DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
A request for continued examination (RCE) under 37 CFR 1.114 was filed in this application on 4/28/2026 after a decision by the Patent Trial and Appeal Board.
Claims 1-5, 7-9, 11-21, 23-62 are pending.
Election/Restrictions
Amended claims 1 and 14 are directed to an invention that is independent or distinct from the invention originally elected for the following reasons:
The restriction requirement mailed 8/4/2022 restricted the product of Group I drawn to a biocompatible polymeric powder from Group III drawn to the process for producing the free flowing biocompatible polymeric powder. For purposes of expedited examination, claims 1 and 14 will be treated as product by process claims, i.e. a free flowing biocompatible polymeric powder for three dimensional printing, made by the process comprising the steps of (a) to (e). See MPEP 821.03.
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 1-5, 7-9, 11-21, 26 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.
Claims 1 and 14 recite the limitation "the microparticles" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claims 2-5, 7-9, 11-21, 26 are subsumed by this rejection because of their dependence.
Appropriate correction and/or clarification is required.
Claim 1 is a process claim for producing a free flowing biocompatible polymeric powder. Claims 2-5, 7-9, 11-13, 15-21, 26 are product claims of a polymeric powder. Therefore, the scope of claims 2-5, 7-9, 11-13, 15-21 is unclear since it would not be clear if they are product claims , or process claims.
Claims 2-5, 7-9, 11-21, 26 are subsumed by this rejection because of their dependence.
Appropriate correction and/or clarification is required.
Claim Rejections - 35 USC § 103
Claims 1-5, 7-9, 11-16, 18-21, 26 are rejected under 35 U.S.C. 103 as being unpatentable over Vucak et al. (US 2014/0004348) in view of Kang et al. (US 2020/0032049).
Since the product of Group I was originally elected, Claims 1 and 14 will be treated as product by product by process claims, i.e. a free flowing biocompatible polymeric powder for three dimensional printing, made by the process comprising the steps of (a) to (e). See MPEP 821.03.
Regarding claim 1: Vucak discloses a process for producing free-flowing biocompatible polymeric powder for biomedical application comprising polymeric particles of polyamide 12 having an average particle size (D50) of 50 um and calcium carbonate as a flow aid having an average particle size (D50) of 0.1-20 µm, including 0.1-2.0 um ([0163] Vucak) measured by laser diffraction [scattering] ([0185] Vucak). Moreover, Vucak discloses that the particles of calcium carbonate are preferably sphere-shaped and essentially amorphous ([0102]).
Although three dimensional printing, wherein the powder is processed in a blade based or roll based powder based 3D printing machine is not mentioned, the free-flowing biocompatible polymeric powder of Vucak is in a form which renders it suitable for three dimensional printing. In other words, the body of claim 1 does not depend on the intended use for three dimensional printing. Further, because the composition of Vucak suggests the claimed composition, it is necessarily capable of being used for three dimensional printing, wherein the powder is processed in a blade based or roll based powder based 3D printing machine.
Vucak doesn’t mention the polymeric powder is cryogenically ground, although mentions polylactic acid particles preferably 50-70 µm ([0065] Vucak).
Kang is directed to polylactic acid particles having a particle diameter of 1-100 um used for a variety of applications (abstract and [0003] Kang). The polymer particles are cryogenically ground polymeric particles ([0055] Kang). One skilled in the art would have been motivated to have selected cryogenically ground polylactic acid particles as the particles of choice in Vucak for improved purity as well as lower costs, improved compressibility, fluidity, and dispersibility in comparison to conventional grinding methods ([0017], [0026] Kang). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have selected the cryogenically ground polylactic acid as the polylactic acid particles of choice in Vucak.
While a specific process of blade based or roll based powder based 3D printing machine is not mentioned in particular, patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the present case, there is no evidence to suggest the product by process of claim 6 would not the same or obvious from that taught in Vucak. In the present case, there is no evidence to suggest the product made by the process of Vucak would be different.
While a process for producing the polymeric powder comprising the claimed steps (a) to (e) is not mentioned, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113. In the present case, it is clear the same product is produced, and therefore meets the claims.
Regarding claim 2: The calcium particles are narrow and preferably all particles have a particle diameter of average particle diameter distribution of -30% of all calcium carbonate particles ([0162]) (equivalent to D90-D10 range of ≤60 µm).
Regarding claim 3: Vucak doesn't specifically recite the bulk density. However, the polymeric powder produced in Vucak is substantially identical to the polymeric powder produced in the instant invention.
Case law holds that 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). MPEP 2112.01(I).
Hence, Vucak suggests a composition having a break energy value and bulk density within the scope of the claims. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 4: The surface of the particles can contain trace amounts of surface active agents (equivalent to a surfactant) ([0105]).
Regarding claim 5: Calcium salts can be present in an amount of below 0.5 wt% ([0103]). The surface of the particles can contain trace amounts of surface active agents (equivalent to a surfactant) ([0105]).
Regarding claims 7-8: Many polymers are disclosed, including polyurethanes [0076].
Regarding claim 9: Calcium carbonate is disclosed, which is defined by the present invention as a bioceramic.
Regarding claim 11: The weight ratio of polymer to calcium salt is preferably 90:10 to 99:1 ([0180]) (equivalent to 1-10 wt%).
Regarding claim 12: Calcium salts are disclosed including calcium carbonate and calcium phosphate ([0171]) (equivalent to a bioceramic).
Regarding claim 13: Polymer particles have an average particle diameter [D50] of 1-500 µm. ([0176]). While 1-10 µm is not mentioned in particular, a prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art. In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003).
Regarding claim 14: Vucak discloses a free-flowing biocompatible polymeric powder for biomedical application comprising polymeric round shaped particles and a flow aid of calcium salt [bioceramic] having an average particle size (D50) of 0.1-20 µm, including 0.1-2.0 um ([0163] Vucak) measured by laser diffraction [scattering] ([0185] Vucak). Vucak discloses that the particles of calcium salt particles are essentially amorphous ([0102]) and are used in biomedical applications ([0042]) (equivalent to partially amorphous biocompatible form).
While a specific process of blade based or roll based powder based 3D printing machine is not mentioned in particular, patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). In the present case, there is no evidence to suggest the product by process of claim 6 would not the same or obvious from that taught in Vucak. In the present case, there is no evidence to suggest the product made by the process of Vucak would be different.
While a specific process of blade based or roll based powder based 3D printing machine is not mentioned in particular, the patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
While a process for producing the polymeric powder comprising the claimed steps (a) to (e) is not mentioned, “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113. In the present case, it is clear the same product is produced, and therefore meets the claims.
Regarding claim 15: The bioceramic of calcium carbonate particles are essentially amorphous (equivalent to a crystallinity of less than 50%).
Regarding claim 16: The weight ratio of polymer to calcium salt is preferably 90:10 to 99:1 ([0180]) (equivalent to 1-10 wt%).
Regarding claims 18-19: The bioceramic is calcium carbonate.
Regarding claims 20-21: Vucak doesn't specifically recite the break energy value or bulk density. However, the polymeric powder produced in Vucak is substantially identical to the polymeric powder produced in the instant invention. Specifically, both have d50 and d90 values of the particles. Further, both the break energy value and bulk density appear to depend directly on the particle size of the polymeric powder as well as the flow aid.
Case law holds that 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). MPEP 2112.01(I).
Hence, Vucak suggests a composition having a break energy value and bulk density within the scope of the claims. Since PTO cannot conduct experiments the proof of burden is shifted to the applicants to establish an unobviousness difference, see In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977). See MPEP § 2112.01.
If it is the applicant’s position that this would not be the case: (1) evidence would need to be provided to support the applicant's position; and (2) it would be the Office's position that the application contains inadequate disclosure, since one skilled in the art would not understand how to obtain the claimed properties with only the claimed reactants, claimed amounts, and substantially similar process of making.
Regarding claim 26: The powder is used as a flow aid for spherical or irregular shaped polymer particles. Specifically, it is used in additive manufacturing process that includes polymer particles that are either spherical or irregular shaped.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Vucak and Kang as applied to claim 14 above, and further in view of Sepulveda et al. (58, 6, 2001, P. 734-740).
Regarding claim 17: Vucak doesn’t mention the BET surface area of the bioceramic.
Sepulveda is directed to a sol gel derived bioactive glass used to form a bond with living bone. The surface area of the sol gel derived powder is 126.5-164.7 m2/g (abstract Sepulveda). One skilled in the art would have been motivated to have selected the sol gel derived bioactive glass of Sepulveda in Vucak since it allowed significant changes in resorption and in vivo responses (abstract Sepulveda). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to have selected the sol gel derived bioactive glass of Sepulveda in Vucak.
Response to Arguments
Applicant's arguments filed 4/28/2026 (herein “Remarks”) have been fully considered and are not persuasive.
Applicant argues (p. 12-13 Remarks) the Board states that patentability does not depend on the method of production. In light of this comment, Applicant has changed claims 1 and 14 to process claims. The use of blade based and roll based test is responsible for the improved powder flowability. A smooth surface is essential for blade based printing since it allows for consistent and even distribution of the powder during the printing process.
This argument is not found persuasive since the product does not depend on the process of producing it. This is discussed in the Examiners Answer mailed 5/6/2025. Further, the use of the claimed free-flowing biocompatible polymeric powder in a blade based or roll based powder based 3D printing machine has nothing to do with the claimed product, namely the free-flowing biocompatible polymeric powder. In other words, using the claimed powder in any machine does not affect the product of a free-flowing biocompatible polymeric powder prior to use in said machine.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT T BUTCHER whose telephone number is (571)270-3514. The examiner can normally be reached Telework M-F 9-5 Pacific Time Zone.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lanee Reuther can be reached at (571) 270-7026. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT T BUTCHER/Primary Examiner, Art Unit 1764
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