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 .
The Response filed 12/4/2025 has been entered. The previous claim objections do not appear to have been addressed by applicant and are therefore maintained. Claims 1, 3, 6-9, and 10-12 remain pending in this application.
Response to Amendment
The Affidavit under 37 CFR 1.131 filed 12/4/2025 appears to have been intended as an Affidavit under 37 CFR 1.132 since it is directed toward providing evidence of unexpected results (see MPEP 716), and is therefore being treated as such.
The Affidavit under 37 CFR 1.132 filed 12/4/2025 is insufficient to overcome the rejection of claims 1, 3, 6-8, and 10 based upon Barralet in view of Asgari as set forth in the last Office action because:
Regarding reasons 1-3: This affidavit is being considered in light of the fact that an affidavit of an applicant as to the advantages of their claimed invention, while less persuasive than that of a disinterested person, cannot be disregarded for this reason alone (see MPEP 716.01c).
Regarding reasons 4-5: Arguments presented by the applicant cannot take the place of evidence in the record. In assessing the probative value of an expert opinion, the examiner has considered the nature of the matter sought to be established, the strength of any opposing evidence, the interest of the expert in the outcome of the case, and the presence or absence of factual support for the expert’s opinion. There is no factual evidence supporting the statement that one should not expect other properties to change when the size of metal-based particles are changed (see MPEP 716.01c).
Regarding reasons 6-8: To be of probative value, any objective evidence should be supported by actual proof. Applicant has not presented any experimental data showing that the claimed particle sizes produce a desired ion-release rate and adequate structural integrity. Due to the absence of tests comparing applicant’s particle sizes with those of the Asgari, applicant’s assertions of unexpected results constitute mere argument and cannot take the place of evidence in the record.
Regarding reasons 9-10: To be given substantial weight in the determination of obviousness and nonobviousness, evidence must be relevant to the subject matter as claimed such that there is a nexus between the merits of the claimed invention and the evidence. In this case, it has been determined that applicant has not demonstrated a factually and legally sufficient connection between the objective evidence of nonobviousness and the claimed invention, because the claims do not recite the apparent unexpected result of driving resorption behavior to provide a desired ion-release rate (see MPEP 716.01b).
Further, any differences between the claimed invention and the prior art may be expected to result in some differences in properties. Applicant has not shown that the properties differ to such an extent that the difference is really unexpected because the evidence relied upon does not establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance (see MPEP 716.02 and 716.02b). Applicant has also not established unexpected results over the entire claimed range because there is a lack of comparison of a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range (see MPEP 716.02d).
Regarding reasons 11-13: The unexpected properties of the claimed invention have not been shown to have a significance equal to or greater than the expected properties and is therefore not sufficient to rebut the evidence of obviousness (see MPEP 716.02c).
Response to Arguments
Applicant's arguments filed 12/4/2025 have been fully considered but they are not persuasive.
With regard to applicant’s argument on page 5 that the particle size range disclosed in Asgari is overly broad and effectively only discloses a range in nanometers, the examiner disagrees. As explained in the previous office action, Asgari teaches that the particles can have an average particle size/edge length from about 0.5 nm to 500 µm (paragraph 0039) and that the selection of particle size can determine the resulting size of the pores within the implant and contemplates selecting a size depending on the use and functional requirements with regard to structural integrity of the implant (paragraph 0066). Therefore, the examiner maintains that it would have been obvious to modify the particles of Asgari, to have the claimed particle sizes, since Asgari teaches that selection of particle size/edge length can determine the resulting size of the pores within the implant and contemplates selecting a size of the particles that is dependent upon the use and functional requirements with regard to structural integrity of the implant, particularly since it has been held that “[i]n 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). Furthermore, though Asgari appears to express a general preference for nanoparticles, the reference does not criticize, discredit or otherwise discourage investigation into the invention claimed range of particle sizes (see MPEP 2145, Section X., D., 1.).
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the particle sizes drive resorption behavior to achieve a desired ion-emission rate) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that Asgari discloses particle sizes in order to increase structural integrity and not to drive resorption behavior, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Claim Objections
Claims 1 and 10 are objected to because of the following informalities: Claims 1 and 10 each recite “the carrier material” (see lines 5 and 16 of claim 1 and line 3 of claim 10), which appears to be referring to – the ceramic carrier material –, as recited earlier in claim 1. Appropriate correction is required.
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.
Claim(s) 1, 3, 6-8, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Application Publication No. 2010/0145469 A1 to Barralet et al. (Barralet) in view of US patent Application Publication No. 2008/0175885 A1 to Asgari (Asgari).
Regarding at least claim 1
Barralet teaches a bioceramic endoprosthesis that includes a reservoir or deposition of a bioactive substance that can provide a biological function such as vascularization of the endoprosthesis (abstract). Barralet meets the limitations of an implant (endoprosthetic) for insertion into a patient (paragraph 0114 discloses using the endoprostheses as orthopedic implants that can be implanted into the head, neck, torso, arms, legs, and the like, including use as a cranial implant), said implant being manufactured using a generative manufacturing process (paragraph 0070 discloses an additive process of direct inkjet printing to form the endoprosthesis) and having an at least partially resorbable (paragraph 0021 discloses resorbable bioactive ceramics) and at least in partial regions porous implant body (paragraph 0050 discloses that the endoprosthesis can be macroporous) comprising a ceramic carrier material and a donor material (paragraph 0046 discloses that the endoprosthesis can include any biocompatible ceramic and any bioactive substance/donor material) that, in the implanted state, emits ions for influencing the patient's cellular metabolism (paragraph 0048 discloses controlled release of bioactive ions and molecules that can be useful for stimulating and guiding tissue regeneration and would affect the patient’s cellular metabolism at least to some degree), wherein the donor material is interspersed in the carrier material so that the donor material is present throughout the entire implant volume (paragraph 0052 discloses that the bioactive substance/donor material can be impregnated within the matrix, disposed within lattice, etc., and that the bioactive substance/donor material can be homogeneously distributed throughout the bioceramic), wherein the implant comprises first layers, last layers and middle layers, wherein the middle layers are surrounded by the first and last layers (paragraphs 0010 and 0091-0092 discloses applying a ceramic powder layer to a substrate, then applying a binder solution layer, then applying a bioactive substance solution layer, and repeating; this process would result in an implant comprising first, last, and middle layers as claimed such that the middle layers are surrounded at least on the top and bottom by the first and last layers, respectively), wherein the first, last and middle layers have different densities/porosities (paragraph 0050 discloses varying porosity throughout the endoprosthesis to allow vessels of different sizes to form within the pores; it is noted that the layered implant formed by Barralet with varying porosity throughout would result in at least some of the first, last and middle layers having different porosities), wherein individual pores in the implant body are connected to each other via connection channels, wherein the donor material is arranged and concentrated in the carrier material in such as a way that, when the ions are released in the implanted state, the connection channels necessarily result in the implant body (paragraph 0048 discloses controlled release of bioactive ions and molecules for stimulating and guiding tissue regeneration - this release of ions would necessarily result in connection channels, particularly since paragraph 0052 discloses that the bioactive substance forms into a pore as it diffuses or dissolves into the body, and as more pores form, they would connect with one another forming the claimed channels in the same way as applicant’s).
Barralet also teaches that the bioactive substance/donor material is preferably an angiogenesis growth factor that can provide a biological function such as vascularization of the endoprosthesis (abstract). However, Barralet does not teach wherein the bioactive substance/donor material comprises ceramic particles and metallic particles.
Asgari teaches at least partially degradable, porous implants (abstract). More specifically, Asgari teaches biodegradable metal-based particles that may be selected from at least partially biodegradable inorganic materials such as metals or ceramics or any mixture thereof (metallic and ceramic) so long as they perform the desired function of being biodegradable (paragraph 0029).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Barralet to specify that the donor material of the endoprosthesis comprises ceramic particles and metallic particles, since it is prima facie obvious to select a known material based on its suitability for an intended purpose (See MPEP 2144.07), namely biodegradability as taught by Asgari.
Barralet also teaches wherein some of the particles are spherical and have a particle size (paragraph 0078 discloses microspheres/particles in which the bioactive substance/donor material can be contained within the microspheres, which are small spherical particles with diameters in the micrometer range, typically 1-1000 µm). However, Barralet does not teach wherein at least some of the spherical ceramic particles and the metallic particles have a particle size between 5-18 µm for the metallic particles, between 25-120 µm for the ceramic particles, or wherein some of the ceramic particles and the metallic particles are cubic and have an edge length between 5-25 µm for the metallic particles and between 40-60 µm for the ceramic particles.
Asgari further teaches that the particles can have a form as desired, for example spherical particles and/or cubes (spherical and cubical particles; paragraph 0037) and can have an average particle size/edge length from about 0.5 nm to 500 µm (paragraph 0039). Asgari also teaches that the shape of the particles can result in a reproducible and rationally designable final structure, and that a mixture of particle types, for example spherical and cubical, can result in the formation of cavities according to the mixture of particle types, for the purpose of providing more complex formations of cavities, e.g. open porous networks (paragraph 0065). Further still, Asgari teaches that the selection of particle size can determine the resulting size of the pores within the implant and contemplates selecting a size of the metal-based particles (which can be a mixture of metals and ceramics; paragraph 0029), depending on the use and functional requirements with regard to structural integrity of the implant (paragraph 0066).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to further modify the invention of Barralet, which teaches spherical particles, to include some spherical particles, in addition to the some cubical particles, in order to form spherical and cubical cavities, resulting in more complex formations of cavities, e.g. open porous networks, as taught by Asgari.
It further would have been obvious to modify the particles (metallic and ceramic mixture) of Asgari which have a size of about 0.5 nm to 500 µm, to have a particle size between 5-18 µm for the spherical metallic particles, a particle size between 25-120 µm for the spherical ceramic particles, and an edge length between 5-25 µm for the cubic metallic particles and between 40-60 µm for the cubic ceramic particles, since Asgari teaches that selection of particle size/edge length can determine the resulting size of the pores within the implant and contemplates selecting a size of the particles that is dependent upon the use and functional requirements with regard to structural integrity of the implant, particularly since it has been held that “[i]n 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).
Regarding at least claim 3
Barralet in view of Asgari teaches the implant according to claim 1. Barralet also teaches wherein the implant body is divided into layers or into partial regions of different density and/or porosity (paragraph 0091-0092 disclose that the implant body is formed as deposited layers and paragraph 0050 discloses varying porosity throughout the endoprosthesis to allow vessels of different sizes to form within the pores; the layered implant formed by Barralet with varying porosity throughout would result in at least some of the layers having different porosities).
Regarding at least claim 6
Barralet in view of Asgari teaches the implant according to claim 1. Barralet also teaches wherein the implant body has a total porosity (paragraph 0050 discloses a porosity from about 40% to about 95%, which overlaps with the claimed range, and that the porosity may be higher or lower depending on the use and the loads applied after implantation).
However, Barralet does not explicitly disclose a total porosity between 3% and 60%.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the porosity of Barralet from about 40% to about 95% to between 3% and 60% since Barralet teaches that the porosity can be higher or lower depending on the use and the loads that may be applied after implantation and since it has been held that “[i]n 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).
Regarding at least claim 7
Barralet in view of Asgari teaches the implant according to claim 1. Barralet also teaches wherein the pore size of the pores in the implant body lies in a range (paragraph 0050 discloses pore sizes from about 200 microns to about 4000 microns, which overlaps with the claimed range, and that the pore size larger than 300 microns allow formation of more vasculature or bone after implantation).
However, Barralet does not explicitly disclose a pore size that lies in a range of 300 µm to 1,500 µm.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the pore size of Barralet from about 200 microns to about 4000 microns to a range of 300 µm to 1,500 µm because Barralet teaches that a pore size larger than 300 microns allow formation of more vasculature or bone after implantation and since it has been held that “[i]n 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).
Regarding at least claim 8
Barralet in view of Asgari teaches the implant according to one of claim 1. Barralet also teaches wherein the ceramic carrier material is provided in the form of powder or granular ceramic particles (the ceramic carrier material/bioceramic is provided in the form of powder as disclosed in at least paragraph 0091).
Regarding at least claim 10
Barralet in view of Asgari also meets the limitations of a method of manufacturing an implant according to claim 1 (see rejection of claim 1 above). Barralet further teaches that the method comprises the steps: a) mixing of carrier material and donor material into a raw mixture (paragraph 0078 discloses mixing the bioactive substance/donor material into the ceramic carrier material), b) spatially-resolved bonding of the raw mixture (RM) into a plurality of individual layers (ES1, ES2, ESn) (paragraph 0091-0092 discloses manufacturing the endoprosthesis by 3D printing by depositing layer upon layer of raw material and bonding them; paragraph 0098 discloses alternate methods including sintering, etc.), and c) superimposing and layer-by-layer bonding of the plurality of individual layers to form the finished implant body (the method of 3D printing includes superimposing and layer-by-layer bonding of the plurality of individual layers to form the finished implant body as disclosed by Barralet in paragraphs 0070-0071, 0091-0092).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Barralet in view of Asgari, as applied to claim 1, and further in view of US Patent Application Publication No. 2003/0114936 A1 to Sherwood et al. (Sherwood).
Regarding at least claim 11
Barralet in view of Asgari teaches the implant according to claim 1. Barralet also teaches a layered implant with varied porosity. However, Barralet does not explicitly teach wherein the middle layers are more porous than the first layers and last layers.
Sherwood teaches composite implantable devices having a gradient or one or more properties forming a transition zone from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties best suited for a different type of tissue (abstract). More specifically, Sherwood teaches that the microarchitectural feature of porosity can be varied between specific regions of the layered device, for example, maximizing porosity in the region specifically to enhance cartilage regeneration, for the purpose of promoting cell attachment and proliferation and allow space for formation of extracellular matrix (paragraph 0068).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the middle layers of Barralet are more porous than the first layers and last layers, depending on the location of the implant, in order to exhibit properties desired for the type of tissue surrounding the implant, as taught by Sherwood. In an implant that is meant to be placed between two bones in a joint, the highly porous cartilage area would be located in the middle layers.
Regarding at least claim 12
Barralet in view of Asgari and Sherwood teaches the implant according to claim 11. Barralet also teaches a layered implant with varied porosity particularly such that one region has properties suited for one type of tissue and transitions to another region having properties suited for a different type of tissue. However, Barralet does not teach explicitly wherein the first layers and last layers are solid.
Sherwood teaches composite implantable devices having a gradient or one or more properties forming a transition zone from a region composed of materials or having properties best suited for one type of tissue to a region composed of materials or having properties best suited for a different type of tissue (abstract).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to specify that the middle layers of Barralet are more porous than the first layers and last layers, depending on the location of the implant, in order to exhibit properties desired for the type of tissue surrounding the implant, as taught by Sherwood. In an implant that is meant to be placed between two bones in a joint, the less porous bone areas would be located in the first and last layers.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MELISSA A HOBAN whose telephone number is (571)270-5785. The examiner can normally be reached Monday-Friday 8:00AM-5:00PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie Tyson can be reached at 571-272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.A.H/Examiner, Art Unit 3774
/MELANIE R TYSON/Supervisory Patent Examiner, Art Unit 3774
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