of such magnesium alloy implants. The range of wire diameters embraces that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-7, and 16 are obvious over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. and Hayashi et al.
Claims 1, 3, 6-10, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 6-7, and 16 above, and further in view of Orlowski et al.
Claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 6-7, and 16. The presence of a polymer coating as instantly claimed is not detailed.
Orlowski et al. teach a stent, a vascular implant, made of magnesium alloy which is provided with a polymer coating to permit added control and delay of its degradation (see abstract an paragraph 11). Their stents are composed of struts (net) (see paragraph 33). Orlowski et al. envision the presence of zinc in the alloy at up 10 wt% along with other alloy components such as calcium (see paragraphs 25-26). The polymer is envisioned as several biodegradable varieties such as polylactide which is as exemplified (see paragraph 35 and example 2). The coating layer of polymer is generally taught to less than 200 nm thickness (see paragraph 34).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the guidance of Orlowski et al. and add their biodegradable polymer coating with their taught thickness to the modified stent of the patented claims. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting range of coating thicknesses overlaps the instantly claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-10, and 16 are obvious over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al., Hayashi et al., and Orlowski et al.
Claims 1, 3, 6-7, 10, 13, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 6-7, and 16 above, and further in view of Toner et al.
Claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 6-7, and 16. The spacing between wire/struts composing the stent structure is not detailed.
Toner teaches that stent struts are commonly separated by a distance of 60-80 mm which also imparts an upper limit of about 30 mm on its polymer coatings (see paragraph 76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the spaces between struts in the stent of the modified patented claims and their biodegradable polymer layer thickness as taught by Toner et al. because they were known to be common and suitable for stents. The ranges meet or overlap those instantly recited, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Therefore claims 1, 3, 6-7, 10, 13, and 16 are obvious over claims 1, 10, and 14 of U.S. Patent No. 9,700,652 in view of Sasaki et al., Hayashi et al., and Toner et al.
Claims 1, 3, 5-7, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al.
Although the claims at issue are not identical, they are not patentably distinct from each other because both claim a cardiovascular implant comprising a magnesium alloy. The patented claims recite the alloy to have 3 to 7 wt% zinc, 0.001 to 0.5 wt% calcium, and limit the total impurities to no more than 0.0048 wt%, where manganese, iron, silicon and rare earths are envision varieties. These ranges meet or overlap with those instantly recited for the zinc and microalloying element, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Further, the patented claims recite the grain size to be less than 7.5 mm. Rare earth elements are not explicitly excluded.
Sasaki et al. teach that rare earth elements are a safety hazard to the human body and therefore detail their exclusion from magnesium alloys employed in stents (see paragraphs 11-12).
Hayashi et al. teach stents, a variety of vascular support implant, composed of a magnesium alloy wire shaped as a mesh (net) (see paragraphs 7-9; instant claims 1 and 6). The wire diameter ranges from 5 to 100 mm (see paragraph 15; instant claim 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to follow the guidance of the patented claims and employ its alloys in an implant because they recite to do so. The range for element proportions overlap that instantly claimed, thereby rendering the claimed ranges obvious (see MPEP 2144.05). It also would have been obvious to exclude rare earth elements in light of Sasaki et al. as the application of the same technique to a similar product in order to yield the same improvement. Configuration of the cardiovascular implant as a stent, in light of Hayashi et al., would have been obvious because it is particular variety of cardiovascular implant where magnesium alloys were known to be useful. Design of the stent of the modified patented claims as wires with sizes as taught by Hayashi et al. would follow. The range of wire diameters embraces that instantly recited, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-7, and 13-14 are obvious over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al.
Claims 1, 3, 5-10, and 13-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 5-7, and 13-14 above, and further in view of Orlowski et al.
Claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 5-7, and 13-14. The presence of a polymer coating as instantly claimed is not detailed.
Orlowski et al. teach a stent, a vascular implant, made of magnesium alloy which is provided with a polymer coating to permit added control and delay of its degradation (see abstract an paragraph 11). Their stents are composed of struts (net) (see paragraph 33; instant claim 6). Orlowski et al. envision the presence of zinc in the alloy at up 10 wt% along with other alloy components such as calcium (see paragraphs 25-26). The polymer is envisioned as several biodegradable varieties such as polylactide which is as exemplified (see paragraph 35 and example 2; instant claims 8-9). The coating layer of polymer is generally taught to less than 200 nm thickness (see paragraph 34; instant claim 10).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to apply the guidance of Orlowski et al. and add their biodegradable polymer coating with their taught thickness to the modified stent of the patented claims. This choice would have been obvious as the application of the same technique to a similar product in order to yield the same improvement. The resulting range of coating thicknesses overlaps the instantly claimed range, thereby rendering the claimed range obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-10, and 13-14 are obvious over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al., Hayashi et al., and Orlowski et al.
Claims 1, 3, 5-7, 10, and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al. as applied to claims 1, 3, 5-7, and 13-14 above, and further in view of Toner et al.
Claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al. and Hayashi et al. render obvious a stent that meets the limitations of instant claims 1, 3, 5-7, and 13-14 4. The spacing between wire/struts composing the stent structure is not detailed.
Toner teaches that stent struts are commonly separated by a distance of 60-80 mm which also imparts an upper limit of about 30 mm on its polymer coatings (see paragraph 76).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to size the spaces between struts in the stent of the modified patented claims and their biodegradable polymer layer thickness as taught by Toner et al. because they were known to be common and suitable for stents. The ranges meet or overlap those instantly recited, thereby rendering the claimed ranges obvious (see MPEP 2144.05). Therefore claims 1, 3, 5-7, 10, and 13-15 are obvious over claims 1-8, 13-16, 19-20 of U.S. Patent No. 10,358,709 in view of Sasaki et al., Hayashi et al., and Toner et al.
Response to Arguments
Applicant's arguments filed May 5, 2026 have been fully considered. In light of the amendment to the claims, the rejections under 35 USC 112 are hereby withdrawn. Upon further consideration, rejections reliant upon Stekker et al. are also withdrawn. New grounds of rejection are made and modified versions of the previous grounds of rejection are detailed in light of amendment. The applicant’s arguments are not persuasive.
The applicant argues that the explicit exclusion of unavoidable impurities in the claims should be permitted and note their attempt to capture the interpretation employed by the Advisory Action of a previous proposed amendment. The issue of unavoidable impurities was raised with claim 16 in the most recent office action due to its closed claim language and absence of magnesium as a recited component. The amendment raises clarity issues, as noted in the new rejection under 35 USC 112(b), due to the overlap in scope between the recited micro-alloying elements and known unavoidable impurities. The applicant’s choice of claim construction makes it unclear which components are permissible and which proportions of the components are permissible. The fact pattern of the case law cited by the applicant in reference to reciting “unavoidable impurities” in the absence of their discussion in the instant disclosure does not match the instant situation. In the case law’s situation, a recitation of “consisting essentially of” component X was deemed indefinite because the permissible amount was not disclosed. This transitional phrasing is partially closed. Here, the preamble recited closed language, where the body of the claim did not match the description of the product in the preamble, such that the body did not permit both essential and unavoidable components. The issue of unpredictability raised was this contradiction, not concerning the proportion of known alloying elements, as the applicant argues
The applicant additionally argues that Stekker et al. teach away from the instant invention. This argument appears to overlook the rejection of most of the instant claims over prior art that does not rely upon Stekker et al. The applicant’s highlighting of the preference by Stekker et al. for proportions of zinc at the low end of and below the range instantly claimed is acknowledged. However, the presence of zinc is nuanced and Stekker et al. do not state a strict teaching away, as the applicant appears to argue. Zinc provides benefits for casting and increases corrosion rate with increasing proportion, which may or may not be useful for the end use, depending on the desired degradation rates (see paragraph 32).
The applicant argues that a recognition of the suitability and desire to use a material for a particular end is insufficient for obviousness. MPEP 2141.03(I) notes that “[a] person of ordinary skill in the art is also a person of ordinary creativity, not an automaton." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 421, 82 USPQ2d 1385, 1397 (2007). ‘[I]n many cases a person of ordinary skill will be able to fit the teachings of multiple patents together like pieces of a puzzle.’ Id. at 420, 82 USPQ2d 1397. Office personnel may also take into account ‘the inferences and creative steps that a person of ordinary skill in the art would employ.’ Id. at 418, 82 USPQ2d at 1396”. Thus the recognized utility of a component for a desired end paired with the knowledge and creativity of the artisan of ordinary skill is sufficient to support a rationale for obviousness. Prior art of record and additional cited prior art still teaches alloys within the instant claim scope as constituents of vascular supports.
The also applicant argues that the alloy of Sasaki et al. does not meet the limitations of the instantly claimed alloy of claim 1 because of the presence of zirconium. They also argue that it would not have been obvious to exclude zirconium as a component from the alloy of Sasaki et al. The rejection does not suggest or mention the exclusion of zirconium from the alloy of Sasaki et al.; therefore the argument concerning exclusion of zirconium is not addressing the conclusions of the rejection of record. The instant claim recites the components of the alloy with open claim language by employing the terms “including” and “comprises”. MPEP 2111.03(I) states that “[t]he transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004)”. Thus unrecited components are permitted in the instantly claimed alloy such hat the presence of zirconium does not preclude the alloy of Sasaki et al. from meeting the instant claim limitations.
Conclusion
No claim is allowed.
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/CARALYNNE E HELM/ Examiner, Art Unit 1615
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