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 filed May 31, 2023 is a continuation-in-part of 17/586,270 filed January 27, 2022 and 18/116,677 filed March 2, 2023. The pending application also claims priority to 63/226,270 filed July 28, 2021, 63/316,077 filed March 3, 2022, 63/347,337 filed May 31, 2022, and 63/389,281 filed July 14, 2022.
Claim Status
This Office Action is in response to Applicant’s Restriction Election and Claim Amendments filed November 18, 2025.
Claims Filing Date
November 18, 2025
Amended
1-10, 12-18, 20, 24, 26-31, 33, 36
Cancelled
11, 19, 25
Under Examination
1-10, 12-18, 20-24, 26-36
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed March 14, 2024 lists US 2008/0068924 with a Publication Date of 2009-03-12 and an applicant of Furst et al. However, US 2008/0068924 was actually published March 20, 2008 and the applicant is Midas et al. Midas is directed to a Mixer with Shaking and Tumbling Motion, which does not appear relevant to applicant’s claimed metal alloy. Therefore, cited US 2008/0068924 was not considered because it is unclear what reference is actually being cited.
Withdrawn Abstract Objection
The following objection is withdrawn due to abstract amendment:
Line 1 “A metal alloy and includes an enhancement coating material.”
Withdrawn Claim Objections
The following objection is withdrawn due to claim cancellation:
Claim 11 line 2 “to improve one or more properties” being repetitive of lines 3-7, “change”, “increase”, “reduce(d)”, “improve”, or “form”.
The following objection is withdrawn due to claim amendment:
Claim 17 lines 1-2 “alloy includes has a controlled amount” is grammatically incorrect.
Claim 27 line 2 “meals” appears to be a typographical error.
Withdrawn Claim Rejections - 35 USC § 112
The following 112(b) rejections are withdrawn due to claim amendment:
Claim 6 lines 2-4 “two or more of…c) 60-99.99 wt.% C” and “i) 0-40 wt.% C”.
Claim 8 lines 5-6 “20-30 wt.%, 0-1 wt.% N”.
Claim 10 lines 4-6 “thermal spray techniques like plasma arc spraying, flame spraying, high velocity oxy fuel spraying (HVOF)”.
Claim 16 lines 1-2 “said metal alloy includes less than 0.1 wt.% metals”.
Claim 20 lines 1-2 “said rhenium-chromium metal alloy”.
Claim 26 lines 8-14 “said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon;
said enhancement coating material includes nitrides and/or oxides;
said enhancement coating material includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon”.
Claim 31 line 3 “partially or fully layer or coated”.
Claim 31 lines 4-7 “said enhancement coating includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon”.
Claim 36 lines 3-6 “said enhancement coating includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon”.
The following 112(b) rejections are withdrawn due to claim cancellation:
Claim 11 line 3 “increase hardness of coated surface”.
Claim 11 lines 3-4 “increase toughness of coated surface”.
Claim 11 lines 4-5 “improve impact wear of coated surface”.
Claim 19 line 2 “0-2 wt.% said one or more additives; said one or more additives selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen”.
Withdrawn Double Patenting Rejections
The applicant persuasively argues a terminal disclaimer has been filed to overcome the double patenting rejections over US App. Nos. 18/280,294; 19/197,045; 18/435,683; and 18/400,338 (Remarks para. spanning pp. 13-14).
The following double patenting rejections are withdrawn due to filing and approval of a Terminal Disclaimer on January 18, 2025:
Claims 1-14 and 26-36 over claims 1-25 of copending Application No. 19/280,294.
Claims 1-14 and 26-36 over claims 31-60 of copending Application No. 19/197,045.
Claims 1-14 and 26-36 over claims 1-2, 5-9, 11-22, 28, and 30-35 of copending Application No. 18/435,683.
Claims 1-14 and 26-36 over claims 1-41 of copending Application No. 18/400,338.
Claims 1-14 and 26-36 over claims 1-30 of U.S. Patent No. 12,318,505.
Response to Remarks filed November 18, 2025
Double Patenting
Applicant's arguments filed November 18, 2025 with respect to double patenting have been fully considered but they are not persuasive.
The applicant argues the following double patenting rejections are distinct from the pending claims: US App. Nos. 18/401,551 and 18/400,781 and US Pat. No. 12,383,399 (Remarks para. spanning pp. 13-14).
Both 18/400,781 and 12,383,399 disclose a medical device made of a rhenium containing metal alloy that includes at least 0.1 wt% Re (App ‘781) or 15 awt% Re (US ‘399) in combination with one or more of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W that is covered with an enhancement coating (App ‘781 claim 1; US ‘399 claim 1), which reads on the claimed coated metal alloy.
In light of claim amendment, the 18/401,551 rejection has been made in view of Vlcek and Zhang. App ‘551 discloses a medical device, a rhenium alloy, and an enhancement coating (claim 55), and Vlcek in view of Zhang discloses the obviousness of the rhenium alloy including a primary additive as recited in the amended claims.
Furst in view of Zhao: Claim 1
Applicant’s arguments, see Remarks p. 15 para. 2, filed November 18, 2025, with respect to the claim 1 rejection over Furst have been fully considered and are persuasive. The rejection of claims 1-10, 12-18, and 20-24 over Furst in view of Zhao has been withdrawn.
The applicant persuasively argues amended independent claim 1 includes limitations regarding the atomic ratio of rhenium to the combined atomic weight of primary additive, which is absent from the cited art of record (Remarks p. 15 para. 2).
Furst discloses a metal alloy that includes at least about 90 weight percent molybdenum and rhenium (6:18-20) with a rhenium content of at least about 40 weight percent (7:15-16), a molybdenum (additive) content of at least 40 weight percent (7:26-27), and at least one additional metal that includes titanium, yttrium, and/or zirconium (primary additive) (8:5-8) with a combined content of less than about 5 weight percent (9:31 to 10:19). An atomic weight ratio of the disclosed molybdenum and rhenium alloy of at least 40 weight percent rhenium and less than about 5 weight percent of titanium, yttrium, and/or zirconium (primary additive) is outside the scope of the 0.7:1 to 1.5:1 range recited in amended claim 1.
Furst in view of Zhao: Claim 26
Applicant's arguments filed November 18, 2025 with respect to the claim 26 rejection over Furst in view of Zhao have been fully considered but they are not persuasive.
The applicant argues amended independent claim 26 includes limitations regarding the atomic ratio of rhenium to the combined atomic weight of primary additive, which is absent from the cited art of record (Remarks p. 15 para. 2).
Furst discloses a metal alloy that includes at least about 90 weight percent molybdenum and rhenium (6:18-20) with a rhenium content of at least about 40 weight percent (7:15-16), a molybdenum (additive) content of at least 40 weight percent (7:26-27), and at least one additional metal that includes titanium, yttrium, and/or zirconium (primary additive) (8:5-8) with a combined content of less than about 5 weight percent (9:31 to 10:19). An atomic weight ratio of the disclosed molybdenum and rhenium alloy of at least 40 weight percent rhenium and less than about 5 weight percent of titanium, yttrium, and/or zirconium (primary additive) is at least about 2.0:1, which overlaps with the claimed ranges of 0.7:1 to 5.1:1, such that a prima facie case of obviousness exists. MPEP 2144.05(I).
Furst in view of Jimenez: Claim 1
Applicant’s arguments, see Remarks p. 15 para. 2, filed November 18, 2025, with respect to the claim 1 rejection over Furst have been fully considered and are persuasive. The rejection of claims 1-10, 12-18, and 20-24 over Furst in view of Jimenez has been withdrawn.
The applicant persuasively argues amended independent claim 1 includes limitations regarding the atomic ratio of rhenium to the combined atomic weight of primary additive, which is absent from the cited art of record (Remarks p. 15 para. 2).
Furst discloses a metal alloy that includes at least about 90 weight percent molybdenum and rhenium (6:18-20) with a rhenium content of at least about 40 weight percent (7:15-16), a molybdenum (additive) content of at least 40 weight percent (7:26-27), and at least one additional metal that includes titanium, yttrium, and/or zirconium (primary additive) (8:5-8) with a combined content of less than about 5 weight percent (9:31 to 10:19). An atomic weight ratio of the disclosed molybdenum and rhenium alloy of at least 40 weight percent rhenium and less than about 5 weight percent of titanium, yttrium, and/or zirconium (primary additive) is outside the scope of the 0.7:1 to 1.5:1 range recited in amended claim 1.
Furst in view of Jimenez: Claim 26
Applicant's arguments filed November 18, 2025 with respect to the claim 26 rejection over Furst in view of Jimenez have been fully considered but they are not persuasive.
The applicant argues amended independent claim 26 includes limitations regarding the atomic ratio of rhenium to the combined atomic weight of primary additive, which is absent from the cited art of record (Remarks p. 15 para. 2).
Furst discloses a metal alloy that includes at least about 90 weight percent molybdenum and rhenium (6:18-20) with a rhenium content of at least about 40 weight percent (7:15-16), a molybdenum (additive) content of at least 40 weight percent (7:26-27), and at least one additional metal that includes titanium, yttrium, and/or zirconium (primary additive) (8:5-8) with a combined content of less than about 5 weight percent (9:31 to 10:19). An atomic weight ratio of the disclosed molybdenum and rhenium alloy of at least 40 weight percent rhenium and less than about 5 weight percent of titanium, yttrium, and/or zirconium (primary additive) is at least about 2.0:1, which overlaps with the claimed ranges of 0.7:1 to 5.1:1, such that a prima facie case of obviousness exists. MPEP 2144.05(I).
New Grounds
In light of claim amendment a new grounds of rejection is made over Vlcek in view of Kawai.
Specification Objection
The disclosure is objected to because of the following informalities:
[0030] “In one specific non-limiting formulation, the atomic weight percent of rhenium to the atomic weight percent of the atomic weight percent of the combination of chromium, niobium, tantalum, and zirconium is 0.7 to 5.1:1…, typically 0.8:1 to 1.5:1”, where “5.1” appears to be a typographical error. In [0030] similarly discussed ratios have an upper limit of “1.5:1” and the narrower ranges have an upper limit of “1.5:1” or less.
Appropriate correction is required.
Claim Objections
Claims 1, 24, and 26-30 are objected to because of the following informalities:
Claim 1 lines 3-6 “one or more…selected from the group consisting of aluminum,…, and/or zirconium” uses “and/or” as the conjunction. Other claim recitations of “one or more…selected from the group consisting of”, such as claim 1 lines 8-10, claim 5 lines 2-3, and claim 9 lines 2-4, use “and” as the conjunction. Claim language should be consistent.
Claim 24 lines 8-9 “a hydrophilicity wherein a contact angle of a water droplet on a surface of said metal alloy of 25-45°” is grammatically incorrect.
Claim 26 line 1 “coated metal alloy a base metal alloy” is grammatically incorrect.
Claim 27 lines 2-4 “0-25 wt.% of one or more metals selected from the group consisting of bismuth,…, and zirconium” includes elements that overlap with the “one or more additives” recited in independent claim 26 lines 2-8. The “one or more metals” of claim 27 should be related to the “one or more additives” of claim 26.
Claim 28 lines 2-4 “0.5-25 wt.% of one or more metals selected from the group consisting of bismuth,…, and zirconium” includes elements that overlap with the “one or more additives” recited in independent claim 26 lines 2-8. The “one or more metals” of claim 28 should be related to the “one or more additives” of claim 26.
Claim 29 lines 2-4 “said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium” does not recite Cr, such that Cr is a secondary material. However, claim 29 depends from claim 27, which recites 25-50 wt.% Cr. The Cr content of claims 27 and 29 is inconsistent.
Claim 30 lines 2-4 “said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium” does not recite Cr, such that Cr is a secondary material. However, claim 30 depends from claim 28, which recites 25-50 wt.% Cr. The Cr content of claims 28 and 30 is inconsistent.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph 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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-10, 12-18, 20-24, and 26-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 lines 2-6 “one or more additives selected from the group consisting of aluminum, bismuth,…, and/or zirconium” and claim 1 lines 8-10 “one or more additives includes a primary additive selected from the group consisting of bismuth, niobium,…, and iridium” fails to comply with the written description requirement.
With respect to claim 1 lines 2-6, applicant discloses this claim limitation in [0028] as “another non-limiting aspect of the present disclosure”. Then, separately, with respect to claim 1 lines 8-10, applicant discloses this claim limitation in [0030] as “another and/or alternative non-limiting aspect of the present disclosure”. Therefore, in claim 1 lines 2-6 and 8-10 are two separate embodiments (aspects) that are not disclosed as capable of being used together. Applicant does not have support for both the “one or more additives” of claim 1 lines 2-6 in combination with the “primary additive” of claim 1 lines 8-10. For the purpose of examination claim 1 will be interpreted as the “one or more additives” being further limited to include “a primary additive” as claimed.
Claim 1 lines 8-10 “primary additive selected from the group consisting of bismuth, niobium,…, and iridium” fails to comply with the written description requirement.
Applicant’s specification does not recite the term “primary additive” nor does it reference “primary” in combination with the recited claim elements. Applicant’s specification recites “primary constituents of the metal alloy (e.g., metals that constitute at least 5 wt.% of the metal alloy)” in [0058], but does not list which constituents are “primary”. Similarly, in [00149]-[00150] a “primary component” of the metal alloy is referenced as constituting at least 2 wt.% of the metal alloy, but also does not list which components are primary”. For the purpose of examination claim 1 is interpreted as requiring a “primary additive” being limited to what is recited in the claim, such that it is selected from the group recited in claim 1 with the claimed atomic weight ratio to rhenium.
Claim 18 lines 1-5 “said based metal alloy includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0.5-25 wt.% of said one or more additives…” fails to comply with the written description requirement.
Applicant discloses this claim limitation as Ex. 87 in the table. This example (embodiment) is absent the “primary additive” recited in amended claim 1. Applicant does not have support for the composition of claim 18 in combination with the “primary additive”, including the atomic weight ratio with rhenium, of claim 1 lines 8-10.
Claim 20 lines 1-8 “said based metal alloy includes 55-75 wt.% rhenium, 25-45 wt.% Cr, and 0.5-25 wt.% of said one or more additives…; and said base metal alloy includes 0-0.1 wt.% of secondary materials…” fails to comply with the written description requirement.
Applicant discloses this claim limitation in original claim 20, which is absent the “primary additive” as recited in amended claim 1. Applicant does not have support for the composition of claim 20 in combination with the “primary additive”, including the atomic weight ratio with rhenium, of claim 1 lines 8-10.
Claims 2-10, 12-17, and 21-24 are rejected as depending from claim 1.
Claim 26 lines 2-6 “one or more additives selected from the group consisting of aluminum, bismuth,…, and zirconium” and claim 26 lines 6-8 “one or more additives includes a primary additive selected from the group consisting of bismuth, chromium,…, and zirconium” fails to comply with the written description requirement.
With respect to claim 26 lines 2-6, applicant discloses this claim limitation in [0028] as “another non-limiting aspect of the present disclosure”. Then, separately, with respect to claim 26 lines 6-8, applicant discloses this claim limitation in [0030] as “another and/or alternative non-limiting aspect of the present disclosure”. Therefore, in claim 26 lines 2-6 and 6-8 are two separate embodiments (aspects) that are not disclosed as capable of being used together. Applicant does not have support for both the “one or more additives” of claim 26 lines 2-6 in combination with the “primary additive” of claim 26 lines 6-8. For the purpose of examination claim 26 will be interpreted as the “one or more additives” being further limited to include “a primary additive” as claimed.
Claim 26 lines 6-8 “primary additive selected from the group consisting of bismuth, chromium,…, and zirconium” fails to comply with the written description requirement.
Applicant’s specification does not recite the term “primary additive” nor does it reference “primary” in combination with the recited claim elements. Applicant’s specification recites “primary constituents of the metal alloy (e.g., metals that constitute at least 5 wt.% of the metal alloy)” in [0058], but does not list which constituents are “primary”. Similarly, in [00149]-[00150] a “primary component” of the metal alloy is referenced as constituting at least 2 wt.% of the metal alloy, but also does not list which components are primary”. For the purpose of examination claim 26 is interpreted as requiring a “primary additive” being limited to what is recited in the claim, such that it is selected from the group recited in claim 26 with the claimed atomic weight ratio to rhenium.
Claim 27 lines 1-4 “said based metal alloy includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0-25 wt.% of said one or more metals…” fails to comply with the written description requirement.
Applicant discloses this claim limitation as Ex. 87 in the table. This example (embodiment) is absent the “primary additive” as recited in amended claim 26. Applicant does not have support for the composition of claim 27 in combination with the “primary additive”, including the atomic weight ratio with rhenium, of claim 26 lines 6-8.
Claim 29 is rejected as depending from claim 27.
Claim 28 lines 1-4 “said based metal alloy includes 55-75 wt.% rhenium, 25-45 wt.% Cr, and 0.5-25 wt.% of said one or more metals…” fails to comply with the written description requirement.
Applicant discloses this claim limitation as Ex. 87 in the table. This example (embodiment) is absent the “primary additive” as recited in amended claim 26. Applicant does not have support for the composition of claim 28 in combination with the “primary additive”, including the atomic weight ratio with rhenium, of claim 26 lines 6-8.
Claim 30 is rejected as depending from claim 27.
Claims 31-36 are rejected as depending from claim 26.
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 1-10, 12-18, 20-24, and 26-36 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 8 “primary additive” renders the claim indefinite. What is a “primary additive”? Is it the first additive? Is it the most abundant additive? Applicant’s specification mentions “additives”, but not “primary additive”. Applicant’s specification also recites “primary constituents of the metal alloy (e.g., metals that constitute at least 5 wt.% of the metal alloy)” in [0058], and in [00149]-[00150] a “primary component” of the metal alloy is referenced as constituting at least 2 wt.% of the metal alloy. It is unclear whether applicant intends the “primary additive” to be at least 2 wt.%, at least 5 wt.%, or something else. For the purpose of examination claim 1 is interpreted as requiring a “primary additive” being limited to what is recited in the claim, such that it is selected from the group recited in claim 1 with the claimed atomic weight ratio to rhenium.
Claim 24 line 10 “the patient” renders the claim indefinite. There is insufficient antecedent basis.
Claim 24 line 14 “the body of a patient” renders the claim indefinite. There is insufficient antecedent basis.
Claims 2-10, 12-18, and 20-23 are rejected as depending from claim 1.
Claim 26 lines 6-7 “primary additive” renders the claim indefinite. What is a “primary additive”? Is it the first additive? Is it the most abundant additive? Applicant’s specification mentions “additives”, but not “primary additive”. Applicant’s specification also recites “primary constituents of the metal alloy (e.g., metals that constitute at least 5 wt.% of the metal alloy)” in [0058], and in [00149]-[00150] a “primary component” of the metal alloy is referenced as constituting at least 2 wt.% of the metal alloy. It is unclear whether applicant intends the “primary additive” to be at least 2 wt.%, at least 5 wt.%, or something else. For the purpose of examination claim 26 is interpreted as requiring a “primary additive” being limited to what is recited in the claim, such that it is selected from the group recited in claim 26 with the claimed atomic weight ratio to rhenium.
Claims 27-36 are rejected as depending from claim 26.
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 26, 31-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Zhao (CN 107287566 machine translation).
Regarding claim 26, Furst discloses a coated metal alloy a base metal alloy and an enhancement coating material (30:21 to 31:9, 75:12-18, 79:25 to 80:3); said base metal alloy comprises rhenium and one or more additives selected from the group consisting of aluminum, bismuth, calcium, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, and zirconium (rhenium and molybdenum) (5:12-14, 6:18 to 7:3, 7:10-18); said one or more additives includes a primary additive selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium (at least one additional metal of titanium, yttrium, and zirconium) (8:5 to 11:10); a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive is 0.7:1 to 5.1:1 (at least 90 wt% molybdenum and rhenium metal alloy with at least one additional metal of titanium, yttrium, and zirconium with at least about 40 wt% rhenium, at least about 40 wt% molybdenum, and less than about 5 wt% of a combination of titanium, yttrium, and zirconium when converted to at% has a minimum atomic weight ratio of rhenium to at least one of titanium, yttrium, and zirconium of about 2.0:1 (for 40 wt% Re, 55 wt% Mo, 5 wt% Ti)) (7:14-16, 25-27, 8:5-8, 9:31 to 10:1); a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 98 wt.% (rhenium and molybdenum is at least 90 wt% with less than about 5 wt% of a combination of titanium, yttrium, and zirconium) (6:18 to 7:3, 9:31 to 10:1); at least a portion of an outer surface of said base metal alloy includes said enhancement coating material that is layered or coated on said outer surface of said base metal alloy; said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon; said enhancement coating material includes nitrides and/or oxides (nitrided layer on the rod or tube that functions as a lubricating surface reads on enhancement coating including a composition with nitrogen) (30:21 to 31:9, 75:12-18, 79:25 to 80:3). 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).
Furst is silent to the enhancement coating including zirconium or titanium and said enhancement coating material includes a) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, b) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, or c) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon.
Zhao discloses an enhancement coating material that is layered or coated on an outer surface of a metal alloy; said enhancement coating including zirconium or titanium and said enhancement coating material includes a) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, b) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, or c) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon (30 to 60 at% zirconium and 20 to 50 at% nitrogen, Zr-Al-Mo-N nitride coating) ([0002], [0008]-[0009], [0025]-[0033]).
It would have been obvious to one of ordinary skill in the art for the lubricating nitrided surface layer in Furst to be a Zr-Al-Mo-N nitride coating because it advantageously has high hardness and strength, low friction coefficient, good oxidation resistance and thermal stability, and high thermal shock resistance and is advantageous for use in areas where friction and wear need to be reduced (Zhao [0005], [0016]). 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 claim 31, Furst discloses a medical device that is at least partially formed of said metal alloy as defined in claim 26 (pp. 3-4, 5:12-14, 6:18 to 7:3, 7:10-18); said medical device includes an expandable metallic frame (2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26) that is at least partially formed of said coated metal alloy (nitrided layer on the rod or tube that functions as a lubricating surface reads on enhancement coating including a composition with nitrogen) (30:21 to 31:9, 75:12-18, 79:25 to 80:3).
Regarding claim 32, Furst in view of Zhao discloses said enhancement coating material includes nitrides and/or oxides (nitrides) (Furst 30:21 to 31:9, 75:12-18, 79:25 to 80:3) of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (Zr, Al) (Zhao [0002], [0007]-[0009], [0011]).
Regarding claim 33, Furst in view of Zhao discloses said enhancement coating material includes two or more of a) 40-85 wt.% Cr, b) 5-60 wt.% N, c) 20-85 wt.% Ti, d) 35-95 wt.% Zr, e) 0-10 wt.% Re, f) 0-20 wt.% Si, g) 0-35 wt.% O, and h) 0-40 wt.% C (Zhao [0008], [0025]-[0031]). 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).
Element
Claims 33, 34
wt%
Zhao [0026]
wt%
(at%)
Zhao [0027]
wt%
(at%)
Zhao [0028]
wt%
(at%)
Zhao [0029]
wt%
(at%)
Zhao [0030]
wt%
(at%)
Zhao [0031]
wt%
(at%)
N
5 to 60
9.3
(36)
6.8
(29)
5.9
(23)
3.8
(20)
6.5
(30)
14.4
(50)
Zr
35 to 95
50.7
(30)
54.6
(36)
70.4
(42)
68.2
(55)
84.1
(60)
60
(32)
Regarding claim 34, Furst in view of Zhao discloses said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, f) 0-8 wt.% Re, g) 0-1 wt.% Si, h) 0-35 wt.% O, and i) 0-1 wt.% C (Zhao [0008], [0025]-[0031]). 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 claim 36, Furst discloses a medical device as defined in claim 26 (pp. 3-4, 5:12-14, 6:18 to 7:3, 7:10-18); said medical device is a) an orthopedic device, b) a PFO (patent foramen ovale) device, c) a spinal implant, d) a dental implant, e) a bone implant, f) a prosthetic implant, g) a bone plate, h) a knee replacement, i) a hip replacement, j) a shoulder replacement, 1) an ankle replacement, m) a rod, or n) a screw (64:27-30).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Zhao (CN 107287566 machine translation) as applied to claim 26 above, and further in view of either one of Vlcek (WO 2005/024080 machine translation) or Novakovic (Novakovic et al. Bulk and Surface Properties of Liquid Cr-Nb-Re Alloys. Journal of Phase Equilibria and Diffusion, JPEDAV. Vol. 35. No. 4. (2014) 35:445-457.).
Regarding claim 27, Furst in view of Zhao is silent to a base metal alloy with the claimed composition.
Vlcek discloses said base metal alloy includes 50-75 wt.% rhenium (45-75 wt% Re), 25-50 wt.% Cr (25-55 wt% Cr), and 0-25 wt.% of one or more meals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Vlcek because it is a ductile CrRe alloy with high-temperature resistance and oxidation resistance with equally good low-temperature properties and suitability for thermal shocks for use as a structural material with good oxidation or corrosion resistance (Vlcek p. 1 paras. 1-3). 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).
As an alternative to Vlcek, Novakovic discloses said base metal alloy includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0.5-25 wt.% of said one or more additives; said one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (Table 2).
Element
Claim 27
Claim 28
Novakovic Table 2
Novakovic Table 2
Novakovic Table 2
Cr-Nb-Re
0.50-0.17-0.33
Cr-Nb-Re
0.60-0.13-0.27
Cr-Nb-Re
0.60-0.10-0.30
Re
50 to 75
55 to 75
59.5
53.7
58.0
Cr
25 to 50
25 to 45
25.2
33.3
32.4
Nb
0 to 25
0.5 to 25
15.3
12.9
9.6
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Novakovic because it is a high strength, ductile, and oxidation resistant alloy with a relatively high level of chemical inertness such that it can be used in severe operating conditions, such as high temperature or aggressive chemicals (Novakovic 1. Introduction). 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 claim 28, Furst in view of Zhao is silent to a base metal alloy with the claimed composition.
Vlcek discloses said base metal alloy includes 55-75 wt.% rhenium (45-75 wt% Re), 25-45 wt.% Cr (25-55 wt% Cr), and 0.5-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Vlcek because it is a ductile CrRe alloy with high-temperature resistance and oxidation resistance with equally good low-temperature properties and suitability for thermal shocks for use as a structural material with good oxidation or corrosion resistance (Vlcek p. 1 paras. 1-3). 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).
As an alternative to Vlcek, Novakovic discloses said base metal alloy includes 55-75 wt.% rhenium, 25-45 wt.% Cr, and 0.5-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (Table 2).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Novakovic because it is a high strength, ductile, and oxidation resistant alloy with a relatively high level of chemical inertness such that it can be used in severe operating conditions, such as high temperature or aggressive chemicals (Novakovic 1. Introduction). 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 claim 29, Furst in view of Zhao and Vlcek discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0.05 to 5 wt% of at least one of Sc, Ce, and Pr) (Vlcek p. 2 para. 5). 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).
Alternatively, Furst in view of Zhao and Novakovic discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0 wt%) (Novakovic Table 2). 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 claim 30, Furst in view of Zhao and Vlcek discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0.05 to 5 wt% of at least one of Sc, Ce, and Pr) (Vlcek p. 2 para. 5). 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).
Alternatively, Furst in view of Zhao and Novakovic discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0 wt%) (Novakovic Table 2). 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).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Zhao (CN 107287566 machine translation) as applied to claim 31 above, and further in view of Drews (US 2005/0165479).
Regarding claim 35, Furst discloses said medical device is a prosthetic heart valve (stent for use in a heart chambers) (4:4-18, 68:21 to 69:5); said prosthetic heart valve includes said expandable metallic frame (2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26); said expandable metallic frame includes a plurality of struts (81:8-13); said expandable metallic frame is configured to be crimped to a crimped state such that a maximum outer diameter of said expandable metallic frame when in said crimped state is less than a maximum outer diameter of said expandable metallic frame when fully expanded to an expanded state (:7 to 4:3, 16:24-26, 17:3-22); said expandable metallic frame has a recoil of less than 5% after being expanded from said crimped state to said expanded state (17:21-22, 23:6-7, 59:20-27, 82:24-26). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05(II)(A).
Furst is silent to said prosthetic heart valve including leaflets.
Drews discloses a medical device that is a prosthetic heart valve ([0037]) including leaflets ([0007]-[0010], [0036], [0096], Fig. 1).
It would have been obvious to one of ordinary skill in the art for the prosthetic heart valve of Furst to include leaflets to provide a valve member (Drews [0010]).
Claims 26, 31-34, and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Jimenez (Jimenez et al. Structure and mechanical properties of nitrogen-containing Zr-Cu based thin films deposited by pulsed magnetron sputtering. J. Phys. D: Appl. Phys. 41 (2008) 155301 (9pp)).
Regarding claim 26, Furst discloses a metal alloy comprising rhenium and one or more additives selected from the group consisting of aluminum, bismuth, calcium, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, and zirconium (rhenium and molybdenum) (5:12-14, 6:18 to 7:3, 7:10-18); said one or more additives includes a primary additive selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium (at least one additional metals which includes titanium, yttrium, and zirconium) (8:5 to 11:10); a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive is 0.7:1 to 5.1:1 (at least 90 wt% molybdenum and rhenium metal alloy with at least one additional metals which includes titanium, yttrium, and zirconium with at least about 40 wt% rhenium, at least about 40 wt% molybdenum, and less than about 5 wt% of a combination of titanium, yttrium, and zirconium, when converted to at% has a minimum atomic weight ratio of rhenium to at least one of titanium, yttrium, and zirconium of about 2.0:1 (40 wt% Re, 55 wt% Mo, 5 wt% Ti)) (7:14-16, 25-27, 8:5-8, 9:31 to 10:1); a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 98 wt.% (rhenium and molybdenum is at least 90 wt% with less than about 5 wt% of a combination of titanium, yttrium, and zirconium) (6:18 to 7:3, 9:31 to 10:1); at least a portion of an outer surface of said metal alloy includes an enhancement coating material that is layered or coated on said outer surface of said metal alloy; said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon; said enhancement coating material includes nitrides and/or oxides (nitrided layer on the rod or tube that functions as a lubricating surface reads on enhancement coating including a composition with nitrogen) (30:21 to 31:9, 75:12-18, 79:25 to 80:3). 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).
Furst is silent to the enhancement coating including zirconium or titanium and said enhancement coating material includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon.
Jimenez discloses an enhancement coating material that is layered or coated on an outer surface of a metal alloy; said enhancement coating including zirconium or titanium and said enhancement coating material includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon, and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon (ZrCu(N) coating) (Abstract, 2. Experimental procedure, Table 1).
It would have been obvious to one of ordinary skill in the art for the coating of Furst to include zirconium (Zr) to form a nanocrystalline coating (Jimenez Abstract) with enhanced properties of increased hardness and coating durability for use in mechanical and load-bearing applications, such as applications with abrasion (Jimenez 1. Introduction). 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 claim 31, Furst discloses a medical device that is at least partially formed of said metal alloy as defined in claim 26 (pp. 3-4, 5:12-14, 6:18 to 7:3, 7:10-18); said medical device includes an expandable metallic frame (2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26) that is at least partially formed of said coated metal alloy (nitrided layer on the rod or tube that functions as a lubricating surface reads on enhancement coating including a composition with nitrogen) (30:21 to 31:9, 75:12-18, 79:25 to 80:3).
Regarding claim 32, Furst in view of Jimenez discloses said enhancement coating material includes nitrides and/or oxides (nitrides) (Furst 30:21 to 31:9, 75:12-18, 79:25 to 80:3) of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (ZrN) (Jimenez 3.1.4. and 3.2.4. Coatings deposited at 5 sccm N2 flow rate, Fig. 3).
Regarding claim 33, Furst in view of Jimenez discloses said enhancement coating material includes two or more of a) 40-85 wt.% Cr, b) 5-60 wt.% N, c) 20-85 wt.% Ti, d) 35-95 wt.% Zr, e) 0-10 wt.% Re, f) 0-20 wt.% Si, g) 0-35 wt.% O, and h) 0-40 wt.% C (Jimenez Table 1). 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).
Element
Claims 33, 34
Jimenez Table 1
Jimenez Table 1
Zr-Cu-N
50-8-42
Zr-Cu-N
33-33-34
Zr
35 to 95
80.6
53.9
N
5 to 60
10.4
8.5
Regarding claim 34, Furst in view of Jimenez discloses said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, f) 0-8 wt.% Re, g) 0-1 wt.% Si, h) 0-35 wt.% O, and i) 0-1 wt.% C (Jimenez Table 1). 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 claim 36, Furst discloses a medical device as defined in claim 26 (pp. 3-4, 5:12-14, 6:18 to 7:3, 7:10-18); said medical device is a) an orthopedic device, b) a PFO (patent foramen ovale) device, c) a spinal implant, d) a dental implant, e) a bone implant, f) a prosthetic implant, g) a bone plate, h) a knee replacement, i) a hip replacement, j) a shoulder replacement, 1) an ankle replacement, m) a rod, or n) a screw (64:27-30).
Claims 27-30 are rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Jimenez (Jimenez et al. Structure and mechanical properties of nitrogen-containing Zr-Cu based thin films deposited by pulsed magnetron sputtering. J. Phys. D: Appl. Phys. 41 (2008) 155301 (9pp)) as applied to claim 26 above, and further in view of either one of Vlcek (WO 2005/024080 machine translation) or Novakovic (Novakovic et al. Bulk and Surface Properties of Liquid Cr-Nb-Re Alloys. Journal of Phase Equilibria and Diffusion, JPEDAV. Vol. 35. No. 4. (2014) 35:445-457.).
Regarding claim 27, Furst in view of Jimenez is silent to a base metal alloy with the claimed composition.
Vlcek discloses said base metal alloy includes 50-75 wt.% rhenium (45-75 wt% Re), 25-50 wt.% Cr (25-55 wt% Cr), and 0-25 wt.% of one or more meals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Vlcek because it is a ductile CrRe alloy with high-temperature resistance and oxidation resistance with equally good low-temperature properties and suitability for thermal shocks for use as a structural material with good oxidation or corrosion resistance (Vlcek p. 1 paras. 1-3). 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).
As an alternative to Vlcek, Novakovic discloses said base metal alloy includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0.5-25 wt.% of said one or more additives; said one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (Table 2).
Element
Claim 27
Claim 28
Novakovic Table 2
Novakovic Table 2
Novakovic Table 2
Cr-Nb-Re
0.50-0.17-0.33
Cr-Nb-Re
0.60-0.13-0.27
Cr-Nb-Re
0.60-0.10-0.30
Re
50 to 75
55 to 75
59.5
53.7
58.0
Cr
25 to 50
25 to 45
25.2
33.3
32.4
Nb
0 to 25
0.5 to 25
15.3
12.9
9.6
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Novakovic because it is a high strength, ductile, and oxidation resistant alloy with a relatively high level of chemical inertness such that it can be used in severe operating conditions, such as high temperature or aggressive chemicals (Novakovic 1. Introduction). 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 claim 28, Furst in view of Jimenez is silent to a base metal alloy with the claimed composition.
Vlcek discloses said base metal alloy includes 55-75 wt.% rhenium (45-75 wt% Re), 25-45 wt.% Cr (25-55 wt% Cr), and 0.5-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Vlcek because it is a ductile CrRe alloy with high-temperature resistance and oxidation resistance with equally good low-temperature properties and suitability for thermal shocks for use as a structural material with good oxidation or corrosion resistance (Vlcek p. 1 paras. 1-3). 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).
As an alternative to Vlcek, Novakovic discloses said base metal alloy includes 55-75 wt.% rhenium, 25-45 wt.% Cr, and 0.5-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (Table 2).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of Furst to be that disclosed by Novakovic because it is a high strength, ductile, and oxidation resistant alloy with a relatively high level of chemical inertness such that it can be used in severe operating conditions, such as high temperature or aggressive chemicals (Novakovic 1. Introduction). 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 claim 29, Furst in view of Jimenez and Vlcek discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0.05 to 5 wt% of at least one of Sc, Ce, and Pr) (Vlcek p. 2 para. 5). 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).
Alternatively, Furst in view of Jimenez and Novakovic discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0 wt%) (Novakovic Table 2). 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 claim 30, Furst in view of Jimenez and Vlcek discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0.05 to 5 wt% of at least one of Sc, Ce, and Pr) (Vlcek p. 2 para. 5). 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).
Alternatively, Furst in view of Jimenez and Novakovic discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium, b) carbon, c) oxygen and d) nitrogen (0 wt%) (Novakovic Table 2). 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).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Furst (WO 2009/079282) in view of Jimenez (Jimenez et al. Structure and mechanical properties of nitrogen-containing Zr-Cu based thin films deposited by pulsed magnetron sputtering. J. Phys. D: Appl. Phys. 41 (2008) 155301 (9pp)) as applied to claim 31 above, and further in view of Drews (US 2005/0165479).
Regarding claim 35, Furst discloses said medical device is a prosthetic heart valve (stent for use in a heart chambers) (4:4-18, 68:21 to 69:5); said prosthetic heart valve includes said expandable metallic frame (2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26); said expandable metallic frame includes a plurality of struts (81:8-13); said expandable metallic frame is configured to be crimped to a crimped state such that a maximum outer diameter of said expandable metallic frame when in said crimped state is less than a maximum outer diameter of said expandable metallic frame when fully expanded to an expanded state (:7 to 4:3, 16:24-26, 17:3-22); said expandable metallic frame has a recoil of less than 5% after being expanded from said crimped state to said expanded state (17:21-22, 23:6-7, 59:20-27, 82:24-26). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05(II)(A).
Furst is silent to said prosthetic heart valve including leaflets.
Drews discloses a medical device that is a prosthetic heart valve ([0037]) including leaflets ([0007]-[0010], [0036], [0096], Fig. 1).
It would have been obvious to one of ordinary skill in the art for the prosthetic heart valve of Furst to include leaflets to provide a valve member (Drews [0010]).
Claims 1-7, 9, 10, 12-18, 20, and 26-30 are rejected under 35 U.S.C. 103 as being unpatentable over Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation).
Regarding claim 1, Vlcek discloses a base metal alloy (CrRe) (p. 1 paras. 1-2);
said base metal alloy comprises rhenium (Re) and one or more additives selected from the group consisting of aluminum, bismuth, calcium, carbon, cerium, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, and/or zirconium (Cr) (45-75 wt% Re, 25-55 wt% Cr) (p. 2 para. 6);
a combined weight percentage of rhenium (Re) and said one or more additives (Cr) in said base metal alloy is at least 98 wt.% (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (p. 2 para. 6);
said one or more additives includes a primary additive selected from the group consisting of bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium (Cr) (25-55 wt% Cr) (p. 2 para. 6);
a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive is 0.7:1 to 1.5:1 (about 0.2:1 to about 0.8:1 calculated by converting wt% to at% using atomic weight) (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (p. 2 para. 6).
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).
Vlcek is silent to a coated metal alloy comprising an enhancement coating.
Kawai discloses a coated metal alloy comprising an enhancement coating (hard film) ([0001]);
wherein at least a portion of an outer surface of said base metal alloy includes said enhancement coating (hard coating 3) material ([0009], Fig. 1);
said enhancement coating (hard coating 3) material is layered or coated on said outer surface of said base metal alloy ([0009], Fig. 1);
said enhancement coating material includes a composition (W, M, and N) selected from the group consisting of a) zirconium or titanium or chromium (M is one or more of Ti, V, Cr, Zr, and Mo) and one or more of carbon, nitrogen, oxygen (N) or b) at least 60 wt.% carbon ([0005]-[0006]).
It would have been obvious to one of ordinary skill in the art for the CrRe alloy of Vlcek to include the hard film (or coating) of Kawai because the alloy of Vlcek is used in high-temperature applications (Vlcek p. 1 para. 1) such as aircraft or jet engines (Vlcek p. 1 para. 3) and the hard film (coating) is used as a coating within an internal combustion engine (Kawai [0001]) for excellent resistance to wear, seizure, cracking, and peeling due to repeated loads from sliding (Kawai [0004], [0006]).
Regarding claim 2, Vlcek in view of Kawai discloses said enhancement coating (hard film 3) material is formed of a single layer or multi layers consisting of the same coating layer composition (Kawai [0009], Fig. 1).
Regarding claim 3, Vlcek in view of Kawai discloses said enhancement coating material includes a composition selected from the group consisting of a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen (W is 10 to less than 90 at%, M is Cr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 45 wt% Cr), c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon (W is 10 to less than 90 at%, M is Ti at more than 0 to 40 at%, N is 10 to 55 at%; up to about 43 wt% Ti), and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon (W is 10 to less than 90 at%, M is Zr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 60 wt% Zr) (Kawai [0005]-[0006]). 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 claim 4, Vlcek in view of Kawai discloses said enhancement coating material includes a composition selected from the group consisting of a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen (W is 10 to less than 90 at%, M is Cr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 45 wt% Cr), c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon (W is 10 to less than 90 at%, M is Ti at more than 0 to 40 at%, N is 10 to 55 at%; up to about 43 wt% Ti), and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon (W is 10 to less than 90 at%, M is Zr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 60 wt% Zr) (Kawai [0005]-[0006]). 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 claim 5, Vlcek in view of Kawai discloses said enhancement coating material includes nitrides and/or oxides (nitrides are formed) of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (M includes one or more of Ti, Cr, and Zr) (Kawai [0005]-[0006]).
Regarding claim 6, Vlcek in view of Kawai discloses said enhancement coating material includes two or more of a) 40-85 wt.% Cr (Cr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 45 wt% Cr), b) 5-60 wt.% N (10 to 55 at%; about 0.8 to about 20 wt%), c) 60- 99.99 wt.% C, d) 20-85 wt.% Ti (Ti at more than 0 to 40 at%; up to about 43 wt% Ti), d) 35-95 wt.% Zr (Zr at more than 0 to 40 at%; up to about 60 wt% Zr), e) 0-10 wt.% Re (0 wt% Re), f) 0-20 wt.% Si (0 wt% Si), g) 0-35 wt.% O (0 wt% O), and h) 0-40 wt.% C (0 wt% C) (W is 10 to less than 90 at%, M is at least one of Cr, Ti, and Zr at more than 0 to 40 at%, N is 10 to 55 at%) (Vlcek [0005]-[0006]). 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 claim 7, Vlcek in view of Kawai discloses enhancement coating material includes two or more of a) 5-60 wt.% N (10 to 55 at%; about 0.8 to about 20 wt%), b) 35-95 wt.% Zr (Zr at more than 0 to 40 at%; up to about 60 wt% Zr), c) 0-8 wt.% Re (0 wt% Re), d) 0-1 wt.% Si (0 wt% Si), e) 0-35 wt.% O (0 wt% O), and f) 0-1 wt.% C (0 wt% C) (W is 10 to less than 90 at%, M is at least one of Cr, Ti, and Zr at more than 0 to 40 at%, N is 10 to 55 at%) (Kawai [0005]-[0006]). 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 claim 9, Vlcek in view of Kawai discloses said enhancement coating material includes one or more of chromium nitride (CrN), diamond-like carbon (DLC), titanium nitride (TiN), zirconium nitride (ZrN), zirconium oxide (ZrO2), zirconium- nitrogen-carbon (ZrNC), zirconium OxyCarbide (ZrOC), and combinations of such coatings (M is one or more of Ti, Cr, and Zr and N content is set so that nitrides are formed, reads on forming one or more of CrN, TiN, and ZrN) (Kawai [0005]-[0006]).
Regarding claim 10, Vlcek in view of Kawai discloses said enhancement coating material is applied by a physical vapor deposition (PVD) process (ion plating or sputtering), a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, a plasma-enhanced chemical vapor deposition (PE-CVD) process, ion implantation, direct energy deposition (DED), plasma arc spraying, flame spraying, or high velocity oxy fuel spraying (HVOF) (Kawai [0007]-[0009], [0014]-[0015]).
Regarding claim 12, Vlcek in view of Kawai discloses said enhancement coating material has a coating thickness of 2 nanometers to 100 microns (5 to 80 microns) (Kawai [0015]). 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 claim 13, Vlcek in view of Kawai discloses said enhancement coating material has a hardness of 5-50 GPa (1300-3000 HV, about 12.75 to 29.42 GPa) (Kawai [0005]-[0006], [0010]). 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 claim 14, Vlcek in view of Kawai discloses a hard film coating with excellent tribological properties (Kawai [0001]), such as resistance to wear, seizure, cracking, and peeling due to repeated sliding loads (Kawai [0003]-[0004], [0028]). The enhancement coating material having a coefficient of friction (COF) of 0.04-0.2 has been considered and determined to recite a property of the claimed enhancement coating material. The prior art discloses an enhancement coating material that is substantially similar to that claimed (Kawai [0005]-[0006]), such that the claimed properties naturally flow from the disclosure of the prior art, including having a coefficient of friction (COF) of 0.04-0.2.
Regarding claim 15, Vlcek in view of Kawai discloses a hard film coating with excellent tribological properties (Kawai [0001]), such as resistance to wear, seizure, cracking, and peeling due to repeated sliding loads (Kawai [0003]-[0004], [0028]). The enhancement coating material having a wear rate of 0.5 x 10-7 mm3/N-m to 3 x 10-7 mm3/N-m has been considered and determined to recite a property of the claimed enhancement coating material. The prior art discloses an enhancement coating material that is substantially similar to that claimed (Kawai [0005]-[0006]), such that the claimed properties naturally flow from the disclosure of the prior art, including having a wear rate of 0.5 x 10-7 mm3/N-m to 3 x 10-7 mm3/N-m.
Regarding claim 16, Vlcek discloses said base metal alloy includes less than 0.1 wt.% metals and impurities other than said rhenium and said one or more additives (45-75 wt% Re, 25-55 wt% Cr, and 0.05 to 5 wt% of at least one of Sc, Ce, and Pr, and about 50 to 500 ppm impurities, 0.005 to 0.05 wt%) (p. 2 paras. 6-7). 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 claim 17, Vlcek discloses a nitrogen content (maximum 50 ppm, 0.005 wt%) in said base metal alloy is less than a combined content of oxygen (maximum of 300 ppm, 0.03 wt%) and carbon (maximum of 0.5 wt%) in said base metal alloy (p. 2 para. 7, para. spanning pp. 2-3), said base metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1 (O maximum of 300 ppm, 0.03 wt%; N maximum of 50 ppm, 0.005 wt%) (p. 2 para. 7, para. spanning pp. 2-3), said base metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1 (C maximum of 0.5 wt%; N maximum of 50 ppm, 0.005 wt%) (p. 2 para. 7, para. spanning pp. 2-3). 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 claim 18, Vlcek discloses said base metal alloy includes 50-75 wt.% rhenium (45-75 wt% Re), 25-50 wt.% Cr (25-55 wt% Cr), (p. 2 para. 6) and 0.5-25 wt.% of said one or more additives; said one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 3 para. 5). 1
Regarding claim 20, Vlcek discloses said rhenium-chromium base metal alloy includes 55-75 wt.% rhenium (45-75 wt% Re), 25-45 wt.% Cr (25-55 wt% Cr) (p. 2 para. 6), and 0.5-25 wt.% of said one or more additives; said one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 3 para. 5);
and said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05 to 5 wt% of at least one of Sc, Ce, and Pr), b) carbon, c) oxygen (typically maximum of 300 ppm, 0.03 wt%) and d) nitrogen (typically maximum of 50 ppm, 0.005 wt%) (p. 2 paras. 6-8).
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 claim 26, Vlcek discloses a base metal alloy (CrRe alloy for high-temperature applications) (p. 1 paras. 1-2);
said base metal alloy comprises comprising rhenium (Re) and one or more additives selected from the group consisting of aluminum, bismuth, calcium, chromium, cobalt, copper, gold, hafnium, iridium, iron, lanthanum, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals, rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc, and zirconium (Cr) (45-75 wt% Re, 25-55 wt% Cr) (p. 2 para. 6);
said one or more additives includes a primary additive selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium (Cr) (25-55 wt% Cr) (p. 2 para. 6);
a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive is 0.7:1 to 5.1:1 (about 0.2:1 to about 0.8:1 calculated by converting wt% to at% using atomic weight) (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (p. 2 para. 6);
a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 98 wt.% (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (p. 2 para. 6).
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).
Vlcek is silent to a coated metal alloy comprising an enhancement coating.
Kawai discloses a coated metal alloy comprising an enhancement coating (hard film) ([0001]);
at least a portion of an outer surface of said base metal alloy includes said enhancement coating (hard coating 3) material that is layered or coated on said outer surface of said base metal alloy ([0009], Fig. 1);
said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon (W, M, and N, where M is one or more of Ti, V, Cr, Zr, and Mo) ([0005]-[0006]);
said enhancement coating material includes nitrides and/or oxides (N content is set so that nitrides are formed) ([0006]);
said enhancement coating material includes a) at least 90 wt.% carbon, b) at least 40 wt.% chromium and one or more of nitrogen, carbon and oxygen (W is 10 to less than 90 at%, M is Cr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 45 wt% Cr), b) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon (W is 10 to less than 90 at%, M is Ti at more than 0 to 40 at%, N is 10 to 55 at%; up to about 43 wt% Ti), or c) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon (W is 10 to less than 90 at%, M is Zr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 60 wt% Zr) (Kawai [0005]-[0006]). 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).
It would have been obvious to one of ordinary skill in the art for the CrRe alloy of Vlcek to include the hard film (or coating) of Kawai because the alloy of Vlcek is used in high-temperature applications (Vlcek p. 1 para. 1) such as aircraft or jet engines (Vlcek p. 1 para. 3) and the hard film (or coating) is used as a coating within an internal combustion engine (Kawai [0001]) for excellent resistance to wear, seizure, cracking, and peeling due to repeated loads from sliding (Kawai [0004], [0006]).
Regarding claim 27, Vlcek discloses said base metal alloy includes 50-75 wt.% rhenium (45-75 wt% Re), 25-50 wt.% Cr (25-55 wt% Cr), and 0-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (0 wt%) (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (p. 2 para. 6). 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 claim 28, Vlcek discloses said base metal alloy includes 55-75 wt.% rhenium (45-75 wt% Re), 25-45 wt.% Cr (25-55 wt% Cr) (p. 2 para. 6), and 0.5-25 wt.% of one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 3 para. 5). 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 claim 29, Vlcek said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05 to 5 wt% of at least one of Sc, Ce, and Pr), b) carbon, c) oxygen (typically maximum of 300 ppm, 0.03 wt%), and d) nitrogen (typically maximum of 50 ppm, 0.005 wt%) (p. 2 paras. 6-8). 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 claim 30, Vlcek discloses said base metal alloy includes 0-0.1 wt.% of secondary materials; said secondary materials are selected from the group consisting of a) metals other than rhenium, bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05 to 5 wt% of at least one of Sc, Ce, and Pr), b) carbon, c) oxygen (typically maximum of 300 ppm, 0.03 wt%), and d) nitrogen (typically maximum of 50 ppm, 0.005 wt%) (p. 2 paras. 6-8). 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).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation) as applied to claim 1 above, and further in view of Zhao (CN 107287566 machine translation).
Regarding claim 8, Vlcek in view of Kawai discloses said enhancement coating material includes first (nitride layer 2) and second coating (hard film 3) layers; said second coating layer is applied to a top surface of said first layer (Kawai [0009]-[0010], [0012], Fig. 1).
Vlcek in view of Kawai is silent to the claimed compositions of the second layer and the first layer.
Zhao discloses an enhancement coating material ([0002], [0008]-[0009], [0025]-[0033]), wherein said second layer includes 80-90 wt.% Zr, 10-20 wt.% N, 0-8 wt.% Re, 0-1 wt.% Si, 0-1 wt.% O, and 0-1 wt.% C; and said first layer includes 70-80 wt.% Zr, 20-30 wt.% , 0-1 wt.% N, 0-8 wt.% Re, 0-1 wt.% Si, and 0-1 wt.% C is a metal layer of zirconium that is applied to said outer surface of said base metal alloy (Zr/ZrN base layer with a nano-composite Zr-Al-Mo nitride coating deposited on top) (Zhao [0008]-[0009], [0013], [0024]).
It would have been obvious to one of ordinary skill in the art in the coated alloy of Vlcek in view of Kawai to use the base layer and nitride coating of Zhao for high hardness and strength, low friction coefficient, good oxidation resistance and thermal stability, and high thermal shock resistance, which is also advantageous for use in areas where friction and wear need to be reduced (Zhao [0005], [0016]), which improves service life (Zhao [0017]). Generally, differences in concentration will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” MPEP 2144.05(II)(A).
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation) as applied to claim 1 above, and further in view of Furst (WO 2009/079282) and Zhang (US 2016/0263287).
Regarding claim 21, Vlcek in view of Kawai is silent to a medical device that is at least partially formed of said coated metal alloy as defined in claim 1.
Furst discloses a medical device that is at least partially formed of said coated metal alloy (2:17-5:17).
It would have been obvious to one of ordinary skill in the art to at least partially form a medical device of the coated metal alloy of Vlcek in view of Kawai because rhenium and chromium are known to be elements present in a medical device metal alloy (Furst 5:12-17) that are nutrient elements or harmless elements in the human body or less toxic elements (Zhang [0026]).
Regarding claim 22, Vlcek in view of Kawai and Furst discloses at least one region of said medical device includes at least one biological agent (Furst 83:1-2, 84:9 to 86:21, 87:26 to 89:13).
Regarding claim 23, Vlcek in view of Kawai and Furst discloses at least one region of said medical device includes at least one polymer, said at least one polymer optionally at least partially coats, encapsulates, or combinations thereof at least one biological agent (Furst 84:9 to 86:21).
Regarding claim 24, Vlcek in view of Kawai and Furst discloses said medical device includes an expandable frame formed of a metal alloy (Furst 2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26); said expandable frame including a plurality of struts (Furst 81:8-13); said expandable frame is configured to be crimped to a crimped state such that a maximum outer diameter of said expandable frame when in said crimped state is less than a maximum outer diameter of said expandable frame when fully expanded to an expanded state (Furst 3:7 to 4:3, 16:24-26, 17:3-22); said expandable frame has a recoil of less than 5% after being subjected to a first crimping process (Furst 17:21-22, 23:6-7, 59:20-27, 82:24-26); and said expandable frame has a recoil of less than 5% after being expanded from said crimped state to said expanded state (Furst 17:21-22, 23:6-7, 59:20-27, 82:24-26). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05(II)(A).
The limitations of 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; and 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 claimed medical device at least partially formed of the metal alloy. The prior art discloses a substantially similar product of a medical device at least partially formed of the coated metal alloy recited in claim 1 (Vlcek p. 2 para. 6; Kawai [0005]-[0006]; Furst pp. 3-4, 5:12-14, 6:18 to 7:3, 7:10-18), such that the claimed properties naturally flow from the disclosure of the prior art, including 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; and 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.
Claims 31-34 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation) as applied to claim 1 above, and further in view of Furst (WO 2009/079282) and Zhang (US 2016/0263287).
Regarding claim 31, Vlcek in view of Kawai is silent to a medical device that is at least partially formed of said coated metal alloy as defined in claim 26; said medical device includes an expandable metallic frame that is at least partially formed of said coated metal alloy.
Furst discloses a medical device that is at least partially formed of said coated metal alloy (2:17-5:17); said medical device includes an expandable metallic frame that is at least partially formed of said coated metal alloy (2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26).
It would have been obvious to one of ordinary skill in the art to at least partially form a medical device of the coated metal alloy of Vlcek in view of Kawai as an expandable metallic frame because rhenium and chromium are known to be elements present in a medical device metal alloy (Furst 5:12-17) that are nutrient elements or harmless elements in the human body or less toxic elements (Zhang [0026]), where an expandable metallic frame advantageously partially expands occluded segments of a body passageway (Furst 81:26-82:26).
Regarding claim 32, Vlcek in view of Kawai and Furst discloses said enhancement coating material includes nitrides and/or oxides (nitrides) (Furst 30:21-31:9, 75:12-18, 79:25-80:3) of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (N is set so nitrides are formed and M includes one or more of Ti, Cr, and Zr) (Kawai [0005]-[0006]).
Regarding claim 33, Vlcek in view of Kawai and Furst discloses said enhancement coating material includes two or more of a) 40-85 wt.% Cr (Cr at more than 0 to 40 at%, N is 10 to 55 at%; up to about 45 wt% Cr), b) 5-60 wt.% N (10 to 55 at%; about 0.8 to about 20 wt%), c) 60- 99.99 wt.% C, d) 20-85 wt.% Ti (Ti at more than 0 to 40 at%; up to about 43 wt% Ti), d) 35-95 wt.% Zr (Zr at more than 0 to 40 at%; up to about 60 wt% Zr), e) 0-10 wt.% Re (0 wt% Re), f) 0-20 wt.% Si (0 wt% Si), g) 0-35 wt.% O (0 wt% O), and h) 0-40 wt.% C (0 wt% C) (W is 10 to less than 90 at%, M is at least one of Cr, Ti, and Zr at more than 0 to 40 at%, N is 10 to 55 at%) (Vlcek [0005]-[0006]). 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 claim 34, Vlcek in view of Kawai and Furst discloses enhancement coating material includes two or more of a) 5-60 wt.% N (10 to 55 at%; about 0.8 to about 20 wt%), b) 35-95 wt.% Zr (Zr at more than 0 to 40 at%; up to about 60 wt% Zr), c) 0-8 wt.% Re (0 wt% Re), d) 0-1 wt.% Si (0 wt% Si), e) 0-35 wt.% O (0 wt% O), and f) 0-1 wt.% C (0 wt% C) (W is 10 to less than 90 at%, M is at least one of Cr, Ti, and Zr at more than 0 to 40 at%, N is 10 to 55 at%) (Kawai [0005]-[0006]). 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 claim 36, Vlcek in view of Kawai and Furst discloses said medical device is a) an orthopedic device, b) a PFO (patent foramen ovale) device, c) a spinal implant, d) a dental implant, e) a bone implant, f) a prosthetic implant, g) a bone plate, h) a knee replacement, i) a hip replacement, j) a shoulder replacement, 1) an ankle replacement, m) a rod, or n) a screw (Furst 64:27-30).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation), Furst (WO 2009/079282), and Zhang (US 2016/0263287) as applied to claim 31 above, and further in view of Drews (US 2005/0165479).
Regarding claim 35, Vlcek in view of Kawai and Furst discloses said medical device is a prosthetic heart valve (stent for use in a heart chambers) (Furst 4:4-18, 68:21 to 69:5); said prosthetic heart valve includes said expandable metallic frame (Furst 2:18-19, 4:13-15, 23:29-31, 69:6-22, 81:26 to 82:26); said expandable metallic frame includes a plurality of struts (Furst 81:8-13); said expandable metallic frame is configured to be crimped to a crimped state such that a maximum outer diameter of said expandable metallic frame when in said crimped state is less than a maximum outer diameter of said expandable metallic frame when fully expanded to an expanded state (Furst 3:7 to 4:3, 16:24-26, 17:3-22); said expandable metallic frame has a recoil of less than 5% after being expanded from said crimped state to said expanded state (Furst 17:21-22, 23:6-7, 59:20-27, 82:24-26). Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. MPEP 2144.05(II)(A).
Vlcek in view of Kawai and Furst is silent to said prosthetic heart valve including leaflets.
Drews discloses a medical device that is a prosthetic heart valve ([0037]) including leaflets ([0007]-[0010], [0036], [0096], Fig. 1).
It would have been obvious to one of ordinary skill in the art for the prosthetic heart valve of Vlcek in view of Kawai and Furst to include leaflets to provide a valve member (Drews [0010]).
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 1-10, 12-18, 20-24, and 26-36 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 55-100 of copending Application No. 18/401,551 (App ‘551) in view of Vlcek (WO 2005/024080 machine translation) and Zhang (US 2016/0263287).
App ‘551 discloses a metal alloy including rhenium (claims 55, 66-71, 77, 84, 87-89, 92-93, 96) with an enhancement coating material (claims 55-62, 65, 71, 74-76, 78-80, 83, 89-90, 96-100) made into a medical device (claims 55, 63-64, 71-73, 81-82, 84-86, 89, 91, 94-96) that overlap with that claimed. 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).
App ‘551 is silent to the additives to the rhenium metal.
Vlcek discloses said base metal alloy (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art for the base metal alloy of App ‘551 to be that disclosed by Vlcek because it is a ductile CrRe alloy with high-temperature resistance and oxidation resistance with equally good low-temperature properties and suitability for thermal shocks for use as a structural material with good oxidation or corrosion resistance (Vlcek p. 1 paras. 1-3) made of nutrient elements or harmless elements in the human body or less toxic elements (Zhang [0026]). 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).
This is a provisional nonstatutory double patenting rejection.
Claims 1-10, 12-18, 20-24, and 26-36 are 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 of copending Application No. 18/400,781 (reference application) (App ‘781).
Although the claims at issue are not identical, they are not patentably distinct from each other because App ‘781 discloses a metal alloy including at least 0.1 wt% rhenium in combination with one or more of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W (claims 1, 17, 26, 31, 33-36) with an enhancement coating material (claims 1, 31-32, 37-42) made into a medical device (claims 1-4, 6-9, 11-13, 16, 18-21, 27, 29-31) that overlap with that claimed. 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).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-10, 12-18, 20-24, and 26-36 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 a metal alloy including at least 15 awt% rhenium in combination with one or more of Mo, Cr, Co, Ni, Ti, Ta, Nb, Zr, and W (claims 1, 13, 19-20, 23-24, 26-27) with an enhancement coating material (claims 1, 23-24, 28-29) made into a medical device (claims 1-12, 14-18, 20-25) that overlap with that claimed. 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).
Related Art
Kuribayashi (US 4,685,948)
Kuribayashi discloses an Ir alloy film with 10, 30, 50, or 55 wt% Re (4:5-12, Table 1 Specimen Nos. 4-7).
Fang (Fang et al. Surface studies of platinum- and niobium-coated impregnated tungsten cathodes. Surface Science. 189-190 (1987) 80-90. Elsevier Science Publishers.)
Fang discloses a 40 wt% Nb- 40wt% Re- 20 wt% W alloy coating (1. Introduction para. 2).
Cichocki (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.)
Cichocki discloses a tungsten-rhenium alloy suture needle (medical device) with a lubricious silicone coating (Abstract, Materials and Methods: Needle processing). The Re:W atomic weight ratio of the W- 26 wt% Re alloy of Cichocki is 0.3:1.
Musil (Musil and Daniel. Structure and mechanical properties of magnetron sputtered Zr-Ti-Cu-N films. Surface and Coatings Technology. 166 (2003) 243-253.)
Musil discloses a Zr-(Ti)-Cu-N film with a hardness of greater than 40 GPa (Abstract) and a thickness of approximately 3 um (2. Experimental para. 1).
Hoppe (US 2010/0171272)
Hoppe discloses a wear protection layer ([0002]) consisting of Zr1-xCrxNy, where x = 0.1 to 0.85 and y = 0.5 to 1 ([0026]-[0027]) deposited by a PVD method ([0017]-[0025]) such as reactive arc process ([0033]) to a thickness of 5 to 60 um ([0031]).
Saito (Saito et al. Experimental Determination of Isothermal Section at 1500°C in the Ternary Re-Cr-Nb System. J. Japan Inst. Met. Mater. Vol. 77, No. 10 (2013), pp. 424-429.)
Saito discloses a metal alloy that includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0.5-25 wt.% of said one or more additives; said one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (Abstract, Table 1).
Element
Claim 18
Saito #9
Saito #10
Re
50 to 75
51.9
59.2
Cr
25 to 50
37.7
35.8
Nb
0.5 to 25
10.4
4.9
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Contact Information
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/STEPHANI HILL/Examiner, Art Unit 1735