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 .
Applicant’s response filed March 24, 2026 has been entered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 5 and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by He (“Additive-manufactured gyroid scaffolds of magnesium oxide, phosphate glass fiber and polylactic acid composite for bone tissue engineering” Polymers 2021, 13(2), 270).
Claim 1: He discloses a process for forming a composite article (p. 2), including extruding a mixture of a transition metal doped amorphous magnesium phosphate and a polymer to form extruded composite filaments (p. 3), and fabricating the article from the filaments via additive manufacturing (p. 3).
Claim 2: He discloses combining the transition metal doped amorphous magnesium phosphate and the polymer and mixing in a powder mixer prior to the extrusion (p. 3).
Claim 5: He discloses fused filament fabrication (p. 3).
Claim 16: He discloses PLA extrusion (p. 3).
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.
Claims 3, 9-10 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over He (“Additive-manufactured gyroid scaffolds of magnesium oxide, phosphate glass fiber and polylactic acid composite for bone tissue engineering” Polymers 2021, 13(2), 270), as applied to claim 1 above, in view of Cheng (“Antibacterial amorphous calcium phosphate nanocomposites with a quaternary ammonium dimethacrylate and silver nanoparticles,” Dent Mater 28(5):561-572 (2012)).
He is silent as to the transition metal being silver. However, Cheng teaches a process of forming a composite article, including incorporating silver into amorphous phosphate phases in polymer composites for antibacterial function. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have incorporated silver (or Cu, Zn, well-known antimicrobial transition metals) into the amorphous phosphate of He to provide an antibacterial function, as taught by Cheng.
Claims 4, 6-8, 14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over He (“Additive-manufactured gyroid scaffolds of magnesium oxide, phosphate glass fiber and polylactic acid composite for bone tissue engineering” Polymers 2021, 13(2), 270), as applied to claim 1 above, in view of Ligon (“Polymers for 3D printing and customized additive manufacturing,” Chem. Rev. 117:10212-10290 (2017)).
Claims 4 and 6-8: He discloses melt-extrusion of PLA composites into filaments but does not disclose the extrusion temperature. However, Ligon teaches FFF extrusion temperature ranges, including “in the range of 385C” for PEEK (p. 10237), which overlaps or is encompassed by the claimed range. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have selected about 340C to about 350C as a routine parameter within the known extrusion temperature window when substituting PEEK for PLA or when optimizing process conditions, and to obtain predictable mechanical and thermal benefits. Moreover, a prima facie case of obviousness exists when the ranges of a claimed element overlap the ranges disclosed in the prior art. E.g., In re Geisler, 116 F.3d 1465, 1469, 43 USPQ2d 1362, 1365 (Fed. Cir. 1997); In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936-37 (CCPA 1976); In re Malagari, 499 F.2d 1297, 1303, 182 USPQ 549, 553 (CCPA 1974).
Claim 14: Ligon discloses cooling to reduce stresses and deformations (p. 10234).
Claim 20: He discloses the article being a patient-specific implant, but is silent as to acquiring a patient image and processing the image to design the article. However, Ligon discloses that CAD-based patient imaging, modeling, and AM fabrication of patient-specific implants allow for end-user parts that can be produced directly according to patient-specific data (p. 10216). It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have acquired a patient image and process the image to design the implant of He in order to allow for end-user parts that can be produced directly according to patient-specific data, as taught by Ligon.
Claims 11-13 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over He (“Additive-manufactured gyroid scaffolds of magnesium oxide, phosphate glass fiber and polylactic acid composite for bone tissue engineering” Polymers 2021, 13(2), 270), as applied to claim 1 above.
He is silent as to the claimed range amounts. However, absent evidence of unexpected results obtained from utilizing the claimed ranges, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the application to have selected a suitable amount of magnesium phosphate or transition metals to effectively form a composite article. The optimization of a range or other variable within the claims that flows from the “normal desire of scientists or artisans to improve upon what is already generally known” is prima facie obvious. In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir. 2003) (determining where in a disclosed set of percentage ranges the optimum combination of percentages lies is prima facie obvious). The discovery of an optimum value of a variable in a known process is usually obvious. In re Aller, 220 F.2d 454, 456 (C.C.P.A. 1955). See also In re Boesch, 617 F.2d 272, 276 (C.C.P.A. 1980) (“[D]iscovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.”). See also In re Geisler, 116 F.3d 1465, 1470 (Fed. Cir. 1997) (“‘[I]t is not inventive to discover the optimum or workable ranges by routine experimentation.’” (quoting Aller, 220 F.2d at 456)); In re Kulling, 897 F.2d 1147, 1149 (Fed. Cir. 1990) (finding no clear error in Board of Patent Appeals and Interferences’ conclusion that the amount of eluent to be used in a washing sequence was a matter of routine optimization known in the pertinent prior art and therefore obvious).
Response to Arguments
Applicant's arguments filed March 24, 2026 have been fully considered but they are not persuasive.
Applicant argues that the words amorphous, magnesium and phosphate are “unreasonably isolate[ed],” and that “the Office improperly collapses distinct material classes into one broad category based only on the presence of phosphate, magnesium, and amorphicity.” This argument has been considered but is not persuasive. Claim terms are given their broadest reasonable interpretation consistent with the specification. The recitation “a transition metal doped amorphous magnesium phosphate” reads on an amorphous material that includes magnesium, phosphate, and a transition-metal dopant. He’s phosphate glass fiber (P48-B12-Ca14-Mg17-Na1-Fe8) is an amorphous (glassy) solid that includes magnesium (as MgO) and phosphate as (P2O5), and iron as a transition metal, which is no less than is required by the instant claims.
Applicant further argues that He’s “phosphate glass fiber is chemically and structurally distinct from the presently recited transition metal doped AMP, because it is a boron/calcium/sodium/iron-containing glass network rather than an AMP phase.” This argument has been considered but is also not persuasive. The claims recite the open transitional phrase “comprising” and there is no limitation excluding additional components. The additional presence of boron, calcium, and sodium in He’s glass does not remove that glass from the scope of a claim that does not exclude those elements and does not require magnesium phosphate to be the sole, or even predominant, constituent of the amorphous phase.
Applicant also argues, “The present application discloses novel AMP particles incorporated into a polymer . . . to form bioactive, osseointegrable composite filaments for dental and orthopedic implants and 3D printing.” And that He doesn’t disclose this. This argument has been considered but is not persuasive because it is not commensurate in scope with the claims. The claims do not require formation of bioactive, osseo integrable composite filaments for dental and orthopedic implants. Features not recited in the claim cannot distinguish over the prior art See In re Self, 671 F.2d 1344 (CCPA 1982) (limitations not appearing in the claims cannot be relied upon for patentability).
With regard to dependent claim 3, Applicant argues that “the metals in He form part of a scaffolding and there is no disclosure or suggestion in Cheng that silver would be suitable for this purpose.” This argument has been considered but is not persuasive. Cheng teaches incorporating silver into an amorphous phosphate phase of a biomaterial composite to impart antibacterial functionality. A person of ordinary skill in the art would have been motivated to incorporate silver into the amorphous phosphate of He to impart antibacterial properties to the implantable bone article, which is a plainly desirable characteristic given the susceptibility of implants to bacterial colonization, with a reasonable expectation of success, both references being directed to metal-dopable amorphous phosphate materials.
With regard to dependent claims 6-8, Applicant argues that He requires a biodegradable polymer, that PEEK is not established as biodegradable or suitable for He’s scaffold, and that substituting PEEK would impermissibly alter He’s principle of operation. The rejection proposed substituting Ligon’s PEEK for He’s PLA, which is a simple substitution of one known additive-manufacturing thermoplastic for another to obtain predictable results. The substitution results in a printable composite filament and a fabricated article. The principle of operation of the process taught by He is melt-extruding a phosphate/polymer mixture into composite filaments and fabricating an article y fused filament fabrication. This principle of operation is not altered by substituting one melt-processable thermoplastic (PEEK) for another (PLA). The extrusion and additive-manufacturing operations proceed in the same way and both PLA and PEEK are established FFF feedstocks.
With regard to dependent claims 11-13, Applicant argues that the relative amount of iron to magnesium in He is outside the claimed ranges. Applicant’s calculation is based on bodily substituting He’s specific glass composition into the claim and comparing He’s iron content against the claimed doping level. But obviousness is not determined by bodily incorporation; it is determined by what the combined teachings would have suggested to a person of ordinary skill in the art. In re Keller, 642 F.2d 413, 425, 208 USPQ 871, 881 (CCPA 1981) (“The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.”) The transition-metal doping level is a result-effective variable which controls, among other things, antimicrobial efficacy and its effect on the phosphate matrix. He discloses the general conditions of the claim which is an amorphous magnesium-containing phosphate combined with a polymer and processed by extrusion and additive manufacturing. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (Claimed process which was performed at a temperature between 40°C and 80°C and an acid concentration between 25% and 70% was held to be prima facie obvious over a reference process which differed from the claims only in that the reference process was performed at a temperature of 100°C and an acid concentration of 10%.); see also Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382 (“The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”) The burden is on Applicant to demonstrate that the claimed ranges are critical, for example by a showing of unexpected results commensurate in scope with the claims. Applicant has provided no such showing.
With regard to claim 20, Applicant argues that there is no evidence in the record that He’s scaffolding could be suitable for a patient-specific implant. This argument has been considered but is not persuasive. Ligon expressly teaches that CAD-based patient imaging, modeling, and additive-manufacturing fabrication enable production of patient-specific implants directly from patient-specific data on page 10216, and additive manufacturing is recognized for enabling geometric customization to individual patient anatomy. He fabricates its bone-engineering article by additive manufacturing. It would have been obvious to acquire and process a patient image to design He’s additively-manufactured article to conform to a specific patient’s anatomy, with the recognized customization benefit of additive manufacturing.
Conclusion
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LARRY THROWER whose telephone number is (571)270-5517. The examiner can normally be reached 9am-5pm MT M-F.
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/LARRY W THROWER/Primary Examiner, Art Unit 1754
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