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 .
In view of the Appeal Brief filed on 1/15/2026, PROSECUTION IS HEREBY REOPENED. New Grounds of Rejection are set forth below.
To avoid abandonment of the application, appellant must exercise one of the following two options:
(1) file a reply under 37 CFR 1.111 (if this Office action is non-final) or a reply under 37 CFR 1.113 (if this Office action is final); or,
(2) initiate a new appeal by filing a notice of appeal under 37 CFR 41.31 followed by an appeal brief under 37 CFR 41.37. The previously paid notice of appeal fee and appeal brief fee can be applied to the new appeal. If, however, the appeal fees set forth in 37 CFR 41.20 have been increased since they were previously paid, then appellant must pay the difference between the increased fees and the amount previously paid.
A Supervisory Patent Examiner (SPE) has approved of reopening prosecution by signing below:
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
DETAILED ACTION
Claims 1-13, 15-17, 19 and 20 are pending in the Claim Set filed 10/15/2025.
Claims 14 and 18 are canceled.
Herein, claims 1-13, 15-17, 19 and 20 are for examination.
Withdrawn Rejections
The rejection of claims 1-14 on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 and 14 of U.S. Patent No. 10537661 (herein ‘661) is withdrawn in view of the Terminal Disclaimer filed 1/15/2026 (Approved 1/25/2026).
The rejection of claims 1-7, 12 and 13 under 35 U.S.C. 103 as being unpatentable over Lee et al (USP 5763092 in view of Kjellin et al (US 20080220233) is withdrawn in favor of the New Grounds of Rejection as set forth below.
The rejection of claims 8-10 under pre-AIA 35 U.S.C. 103 as being unpatentable over Lee et al (USP 5763092, listed in IDS filed 4/30/2024) [Lee] in view of Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] as applied to claim 1-7, 12 and 13 above and further in view of Saban et al (US 9,057,124) is withdrawn in favor of the New Grounds of Rejection as set forth below.
The rejection of claim 11 under pre-AIA 35 U.S.C. 103 as being unpatentable over Lee et al (USP 5763092, listed in IDS filed 4/30/2024) [Lee] in view of Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] as applied to claim 1-7, 12 and 13 above and further in view of Wang et al (Calcium-Deficient hydroxyapatite, Colloids and Surfaces B Biointerfaces, p.254, July 2011) [Wang] is withdrawn in favor of the New Grounds of Rejection as set forth below.
The rejection of claims 15, 16, 17 and 20 under 35 U.S.C. 103 as being unpatentable over Lee et al (USP 5763092, listed in IDS filed 4/30/2024) [Lee] in view of Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] and Goodman et al (The future of biologic coatings for orthopaedic implants, Biomaterials, p.3174, February, 2013, cited in IDS filed 4/30/2024)) [Goodman] is withdrawn in favor of the New Grounds of Rejection as set forth below.
The rejection claim 19 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Lee et al (USP 5763092, listed in IDS filed 4/30/2024) [Lee] in view of Goodman et al (The future of biologic coatings for orthopaedic implants, Biomaterials, p.3174, February, 2013, cited in IDS filed 4/30/2024)) [Goodman] as applied to claims 15, 16, 17 and 20 above and further in view of Wang et al (Calcium-Deficient hydroxyapaptite, Colloids and Surfaces B Biointerfaces, p.254, July 2011) [Wang] is withdrawn in favor of the New Grounds of Rejection as set forth below.
New Grounds of Rejection(s)
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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin].
Regarding claim 1,
Kjellin teaches a synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface, such as a titanium (titanium oxide) surface having an oxide layer: Titanium oxides, having a specific surface area (SSA) of 180 m2/g ([0019-0021; [0075]). The calcium phosphate, e.g., hydroxyapatite, in the form of a coating having a specific surface area (SSA) of 180 m2/g matches the claimed calcium phosphate.
Kjellin teaches synthetic nano-sized crystalline calcium phosphate, in particular, hydroxyapatite [0001].
Kjellin teaches highly crystalline nano-sized apatites, especially hydroxyapatite in the form of a coating on a surface. A thin, clean and highly crystalline apatite, i.e. calcium phosphate, such as hydroxyapatite, coating can be applied onto objects, e.g., implants ([001]; [0009]).
Kjellin teaches the invention provides a solution which easily can be deposited on surfaces of either metal or non-metal substrates. Kjellin teaches the invention gives an apatite layer which can follow the surface roughness of the substrate giving the possibilities if combining surface structure and apatite-coating, which is of great importance in osseointegration [0010].
Kjellin teaches the synthetic nano-sized crystals of hydroxyapatite of the invention resemble the hydroxyapatite particles that are present in the living body, which make them highly suitable in the biomimicking of body tissue for the making of body implants. Thus, the hydroxyapatite of the invention is suitable for being deposited on the surface of an implant giving it a highly bioactive surface in order to stimulate the bone growth during the initial healing process [0012].
Because Kjellin uses the exact same structure and material using essentially the same claim language, the subject matter of claim 1 is anticipated by Kjellin.
Therefore, claim 1 is anticipated by Kjellin.
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 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(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 1-7, 12 and 13 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] in view of Lee et al (USP 5763092, of record) [Lee].
Regarding claim 1,
Regarding claim 1: The teachings of Kjellin et al (US 20080220233) above are incorporated herein in their entirety. Although a claimed invention can be obvious but not anticipated, it “cannot have been anticipated and not have been obvious.” In re Fracalossi, 681 F.2d 792, 794 [215 USPQ 569] (CCPA 1982) (i.e., that which is anticipated is necessarily obvious).
Regarding claim 2,
Claim 2 depends directly on claim 1. Claims in dependent form shall be construed to include all the limitations of the claim incorporated by reference into the dependent claim. (See MPEP 608.01 (n)).
Claim 2 recites:
The calcium phosphate coating of claim 1, wherein the calcium phosphate coating is substantially free of carbonate as measured by infrared spectroscopy.
Kjellin differs from the claims in that the document does not teach the calcium phosphate coating is substantially free of carbonate as measured by infrared spectroscopy.
However, Lee cures the deficiency.
Lee teaches a process for coating orthopedic and dental implant materials with highly crystalline calcium phosphate, for example, hydroxyapatite, having improved crystallinity over the prior processes and reduced solubility and the production of a coating containing greater than 90% crystalline hydroxyapatite (col.1, lns.15-60; col.3, lns.33-36). Lee teaches removal of CO2 is advantageous when treating certain coatings that would otherwise form some carbonate apatite (col.4, 36-51; col.4, lns.64-67 to col.5, lns.1-12). Lee teaches carbonate apatite (carbonate hydroxyapatite) is undesirable because it is much more soluble than hydroxyapatite (col.5, lns.40-59).
Kjellin teaches pure hydroxyapatite, wherein the hydroxyapatite (calcium phosphate) is completely crystalline and has a high specific surface area ([0078]. It would necessarily follow that pure hydroxyapatite as taught by Kjellin is free of carbonate. Lee suggests hydroxyapatite coating free of carbonate by removing CO2 and since it is undesirable for implants and provides clear motivation to remove it. Thus, one skilled in the art would have been motivated to provide pure hydroxyapatite of Kjellin for coating an implant. Furthermore, measuring carbonate using infrared spectroscopy would not change the physical or chemical properties of hydroxyapatite.
Where the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). "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). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433.
Thus, based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the hydroxyapatite (calcium phosphate) coating and improve its stability thereby providing a hydroxyapatite (calcium phosphate) coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy.
Regarding claim 3,
Claim 3 depends directly on claim 2.
Kjellin teaches a Ca/P ratio of 1.67, of which is the ratio of naturally occurring hydroxyapatite [0051-0052].
A Ca/P ratio of 1.67 as taught by Kjellin lies inside the claimed ration of 1 to 2. This ratio lies inside the claimed range.
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); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Therefore, absence a showing of the criticality of a Ca/P ratio of 1 to 2, the subject matter of claim 3 would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide a calcium phosphate coating having Ca/P ratio of 1 to 2 having a reasonable expectation of success
Regarding claims 4-7 and 12,
Kjellin teaches synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface. Kjellin teaches calcium phosphate, e.g., hydroxyapatite (HA), in form of a coating that is deposited (i.e., in contact with the metal surface; Instant claim 4), where the metal surface is titanium, where the metal has an oxide layer (titanium oxide, i.e., metal oxide) where the titanium surface is porous (Instant claims 5, 6, 7). Kjellin teaches that the calcium phosphate is suitable for being deposited on the surface of an implant giving it a highly bioactive surface to stimulate the bone growth during the initial healing process, thus, it discloses the capability and intended use of a calcium phosphate coating on the surface of an orthopedic implant, wherein it would necessarily follow that the calcium phosphate is in contact with a metal surface of an orthopedic implant (para. [0019-0021; [0050]; [0055]; [0075]; [0093]; claim 31; See entire document).
Kjellin teaches pure hydroxyapatite coating (i.e., calcium phosphate coating) is pure hydroxyapatite that is completely crystalline, thus, it would necessarily provide crystallinity of hydroxyapatite that is greater than about 90% (Instant claim 12).
Regarding claim 13,
Claim 13 depends on claim 2.
The calcium phosphate, e.g., hydroxyapatite, as taught by Kjellin and Lee, as a whole, is indistinguishable from the claimed calcium phosphate, wherein it is substantially free of carbonate. Lee teaches calcium phosphate substantially free of carbonate having reduced solubility and the production of a coating containing greater than 90% crystalline supra. Lee teaches that the hydroxyapatite dissolves continuously over 1400 minutes (i.e., more than 2 hours in vitro) (See Fig. 2; col.3, lns.26-56; col.6, lns.26-45).
Therefore, it would necessarily follow that the calcium phosphate coating dissolves for more than 2 hours in vitro.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Kjellin and Lee, as a whole.
Claims 8-10 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] in view of Lee et al (USP 5763092, of record) [Lee] as applied to claims 1-7, 12 and 13 above and further in view of Saban et al (US 9,057,124, of record).
The teachings of Kjellin and Lee, as a whole, are described above.
Kjellin and Lee differ from the claims in that the document does not teach thickness of the metal surface of the implant
However, Saban cures the deficiency.
Saban teaches metal implants that are to be inserted into bone tissue (Abstract; col.1, lns.1-10; col.4, lns.5-13). Saban teaches a titanium-based implant comprising titanium oxide, wherein the surface thickness is between 8-50 nm, wherein the thickness provides a better cellular response, and therefore, a better implant-bone binding (col.1, lns.20-23; col.4, lns.44-67; claim 1; See entire document), of which overlaps with the claimed ranges. 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); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to provide an orthopedic implant, wherein the metal surface comprises a titanium metal surface having a thickness between 8-50 nm, wherein the thickness would be expected to provide a better cellular response, and therefore, a better implant-bone binding as taught by Saban.
Claims 11 is rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin] in view of Lee et al (USP 5763092, of record) [Lee] as applied to claims 1-7, 12 and 13 above and further in view of Wang et al (Calcium-Deficient hydroxyapatite, Colloids and Surfaces B Biointerfaces, p.254, July 2011, of record) [Wang].
The teachings of Kjellin and Lee, as a whole, are described above.
Kjellin and Lee differ from the claims in that the document does not teach the calcium phosphate of the calcium phosphate coating comprises a calcium-deficient hydroxyapatite.
However, Wang cures the deficiency.
Wang teaches calcium deficient hydroxyapatite, wherein a calcium deficient hydroxyapatite coated implant provides in vivo degradation of the Ca-def HA coating almost simultaneously and in vivo valid life of the coating is about 8 weeks, after that the degradation rate of the coated implants increases obviously, wherein the main reasons for the Ca-def HA coating degradation can be attributed to its reaction with body fluid, wherein Ca-def HA coating has good osteoconductivity and is in favor of the formation of more new bone (Abstract; See entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the HA composition as taught by Lee and Kjellin, as a whole, in accordance with the teaching of Wang to provide an improved osteoconductive composition that is provided as a coating on a metallic substrate because Ca-def HA has good osteoconductivity and is in favor of the formation of more new bone as taught by Wang.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Kjellin, Lee and Wang, as a whole.
Claims 15, 16, 17 and 20 are rejected under pre-AIA 35 U.S.C. 103 as being unpatentable over Kjellin et al (US 20080220233, cited in IDS filed 4/30/2024) [Kjellin], Lee et al (USP 5763092, of record) [Lee] and Goodman et al (The future of biologic coatings for orthopaedic implants, Biomaterials, p.3174, February, 2013, cited in IDS filed 4/30/2024)) [Goodman].
Regarding claims 15, 16, 17 and 20,
The teachings of Kjellin and Lee, as a whole, are described above.
Goodman teaches that hydroxyapatite is osteoconductive, wherein the presence of an HA coating prevents the formation of fibrous tissue that would normally result due to micromovements of an uncoated titanium implant (p.3175, right column, first, second and fifth paragraphs; p.3176, left column, in Section 2.1.2; see entire document). Thus, it would necessarily follow that hydroxyapatite (calcium phosphate) composition as taught by Kjellin and Lee, as a whole, is an osteoconductive composition. Further, it would have been obvious to one of ordinary skill to provide an orthopedic implant having osteoconductive composition disposed on the metal surface of the implant in view of the teachings of Kjellin, Lee and Goodman, as a whole (Instant claim 15).
Kjellin teaches a titanium implant, comprising on its surface a metal oxide layer (Titanate), wherein the metal oxide layer is porous. This surface is coated with crystalline hydroxyapatite, wherein the crystals have an average particle size of 1-10 nm and 20-40 nm in length (i.e., of about 10 to about 100 nm), as determined by TEM (. 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); In re Woodruff, 91 9 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP 2144.05. (Instant claim 16). Kjellin teaches pure hydroxyapatite coating (i.e., calcium phosphate coating) that is completely crystalline. Since the claim does not limit the structure to only a single specific crystal XRD can detect, then any standard technique used to calculate or estimate direction specific crystallite size would apply, e.g., TEM. Pure hydroxyapatite would inherently possess crystallite dimensions along its crystallographic axes, such as [001]. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). Thus, the claiming of a new use, new function or unknown property which is inherently present in the prior art does not necessarily make the claim patentable. In re Best, 562 F.2d 1252, 1254, 195 USPQ 430, 433 (CCPA 1977). In In re Crish, 393 F.3d 1253, 1258, 73 USPQ2d 1364, 1368 (Fed. Cir. 2004) (MPEP 2112 I.)
Kjellin teaches pure hydroxyapatite coating (i.e., calcium phosphate coating) is pure hydroxyapatite that is completely crystalline, thus, it would necessarily provide crystallinity of hydroxyapatite of about 70 wt% to about 100 wt% (Instant claim 17).
Kjellin teaches calcium phosphate(hydroxyapatite) in form of a coating that is deposited (i.e., in contact with the metal surface) (Instant claim 20).
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Kjellin, Lee and Goodman, as a whole.
Claim 19 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Lee et al (USP 5763092, listed in IDS filed 4/30/2024) [Lee] in view of Goodman et al (The future of biologic coatings for orthopaedic implants, Biomaterials, p.3174, February, 2013, cited in IDS filed 4/30/2024)) [Goodman] as applied to claims 15, 16, 17 and 20 above and further in view of Wang et al (Calcium-Deficient hydroxyapaptite, Colloids and Surfaces B Biointerfaces, p.254, July 2011) [Wang].
The teachings of Kjellin, Lee and Goodman, as a whole, are described above.
Kjellin, Lee and Goodman differ from the claims in that the documents do not teach the calcium phosphate of the calcium phosphate coating comprises a calcium-deficient hydroxyapatite.
However, Wang cures the deficiency.
Wang teaches calcium deficient hydroxyapatite, wherein a calcium deficient hydroxyapatite coated implant provides in vivo degradation of the Ca-def HA coating almost simultaneously and in vivo valid life of the coating is about 8 weeks, after that the degradation rate of the coated implants increases obviously, wherein the main reasons for the Ca-def HA coating degradation can be attributed to its reaction with body fluid, wherein Ca-def HA coating has good osteoconductivity and is in favor of the formation of more new bone (Abstract; See entire document).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the HA composition as taught by Lee and Goodman, as a whole, in accordance with the teaching of Wang to provide an improved osteoconductive composition that is disposed on the metal surface of the orthopedic implant because Ca-def HA has good osteoconductivity and is in favor of the formation of more new bone as taught by Wang.
Thus, it would have been obvious for one of ordinary skill in the art to provide instantly claimed invention and one of ordinary skill would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by Kjellin, Lee, Goodman and Wang, as a whole.
Response to Arguments in the Appeal Brief filed 1-15-2026
Appellant argument: I. A: Independent Claim 1 (Appeal Brief at pages 3-6): Independent Claim 1: the teachings of Lee and Kjellin demonstrate that the person of ordinary skill in the art (POSITA) would not have had a reasonable expectation of success in modifying Lee's coating in accordance with the teaching of Kjellin." "[O]bviousness ... requires ... that a person of ordinary skill in the art would have had a reasonable expectation of success. Lee discloses that in a typical process; a titanium or chromium/ cobalt alloy implant is coated by a standard thermal plasma spray process (6:4-6; 3:67-4:2). The coatings are then recrystallized using a recrystallization medium that includes hydroxyapatite particles and a liquid and heating the coated article to effect crystallization of the coating. This process of applying a coating and then recrystallizing the applied coating affords a "high crystallinity hydroxyapatite coating." “In contrast to Lee's "plasma spray process," the coatings in Kjellin are prepared through a different dipping process that uses a liquid crystalline phase. This phase uses a "surfactant self-assembly" to "control the crystal size as well as getting its desired crystallinity." The surfactant functions as a "directing agent for the formation of the crystalline apatite. Kjellin highlights that his dipping process is different than "plasma sputtering, which provides a "thick layer of partly amorphous hydroxyapatite ... with a low specific surface. Given Kjellin's teachings contrasting his "dipping" process with "plasma sputtering" processes, like those used in Lee, the POSITA would not have thought that Lee's plasma spray process could somehow be modified to achieve the surface areas taught in Kjellin. Beyond saying that the POSITA would have been motivated to achieve the surface areas taught Kjellin, the Examiner has never articulated what specific modifications the POSITA could have made to Lee to achieve those surface areas. The two references teach significantly different methods for applying a coating, and the Examiner has not explained what parameter or step of Lee would have been obvious to modify according to Kjellin to arrive at the coating of claim 1. Since it was not apparent how Lee could have been modified in view of Kjellin to actually achieve the claimed invention, the POSITA would not have had a reasonable expectation of success in doing so. Additionally, the POSITA would have been dissuaded from attempting to make some (unspecified) modification to Lee in view of Kjellin based on Kjellin's disparagement of Lee's "plasma sputtering." Kjellin noting the "thick layer of partly amorphous hydroxyapatite ... with a low specific surface" that results from "plasma sputtering," in contrast to his dipping process. It is improper to combine references where the references themselves teach away from their combination. Appellant argues that the POSITA would not have found it obvious to "modify the calcium phosphate coating as taught by Lee in accordance with the teaching of Kjellin," as proposed by the Examiner, because the POSITA would not have had a reasonable expectation of success in doing so (Appeal Brief at pages 3-6).
Appellant’s arguments have been fully considered but they are not persuasive, because the rejections have been modified supra where Kjellin is now the lead reference and the teachings of Lee are provided to modify Kjellin about the limitation in claim 2 to provide calcium phosphate coating that is substantially free carbonate as measured by infrared spectroscopy. Further ‘plasma sputtering’ as mentioned by Kjellin and ‘plasma spray process’ as taught by Lee are distinct surface coating methods with different operational environments and coating thicknesses where ‘plasma sputtering’ requires high-vacuum chamber. Kjellin teaches plasma sputtering produces a thick layer of partly amorphous hydroxyapatite is obtained together with a low specific surface (p.5, right column, para. [0078]. Therefore, Kjellin does criticize, discredit or otherwise discourage the ‘plasma spray process’ as taught by Lee.
Further, Kjellin teaches the dipping process comprises dipping an oxide layer-coated surface of an object into the microemulsion to deposit the microemulsion onto the surface, evaporating the organic solvent from the surface, followed by heating under inert atmosphere in order to remove the surfactant (Kjellin: claim 27). Further, Kjellin teaches crystalline calcium phosphate, e.g., hydroxyapatite (HA), in form of a coating on a metal surface, such as titanium oxide, having a specific surface area (SSA) of 180 m2/g., of which lies within the claimed surface area. Moreover, Kjellin teaches the HA particles resemble the HA particles that are present in the living body, which make them highly suitable in the biomimicking of body tissue for the making of body implants. Thus, the HA of the invention is suitable for being deposited on the surface of an implant giving it a highly bioactive surface in order to stimulate the bone growth during the initial healing process.
Kjellin teaches producing a coating of nano-sized crystalline calcium phosphate comprising the steps of a) providing a solution of water and stoichiometric solved amounts of a phosphor precursor and of a calcium salt precursor, b) adding a surfactant, and optionally a hydrophobic organic solvent, to the solution of a) to create a liquid crystalline phase, c) allowing the liquid crystalline phase to equilibrate, (step d is optional), and e3) diluting the liquid crystalline phase of c) with a hydrophobic organic solvent to create a microemulsion, f3) dipping an oxide layer-coated surface of an object into the microemulsion of e3) to deposit the microemulsion onto the surface, g3) evaporating the organic solvent from the surface of f3) to form a liquid crystalline phase, and h3) placing the surface of g3) in an ammonia atmosphere to raise the pH so that nano-sized crystals of calcium phosphate are formed in the water domains of the liquid crystalline phase and are deposited on the surface, followed by i2) heating under inert atmosphere in order to remove the surfactant (claim 27).
However, Kjellin differs from the claims in that the document does not teach the calcium phosphate coating is substantially free of carbonate as measured by infrared spectroscopy (recited in claim 2). Lee cures the deficiency.
Lee teaches the oxygen activity of the system is reduced by boiling the liquid of the recrystallization medium to drive out dissolved gases. Boiling for 1 to 30 minutes is sufficient. Lee teaches boiling has several advantageous results: (1) vapor replaces air (particularly oxygen), forming a deoxygenated atmosphere above the recrystallization medium; (2) oxygen dissolved in the recrystallization liquid is released, further decreasing the amount of molecular oxygen of the system; (3) carbon dioxide dissolved in the recrystallization liquid is also released. The first two effects result in decreased oxidation of the implant. The third effect, removal of CO2, is advantageous when treating certain coatings that would otherwise form some carbonate apatite, where carbonate apatite is undesirable because it is much more soluble than hydroxyapatite. Lee teaches the oxygen activity of a system is reduced by boiling the liquid of the recrystallization medium to drive out dissolved gases. Boiling for 1 to 30 minutes is sufficient, wherein carbon dioxide is released. Thus, Lee can be combined with or used to modify Kjellin straightforwardly requiring only ordinary skill and no undue experimentation so that this establishes that one of ordinary skill in the art (POSITA) would have a reasonable expectation of success. One of ordinary skill in the art would have been motivated to modify Kjellin in view of Lee to remove carbon dioxide to decrease calcium phosphate solubility in order to lower the solubility of a calcium phosphate coating disposed on an orthopedic implant. Thus, aiming for a calcium phosphate coating substantially free of carbonate represents routine optimization. Optimization of parameters is a routine practice that would be obvious to a person of ordinary skill in the art to employ and reasonably expect success. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233,235 (CCPA 1955) & MPEP 2144.05. Accordingly, it would have been well within the purview of one skilled in the art to modify the teachings of Kjellin in at least step i2) heating (i.e., boiling) under inert atmosphere in order to remove the surfactant (Kjellin: claim 27). Thus, Kjellin can be easily modified by boiling under an inert atmosphere to remove both the surfactant and carbon dioxide. One skilled in the art would have reasonably expected that boiling under an inert atmosphere effectively removes the surfactant and carbon dioxide without requiring extensive optimization. Kjellin does criticize, discredit or otherwise discourage the removal of carbon dioxide in step i2). Moreover, one of ordinary skill would have been motivated to do so to avoid producing carbonate apatite that is undesirable because it is much more soluble than hydroxyapatite as taught by Lee. Thus, based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy. Furthermore, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate. The test for obviousness is not whether the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
Thus, Lee can be combined with or used to modify Kjellin without difficulty requiring only ordinary skill and no undue experimentation. This establishes that one of ordinary skill in the art (POSITA) would have a reasonable expectation of success and negates Appellants ‘teach away’ argument. Appellant directs us to no disclosure in Kjellin cautioning against removal of carbon dioxide and we discern none.
Appellant argument: I. B: Dependent Claims 2-7, 12 and 13 (Appeal Brief at pages 6-8): Dependent Claims 2-7, 12 and 13: The arguments and authorities set forth above in Section I(A) are expressly incorporated into this Section. Dependent claims 2-7, 12, and 13 depend from independent claim 1 and are therefore patentable for at least the same reasons as claim 1. Moreover, Appellant's claim 2 includes additional limitations that further specify patentable subject matter. Claim 2 recites that "the calcium phosphate coating is substantially free of carbonate as measured by infrared spectroscopy." Appellant's specification explains that "'substantially carbonate-free' coatings refers to coatings that do not have a distinguishable carbonate peak between 1500 cm-1 and 1300 cm-1 when subjected to IR spectroscopy." Neither Lee nor Kjellin describe forming a coating that is substantially free of carbonate or confirming that property using IR spectroscopy. Nevertheless, the Examiner asserts Lee meets this claim limitation because "Lee teaches a coating comprising a hydroxyapatite (HA) composition" and "HA is free of carbonate." The Examiner does not cite any disclosure, in Lee or otherwise, establishing that "HA is free of carbonate." Without an express teaching in this regard, the Examiner is attempting to rely on inherency. "In relying upon the theory of inherency, the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." "The fact that a certain result or characteristic may occur or be present in the prior art is not sufficient to establish the inherency of that result or characteristic. Here, the Examiner has not provided evidence sufficient to support a finding that Lee inherently discloses a coating "substantially free of carbonate as measured by infrared spectroscopy." The Office Action therefore fails to establish that the proposed modification of Lee in view of Kjellin would have arrived at the invention of claim 2. Claims 3-7, 12, and 13 each depend from claim 2, include the limitations of that claim, and are patentable for at least the same reasons.
Appellant’s arguments have been fully considered but they are not persuasive, because based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above). Moreover, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
Appellant argument: II: Claims 8-10 (Appeal Brief at page 8): The arguments and authorities set forth above in Sections I(A) and I(B) are expressly incorporated into this Section. Dependent claims 8-10 depend from independent claim 1, as well as intervening dependent claim 2, and are therefore patentable over Lee and Kjellin for at least the same reasons discussed in Sections I(A) and I(B). Saban does not remedy those deficiencies. Accordingly, the § 103 rejection of claims 8-10 over Lee, Kjellin, and Saban should be reversed.
Appellant’s arguments have been fully considered but they are not persuasive, because based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy supra.
However, Kjellin and Lee differ from the claims in that the document does not teach thickness of the metal surface of the implant. However, Saban cures the deficiency. Saban cures the deficiency.
Saban teaches metal implants that are to be inserted into bone tissue (Abstract; col.1, lns.1-10; col.4, lns.5-13). Saban teaches a titanium-based implant comprising titanium oxide, wherein the surface thickness is between 8-50 nm, wherein the thickness provides a better cellular response, and therefore, a better implant-bone binding (col.1, lns.20-23; col.4, lns.44-67; claim 1; See entire document). Thus, Saban was not intended to modify Kjellin to provide calcium phosphate to form of a coating on a metal surface having a specific surface area (SSA) of about 15 m2/g to about 200 m2/g, wherein the calcium phosphate is substantially free of carbonate as measured by infrared spectroscopy. Based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above). Kjellin teaches a synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of 180 m2/g supra. Furthermore, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
. Appellant argument: III: Claim 11 (Appeal Brief at pages 8-9): The arguments and authorities set forth above in Sections I(A) and I(B) are expressly incorporated into this Section. Dependent claim 11 depends from independent claim 1, as well as intervening dependent claim 2, and is therefore patentable over Lee and Kjellin for at least the same reasons discussed in Sections I(A) and I(B). Wang does not remedy those deficiencies. Accordingly, the § 103 rejection of claim 11 over Lee, Kjellin, and Wang should be reversed. Appellant’s arguments have been fully considered but they are not persuasive, because
Appellant’s arguments have been fully considered but they are not persuasive, because based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy supra.
However, Kjellin and Lee differ from the claims in that the document does not teach the calcium phosphate of the calcium phosphate coating comprises a calcium-deficient hydroxyapatite. Wang cures the deficiency.
Wang teaches (in part) the main reasons for the Ca-def HA coating degradation can be attributed to its reaction with body fluid, wherein Ca-def HA coating has good osteoconductivity and is in favor of the formation of more new bone (Abstract; See entire document). Thus, Wang was not intended to modify Kjellin to provide calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of about 15 m2/g to about 200 m2/g, wherein the calcium phosphate is substantially free of carbonate as measured by infrared spectroscopy. Based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above). Kjellin teaches a synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of 180 m2/g supra. Furthermore, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
Appellant argument: IV A.: Claims 15-17 and 20 (Appeal Brief at pages 9-10): Under the fourth ground of rejection on appeal, claims 15-17 and 20 stand rejected under 35 U.S.C. § 103 as being unpatentable over Lee and Kjellin in view of Goodman et al. Appellant urges the Board to reverse the fourth ground of rejection and will argue the claims within this ground in a single group. Independent claim 15 recites, in part, "[a]n osteoconductive composition comprising calcium phosphate, ... wherein the calcium phosphate has a surface area of about 15 m2/g to about 200 m2 /g." The Examiner admits that Lee fails to teach that its "hydroxyapatite (calcium phosphate) coating has surface area of about 15 m2/g to about 200 m2 /g," among other things. Instead, the Examiner relies on Kjellin as allegedly teaching this feature and asserts that it "would have been obvious to one of ordinary skill in the art before the effective date of the invention to modify the calcium phosphate coating as taught by Lee in accordance with the teaching of Kiellin to provide a coating having a high surface area that is especially suitable for being deposited on the surface of an orthopedic implant giving it a highly bioactive surface in order to stimulate bone growth during the healing process." However, as discussed in detail above in Section I(A) (the arguments and authorities of which are expressly incorporated into this Section), the teachings of Lee and Kjellin demonstrate that the POSIT A would not have had a reasonable expectation of success in modifying Lee's coating "in accordance with the teaching of Kjellin." First, the record contains no explanation of how the POSITA allegedly could have modified Lee based on the teachings of Kjellin. Without recognition of some modification that could be made to Lee to achieve the surface area taught in Kjellin, the POSITA would have had no expectation of success in doing so. Second, the POSITA would have been dissuaded from attempting to make some (unspecified) modification to Lee in view of Kjellin based on Kjellin's disparagement of Lee's "plasma sputtering. For at least the foregoing reasons, Appellant requests that the Board reverse the fourth ground of rejection.
Appellant’s arguments have been fully considered but they are not persuasive, because the rejections have been modified supra where Kjellin is now the lead reference and the teachings of Lee are provided to modify Kjellin about the limitation in claim 2 to provide calcium phosphate coating is substantially free carbonate as measured by infrared spectroscopy. Based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above).
It would have been obvious to modify the teachings of Kjellin for producing a coating of nano-sized crystalline calcium phosphate to include the process of removal of carbon dioxide. One skilled in the art would have been motivated to do so to avoid producing carbonate apatite that is undesirable because it is much more soluble than hydroxyapatite. Kjellin teaches a synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of 180 m2/g supra. Furthermore, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
Appellant argument: IV B.: Claim15 (Appeal Brief at page 11): Independent claim 15 also recites, in part, "the calcium phosphate is substantially free of carbonate as measured by infrared spectroscopy." The Examiner asserts Lee meets this claim limitation because "Lee teaches a hydroxyapatite (HA) composition" and "HA is free of carbonate." The Examiner does not cite any disclosure, in Lee or otherwise, establishing that "HA is free of carbonate." As discussed in detail above in Section I(B) (the arguments and authorities of which are expressly incorporated into this Section), without an express teaching of this claimed feature, the Examiner is attempting to rely on inherency. But to do so, "the examiner must provide a basis in fact and/or technical reasoning to reasonably support the determination that the allegedly inherent characteristic necessarily flows from the teachings of the applied prior art." The Examiner has provided no evidence that would support such a finding here. For this additional reason, Appellant respectfully requests that the Board reverse the fourth ground of rejection.
Appellant’s arguments have been fully considered but they are not persuasive, because the rejections have been modified supra where Kjellin is now the lead reference and the teachings of Lee are provided to modify Kjellin about the limitation in claim 2 to provide calcium phosphate coating is substantially free carbonate as measured by infrared spectroscopy. Based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above). Lee explicitly teaches carbonate apatite (carbonate hydroxyapatite) is undesirable because it is much more soluble than hydroxyapatite (col.5, lns.40-59). Accordingly, it would have been obvious to modify the teachings of Kjellin for producing a coating of nano-sized crystalline calcium phosphate to incorporate the process of removal of carbon dioxide. One skilled in the art would have been motivated to do so to avoid producing carbonate apatite that is undesirable because it is much more soluble than hydroxyapatite. Further, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
Appellant argument: V: Claim 19 (Appeal Brief at pages 11-12): Under the fifth ground of rejection on appeal, claim 19 stands rejected under 35 U.S.C. § 103 as being unpatentable over Lee, Kjellin, and Goodman in further view of Wang. Appellant urges the Board to reverse the fifth ground of rejection. The arguments and authorities set forth above in Sections I and IV are expressly incorporated into this Section. Dependent claim 19 depends from independent claim 15 and is therefore patentable over Lee, Kjellin, and Goodman for at least the same reasons discussed in Section IV. Wang does not remedy those deficiencies. Accordingly, the § 103 rejection of claim 19 over Lee, Kjellin, Goodman, and Wang should be reversed.
Appellant’s arguments have been fully considered but they are not persuasive, because based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy supra.
However, Kjellin and Lee differ from the claims in that the document does not teach the calcium phosphate of the calcium phosphate coating comprises a calcium-deficient hydroxyapatite. Wang cures the deficiency.
Wang teaches (in part) the main reasons for the Ca-def HA coating degradation can be attributed to its reaction with body fluid, wherein Ca-def HA coating has good osteoconductivity and is in favor of the formation of more new bone (Abstract; See entire document). Thus, Wang was not intended to modify Kjellin to provide calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of about 15 m2/g to about 200 m2/g, wherein the calcium phosphate is substantially free of carbonate as measured by infrared spectroscopy. Based on Kjellin in view of Lee, one of ordinary skill in the art would have been motivated to remove carbon dioxide to lower the solubility of the calcium phosphate coating and improve its stability thereby providing a calcium phosphate coating on a surface of an orthopedic implant that is substantially free of carbonate as measured by infrared spectroscopy (See Kjellin in view of Lee, as described above). Kjellin teaches a synthetic nano-sized crystalline calcium phosphate in form of a coating on a metal surface having a specific surface area (SSA) of 180 m2/g supra. Furthermore, one of ordinary skill in the art would routinely use infrared spectroscopy to confirm removal of undesirable carbonate peaks by monitoring the well-known analytical peaks at 1300-1500 cm-1 for carbonate.
Appellant argument: VI: Claims 1-13 (Appeal Brief at pages 11-12): Under the sixth ground of rejection on appeal, claims 1-13 stand rejected for obviousness-type double patenting over Appellant's U.S. Patent No. 10,537,661. With this Appeal Brief, Appellant has filed a terminal disclaimer in compliance with 37 C.F.R. § 1.32 l(c), thereby obviating the double patenting rejection. Accordingly, Appellant urges the Board to reverse the sixth ground of rejection.
Appellant’s arguments have been fully considered. The rejection of claims 1-14 on the ground of nonstatutory double patenting as being unpatentable over claim 1-10 and 14 of U.S. Patent No. 10537661 (herein ‘661) is withdrawn in view of the Terminal Disclaimer filed 1/15/2026 (Approved 1/25/2026). Claim 14 has been canceled in Claim Set filed 10-15-2025.
Conclusions
No claim is allowed.
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/T.W./ Examiner, Art Unit 1619
/DAVID J BLANCHARD/Supervisory Patent Examiner, Art Unit 1619
