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 Amendments and Status of Claims
Applicant’s amendments to the claims, filed May 29, 2026, are acknowledged. Claims 5, 7-12, 14-15, 33, and 35-47 are amended.
Claims 5-15 and 33-47 are currently pending and considered in this office action.
Claim Objections
Claim 33 is objected to because of the following informalities: two different steps are regarded as step “c)”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 5, and dependent Claims 6-15, Claim 33, and dependent Claims 34-42, and Claim 43, and dependent Claims 44-47, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 5, the claims recite wherein ‘at least 80% of a longitudinal length of said metal rod is initially exposed to said final heat treatment process at the same time”. This language and limitation cannot be found in the specification.
Regarding Claim 33, the claim recites “said first and second final heat treatment processes initially occurring at a same time by exposing said complete metal rod to an elevated temperature”. This language and limitation cannot be found in the specification.
Regarding Claim 43, the claim recites “said first and second final heat treatment processes initially occurring at a same time by exposing said complete metal rod to an elevated temperature”. This language and limitation cannot be found in the specification.
Regarding Claim 43, the claim recites “drawing down”. This language and limitation cannot be found in the specification.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 5, and dependent Claims 6-15, Claim 33, and dependent Claims 34-42, and Claim 43, and dependent Claims 44-47, 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.
Regarding Claim 5, the claim recites wherein the at least 80% of the longitudinal length of the metal is exposed to said final heat treatment process at the same time. It is unclear what heat treatment process is being referred to, as the claim recites wherein there are different heat treatment processes. It is unclear how different heat treatment processes with, different temperatures and/or different times are applied using the same elevated temperature exposure at the same time.
Regarding Claim 33 and Claim 43, the claims recite wherein “said first and second final heat treatment processes initially occurring at a same time by exposing said complete metal rod to an elevated temperature”. It is unclear how two different heat treatment processes with two different temperatures and two different process durations are applied by using the same elevated temperature on the entire rod or tube at the same time.
Regarding Claim 33 and Claim 43, the claims recite “metal tube or rod” but the claim also recites wherein “said first and second final heat treatment processes initially occurring at a same time by exposing said complete metal rod to an elevated temperature”. It is therefore unclear if the metal alloy must be in the form of a rod or may be a tube.
Regarding Claim 11 and Claim 14, the claim recites “said step of cooling”. There is insufficient antecedent basis for this limitation.
Regarding Claim 41, the claim recites “said step of cooling”. There is insufficient antecedent basis for this limitation.
Regarding Claim 43 and Claim 45, the claim recites “said step of cooling”. There is insufficient antecedent basis for this limitation.
Regarding Claim 47, the claim recites multiple alloys, including a stainless steel, a Co-Cr alloy, TiNi alloy, TiAlV alloy, Al alloy, Ni alloy, Ti alloy, Cu alloy, Be-Cu alloy, an alloy with 30wt% of one of Nb, Ti, Co, Cr, or Zr, an alloy with 50wt% of Nb, Ti, Co, Cr, Zr and 1-40wt% of Al, Bi, Ca, C, Cu, Au, Hf, Ir, Fe, La, La2O3, Pb, Mg, Mn, Ni, Os, RE, Si, Ag, Tc, Sn, Ti, V, Y, and Zn, and comprising at least 15at% Re. One of ordinary skill in the art would appreciate that these alloys would not be the described alloys, but would be Re-based alloys, as Re is substantially the heavier element. One of ordinary skill in the art would appreciate for example that a TiNi alloy with 15at% Re would necessarily be a Re alloy with Ti and Ni. Further, it is unclear what the composition of most of the claimed alloys would be or if they are even capable of existing. For example, a stainless steel with at least 15at% Re would cease to be a stainless steel, and it is unclear what composition this alloy, if capable of existing, would be.
Regarding Claim 47, the claim recites an alloy of 50wt% Re, 20wt%, and up to 80wt% of Nb, Ti, Co, Cr, or Zr, and an alloy with 50wt% of Nb, Ti, Co, Cr, Zr and 1-40wt% of Al, Bi, Ca, C, Cu, Au, Hf, Ir, Fe, La, Pb, Mg, Mn, Ni, Os, RE, Si, Ag, Tc, Sn, Ti, V, Y, and Zn, and further alloy compositions p)-u). Claim 47 also depends from Claim 43 which requires at least 15at% Re. It is unclear what the composition of these alloys could possibly be to satisfy the claimed ranges of each of the alloys of Claim 47 and further the claimed ranges of both Claim 43 and Claim 47. It is unclear if most of these alloys are even capable of existing in nature.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 5, 7-12 and 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ma (US 20180347023 A1).
Regarding Claim 5, Ma discloses a method for forming a rod that has different physical properties along a longitudinal length of a metal alloy rod (Abstract; para. [0017]; Fig. 1), comprising the steps of:
providing said metal rod formed of a metal alloy including niobium and molybdenum (para. [0015]),
and
b) subjecting different portions of said metal rod to a different final heat treatment process along a longitudinal length of said metal rod such that different portions of said metal rod at different longitudinal locations have one or more different physical properties selected from the group consisting of:
a) a different flexibility or bendability
b) a different yield strength
c) a different ultimate tensile strength, and
d) a different metal alloy crystalline structure (Abstract, flexibility; para. [0024]; [0026]; strength, para. [0074]-[0075]; para. [0012], crystalline structure);
at least 80% of a longitudinal length of said metal rod is initially exposed to said final heat treatment process at a same time (para. [0030]; para. [0057]; para. [0147]-[0148], wherein entire rod is heated in tube furnace with selective insulation during heat treatment process);
and
wherein said different final heat treatment process includes:
I) subjecting said metal alloy to a different final heat treatment temperature,
II) exposing said metal alloy to said final heat treatment temperature for different time periods, and/or
III) cooling said metal rod or tube after subjecting said metal rod or tube to said final heat treatment temperature at different cooling rates (para. [0029]-[0033]; softening heat treatment and stiffening heat treatment (different heat treatment temperatures); see also para. [0065]; [0069] and [0116]-[0117]; para. [0146], different times). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C). One of ordinary skill in the art would also appreciate that the cooling rate to room temperature in air cooling would slightly differ for different maximum heating temperatures.
Regarding Claim 7, Ma discloses wherein said metal rod has a constant cross-sectional shape and size along 80%-100% of said longitudinal length of said metal rod or tube (Fig. 1; Fig. 4).
Regarding Claim 8, Ma discloses wherein each of the softening and/or stiffening heat treatments is at least 100C (para. [0065]-[0066]; para. [0069]-[0070]). Ma is silent towards quenching after heat treating, and one of ordinary skill in the art would appreciate therefore that Ma does not quench the heat treated portion after the softening and/or stiffening treatment, as claimed.
Regarding Claim 9, Ma discloses wherein said maximum temperature of each of said final heat treatment temperatures is 500-1000C (para. [0065]-[0066]; para. [0069]-[0070]).
Regarding Claim 10, Ma discloses wherein each of said final heat treatments are performed within the claimed range of 0.25-25 hours (para. [0065]-[0066]; para. [0069]-[0070]).
Regarding Claim 11, Ma discloses wherein portions may be subjected to air cooling, which reads on a cooling rate of less than 100C/s or less (para. [0121]). One of ordinary skill in the art would also appreciate that in the absence of disclosing a specific cooling rate for the softening or stiffening heat treatments, that the cooling would also be air cooling and not quenching, and therefore read on the claimed cooling rate of less than 100C/s or less.
Regarding Claim 12, Ma discloses heating a portion of the rod from room temperature to the heat treating temperature for a softening treatment for a duration of time (para. [0061]; para. [0065]). One of ordinary skill in the art would appreciate the rod of Ma to be heated from room temperature because cold rolling/working is performed prior to the heat treating step, and that the heating would not be instantaneous and would be occurring over a first period of time, which reads on claimed steps a) and b) (see also para. [0062], wherein cold working is performed at room temperature; see para. [0147], wherein cold swaging is performed at room temperature).
Regarding Claim 14, Ma discloses wherein portions may be subjected to air cooling, which reads on cooling in an air environment at a temperature of 10-100C as claimed (para. [0121]). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C).
Regarding Claim 15, Ma discloses marking said metal rod to indicate a relatively degree of flexibility of said metal rod (Fig. 1 and Fig. 4, where different portions are designated to for varying flexibility, which reds on marking to indicate a relative degree of flexibility; see also para. [0026]).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1), as applied to Claim 5 above, in further view of Roth995 (previously cited, US 20190008995 A).
Regarding Claim 6, Ma discloses a metal alloy, and non-limiting examples including Ti-Nb alloys, but fails to expressly disclose a metal alloy including at least 15 at.% rhenium.
Roth995 discloses wherein a molybdenum-rhenium metal alloy is suitable for an implantable rod such as a spinal rod (para. [0006]; [0010], Claim 2-3; para. [0074]; MoRe alloy with 40-99wt% Mo (up to 60 wt% Re) reads on at least 15at% Re). Roth995 teaches wherein heat treating may vary the physical properties by final annealing and/or by a softening treatment (para. [0052], final annealing generally at 900-1600; para. [0017], softening after forming, prior to machining; additionally, one of ordinary skill in the art would appreciate the softening treatment is final if no further heat treatments are applied).
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 a MoRe alloy with up to 60wt% Re, which reads on the claimed 15at% Re, for the invention disclosed by Ma, because Roth995 teaches wherein MoRe is an appropriate material for a medical implant such as a spinal rod, as desired by Ma (see para. [0017]; [0024]), and because MoRe alloy physical properties may be changed by heat treatment, as taught by Roth995 and as required by Ma (see teachings above, para. [0085]). Additionally, it has been held to be within general skill of one of routine skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (see MPEP 2144.07).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1), as applied to Claim 5 above, in view of Huang (CN 109468562 A, English Machine Translation provided).
Regarding Claim 13, Ma discloses wherein:
room temperature (minimum temperature) is about 15-30C, which reads on the claimed 10-250C (para. [0040]), wherein
the softening treatment temperature (maximum temperature) is 150-1200C, or about 600C, and the stiffening treatment temperature is 400-650C para. [0065]; para. [0070], which reads on the claimed range of 500-1000C, and wherein
the softening treatment is performed for 1-20 minutes, and the stiffening heat treatment is performed for 6-168 hours (para. [0065]; para. [0070]), which reads on the claimed range of 0.01-15 hours.
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.
Ma fails to disclose the heating rate from room temperature to the heat treatment temperatures, and therefore fails to disclose wherein the first period of time is 0.5-10 hours.
Huang teaches a similar Ti-Nb-Mo alloy, wherein the alloy is heat treated within the range of 400-850C using a heating rate from room temperature of 10-20C/min (para. [0011]; [0013]; [0016]; [0018]). One of ordinary skill in the art would appreciate that heating from room temperature (20C) to 500-1000C, for example, at a rate of 10C/min would require heating for 48-98 minutes, or 0.8-1.6 hours.
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 a heating rate of 10-20C/min, and therefore a heating duration within the claimed range of 0.5-10 hours, as taught by Huang, for the invention disclosed by Ma, in order to successfully heat to the heating temperatures required by Ma. Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and Applicant has not provided a showing of criticality. See MPEP 2144.05.I.
Claims 33-36, 43 and 45-47 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1) in view of Roth827 (previously cited, US 20190117827 A).
Regarding Claim 33, Ma discloses a method for forming a metal alloy rod that has different physical properties along a longitudinal length of the metal alloy rod (Abstract; para. [0017]; Fig. 1), comprising the steps of:
providing said metal tube formed of a metal alloy including niobium and molybdenum (para. [0015]),
subjecting a first portion of said metal rod to a first final heat treatment (softening treatment) along a first longitudinal length (Fig. 1, portions 110 and 130; para. [0053])
subjecting a second portion of said metal rod to a second final heat treatment (stiffening treatment) along a second longitudinal length (Fig. 1, portion 120; para. [0059]);
wherein the softening and stiffening treatments are different from each other and applied to different portions and different longitudinal lengths along the metal alloy rod, and wherein the entire rod is subjected to the heat treatment processes at the same time (para. [0030]; para. [0057]; para. [0147]-[0148], wherein entire rod is heated in tube furnace during heat treatment process and selective insulating/cooling is used to apply different heat treatment temperatures from the maximum elevated temperature; Fig. 1, 4 and 5, differing lengths and portions for softening and stiffening treatments);
wherein first and second longitudinal lengths of said metal rod have:
a) a different flexibility or bendability
b) a different yield strength
c) a different ultimate tensile strength, and
d) a different metal alloy crystalline structure (Abstract, flexibility; para. [0024]; [0026]; strength (reads on both yield and UTS), para. [0074]-[0075]; para. [0012], crystalline structure); and
wherein the softening treatment and stiffening treatment differ by:
I) heat treatment temperature,
II) a time of exposure, and
III) cooling rate (para. [0029]-[0033]; softening heat treatment and stiffening heat treatment (different heat treatment temperatures); see also para. [0065]; [0069] and [0116]-[0117]; para. [0146], different times). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C). One of ordinary skill in the art would also appreciate that the cooling rate to room temperature in air cooling would slightly differ for different maximum heating temperatures.
Ma discloses a metal alloy, and non-limiting examples including Ti-Nb alloys, but fails to expressly disclose a metal alloy including at least 15 at.% rhenium.
Roth827 discloses wherein a tungsten-rhenium metal alloy is suitable for a spinal implant such as a rod (para. [0008]-[0009], 1-40wt% Re and 60-99wt% W reads on at least 15at% Re; para. [0020]; para. [0074]). Roth827 teaches wherein heat treating may vary the physical properties by strengthening a worked alloy in a final annealing, or by softening the raw material in an as-formed (raw) piece (para. [0062], final annealing for final strengthening; para. [0026], softening after forming, prior to machining; additionally, one of ordinary skill in the art would appreciate the softening treatment is final if no further heat treatments are applied).
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 a WRe alloy with up to 40wt% Re, which reads on the claimed 15at% Re, for the invention disclosed by Ma, because Roth827 teaches wherein WRe is an appropriate material for a spinal rod, as desired by Ma, and because WRe alloy physical properties may be changed by softening/stiffening and/or strengthening heat treatments, as taught by Roth827 and as required by Ma (see teachings above). Additionally, it has been held to be within general skill of one of routine skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (see MPEP 2144.07).
Ma fails to disclose wherein the metal tube is formed by i) pressing together metal alloy powder at a pressure of 1-300 tsi to form pressed metal powder in a net shape of a tube, and ii) thereafter sintering the pressed metal powder at a temperature of at least 1600C.
Roth827 further teaches wherein the WRe alloy may be formed by pressing powder with a pressure of 10-300 tsi, sintering at 1600-2600C and post-sinter pressing at 10-300 tsi at a temperature of 20-40C, in order to form a near net shape by sintering powder while still obtaining increased mechanical strength from cold work (para. [0074]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the WRe alloy tube by pressing powder with a pressure of 10-300 tsi, sintering at 1600-2600C and post-sinter pressing at 10-300 tsi at a temperature of 20-40C, as taught by Roth827, for the invention of Ma in view of Roth827, in order to form a near net shape by sintering powder while still obtaining increased mechanical strength from cold work (see teaching above).
Regarding Claim 34, Ma discloses wherein said metal rod or tube has a constant cross-sectional shape and size along 80%-100% of said longitudinal length of said metal rod or tube (Fig. 1 and Fig. 4).
Regarding Claim 35, Roth827 teaches that for a WRe alloy, cooling rates are at least 50-500 C/minute (0.83-8.3 C/s) in order to prevent the formation of sigma phase. One of ordinary skill in the art would appreciate these cooling rates to not be considered quenching (see also para. [0093]-[0094] and [0171] of instant specification wherein cooling rates are 100C/s or less).
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 a cooling rate of 50-500C/minute, and therefore not subjecting the metal tube to quenching, as taught by Roth827, for the first and second final heat treatments and invention disclosed by Ma and Roth827, in order to prevent the formation of sigma phase (see teaching above).
Ma and Roth827 further disclose where said first and second final heat treatment temperatures are at least 100C, as claimed (Roth827, para. [0062], 900-1300C; Ma, para. [0064]-[0070]).
Regarding Claim 36, Ma and Roth827 disclose wherein said maximum temperature of said first and second final heat treatment temperatures is 900-1300C, which reads on the claimed 500-1000°C (para. [0062]; Ma, para. [0064]-[0070]). 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 43, Ma discloses a method for forming a metal alloy rod that has different physical properties along a longitudinal length of the metal alloy rod (Abstract; para. [0017]; Fig. 1), comprising the steps of:
providing said metal tube formed of a metal alloy including niobium and molybdenum (para. [0015]),
subjecting a first portion of said metal rod to a first final heat treatment (softening treatment) along a first longitudinal length which comprises 30-50% of said longitudinal length (Fig. 1, portions 110 and 130; para. [0053]; para. [0026], each section is 33% for example), and
c*) subjecting a second portion of said metal rod to a second final heat treatment (stiffening treatment) along a second longitudinal length which comprises 30-50% of said longitudinal length (Fig. 1, portion 120; para. [0059]; para. [0026]);
wherein the softening and stiffening treatments are different from each other and applied to different portions and different longitudinal lengths along the metal alloy rod, and wherein the entire rod is subjected to the heat treatment processes at the same time (para. [0030]; para. [0057]; para. [0147]-[0148], wherein entire rod is heated in tube furnace during heat treatment process and selective insulating/cooling is used to apply different heat treatment temperatures from the maximum elevated temperature; Fig. 1, 4 and 5, differing lengths and portions for softening and stiffening treatments);
wherein first and second longitudinal lengths of said metal rod have:
a) a different flexibility or bendability
b) a different yield strength
c) a different ultimate tensile strength, and
d) a different metal alloy crystalline structure (Abstract, flexibility; para. [0024]; [0026]; strength (reads on both yield and UTS), para. [0074]-[0075]; para. [0012], crystalline structure); and
wherein the softening treatment and stiffening treatment differ by:
I) heat treatment temperature,
II) a time of exposure, and
III) cooling rate (para. [0029]-[0033]; softening heat treatment and stiffening heat treatment (different heat treatment temperatures); see also para. [0065]; [0069] and [0116]-[0117]; para. [0146], different times). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C). One of ordinary skill in the art would also appreciate that the cooling rate to room temperature in air cooling would slightly differ for different maximum heating temperatures and/or longitudinal lengths.
Ma discloses a metal alloy, and non-limiting examples including Ti-Nb alloys, but fails to expressly disclose a metal alloy including at least 15 at.% rhenium.
Roth827 discloses wherein a tungsten-rhenium metal alloy is suitable for a spinal implant such as a rod (para. [0008]-[0009], 1-40wt% Re and 60-99wt% W reads on at least 15at% Re; para. [0020]; para. [0074]). Roth827 teaches wherein heat treating may vary the physical properties by strengthening a worked alloy in a final annealing, or by softening the raw material in an as-formed (raw) piece (para. [0062], final annealing for final strengthening; para. [0026], softening after forming, prior to machining; additionally, one of ordinary skill in the art would appreciate the softening treatment is final if no further heat treatments are applied).
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 a WRe alloy with up to 40wt% Re, which reads on the claimed 15at% Re, for the invention disclosed by Ma, because Roth827 teaches wherein WRe is an appropriate material for a spinal rod, as desired by Ma, and because WRe alloy physical properties may be changed by softening/stiffening and/or strengthening heat treatments, as taught by Roth827 and as required by Ma (see teachings above). Additionally, it has been held to be within general skill of one of routine skill in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice (see MPEP 2144.07).
Ma fails to disclose wherein the metal tube is formed by i) pressing together metal alloy powder at a pressure of 1-300 tsi to form pressed metal powder in a net shape of a tube, and ii) thereafter sintering the pressed metal powder, and further b) drawing down and annealing the sintered metal rod
Roth827 further teaches wherein the WRe alloy may be formed by pressing powder with a pressure of 10-300 tsi, sintering at 1600-2600C and post-sinter pressing at 10-300 tsi at a temperature of 20-40C, in order to form a near net shape by sintering powder while still obtaining increased mechanical strength from cold work (para. [0074]). Roth827 further discloses wherein the formed blank or tube may be subjected to a drawing process at 400-500C to remove impurities from the surface (para. [0059]), which reads on the claimed drawing down and annealing step.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the WRe alloy tube by pressing powder with a pressure of 10-300 tsi, sintering at 1600-2600C and post-sinter pressing at 10-300 tsi at a temperature of 20-40C, and further drawing down and annealing the sintered tube, as taught by Roth827, for the invention of Ma in view of Roth827, in order to form a near net shape by sintering powder while still obtaining increased mechanical strength from cold work, and in order to remove impurities from the surface of the tube (see teaching above).
Roth827 teaches that for a WRe alloy, cooling rates are at least 50-500 C/minute (0.83-8.3 C/s) in order to prevent the formation of sigma phase. One of ordinary skill in the art would appreciate these cooling rates to not be considered quenching (see also para. [0093]-[0094] and [0171] of instant specification wherein cooling rates are 100C/s or less).
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 a cooling rate of 50-500C/minute, and therefore not subjecting the metal tube to quenching, as taught by Roth827, for the first and second final heat treatments and invention disclosed by Ma and Roth827, in order to prevent the formation of sigma phase (see teaching above).
Ma and Roth827 further disclose where said first and second final heat treatment temperatures are at least 100C, as claimed (Roth827, para. [0062], 900-1300C; Ma, para. [0064]-[0070]).
Ma and Roth827 disclose wherein said maximum temperature of said first and second final heat treatment temperatures is 900-1300C, which reads on the claimed 500-1000°C (para. [0062]; Ma, para. [0064]-[0070]). 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 45, Ma discloses wherein portions may be subjected to air cooling, which reads on cooling in an air environment at a temperature of 10-100C as claimed (para. [0121]). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C).
Regarding Claim 46, Ma discloses marking said metal rod to indicate a relatively degree of flexibility of said metal rod (Fig. 1 and Fig. 4, where different portions are designated to for varying flexibility, which reds on marking to indicate a relative degree of flexibility; see also para. [0026]).
Regarding Claim 47, Roth827 discloses wherein said metal alloy includes h) W alloy that includes at least 15 at% rhenium (para. [0008]-[0009], 1-40wt% Re and 60-99wt% W reads on at least 15at% Re). 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.
Claims 37-39 are rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1) and Roth827 (previously cited, US 20190117827 A), as applied to Claim 36 above, in further view of Bergeron (previously cited, US 3399981 A).
Regarding Claim 37, Ma discloses wherein each of said softening and stiffening heat treatments are performed within the claimed range of 0.25-25 hours (para. [0065]-[0066]; para. [0069]-[0070]).
Additionally, Bergeron teaches wherein tungsten-rhenium alloys are annealed for 1 hour in order to strengthen the alloy (see Table 1, annealing at 1 hour).
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 a heat treatment times of Ma to soften or stiffen the alloy, or of 1 hour to strengthen the alloy, as taught by Bergeron, for the invention disclosed Ma and Roth827. Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and Applicant has not provided a showing of criticality. See MPEP 2144.05.I.
Regarding Claim 38, Roth827 further teaches that for a WRe alloy, cooling rates are at least 50-500 C/minute (0.83-8.3 C/s) in order to prevent the formation of sigma phase. One of ordinary skill in the art would appreciate these cooling rates to not be considered quenching (see also para. [0093]-[0094] and [0171] of instant specification wherein cooling rates are 100C/s or less).
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 a cooling rate of 50-500C/minute (0.8-8.3 C/s), which reads on the claimed 100C/s or less, as taught by Roth827, for the invention disclosed by Ma and Roth827, in order to prevent the formation of sigma phase (see teaching above).
Regarding Claim 39, Ma discloses heating a portion of the rod from room temperature to the heat treating temperature for the softening treatment and/or stiffening treatment for a duration of time (para. [0061]; para. [0065]; [0068]-[0072]). One of ordinary skill in the art would appreciate the rod of Ma to be heated from room temperature unless otherwise noted and because cold rolling/working is performed prior to the heat treating step, and that the heating would not be instantaneous and would be occurring over a first period of time, which reads on claimed steps a) and b) (see also para. [0062], wherein cold working is performed at room temperature; see para. [0147], wherein cold swaging is performed at room temperature; see also Roth827, para. [0061] wherein the rod is cooled after drawing and annealing).
Claims 40-42 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1) in view of Roth827 (previously cited, US 20190117827 A) and Bergeron (previously cited, US 3399981 A), as applied to Claim 39 above, in further view of Jiang (previously cited, CN 109680173 B, English Machine Translation provided).
Regarding Claim 40, Ma discloses wherein room temperature (minimum temperature) is about 15-30C, which reads on the claimed 10-250C (para. [0040]), wherein
the softening treatment temperature (maximum temperature) is 150-1200C, or about 600C, and the stiffening treatment temperature is 400-650C para. [0065]; para. [0070], which reads on the claimed range of 500-1000C, and wherein
the softening treatment is performed for 1-20 minutes, and the stiffening heat treatment is performed for 6-168 hours (para. [0065]; para. [0070]), which reads on the claimed range of 0.01-15 hours.
Roth827 also disclose heating from a minimum temperature (room temperature), which reads on the claimed range 10-250C, to a maximum temperature of 900-1300C, which reads on the claimed 500-1000C, and holding at the maximum temperature for 5 minutes (0.083 hours), which reads on the claimed second period of time of 0.01-15 hours.
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.
Ma and Roth827 fail to disclose the heating rate from room temperature to the heat treatment temperatures, and therefore fails to disclose wherein the first period of time is 0.5-10 hours.
Jiang teaches a heating rate for annealing a W-Re alloy from room temperature to temperatures such as 900C by heating to 600C within 50-60 minutes (0.83-1.0 hours), holding for 30-40 minutes, and then heating to 900C within 45-50 minutes (total duration from room temperature to 900C of 125-150 minutes, or 2.08-2.5 hours) in order to perform stress relief annealing (para. [0019]). Reaching 900C from room temperature in 2.08-2.5 hours reads on the claimed ‘first time period’ of 0.5-10 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have heated to the heat treatment temperatures required for the stiffening or softening treatments by increasing the temperature in a time period of at least 0.83-1.0 hours and up to 2.08-2.5 hours, as taught by Jiang, for the WRe alloy and invention of Ma and Roth827, in order to successfully reach the heat treatment temperature required by Ma and/or Roth827 while also acquiring stress relief (see teaching above by Jiang). Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and Applicant has not provided a showing of criticality. See MPEP 2144.05.I.
Regarding Claim 41, Ma discloses wherein the portions may be subjected to air cooling, which reads on cooling in an air environment at a temperature of 10-100C as claimed (para. [0121]). One of ordinary skill in the art would also appreciate cooling after the softening or stiffening heat treatments would be air cooling to room temperature unless otherwise stated (see para. [0022], wherein room temperature is 15-30C).
Regarding Claim 42, Ma discloses marking said metal rod to indicate a relatively degree of flexibility of said metal rod (Fig. 1 and Fig. 4, where different portions are designated to for varying flexibility, which reds on marking to indicate a relative degree of flexibility; see also para. [0026]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Ma (US 20180347023 A1) and Roth827 (previously cited, US 20190117827 A), as applied to Claim 43 above, in further view of Jiang (previously cited, CN 109680173 B, English Machine Translation provided).
Regarding Claim 44, Ma discloses wherein room temperature (minimum temperature) is about 15-30C, which reads on the claimed 10-250C (para. [0040]), wherein
the softening treatment temperature (maximum temperature) is 150-1200C, or about 600C, and the stiffening treatment temperature is 400-650C para. [0065]; para. [0070], which reads on the claimed range of 500-1000C, and wherein
the softening treatment is performed for 1-20 minutes, and the stiffening heat treatment is performed for 6-168 hours (para. [0065]; para. [0070]), which reads on the claimed range of 0.01-15 hours.
Roth827 also disclose heating from a minimum temperature (room temperature), which reads on the claimed range 10-250C, to a maximum temperature of 900-1300C, which reads on the claimed 500-1000C, and holding at the maximum temperature for 5 minutes (0.083 hours), which reads on the claimed second period of time of 0.01-15 hours.
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.
Ma and Roth827 fail to disclose the heating rate from room temperature to the heat treatment temperatures, and therefore fails to disclose wherein the first period of time is 0.5-10 hours.
Jiang teaches a heating rate for annealing a W-Re alloy from room temperature to temperatures such as 900C by heating to 600C within 50-60 minutes (0.83-1.0 hours), holding for 30-40 minutes, and then heating to 900C within 45-50 minutes (total duration from room temperature to 900C of 125-150 minutes, or 2.08-2.5 hours) in order to perform stress relief annealing (para. [0019]). Reaching 900C from room temperature in 2.08-2.5 hours reads on the claimed ‘first time period’ of 0.5-10 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have heated to the heat treatment temperatures required for the stiffening or softening treatments by increasing the temperature in a time period of at least 0.83-1.0 hours and up to 2.08-2.5 hours, as taught by Jiang, for the WRe alloy and invention of Ma and Roth827, in order to successfully reach the heat treatment temperature required by Ma and/or Roth827 while also acquiring stress relief (see teaching above by Jiang). Additionally, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art, and Applicant has not provided a showing of criticality. See MPEP 2144.05.I.
Response to Arguments
Applicant’s arguments, filed May 29, 2026, with respect to Claim 5 rejected under 35 U.S.C. 102(a)(1) over Rafiee, and dependent claims thereof, and Claims 33 and 43, rejected under 35 U.S.C. 103 over Rafiee in view of Roth827, and dependent claims thereof, have been fully considered and are persuasive in view of Applicant’s amendments to the claims further limiting the composition, the processing requirements and the form of the metal alloy (see Claim 5). Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made over Ma (Claim 5) and over Ma in view of Roth827, as detailed above.
Applicant’s arguments are deemed moot in view of the new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Matsuo (US 6573738 B1): teaches wherein Re-W alloys are softened by annealing 500-600C and hardened through working (Col. 5, lines 10-13).
Roth995 (US 20190008995 A, applied and cited above, further teachings): teaches wherein a molybdenum-rhenium metal alloy is suitable for a catheter (para. [0005]; [0011], Claim 2-3; para. [0074]; MoRe alloy with 40-99wt% Mo (up to 60 wt% Re) reads on at least 15at% Re). Roth995 teaches wherein heat treating may vary the physical properties by final annealing and/or by a softening treatment (para. [0057], final annealing generally at 900-1600; para. [0019], softening after forming, prior to machining; additionally, one of ordinary skill in the art would appreciate the softening treatment is final if no further heat treatments are applied).
Paliwal (US 20150078950 A1): teaches applying a final stress relief anneal to a Mo-Re alloy with up to 50wt% Re using a temperature of 800-1200C, thereby reducing strength and hardness without significantly changing the microstructure (para. [0024]; Table 1; Claim 6). Paliwal teaches stress annealing for 0.5 hours (para. [0034]).
Shields (“The Effect of Annealing on the Structure and Mechanical Properties of Mo – 47.5 Wt. % Re Alloy Sheet”): teaches wherein cold-worked Mo-Re alloys comprising 47.5% Re are softened by stress-relief annealing at 1173-1573K (900-1300C) for 1 hour in hydrogen, and wherein softening onset temperature is further dependent on thickness (Fig. 2; Pg. 836, Para. 3; Tables 3-4, total elongation).
Sakai (US 20040048218 A1): discloses a method for forming a metal piece that has different physical properties along a longitudinal length (Abstract; para. [0010]; Fig. 2), comprising the steps of subjecting the different portions of the wheel to different heat treatment temperatures and times along the longitudinal length such that different portions comprise different mechanical properties including different tensile strengths, proof (yield) strength and elongation (flexibility) and different crystal structures (para. [0003]; para. [0009]; Fig. 3-4; para. [0039]-[0040]; para. [0054]; one of ordinary skill in the art would appreciate that different heat treatments and age hardening creates different crystal structures; Fig. 7).
Sakai teaches wherein said maximum temperature of said final heat treatment temperature is 500-1000°C (para. [0035], 540-550C; final heat treatment includes both solution heat treatment and aging) and occurs for 60 minutes (para. [0054], 60 minutes).
Rafiee (previously cited, US 20060074403 A1): teaches a catheter comprising different regions of flexibility by applying different heat treatments on a TiNi or MP35N alloy (Abstract; para. [0074]; 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
Prosecution Insights