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 .
Applicant is reminded of the requirement to mark changes to the claims that are made via amendment, as detailed in MPEP 714.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 16 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention.
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
The invention relates to a vascular support implant comprising a magnesium alloy “consisting of: 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.”. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. The claim initially recites that the vascular support implant comprises a magnesium alloy. However, the recitation reciting the components that are permitted in the magnesium alloy do not include magnesium, given the absence of this component in the “consisting of” language employed to limit the scope of the magnesium alloy. Sasaki et al. detail that magnesium alloys contain unavoidable impurities that include iron, nickel, cobalt, and copper (see US PGPub No. 2021/0001013 paragraph 42). The instant claim scope excludes several of these unavoidable impurities from its magnesium alloy.
The instant disclosure includes no examples or discussion about how the magnesium alloy is made or any discussion of how to eliminate impurities that are considered unavoidable by the art. Thus no guidance is provided for how to make a magnesium alloy in accordance with the claim.
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed product could be made. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the invention claimed in the patent a person of ordinary skill in the art would have to engage in undue experimentation, with no assurance of success.
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 16 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.
The claim recites “a vascular support implant comprising a magnesium alloy consisting of: 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.” The proportions of the only permitted components in the magnesium alloy do not add to 100%. In spite of being called a “magnesium alloy”, magnesium is not a permitted component, due to the “consisting of” language. As a result, the metes and bounds of the “magnesium alloy” and the product as a whole are unclear.
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, 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. “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). 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 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 Stekker 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 thickness of the biodegradable polymer coating layer is not detailed.
Stekker et al. teach a stent, a vascular implant, made of magnesium alloy (see abstract). Their stents are net shaped endoprosthesis composed of struts that are as thin as possible (wire) (see paragraph 112; instant claim 6). Another example contains zinc and zirconium at the same weight proportions and is further coated with a copolymer of polylactide and polyglycolide (biodegradable polymer) (see example 7; instant claims 8-9). The coating layer of polymer is generally taught to range from 10 nm to 100 mm in thickness (see paragraph 146).
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 Stekker 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 Stekker 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. (US PGPub No. 2006/0198867).
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 claim 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).
While a single claim lineage does not recite all the claimed component elements at the claimed proportion in an vascular implant, specifically, 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 la 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, 5-10, 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. and Stekker 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).
Stekker et al. disclose stents made of magnesium alloy (see abstract). Their stents are net shaped endoprosthesis composed of struts that are as thin as possible (wire) (see paragraph 112). The presence of some impurities is generally unavoidable (see paragraph 41). Silicon is the main ingredient of such impurities that are present at up to 0.4 wt%, while non-silicon impurities such as are present at less than 0.3 wt% (see paragraph 41). An example contains zinc and zirconium at the same weight proportions and is further coated with a copolymer of polylactide and polyglycolide (degradable polymer) (see example 7; instant claims 8-9). The coating layer of polymer is generally taught to range from 10 nm to 100 mm (see paragraph 146). The polymer regulates the rate of degradation of the alloy (see paragraph 135).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a biodegradable polymer coating as detailed by Stekker et al. to control the degradation of the modified patented polymer. This modification is obvious as the application of the same technique to a similar product in order to yield the same improvement. The polymer thickness is a range that embraces that instantly claimed, thereby rendering the claimed range obvious (see MPEP 2144.05). It additionally would have been obvious to produce the stent from a wire sized as detailed by Hayashi et al. because it was a known way to configure a similar magnesium, alloy as a stent. 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 Stekker et al.
Claims 1, 3, 5-10, 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., Hayashi et al., and Stekker et al. as applied to claims 1, 3, 5-10, 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., Hayashi et al., and Stekker et al. render obvious a stent that meets the limitations of instant claims 1, 3, 5-10, 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 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, 5-6, 8-10, 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., Stekker et al., and Toner et al.
Response to Arguments
Applicant's arguments filed October 24, 2025 have been fully considered. In light of the amendment to the claimed, the previous grounds of rejection are withdrawn. New grounds of rejection are detailed to address the new claim limitations.
Conclusion
No claim is allowed.
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 CARALYNNE E HELM whose telephone number is (571)270-3506. The examiner can normally be reached Mon-Fri 9-5.
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/CARALYNNE E HELM/Examiner, Art Unit 1615
/MELISSA S MERCIER/Primary Examiner, Art Unit 1615