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Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114.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 23 April 2026 has been entered.
Status of the Claims
Applicants filed claims 1 - 18, 20 - 23 and 25 – 42 with the instant application according to 37 CFR § 1.114, on 1 August 2011. In an Amendment entered with the Request for Continued Examination, Applicants amended claims 17, 23, 39, and 40, added new claims 43 – 45, and canceled claim 14. Claims 1 – 13, 15, 16, and 26 – 38 remain withdrawn as being directed to a non-elected invention. Consequently, claims 17, 18, 20 – 23, 25, and 39 - 45 are available for substantive consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejection set forth in the Action of 18 March 2025 is hereby withdrawn in light of Applicants’ amendments to the claims, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
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.
Claims 17, 18, 20 – 23, 25, and 39 – 45 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2014/0236299 A1 to Roeder, R., et al., published 21 August 2014 (“Roeder ‘299”), in view of Morgan, E., et al., Annu. Rev. Biomed. Eng. 20: 119 – 143 (2018).
The Invention As Claimed
Applicants claim a surgical implant comprising a thermoplastic extrusion comprising a bioceramic-containing solid particle or fiber having an average size of less than 500 micrometers dispersed in a thermoplastic material in a weight ratio of thermoplastic material to bioceramic-containing solid particle or fiber from 2:1 to 50:1, wherein the surgical implant comprises a tensile strength of from 20 MPa to 90 MPa and/or a modulus of elasticity of from 1.0 GPa to 10.0 GPa, such that the implant comprises zones of higher bioceramic-containing solid particle or fiber concentration and zones of lower bioceramic-containing solid particle or fiber concentration, the concentration defined as a ratio of bioceramic-containing solid particle or fiber in the implant to bioceramic-containing solid particle or fiber and thermoplastic material in the implant, wherein the bioceramic-containing solid particle or fiber is homogenously dispersed in the thermoplastic material, wherein at least a portion of the bioceramic containing solid particle or fiber is exposed at a surface of the implant, wherein the implant comprises hygroscopic properties, and wherein the implant includes variable zones of differing thermoplastic physical or chemical properties that, in combination with the bioceramic-containing solid particle or fiber, imparts regional zones having different mechanical and biological functions within the implant.
Applicants also claim a surgical implant comprising a bioceramic-containing solid particle or fiber dispersed in a thermoplastic material, wherein the surgical implant comprises a tensile strength of from 20 MPa to 90 MPa and/or a modulus of elasticity of from 1.0 GPa to 10.0 GPa; the implant comprising zones of higher bioceramic-containing solid particle or fiber concentration and zones of lower bioceramic containing solid particle or fiber concentration, wherein the surgical implant is monolithic, wherein the surgical implant is hygroscopic, and wherein the wherein the bioceramic is a calcium phosphate and the thermoplastic material comprises polymethyl methacrylate.
The Teachings of the Cited Art
Roeder ‘299 discloses synthetic composite materials for use as orthopedic implants comprising a porous matrix of a thermoplastic polymer with a plurality of calcium phosphate particles integrally formed, embedded in, or exposed on a surface of the matrix, the particles providing bioactivity to the materials (see Abstract), wherein the composites are tailored to mimic biological and mechanical properties of bone tissue for implant fixation, synthetic bone graft substitutes, tissue engineering scaffolds, interbody spinal fusion, or other orthopedic applications, and can reduce subsidence and/or bone resorption resulting from mechanical mismatch problems between a synthetic scaffold of an implant device and the peri-implant tissue (see ¶[0016]), wherein the composite material are synthesized or made through a process that enables reinforcement particles to be integrally formed with, or embedded within, polymer matrices, the particles also exposed on a surface of the matrices which promotes bioactivity and/or bioresorption, and provides flexibility to tailor the level of reinforcement particles for a desired application (see ¶[0017]), wherein, by varying the volume of the reinforcement particles and the porosity of the example scaffold, the mechanical properties (e.g., stiffness, strength, toughness, etc.) of the implant devices may be tailored to match those of the adjacent peri-implant bone tissue to reduce mechanical mismatch problems, reducing mechanical mismatch, and providing a decreased risk of subsidence, stress shielding, bone resorption, and/or subsequent failure of adjacent peri-implant bone tissue (see ¶[0018]), wherein, depending on
the application, synthetic composite materials for use as scaffolds and/or spinal fusion cages or other implant devices should possess the mechanical properties exhibited by the cortical bone or the trabecular bone (see ¶[0021]), wherein, to avoid the mechanical mismatch problems, such as stress shielding, the example scaffold of the implant device described herein may be tailored to substantially match or mimic the mechanical properties (e.g., stiffness, strength, toughness, etc.) of the adjacent and/or substituted bone tissue, taking advantage of several factors that may be varied during the synthesis of the composite material and scaffold of the implant device to tailor the mechanical properties including the calcium phosphate reinforcement volume fraction, aspect ratio, size and orientation, the polymer; and the size, volume fraction, shape and directionality of the void space and/or porosity, so that tailoring the mechanical properties of the scaffold results in a reduction in the likelihood of mechanical mismatch leading to a decreased risk of subsidence, stress shielding, bone resorption and/or subsequent failure of adjacent vertebrae (see ¶[0022]), wherein the thermoplastic polymer is polymethyl methacrylate (see ¶[0027]), wherein the aspect ratio, size, volume fraction and degree of preferred orientation of the calcium phosphate particles may be tailored for the desired material properties (see ¶[0028]), wherein, due to their morphology, the calcium phosphate reinforcements particles may be oriented in bulk or near the surface of the polymer matrix to provide directional properties, if desired, providing anisotropy for the overall composite, which can be tailored to be similar to the anisotropic mechanical properties of bone tissues (see ¶[0030]), wherein there are no limits on the size or amount of the calcium phosphate particles in matrix provided that the calcium phosphate particles are dispersed within and/or exposed at the surface of the polymer matrix, with maximum dimensions from about 2 nm to about 2 mm, or from 20 nm to about 100 µm, with micro-scale particles being particularly effective for obtaining a uniform dispersion within the matrix (see ¶[0031]), wherein suitable calcium phosphates may include, without limitation, calcium HA, HA whiskers, HA, carbonated calcium HA, β-tricalcium phosphate (β-TCP), α-tricalcium phosphate (α-TCP), amorphous calcium phosphate (ACP), octacalcium phosphate (OCP), tetracalcium phosphate, biphasic calcium phosphate (BCP), anhydrous dicalcium phosphate (DCPA), dicalcium phosphate dihydrate (DCPD), anhydrous monocalcium phosphate (MCPA), monocalcium phosphate monohydrate (MCPM), and combinations thereof (see ¶[0032]), wherein the bioactive calcium phosphate particles (e.g., HA whiskers) exposed on the surface of the polymer matrix promote a stable bone-implant interface (see ¶[0033]), wherein the pores of the matrices can be functionally graded in any material or implant direction, from a highly porous region to a relatively dense region, such that the change in porosity from one region to another may be very distinct, and the graded change may be uniform or variant, or instead of a graded change, there may be a combination of materials having two or more densities of pores (see ¶[0034]), wherein the materials are manufactured by methods common to reinforced thermoplastic and thermosetting polymers, including, among others, extrusion (see ¶[0045]), and wherein densifying and molding the composite material includes aligning the calcium phosphate reinforcement particles morphologically and/or crystallographically within the scaffold (see ¶[0053]). The reference does not expressly disclose composite implant materials with a tensile strength from 20 MPa to 90 MPa and/or a modulus of elasticity from 1.0 GPa to 10.0 GPa, or composite implants comprising zones of higher bioceramic-containing solid particle or fiber concentration and zones of lower bioceramic-containing solid particle or fiber concentration. The teachings of Morgan (2018) remedy those deficiencies.
Morgan (2018) discloses that the typical Young’s modulus of human trabecular bone ranges between 10 and 3,000 MPa, whereas strength, which is linearly and strongly correlated with modulus, is generally two orders of magnitude smaller, in the range 0.1–30 MPa (see p. 128, 1st para.; see also, Figure 4).
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 synthetic composite materials for use as orthopedic implants comprising a porous matrix of a thermoplastic polymer with a plurality of calcium phosphate particles integrally formed, embedded in, or exposed on a surface of the matrix, the particles providing bioactivity to the materials, wherein the composites are tailored to mimic biological and mechanical properties of bone tissue for implant fixation, synthetic bone graft substitutes, tissue engineering scaffolds, interbody spinal fusion, or other orthopedic applications, and can reduce subsidence and/or bone resorption resulting from mechanical mismatch problems between a synthetic scaffold of an implant device and the peri-implant tissue, wherein the composite material are synthesized or made through a process that enables reinforcement particles to be integrally formed with, or embedded within, polymer matrices, the particles also exposed on a surface of the matrices which promotes bioactivity and/or bioresorption, and provides flexibility to tailor the level of reinforcement particles for a desired application, wherein, by varying the volume of the reinforcement particles and the porosity of the example scaffold, the mechanical properties (e.g., stiffness, strength, toughness, etc.) of the implant devices are tailored to match those of the adjacent peri-implant bone tissue to reduce mechanical mismatch problems, reducing mechanical mismatch, and providing a decreased risk of subsidence, stress shielding, bone resorption, and/or subsequent failure of adjacent peri-implant bone tissue, wherein, depending on the application, synthetic composite materials for use as scaffolds and/or spinal fusion cages or other implant devices should possess the mechanical properties exhibited by the cortical bone or the trabecular bone, wherein, to avoid the mechanical mismatch problems, such as stress shielding, the disclosed scaffolds/implant devices are tailored to substantially match or mimic the mechanical properties (e.g., stiffness, strength, toughness, etc.) of the adjacent and/or substituted bone tissue, taking advantage of several factors that may be varied during the synthesis of the composite material and scaffold of the implant device to tailor the mechanical properties including the calcium phosphate reinforcement volume fraction, aspect ratio, size and orientation, the polymer; and the size, volume fraction, shape and directionality of the void space and/or porosity, so that tailoring the mechanical properties of the scaffold results in a reduction in the likelihood of mechanical mismatch leading to a decreased risk of subsidence, stress shielding, bone resorption and/or subsequent failure of adjacent bone structures such as vertebrae, wherein the thermoplastic polymer is polymethyl methacrylate, wherein the aspect ratio, size, volume fraction and degree of preferred orientation of the calcium phosphate particles may be tailored for the desired material properties, wherein, due to their morphology, the calcium phosphate reinforcements particles may be oriented in bulk or near the surface of the polymer matrix to provide directional properties, if desired, providing anisotropy for the overall composite, which can be tailored to be similar to the anisotropic mechanical properties of bone tissues, wherein there are no limits on the size or amount of the calcium phosphate particles in matrix provided that the calcium phosphate particles are dispersed within and/or exposed at the surface of the polymer matrix, with maximum dimensions from about 2 nm to about 2 mm, or from 20 nm to about 100 µm, with micro-scale particles being particularly effective for obtaining a uniform dispersion within the matrix, wherein suitable calcium phosphates may include, without limitation, calcium HA, HA whiskers, HA, carbonated calcium HA, β-tricalcium phosphate (β-TCP), α-tricalcium phosphate (α-TCP), amorphous calcium phosphate (ACP), octacalcium phosphate (OCP), tetracalcium phosphate, biphasic calcium phosphate (BCP), anhydrous dicalcium phosphate (DCPA), dicalcium phosphate dihydrate (DCPD), anhydrous monocalcium phosphate (MCPA), monocalcium phosphate monohydrate (MCPM), and combinations thereof (see ¶[0032]), wherein the bioactive calcium phosphate particles (e.g., HA whiskers) exposed on the surface of the polymer matrix promote a stable bone-implant interface (see ¶[0033]), wherein the pores of the matrices can be functionally graded in any material or implant direction, from a highly porous region to a relatively dense region, such that the change in porosity from one region to another may be very distinct, and the graded change may be uniform or variant, or instead of a graded change, there may be a combination of materials having two or more densities of pores, wherein the materials are manufactured by methods common to reinforced thermoplastic and thermosetting polymers, including, among others, extrusion, and wherein densifying and molding the composite material includes aligning the calcium phosphate reinforcement particles morphologically and/or crystallographically within the scaffold, as taught by Roeder ‘299, and wherein the implants are tailored to display elasticity and strength that closely approximates that of, for example, trabecular bone, with a Young’s modulus between 10 and 3,000 MPa, and a strength, which is linearly and strongly correlated with modulus, in the range 0.1 – 30 GPa, as taught by Morgan (2018). One of ordinary skill in the relevant art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings of the Roeder ‘299 to the effect that the disclosed components of the composite materials, a PMMA polymer, calcium phosphate reinforcement particles, provide a functionally useful implant material with properties that can be tailored to achieve desired and/or optimal properties in a clinical setting, and that the composite materials can be tailored to mimic biological and mechanical properties of bone tissue for various orthopedic applications.
With respect to claims 17 and 39, which claims recited limitations directed to quantitative ranges for particle size (claim 17) and mechanical properties (claim 39), the Examiner notes that the cited references do not disclose quantitative ranges for those properties that are exactly congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches a range of quantitative values for the properties at issue that significantly overlaps with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “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).”
With respect to claims 18, 21, 23, 39, 40, and 42, the Examiner notes that these claims recite limitations directed to processes for manufacture of the biomaterial of the invention. However, it is the Examiner’s position that such limitations render the claims product-by-process claims, wherein the recited process steps do not serve to distinguish the claimed invention from the prior art. See MPEP § 2113:
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.
With respect to claims 22 and 41, which claims recite a limitation directed to “hygroscopic properties” of the implants of the invention, the Examiner notes that this limitation is directed to a functional property of the compositions. However, the invention as claimed is not structurally distinguishable from the teachings of Roeder ‘299, modified in accord with the express teachings of Morgan (2018). Consequently, it is the Examiner's position that the hygroscopic properties of the material are an inherent property of the invention taught by the cited reference. Because the Patent and Trademark Office does not have the facilities for examining and comparing the claimed material with the disclosed materials of Roeder ‘299 and Roeder ‘282, the burden of proof is upon Applicants to show an unobvious distinction between the structural and functional characteristics of the claimed formulation and the formulation of the prior art. See In re Best, 562 F.2d 1252, 195 U.S.P.O. 430 (CCPA 197), and Ex parte Gray, 10 USPO 2d 1922 1923 (PTO Bd. Pat. App. & Int.). The reference does not expressly disclose implants comprising variable zones of differing bioceramic-containing solid content, which deficiency is addressed below.
With respect to claim 25, which claim recites a limitation directed to the implants of the invention comprising variable zones of differing bioceramic-containing solid content to impart regional mechanical and biological functions, the Examiner notes that the composite implant materials of both Roeder ‘299 can be prepared in a manner involving variable distribution of porogen particles to create tailored porosity within the material. It is the Examiner’s position that such varied porosity would necessarily result in a non-uniform distribution of the calcium phosphate particles within the polymer matrix in that areas of greater porosity are characterized by lower density/volume of the polymer and, thus, a lower capacity to incorporate the calcium phosphate particles.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 17, 18, 20 – 23, 25, and 39 - 42 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments proffered by Applicants in the Response filed 23 April 2026, but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Applicants first argue that the limitations added the limitations added to newly amended claim 1 and 39, the limitations directed to quantitative ranges for the modulus of elasticity and the tensile strength of the composite implant materials of the invention, are sufficient to distinguish over corresponding properties for the composite implant materials disclosed in Roeder ‘299 (see ¶[0060]), which values Applicants contend differ from the new limitations by a factor of 10.
In this regard, the Examiner would note that Applicants’ primary argument is improperly based on an overly narrow interpretation of the disclosures of Roedeer ‘299. First of all, the data on which Applicants rest the alleged distinction between their claimed invention and the teachings of the reference is characterized in the reference as arising from a series of “example” scaffolds that differ primarily in porosity (70 – 90%) and content of HA whiskers (0 – 40 vol. %). For all scaffolds in this series, the thermoplastic polymer is polyetherketoneketone (PEKK), rather than polymethyl methacrylate (PMMA) used in Applicants’ examples (see ¶[0049]), and in the examples presented in the Kirschman Declaration. However, the reference explicitly discloses a number of possible thermoplastic polymers, other than PEKK, including PMMAS (see ¶[0027]).
As regards the broader teachings of Roeder ‘299, “a reference is not limited to the disclosure of specific working examples.” In re Mills, 470 F.2d 649, 651 (CCPA 1972) (citations omitted); see also In re Schreiber, 128 F.3d 1473, 1479 (Fed. Cir. 1997) (explaining that an exemplary use is not a limiting use absent contrary suggestion in prior art reference, and affirming anticipation finding). Indeed, “a reference can anticipate a claim even if it ‘d[oes] not expressly spell out’ all the limitations arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination.” Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381 (Fed. Cir. 2015) (quoting In re Petering, 301 F.2d 676, 681 (CCPA 1962)).
By focusing on the one series of scaffolds in Roeder ‘299 for which elastic modulus data is provided, Applicants are ignoring a significant aspect of the disclosures of the reference. It is the Examiner’s position that one of ordinary skill in the art, reading the reference, would recognize that the reference has not only identified an issue (mechanical mismatch problems, such as stress shielding, that can lead to bone resorption and/or subsequent failure of adjacent bone structures (see ¶[0022]), but has also provided a practical solution to that problem: tailoring the mechanical properties of the scaffold to match the properties of adjacent bone to reduce the likelihood of a mechanical mismatch. Furthermore, the reference is replete with guidance as to how to tailor the mechanical properties of the implant materials to achieve a desired end: varying the calcium phosphate reinforcement volume fraction, aspect ratio, size and orientation, the polymer; and the size, volume fraction, shape and directionality of the void space and/or porosity, consistent with the disclosure that, depending on the application, synthetic composite materials for use as scaffolds and/or spinal fusion cages or other implant devices should possess the mechanical properties exhibited by the cortical bone or the trabecular bone at the implant site.
As to what specific values the mechanical properties of the implants should strive to match, Roeder ‘299 is silent. However, that deficiency is amply remedied by the teachings of Morgan (2018).
Applicants also place considerable emphasis in their arguments on the fact that Roeder ‘299 makes use of variations in porosity as one way to achieve the type mechanical matching to adjacent tissues that addresses problems arising from shielding. Although not taking issue with the reference’s use of porosity variations, it is by far not the only property that can be optimized to Achieve the desired results. Furthermore, Applicants’ invention as claimed does not recite any limitations that would preclude the use of porosity as an optimizable variable.
Consequently, based on the above discussion, Applicants’ arguments are unpersuasive and claims 17, 18, 20 – 23, 25, and 39 – 45 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
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 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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