DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on April 20, 2026 has been entered.
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 Remarks and Claim Amendments filed April 20, 2026.
Claims Filing Date
April 20, 2026
Amended
1, 18, 20, 24, 26-30
New
37
Cancelled
10, 11, 19, 25
Under Examination
1-9, 12-18, 20-24, 26-37
The applicant argues support for the ratio limitation in [0030] (p. 14 para. 4) and support for the list of additives in [0026] and original claim 1 (p. 14 para. 4).
Support for the enhancement coating application process is in original claim 10 and for the enhancement coating not being a nitride surface layer formed by a nitriding process in [0058]-[0059], [0075], [0080]. Any negative limitation must have basis in the original disclosure. If alternate elements (embodiments) are positively recited in the specification, they may be explicitly excluded in the claims. MPEP 2173.05(i).
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Withdrawn Specification Objection
The following objection is withdrawn due to specification amendment:
[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.
Withdrawn Claim Objections
The following objections are withdrawn due to claim amendment:
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°”.
Claim 26 line 1 “coated metal alloy a base metal alloy”.
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.
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”.
Withdrawn Claim Rejections - 35 USC § 112
The applicant persuasively argues reference to “primary additive” has been removed from independent claims 1 and 26 (p. 14 para. 4) and claim amendments clarify the scope (p. 14 para. 5).
The following 112(a) rejections have been withdrawn due to claim amendment:
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”.
Claim 1 lines 8-10 “primary additive selected from the group consisting of bismuth, niobium,…, and iridium”.
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…”.
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…”.
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”.
Claim 26 lines 6-8 “primary additive selected from the group consisting of bismuth, chromium,…, and zirconium”.
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…”.
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…”.
The following 112(b) rejections are withdrawn due to claim amendment:
Claim 1 line 8 “primary additive”.
Claim 24 line 10 “the patient”.
Claim 24 line 14 “the body of a patient”.
Claim 26 lines 6-7 “primary additive”.
Response to Remarks filed April 20, 2026
Furst (WO 2009/079282) in view of Zhao (CN 107287566 machine translation); Furst (WO 2009/079282) in view of Jimenez
Applicant’s claim amendments, see claim 26 lines 8-10, filed April 20, 2026, with respect to Furst have been fully considered and are persuasive. The claim 26 rejections of Furst in view of Zhao and Furst in view of Jimenez have been withdrawn.
Amended claim 26 lines 8-10 recite “a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium is 0.7:1 to 1.5:1”.
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 does not read on the claimed ratio of 0.7:1 to 1.5:1.
However, in light of claim amendment and upon further consideration, claims 1-9, 12-17, and 21-24 are rejected over Furst in view of Zhao and over Furst in view of Jimenez. With respect to the new rejections, applicant’s arguments filed April 20, 2026 directed to Furst have been fully considered but they are not persuasive.
The applicant argues the nitride coating of Furst is not an enhancement coating and amended claims 1 and 26 expressly exclude a nitride coating formed by a nitriding process (p. 17 para. 1) and require certain coating processes (p. 17 para. 2), where Furst does not disclose a nitride coating formed by the claimed process (p. 17 para. 3).
Furst discloses coating the medical device with one or more agents that facilitate in the success of the medical device and/or treated area and that the agent is a substance that prevents, inhibits, and/or treats one or more clinical and/or biological events and/or promotes healing (37:4-9).
The coating of Zhao 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]). Similarly, Furst discloses the medical device has improved physical properties, such as strength, durability, hardness, and coefficient of friction (Furst 3:7 to 4:3). Furthermore, Zhao deposits the coating by vacuum deposition (Zhao [0013]), which is within the scope of Furst (vacuum deposition) (Furst 4:1-3).
The coating of Jimenez advantageously has increased hardness and durability and is for use in mechanical and load-bearing applications, such as applications with abrasion (Jimenez 1. Introduction). Similarly, Furst discloses the medical device has improved physical properties, such as durability, hardness, and coefficient of friction (Furst 3:7 to 4:3). Furthermore, Jimenez depositions the coating by sputtering (Jimenez 2. Experimental procedure), which is within the scope of Furst (sputtering) (Furst 4:1-3).
For the above cited reasons rejections of Furst in view of Zhao and Furst in view of Jimenez are made over claim 1.
Vlcek (WO 2005/024080 machine translation) in view of Kawai (JP 2002-256968 machine translation)
Applicant's arguments filed April 20, 2026 with respect to Vlcek have been fully considered but they are not persuasive.
The applicant argues Vlcek discusses a ReCr alloy, which is a very different metal alloy from the metal alloy defined in the pending claims (p. 18 para. 1).
Vlcek states in the abstract that “The CrRe is made of at least 45 – 75 wt. % rhenium (Re), 25 – 55 wt. % chromium (Cr), 0.05 – 5 wt. % of at least one element from the group comprising of scandium (Sc), cerium (Ce) and praseodymium (Pr), and unavoidable impurities.” This same alloy is also recited on page 2/5 of Vlcek around lines 17-18.
This alloy disclosed by Vlcek reads on the claimed base metal alloy that comprises rhenium (45 – 75 wt. % Re) and one or more additives selected from the group consisting of aluminum bismuth, calcium, carbon, cerium, chromium (25 – 55 wt.% Cr), cobalt, copper, gold, hafnium, iridium, iron, lanthanum, magnesium, manganese, molybdenum, nickel, niobium, osmium, platinum, rare earth metals (0.05 – 5 wt. % at least one of Sc, Ce, and Pr), rhodium, ruthenium, silver, tantalum, technetium, titanium, tungsten, vanadium, yttrium, zinc and/or and zirconium; a combined weight percent of rhenium and said one or more additives in said base metal alloy is at least 98 wt. % (100 wt.%).
Therefore, the rejection over Vlcek is maintained.
Double Patenting
Applicant’s arguments, see Remarks p. 15 para. 2, filed April 20, 2026, with respect to the double patenting rejections over 18/401,551 and 18/400,781 have been fully considered and are persuasive. The double patenting rejections over 18/401,551 and 18/400,781 have been withdrawn.
The applicant persuasively argues a terminal disclaimer has been filed to overcome the nonstatutory double patenting rejections over copending Application Nos. 18/401,551 and 18/400,781 (p. 15 para. 2).
The terminal disclaimer filed April 20, 2026 listing Application Nos. 18/401,551 and 18/400,781 was approved on April 20, 2026.
New Grounds
In light of claim amendment and filing of a new claim and upon further consider new grounds of rejection are made over Hu (CN 102534617 machine translation) and over Morris (US 4,045,247) in view of Heitzinger (US 3,960,604).
Claim Objections
Claims 1, 27, and 28 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 and zirconium” uses “and/or and” as the conjunction. This is two separate conjunctions, either “and/or” or “and” should be used. Further, other claim recitations of “one or more…selected from the group consisting of”, such as claim 5 lines 2-3 and claim 9 lines 2-4, use “and” as the conjunction. Claim language should be consistent.
Claim 27 lines 2-4 “0-25 wt.% of one or more additives 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 additives 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.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 20 and 24 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 20 lines 2-8 “base metal alloy includes…rhenium,…Cr, and…one or more additives includes one or more metals selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium; and…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” renders the claim indefinite. It is unclear if it is within the scope of claim 20 for chromium (Cr) to be a secondary material because it is not excluded from the listed metals. For the purpose of examination claim 20 is interpreted as chromium being a secondary material.
Claim 24 lines 1-2 “The medical device as defined in claim 21, wherein said medical device includes an expandable frame formed of a metal alloy” renders the claim indefinite. Claim 21 is directed to a medical device at least partially formed of the coated metal alloy as defined in claim 1. It is unclear how “a metal alloy” that forms “an expandable frame” is related to the coated metal alloy as defined in claim 1. In claim 24 line “a metal alloy” could be distinct from a coated metal alloy comprising a base metal alloy and an enhancement coating material, it could be a coated metal alloy comprising a base metal alloy and an enhancement coating material, or it could be a base metal alloy. For the purpose of examination claim 24 is interpreted as requiring an expandable frame to be formed of a non-limited metal alloy.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hu (CN 102534617 machine translation).
Regarding claim 1, Hu discloses a coated metal alloy comprising a base metal alloy (Mo-Re alloy matrix) and an enhancement coating material (TiO2 film on the surface) (Example 4 [0039]-0042]);
said base metal alloy comprises rhenium 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 and zirconium (molybdenum-rhenium alloy matrix) (Example 4 [0040]);
a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 98 wt.% (molybdenum-rhenium alloy matrix) (Example 4 [0040]);
and wherein at least a portion of an outer surface of said base metal alloy includes said enhancement coating material (TiO2 film on the surface) (Example 4 [0039]-[0042]);
said enhancement coating material is layered or coated on said outer surface of said base metal alloy (TiO2 film on the surface) (Example 4 [0029]-[0042]);
said enhancement coating material includes a composition selected from the group consisting of a) compound that includes zirconium or titanium or chromium and one or more of carbon, nitrogen, oxygen or b) at least 60 wt.% carbon (TiO2 includes titanium and oxygen) (Example 4 [0042]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (vapor deposition) (Example 4 [0042]);
said enhancement coating is not a nitride surface layer formed by a nitriding process (Example 4 [0039]-[0042]).
Regarding claim 2, Hu discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material is formed of a single layer or multi layers consisting of the same coating layer composition (dense TiO2 film) ([0039]-[0042]).
Regarding claim 3, Hu discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon (TiO2 is 60 wt% Ti and 40 wt% O, where Ti has a weight of 47.867 and O has a weight of 15.999), and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon ([0039]-[0042]).
Regarding claim 4, Hu discloses the coated metal alloy as defined in claim 2 as cited above, wherein 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, c) at least 20 wt.% titanium and one or more of nitrogen, oxygen, and carbon (TiO2 is 60 wt% Ti and 40 wt% O, where Ti has a weight of 47.867 and O has a weight of 15.999), and d) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon ([0039]-[0042]).
Regarding claim 5, Hu discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes nitrides and/or oxides of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (TiO2 includes oxides of Ti) ([0039]-[0042]).
Regarding claim 16, Hu discloses the coated metal alloy as defined in claim 1 as cited above, wherein said base metal alloy includes less than 0.1 wt.% metals other than said rhenium and said one or more additives (Mo-Re alloy) ([0040]).
Claim Rejections - 35 USC § 102/103
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 13-15 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Hu (CN 102534617 machine translation) as applied to claim 1 above.
Regarding claim 13, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Said enhancement coating material having a hardness of 5-50 GPa has been considered and determined to recite a property of the claimed enhancement coating. The prior art discloses an enhancement coating with a substantially similar composition (TiO2) and deposition method (vapor deposition) (Hu [0039]-[0042]) as that recited in claim 1, such that the claimed properties of the enhancement coating are anticipated by or obvious over the prior art, including a hardness of 5-50 GPa.
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” MPEP 2112(III).
Regarding claim 14, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Said 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. The prior art discloses an enhancement coating with a substantially similar composition (TiO2) and deposition method (vapor deposition) (Hu [0039]-[0042]) as that recited in claim 1, such that the claimed properties of the enhancement coating are anticipated by or obvious over the prior art, including a coefficient of friction (COF) of 0.04-0.2.
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” MPEP 2112(III).
Regarding claim 15, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Said 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. The prior art discloses an enhancement coating with a substantially similar composition (TiO2) and deposition method (vapor deposition) (Hu [0039]-[0042]) as that recited in claim 1, such that the claimed properties of the enhancement coating are anticipated by or obvious over the prior art, including a wear rate of 0.5 x 10-7 mm3/N-m to 3 x 10-7 mm3/N-m.
Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. “There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102.” MPEP 2112(III).
Claim Rejections - 35 USC § 103
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) as applied to claim 1 above.
Regarding claim 6, Hu discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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 (TiO2 is 60 wt% Ti and 40 wt% O, where Ti has a weight of 47.867 and O2 has a weight of 15.999 x 2 = 31.998) ([0039]-[0042]). With respect to the O, a prima facie of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.” MPEP 2144.05(I).
Regarding claim 12, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu is silent to the coating thickness of Example 4 ([0039]-[0042]).
Hu discloses said enhancement coating material has a coating thickness of 2 nanometers to 100 microns (4-12 um, Example 6; 1.0-5.6 um, Example 7) ([0050], [0054]).
It would have been obvious to one of ordinary skill in the art for the coating thickness of Example 4 in Hu to be 1.0 to 12 um because this is the range of thicknesses disclosed as being within the scope of Hu’s invention ([0050], [0054]).
Claims 7 and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) as applied to claim 1 above, and further in view of Rowe (US 2010/0279146).
Regarding claim 7, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu discloses a molybdenum-rhenium alloy with a TiO2 coating ([0039]-[0042]).
Hu is silent to said enhancement coating material including two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, c) 0-8 wt.% Re, d) 0-1 wt.% Si, e) 0-35 wt.% O, and f) 0-1 wt.% C.
Rowe discloses a coated metal alloy comprising a base metal alloy (at least Mo with alloying materials) ([0006]) and an enhancement coating material (surface coating) ([0032]) said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, c) 0-8 wt.% Re, d) 0-1 wt.% Si, e) 0-35 wt.% O, and f) 0-1 wt.% C (ZrN is 13 wt% N and 87 wt% Zr) ([0032]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the coating of Hu to be ZrN because it is an art recognized equivalent oxidation resistant coating to TiO2 for a molybdenum alloy (Rowe [0006], [0032]). It is prima facie obvious to substitute equivalents known for the same purpose. MPEP 2144.06(II).
Regarding claim 9, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu discloses a molybdenum-rhenium alloy with a TiO2 coating ([0039]-[0042]).
Hu is silent to one or more of the claimed enhancement coating materials.
Rowe discloses a coated metal alloy comprising a base metal alloy (at least Mo with alloying materials) ([0006]) and an enhancement coating material (surface coating) ([0032]) 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 (TiN, ZrN, and/or ZrO2) ([0032]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the coating of Hu to be TiN, ZrN, ZrO2, or combinations thereof because they are art recognized equivalent oxidation resistant coatings to TiO2 for a molybdenum alloy (Rowe [0006], [0032]). It is prima facie obvious to substitute equivalents known for the same purpose. MPEP 2144.06(II).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) as applied to claim 1 above, and further in view of Rowe (US 2010/0279146) and Zhao (CN 107287566 machine translation).
Regarding claim 8, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu is silent to said enhancement coating including first and second coating layers as claimed.
Rowe discloses a coated metal alloy comprising a base metal alloy (at least Mo with alloying materials) ([0006]) and an enhancement coating material (surface coating) ([0032]) said enhancement coating material includes a second coating layer; 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 (ZrN is 13 wt% N and 87 wt% Zr) ([0032]).
Zhao discloses said enhancement coating material includes first and second coating layers (Zr/ZrN base layer) ( [0009], [0013], [0024]); 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; said second coating layer is applied to a top surface of said first layer; said first layer is a metal layer of zirconium that is applied to said outer surface of said base metal alloy ([0008]).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention for the enhancement coating of Hu to a Zr/ZrN coating material that 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]). Furthermore, a ZrN coating is an art recognized equivalent oxidation resistant coating to TiO2 for a molybdenum alloy (Rowe [0006], [0032]).
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).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) as applied to claim 1 above, and further in view of Furst (WO 2009/079282).
Regarding claim 17, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu is silent to a content of nitrogen, oxygen, and carbon in the base metal alloy.
Furst discloses a base metal alloy (rhenium and molybdenum) (5:12-14, 6:18 to 7:3, 7:10-18) wherein a nitrogen content in said base metal alloy is less than a combined content of oxygen and carbon in said base metal alloy, said base metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, said base metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1 (12:1 to 15:17).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention in the Mo-Re alloy of Hu to include the nitrogen, oxygen, and carbon contents as disclosed by Furst to minimize the tendency of the metal alloy to form micro-cracks during forming and/or use and to prevent an unacceptable decrease in the ductility of the metal alloy (Furst 12:1 to 15:17).
Claims 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) as applied to claim 1 above, and further in view of Vlcek (WO 2005/024080 machine translation).
Regarding claim 18, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu is silent to a metal alloy with the claimed composition.
Vlcek discloses a base metal alloy that includes 50-75 wt.% rhenium (45-75 wt% Re), 25-50 wt.% Cr (25-55 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, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 2, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5); a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the metal alloy of Hu 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). The base metal alloy of Hu desires similar properties of excellent high temperature properties such as oxidation resistance and mechanical properties (Hu [0004]-[0005]). 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 20, Hu discloses the coated metal alloy as defined in claim 1 as cited above.
Hu is silent to a metal alloy with the claimed composition.
Vlcek discloses a base metal alloy that includes 55-75 wt.% rhenium (45-75 wt% Re), 25-45 wt.% Cr (25-55 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, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (0.05-0.5 wt% Zr and/or 0.05-0.5 wt% Y) (p. 1 para. 2, p. 2 paras. 4-8, p. 2 para. 12 to 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, b) carbon, c) oxygen and d) nitrogen (0.05 to 5 wt% of at least one of Sc, Ce, and Pr) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 12 to p. 3 para. 5); a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the metal alloy of Hu 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). The base metal alloy of Hu desires similar properties of excellent high temperature properties such as oxidation resistance and mechanical properties (Hu [0004]-[0005]). 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).
Claims 21-24 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 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, Hu discloses said coated metal alloy as defined in claim 1 as cited above.
Hu discloses a Mo-Re alloy ([0040]).
Hu is silent to a medical device 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 (molybdenum and rhenium) (2:17 to 5:17).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention to at least partially form a medical device of the coated metal alloy of Hu because rhenium and molybdenum are known to be elements present in a medical device metal alloy (Furst 5:12-17), where Re is a nutrient element or harmless element in the human body or a less toxic element (Zhang [0026]).
Regarding claim 22, Hu in view of Furst and Zhang discloses the medical device as defined in claim 21 as cited above, wherein 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, Hu in view of Furst and Zhang discloses the medical device as defined in claim 22 as cited above, wherein 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, Hu in view of Furst and Zhang discloses the medical device as defined in claim 21 as cited above, wherein said medical device includes an expandable frame formed of a metal alloy (Furst 2:18-19, 4:13-15, 23:29-31, 69:6-11, 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); 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 claimed 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 such that a contact angle of a water droplet on a surface of said metal alloy is 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the a body of the 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 alloy as cited above with respect to claim 1, such that the claimed properties naturally flow from the disclosure of the prior art, including said metal alloy having a hydrophilicity such that a contact angle of a water droplet on a surface of said metal alloy is 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 a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy having an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in the a body of the patient.
Claims 26-30 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) in view of Vlcek (WO 2005/024080 machine translation).
Regarding claim 26, Hu discloses coated metal alloy formed of a base metal alloy and an enhancement coating material (Example 4 [0039]-[0042]);
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; said one or more additives includes a primary additive selected from the group consisting of bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium (molybdenum-rhenium alloy) ([0040]);
a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 98 wt.% (molybdenum-rhenium alloy) ([0040]);
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 ([0039]-[0042]);
said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon (TiO2) ([0041]-[0042]);
said enhancement coating material includes nitrides and/or oxides (TiO2) ([0041]-[0042]);
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 (TiO2 includes 60 wt% Ti), or c) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon ([0041]-[0042]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (vacuum deposition) ([0042]);
said enhancement coating is not a nitride surface layer formed by a nitriding process (TiO2 coating by vacuum deposition) ([0042]).
Hu is silent to a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium is 0.7:1 to 5.1:1 1.5:1.
Vlcek discloses a base metal alloy that includes a ratio of an atomic weight of rhenium to a combined atomic weight of said primary additive bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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 to 5 wt% of at least one of Sc, Ce, and Pr) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 6, p. 2 para. 12 to p. 3 para. 5)
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the metal alloy of Hu 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). The base metal alloy of Hu desires similar properties of excellent high temperature properties such as oxidation resistance and mechanical properties (Hu [0004]-[0005]). 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 27, Hu in view of Vlcek discloses the coated metal alloy as defined in claim 26 as cited above, wherein said base metal alloy includes 50-75 wt.% rhenium, 25-50 wt.% Cr, and 0-25 wt.% of one or more metals additives selected from the group consisting of bismuth, iridium, manganese, molybdenum, niobium, tantalum, vanadium, titanium, tungsten, yttrium, and zirconium (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr) (Vlcek 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, Hu in view of Vlcek discloses the coated metal alloy as defined in claim 26 as cited above, wherein said base metal alloy includes 55-75 wt.% rhenium, 25-45 wt.% Cr, and 0.5-25 wt.% of one or more metals additives selected from the group consisting of bismuth, iridium, molybdenum, niobium, tantalum, vanadium, yttrium, and zirconium (45-75 wt% Re, 25-55 wt% Cr) (Vlcek p. 2 para. 6) (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, Hu in view of Vlcek discloses the coated metal alloy as defined in claim 27 as cited above, wherein 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, chromium, 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, Hu in view of Vlcek discloses the coated metal alloy as defined in claim 28 as cited above, wherein 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, chromium, 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 37, Hu discloses a coated metal alloy formed of a base metal alloy and an enhancement coating material (Example 4 [0039]-[0042]);
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 (molybdenum-rhenium alloy) ([0040]);
a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 99.9 wt.% (molybdenum-rhenium alloy) ([0040]);
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 ([0039]-[0042]);
said enhancement coating material includes two or more elements selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon (TiO2) ([0041]-[0042]);
said enhancement coating material includes nitrides and/or oxides (TiO2) ([0041]-[0042]);
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 (TiO2 is 60 wt% Ti), or c) at least 5 wt.% zirconium and one or more of nitrogen, oxygen and carbon ([0041]-[0042]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (vacuum deposition) ([0041]-[0042]);
said enhancement coating is not a nitride surface layer formed by a nitriding process ([0041]-[0042]).
Hu is silent to an atomic weight percent of said rhenium to an atomic weight percent of a combination of said bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium is 0.9:1 to 1.1:1.
Vlcek discloses a base metal alloy that includes an atomic weight percent of said rhenium to an atomic weight percent of a combination of said bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium is 0.9:1 to 1.1:1 (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 to 5 wt% of at least one of Sc, Ce, and Pr) (p. 1 para. 1, p. 2 paras. 4-8, p. 2 para. 6, p. 2 para. 12 to p. 3 para. 5).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the metal alloy of Hu 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). The base metal alloy of Hu desires similar properties of excellent high temperature properties such as oxidation resistance and mechanical properties (Hu [0004]-[0005]).
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).
Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.” MPEP 2144.05(I).
Claims 31-33 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) in view of Vlcek (WO 2005/024080 machine translation) as applied to claim 26 above, and further in view of Furst (WO 2009/079282) and Zhang (US 2016/0263287).
Regarding claim 31, Hu in view of Vlcek discloses said coated metal alloy as defined in claim 26 as cited above.
Hu in view of Vlcek a medical device that is at least partially formed of said coated metal alloy as defined in claim 26.
Furst discloses a medical device that is at least partially formed of a coated metal alloy (2:!7-5:17); 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 at the time of filing of the instant invention to at least partially form a medical device of the coated metal alloy of Hu in view of Vlcek 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, Hu in view of Vlcek, Furst, and Zhang discloses the medical device as defined in claim 31 as cited above, wherein said enhancement coating material includes nitrides and/or oxides of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (TiO2) (Hu [0041]-[0042]).
Regarding claim 33, Hu in view of Vlcek, Furst, and Zhang disclose the medical device as defined in claim 31 as cited above, wherein 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 (TiO2 includes 60 wt% Ti and 40 wt% O) ([0041]-[0042]).
Regarding claim 36, Hu in view of Vlcek, Furst, and Zhang disclose the medical device as defined in claim 31 as cited above; 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 34 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) in view of Vlcek (WO 2005/024080 machine translation), Furst (WO 2009/079282), and Zhang (US 2016/0263287) as applied to claim 31 above, and further in view of Rowe (US 2010/0279146).
Regarding claim 34, Hu in view of Vlcek, Furst, and Zhang discloses the medical device as defined in claim 31 as cited above.
Hu discloses a molybdenum-rhenium alloy with a TiO2 coating ([0039]-[0042]).
Hu in view of Vlcek, Furst, and Zhang is silent to said enhancement coating material including 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.
Rowe discloses a coated metal alloy comprising a base metal alloy (at least Mo with alloying materials) ([0006]) and an enhancement coating material (surface coating) ([0032]) said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, c) 0-8 wt.% Re, d) 0-1 wt.% Si, e) 0-35 wt.% O, and f) 0-1 wt.% C (ZrN is 13 wt% N and 87 wt% Zr) ([0032]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the coating of Hu to be ZrN because it is an art recognized equivalent oxidation resistant coating to TiO2 for a molybdenum alloy (Rowe [0006], [0032]). It is prima facie obvious to substitute equivalents known for the same purpose. MPEP 2144.06(II).
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Hu (CN 102534617 machine translation) in view of Vlcek (WO 2005/024080 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, Hu in view of Vlcek, Furst, and Zhang discloses the medical device as defined in claim 31 as cited above,
wherein said medical device is a prosthetic heart valve (stent for use in a heart chamber) (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).
Hu in view of Vlcek, Furst, and Zhang is silent to said prosthetic heart valve including leaflets.
Drews discloses a medical device that is 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 at the time of filing the instant invention for the prosthetic heart valve of Hu in view of Vlcek, Furst, and Zhang to include leaflets to provide a valve member (Drews [0010]).
Claims 1-9, 12-17, and 21-24 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 1, Furst discloses a coated metal alloy comprising a base metal alloy (medical device at least partially made of a metal alloy) and an enhancement coating material (coated with one or more agents) (3:7 to 4:3, 37:4-9);
said base metal alloy comprises rhenium 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 and zirconium (rhenium and molybdenum) (5:!2-14, 6:18 to 7:3, 7:10-18);
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);
and wherein at least a portion of an outer surface of said base metal alloy (medical device) includes said enhancement coating material (coated with one or more agents) (37:4-9);
said enhancement coating material is layered or coated on said outer surface of said base metal alloy (medical device coated with one or more agents) (37:4-9);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (manufacturing processes include sputtering coating and vacuum deposition) (3:31 to 4:3);
said enhancement coating is not formed by a nitriding process (manufacturing processes including sputtering coating and vacuum deposition) (3:31 to 4:3).
Furst is silent to the composition of said enhancement coating.
Zhao discloses a coated metal alloy comprising a base metal alloy and an enhancement coating; said enhancement coating material includes a composition selected from the group consisting of a) compound that includes zirconium or titanium or chromium and one or more of carbon, nitrogen, oxygen or b) at least 60 wt.% carbon (30 to 60 at% zirconium and 20 to 50 at% nitrogen, Zr-Al-Mo-N nitride coating) ([0002], [0008]-[0009], [0025]-[0033]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process; said enhancement coating is not a nitride surface layer formed by a nitriding process (physical vapor deposition using a multi-age ion plating machine) (Zhao [0013]-[0014]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the coating agent 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]). Similarly, Furst discloses the medical device has improved physical properties, such as strength, durability, hardness, and coefficient of friction (Furst 3:7 to 4:3).
Regarding claim 2, Furst in view of Zhao disclose the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material is formed of a single layer or multi layers consisting of the same coating layer composition (Furst 37:4-9; Zhao [0009], [0037], [0040]).
Regarding claim 3, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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, 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 (at least 5 wt.% zirconium and nitrogen) (Zhao [0008], [0025]-[0033]). 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, Furst in view of Zhao discloses the coated metal alloy as defined in claim 2 as cited above, wherein 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, 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 (at least 5 wt.% zirconium and nitrogen) (Zhao [0008], [0025]-[0033]) 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, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes nitrides and/or oxides of one or more elements selected from the group consisting of Cr, Ti, Zr, and Al (nitrides of Zr and Al) (Zhao [0002], [0007]-[0009], [0011]).
Regarding claim 6, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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 6, 7
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 7, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, c) 0-8 wt.% Re, d) 0-1 wt.% Si, e) 0-35 wt.% O, and f) 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 8, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes first and second coating layers (Zr/ZrN base layer) (Zhao [0009], [0013], [0024]); 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; said second coating layer is applied to a top surface of said first layer; said first layer is a metal layer of zirconium that is applied to said outer surface of said base metal alloy (Zhao [0008]). 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).
Regarding claim 9, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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 (nitrides of ZrN) (Zhao [0002], [0008]-[0009], [0025]-[0033]).
Regarding claim 12, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material has a coating thickness of 2 nanometers to 100 microns (2.8 to 3.4 um) (Zhao [0009], [0024]). 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, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material has a hardness of 5-50 GPa (reaches 33.6 GPa) (Zhao [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 14, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above. Said 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 enhancement coating material. Furst in view of Zhao discloses the enhancement coating has a low coefficient of friction (Zhao [0005]) that can be adjusted by changing the content of each element in the coating (Zhao [0016]). Therefore, the coefficient of friction is a result-effective variable (i.e. a variable which achieves a recognized result) of the enhancement coating composition, such that the determination of the optimum or workable ranges might be characterized as routine experimentation. MPEP 2144.05(II)(B).
Additionally or alternatively, differences in concentration of temperature (or coefficient of friction) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature (or coefficient of friction) 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).
Additionally or alternatively, the prior art disclosed a substantially similar enhancement coating (Zhao [0002], [0008]-[0009], [0025]-[0033]), such that the claimed properties naturally flow from the disclosure of the prior art, including a coefficient of friction (COF) of 0.04-0.2.
Regarding claim 15, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above. Said 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 enhancement material. Furst in view of Zhao discloses the enhancement coating has an important use in areas where wear needs to be reduced (Zhao [0005]). Differences in concentration or temperature (or wear rate) will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature (or wear rate) 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).
Alternatively or additionally, the prior art discloses a substantially similar enhancement coating (Zhao [0002], [0008]-[0009], [0025]-[0033]), such that the claimed properties naturally flow from the disclosure of the prior art, including a wear rate of 0.5 x 10-7 mm3/N-m to 3 x 10-7 mm3/N-m.
Regarding claim 16, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein said base metal alloy includes less than 0.1 wt.% metals other than said rhenium and said one or more additives (alternatively less than 0.1 weight percent other metals and/or impurities) (Furst 11:11-31). 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, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above, wherein a nitrogen content in said base metal alloy is less than a combined content of oxygen and carbon in said base metal alloy, said base metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, said base metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1 (12:1 to 15:17). 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 21, Furst in view of Zhao discloses a medical device that is at least partially formed of said coated metal alloy as defined in claim 1 (Furst pp. 3-4).
Regarding claim 22, Furst in view of Zhao discloses the medical device as defined in claim 21 as cited above, wherein 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, Furst in view of Zhao discloses the medical device as defined in claim 22 as cited above, wherein 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, Furst in view of Zhao discloses the medical device as defined in claim 21 as cited above, wherein said medical device includes an expandable frame formed of a metal alloy (Furst 2:18-19, 4:13015, 23:29-31, 69:6-22, 81:26 to 82:26); said expandable frame including a plurality of struts (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 (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 (17:21-22, 23:6-7 59:20-27, 82:24-26); said expandable 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).
The limitations of said metal alloy has a hydrophilicity wherein such that a contact angle of a water droplet on a surface of said metal alloy is 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in a body of the 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 metal alloy recited in claim 1 (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 has a hydrophilicity wherein such that a contact angle of a water droplet on a surface of said metal alloy is 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in a body of the patient.
Claims 1-9, 12-17, and 21-24 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 1, Furst discloses a coated metal alloy comprising a base metal alloy (medical device at least partially made of a metal alloy) and an enhancement coating material (coated with one or more agents) (3:7 to 4:3, 37:4-9);
said base metal alloy comprises rhenium 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 and zirconium (rhenium and molybdenum) (5:!2-14, 6:18 to 7:3, 7:10-18);
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);
and wherein at least a portion of an outer surface of said base metal alloy (medical device) includes said enhancement coating material (coated with one or more agents) (37:4-9);
said enhancement coating material is layered or coated on said outer surface of said base metal alloy (medical device coated with one or more agents) (37:4-9);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (manufacturing processes include sputtering coating and vacuum deposition) (3:31 to 4:3);
said enhancement coating is not formed by a nitriding process (manufacturing processes including sputtering coating and vacuum deposition) (3:31 to 4:3).
Furst is silent to the composition of said enhancement coating.
Jimenez discloses a coated metal alloy comprising a base metal alloy and an enhancement coating; said enhancement coating material includes a composition selected from the group consisting of a) compound that includes zirconium or titanium or chromium and one or more of carbon, nitrogen, oxygen or b) at least 60 wt.% carbon (ZrCu(N) coating) (Abstract, 2. Experimental procedure, Table 1);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process; said enhancement coating is not a nitride surface layer formed by a nitriding process (reactive pulsed-dc closed-field unbalance magnetron (CFUBM) sputtering) (2. Experimental procedure).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the coating agent in Furst to be a ZrCu(N) 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). Similarly, Furst discloses the medical device has improved physical properties, such as strength, durability, hardness, and coefficient of friction (Furst 3:7 to 4:3).
Regarding claim 2, Furst in view of Jimenez disclose the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material is formed of a single layer or multi layers consisting of the same coating layer composition (Furst 37:4-9; Jimenez 2. Experimental procedure, 3.1. Coating morphology, Fig. 2, 4. Conclusions).
Regarding claim 3, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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, 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 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 4, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 2 as cited above, wherein 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, 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 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 5, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes nitrides and/or oxides 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 6, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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
Claim 6
wt%
Jimenez Table 1
Jimenez Table 1
Zr-Cu-N
50-8-42
Zr-Cu-N
33-33-34
N
5 to 60
10.4
8.5
Zr
35 to 95
80.6
53.9
Regarding claim 7, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material includes two or more of a) 5-60 wt.% N, b) 35-95 wt.% Zr, c) 0-8 wt.% Re, d) 0-1 wt.% Si, e) 0-35 wt.% O, and f) 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 8, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above. Furst in view of Jimenez discloses hardness and elastic modulus, Er, for Zr-Cu-N coatings, where both hardness and elastic modulus increase with N content (Jimenez Table 1).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for a first layer of coating to have lower hardness and lower elastic modulus, Er, to better adhere to the surface of the implant and for a second layer of coating to have higher hardness for better surface wear resistance. Therefore, the first layer has lower N and higher Zr and the second layer has higher N and lower Zr (Jimenez Table 1). Differences in concentration will not support the patentabiliy of subject matter encompassed by the prior art unless there is evidence indicating such concentration is critical. “[W]here the general conditions of a claimed 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).
Regarding claim 9, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein 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 (Jimenez 3.1.4. and 3.2.4. Coatings deposited at 5 sccm N2 flow rate, Fig. 3).
Regarding claim 12, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material has a coating thickness of 2 nanometers to 100 microns (1.7 um, 1.9 um, 2.0 um) (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 13, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein said enhancement coating material has a hardness of 5-50 GPa (22.5 +/- 1.1 GPa, 9.5 +/- 0.5 GPa, 3.7 +/- 0.3 GPa) (Jimenez 3.3.4. Coatings deposited at 5 sccm N2 flow rate, 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 14, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above. Said 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 enhancement coating material. The prior art disclose a substantially similar enhancement coating (Jimenez Abstract, 2. Experimental procedure, Table 1), such that the claimed properties naturally flow from the disclosure of the prior art, including a coefficient of friction (COF) of 0.04-0.2.
Regarding claim 15, Furst in view of Zhao discloses the coated metal alloy as defined in claim 1 as cited above. Said 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 enhancement material. The prior art discloses a substantially similar enhancement coating (Jimenez Abstract, 2. Experimental procedure, Table 1), such that the claimed properties naturally flow from the disclosure of the prior art, including a wear rate of 0.5 x 10-7 mm3/N-m to 3 x 10-7 mm3/N-m.
Regarding claim 16, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein said base metal alloy includes less than 0.1 wt.% metals other than said rhenium and said one or more additives (alternatively less than 0.1 weight percent other metals and/or impurities) (Furst 11:11-31). 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, Furst in view of Jimenez discloses the coated metal alloy as defined in claim 1 as cited above, wherein a nitrogen content in said base metal alloy is less than a combined content of oxygen and carbon in said base metal alloy, said base metal alloy has an oxygen to nitrogen atomic ratio of at least about 1.2:1, said base metal alloy has a carbon to nitrogen atomic ratio of at least about 2:1 (Furst 21:1 to 15:17). 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 21, Furst in view of Jimenez discloses a medical device that is at least partially formed of said coated metal alloy as defined in claim 1 (Furst pp. 3-4).
Regarding claim 22, Furst in view of Jimenez discloses the medical device as defined in claim 21 as cited above, wherein 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, Furst in view of Jimenez discloses the medical device as defined in claim 22 as cited above, wherein 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, Furst in view of Jimenez discloses the medical device as defined in claim 21 as cited above, wherein said medical device includes an expandable frame formed of a metal alloy (Furst 2:18-19, 4:13015, 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); 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 has a hydrophilicity wherein such that a contact angle of a water droplet on a surface of said metal alloy is 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in a body of the 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 metal alloy recited in claim 1 (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 has a hydrophilicity wherein such that a contact angle of a water droplet on a surface of said metal alloy is 25-45°; said metal alloy has a maximum ion release of a primary component of said metal alloy when inserted or implanted on or in a body of the a patient of no more than 0.5 ug/cm2 per day, wherein said primary component constitutes at least 2 wt.% of said metal alloy; said metal alloy has an absolute increase in ion release per dose of metal alloy in tissue about said medical device of no more than 50 days after inserted or implanted on or in a body of the patient.
Claims 1-7, 9, 12-18, 20, 26-30, and 37 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).
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]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (PVD) ([0006]-[0009], [0014]-[0015]);
said enhancement coating is not a nitride surface layer formed by a nitriding process ([0006]-[0007], [0015]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the CrRe alloy of Vlcek to include the hard film (or coating) of Kawai formed by a PVD (physical vapor deposition) process 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, where film chipping and peeling is prevented during deposition (Kawai [0004], [0006]) and the PVD process is performed such that the coating has good adhesion (Kawai [0015]).
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 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); a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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, 25-5 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 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);
a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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, 25-5 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 26, Vlcek discloses a metal alloy formed of 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);
a ratio of an atomic weight of rhenium to a combined atomic weight of said bismuth, chromium, iridium, niobium, tantalum, titanium, yttrium, and zirconium 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);
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 formed of an enhancement coating.
Kawai discloses a coated metal alloy formed of 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]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (PVD) ([0006]-[0009], [0014]-[0015]);
said enhancement coating is not a nitride surface layer formed by a nitriding process ([0006]-[0007], [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).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention 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, where film chipping and peeling is prevented during deposition (Kawai [0004], [0006]) and the PVD process is performed such that the coating has good adhesion (Kawai [0015]).
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 additives 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 additives 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, chromium, 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, chromium, 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 37, Vlcek discloses a metal alloy formed of a base metal alloy (CrRe) (p. 1 paras. 1-2);
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 (Cr) (45-75 wt% Re, 25-55 wt% Cr) (p. 2 para. 6);
an atomic weight percent of said rhenium to an atomic weight percent of a combination of said bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium is 0.9:1 to 1.1: 1 (about 0.2:1 to about 0.8:1 calculated by converting wt% to at% using atomic weight) (45-75 wt% Re, 25-5 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 (Re) and said one or more additives (Cr) in said base metal alloy is at least 99.9 wt.% (45-75 wt% Re, 25-55 wt% Cr, 0.05-5 wt% of at least one of Sc, Ce, and Pr, for 0.05 to 0.1 wt% of at least one of Sc, Ce, and Pr the combined weight of Re and Cr is 99.9 to 99.95 wt%) (p. 2 para. 6).
A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are close. “The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.” MPEP 2144.05(I).
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 formed of an enhancement coating.
Kawai discloses a coated metal alloy formed of 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 (W, M, and N) selected from the group consisting of carbon, nitrogen, titanium, oxygen, zirconium and silicon (M is one or more of Ti, V, Cr, Zr, and Mo; N is nitrogen) ([0005]-[0006]);
said enhancement coasting material includes nitrides and/or oxides (nitrides are formed) ([0005]-[0006]);
said enhancement coating material includes a) 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 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) ([0005]-[0006]);
said enhancement coating is applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process (PVD) ([0006]-[0009], [0014]-[0015]);
said enhancement coating is not a nitride surface layer formed by a nitriding process ([0006]-[0007], [0015]).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant invention for the CrRe alloy of Vlcek to include the hard film (or coating) of Kawai formed by a PVD (physical vapor deposition) process 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, where film chipping and peeling is prevented during deposition (Kawai [0004], [0006]) and the PVD process is performed such that the coating has good adhesion (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).
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 at the time of filing the instant invention 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 at the time of filing the instant invention 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 such that a contact angle of a water droplet on a surface of said metal alloy is 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 a 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 a body of the 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 at the time of filing the instant invention 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 at the time of filing the instant invention for the prosthetic heart valve of Vlcek in view of Kawai and Furst to include leaflets to provide a valve member (Drews [0010]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Morris (US 4,045,247) in view of Heitzinger (US 3,960,604).
Regarding claim 37, Morris discloses a coated metal alloy formed of a base metal alloy (bimetallic thermocouple) and an enhancement coating material (sheathed and insulated) (1:13-39, 2:27 to 3:11, 5:9-26);
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 (bimetallic tantalum alloy having about 0 to about 49 wt% rhenium) (2:62-66, 3:2-7, 59-67, 4:31-36);
an atomic weight percent of said rhenium to an atomic weight percent of a combination of said bismuth, niobium, tantalum, tungsten, titanium, vanadium, chromium, manganese, yttrium, zirconium, technetium, ruthenium, rhodium, hafnium, osmium, copper, and iridium is 0.9:1 to 1.1:1 (about 0:1 to about 0.93:1, calculated from a bimetallic tantalum alloy having about 0 to about 49 wt% rhenium) (2:62-66, 3:2-7, 59-67, 4:31-36);
a combined weight percentage of rhenium and said one or more additives in said base metal alloy is at least 99.9 wt.% (bimetallic tantalum alloy having about 0 to about 49 wt% rhenium) (2:62-66, 3:2-7, 59-67, 4:31-36);
at least a portion of an outer surface of said base metal alloy (bimetallic thermocouple) includes said enhancement coating material that is layered or coated on said outer surface of said base metal alloy (sheathed and insulated) (1:29-33, 5:18-23);
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.
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).
Morris is silent the enhancement coating composition.
Heitzinger discloses a coated metal alloy formed of a base metal alloy (thermocouple) and an enhancement coating material (sheath) (1:4-14)
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 (zirconia, ZrO2, includes 74% Zr) (2:3-19, 37-66, 3:1-54, Figs. 1-5);
said enhancement coating is not a nitride surface layer formed by a nitriding process (ceramic tube preferably of refractory oxide of zirconia) (2:3-7).
It would have been obvious to one of ordinary skill in the art at the time of filing of the instant invention for the sheath (enhancement coating material) of Morris to be zirconia as disclosed by Heitzinger because it forms a gastight ceramic tube (Heitzinger 2:3-7) for high-temperature thermocouples (Heitzinger 1:15-16) that is heat-resistant (Heitzinger 2:66).
Therefore, Morris in view of Heitzinger discloses a bimetallic Ta-Re thermocouple (Morris 2:62-66, 3:2-7, 59-67, 4:31-36) with a ceramic tube sheath (enhancement coating) (Morris 1:29-33, 5:18-23) of zirconia (Heitzinger 2:3-19, 37-66, 3:1-54, Figs. 1-5).
The limitation of said enhancement coating being applied to said outer surface of said base metal alloy by one or more application process selected from the group consisting of a physical vapor deposition (PVD) process, a chemical vapor deposition (CVD) process, an atomic layer deposition (ALD) process, or a plasma-enhanced chemical vapor deposition (PE-CVD) process has been considered and determined to recite a product-by-process claim limitation that does not further limit the structure of the claimed coated metal alloy. The prior art discloses a coated metal alloy that reads on that claimed, such that the claim is rendered obvious.
Determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. MPEP 2113(I).
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 26-37 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
Yu (Yu and Li. Oxidation-resistant coating on molybdenum, tungsten and tungsten-rhenium thermocouple wires. Huanan Gongxueyuan Xyebai (1984), 12(1), 53-71.)
Yu discloses W-Re alloys with an oxidation resistant coating applied by chemical vapor deposition (STN Abstract).
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/STEPHANI HILL/Examiner, Art Unit 1735
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