DETAILED ACTION
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 .
Summary
Claims 1-3, 6-12, 21-22, 24-25, 28, 33, 37, 43, and 45-46 are pending in this office action. Claims 4-5, 13-20, 23, 26-27, 29-32, 34-36, 38-42, and 44 are cancelled. All pending claims are under examination in this application.
Priority
The current application filed on July 2, 2021 is a 371 of PCT/US2020/012888 filed January 9, 2020, which in turn claims domestic priority to provisional patent application 62/790,642 filed on January 10, 2019.
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 (i.e., changing from AIA to pre-AIA ) 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 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.
The factual inquiries 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 non-obviousness.
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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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 1-3, 6-10, 12, 21-22, 25, 28, 33, 37, and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. (US6136029A) in view of Hubbard et al. (US7060287B1), Okazaki et al. (Biomaterials, 1999), Fahami et al. (Materials Science and Engineering C, 2016) and Gineste et al. (Journal of Biomaterials Research, 1999).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Johnson et al.
Johnson et al. is regarded as being the prior art closest to the subject-matter of the present application as it teaches bone substitute materials (see title). Additionally, Johnson et al. disclose a strong, porous article useful as a bone substitute material
and having an outer surface defining a shape having a bulk volume and having open interconnecting interstices extending throughout said volume and opening through said surface. The article comprises a continuous strong framework structure having interstices which interconnect throughout the bulk volume and a second continuous material occupying at least a portion of the same bulk volume as the framework structure. The second material comprises an osteoinductive and/or osteoconductive composition. This composition may be present in one of several forms. One of these is as a coating on the surface of the framework structure. A second form is in the form of a composite, intimately mixed with the framework material within the framework struts. The third form is as a porous mass within the interstices of the framework structure, having pores which are interconnecting with themselves, and with the interstices of the framework structure. Desirably, the porous osteoinductive or osteoconductive composition extends throughout said bulk volume. In a preferred embodiment, the framework structure is formed of a ceramic material. In a further embodiment, the framework structure may be further structurally reinforced with a dense material component integrally affixed thereto (see abstract).
2. Hubbard et al.
Hubbard et al. teach tissue augmentation material and method (see title).
Additionally, Hubbard et al. disclose a permanent, biocompatible material for soft tissue augmentation. The biocompatible material comprises a matrix of smooth, round, finely divided, substantially spherical particles of a biocompatible ceramic material, close to or in contact with each other, which provide a scaffold or lattice for autogenous, three dimensional, randomly oriented, non-scar soft tissue growth at the augmentation site. The augmentation material can be homogeneously suspended in a biocompatible, resorbable lubricious gel carrier comprising a polysaccharide. This serves to improve the delivery of the augmentation material by injection to the tissue site where augmentation is desired. The augmentation material is especially suitable for urethral sphincter augmentation, for treatment of incontinence, for filling soft tissue voids, for creating soft tissue blebs, for the treatment of unilateral vocal cord paralysis, and for mammary implants. It can be injected intradermally, subcutaneously or can be implanted (see abstract).
Furthermore, Hubbard et al. cites a sintering temperature of about 1050-1200 °C (see column 6, lines 16-17), and uses fluorapatite within their tissue augmentation materials (see column 7, line 45).
3. Okazaki et al.
Okazaki et al. teach a fluoridated apatite synthesized using a multi-step
fluoride supply system (see title). In addition, Okazaki et al. disclose fluoridated apatite was synthesized at 80±1°C, pH 7.4±0.2, using a 5-step fluoride supply system. During the synthesis experiment, 0, 5, 10, 15 and 20 mmol/l of fluoride were each supplied for one-fifth of the experimental period with calcium and phosphate. X-ray diffraction analysis showed a typically apatitic pattern, although the (300) reflection was broader than that of homogeneous fluorapatite. Scanning electron micrographic observation indicated that the apatite was composed of needle-like crystals similar to hydroxyapatite and fluorapatite. High-resolution transmission electron microscopy showed a slender hexagonal shape similar to homogeneous hydroxyapatite in cross-sections perpendicular to the c-axis and the structural damage in the core of the crystal, although no boundary of step-like layers was observed. The apparent solubility in 0.5 mol/l acetate buffer solution (37°C and pH 4.0) was 12.5±0.2 mmol/l, much less than that of homogeneous hydroxyapatite 32.3±1.9 mmol/l, and similar to that of heterogeneous two-layer fluoridated apatite with an outer fluoride-rich layer 12.5±0.6 mmol/l, which was synthesized previously by supplying fluoride during the latter half of the experimental period (see abstract).
4. Fahami et al.
Fahami et al. teach the synthesis, bioactivity and zeta potential investigations of chlorine and fluorine substituted hydroxyapatite (see title). In addition, Fahami et al. disclose chlorine and fluorine substituted hydroxyapatites (HA-Cl–F) with different degrees of ion replacement that were successfully prepared by the one step mechanochemical activation method. X-ray diffraction (XRD) and FT-IR spectra
indicated that substitution of these anions in milled powders resulted in the formation of pure hydroxyapatite phase except for the small observed change in the lattice parameters and unit cell volumes of the resultant hydroxyapatite. Microscopic observations showed that the milled product had a cluster-like structure made up
of polygonal and spherical particles with an average particle size of approximately ranged from 20 ± 5 to 70±5 nm. The zeta potential of milled samples was performed at three different pH (5, 7.4, and 9). The obtained zeta potential values were negative for all three pH values. Negative zeta potential was described to favor osseointegration, apatite nucleation, and bone regeneration. The bioactivity of samples was investigated on sintered pellets soaked in simulated body fluid (SBF) solution and apatite crystals formed on the surface of the pellets after being incubated for 14 days. Zeta potential analysis and bioactivity experiment suggested that HA-Cl–F will lead to the formation of new apatite particles and therefore be a potential implant material (see abstract).
5. Gineste et al.
Gineste et al. teach the degradation of hydroxylapatite, fluorapatite, and
fluorhydroxyapatite coatings of dental implants in dogs (see title). Furthermore, Gineste et al. disclose that calcium phosphate coatings on dental implants enhance integration of the material. Resorption of the ceramic coatings has raised some concern about the behavior of the bone–implant interfaces after the coating disappearance. Substitution of the OH- ions by fluoride in the hydroxylapatite (HA) lattice makes the calcium phosphate more stable. We investigated the degradation rate of dental implants with 50- and 100-mm coatings of HA, fluorapatite (FA), or fluorhydroxylapatite (FHA). The implants were inserted in dog jaws and retrieved for histological analysis after 3, 6, and 12 months. The thickness of the calcium phosphate coatings was evaluated using an image analysis device. A relative resorption index and its standard deviation were studied. HA and FA coatings (even at 100-mm thickness) were almost totally degraded within the implantation period. In contrast, the FHA coatings did not show significant degradation during the same period. The standard deviation showed that the resorption process for FHA with thicknesses of 50 or 100 mm was the same. Such a difference was not observed between the 50- and 100-mm thick coatings of FA and HA. In conclusion, the
FHA coatings showed good integration in the bone tissue and lasted much longer than classic calcium phosphate coatings (see abstract).
Combination of Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al.
Regarding instant claim 1, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach an implant, comprising: an implant body defining one or more surfaces; and a fluoridated apatite coating disposed on at least a portion of the one or more surfaces, the fluoridated apatite coating comprising fluorapatite particles. The necessary citations within Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. that correspond to instant claim 1 are compiled within Table I.
Table I
Instant Claim 1
Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. Citations
an implant, comprising:
Johnson et al. disclose an implant (see column 8, lines 40-45; prosthesis has been implanted in the femur of a patient, and Figure 4 showing an implant; both within Johnson et al.), comprising:
an implant body defining one or more surfaces;
Johnson et al. disclose an implant body defining one or more surfaces (see Figure 4 showing the implant body labeled 34 and defining a surface labeled 38 within Johnson et al.)
and a fluoridated apatite coating disposed on at least a portion of the one or more surfaces, the fluoridated apatite coating comprising fluorapatite particles having an average particle size of 60 µm to 200 µm;
Johnson et al. disclose an apatite (see column 4, lines 35-40; examples of ceramic materials for the osteoconductive portion include calcium phosphates like hydroxyapatite and fluorapatite; within Johnson et al.) coating disposed on at least a portion of the one or more surfaces (see column 8, lines 40-45; coating labeled 38 promotes bone ingrowth; also see Figure 4 part labeled 38; and column 6 lines 50-55; once the ceramic framework is cooled the struts may be coated with a slip containing calcium phosphate [hydroxyapatite or fluorapatite] within Johnson et al.); furthermore, Johnson et al. disclose coating particles (fluorapatite particles) (see column 4, line 23; column 6, line 39; and column 6, line 59; all within Johnson et al.).
Hubbard et al. disclose a particle size distribution of 35 to 150 microns (see column 8, lines 15-20, within Hubbard et al.) for fluoridated apatite particles (see column 7, line 46, within Hubbard et al.) [indicating an overlapping region].
wherein the fluoridated apatite coating exhibits a zeta potential
consistent with having been sintered at about 1050 °C or more to about 1250 °C,
wherein the apatite coating (see Figure 4 part labeled 38 within Johnson et al.) exhibits a surface morphology and porosity (see column 2, lines 60-67, porous osteoconductive composition within Johnson et al.) consistent with having been sintered at about 950 °C or more (see column 10, Iines 55-60; were sintered at a temperature of 1400 °C, therefore as the porous coating is made of apatite and is sintered at 1400 °C, the morphology and porosity is inherently consistent with having been sintered at 1050 degrees C or above within Johnson et al.). Furthermore, Johnson et al. disclose within Example 4 a sintering temperature of 1300 °C. However, these temperatures are outside the claimed range.
Hubbard et al. disclose sintering temperatures of 1050 to 1200 °C (see column 6, lines 16-17 within Hubbard et al.). Additionally, Johnson et al., Hubbard et al., and Okazaki et al. do not investigate and report the zeta potential. But Fahami et al. does (see title and abstract within Fahami et al.) therefore, making available to a skilled artisan the importance of collecting zeta potential values. These data points could be noted under routine experimental conditions for the sintered material supplied by Hubbard et al.
Thus, a skilled artisan (POSITA; person having ordinary skill in the art) would be motivated to investigate the sintering properties (such as morphology, porosity, fracture toughness, hardness, brittleness, and elastic modulus) based on the Hubbard et al. reference.
and wherein the fluoridated apatite particles exhibit crystallinity and solubility consistent with being synthesized at about 50 °C to about 95 °C.
Okazaki et al. disclose the synthesis of fluoridated apatite particles at 80±1°C (see abstract within Okazaki et al.).
[The Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. references teach all the elements of instant claim 1 within the remainder of this 35 U.S.C. 103 rejection.]
Regarding instant claim 2, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the implant body includes a percutaneous implant and the at least a portion of the one or more surfaces includes portions of the implant body expected to be disposed in contact with a tissue of a subject upon implantation. Johnson et al. disclose wherein the implant body includes a percutaneous implant (see column 8, lines 20-25; rod useful as a stem receivable in the intramedullary canal of a long bone within Johnson et al.) and the at least a portion of the one or more surfaces includes portions of the implant body expected to be disposed in contact with a tissue of a subject upon implantation (see Figure 4 showing the femoral hip stem prosthesis and also see column 8, lines 40-45; prosthesis has been implanted in the femur of a patient within Johnson et al.).
Regarding instant claim 3, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the implant body includes an osseointegrated implant or a dental implant. Johnson et al. disclose wherein the implant body includes an osseointegrated implant (see column 8, lines 30-35; femoral hip stem prosthesis within Johnson et al.; also see PTO-892 NPL W).
Regarding instant claim 6, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the surface morphology includes spherical, semi-spherical, prismatic, pseudo-prismatic, ellipsoid, or irregularly rounded fluoridated apatite particles that are devoid of rod-like or needle-like fluoridated apatite particles. Fahami et al. disclose the microscopic observations showed that the milled product had a cluster-like structure made up of polygonal and spherical particles with an average particle size of approximately ranged from 20±5 to 70±5 nm (see abstract within Fahami et al.). Furthermore, Fahami et al. disclose an unsintered particle size of the fluorapatite of ~ 40 nm and a sintered (800 °C, 1h) sample of ~ 140 nm (see page 81, Figure 3, within Fahami et al.).
Regarding instant claim 8, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the fluoridated apatite coating exhibits a zeta potential of less than -10 mV, when measured in a solution of 0.154 M NaCl (pH 7.4) at a concentration of 0.01 g/ml. Fahami et al. disclose the unsintered value of -37 mV at neutral pH (see page 83, Figure 6 for sample A4, and right column, paragraph 1, within Fahami et al.). Furthermore, Hubbard et al. disclose sintering at 1050 °C to 1200 °C (see Table I). A research and development scientist (POSITA) would sinter the fluoridated apatite at a temperature range of 800 °C (low end, see page 79, paragraph 2 within Fahami et al.) to 1250 °C (high end, disclosed by Hubbard et al.) and obtain the zeta potential results. Particle size is the most prominent factor in impacting the zeta potential (see PTO-892 NPL V). The discussion within instant claim 6 concludes there is a > 3-fold increase in particle size upon sintering the fluorapatite sample. Larger particle sizes have lower zeta potential values (see PTO-892 NPL V). Therefore, a zeta potential value of -37 mV for the unsintered fluorapatite sample would more than satisfy the instant claim 8 limitation.
Regarding instant claim 9, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the fluoridated apatite coating exhibits a zeta potential of about -26 mV to -80 mV, when measured in a solution of 0.154 M NaCl (pH 7.4) at a concentration of 0.01 g/ml. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claim 8, for the relevant rejection text.
Regarding instant claim 10, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the implant of instant claim 1, wherein the implant body includes titanium. Johnson et al. disclose the use of titanium for the implant body (see column 4, lines 43-58 within Johnson et al.).
Regarding instant claim 12, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach a method of forming a coated implant, the method comprising: providing fluoridated apatite particles that exhibit a zeta potential consistent with having been sintered at a temperature of about 1050 °C to about 1250 °C, the fluoridated apatite particles comprising fluorapatite particles having average particle size of 60 µm to 200 µm, and the fluoridated apatite particles exhibit crystallinity and solubility consistent with being synthesized at about 50 °C to about 95 °C; and affixing the fluoridated apatite particles onto at least a portion of an implant. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claim 1 (Table I) for the relevant rejection text.
In the context of instant method claim 12, the desired purpose defines an effect that arises from, and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to instant claims 1-3 and 10, and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Regarding instant claim 21, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 12, wherein providing fluoridated apatite particles includes providing fluorapatite particles with an average particles size between 70 mm to 100 mm. Hubbard et al. disclose a particle size distribution of 35 to 150 microns (see column 8, lines 15-20, within Hubbard et al.) for fluoridated apatite particles (see column 7, line 46, within Hubbard et al.).
Regarding instant claim 22, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 12, wherein providing fluoridated apatite particles includes providing fluoridated apatite particles having a zeta potential of less than -10 mV, when measured in a solution of 0.154 M NaCl (pH 7.4) at a concentration of 0.01 g/ml. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claim 8, for the relevant rejection text.
Regarding instant claim 25, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 12, wherein affixing the fluoridated apatite particles onto at least a portion of an implant includes affixing the fluoridated apatite particles onto a percutaneous implant, an osseointegrated implant, or a dental implant. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claim 1 (Table I) for the relevant rejection text. Johnson et al. disclose the use of an osseointegrated implant (see column 8, lines 30-35; femoral hip stem prosthesis within Johnson et al.; also see PTO-892 NPL W).
Regarding instant claim 28, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach a method of using an implant having a fluoridated apatite coating, the method comprising: providing an implant including one or more surfaces at least partially coated with fluoridated apatite, wherein the fluoridated apatite comprises fluorapatite particles having an average particle size of 60 µm to 200 µm and exhibits a zeta potential consistent with having been sintered at about 1050 °C to about 1250°C, and wherein the fluoridated apatite particles exhibit crystallinity and solubility consistent with being synthesized at about 50 °C to about 95 °C, and implanting the implant in a subject. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claim 1 (Table I), and instant claims 12 and 25 for the relevant rejection text.
Regarding instant claim 33, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 28, wherein the fluoridated apatite exhibits a zeta potential of less than -10 mV, when measured in a solution of 0.154 M NaCl (pH 7.4) at a concentration of 0.01 g/ml. Please see the Johnson et al., Gross et al., Okazaki et al., Bianco et al., and Fahami et al. citations within instant claim 8, for the relevant rejection text.
Regarding instant claim 37, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 28, wherein the implant includes a titanium body at least partially coated in the fluoridated apatite. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claims 1 (Table I) and 10, for the relevant rejection text.
Regarding instant claim 43, Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. teach the method of instant claim 28, wherein the implanting the implant in a subject includes implanting the implant such that portions of the implant having the coating thereon are in contact with one or more of skin, bone, or tissue of the subject. Please see the Johnson et al., Hubbard et al., Okazaki et al., and Fahami et al. citations within instant claims 1 (Table I) and 2, for the relevant rejection text. Additionally, as an example, Johnson et al. disclose a femoral hip stem prosthesis that is implanted in the femur of a patient (see column 8, lines 33-41 within Johnson et al.). Thus, indicating contact within the bone of a patient. Furthermore, Johnson et al. disclose bone substitutes (see claims 1, 14, 18, and 20 within Johnson et al.), which would contact skin, bone, and/or tissue.
Combination of Johnson et al., Gross et al., Okazaki et al., Bianco et al. and Gineste et al.
Regarding instant claim 7, Johnson et al., Gross et al., Okazaki et al., Bianco et al. and Gineste et al. teach the implant of instant claim 1, wherein the fluoridated apatite coating further includes fluorohydroxyapatite particles. Gineste et al. disclose the use of fluorhydroxyapatite (FHA) used for a dental implant (see abstract within Gineste et al.). Additionally, Gross et al. uses a blend of fluorapatite and hydroxyapatite (see abstract within Gineste et al.) to evaluate the mixture. Therefore, a skilled artisan (POSITA) would under routine experimental conditions extend the blend to fluoridated apatite particles and fluorohydroxyapatite particles for further
Analogous Art
The Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. disclosures are all relevant for the rejection of instant claims 1-3, 6-10, 12, 21-22, 25, 28, 33, 37, and 43 due to their direct application to the present invention.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorapatite coated implant disclosed by Johnson et al., using the teachings of Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. to incorporate the necessary claim limitations. Starting with Johnson et al., the skilled person only had to try the addition of the necessary claim limitations disclosed by Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. The combination of Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. would allow one to arrive at the present application without employing inventive skill. This combination of the fluorapatite coated implant taught by Johnson et al. along with the use the necessary claim limitations taught by Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the fluorapatite coated implant disclosed by Johnson et al. with the use of the necessary claim limitations taught by Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. This combined modification would have led to an enhanced fluorapatite coated implant that would be beneficial for patients.
Claims 1, 11-12, 21, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. in view of Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., as applied to claims 1-3, 6-10, 12, 21-22, 25, 28, 33, 37, and 43 above, and further in view of McKinley (US2008/0306554A1).
The teachings of the references are outlined above. They fail to teach the following claim limitations:
wherein the fluoridated apatite coating has a thickness of about 1 mm to about 1 mm, and
The method of instant claim 12, wherein affixing the fluoridated apatite particles onto at least a portion of an implant includes using one or more of dip coating, sputter coating, pulse layer deposition, hot pressing, isostatic pressing, electrophoretic deposition, thermal spraying, ion beam assisted deposition ("IBAD"), ultrasonic spray pyrolysis, or sol-gel techniques to affix the fluoridated apatite particles to at least a portion of one or more surfaces of the implant.
However, McKinley teaches these limitations.
McKinley teaches osseointegration and biointegration coatings for bone screw implants (see title). In addition, McKinley discloses novel orthopaedic bone screws/spinal pedicle screws and implants that include coatings to help promote a structurally stable interface between the implant and the patient's bone/tissue, and methods of coating such screws and implants are provided. The implants and methodologies described involve at least a coating that facilitates osseous integration, and additionally at least one coating that either reduces the risk of infection in immunologically suppressed patients and/or for utilization in patients who have infection, but who require stabilization, or coatings that permit the use of dissimilar
metals and prevent galvanic corrosive reactions (see abstract).
Combination of Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and McKinley
Regarding instant claim 11, Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and McKinley teach the implant of instant claim 1, wherein the fluoridated apatite coating has a thickness of about 1 mm to about 1 mm. Johnson et al. disclose all the limitations within instant claim 1. McKinley discloses a coating of 500 mm to 1000 mm thick, applied by plasma methodology (see paragraph [0051] within McKinley).
Regarding instant claim 24, Johnson et al., Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and McKinley teach the method of claim 12, wherein affixing the fluoridated apatite particles onto at least a portion of an implant includes using one or more of dip coating, sputter coating, pulse layer deposition, hot pressing, isostatic pressing, electrophoretic deposition, thermal spraying, ion beam assisted deposition ("IBAD"), ultrasonic spray pyrolysis, or sol-gel techniques to affix the fluoridated apatite particles to at least a portion of one or more surfaces of the implant. McKinley discloses the sol-gel process is a colloidal chemical method in which an organometallic compound is prepared from the metal component of the metal oxide intended for the coating and organosol formed from the compound with an organic solvent, the combination of which polymerizes into a gel on the surface of the implant. Upon drying the gel condenses, followed by heat treating to remove the solvent and the organic component. The material converts to solid form and through sintering, compacts into a very fine structured coating. The most sensitive stage in the procedure is the heat treatment on which the quality compactness and the structure of the layer depend. With this method, good quality uniform compact layer of calcium phosphate can be prepared on the surface of a titanium implant. A hydroxyapatite coating can also be prepared onto implants by procedures similar to the sol-gel process. Here, coating is done by a thermal decomposition of calcium oxide dissolved in an organic solvent, such as phosphate (see paragraph [0132] within McKinley).
Analogous Art
The Examiner admits that the McKinley disclosure does not teach all the limitations within instant claim 1. However, because both references use implants that are coated with fluoridated apatite they are both relevant to the instant application.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorapatite coated implant disclosed by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., using the teaching of McKinley to incorporate the necessary claim limitations. Starting with Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., the skilled person only had to try the addition of the necessary claim limitations disclosed by McKinley. The combination of Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and McKinley would allow one to arrive at the present application without employing inventive skill. This combination of the fluorapatite coated implant taught by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., along with the use the necessary claim limitations taught by McKinley would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the fluorapatite coated implant disclosed by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., with the use of the necessary claim limitations taught by McKinley. This combined modification would have led to an enhanced fluorapatite coated implant that would be beneficial for patients.
Claims 1, 12, 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Johnson et al. in view of Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., as applied to claims 1-3, 6-10, 12, 21-22, 25, 28, 33, 37, and 43 above, and further in view of Jodaikin et al. (US2015/0125810A1).
The teachings of the references are outlined above. They fail to teach the following claim limitations:
wherein the fluoridated apatite is synthesized from a solution comprising Ca(NO3)2, Na2HPO4, and NaF, and
The method of claim 12, wherein the fluoridated apatite is synthesized from a solution comprising Ca(NO3)2, Na2HPO4, and NaF.
However, Jodaikin et al. teach these limitations.
Jodaikin et al. teach a device for fixation at a dental site (see title). Also, Jodaikin et al. disclose a reshapable retention device for insertion at a dental site and contact with adjacent dental surfaces, for the controlled delivery to the dental site of at least one material having a predetermined intraoral activity. The retention device comprises at
least one matrix containing the material. The retention device is adapted for physically affixing at the dental site for at least a predetermined time period correlated to the delivery of a predetermined portion of the at least one matrix to the dental site in a controlled single, bi or multiphase pattern. The retention device comprises a first configuration in which the overall dimensions of the retention device are larger than at least one dimension of the dental site. The first configuration is reshapable to a second configuration in which at least one dimension of the retention device is reduced to enable physically affixing the retention device at the dental site. In the second configuration the retention device comprises a predetermined shape having contours for affixing at the dental surfaces (see abstract).
Combination of Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and Jodaikin et al.
Regarding instant claims 45 and 46, Johnson et al., Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., Gineste et al., and Jodaikin et al. teach the implant of instant claim 1 or method of instant claim 12, wherein the fluoridated apatite is synthesized from a solution comprising Ca(NO3)2, Na2HPO4, and NaF. Jodaikin et al. disclose wherein the material is at least one fluoridation agent, and/or at least one remineralization agent, and/or at least one mineralization agent, and/or at least one demineralization inhibiting agent (see paragraph [0030] within Jodaiikin et al.). Jodaikin et al. disclose the use of Ca(NO3)2 (see paragraph [0228] as a mineralizing and/or remineralizing agent within Jodaiikin et al.; calcium nitrate), Na2HPO4 (see paragraph [0228] as a mineralizing and/or remineralizing agent within Jodaiikin et al.; disodium phosphate), and NaF (see paragraph [0030] as a fluoridation agent within Jodaiikin et al.; sodium fluoride). Therefore, all of the claimed limitation components are present within the Jodaikin et al. citation.
Analogous Art
The Examiner admits that the Jodaikin et al. disclosure does not teach all the limitations within instant claim 1. However, because the reference uses all of the components for fluoridated apatite, the citation is relevant to the instant application.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the fluorapatite coated implant disclosed by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., using the teachings of Jodaikin et al. to incorporate the necessary claim limitations. Starting with Johnson et al. Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., the skilled person only had to try the addition of the necessary claim limitations disclosed by Jodaikin et al. The combination of Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al., and Jodiakin et al. would allow one to arrive at the present application without employing inventive skill. This combination of the fluorapatite coated implant taught by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. along with the use the necessary claim limitations taught by Jodaikin et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application. It would have only required routine experimentation to modify the fluorapatite coated implant disclosed by Johnson et al., Hubbard et al., Okazaki et al., Fahami et al., and Gineste et al. with the use of the necessary claim limitations taught by Jodaikin et al. This combined modification would have led to an enhanced fluorapatite coated implant that would be beneficial for patients.
Response to Arguments
Applicant's arguments filed July 14, 2025 have been fully considered but they are not persuasive.
The Applicant’s claim amendments were sufficient to remove the 112(a) and 112(b) rejections.
Therefore, the 112(a) and 112(b) rejections are withdrawn from the Non-Final Office Action dated February 14, 2025.
Furthermore, the Applicant’s claim amendments prompted the Examiner to reorganize and apply the references of record. These necessitated new grounds of rejections.
Applicant Argument: The Applicant argues that the Gross et al. reference teaches a fluorapatite particle size of 300 nm, and since the Examiner is relying on Gross et al. regarding the appropriate sintering temperature, the particle size of 300 nm must be associated with the product.
Examiner’s Rebuttal: This argument is now moot. The Examiner has withdrawn the Gross et al. and Bianco et al. references from the record. Furthermore, the Examiner has added the Hubbard et al. reference to address this claim limitation, citing a particle size of 35-150 µm and the correct sintering range (see the discussion within instant claim 1). Thus, meeting all the claim limitations.
Therefore, the 35 U.S.C. 103 rejection is maintained for instant claims 1-3, 6-12, 21-22, 24-25, 28, 33, 37, 43, and 45-46.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615 /Robert A Wax/Supervisory Patent Examiner, Art Unit 1615