Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Request for Continued Examination
A Request for Continued Examination pursuant to 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Because this application is eligible for continued examination pursuant to 37 CFR § 1.114, and Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 1 January 2026 has been entered.
Status of the Claims
Applicants filed claims 1 - 5, 8 - 9, 11 - 12, 17 - 23, 25, 27 - 29, 31 - 35 and 90 with the instant application according to 37 CFR § 1.114, on 1 January 2026. No claims were amended therein. Claims 8, 9, 11, 12, 19 – 23, 25, 27 – 29, and 31 - 35 remain withdrawn as being directed to a non-elected invention. Consequently, claims 1 – 5, 17, 18, and 90 are available for active consideration.
REJECTIONS MAINTAINED
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that 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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 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.
The rejection of claims 1 – 5, 17, 18, and 90 pursuant to 35 U.S.C. § 103, as being obvious over US 2021/0129396 A1 to Jarman-Smith, M., et al., claiming priority to 14 February 2011 (“Jarman-Smith ‘396”), Daculsi, G., et al., Key Engineering Materials 529-530: 19 – 23 (2012) (“Daculsi (2012)”), and Brown, O., et al., J Mater Sci: Mater Med 21: 2271–2279 (2010) (“Brown (2010)), is hereby maintained.
The Invention As Claimed
Applicants claim a composition, the composition comprising a composite that comprises a high-viscosity, polyetheretherketone (PEEK) polymeric matrix, and a homogenously distributed additive comprising biphasic calcium phosphate (BCP), the BCP comprising a blend of HA and TCP in a ratio of 80:20, present at 1 – 25% wgt of the composition, wherein the average particle size of the BCP is between about 0.2 µm to about 1.5 µm, wherein the additive acts as a flowing-aid, wherein the PEEK polymeric matrix comprises a powder before processing, the powder having an average diameter between about 5 µm to about 2,500 µm, wherein the powder has a density of about 1.15 g/cm3 to about 1.5 g/cm3, wherein the PEEK has a melt volume flow rate (MVR) of about 13 cm3/10 min to about 15 cm3/10 min, or about 9 cm3/10 min to about 12 cm3/10 min, at 400° C and 5 kg of mass, and wherein the PEEK has an elongation to failure of about 55% to about 70%, or about 25% to about 50%.
The Teachings of the Cited Art
Jarman-Smith ‘396 discloses methods for the preparation of a component material for use in medical implants (see ¶[0001]), wherein the component comprises a polymeric material, such as polyetheretherketone (PEEK), and a calcium phosphate as a bioactive material (see ¶[0002]), wherein the calcium phosphate comprises tricalcium phosphate, β-tricalcium phosphate (β-TCP), or hydroxyapatite (HA) (see ¶[0012]), the methods comprise producing a bio-active component that comprises a polymeric material-bioactive material composite having the ability to bond with tissue, such as bone (see ¶[0049]), wherein the composite material is prepared by heating the mixture in an extruder until the polymeric material is molten and then adding the bioactive material to the extruder such that the bioactive material is mixed with the molten polymeric material by the extruder (see ¶¶[0105] – [0108]), to yield a material that has tensile properties that are relatively close to those of PEEK while also having high bioactivity (see ¶[0031]), wherein use of a screw extrusion process results in better dispersion of bioactive material through a polymeric material such as PEEK than other methods of blending, resulting in high availability of HA at the surface of the molded bioactive component which allows for lower levels of the bioactive material to be used, thus allowing other physical properties of the component to be less compromised so that the polymeric material may be maintained at higher levels in the composite without significantly affecting bioactivity of the component (see ¶[0032]), wherein the process produces a component material comprising a polymeric material-bioactive material composite having tensile strength and/or flexural strength that is at least 85% of the respective strength of the unblended PEEK material (see ¶[0037]), wherein the component material has an impact strength of from at least 5 KJ/m2 to no more than 10 KJ/m2 (see ¶[0041]), wherein the component material has a flexural strength of at least 155 mPa (see ¶[0043]), and a flexural modulus of 6 GPa, or less (see ¶[0044]), wherein the component material exhibits a strain at break of at least 8% (see ¶[0047]), wherein the component material comprises the calcium phosphate material in an amount of 20% wgt (see ¶¶[0057] – [0058]), wherein the component material comprises PEEK in an amount of 80% wgt (see ¶¶[0060]), wherein the component material may be doped with one or more additional chemical elements (see ¶[0067]), wherein the dopant may be fluorine (see ¶[0071]), wherein particles of PEEK have a maximum dimension in one direction of at least 0.3 mm to less than 0.8 mm (see ¶[0115]), wherein the component material may comprise a part, or the whole, of a device that can be incorporated into, or associated with, a human body, the medical implant arranged to replace or supplement bone (see ¶[0188]), and wherein, in exemplified embodiment, the PEEK was in the form of granules of approximately 3 mm by 2 mm size and the calcium phosphate material was in the form of particles having mean particle size of 5 µm (see ¶[0225]). The reference does not explicitly disclose that the calcium phosphate material is in a biphasic form with a ratio of HA:TCP of 80:20, or a material comprising a PEEK that has a melt volume flow rate (MVR) of about 13 cm3/10 min to about 15 cm3/10 min at 400° C and 5 kg of mass, or a PEEK that has an elongation to failure of about 55% to about 70%, or a composite that has a melt volume flow rate of about 9 cm3/10 min to about 12 cm3/10 min at 400° C and 5 kg of mass, or a composite has an elongation to failure of about 25% to about 50%. The teachings of Daculsi (2013) and Brown (2010) remedy those deficiencies.
Daculsi (2013) discloses that Micro Macroporous biphasic CaP, (MBCP+™) is a concept based on an optimum balance of the more stable phase of HA and more soluble TCP, wherein the material is soluble and gradually dissolves in the body, seeding new bone formation as it releases Ca and P ions into the biological medium, wherein, with MBCP+ materials, higher permeability and absorption ability were essentially due to distribution of pore size, particularly mesopores and the high micropore content representing around 40% of the total porosity, wherein, after implantation, bone ingrowth is observed at the expense of the bioceramic, and newly-formed bone progressively replaced the bioactive material, followed by haversian bone remodelling, wherein in vivo experiments indicated high cell colonization by osteogenic cells due to this interconnected and microporous structure associated to higher solubility, with an HA/β-TCP demonstrating the best composition for tissue engineering, i.e., a combination with both stem cell cultivation and expansion (see p. 22, 5th para.), and wherein advanced MBCP+ bioceramics technology demonstrated higher efficacy of the calcium phosphate scaffolds for surgical technologies in bone tissue regeneration (see p. 23, 2nd para.).
Brown (2010) discloses that the majority of synthetic bone grafts are made from biphasic calcium phosphates (BCPs), combining hydroxyapatite (HA) and β-tricalcium phosphate (β-TCP), which is a resorbing ceramic, while HA does not readily resorb, so that combining the two calcium phosphates in a biphasic mix allows the rate of resorption to be controlled (see p. 2271, 2nd col., 2nd para.), wherein BCP discs were made having HA/β-TCP weight percentage ratios of 80/20 (see p. 2272, 1st col., 3rd para.), wherein the discs were subjected to sintering programs, wherein Sintering program 1 involved a simple heating and cooling schedule and temperatures of 1100, 1250, 1275 and 1300° C, and produced samples containing an additional α-tricalcium phosphate (α-TCP) phase at temperatures above 1100° C (see Abstract), reflecting that the use of high sintering temperatures can cause an unwanted phase change from β-TCP to α-TCP (see p. 2272, 1st col., 1st para.), wherein, for HA80/β-TCP20 discs, under Sintering program 1, less conversion of the β-TCP to α-TCP was observed than for discs with 50 or 20 % HA (see p. 2272, 2nd col., 3rd para.), with an increase in the amount of HA (see p. 2272, 2nd col., 6th para.), wherein, in Sintering program 2, the heating and cooling schedules of Sintering program 1 were retained, with the addition of a 900° C hold stage to allow an α-TCP to a β-TCP conversion to take place, such that, at temperatures of 1250 and 1275° C, Sintering program 2 was successful in completely removing the α-TCP phase and preserving the HA:β-TCP ratio (see Abstract; see also, p. 2274, 2nd col., last para. – p. 2275, 1st para., Figure 5), and wherein HA80/β-TCP20 discs demonstrated the smallest change in phase among all three compositions tested (see Table 1, p. 2276).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare a composite material for use in medical implants, wherein the material comprises a polymeric material comprising polyetheretherketone (PEEK) and a calcium phosphate, as a bioactive material, wherein the calcium phosphate is tricalcium phosphate, β-tricalcium phosphate (β-TCP), or hydroxyapatite (HA), wherein the composite material is prepared by heating the mixture in an extruder until the polymeric material is molten and then adding the bioactive material to the extruder such that the bioactive material is mixed with the molten polymeric material by the extruder to yield a material that has tensile properties that are relatively close to those of PEEK while also having high bioactivity, the combination of properties likely arising from the process for preparing the material, wherein the process produces a component material comprising a polymeric material-bioactive material composite having tensile strength and/or flexural strength that is at least 85% of the respective strength of the unblended PEEK material, wherein the composite material comprises the calcium phosphate component in an amount of 20% wgt and the PEEK component in an amount of 80% wgt, wherein the composite material consists essentially of a single type of polymeric material and a single type of bioactive material, and wherein, in exemplified embodiment, the PEEK was in the form of granules of approximately 3 mm by 2 mm size and the calcium phosphate material was in the form of particles having mean particle size of 5 µm, as taught by Jarman-Smith ‘396, wherein the calcium phosphate component comprises biphasic calcium phosphate with HA/TCP at a ratio of 20/80, which material proved to be more efficient for combination with total bone marrow or stem cell cultivation and expansion, and wherein the biphasic calcium phosphate materials demonstrated higher efficacy for surgical technologies in bone tissue regeneration than single-phase CaP materials, as taught by Daculsi (2013), and wherein, due to the fact that β-tricalcium phosphate (β-TCP) is a resorbing ceramic, while HA does not readily resorb, so that combining the two calcium phosphates in a biphasic mix allows the rate of resorption to be controlled, and including HA/β-TCP discs with a weight percentage ratio of 80/20, which ratio is most closely maintained under a high temperature sintering program, as taught by Brown (2010). One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of Daculsi (2013) and Brown (2010) to the effect that biphasic calcium phosphates offer advantages over other calcium phosphate ceramics in the ability to custom tailor the rate of resorption of such materials as a function of the HA:β-TCP ratios, and that the desired ratios of HA to β-TCP are better retained for HA20/β-TCP discs subject to high temperature sintering.
With respect to the limitation recited in amended claim 1, directed to the additive (BCP) “acting as a flowing-aid,” the Examiner notes that the cited references do not expressly address such functional characteristic of the BCP. However, given that the biphasic calcium phosphate disclosed by the cited reference is substantially identical to that claimed by Applicants, HA and β-TCP at a mass ratio of 80/20 (cf. claim 1), it is the Examiner’s position that the biphasic CaP of the cited references would necessarily function as a flow aid. See MPEP § 2145 II.: “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979);” see also, MPEP § 2112.01 I.: “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).”
With respect to the limitations recited in claims 3 – 5, 17, and 18, directed to mechanical or structural properties of PEEK (claims 3 – 5), and the PEEK/β-TCP composite (claims 17 and 18), the Examiner notes that the references do not address the mechanical properties of the composite and polymeric materials using the same measures of those mechanical properties as recited in the claims. However, it is the Examiner’s that due to identity between the polymeric and composite materials taught in the reference and the claimed polymeric and composite materials, as well as the substantially identical preparation processes (see Jarman-Smith ‘396, ¶[0105]; see specification, ¶[0050]), the PEEK and PEEK/CaP materials would necessarily exhibit mechanical properties reading on the claim limitations in question. Further in this regard, the Examiner notes that Applicants’ specification does not disclose any chemical or mechanical properties specific to the PEEK of the invention that would serve to distinguish over the PEEK of the cited reference. In addition, Jarman-Smith ‘396 teaches that the disclosed composite materials exhibit tensile and/or flexural strengths that are at least 85% of the respective strength of the unblended PEEK material (see ¶[0037]; see also, for example Table 1). Applicants’ specification specifically teaches that “introduction [of] biphasic calcium phosphate to the polyetheretherketone (PEEK) material results in a melt volume flow rate (MVR) comparable to the virgin polyetheretherketone (PEEK) material containing no additive” (see ¶0039]). It is the Examiner’s position that one of ordinary skill in the art would understand that this teaching is directed to a fundamental goal of Applicants’ invention – producing a composite material with mechanical properties that are as close as possible to the properties of the polymeric material contained therein. Thus, both the cited references and Applicants are pursuing the same goal for the composite materials disclosed therein.
With respect to the melt volume flow rates (MVR) as recited in claim 4, the Examiner notes that the cited references do not address this specific property of the polymeric material. However, the Examiner notes that, as addressed above, composite materials prepared in accord with the teachings of the cited references comprise a composite material with the same ratio of PEEK:BCP of 80:20 as Applicants disclose in the specification(see p. 12, ll. 34 – 35); furthermore, the composite material of the prior art also comprises the same PEEK polymer matrix as claimed, and the material is prepared by a substantially similar process as that disclosed by Applicants comprising mixing of the two powder components, followed by heating to a temperature above the melting point of PEEK, and further mixing of the BCP with the molten PEEK in a screw extruder. Consequently, it is the Examiner’s position that, due to these similarities in both components and their loadings, as well as the processes for preparing the composites, the materials according to the cited references would necessarily display melt flow rates that would read on the limitation in question.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 1 – 5, 17, 18, and 90 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered Applicants’ arguments submitted with the Response of 1 January 2026, but does not find them persuasive. Applicants first argue that “the cited references do not teach the additive (BCP) as a flowing-aid,” and that the limitation reflects “an unexpected property of the present invention.” However, with respect to BCP as a “flowing-aid,” the fact that Applicants have recognized another advantage that would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). It is clear from the teachings of the cited references that inclusion of BCP in the composite material provides recognized advantages in terms of bone repair processes and that these recognized advantages provide ample motivation to the skilled practitioner to use that form of a calcium phosphate material in the composites. Furthermore, Applicants’ argument fails to take into account the fact that the invention as claimed (a bioactive composition) falls into a statutory category of patentable inventions as a composition of matter. As such, the invention is examiner for patentability on the basis of the compositional and structural characteristics of the composition, as claimed. The limitation directed to “the additive act[ing] as a flowing-aid” is not reflective of any compositional or structural characteristics, other than reflecting that an additive (BCP) is a component of the inventive composition. In contrast, if Applicants chose to claim their invention in a form consistent with a different statutory category, such as, perhaps, a method of improving the flow characteristics of molten PEEK, then the “flowing-aid” limitation could carry more weight in the consideration of patentability. However, that is not the case. The issue of whether Applicants’ alleged discovery that 80:20 BCP particles with an average particle size between about 0.2 to 1.5 µm improves the flowability of what the Examiner presumes refers to molten PEEK is unexpected and, therefore, renders the claimed composition non-obvious, is simply not controlling. The Examiner would also note that neither the claims under examination, nor Applicants’ specification, provide any disclosure that would relate the “flowability” phenomenon to structural or compositional characteristics of the claimed composition.
Applicants further argue that “[b]iphasic calcium phosphate is a composite material. It is not just a physical mixture of two powder forms, but a more compact mixture.” Applicants’ argument in this regard appears to be based on the teachings of the primary reference, Jarman-Smith ‘396, which discloses the use of mixtures of different calcium phosphates, such as hydroxyapatite and β-tricalcium phosphate, as Applicants incorrectly point to “a simple physical mixture of HA and p -TCP as in the cited references.” As addressed above, and admitted in the rejection of record, Jarman-Smith ‘396 discloses a physical mixture of HA and β-TCP, but Applicants’ argument fails to take into consideration the role of the teachings of all of the cited references, including Daculsi (2012) and Brown (2010), and how rejection is structured on those teachings .
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive, and claims 1 – 5, 17, 19, and 90 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
THIS ACTION IS MADE FINAL. Applicants are reminded of the extension of time policy as set forth in 37 CFR § 1.136(a).
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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 Response 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 extension fee 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619