DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment and Status of Claims
Applicant’s amendments to the claims, filed February 6, 2026, are acknowledged. Claims 1 and 3 are amended. No new matter has been added.
Claims 1, 3-4, 6-11 and 22-24 are currently pending and considered in this office action.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 3, the claimed polygon appears to be outside the bounds of the polygon from independent Claim 1 (see Image 2 below, wherein darker shaded region bound by No.3-C2-C3-C4 is not completely within the bounds of the lighter shaded region bound by No.3-C2-A2-B3-B4 from Claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3-4, 6-7, 9-10, 17, 19 and 22-24 are rejected under 35 U.S.C. 103 as being unpatentable over Van Dijk (previously cited, US 20050121120 A1) in view of Burnett (previously cited, US 3716356 A) and Van der Zel (previously cited, US 5472333 A, equivalent to EP 0598431 A).
Regarding Claim 1, Van Dijk discloses a medical device comprising an alloy comprising one or more metals selected from the group of gold, platinum and palladium (Abstract),
wherein the medical device is one of a stent, aneurysm clip, and occlusion coils, which reads on the claim language wherein the medical device is one of a stent, catheter, an embolization coil, an embolization clip and a guide wire (para. [Abstract; para. [0001]-[0002]; para. [0048]), and
wherein at least 75% (which is inclusive of 100%) by weight of the alloy consists of precious metals (gold, palladium, platinum and/or silver), wherein the alloy is further and specifically based on the combination of gold and palladium, comprising a weight ratio of gold to palladium of 0.5:1 to 3:1, and wherein at least 10wt% or more (inclusive of 100%) of the alloy is gold, platinum and palladium (para. [0010]-[0012]). One of ordinary skill in the art would appreciate therefore that silver is not required when using a combination of gold and palladium, and that the doping elements are merely a preferred embodiment and not required (see para. [0013] regarding doping elements).
While Van Dijk discloses an alloy of Au, Pd and Pt, and a specific ratio of Au:Pd, Van Dijk does not expressly disclose a particular range for Pd and Pt in the Au-Pd alloy.
Burnett teaches wherein a gold-palladium alloy comprises 5-40wt% palladium in combination with up to 10wt% platinum in order to form a fine equiaxed grain structure, thereby preventing cracking during cold working, and thereby to produce an alloy readily adapted to working into nugget, foil and wire forms, which are forms desired by Van Dijk (Col. 1, lines 27-42 and lines 54-59; Col. 2, lines 1-4; Col. 3, lines 13-18; see Van Dijk, para. [0003], wire). Burnett further teaches wherein palladium and platinum do not exceed 40wt%, and wherein platinum is required when palladium is 25wt% or less in order to achieve the effect of the fine equiaxed grain structure (Col. 1, lines 60-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have comprised 5-40wt% Pd and up to 10wt% Pt, for the alloy disclosed by Van Dijk, as taught by Burnett, in order to comprise a fine equiaxed grain structure, thereby preventing cracking during cold working and thereby facilitating the manufacture of forms such as nuggets, foils or wires (see teaching above).
The invention of Van Dijk and Burnett therefore includes an alloy such as one comprising 67.5wt% Au, 22.5wt% Pd and 10wt% Pt, which comprises a gold to palladium ratio of 3:1 and within the range required by Van Dijk, comprises Pd and Pt in the ranges taught by Burnett (see above teaching), and is an alloy comprising only precious metals as disclosed by Van Dijk, thereby obtaining sufficient mechanical properties to be used in stents and other biomedical aids, and while comprising optimum magnetic properties and electrical conductivity for achieving good imaging in an MRI (see Van Dijk, para. [0010]-[0011]).
An alloy comprising 67.5wt% Au, 22.5wt% Pd and 10wt% Pt equates to an alloy comprising 56.65at% Au, 34.88at% Pd, and 8.47at% Pt, which reads on the claimed composition defined by any point on or inside the polygon defined by points No.3 (Au: 55.4 atom%, Pt: 10.2 atom%, and Pd: 34.4 atom%), C2 (Au: 60 atom%, Pt: 4 atom%, and Pd: 36 atom%), A2 (Au: 70 atom%, Pt: 4 atom%, and Pd: 26 atom%), B3 (Au: 70 atom%, Pt: 20 atom%, and Pd: 10 atom%) and B4 (Au: 55 atom%, Pt: 35 atom%, and Pd: 10 atom%) in a Au-Pt-Pd ternary state diagram (see Image 1 below). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
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Image 1: Claim 1 polygon (No3.-C2-A2-B3-B4)and compositional point 56.65at% Au, 34.88at% Pd, and 8.47at% Pt (67.5wt%Au, 22.5wt% Pd, 10wt% Pt) taught by Van Dijk and Burnett.
Further, in the case that it is deemed that 56.65at% Au, 34.88at% Pd, and 8.47at% Pt does not overlap the claimed compositional polygon, it is the Examiner’s position that the amounts in question are so close that it is prima facie obvious that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 227 USPQ 773 (MPEP § 2144.05.I). Additionally, Applicant has not provided criticality regarding the claimed polygon.
Van Dijk discloses wherein the medical alloy comprises a low volume magnetic susceptibility ([0011]; Table 1, MRI image), but does not disclose the claimed range of -20ppm to 30ppm.
Van Dijk and Burnett additionally fail to disclose the claimed microstructural features.
However, Van Dijk discloses wherein processing of the alloy includes those known in the art, such as the process described in patent application EP 0598431 (which is equivalent to the previously cited patent application US 5472333 A, Van der Zel), and may be manufactured by casting to form an ingot, homogenizing with a tempering step including tempering up to 1200C and immediately cooling quickly with water, rolling or wire drawing (cold working) in different steps, with alternating steps of tempering up to 1200C (and cooling) between, and hardening from 400-700C, preferably 500-650C (para. [0044]-[0045]).
The cited reference by Van Dijk, Van der Zel, further discloses performing homogenization for 1 hour at 1150C, chilling in water, rolling from 15mm to 1mm in several steps, annealing (solution heat treatment) at 1150C for 30 minutes and rapidly cooling in water, and hardening (aging) at 550C for 5 hours (Col. 5, lines 41-52). One of ordinary skill in the art would appreciate that rolling from 15mm to 1mm in several steps (a total accumulated reduction of 93%) would require a reduction rate for each step which overlaps the instant range of preferably 30-90%. Additionally, while the solution treatment of Van der Zel is 30 minutes by the disclosed example, one of ordinary skill in the art would appreciate performing this treatment for at least an hour in order to further maximize the homogeneity of the structure after cold working (see wherein annealing after casting up to 1200C occurs for 1 hour – Van der Zel, Pg. 4, line 56; see Van Dijk, para. [0045], wherein annealing (tempering) up to 1200C after casting is a homogenizing treatment). Moreover, the instant invention discloses wherein the rolling reduction (plastic working) rate is merely a preferred range and not limited, and wherein the solution treatment time is also merely a preferred range (see para. [0036]-[0037]).
Therefore, the process of Van Dijk, and the incorporated and cited process of Van der Zel, reads on the instant process, including melting and casting, homogenization at 1000-1200C for preferably 1-48 hours, preferably cold plastic working with a working rate of preferably 30-90%, solution heat treatment at 1000-1200C for preferably 1-24 hours, followed by rapid cooling in water, and aging heat treatment at 400-800C for 0.5-48 hours.
Thus, one of ordinary skill in the art would appreciate that the invention of Van Dijk (and by citation of process, Van der Zel) and Burnett would comprise the claimed microstructural features regarding the Au-rich phase, Pt-rich phase and mother phase, and further the claimed volume magnetic susceptibility of -20ppm to 30ppm, because the composition of Van Dijk and Burnett, and the processing of Van Dijk and Van der Zel, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Regarding Claim 3, the alloys of Van Dijk and Burnett include 67.5wt% Au, 22.5wt% Pd and 10wt% Pt (56.65at% Au, 34.88at% Pd, and 8.47at% Pt; see Claim 1 above), which reads on and overlaps the claimed composition on and/or within the polygon defined by No.3 (Au: 55.4 atom%, Pt: 10.2 atom%, and Pd: 34.4 atom%) - C2 (Au: 60 atom%, Pt: 4 atom%, and Pd: 36 atom%) - C3 (Au: 70 atom%, Pt: 20 atom%, and Pd: 10 atom%) - and C4 (Au: 55 atom%, Pt: 35 atom%, and Pd: 10 atom%) in a Au-Pt-Pd ternary state diagram (see Image 2 below). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
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Image 2: Claim 3 (No3.-C2-C3-C4) polygon overlayed on Claim 1 polygon (lighter grey polygon), and compositional point 56.65at% Au, 34.88at% Pd, and 8.47at% Pt (67.5wt%Au, 22.5wt% Pd, 10wt% Pt) taught by Van Dijk and Burnett.
Further, in the case that it is deemed that 56.65at% Au, 34.88at% Pd, and 8.47at% Pt does not overlap the claimed compositional polygon, it is the Examiner’s position that the amounts in question are so close that it is prima facie obvious that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 227 USPQ 773 (MPEP § 2144.05.I). Additionally, Applicant has not provided criticality regarding the claimed polygon.
Regarding Claim 4 and Claim 6, Van Dijk is silent towards Young’s modulus; however, it would be obvious that the invention of Van Dijk (and by citation of process, Van der Zel) and Burnett comprises the claimed Young’s Modulus of 100GPa or more, because the composition of Van Dijk and Burnet, and the processing of Van Dijk and Van der Zel, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Regarding Claim 7 and Claim 17, Van Dijk disclose wherein the medical device is a stent (Abstract).
Regarding Claim 9, Van Dijk discloses wherein the medical device may be one of a occlusion coil, which reads on the claimed embolization coil.
Regarding Claim 10, Van Dijk discloses wherein the medical device may be one of an aneurysm clip, which reads on the claimed embolization clip.
Regarding Claim 19, Van Dijk discloses wherein the medical device may be one of a occlusion coil or an aneurysm clip, which reads on the claimed embolization coil or embolization clip.
Regarding Claim 22, Van Dijk discloses wherein the medical alloy may consist of precious metals and may further be a combination of Au, Pd and Pt, wherein Ag and doping elements are not required, which reads on the claimed composition comprising optionally 0-0.5wt% Ca and/or Zr and inevitable impurities of 0-200ppm of Ag, Co, Cr, Fe, Ir, Mg, Ni, Rh, Ru, Si, Sn and Ti (see para. [0010]-[0011]; see example alloy B (para. [0051]), wherein alloy does not comprise Ag; see para. [0013], wherein dopes are merely a preferred embodiment and therefore optional). Additionally, Van Dijk discloses wherein Zr may be included from 0.1-2wt%, which reads on the claimed range of optionally up to 0.5wt% Zr (para. [0035]), and it would be obvious to one of ordinary skill in the art that inevitable impurities, which are undesired elements, be kept to as low and as close to 0% as possible.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Regarding Claim 23 and Claim 24, Van Dijk fails to disclose the claimed range of volume magnetic susceptibility of -20ppm to 0ppm, and is silent towards the Young’s modulus; however, it would be obvious that the invention of Van Dijk (and by citation of process, Van der Zel) and Burnett comprises the claimed volume magnetic susceptibility and Young’s Modulus of 130GPa or more, because the composition of Van Dijk and Burnet, and the processing of Van Dijk and Van der Zel, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Claims 8, 11, 18 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Van Dijk (US 20050121120 A1) in view of Burnett (US 3716356 A) and Van der Zel (previously cited, US 5472333 A, equivalent to EP 0598431 A), as applied to Claim 1 and Claim 3 above, respectively, in further view of Shima (previously cited and cited by Applicant in IDS filed December 14, 2022, US 20170029927 A1).
Regarding Claim 8, Claim 11, Claim 18 and Claim 20, Van Dijk discloses wherein the medical device may be one of a stent, aneurysm clip, and occlusion coils, but fails to disclose (Claim 8 and Claim 18) a catheter or (Claim 11 and Claim 20) a guide wire.
Shima teaches an alloy consisting of precious metals (Au-Pt), and therefore comprising corrosion resistance, biocompatibility and a low magnetic susceptibility which reduces artifacts seen in an MRI, as well as workability, thereby being useful as a medical device such as a stent, catheter, embolization coil (occlusion coil), embolization clip (aneurysm clip), and a guild wire (Abstract; para. [0001]-[0003]; para. [0065]). Thus, Shima demonstrates it is well-known in the art and recognizes the art equivalence for suitability to construct a catheter or guide wire from the same material used for manufacturing stents, embolization coils and embolization clips.
Van Dijk discloses wherein the alloy is biocompatible with no oxide formation, and has a low magnetic susceptibility (para. [0009], reduction in oxide formation reads on corrosion resistant; para. [0011]), and Burnett teaches wherein the alloy comprises workability (Col. 1, lines 39-41; Col. 3, lines 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the alloy of Van Dijk and Burnett to manufacture (Claim 8 and Claim 18) a catheter or (Claim 11 and Claim 20) a guide wire, as taught by Shima, because the alloy of Van Dijk and Burnett comprises good biocompatibility, corrosion resistance, low magnetic susceptibility and workability, thereby making it suitable for a catheter and one visible in an MRI without artifacts (see teachings above by Shima), and because Shima teaches wherein alloys suitable for the manufacture of stents, embolization coils and/or embolization clips, are also suitable for catheters and guide wires.
Claims 1, 3-4, 6-11, 17-20 and 22-24 are alternatively rejected under 35 U.S.C. 103 as being unpatentable over Van Dijk (previously cited, US 20050121120 A1) in view of Burnett (previously cited, US 3716356 A), Van der Zel (previously cited, US 5472333 A, equivalent to EP 0598431 A) and Shima (previously cited and cited by Applicant in IDS filed December 14, 2022, US 20170029927 A1).
Regarding Claim 1, Van Dijk discloses a medical device comprising an alloy comprising one or more metals selected from the group of gold, platinum and palladium (Abstract),
wherein the medical device is one of a stent, aneurysm clip, and occlusion coils, which reads on the claim language wherein the medical device is one of a stent, catheter, an embolization coil, an embolization clip and a guide wire (para. [Abstract; para. [0001]-[0002]; para. [0048]), and
wherein at least 75% (which is inclusive of 100%) by weight of the alloy consists of precious metals (gold, palladium, platinum and/or silver), wherein the alloy is further and specifically based on the combination of gold and palladium, comprising a weight ratio of gold to palladium of 0.5:1 to 3:1, and wherein at least 10wt% or more (inclusive of 100%) of the alloy is gold, platinum and palladium (para. [0010]-[0012]). One of ordinary skill in the art would appreciate therefore that silver is not required when using a combination of gold and palladium, and that the doping elements are merely a preferred embodiment and not required (see para. [0013] regarding doping elements).
While Van Dijk discloses an alloy of Au, Pd and Pt, and a specific ratio of Au:Pd, Van Dijk does not expressly disclose a particular range for Pd and Pt in the Au-Pd alloy.
Burnett teaches wherein a gold-palladium alloy comprises 5-40wt% palladium in combination with up to 10wt% platinum in order to form a fine equiaxed grain structure, thereby preventing cracking during cold working, and thereby to produce an alloy readily adapted to working into nugget, foil and wire forms, which are forms desired by Van Dijk (Col. 1, lines 27-42 and lines 54-59; Col. 2, lines 1-4; Col. 3, lines 13-18; see Van Dijk, para. [0003], wire). Burnett further teaches wherein palladium and platinum do not exceed 40wt%, and wherein platinum is required when palladium is 25wt% or less in order to achieve the effect of the fine equiaxed grain structure (Col. 1, lines 60-63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have comprised 5-40wt% Pd and up to 10wt% Pt, for the alloy disclosed by Van Dijk, as taught by Burnett, in order to comprise a fine equiaxed grain structure, thereby preventing cracking during cold working and thereby facilitating the manufacture of forms such as nuggets, foils or wires (see teaching above).
The invention of Van Dijk and Burnett therefore includes an alloy such as one comprising 67.5wt% Au, 22.5wt% Pd and 10wt% Pt, which comprises a gold to palladium ratio of 3:1 and within the range required by Van Dijk, comprises Pd and Pt in the ranges taught by Burnett (see above teaching), and is an alloy comprising only precious metals as disclosed by Van Dijk, thereby obtaining sufficient mechanical properties to be used in stents and other biomedical aids, and while comprising optimum magnetic properties and electrical conductivity for achieving good imaging in an MRI (see Van Dijk, para. [0010]-[0011]).
An alloy comprising 67.5wt% Au, 22.5wt% Pd and 10wt% Pt equates to an alloy comprising 56.65at% Au, 34.88at% Pd, and 8.47at% Pt, which reads on the claimed composition defined by any point on or inside the polygon defined by points No.3 (Au: 55.4 atom%, Pt: 10.2 atom%, and Pd: 34.4 atom%), C2 (Au: 60 atom%, Pt: 4 atom%, and Pd: 36 atom%), A2 (Au: 70 atom%, Pt: 4 atom%, and Pd: 26 atom%), B3 (Au: 70 atom%, Pt: 20 atom%, and Pd: 10 atom%) and B4 (Au: 55 atom%, Pt: 35 atom%, and Pd: 10 atom%) in a Au-Pt-Pd ternary state diagram (see Image 1 above). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Further, in the case that it is deemed that 56.65at% Au, 34.88at% Pd, and 8.47at% Pt does not overlap the claimed compositional polygon, it is the Examiner’s position that the amounts in question are so close that it is prima facie obvious that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 227 USPQ 773 (MPEP § 2144.05.I). Additionally, Applicant has not provided criticality regarding the claimed polygon.
Van Dijk discloses wherein the medical alloy comprises a low volume magnetic susceptibility ([0011]; Table 1, MRI image), but does not disclose the claimed range of -20ppm to 30ppm.
Van Dijk and Burnett additionally fail to disclose the claimed microstructural features.
However, Van Dijk discloses wherein processing of the alloy includes those known in the art, such as the process described in patent application EP 0598431 (which is equivalent to the previously cited patent application US 5472333 A, Van der Zel), and may be manufactured by casting to form an ingot, homogenizing with a tempering step including tempering up to 1200C and immediately cooling quickly with water, rolling or wire drawing (cold working) in different steps, with alternating steps of tempering up to 1200C (and cooling) between, and hardening from 400-700C, preferably 500-650C (para. [0044]-[0045]).
The cited reference by Van Dijk, Van der Zel, further discloses performing homogenization for 1 hour at 1150C, chilling in water, rolling from 15mm to 1mm in several steps, annealing (solution heat treatment) at 1150C for 30 minutes and rapidly cooling in water, and hardening (aging) at 550C for 5 hours (Col. 5, lines 41-52). One of ordinary skill in the art would appreciate that rolling from 15mm to 1mm in several steps (a total accumulated reduction of 93%) would require a reduction rate for each step which overlaps the instant range of preferably 30-90%.
Additionally, Shima, whom discloses an overlapping process to Van der Zel, further teaches wherein cold working is 30% or greater prior to solution heat treatment in order to eliminate segregation caused by casting and melting, and to facilitate the movement of atoms, thereby facilitating the formation of a single a-phase (super saturated solid solution) structure during solution heat treatment (see para. [0028]-[0030]). It would have been obvious to have cold worked for a reduction of at least 30%, as taught by Shima, for the invention disclosed by Van Dijk and Van der Zel, in order to eliminate segregation caused by casting and melting, and to facilitate the movement of atoms, thereby facilitating the formation of a single a-phase (super saturated solid solution) structure during solution heat treatment (see teaching above).
Further, while the solution treatment of Van der Zel is 30 minutes by the disclosed example, Shima also teaches wherein solution heat treatment times may be preferably in the range of 1-24 hours (para. [0031]), and one of ordinary skill in the art would appreciate performing the solution treatment for at least an hour in order to further maximize the homogeneity of the structure after cold working (see wherein annealing up to 1200C after casting occurs for 1 hour – Van der Zel, Pg. 4, line 56; see Van Dijk, para. [0045], wherein annealing (tempering) up to 1200C after casting is a homogenizing treatment).
Moreover, regarding cold rolling and solution heat treatment, the instant invention discloses wherein the rolling reduction (plastic working) rate is merely a preferred range and not limited, and wherein the solution treatment time is also merely a preferred range (see para. [0036]-[0037]).
Therefore, the process of Van Dijk, the incorporated and cited process of Van der Zel, and Shima, reads on the instant process, including melting and casting, homogenization at 1000-1200C for preferably 1-48 hours, preferably cold plastic working with a working rate of preferably 30-90%, solution heat treatment at 1000-1200C for preferably 1-24 hours, followed by rapid cooling in water, and aging heat treatment at 400-800C for 0.5-48 hours.
Thus, one of ordinary skill in the art would appreciate that the invention of Van Dijk (and by citation of process, Van der Zel), Burnett and Shima would comprise the claimed microstructural features regarding the Au-rich phase, Pt-rich phase and mother phase, and further the claimed volume magnetic susceptibility of -20ppm to 30ppm, because the composition of Van Dijk and Burnett, and the processing of Van Dijk and Van der Zel in view of Shima, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Additionally, Shima teaches a volume magnetic susceptibility of -13 to -5ppm in order to comprise biocompatibility and to prevent artifacts during MRI scans (para. [0006]-[0007]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically comprised a volume magnetic susceptibility of -13 to -5ppm, which overlaps the claimed range of -20 to 0 ppm, as taught by Shima, for the invention disclosed by Van Dijk (and Van der Zel) and Burnett, in order to comprise biocompatibility and to prevent artifacts during MRI scans. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Regarding Claim 3, the alloys of Van Dijk and Burnett include 67.5wt% Au, 22.5wt% Pd and 10wt% Pt (56.65at% Au, 34.88at% Pd, and 8.47at% Pt; see Claim 1 above), which reads on and overlaps the claimed composition on and/or within the polygon defined by No.3 (Au: 55.4 atom%, Pt: 10.2 atom%, and Pd: 34.4 atom%) - C2 (Au: 60 atom%, Pt: 4 atom%, and Pd: 36 atom%) - C3 (Au: 70 atom%, Pt: 20 atom%, and Pd: 10 atom%) - and C4 (Au: 55 atom%, Pt: 35 atom%, and Pd: 10 atom%) in a Au-Pt-Pd ternary state diagram (see Image 2 above). In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Further, in the case that it is deemed that 56.65at% Au, 34.88at% Pd, and 8.47at% Pt does not overlap the claimed compositional polygon, it is the Examiner’s position that the amounts in question are so close that it is prima facie obvious that one skilled in the art would have expected them to have the same properties. Titanium Metals Corp. v. Banner, 227 USPQ 773 (MPEP § 2144.05.I). Additionally, Applicant has not provided criticality regarding the claimed polygon.
Regarding Claim 4 and Claim 6, Van Dijk is silent towards Young’s modulus; however, it would be obvious that the invention of Van Dijk (and by citation of process, Van der Zel) and Burnett comprises the claimed Young’s Modulus of 100GPa or more, because the composition of Van Dijk and Burnet, and the processing of Van Dijk and Van der Zel, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Further, Van der Zel teaches wherein similarly compositioned alloys (i.e., comprising Au-Pd-Pt) are manufactured with the same processing obtain a Young’s Modulus of 140 GPa (see Abstract; Table 1a-1b; Col. 5, line 57). Van der Zel teaches wherein the higher modulus allows for the advantage of manufacturing of thinner products (see Col. 4, line 64 - Col. 5, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have comprised a Young’s modulus of 140 GPa, as further taught by Van der Zel, for invention disclosed by Van Dijk and Burnett, in order to manufacture advantageously thinner products (see teaching by Van der Zel above).
Regarding Claim 7 and Claim 17, Van Dijk disclose wherein the medical device is a stent (Abstract).
Regarding Claim 9, Van Dijk discloses wherein the medical device may be one of a occlusion coil, which reads on the claimed embolization coil.
Regarding Claim 10, Van Dijk discloses wherein the medical device may be one of an aneurysm clip, which reads on the claimed embolization clip.
Regarding Claim 19, Van Dijk discloses wherein the medical device may be one of a occlusion coil or an aneurysm clip, which reads on the claimed embolization coil or embolization clip.
Regarding Claim 22, Van Dijk discloses wherein the medical alloy may consist of precious metals and may further be a combination of Au, Pd and Pt, wherein Ag and doping elements are not required, which reads on the claimed composition comprising optionally 0-0.5wt% Ca and/or Zr and inevitable impurities of 0-200ppm of Ag, Co, Cr, Fe, Ir, Mg, Ni, Rh, Ru, Si, Sn and Ti (see para. [0010]-[0011]; see example alloy B (para. [0051]), wherein alloy does not comprise Ag; see para. [0013], wherein dopes are merely a preferred embodiment and therefore optional). Additionally, Van Dijk discloses wherein Zr may be included from 0.1-2wt%, which reads on the claimed range of optionally up to 0.5wt% Zr (para. [0035]), and it would be obvious to one of ordinary skill in the art that inevitable impurities, which are undesired elements, be kept to as low and to close to 0% as possible.
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Regarding Claim 23 and Claim 24, Van Dijk fails to disclose the claimed range of volume magnetic susceptibility of -20ppm to 0ppm, and is silent towards the Young’s modulus; however, it would be obvious that the invention of Van Dijk (and by citation of process, Van der Zel) and Burnett comprises the claimed volume magnetic susceptibility and Young’s Modulus of 130GPa or more, because the composition of Van Dijk and Burnet, and the processing of Van Dijk and Van der Zel, are the same as the instant invention. When the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). See MPEP 2112.01.
Additionally, Shima discloses a volume magnetic susceptibility of -13 to -5ppm in order to comprise biocompatibility and to prevent artifacts during MRI scans (see Claim 1 rejection above; see Shima, para. [0006]-[0007]), and Van der Zel teaches wherein similarly compositioned alloys (i.e., comprising Au-Pd-Pt) manufactured with the same processing obtain a Young’s Modulus of 140 GPa (see Abstract; Table 1a-1b; Col. 5, line 57), wherein the higher modulus allows for the advantage of manufacturing of thinner products (see Col. 4, line 64 - Col. 5, line 6).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have specifically comprised a volume magnetic susceptibility of -13 to -5ppm, which overlaps the claimed range of -20 to 0 ppm, as taught by Shima, and a Young’s modulus of 140 GPa, as further taught by Van der Zel, for the invention disclosed by Van Dijk (and Van der Zel) and Burnett, in order to comprise biocompatibility and to prevent artifacts during MRI scans (see teaching by Shima above) and to manufacture advantageously thinner products (see teaching by Van der Zel above).
In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). See MPEP § 2144.05.I.
Regarding Claim 8, Claim 11, Claim 18 and Claim 20, Van Dijk discloses wherein the medical device may be one of a stent, aneurysm clip, and occlusion coils, but fails to disclose (Claim 8 and Claim 18) a catheter or (Claim 11 and Claim 20) a guide wire.
Shima further teaches an alloy consisting of precious metals (Au-Pt), and therefore comprising corrosion resistance, biocompatibility and a low magnetic susceptibility which reduces artifacts seen in an MRI, as well as workability, thereby being useful as a medical device such as a stent, catheter, embolization coil (occlusion coil), embolization clip (aneurysm clip), and a guild wire (Abstract; para. [0001]-[0003]; para. [0065]). Thus, Shima demonstrates it is well-known in the art and recognizes the art equivalence for suitability to construct a catheter or guide wire from the same material used for manufacturing stents, embolization coils and embolization clips.
Van Dijk discloses wherein the alloy is biocompatible with no oxide formation, and has a low magnetic susceptibility (para. [0009], reduction in oxide formation reads on corrosion resistant; para. [0011]), and Burnett teaches wherein the alloy comprises workability (Col. 1, lines 39-41; Col. 3, lines 15-17).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the alloy of Van Dijk and Burnett to manufacture (Claim 8 and Claim 18) a catheter or (Claim 11 and Claim 20) a guide wire, as taught by Shima, because the alloy of Van Dijk and Burnett comprises good biocompatibility, corrosion resistance, low magnetic susceptibility and workability, thereby making it suitable for a catheter and one visible in an MRI without artifacts (see teachings above by Shima), and because Shima teaches wherein alloys suitable for the manufacture of stents, embolization coils and/or embolization clips, are also suitable for catheters and guide wires.
Response to Arguments
Applicant’s arguments, filed February 6, 2026, with respect to Claims 1, and dependent claims thereof, rejected under 35 U.S.C. 103 over Van Dijk, Burnett and Van der Zel (and alternatively, in further view of Shima), have been fully considered, and are persuasive in view of the amendments further limiting the claimed compositional polygon. Therefore, the previous rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Van Dijk, Burnett and Van der Zel (and alternatively, in further view of Shima), as detailed above.
Regarding the overlap of Van Dijk and Burnett:
Applicant argues that the compositions of Van Dijk and Burnett do no overlap, as shown in the figures supplied by Applicant in the remarks (pg. 11-13). This argument is not found persuasive.
The composition comprising 67.5wt% Au, 22.5wt% Pd and 10wt% Pt appears to overlap the claimed polygon (see Image 1 and Image 2 above). The figures produced by applicant do not appear to accurately represent this composition, 67.5wt% Au, 22.5wt% Pd and 10wt% Pt, which is included in the teachings of Van Dijk and Burnett. However, in the case that it is found that the point does not intersect the line connecting compositional point No.3 and point C2, the value is so extremely close to the claimed polygon that it is prima facie obvious that the obvious that one skilled in the art would have expected them to have the same properties (see rejections above). Titanium Metals Corp. v. Banner, 227 USPQ 773. Additionally, Applicant has not provided criticality regarding the newly claimed polygon.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Doc1 (cited by Applicant in IDS filed December 14, 2022, RD 455074): teaches a dental Au-Pt-Pd alloy with an overlapping composition (see para. 1, para. 6 and para. 7). Compositions of 70-90% Au, 4-20% Pt, and 4-20% Pd (see para. 6) and of 1-55% Au, 30-90% Pd, and up to about 5% Pt (see para. 7), when converted to atomic percent, read on the claimed compositions within the ternary phase diagram.
Powell (cited by Applicant in IDS filed April 24, 2023, US 2071216 A): teaches wherein adding 5-25wt% Pd may be added to a Au-30wt%Pt alloy in order to overcome segregation issues during casting and elongated solution annealing times, while also increasing synergistic effects for subsequent hardening (Col. 1, lines 10-17, lines 26-33 and lines 41-44).
Hale (cited by Applicant in IDS filed December 14, 2022, US 20120039744 A1): discloses a medical dental Au-Pt-Pd alloy with an overlapping composition (see Abstract).
Seol (cited by Applicant in IDS field April 15, 2024, “Age-hardening by miscibility limit in a multi-purpose dental gold alloy containing platinum”): teaches wherein the heterogenous precipitation of Pt-rich phase with an Au-rich phase, due to the miscibility limit of the Au-Pt system, results in a significant increase of hardness (Abstract).
Tazaki (previously cited and cited by Applicant in IDS filed March 15, 2023, JP 2000336439 A; English Machine Translation provided): teaches a dental implant alloy comprising a Au-Pt-Pd composition of 8-20wt% Pt, 5-20wt% Pd, and a balance of Au, which overlaps the claimed composition (see Abstract and para. [0013]; the cited dental implant materials read on medical alloy). For example, the composition comprising 65wt% Au, 17.5wt% Pt and 17.5wt% Pd (see ranges disclosed above by Tazaki) is equivalent to 56.5at% Au, 15.4at% Pt, and 28.2at% Pd, which lies within the claimed polygon of the ternary phase diagram.
Hondel (previously cited, “Strengthening mechanisms in gold-platinum alloys”): teaches an overlapping process to Van der Zel, wherein an Au-Pt-Pd alloy is solution heat treated (solubilization) from 1000-1200C for 30 minutes, quenched, and aged from 400-700C for 3 hours, in order to produce a hardened microstructure comprising a Pt-rich phase (Pg. 27, 3.1, The Au-Pt-(Pd-)Rh alloys; Pg. 30, 3.2, Heat treatment parameters). Hondel further teaches heat treating at temperatures 400C or above results in a Pt-rich and an Au-rich phase, and subsequently increases hardness and strength, while producing a more corrosive-resistant alloy than the AuPdRh alloy (see section 2.5.3, para. 5 and 6; one of ordinary skill in the art would appreciate that the Au and Pt-rich phases comprise the composition claimed such that the Au-rich phase comprises 4at% or more Au than the matrix phase, and the Pt-rich phases similar comprises 4at% or more Pt than the matrix phase).
Wagner (cited by Applicant in IDS filed December 14, 2022, US 20080063890 A1): teaches wherein it is important for medical materials, and those which are to be biocompatible, to comprise a volume magnetic susceptibility which is matched to surrounding tissue or air (see para. [0015]). Wagner teaches that a range of -50ppm to 50ppm for volume magnetic susceptibility is appropriate for biocompatible materials and those used for implants because it incorporates the volume magnetic susceptibilities of air, water and organic materials (see para. [0018]).
Shima (cited above, additional teachings not relied upon): teaches forming a metal structure comprising a mixture of an Au-rich phase and the Pt-rich phase in a mother phase (Abstract; see para. [0019] and [0055]; see Fig. 2 regions of precipitated phases), wherein the Pt-rich phase comprises a Pt content higher by 4 atom% or more than that of the mother phase (Abstract; Pt-rich phase is 1.2-3.8 times the content of the mother phase, alpha; para. [0019]-[0021]), and wherein a total area ratio of the Au-rich phase and an area ratio of the Pt-rich phase of 1.5-25.4% (see Table 1 wherein a1+a2 values fall within the claimed range).
Shima teaches wherein this microstructure and the inclusion of the phase Au-rich and Pt-rich compositions and fractions thereof, allows for biocompatibility, corrosion resistance, workability, and a controlled magnetic susceptibility within 4ppm of water (within the range of -13 to -5ppm), thereby further reducing artifacts in MRI’s (Abstract; para. [0006]-[0007]; para. [0019]-[0021]; para. [0043]).
Kim (previously relied upon, and cited by Applicant in IDS filed January 3, 2024, “Lamellar-forming grain boundary reaction related to age-hardening mechanism in an Au-Pt-Pd-In metal-ceramic alloy”): teaches a medical Au-Pt-Pd alloy with a microstructure comprising at least one of a Au-rich phase comprising an Au-rich phase which is an alloy phase having a Au content higher by 4at% or more than that of the mother phase and a Pt-rich phase comprising Pt content higher by 4 atom% or more than that of the mother phase, wherein the Au-rich phase and Pt-rich phases produce a hardening effect (Abstract; Table 3; pg. 201, Col. 2, para. 1, see Pt-rich phase composition of (b-P), Au-rich phase composition of (b-M) and mother phase composition (a-M) and (b-G)).
Shimodaira (WO 2008032370 A1, cited by Applicant in IDS filed December 14, 2022, English Translation provided): teaches a stent comprising an Au-Pd alloy defined by a relationship which satisfies 0.65≤X1/(X1+X2)≤0.95, where X1 is mol% of Au and X2 is mol% of Pd (Abstract).
Mikami (US 20120312428 A1): teaches adding 0.5-30wt% of at least one element of Cu, Ag, Pd and Pt to high purity Au in order to tailor strength of a wire by heat treating at 450-650C without impacting elongation properties (Abstract; Fig. 1).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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CATHERINE P. SMITH
Patent Examiner
Art Unit 1735
/CATHERINE P SMITH/ Examiner, Art Unit 1735
/KEITH WALKER/ Supervisory Patent Examiner, Art Unit 1735