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 pending application was filed July 28, 2022. Applicant’s claim to priority as detailed in [0001]-[0006] is acknowledged. The earliest priority date is June 24, 2014.
The pending application is afforded a priority date of filing of July 28, 2022.
The following priority documents are directed to Mo-Re alloys that are outside the scope of the claimed refractory alloy: 62/016,189 (June 14, 2014); 18/320,830 (May 5, 2015); 17/512,174 (December 21, 2016); and 17/512,174 (October 27, 2021).
The following priority documents are directed to ReW alloys without details regarding the relative percentages and/or without disclosing a refractory alloy with “at least 50 wt.% niobium or tantalum or tungsten”: 63/226,270 (July 28, 2021) and 63/389,481 (July 15, 2022).
The following priority documents require Cr and Re in the alloy in amounts that are outside the scope of the pending refractory alloy: 17/586,270 (January 27, 2022) and 63/316,077 (March 3, 2022).
The following priority document discloses an alloy substantially broader than that claimed, including grouping the elected rhenium “metal additive” with the niobium, tantalum, or tungsten: 63/247,540 (September 23, 2021).
Information Disclosure Statement
The information disclosure statement filed December 7, 2022 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed.
The following foreign patent documents were not considered because a copy was not provided:
EP 1491651; SU 26388; WO 1993/019803; WO 1995/030384; WO 2000/012175; WO 2004/019822; WO 2014/0079591
Response to Restriction Election
Applicant’s election of the following in the reply filed on December 5, 2025 is acknowledged:
Group I, drawn to a medical device.
Species Alloy-II with a rhenium metal additive.
Species Expand-V.
Species Implant-II.
Species Mechanical-I.
Species MD-III, which is noted as generic to and encompassing Species MD-I-II and Species MD-IV-V.
Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
This Office Action is in response to Applicant’s Restriction Election and Claim Amendments filed December 5, 2025.
Claims Filing Date
December 5, 2025
Amended
1, 30, 39, 40, 45, 51
Cancelled
3-5, 11-29, 33-35, 41-43, 46, 48-50
Under Examination
1, 2, 6-10, 30-32, 36-40, 44, 45, 47, 51
Drawings Objection
The drawings are objected to because
The graph in Fig. 5 does not include labels for the x and y axes.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claims 1, 30, 39, 40, 44, 45, 47, and 51 are objected to because of the following informalities:
Claim 1 lines 19-21 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Claim 30 lines 13-15 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Claim 39 lines 8-10 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Claim 40 lines 8-10 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Claim 44 line 7 “after inserted or implanted” is grammatically incorrect.
Claim 44 lines 1-7 “said metal alloy has a hydrophilicity…; said metal alloy has a maximum ion release…; said metal alloy has an absolute increase…” is missing a conjunction between the last two claim limitations.
Claim 45 lines 8-10 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Claim 47 lines 1-7 “said metal alloy has a hydrophilicity…; said metal alloy has a maximum ion release…; said metal alloy has an absolute increase…” is missing a conjunction between the last two claim limitations.
Claim 51 lines 9-11 “said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium” is grammatically incorrect. Between “metal additive” and the list of elements a transition is missing. The list of elements is missing a conjunction between the last two elements.
Appropriate correction is required.
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, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 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 line 4 “said expandable metal frame is expandable to an outer diameter of at least 25 mm” renders the claim indefinite. Does this limitation require the metal frame of the medical device product to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm? For the purpose of examination claim 1 will be interpreted as requiring the metal frame of the medical device to perform the function.
Claim 1 lines 7-13 “two or more features selected from the group consisting of a).., b)…, c)…, d)…, and/or e)…”renders the claim indefinite. Are two features required because the claim recites “two or more” of a)-e) or is one feature required because the claim includes the conjunction “or” for the features, which connects alternatives? For the purpose of examination claim 1 will be interpreted as requiring two or more features.
Claim 1 line 8 “a) a plurality of strut joints that is less than 0.7 mm” renders the claim indefinite. How can a plurality of strut joints be less than 0.7 mm? Are the plurality of strut joints added together to be less than 0.7 mm? What about the plurality of strut joints is less than 0.7 mm? Is it their length or width or diameter or thickness? Applicant’s specification at [00204] and Figs. 2A-2B disclose a struct joint width, SJW. For the purpose of examination claim 1 will be interpreted as a) requiring a plurality of strut joints, with each of the plurality of strut joints having a width (SJW) of less than 0.7 mm.
Claim 1 line 9 “said strut” renders the claim indefinite. There is insufficient antecedent basis. Claim 1 previously refers to “a plurality of struts”, but not “a strut”.
Claim 1 line 12 “said crimped state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 1 line 13 “said crimped state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 6 lines 1-2 “I) has a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy on said expandable metal frame is 24-45°” renders the claim indefinite. What is “on said expandable metal frame”, the water droplet or the refractory metal alloy? How can the contact angle of the water droplet be both on “a surface of said refractory metal alloy” and “on said expandable metal frame”? For the purpose of examination claim 6 will be interpreted as I) requiring a water droplet on a surface of said refractory metal alloy that the expandable metal frame is formed of.
Claim 6 lines 4-7 “II) said refractory metal alloy on said expandable metal frame has a maximum ion release of a primary component of said refractory metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 6 depends from claim 1. Claim 1 recites in line 5 “said expandable metal frame is formed of a refractory metal alloy”. How can the expandable metal frame both be formed of the refractory metal alloy (claim 1 line 5), but also require the refractory metal alloy to be on the frame (claim 6 line 4)? Claim 1 recites a refractory metal alloy composition in lines 14-21. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 6 will be interpreted as requiring the expandable metal frame to be formed of said refractory metal alloy, a “primary component” refers to any component of the refractory metal alloy that is “at least 2 wt.%”, and the alloy is placed on or inserted or implant in the body.
Claim 7 line 2 “an expandable graph” renders the claim indefinite. What medical device is an expandable graph? A graph is defined as a diagram showing a relationship between variables.
Claim 8 lines 4-10 “A) has at least 10% less material as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium- nickel alloy that can be expanded to an outer diameter of at least 25 mm; said expandable metal frame has a same or greater ultimate tensile strength, greater yield strength, greater elastic deformation latitude, greater stress to plastic deformation and failure, greater stiffness, greater strength, greater durability, and/or greater fatigue ductility as compared to a said similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy” renders the claim indefinite.
How are “at least 10% less material”, ultimate tensile strength, yield strength, elastic deformation latitude, stress to plastic deformation and failure, stiffness, strength, durability, and fatigue ductility assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 8 A) will be interpreted as reciting properties of the metal frame formed of a refractory metal as recited in claim 1.
Claim 8 lines 10-13 “B) has at least 10% greater conformity to a treatment area when expanded as comparted to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least 10% greater conformity to a treatment area assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 8 B) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 8 lines 13-15 “C) has at least a 10% greater hydrophilicity as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least a 10% greater hydrophilicity assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 8 C) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 8 lines 15-18 “D) has at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 8 D) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 30 line 2 “inserted or implanted on…the body” renders the claim indefinite. The terms “inserted” and “implanted” require something placed into something else. How can the medical device be both “on” the body and inserted or implanted (inside)? For the purpose of examination claim 30 will be interpreted as requiring the alloy to be placed on or inserted or implanted in the body.
Claim 30 line 20 “said crimped state to said expanded state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 30 line 21 “said crimped state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 30 lines 23-26 “e) a maximum ion release of a primary component of said refractory metal alloy from said expandable metal frame when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 30 recites a refractory metal alloy composition in lines 8-15. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 30 will be interpreted as a “primary component” referring to any component of the refractory metal alloy that is “at least 2 wt.%” and the alloy is placed on or inserted or implant in the body.
Claim 30 lines 26-29 “f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said expandable metal frame medical device after said expandable metal frame is inserted or implanted on or in the body of a patient for at least 90 days” renders the claim indefinite.
What is an absolute increase in ion release and how is it assessed? What is the dose of? Why does “50” not have units? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 30 f) will be interpreted as reciting a property of the metal frame formed of a refractory metal, where the alloy is placed on or inserted or implant in the body.
Claim 31 line 2 “said expandable metal frame is expandable to an outer diameter of at least 25 mm” renders the claim indefinite. Does this limitation require the metal frame of the medical device product to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm? For the purpose of examination claim 31 will be interpreted as requiring the metal frame of the medical device to perform the function.
Claim 31 lines 2-3 “at least 50 wt.% of said expandable metal frame is formed of a refractory metal alloy” renders the claim indefinite. How does “a refractory metal alloy” of dependent claim 31 relate to “a refractory metal alloy” of independent claim 30, such as in lines 3 and 7-16? Is claim 31 limited to the same refractory alloy recited in claim 30 or does any refractory metal alloy satisfy claim 31? For the purpose of examination claim 31 will be interpreted as requiring any refractory alloy, such that it is not limited by a refractory metal alloy composition recited in claim 30.
Claim 31 line 4 “said medical device” renders the claim indefinite. There is insufficient antecedent basis. Claim 31 depends from claim 30, which recites in line 1 “An expandable medical device”. Is the medical device of claim 31 also expandable?
Claim 31 line 5 “a) a plurality of strut joints that is less than 0.7 mm” renders the claim indefinite. How can a plurality of strut joints be less than 0.7 mm? Are the plurality of strut joints added together to be less than 0.7 mm? What about the plurality of strut joints is less than 0.7 mm? Is it their length or width or diameter or thickness? Applicant’s specification at [00204] and Figs. 2A-2B disclose a struct joint width, SJW. For the purpose of examination claim 31 will be interpreted as a) requiring a plurality of strut joints, with each of the plurality of strut joints having a width (SJW) of less than 0.7 mm.
Claim 36 lines 2-4 “I) has a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy on said expandable metal frame is 24-45°” renders the claim indefinite. What is “on said expandable metal frame”, the water droplet or the refractory metal alloy? How can the contact angle of the water droplet be both on “a surface of said refractory metal alloy” and “on said expandable metal frame”? For the purpose of examination claim 36 will be interpreted as I) requiring a water droplet on a surface of said refractory metal alloy that the expandable metal frame is formed of.
Claim 36 lines 4-7 “II) said refractory metal alloy on said expandable metal frame has a maximum ion release of a primary component of said refractory metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 36 depends from claim 30. Claim 30 recites in line 3 “expandable metal frame that is at least partially formed of a refractory metal alloy”. How can the expandable metal frame both be formed of the refractory metal alloy (claim 30 line 3), but also require the refractory metal alloy to be on the frame (claim 36 line 4)? Claim 30 recites a refractory metal alloy composition in lines 8-15. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 36 will be interpreted as requiring the expandable metal frame to be formed of said refractory metal alloy, a “primary component” refers to any component of the refractory metal alloy that is “at least 2 wt.%”, and the alloy is placed on or inserted or implant in the body.
Claim 37 line 2 “an expandable graph” renders the claim indefinite. What medical device is an expandable graph? A graph is defined as a diagram showing a relationship between variables.
Claim 38 lines 4-10 “A) has at least 10% less material as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium- nickel alloy that can be expanded to an outer diameter of at least 25 mm; said expandable metal frame has a same or greater ultimate tensile strength, greater yield strength, greater elastic deformation latitude, greater stress to plastic deformation and failure, greater stiffness, greater strength, greater durability, and/or greater fatigue ductility as compared to a said similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy” renders the claim indefinite.
How are “at least 10% less material”, ultimate tensile strength, yield strength, elastic deformation latitude, stress to plastic deformation and failure, stiffness, strength, durability, and fatigue ductility assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 38 A) will be interpreted as reciting properties of the metal frame formed of a refractory metal as recited in claim 1.
Claim 38 lines 10-13 “B) has at least 10% greater conformity to a treatment area when expanded as comparted to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least 10% greater conformity to a treatment area assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 38 B) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 38 lines 13-15 “C) has at least a 10% greater hydrophilicity as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least a 10% greater hydrophilicity assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 38 C) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 38 lines 15-18 “D) has at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm” renders the claim indefinite.
How is at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel assessed for the expandable metal frame? How is a similar shaped frame identified? How can a frame be formed of a cobalt-chromium alloy and a titanium-nickel alloy? Does this limitation require the metal frame of the comparison to have an outer diameter of at least 25 mm or to be able to perform the function of expanding to an outer diameter of at least 25 mm?
For the purpose of examination claim 38 D) will be interpreted as reciting a property of the metal frame formed of a refractory metal as recited in claim 1.
Claim 39 lines 1-2 “inserted or implanted on…the body” renders the claim indefinite. The terms “inserted” and “implanted” require something placed into something else. How can the medical device be both “on” the body and inserted or implanted (inside)? For the purpose of examination claim 39 will be interpreted as requiring the alloy to be placed on or inserted or implanted in the body.
Claim 39 line 16 “said crimped state to said expanded state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 line 18 “said crimped state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 line 19 “said frame” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 line 20 “said frame” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 lines 19-22 “e) a maximum ion release of a primary component of said refractory metal alloy from said frame when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 39 recites a refractory metal alloy composition in lines 4-10. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 39 will be interpreted as a “primary component” referring to any component of the refractory metal alloy that is “at least 2 wt.%” and the alloy is placed on or inserted or implant in the body.
Claim 39 line 23 “said frame” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 lines 22-24 “f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said frame of said medical device after said expandable metal frame is inserted or implanted on or in the body of a patient for at least 90 days” renders the claim indefinite.
What is an absolute increase in ion release and how is it assessed? What is the dose of? Why does “50” not have units? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 39 f) will be interpreted as reciting a property of the metal frame formed of a refractory metal, where the alloy is placed on or inserted or implant in the body.
Claim 40 lines 12-13 “said refractory metal alloy has a greater fatigue ductility as compared to a cobalt-chromium alloy” renders the claim indefinite. How is fatigue ductility assessed for the refractory metal alloy? For the purpose of examination claim 40 will be interpreted as reciting a property of the refractory metal.
Claim 44 lines 1-2 “said metal alloy” renders the claim indefinite. There is insufficient antecedent basis. How does the “metal alloy” of claim 44 relate to the “refractory metal alloy” of claim 40?
Claim 44 lines 3-5 “said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 44 depends from claim 40. Claim 40 recites a refractory metal alloy composition in lines 4-10. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 44 will be interpreted as a “primary component” referring to any component of the refractory metal alloy that is “at least 2 wt.%” and the alloy is placed on or inserted or implant in the body.
Claim 44 lines 5-7 “said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient” renders the claim indefinite.
What is an absolute increase in ion release and how is it assessed? How much is a dose? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 44 will be interpreted as reciting a property of the metal frame formed of a refractory metal, where the alloy is placed on or inserted or implant in the body.
Claim 45 lines 13-14 “said refractory metal alloy has a greater fatigue ductility as compared to a cobalt-chromium alloy” renders the claim indefinite. How is fatigue ductility assessed for the refractory metal alloy? For the purpose of examination claim 40 will be interpreted as reciting a property of the refractory metal.
Claim 47 lines 1-2 “said metal alloy” renders the claim indefinite. There is insufficient antecedent basis.
Claim 47 lines 3-5 “said metal alloy has a maximum ion release of a primary component of said refractory metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 47 depends on claim 45. Claim 45 recites a refractory metal alloy composition in lines 4-10. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 47 will be interpreted as a “primary component” referring to any component of the refractory metal alloy that is “at least 2 wt.%” and the alloy is placed on or inserted or implant in the body.
Claim 47 lines 5-7 “said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient” renders the claim indefinite.
What is an absolute increase in ion release and how is it assessed? How much is a dose? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 47 will be interpreted as reciting a property of the metal frame formed of a refractory metal, where the alloy is placed on or inserted or implant in the body.
Claim 51 lines 1-2 “inserted or implanted on…the body” renders the claim indefinite. The terms “inserted” and “implanted” require something placed into something else. How can the metal alloy be both “on” the body, but also inserted or implanted? For the purpose of examination claim 51 will be interpreted as the alloy being placed on or inserted or implant in the body.
Claim 51 line 17 “said crimped state to said expanded state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 39 line 18 “said crimped state” renders the claim indefinite. There is insufficient antecedent basis.
Claim 51 lines 20-23 “e) a maximum ion release of a primary component of said refractory metal alloy from said frame of said medical device when said frame is inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy” renders the claim indefinite.
Claim 51 recites a refractory metal alloy composition in lines 4-11. How does a “primary component” relate to “at least 50 wt.% of niobium or tantalum or tungsten and at least 0.1 wt.% metal additive…”? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 51 will be interpreted as a “primary component” referring to any component of the refractory metal alloy that is “at least 2 wt.%” and the alloy is placed on or inserted or implant in the body.
Claim 51 lines 23-26 “f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said frame of said medical device after said frame is inserted or implanted on or in the body of a patient for at least 90 days” renders the claim indefinite.
What is an absolute increase in ion release and how is it assessed? What is the dose of? Why does “50” not have units? The terms “insert” and “implant” require something placed into something else. How can the metal alloy be both “on” the body and also inserted or implanted (inside)?
For the purpose of examination claim 51 f) will be interpreted as reciting a property of the metal frame formed of a refractory metal, where the alloy is placed on or inserted or implant in the body.
Claim 2 is rejected as depending from claim 1.
Claims 9 and 10 are rejected as depending from claim 8.
Claim 32 is rejected as depending from claim 30.
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.
Claims 1, 2, 6, 7, 30, 32, 36, 37, 39, 40, 44, 45, 47, and 51 are rejected under 35 U.S.C. 103 as being unpatentable over Nagura (JP 2012-196264 machine translation) as evidenced by Cardarelli (Rhenium Alloys. Materials Handbook. 2nd ed. Francois Cardarelli, Springer-Verlag, London, 2008.).
Regarding claim 1, Nagura discloses a medical device for implantation into a body passageway (stent) ([0001], [0026]);
said medical device includes an expandable metal frame that is configured to expand in the body passageway when said medical device is positioned in a treatment site in the body passageway (expandable stent for use in treating a lumen in a living body) ([0001]);
said expandable metal frame is expandable to an outer diameter of at least 25 mm (1 to 50 mm) ([0027]);
at least 50 wt.% of said expandable metal frame is formed of a refractory metal alloy (W-Re alloy) ([0013], [0031]-[0035]);
said refractory metal alloy is not a self-expanding metal alloy (balloon expandable stent) ([0019], [0061]);
said expandable metal frame of said medical device includes a plurality of struts and strut joints (linear connecting members 13) ([0028]-[0030], Fig. 1);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc, Cardarelli W-26 Re) ([0035], [0060], [0063]);
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt% tungsten) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. MPEP 2144.05(I).
Regarding said expandable metal frame including two or more features selected from the group consisting of a) a plurality of strut joints that is less than 0.7 mm, b) a plurality of struts that have an average width along a longitudinal of said strut that is no more than 0.3 mm, c) a recoil percentage of less than 5% when said expandable metal frame is crimped to a crimped state, d) a recoil percentage of less than 5% when said expandable metal frame is expanded from said crimped state, and/or e) a longitudinal foreshortening percentage of less than 20% when said expandable metal frame is expanded from said crimped state, the features of c), d), and e) have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 2, i) a recoil percentage of no more than 2% when said expandable metal frame is crimped to said crimped state, ii) a recoil percentage of no more than 2% when said expandable metal frame is expanded from said crimped state, and iii) a longitudinal foreshortening percentage of no more than 15% when said expandable metal frame is expanded from said crimped state have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 6, said expandable metal frame including said refractory metal alloy that I) has a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy on said expandable metal frame is 25-45°, and/or II) said refractory metal alloy on said expandable metal frame has a maximum ion release of a primary component of said refractory metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 7, Nagura discloses said medical device is an expandable stent, an expandable valve, an expandable graph, or an expandable sheath (expandable stent) ([0001], [0026]).
Regarding claim 30, Nagura discloses an expandable medical device that is configured to be inserted or implanted on or in the body of a patient (expandable stent for use in treating a lumen in a living body) ([0001], [0026]);
said expandable medical device includes an expandable metal frame that is at least partially formed of a refractory metal alloy (W-Re alloy) ([0013], [0031]-[0035]);
said expandable metal frame includes a plurality of struts (linear connecting members 13) ([0028]-[0030], Fig. 1);
said expandable metal frame is configured to be crimped to a crimped state such that a maximum outer diameter of said expandable metal frame when in said crimped state is at least 50% less than a maximum outer diameter of said expandable metal frame when expanded to an expanded state (prepared diameter of 2 mm with a stent body diameter of 1 to 50 mm depending on the application) ([0027], [0070]);
said refractory metal alloy is not a self-expanding metal alloy (balloon expandable stent) ([0019], [0061]);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc) (Nagura [0035], [0060], [0063]; Cardarelli W-26 Re); and
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt% tungsten) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
Said expandable metal frame having three or more properties selected form the group consisting of a) a recoil percentage of less than 5% after being subjected to a first crimping process, b) a recoil percentage of less than 5% after being expanded from said crimped state to said expanded state, c) a longitudinal foreshortening percentage of less than 20% when said expandable metal frame is expanded from said crimped state, d) a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy of said expandable metal frame is 25-45°, e) a maximum ion release of a primary component of said refractory metal alloy from said expandable metal frame when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy, and f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said expandable metal frame medical device after said expandable metal frame is inserted or implanted on or in the body of a patient for at least 90 days have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 32, said expandable metal frame i) having a recoil percentage of no more than 2% when said expandable metal frame is crimped to a crimped state, ii) a recoil percentage of no more than 2% when said expandable metal frame is expanded from said crimped state, and/or iii) a longitudinal foreshortening percentage of no more than 15% when said expandable metal frame is expanded from said crimped state have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 36, said expandable metal frame that includes said refractory metal alloy I) having a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy on said expandable metal frame is 25-45°, and/or II) said refractory metal alloy on said expandable metal frame having a maximum ion release of a primary component of said refractory metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 37, Nagura discloses said medical device is an expandable stent, an expandable valve, an expandable graph, or an expandable sheath (expandable stent) ([0001], [0026]).
Regarding claim 39, Nagura discloses a medical device that is configured to be inserted or implanted on or in the body of a patient (expandable stent for use in treating a lumen in a living body) ([0001], [0026]);
said medical device includes a refractory metal alloy (W-Re alloy) ([0013], [0031]-[0035]);
said refractory metal alloy is not a self-expanding metal alloy (balloon expandable stent) ([0019], [0061]);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc) (Nagura [0035], [0060], [0063]; Cardarelli W-26 Re);
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt% tungsten) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
Said medical device having three or more properties selected form the group consisting of a) a frame of said medical device has a recoil percentage of less than 5% after being subjected to a first crimping process, b) a frame of said medical device has a recoil percentage of less than 5% after being expanded from said crimped state to said expanded state, c) a frame of said medical device has a longitudinal foreshortening percentage of less than 20% when said expandable metal frame is expanded from said crimped state, d) a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy of said frame is 25-45°, e) a maximum ion release of a primary component of said refractory metal alloy from said frame when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy, and f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said frame of said medical device after said frame is inserted or implanted on or in the body of a patient for at least 90 days have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura), including three or more of a)-f).
Regarding claim 40, Nagura discloses a medical device in the form of an implantable orthopedic device or a valve or a stent for insertion into a body passageway (expandable stent for use in treating a lumen in a living body) ([0001], [0026]);
said medical device is at least partially formed of a metal alloy that includes a refractory metal (W-Re alloy) ([0013], [0031]-[0035]);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc) (Nagura [0035], [0060], [0063]; Cardarelli W-26 Re);
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt% tungsten) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
Nagura discloses a stent with excellent ductility ([0009]) improved by making the crystal grain finer ([0010]). Said refractory metal alloy having a greater fatigue ductility as compared to a cobalt-chromium alloy has been considered and determined to recite a property of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed property naturally flows from the disclosure of the prior art (Nagura).
Regarding claim 44, said metal alloy having a hydrophilicity wherein a contact angle of a water droplet on a surface of said metal alloy of 25-45°; said metal alloy having a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy having an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flows from the disclosure of the prior art (Nagura).
Regarding claim 45, Nagura discloses a medical device in the form of an implantable orthopedic device or a valve or a stent for insertion into a body passageway (expandable stent for use in treating a lumen in a living body) ([0001], [0026]);
said medical device is at least partially formed of a metal alloy that includes a refractory metal (W-Re alloy) ([0013], [0031]-[0035]);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc, Cardarelli W-26 Re) ([0035], [0060], [0063]); and
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt.%) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
Nagura discloses a stent with excellent ductility ([0009]) improved by making the crystal grain finer ([0010]). Said refractory metal alloy having a greater fatigue ductility as compared to a cobalt-chromium alloy has been considered and determined to recite a property of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed property naturally flows from the disclosure of the prior art (Nagura).
Regarding claim 47, said metal alloy has a hydrophilicity wherein a contact angle of a water droplet on a surface of said metal alloy of 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the body of a patient have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Regarding claim 51, Nagura discloses a medical device that is configured to be inserted or implanted on or in the body of a patient; said medical device is a stent or valve or valve frame (expandable stent for use in treating a lumen in a living body) ([0001], [0026]);
said medical device includes a refractory metal alloy (W-Re alloy) ([0013], [0031]-[0035]);
said refractory metal alloy is not a self- expanding metal alloy (balloon expandable stent) ([0019], [0061]);
said refractory metal alloy has a density of at least 11 gm/cc (W-26Re alloy has a density of 19.7 gm/cc, Cardarelli W-26 Re) ([0035], [0060], [0063]); and
said refractory metal alloy includes at least 50 wt.% niobium or tantalum or tungsten (74 wt.& tungsten) and at least 0.1 wt.% metal additive, and wherein said metal additive calcium, chromium, cobalt, copper, hafnium, iridium, manganese, molybdenum, nickel, osmium, Rare Earth Metal, rhenium, ruthenium, technetium, titanium, vanadium, yttrium, zirconium (26 wt% rhenium) (W-26Re alloy) (Nagura [0035], [0060], [0063]).
Said medical device having two or more properties selected form the group consisting of a) a frame of said medical device has a recoil percentage of less than 5% after being subjected to a first crimping process, b) said frame of said medical device has a recoil percentage of less than 5% after being expanded from said crimped state to said expanded state, c) said frame of said medical device has a longitudinal foreshortening percentage of less than 20% when said frame is expanded from said crimped state, d) a hydrophilicity wherein a contact angle of a water droplet on a surface of said refractory metal alloy of said frame of said medical device is 25-45°, e) a maximum ion release of a primary component of said refractory metal alloy from said frame of said medical device when said frame is inserted or implanted on or in the body of the patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said refractory metal alloy, and f) an absolute increase in ion release per dose of no more than 50 of refractory metal alloy in tissue about said frame of said medical device after said frame is inserted or implanted on or in the body of a patient for at least 90 days have been considered and determined to recite properties of the expandable metal frame formed of a refractory metal alloy. The prior art discloses an expandable metal frame (Nagura [0001], [0026]-[0027]) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura).
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Nagura (JP 2012-196264 machine translation) as evidenced by Cardarelli (Rhenium Alloys. Materials Handbook. 2nd ed. Francois Cardarelli, Springer-Verlag, London, 2008.) as applied to claim 1 above, and further in view of Levi (US 2012/0123529) and Drews (US 2006/0195186).
Regarding claim 8, Nagura is silent to said medical device being a prosthetic heart valve.
Levi discloses said medical device is a prosthetic heart valve ([0008]); said prosthetic heart valve includes said expandable metal frame (12), a leaflet structure supported by said expandable metal frame (40), and an inner skirt secured to said expandable metal frame (16) ([0051]-[0052], Figs. 1-3).
It would have been obvious to one of ordinary skill in the art for the W-26Re stent medical device of Nagura to be a prosthetic heart valve because the frame of the prosthetic heart valve is a stent (Levi [0051]) and a tungsten-rhenium alloy is a known material to use in manufacturing a prosthetic heart valve (Drews [0006], [0092]).
The limitations of said expandable metal frame A) having at least 10% less material as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium- nickel alloy that can be expanded to an outer diameter of at least 25 mm; said expandable metal frame has a same or greater ultimate tensile strength, greater yield strength, greater elastic deformation latitude, greater stress to plastic deformation and failure, greater stiffness, greater strength, greater durability, and/or greater fatigue ductility as compared to a said similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy, B) having at least 10% greater conformity to a treatment area when expanded as comparted to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm, C) having at least a 10% greater hydrophilicity as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm, and D) having at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel as compared to a similar shaped frame formed of cobalt- chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm have been considered and determined to recite properties of the expandable metal frame of the prosthetic heart valve formed of a refractory metal alloy. The prior art discloses a prosthetic heart valve (Levi [0008]) with an expandable metal frame (Levi 12, [0051]-[0052], Figs. 1-3; Nagura [0001], [0026]-[0027]; ) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]; Drews [0006], [0092]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura in view of Levi and Drews).
Regarding claim 9, Nagura in view of Levi discloses said expandable metal frame is a radially collapsible and expandable annular frame (12) ([0016]-[0022]);
said expandable metal frame (12) includes a plurality of rows and wherein each row is formed of a plurality of struts (22, 24, 26) ([0012], [0022]-[0023], [0051]-[0052], [0055]-[0060], Figs. 1-8);
said leaflet structure comprising a plurality of leaflets (40) (three) ([0018]-[0022], [0052], Fig. 2);
each of said leaflets has an upper edge portion, a lower edge portion and two side flaps ([0031]-[0034], [0052], [0075]-[0083], Figs. 21-40);
each side flap is connected to an adjacent side flap of another leaflet ([0031]-[0034], [0052], [0075]-[0083], Figs. 21-40);
at least a portion of said leaflet structure is connected to said expandable metal frame ([0031]-[0034], [0052], [0075]-[0083], Figs. 21-40).
Regarding claim 10, Nagura in view of Levi discloses said leaflet structure is attached to said expandable metal frame using a plurality of sutures, staples or adhesive (sutures) ([0012], [0049], [0052], [0080]-[0081], [0102]-[0113], Figs. 29-33, 63-71).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Nagura (JP 2012-196264 machine translation) as evidenced by Cardarelli (Rhenium Alloys. Materials Handbook. 2nd ed. Francois Cardarelli, Springer-Verlag, London, 2008.) as applied to claim 30 above, and further in view of Kugler (US 2001/0053930).
Regarding claim 31, Nagura discloses said expandable metal frame is expandable to an outer diameter of at least 25 mm (1 to 50 mm) ([0027]);
at least 50 wt.% of said expandable metal frame is formed of a refractory metal alloy (W-Re alloy) ([0013], [0031]-[0035]); and
said expandable metal frame of said medical device includes a plurality of struts and strut joints (linear connecting members 13) ([0028]-[0030], Fig. 1).
Nagura is silent to said expandable metal frame having a) a plurality of strut joints that is less than 0.7 mm and b) a plurality of struts having an average width along a longitudinal of said strut that is no more than 0.3 mm.
Kugler discloses an expandable metal frame (stent) ([0013]-[0014]) having a) a plurality of strut joints that is less than 0.7 mm (about 0.5 mm (0.05 cm), the intersection of two struts about 0.025 mm width each), and b) a plurality of struts having an average width along a longitudinal of said strut that is no more than 0.3 mm (taper width about 0.178 mm (0.0178 cm) or reverse taper width about 0.28 mm (0.028 cm)) ([0027], [0067]-[0070] Figs. 6G, 6H).
It would have been obvious to one of ordinary skill in the art in the expandable metal frame to form the strut and strut joints with dimensions as disclosed by Kugler to minimize the maximum stresses in the struts by having a tapering width so that the stresses in the strut are spread out away from the intersection (Kugler [0067]) or to maximize resistance to local deformation by having a reverse taper (Kugler [0068]) so that fatigue fracture of struts is reduced (Kugler [0069]).
Claim 38 is rejected under 35 U.S.C. 103 as being unpatentable over Nagura (JP 2012-196264 machine translation) as evidenced by Cardarelli (Rhenium Alloys. Materials Handbook. 2nd ed. Francois Cardarelli, Springer-Verlag, London, 2008.) as applied to claim 30 above, and further in view of Levi (US 2012/0123529) and Drews (US 2006/0195186).
Regarding claim 38, Nagura is silent to said medical device being a prosthetic heart valve.
Levi discloses said medical device is a prosthetic heart valve ([0008]); said prosthetic heart valve includes said expandable metal frame (12), a leaflet structure supported by said expandable metal frame (40), and an inner skirt secured to said expandable metal frame (16) ([0051]-[0052], Figs. 1-3).
It would have been obvious to one of ordinary skill in the art for the W-26Re stent medical device of Nagura to be a prosthetic heart valve because the frame of the prosthetic heart valve is a stent (Levi [0051]) and a tungsten-rhenium alloy is a known material to use in manufacturing a prosthetic heart valve (Drews [0006], [0092]).
The limitations of said expandable metal frame A) having at least 10% less material as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium- nickel alloy that can be expanded to an outer diameter of at least 25 mm; said expandable metal frame has a same or greater ultimate tensile strength, greater yield strength, greater elastic deformation latitude, greater stress to plastic deformation and failure, greater stiffness, greater strength, greater durability, and/or greater fatigue ductility as compared to a said similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy, B) having at least 10% greater conformity to a treatment area when expanded as comparted to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm, C) having at least a 10% greater hydrophilicity as compared to a similar shaped frame formed of cobalt-chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm, and D) having at least 20% less corrosion and/or metal ion release when exposed to fluid in a blood vessel as compared to a similar shaped frame formed of cobalt- chromium alloy and/or titanium-nickel alloy that can be expanded to an outer diameter of at least 25 mm have been considered and determined to recite properties of the expandable metal frame of the prosthetic heart valve formed of a refractory metal alloy. The prior art discloses a prosthetic heart valve (Levi [0008]) with an expandable metal frame (Levi 12, [0051]-[0052], Figs. 1-3; Nagura [0001], [0026]-[0027]; ) of a refractory metal alloy (Nagura [0013], [0031]-[0035], [0060], [0063]; Drews [0006], [0092]) that is substantially similar to that claimed. Therefore, the claimed properties naturally flow from the disclosure of the prior art (Nagura in view of Levi and Drews).
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, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of copending Application No. 19/427,207 (App ‘207) (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘207 discloses a medical device with an overlapping structure (claims 20-21), properties (claims 20-21), and composition (claims 9-16).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4, 6-9, 11-13, 16-21, 26-27, 29-42, 66-78 of copending Application No. 18/400,781 (App ‘781) (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘781 discloses a medical device with an overlapping structure, properties, and composition (such as claim 1).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1,10-14, 16-17, 20-24, and 43-45 of copending Application No. 18/126,070 (App ‘070) in view of Levi (US 2012/0123529).
App ‘070 discloses a medical device for plantation in a body passageway (claim 20) that is expandable (claims 21, 43) with an overlapping composition (claims 1, 11-14, 16-17), such that the claimed properties naturally flow from the App ‘070 claims.
App ‘070 is silent to said medical device being a prosthetic heart valve.
Levi discloses said medical device is a prosthetic heart valve ([0008]); said prosthetic heart valve includes said expandable metal frame (12), a leaflet structure supported by said expandable metal frame (40), and an inner skirt secured to said expandable metal frame (16) ([0051]-[0052], Figs. 1-3).
It would have been obvious to one of ordinary skill in the art for the expandable medical device to be a prosthetic heart valve because the frame of the prosthetic heart valve is a stent (Levi [0051]).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 12,383,399 (US ‘399).
Although the claims at issue are not identical, they are not patentably distinct from each other because US ‘399 discloses an expandable prosthetic valve with an overlapping metal alloy (such as claim 1).
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-49, 59, 61-62 of copending Application No. 18/429,919 (App ‘919) (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘919 discloses a medical device with an overlapping structure, properties, and composition (such as claim 29).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,157,934 (US ‘934) in view of Levi (US 2012/0123529).
App ‘934 discloses a medical device for plantation in a body passageway (claim 13) that is expandable (claims 5, 12) with an overlapping composition (claims 5, 12, 13), such that the claimed properties naturally flow from the App ‘070 claims.
App ‘934 is silent to said medical device being a prosthetic heart valve.
Levi discloses said medical device is a prosthetic heart valve ([0008]); said prosthetic heart valve includes said expandable metal frame (12), a leaflet structure supported by said expandable metal frame (40), and an inner skirt secured to said expandable metal frame (16) ([0051]-[0052], Figs. 1-3).
It would have been obvious to one of ordinary skill in the art for the expandable medical device to be a prosthetic heart valve because the frame of the prosthetic heart valve is a stent (Levi [0051]).
Claims 1, 2, 6-10, 30-32, 36-40, 44, 45, 47, and 51 provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 29-49, 59, 61-62 of copending Application No. 18/967,034 (App ‘034) (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘034 discloses a medical device with an overlapping structure, properties, and composition (such as claims 26 and 35).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Related Art
The following references cited in Applicant’s December 7, 2022 information disclosure statement (IDS) disclose a W-Re alloy:
Bryskin. Refractory Metals Forum: Rhenium and Its Alloys. Advanced Materials & Processes. 9/92. 22-27.
Bryskin and Carlen. Rhenium and Molybdenum/Tungsten Based Alloys: An Overview of Database. Molybdenum and Molybdenum Alloys, The Minerals, Metals & Materials Society, 1998. 11-37.
Geach and Hughes. XXII. The Alloys of Rhenium with Molybdenum or with Tungsten and Having Good High Temperature Properties. Plansee Seminar. 245-253.
Klopp. Technology Status of Molybdenum and Tungsten Alloys. Space Nuclear Power Systems 1964. Chapter 42. 359-369.
Sirhan (US 2017/0290686)
Sirhan discloses a suitable stent material is a tungsten alloy of rhenium ([0130]) with inward recoil of 1% to 10% after deployment ([0056]).
Stinson (US 2006/0153729)
Stinson discloses a medical device having tantalum, niobium, tungsten, and zirconium ([0006]) such as a stent ([0005]) with reduced recoil ([0024], [0034]).
Patel (US 2010/0131044)
Patel discloses a metal alloy stent of tungsten ([0019], [0032]) with reduced foreshortening ([0008], [0010], [0014], [0086]) and improved recoil ([0018], [0033], [0043], [0044]).
Globerman (US 2010/0131045)
Globerman discloses a stent ([0002]) of tungsten-rhenium ([0024]) with recoil of less than 5% ([0129]).
Wachter (US 2007/0276488)
Wachter discloses a medical device or implant such as a stent ([0006]-[0007], [0017], [0021]. [0036]) made of a Tantalum base alloy with about 0.1 to 70 wt% Niobium, about 0.1 to 30 wt% one or more of Tungsten, Zirconium, and Molybdenum, and up to 5 wt% Rhenium ([0022]-[0035]).
The following Wachter publications are also related: US 2004/0158309, US 2012/0231048, and US 2010/0222866.
The following prior art references published by Cichocki disclose a W-Re suture needle:
US 2008/0295927; 2010/0236935; and Cichocki et al. Clinical Device-Related Article: Tungsten-rhenium suture needles with improved properties for coronary artery bypass graft surgery. Journal of Biomedical Materials Research B: Applied Biomaterials. Aug 2010. Vol. 94B, Issue 2. 493-500.
The following prior art references are directed to a W-Re medical wire:
JP 2009-077779 machine translation; and US 2011/0319931.
The following prior art references are directed to a W-Re medical device, such as a stent:
US 2007/0280850
The following prior art reference is directed to a Ta-Re medical device:
US 2015/0164619 (dental implant)
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANI HILL whose telephone number is (571)272-2523. The examiner can normally be reached Monday-Friday 7am-12pm.
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/STEPHANI HILL/Examiner, Art Unit 1735