DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Priority
Applicant’s claim to priority in provisional application no. 61/600,963, filed February 20, 2012, is acknowledged.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 17-18 and Claim 21 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 17, the claim recites “adjusting the predetermined time and the predetermined temperature of the treatment until the friction value determined subsequent to the treating is at least substantially the same as the friction value prior to the treating”. It is unclear if the porous titanium alloy structure is undergoing multiple heat treatments, or if the claim is attempting to recite experimental methods of test products, which are not currently positively recited, to then perform on a final product. Examiner interprets wherein the thermal treating is only performed once on the additively manufactured titanium alloy structure.
Regarding Claim 18, the claim recites “adjusting the predetermined time and the predetermined temperature of the treatment until the friction value determined subsequent to the treating is higher than the friction value prior to the treating”. It is unclear if the porous titanium alloy structure is undergoing multiple heat treatments, or if the claim is attempting to recite experimental methods of test products, which are not currently positively recited, to then perform on a final product. Examiner interprets wherein the thermal treating is only performed once on the additively manufactured titanium alloy structure.
Regarding Claim 21, the claim recites “adjusting the predetermined time and the predetermined temperature of the treatment until the friction value determined subsequent to the treating is substantially the same as or higher than the friction value prior to the treating”. It is unclear if the porous titanium alloy structure is undergoing multiple heat treatments, or if the claim is attempting to recite experimental methods of test products, which are not currently positively recited, to then perform on a final product. Examiner interprets wherein the thermal treating is only performed once on the additively manufactured titanium alloy structure.
Regarding Claim 21, the claim recites wherein the predetermined temperature is 1050C, but also wherein the predetermined temperature is determined based on a desired aspect ratio of asperities and a desired friction of a surface of the porous titanium structure. Thus, it appears there are two criteria outlined for the predetermined temperature and it is unclear if the temperature must be 1050C or alternatively is determined to be a temperature that may or may not be 1050C and based on asperity feature results. Therefore, the metes and bounds of the predetermined temperature are unclear.
Regarding Claim 21, the claim recites adjusting the thermal treating (predetermined time) to be a friction value which is greater than or equal to the friction value of the additively manufactured titanium alloy structure before thermal treatment, but then also recites a specific value for the coefficient of friction, which is a narrower statement. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
In the present instance, Claim 21 recites the broad recitation of a friction value higher than or equal to the friction value prior to thermal treating, and the claim also recites a friction coefficient of about 1.13 +/- 0.04, which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 2-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hollander (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, “Structural, mechanical and in vitro characterization of individually structured Ti–6Al–4V produced by direct laser forming”) in view of Vilaro (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, “As-Fabricated and Heat-Treated Microstructures of the Ti-6Al-4V Alloy Processed by Selective Laser Melting“) and Levin (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, US 4,655,855 A).
Regarding Claim 2, Hollander discloses a method (Abstract) comprising:
forming a porous titanium alloy structure by direct laser forming (DLF) with spherical Ti-64 metal microparticles and subsequent heat treating at 950C for 30 minutes for homogenization (Pg. 956, sect. 2.1. DLF production), which reads on one of direct metal fabrication, direct metal laser sintering and solid free-form fabrication, as claimed. One of ordinary skill in the art would also appreciate the DLF structure to comprise a micro-particles attached to the porous titanium alloy structure as claimed because Hollander uses microparticles in the DLF process and because the DLF process is the same as claimed (see Hollander, Fig. 3a; see MPEP 2112.01).
Hollander fails to expressly disclose wherein the thermal treating obtains the claimed features directed to particle bond strength, average neck size and surface area; however, Hollander in view of Vilaro and Levin (see details below) disclose the same process as the instant invention, and one of ordinary skill in the art would appreciate the invention of Hollander, Vilaro and Levin to result in the claimed features.
Specifically, while Hollander discloses heat treating for homogenization, Hollander fails to disclose heat treating at a temperature of about 1050C and duration of 120 minutes (2 hours) as in the instant invention (see instant specification, para. [0042]-[0043], [0051]; see also Claims 11-12).
Vilaro similarly teaches wherein post-process heat treatments restore homogeneous and stable microstructures in SLM manufactured Ti-6Al-4V parts, and further wherein a supertransus temperature of 1050C is used in place of the conventional subtransus temperature of 950C in order to eliminate additive manufacturing grain structure and enable complete formation of new martensite, thereby forming an equiaxed microstructure beneficial to fatigue properties (Abstract; Pg. 3193, IV. Heat Treatment Optimization, Para. 1; SLM reads on one of direct metal fabrication, direct metal laser sintering and solid free-form fabrication; Pg. 3194, Col. 1, Para. 2-Pg. 3195, Col. 1, Para. 3, wherein equiaxial grains are preferred for fatigue; Pg. 3199, Col. 1, Para. 1).
Vilaro teaches a time of 60 minutes, but fails to disclose 120 minutes.
However, Levin also teaches wherein above beta transus solution heat treatments for titanium alloys such as Ti-6Al-4V improve fatigue properties, and further occur for 10-240 minutes depending on article size (Col. 2, line 53; Fig. 3-4; Col. 3, lines 15-19; see Col. 4, lines 50-56, used for surgical body implantations including hip joints).
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 temperature of 1050C, as taught by Vilaro, and a heat treatment time of 10-240 minutes, which reads on and overlaps 120 minutes (see instant specification, para. [0043] and [0051]; Claims 11-12), as taught by Levin, for the invention disclosed by Hollander, in order to eliminate additive manufacturing grain structure and enable the complete formation of new martensite, thereby producing an equiaxed microstructure with improved fatigue properties, and for articles of increased sizes (see teachings above by Vilaro and Levin).
Regarding heat treatment temperature and time, 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. Additionally, Applicant has not demonstrated criticality or a show of unexpected results in regards to the treating temperature and the treating time.
Thus, Hollander, Vilaro and Levin disclose the same process as the instant invention because Hollander discloses the same rapid manufacturing technique (direct metal fabrication/direct laser fabrication) with spherical Ti-64 metal particles, and Vilaro and Levin disclose the same heat treatment temperature and times. Therefore, one of ordinary skill in the art would appreciate the heat treatment and invention of Hollander, Vilaro and Levin to result in the claimed features. 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, Hollander, Vilaro and Levin disclose the same process as the instant invention (see Claim 2 above), and one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in a plurality of microparticles attached to one or more other microparticles or a strut, as claimed, and further the claimed neck size features (see Claim 2 above). 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 4, Claim 5, Claim 6, and Claim 7, Hollander, Vilaro and Levin disclose the same process as the instant invention (see Claim 2 above), and one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed particle diameter to neck size ratio features. 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 8, Hollander does not expressly disclose the furnace type for heat treatment, but one of ordinary skill in the art would appreciate that in the absence of a description, the furnace would be at least one which generates heat by resistance or radiative means, as is routine and well-known in the art.
Additionally, Vilaro discloses wherein heat treatment at 1050C (see Claim 1 above) occurs at 10-6 torr (Pg. 3191, Col. 2, Para. 4). One of ordinary skill in the art would appreciate this to occur in a high vacuum furnace as a furnace is required for the heat treatment temperatures of Vilaro and a high vacuum furnace would be required to reach the disclosed pressures of Vilaro. It would be obvious to use the high vacuum furnace of Vilaro because Vilaro demonstrates this furnace is suitable to heat treat the additive manufactured part at 1050C.
Regarding Claim 9, Hollander, Vilaro and Levin disclose the same process as the instant invention (see Claim 2 above), and one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed features of increased bond strength between particles and also the claimed roughness and friction features. 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 10, Hollander discloses using 25-45um Ti-64 spherical particles, which reads on microparticles and a powder of a metal (Pg. 956, sect. 2.1. DLF production).
Regarding Claim 11, Vilaro and Levin disclose wherein heat treatment occurs at 1050C for 2 hours, which reads on the claimed 120 minutes and temperature about 1040C to about 1060 C (see Claim 2 teachings above; Vilaro, Pg. 3194, B. High-Temperature Strategy, 1. Solution treatment, para. 2; Levin, Col. 3, lines 14-19).
Regarding Claim 12, Vilaro discloses wherein heat treatment occurs at 1050C (see Claim 2 teachings above; Vilaro, Pg. 3194, B. High-Temperature Strategy, 1. Solution treatment, para. 2).
Regarding Claim 13, Hollander does not expressly disclose the furnace type for heat treatment; however, Vilaro discloses wherein heat treatment at 1050C (see Claim 1 above) occurs at 10-6 torr (Pg. 3191, Col. 2, Para. 4). One of ordinary skill in the art would appreciate this to occur in a high vacuum furnace as a furnace is required for the heat treatment temperatures of Vilaro and a high vacuum furnace would be required to reach the disclosed pressures of Vilaro. It would be obvious to use the high vacuum furnace of Vilaro, which reads on the claimed vacuum furnace, because Vilaro demonstrates this furnace is suitable to heat treat the additive manufactured part at 1050C.
Regarding Claim 14, Hollander, Vilaro and Levin disclose the same process as the instant invention, including using the same predetermined time and predetermined temperature for heat treating and the same Ti-64 powder material (see Claim 2 above). Therefore, the claimed limitation of determining the predetermined time and temperature has been met, and one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed asperity features. 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 15, Hollander, Vilaro and Levin disclose the same process as the instant invention, including using the same predetermined time and predetermined temperature for heat treating and the same Ti-64 powder material (see Claim 2 above). Therefore, one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed facet formation in the microparticles from the heat treating. 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 16, Hollander, Vilaro and Levin disclose the same process as the instant invention, including using the same predetermined time and predetermined temperature for heat treating and the same Ti-64 powder material (see Claim 2 above). Therefore, the claimed limitation of determining the predetermined time and temperature has been met. 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 17, Hollander, Vilaro and Levin disclose the same process as the instant invention because Hollander discloses the same rapid manufacturing technique (direct metal fabrication/direct laser fabrication) with spherical Ti-64 metal particles, and Vilaro and Levin disclose the same heat treatment temperature and times. One of ordinary skill in the art would therefore appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed friction value.
Regarding the limitation of determining a friction value before and after treating and adjusting the predetermined time in order to reach a friction value equal to the friction value prior to treating, Vilaro and Levin disclose the predetermined temperature and predetermined time identical to the instant invention. Therefore, the claimed limitations have been met, and one of ordinary skill in the art would appreciate that the heat treating of Vilaro and Levin would result in a friction value equal to the friction value prior to heat treating as claimed. 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, Applicant has not provided criticality towards heat treatment times or temperatures and the influence thereof to produce specific friction values, respectively. Further, finding a workable range or routine optimization of heat treatment time by trial and error (determining a value before and after treatment and adjusting based on the whether a desired outcome occurs) is generally recognized as being within the level of one of ordinary and routine skill in the art. See MPEP 2144.05.I.
Regarding Claim 18, Hollander, Vilaro and Levin disclose the same process as the instant invention because Hollander discloses the same rapid manufacturing technique (direct metal fabrication/direct laser fabrication) with spherical Ti-64 metal particles, and Vilaro and Levin disclose the same heat treatment temperature and times. One of ordinary skill in the art would therefore appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed friction value.
Regarding the limitation of determining a friction value before and after treating and adjusting the predetermined time in order to reach a friction value higher than the friction value prior to treating, Vilaro and Levin disclose the predetermined temperature and predetermined time identical to the instant invention. Therefore, the claimed limitations have been met, and one of ordinary skill in the art would appreciate that the heat treating of Vilaro and Levin would result in a friction value higher than the friction value prior to heat treating as claimed. 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, Applicant has not provided criticality towards heat treatment times or temperatures and the influence thereof to produce specific friction values, respectively. Further, finding a workable range or routine optimization of heat treatment time by trial and error (determining a value before and after treatment and adjusting based on the whether a desired outcome occurs) is generally recognized as being within the level of one of ordinary and routine skill in the art. See MPEP 2144.05.I.
Regarding Claim 19, Hollander, Vilaro and Levin disclose the same process as the instant invention, including using the same predetermined time and predetermined temperature for heat treating and the same Ti-64 powder material (see Claim 2 above). Therefore, the claimed limitation of determining the predetermined time and temperature has been met, and one of ordinary skill in the art would appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed friction value features. 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 20, Hollander, Vilaro and Levin disclose the same process as the instant invention, including using the same predetermined time and predetermined temperature for heat treating and the same Ti-64 powder material (see Claim 2 above). Therefore, one of ordinary skill in the art would appreciate that the invention and heat treating step of Hollander, Vilaro and Levin would result in the claimed coefficient of friction value features. 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 21, Hollander discloses a method (Abstract) comprising:
forming a porous titanium alloy structure by direct laser forming (DLF) with spherical 25-45um Ti-64 metal particles and subsequent heat treating at 950C for 30 minutes for homogenization (Pg. 956, sect. 2.1. DLF production). Spherical 25-45um Ti-64 metal particles reads on microparticles of a powder including a metal, as claimed.
Hollander fails to expressly disclose wherein the thermal treating is performed at 1050C, and wherein the heat treating further results in the claimed features directed to particle bond strength, surface area, preserved spherical particle shape, roughness and friction features of the porous titanium alloy structure (including the coefficient of friction), the particle neck size to particle diameter size ratio, and/or the asperity aspect ratio.
However, Hollander in view of Vilaro and Levin (see details below) disclose the same process as the instant invention, including heat treating at 1050C (see teaching below), and one of ordinary skill in the art would appreciate the invention of Hollander, Vilaro and Levin to result in the claimed features.
Specifically, while Hollander discloses heat treating for homogenization, Hollander fails to disclose heat treating at a temperature of about 1050C and duration of 120 minutes (2 hours) as in the instant invention (see instant specification, para. [0042]-[0043], [0051]; see also Claims 11-12).
Vilaro similarly teaches wherein post-process heat treatments restore homogeneous and stable microstructures in SLM manufactured Ti-6Al-4V parts, and further wherein a supertransus temperature of 1050C is used in place of the conventional subtransus temperature of 950C in order to eliminate additive manufacturing grain structure and enable complete formation of new martensite, thereby forming an equiaxed microstructure beneficial to fatigue properties (Abstract; Pg. 3193, IV. Heat Treatment Optimization, Para. 1; SLM reads on one of direct metal fabrication, direct metal laser sintering and solid free-form fabrication; Pg. 3194, Col. 1, Para. 2-Pg. 3195, Col. 1, Para. 3, wherein equiaxial grains are preferred for fatigue; Pg. 3199, Col. 1, Para. 1).
Vilaro teaches a time of 60 minutes, but fails to disclose 120 minutes.
Levin also teaches wherein above beta transus solution heat treatments for titanium alloys such as Ti-6Al-4V improve fatigue properties, and further occur for 10-240 minutes depending on article size (Col. 2, line 53; Fig. 3-4; Col. 3, lines 15-19; see Col. 4, lines 50-56, used for surgical body implantations including hip joints).
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 temperature of 1050C, as taught by Vilaro, and a heat treatment time of 10-240 minutes, which includes 120 minutes (see instant specification, para. [0043] and [0051]; Claims 11-12), as taught by Levin, for the invention disclosed by Hollander, in order to eliminate additive manufacturing grain structure and enable the complete formation of new martensite, thereby producing an equiaxed microstructure with improved fatigue properties, and for articles of increased sizes (see teachings above by Vilaro and Levin).
Regarding heat treatment temperature and time, 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. Additionally, Applicant has not demonstrated criticality or a show of unexpected results in regards to the treating temperature and the treating time.
Thus, Hollander, Vilaro and Levin disclose the same process as the instant invention because Hollander discloses the same rapid manufacturing technique (direct metal fabrication/direct laser fabrication) with spherical Ti-64 metal particles, and Vilaro and Levin disclose the same heat treatment temperature and times. One of ordinary skill in the art would therefore appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed features including: particle bond strength, surface area of the porous titanium alloy, preserved spherical particle shape, the claimed roughness and friction features of the porous titanium alloy structure (including the coefficient of friction), the particle neck size to particle diameter size ratio and further the asperity aspect ratio.
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 the limitations directed to determining the predetermined time and predetermined temperature based on a desired aspect ratio of asperities, and determining a friction value before and after treating and adjusting the predetermined time in order to reach a friction value equal to or higher than the friction value prior to treating, Vilaro and Levin disclose the predetermined temperature and predetermined time identical to the instant invention. Therefore, the claimed limitations have been met and one of ordinary skill in the art would appreciate that the heat treating of Vilaro and Levin would result in a friction value equal to or higher than the friction value prior to heat treating and one which results in the asperity features of the claimed 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, Applicant has not provided criticality for or provided any values of aspect ratios for the instant invention, and has not provided criticality towards heat treatment times or temperatures and the influence thereof to produce a specific aspect ratio and/or friction value, respectively. Further, finding a workable range or routine optimization of heat treatment time by trial and error (determining a value before and after treatment and adjusting based on the whether a desired outcome occurs) is generally recognized as being within the level of one of ordinary and routine skill in the art. See MPEP 2144.05.I.
Hollander does not expressly disclose the furnace type for heat treatment, but one of ordinary skill in the art would appreciate that in the absence of a description, the furnace would be at least one which generates heat by resistance or radiative means, as is routine and well-known in the art.
Additionally, Vilaro discloses wherein heat treatment at 1050C (see Claim 1 above) occurs at 10-6 torr (Pg. 3191, Col. 2, Para. 4). One of ordinary skill in the art would appreciate this to occur in a high vacuum furnace as a furnace is required for the heat treatment temperatures of Vilaro and a high vacuum furnace would be required to reach the disclosed pressures of Vilaro. It would be obvious to use the high vacuum furnace of Vilaro because Vilaro demonstrates this furnace is suitable to heat treat the additive manufactured part at 1050C.
Claims 17-18 and 21 are alternatively rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Hollander (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, “Structural, mechanical and in vitro characterization of individually structured Ti–6Al–4V produced by direct laser forming”) in view of Vilaro (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, “As-Fabricated and Heat-Treated Microstructures of the Ti-6Al-4V Alloy Processed by Selective Laser Melting“) and Levin (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, US 4,655,855 A), as applied to Claim 2 above in regards to Claim 17 and Claim 18, and further in view of Stamp (previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025, “The development of a scanning strategy for the manufacture of porous biomaterials by selective laser melting”).
Regarding Claim 17 and Claim 18, Hollander discloses using the porous titanium structure as an osteoblast and discloses wherein there are known dimensions considered to be effective for bone tissue ingrowth, and wherein there are surface requirements for hard tissue substitution (Abstract; Pg. 961, Col. 2, Para. 2; Pg. 962, Col. 2, Para. 1). One of ordinary skill in the art would therefore appreciate that Hollander has determined a desired friction value prior to the process (including thermal treatment).
Hollander does not disclose analyzing surface properties after thermal heat treatment.
Stamp assesses surface topography and teaches that micro surface roughness results from thermal treatment after rapid manufacturing (SLM), and may promote osteo-integration and enhance performance as a bone ingrowth structure (Pg. 1845, Col. 2, Para. 2; see also Table 1; section 2.5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have assessed the surface topography and analyzed the surface roughness before and after thermal treatment, as taught by Stamp, for the invention disclosed by Hollander, in order to assess the use of the porous titanium structure for osteo-integration and its performance as a bone ingrowth structure (see teachings above). Measuring the surface topography/roughness of the thermally treated specimen reads on determining a friction value of the porous titanium alloy structure subsequent to the treating, as claimed.
While Hollander and Stamp do not expressly disclose the subsequent step of ‘adjusting the time and temperature of said treatment until the friction value subsequent to treatment is at least substantially the same as the friction value prior to treatment’ (see 112b rejection and interpretation above), Hollander discloses determining a friction value necessary for osteoblasts prior to processing and determining if criteria has been met, and Stamp discloses wherein there is a relationship between the thermal treatment and the surface roughness/topography and determining the friction value after thermally treating.
Thus, it would have been obvious and routine skill in the art for the invention to have used the criteria for a usable osteoblast disclosed by Hollander and Stamp, the determination of topography/roughness, and therefore friction value, of before and after heat treatment, and the recognized relationship between thermal treatment and surface roughness taught by Stamp, in a method of trial and error, or statistical process control, for obtaining optimized friction values and one that is (Claim 17) at least the same or (Claim 18) higher than the friction value before heat treatment. One of ordinary skill in the art will appreciate that trial and error experimentation is a common and well-known technique in the art, and 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. See MPEP 2144.05.I.
Regarding Claim 21, Hollander discloses a method (Abstract) comprising:
forming a porous titanium alloy structure by direct laser forming (DLF) with spherical Ti-64 metal microparticles and subsequent heat treating at 950C for 30 minutes for homogenization (Pg. 956, sect. 2.1. DLF production), which reads on one of direct metal fabrication, direct metal laser sintering and solid free-form fabrication, as claimed. One of ordinary skill in the art would also appreciate the DLF structure to comprise a micro-particles attached to the porous titanium alloy structure as claimed because Hollander uses microparticles in the DLF process and because the DLF process is the same as claimed (see Hollander, Fig. 3a; see MPEP 2112.01).
Additionally, spherical 25-45um Ti-64 metal particles further reads on microparticles of a powder including a metal, as claimed.
Hollander fails to expressly disclose wherein the thermal treating is performed at 1050C, and wherein the heat treating further results in the claimed features directed to particle bond strength, surface area, preserved spherical particle shape, roughness and friction features of the porous titanium alloy structure (including the coefficient of friction), the particle neck size to particle diameter size ratio, and/or the asperity aspect ratio.
However, Hollander in view of Vilaro and Levin (see details below) disclose the same process as the instant invention, including heat treating at 1050C (see teaching below), and one of ordinary skill in the art would appreciate the invention of Hollander, Vilaro and Levin to result in the claimed features.
Specifically, while Hollander discloses heat treating for homogenization, Hollander fails to disclose heat treating at a temperature of about 1050C and duration of 120 minutes (2 hours) as in the instant invention (see instant specification, para. [0042]-[0043], [0051]; see also Claims 11-12).
Vilaro similarly teaches wherein post-process heat treatments restore homogeneous and stable microstructures in SLM manufactured Ti-6Al-4V parts, and further wherein a supertransus temperature of 1050C is used in place of the conventional subtransus temperature of 950C in order to eliminate additive manufacturing grain structure and enable complete formation of new martensite, thereby forming an equiaxed microstructure beneficial to fatigue properties (Abstract; Pg. 3193, IV. Heat Treatment Optimization, Para. 1; SLM reads on one of direct metal fabrication, direct metal laser sintering and solid free-form fabrication; Pg. 3194, Col. 1, Para. 2-Pg. 3195, Col. 1, Para. 3, wherein equiaxial grains are preferred for fatigue; Pg. 3199, Col. 1, Para. 1).
Vilaro teaches a time of 60 minutes, but fails to disclose 120 minutes.
Levin also teaches wherein above beta transus solution heat treatments for titanium alloys such as Ti-6Al-4V improve fatigue properties, and further occur for 10-240 minutes depending on article size (Col. 2, line 53; Fig. 3-4; Col. 3, lines 15-19; see Col. 4, lines 50-56, used for surgical body implantations including hip joints).
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 temperature of 1050C, as taught by Vilaro, and a heat treatment time of 10-240 minutes, which includes 120 minutes (see instant specification, para. [0043] and [0051]; Claims 11-12), as taught by Levin, for the invention disclosed by Hollander, in order to eliminate additive manufacturing grain structure and enable the complete formation of new martensite, thereby producing an equiaxed microstructure with improved fatigue properties, and for articles of increased sizes (see teachings above by Vilaro and Levin).
Regarding heat treatment temperature and time, 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. Additionally, Applicant has not demonstrated criticality or a show of unexpected results in regards to the treating temperature and the treating time.
Thus, Hollander, Vilaro and Levin disclose the same process as the instant invention because Hollander discloses the same rapid manufacturing technique (direct metal fabrication/direct laser fabrication) with spherical Ti-64 metal particles, and Vilaro and Levin disclose the same heat treatment temperature and times. One of ordinary skill in the art would therefore appreciate that the invention of Hollander, Vilaro and Levin would result in the claimed features including: particle bond strength, surface area of the porous titanium alloy, preserved spherical particle shape, the claimed roughness and friction features of the porous titanium alloy structure (including the coefficient of friction), the particle neck size to particle diameter size ratio and further the asperity aspect ratio.
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 the limitations directed to determining the predetermined time and predetermined temperature based on a desired aspect ratio of asperities, and determining a friction value before and after treating and adjusting the predetermined time in order to reach a friction value equal to or higher than the friction value prior to treating, Vilaro and Levin disclose the predetermined temperature and predetermined time identical to the instant invention. Therefore, the claimed limitations have been met and one of ordinary skill in the art would appreciate that the heat treating of Vilaro and Levin would result in a friction value equal to or higher than the friction value prior to heat treating and one which results in the asperity features of the claimed invention (See MPEP 2112.01).
Further, Hollander discloses using the porous titanium structure as an osteoblast and discloses wherein there are known dimensions considered to be effective for bone tissue ingrowth, and wherein there are surface requirements for hard tissue substitution (Abstract; Pg. 961, Col. 2, Para. 2; Pg. 962, Col. 2, Para. 1). One of ordinary skill in the art would therefore appreciate that Hollander has determined a desired friction value prior to the process (including thermal treatment).
Stamp assesses surface topography and teaches that micro surface roughness results from thermal treatment after rapid manufacturing (SLM), and may promote osteo-integration and enhance performance as a bone ingrowth structure (Pg. 1845, Col. 2, Para. 2; see also Table 1; section 2.5).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have assessed the surface topography and analyzed the surface roughness before and after thermal treatment, as taught by Stamp, for the invention disclosed by Hollander, in order to assess the use of the porous titanium structure for osteo-integration and its performance as a bone ingrowth structure (see teachings above). Measuring the surface topography/roughness of the thermally treated specimen reads on determining a friction value of the porous titanium alloy structure subsequent to the treating, as claimed.
While Hollander and Stamp do not expressly disclose the subsequent step of ‘adjusting the predetermined time and of the treating until the friction value determined subsequent to treating is at least substantially the same as or higher than the friction value prior to the treating (see 112b rejection and interpretation above), Hollander discloses determining a friction value necessary for osteoblasts prior to processing and determining if criteria has been met, and Stamp discloses wherein there is a relationship between the thermal treatment and the surface roughness/topography and determining the friction value after thermally treating.
Thus, it would have been obvious and routine skill in the art for the invention to have used the criteria for a usable osteoblast disclosed by Hollander and Stamp, the determination of topography/roughness, and therefore friction value, of before and after heat treatment, and the recognized relationship between thermal treatment and surface roughness taught by Stamp, in a method of trial and error, or statistical process control, for obtaining optimized friction values and one that is at least the same or higher than the friction value before heat treatment. One of ordinary skill in the art will appreciate that trial and error experimentation is a common and well-known technique in the art, and 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. See MPEP 2144.05.I.
Additionally, Applicant has not provided criticality for or provided any values of aspect ratios for the instant invention, and has not provided criticality towards heat treatment times or temperatures and the influence thereof to produce a specific aspect ratio and/or friction value, respectively.
Hollander does not expressly disclose the furnace type for heat treatment, but one of ordinary skill in the art would appreciate that in the absence of a description, the furnace would be at least one which generates heat by resistance or radiative means, as is routine and well-known in the art.
Additionally, Vilaro discloses wherein heat treatment at 1050C (see Claim 1 above) occurs at 10-6 torr, which reads on a high vacuum furnace (Pg. 3191, Col. 2, Para. 4), and Stamp similarly teaches wherein thermal treatment after the formation of a porous preform made by rapid prototype manufacturing takes place in a high-vacuum furnace (see Pg. 1842, Sect. 2.4). It would be obvious to use the high vacuum furnace of Vilaro and Stamp because Vilaro and Stamp demonstrate this furnace is suitable to heat treat the additive manufactured part and at the required temperature of 1050C.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Previously cited in parent application no. 16/513,259 and by Applicant in IDS filed September 16, 2025:
Thomas (US 20100057212 A1): teaches a high coefficient of friction ranging from 0.7-1.5 in order to encourage bone ingrowth (para. [0037]-[0038]).
Unwin (US 20040243237 A1): teaches method of forming a porous titanium alloy structure by SLS and heat treating from 900-1300C (para. [0038]; para. [0040]; Fig. 2a-2c; porous section 32b; Fig. 3a-3c; porous section 44; para. [0018]; [0040]-[0041]; para [0045]).
Esen2009 (“Characterization of loose powder sintered porous titanium and Ti6Al4V alloy”): teaches average neck to average particle diameter ratios for heat treatment at different temperatures (see Fig. 6).
Esen (“Production and Characterization of Porous Titanium Alloys”): teaches wherein a sintered materials’ strength may be correlated with the square of the neck to diameter ratio (Pg. 75, see also equation 2.21) such that when the ratio of the neck to diameter is close to 1, such as 0.95 (this would give a diameter to neck ratio of 1.05, which is greater than 1), the materials’ strength may be high.
Xie (CN 102335742 A, English Machine translation provided): Xie teaches a similar method of additively forming (by SLS) a porous titanium alloy (Ti-Mo) structure (para. [0007]; par. [0009], section (3)), which is then thermally treated at a temperature of 800-1500C for 30 minutes to 3 hours, in order to increase bonding strength (para. [0009], section (5); see para. [0021] wherein 1100C is applied for 2 hours (120 minute)).
Wang (“Computer modeling and simulation of solid-state sintering: A phase field approach”): demonstrates facet formation of spherical particles undergoing solid state sintering (see Fig. 4(a)-Fig.4(b)).
Levin (additional teachings, US 4,655,855 A): teaches beta-solution heat treatment temperatures are up to 10% above the beta-transus temperature, preferably up to 5% above the beta-transus temperature (Col. 3, lines 5-18). One of ordinary skill in the art would appreciate the beta-transus temperature for Ti-6Al-4V alloy is about 995C, and that 5-10% above 995C would be a temperature from 1045-1095C. One of ordinary skill in the art would also appreciate that 1045C reads on about 1050C.
Pattanayak (“Fabrication of Bioactive Porous Ti Metal with Structure Similar to Human Cancellous Bone by Selective Laser Melting”): teaches heat treatment temperatures ranging from 700-1300C, wherein increasing heat treatment temperature improves elongation with a tradeoff in tensile strength (Pg. 2, Col. 1, Para. 2; Fig. 3), and demonstrates surface morphologies in as-fabricated SLM structures which are substantially similar to Hollander and that of the instant invention (Pattanayak, Fig. 2, as laser processed; Hollander Fig. 3a; instant invention, Fig. 4a). Further, one of ordinary skill in the art would appreciate that the image of Pattanayak after heating to 1200C for 1hr is also substantially similar to the image of the instant invention after heating to 1200C for 2hr (Pattanayak, Fig. 2, 1200C; instant invention, Fig. 7).
Wilson (WO 2010004261 A2): teaches wherein the texture of the surface, including height, spacing and 3D shape, are controlled by processing parameters, and is critical to forming surface asperities and therefore surface topography which enables osteoblast attachment (Pg. 6, para. 6 – Pg. 7, para. 3). Wilson teaches wherein asperities are designed to have a desired aspect ratio and a desired height, width, and spacing between to achieve these implant features (Pg. 6, Para. 4, desired high aspect ratio; Pg. 7, para. 4-6). One of ordinary skill in the art would appreciate that a desired height and a desired width also produces a desired aspect ratio. It would have been obvious to one of ordinary skill in the art to have chosen processing parameters and particular computer-aided designs to achieve a desired asperity aspect ratio, as taught by Wilson, for the invention disclosed by Hollander, in order to comprise a surface condition with asperities which are usable as an implant material for which produces osteoblasts on the surface thereof (see teaching by Wilson above).
Liu (US 20090326674 A1): teaches wherein the inclined plane method is particularly suitable for measuring friction values of a porous sintered titanium structure (para. [0026]; one of ordinary skill in the art would appreciate that ASTM D4518-91 refers to the inclined plane method of measuring surface roughness and friction coefficients).
Stamp (cited above, further teachings, “The development of a scanning strategy for the manufacture of porous biomaterials by selective laser melting”): teaches wherein thermal treatment after the formation of a porous preform made by rapid prototype manufacturing takes place in a high-vacuum furnace (see Pg. 1842, Sect. 2.4).
Newly cited:
Facchini (“Ductility of a Ti‐6Al‐4V alloy produced by selective laser melting of prealloyed powders"): teaches forming a titanium alloy (Ti-64) part by SLM followed by a subsequent heat treatment, outlined by Hollander 2006, in order to modify the martensitic microstructure to produce varying strength and ductility values (Abstract).
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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
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