Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response, filed 21 November 2025. Claims 153, 167, 168, and 170 - 172 are amended therein, and claims 164 - 166 are cancelled. Claims 1 and 3 - 5 remain withdrawn as being directed to a non-elected invention. Accordingly, claims 153 – 163 and 167 - 176 remain available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection pursuant to 35 U.S.C. § 112(b) set forth in the Action of 30 September 2025 is hereby withdrawn in light of Applicants’ amendment of the claims.
Rejections Pursuant to 35 U.S.C. § 103
The rejections pursuant to 35 U.S.C. § 103 set forth in the Action of 30 September 2025 are hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that forms the basis for all obviousness rejections set forth in this Office Action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 37 CFR § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 153 – 163 and 167 - 173 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2016/0082156 A1 to Wilson, C., et al., published 24 March 2016 (“Wilson ‘156”), in view of US 2021/0024430 A1 to Dunkley, I. and G. Senders, claiming priority to 26 July 2019 (“Dunkley ‘430”), and WO 2014/152113 A2 to Bagga, C., et al., published 25 September 2014 (“Bagga WO ‘113”).
The Invention As Claimed
Applicants claim an implantable orthobiologic comprising a porous biocompatible matrix and a population of composite granules, wherein each granule comprises a resorption component that comprises at least 90% by weight of the granule, wherein the matrix comprises collagen, wherein the matrix comprises bioactive glass particles, wherein the matrix exhibits a porosity interconnectivity of at least 70%, or 80%, or 80 - 90%, wherein the matrix comprises pores of at least 350 µm diameter, wherein the matrix comprises pores of a diameter ranging from 500 to 600 µm, or from 530 to 570 µm, wherein the granules are embedded in the matrix, wherein the granules exhibit a higher density than the matrix, wherein the resorption component comprises about 95% by weight of the granule for each granule, wherein the resorption component comprises β-tricalcium phosphate, wherein the granules comprise a structural component, wherein the structural component comprises no more than 10% by weight of the granule for each granule, or no more than 5% wgt of the granule, or about 5% by weight, and the resorption component comprises about 95% by weight of the granule for each granule, and wherein the structural component comprises hydroxyapatite.
The Teachings of the Cited Art
Wilson ‘156 discloses osteoinductive synthetic bone grafts comprising porous ceramic granules loaded with an osteoinductive material, and in contact with a biocompatible matrix material (see Abstract), wherein the grafts are in the form of composite osteoinductive scaffolds that comprise an osteoinductive material (such as proteins or peptides), at least one calcium ceramic granule and a flowable biocompatible matrix material (see ¶[0005]), wherein the matrix comprises hyaluronic acid (HA), modified HA, collagen, gelatin, fibrin, chitosan, alginate, agarose, a self-assembling peptide, whole blood, platelet-rich plasma, bone marrow aspirate, polyethylene glycol (PEG), and/or derivatives, PEG, poly(lactide-co-glycolide), poly(caprolactone), poly(lactic acid), poly(glycolic acid), a poloxamer, and copolymers, or combinations thereof (id.), wherein the granules comprise monocalcium phosphate monohydrate, dicalcium phosphate, dicalcium phosphate dehydrate, octacalcium phosphate, precipitated hydroxyapatite, precipitated amorphous calcium phosphate, monocalcium phosphate, α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), sintered hydroxyapatite, oxyapatite, tetracalcium phosphate, hydroxyapatite, calcium-deficient hydroxyapatite, and combinations thereof (id.), wherein the osteoinductive material comprises bone morphogenetic protein 2 (BMP-2), BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-9, a designer BMP, fibroblast growth factor, insulin-like growth factor, platelet-derived growth factor, transforming growth factor-beta (TGF-β), and combinations thereof (id.), wherein the protein-loaded calcium ceramic granule is in a biocompatible matrix comprising collagen that can be flowed over the osteoinductive material-loaded granules (see ¶[0006]), wherein the implant comprises a biocompatible matrix, an osteoinductive material associated with an interior surface (e.g., a pore surface) of a calcium ceramic granule, which calcium ceramic granule is, in tum, associated with the matrix (see ¶[0007]), wherein an osteoconductive material refers to any material which facilitates the ingrowth of osteoblastic cells including osteoblasts, pre-osteoblasts, osteoprogenitor cells, mesenchymal stem cells, and other cells that are capable of differentiating into or otherwise promoting the development of cells that synthesize and/or maintain skeletal tissue, such as, specifically, a porous granule comprising an osteoconductive calcium phosphate ceramic that include both micro- and macro-pores that define surfaces on which the osteoinductive substance can associate, both the micro-pores and macro-pores increasing the total surface area to which the osteoinductive substance can adhere, but only the macro-pores permit infiltration by cells (see ¶[0033]), wherein the granules are characterized by a porosity that can be selected to achieve desired granule residence times or kinetics of release of osteoinductive material, such that osteoinductive substances within the micropores becomes only gradually as the granule is degraded by cells infiltrating the macropores (id.), wherein the granules are characterized by a porosity that is selected to allow an implant of the invention to remain in place and to release osteoinductive material over time intervals optimal for the formation and knitting of bone (e.g. days, weeks, or months), the porosity comprising both a microporosity and a macroporosity, which porosities can be selected to achieve desired granule residence times or kinetics of release of osteoinductive materials, wherein the micropores are large enough to permit infiltration of oesteoinductive factors such as solutions of BMP’s, and the macropores are large enough to permit infiltration by cells (see ¶[0035]), wherein the disclosed scaffolds comprise a biocompatible matrix, which matrix can be any suitable biocompatible material which, preferably, when used in concert with the granules, exhibits sufficient rigidity and/or column strength to withstand the loads placed upon it when implanted, and which does not cause excessive inflammation (i.e., inflammation sufficient to inhibit or prevent the formation of new bone or the knitting of a broken bone), or inhibit the proliferation of osteoblasts, or otherwise interfere with the activity of the granules and/or the osteoinductive material, and the biocompatible matrix is made from a flowable precursor material that reacts to form a solid mass, by polymerizing and/or cross-linking in the presence of the granules, such as collagen (see ¶[0037]), wherein, following a loading step, loaded granules are embedded into the biocompatible matrix (see ¶[0040]), wherein implants were tested for their density and elastic modulus across four slices, with the results demonstrating that the density across slices within a given scaffold was relatively uniform (see ¶[0061]), and wherein implants comprising 30% granules had a deviation between implants of approximately 8%, while implants with 20% and 25% granules did not, and a proximal slice from a scaffolds tended to have a relatively lower elastic modulus in the proximal slice than at the distal end, which can be attributed to the falling of the heavier granules in the hydrogel matrix at the end of mixing (see ¶[0063]). The reference does not disclose implants with composite granules comprising both HA and β-TCP, with β-TCP comprising about 95% of the composite granule, and HA from no more than 5%, or implants comprising a bioactive glass component, or implants comprising an interconnected porosity of from at least 70%, to 80 - 90%, or implants comprising pores with diameters from at least 350 µm diameter to 600 µm. The teachings of Dunkley ‘430 and Bagga WO ‘113 remedy those deficiencies.
Dunkley ‘430 discloses porous ceramic granules and methods of making them (see Abstract), wherein the granules comprise hydroxyapatite in an amount of about 8 to about 22% wgt and β-tricalcium phosphate in an amount of about 78 to about 92% wgt, with a microporosity, and a diameter of each of the micropores is less than about 10 µm, a BET surface area from about 0.2 to about 10 m2/g, and an average diameter from about 50 µm to 800 µm (see ¶[0009]), wherein, when disposed in a bone graft, the concave surfaces on the outer surface of each granule can facilitate an increase in new bone attachment since the surface makes new bone attachment easier (e.g., vascularization and penetration of associated cells) than attachment would be on a standard ceramic granule, facilitating rapid and homogeneous osseointegration that supports bone healing by acting as a scaffold over which bone can grow (see ¶[0068]), wherein additional synthetic ceramics can be used to form the porous ceramic granules, such as calcium phosphate ceramics, biological glasses, tricalcium phosphate (TCP), biphasic calcium phosphate, calcium sulfate, hydroxyapatite, coralline hydroxyapatite, silicon carbide, silicon nitride (Si3N and biocompatible ceramics) (see ¶[0077]), wherein the biphasic calcium phosphate can have a tricalcium phosphate:hydroxyapatite weight ratio of about 50:50 to about 95:5 (see ¶[0079]), wherein the granules can be used in a bone graft that can be utilized in a wide variety of orthopedic, periodontal, neurosurgical, oral and maxillofacial surgical procedures such as the repair of simple and/or compound fractures and/or non-unions (see ¶[0081]), and wherein the granules may be treated or chemically modified with one or more bioactive agents or bioactive compounds, such as osteogenic or chondrogenic proteins or peptides (see ¶[0082]).
Bagga WO ‘113 discloses bioactive porous composite bone graft implants suitable for use in bone tissue regeneration and/or repair, the implants having an engineered porosity, and that comprise bioactive glass (see Abstract), wherein porosity is necessary to allow vascularization, and the desired scaffold should have a porous interconnected pore network with surface properties that are optimized for cell attachment, migration, proliferation and differentiation (see p. 1, last para.), wherein the roles of porosity, pore size and pore size distribution in promoting revascularization, healing, and remodeling of bone have long been recognized as important contributing factors for successful bone grafting implants, suggesting an ideal range of porosities and pore size distributions for achieving bone graft success (see p. 2, 3rd para.), wherein synthetic bone repair implants offer advantages over the use of autogenous bone because, in comparison, the use of autogenous bone requires the patient to undergo multiple or extended surgeries, consequently increasing the time the patient is under anesthesia, and leading to considerable pain, increased risk of infection and other complications, and morbidity at the donor site (see p. 3, 1st para.), wherein materials such as bioactive glass (“BAG”) are an increasingly viable alternative, or supplement, to natural bone-derived graft materials with the advantage of avoiding painful and inherently risky harvesting procedures on patients, and can reduce the risk of disease transmission (see p. 3, 2nd para.), wherein different stoichiometric implants, such as hydroxyapatite (HA), tricalcium phosphate (TCP), tetracalcium phosphate (TTCP), and other calcium phosphate (CaP) salts and minerals have all been employed in attempts to match the adaptability, biocompatibility, structure, and strength of natural bone (see p. 3, 3rd para.), wherein, because calcium phosphate materials are inherently rigid, they are generally provided as part of an admixture with a carrier material, at relative loadings in the range of 50:50 – 10:90, in order to facilitate handling (see p. 3, last para. – p. 4, 1st para.), wherein implants made from hydroxyapatite tend to take too long to resorb, while implants made from calcium sulfate or β-TCP tend to resorb too quickly (see p. 4, 2nd para.), wherein if the porosity of the implant is too high (e.g., around 90% ), there may not be enough base material left after resorption has taken place to support osteoconduction and, conversely, if the porosity of the implant is too low (e.g., 10%,) then too much material must be resorbed, leading to longer resorption rates (id.), wherein the disclosed implants serve as cellular scaffolds to provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation (see p. 5, 1st para.), wherein the composite implants comprise a pore size distribution including pores characterized by pore diameters ranging from about 100 nm to about 1 mm (see p. 5, 2nd para.), wherein the implants comprise bioactive glass, in the form of granules or fibers, and a bioresorbable polymer (see p. 5, 3rd para.; see also, p. 6, 1st para.), wherein the implants provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation (see p. 12, 1st para.), wherein the carrier material is porous and helps contribute to healing, and the carrier material has the appropriate porosity to create a capillary effect to bring in cells and/or nutrients to the implantation site (see p. 13, 3rd para.), wherein the inclusion of bioactive glass granules can be accomplished using granules having a wide range of sizes or configurations to include roughened surfaces, very large surface areas, and the like (see p. 14, 3rd para.), wherein the implant materials possess nano-, micro-, meso-, and macro-porosity, the nanopores have a pore having a diameter below about 1 µm, down to as small as 100 nm, or less, the micropores having diameters between about 1 to 10 µm, the mesopores having diameters between about 10 to 100 µm, and macropores having diameters greater than about 100 µm to 1 mm, or even larger (see p. 15, 1st para.), wherein the bioactive glass material may be provided with variable degrees of porosity, and is preferably ultraporous, and the porosity may be provided inherently by the actual bioactive glass material itself, as well as the matrices separating the material within the overall implant (see p. 17, 2nd para.), wherein the pores are interconnected, allowing cell migration throughout the implant matrix (see p. 18, 2nd para.), wherein the binding material for the graft material comprises human-derived collagen or animal-derived collagen, which could be provided as a slurry and then hardened such as by freeze-drying (see p. 26, last para.), wherein the implants can further comprise biological agents, such as bone morphogenic protein (BMP), a peptide, a bone growth factor such as platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), insulin derived growth factor (IDGF), a keratinocyte derived growth factor (KDGF), or a fibroblast derived growth factor (FDGF), stem cells, bone marrow, and
platelet rich plasma (PRP) (see p. 30, 1st para.), and wherein the bioactive glass granules have diameters in the range of about 1 to 5 mm, or about 950 microns to about 3 mm, or about 850 microns to about 3 mm, or about 50 to 450 microns, or about 150 to 450 microns (see p. 44, 6th para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare synthetic bone grafts in the form of composite osteoinductive scaffolds that comprise an osteoinductive material, calcium ceramic granules, and a flowable biocompatible matrix material, such as collagen, wherein the granules comprise β-tricalcium phosphate (β-TCP), hydroxyapatite (HA), and combinations thereof, wherein the ceramic granules are in a biocompatible matrix comprising collagen that can be flowed over the osteoinductive material-loaded granules, wherein an osteoconductive material refers to any material which facilitates the ingrowth of osteoblastic cells including osteoblasts, pre-osteoblasts, osteoprogenitor cells, mesenchymal stem cells, and other cells that are capable of differentiating into or otherwise promoting the development of cells that synthesize and/or maintain skeletal tissue, such as, specifically, a porous granule comprising an osteoconductive calcium phosphate ceramic that include both micro- and macro-pores that define surfaces on which the osteoinductive substance can associate, both the micro-pores and macro-pores increasing the total surface area to which the osteoinductive substance can adhere, but only the macro-pores permit infiltration by cells, wherein the granules are characterized by a porosity that can be selected to achieve desired granule residence times or kinetics of release of an osteoinductive material, the porosity comprising both a microporosity and a macroporosity, wherein the micropores are large enough to permit infiltration of oesteoinductive factors such as solutions of BMP’s, and the macropores are large enough to permit infiltration by cells, wherein loaded granules are embedded into the biocompatible matrix, wherein implants were tested for their density and elastic modulus across multiple slices, and wherein a proximal slice from scaffolds tended to have a relatively lower elastic modulus in the proximal slice than at the distal end, which can be attributed to the falling of the heavier granules in the hydrogel matrix at the end of mixing, as taught by Wilson ‘156, wherein the biphasic calcium phosphate has a tricalcium phosphate:hydroxyapatite weight ratio of about 50:50 to about 95:5, with a microporosity, and a diameter of each of the micropores is less than about 10 µm, a BET surface area from about 0.2 to about 10 m2/g, and an average diameter from about 50 µm to 800 µm, wherein additional synthetic ceramics can be used to form the porous ceramic granules, such as biological glasses, wherein the granules may be treated or chemically modified with one or more bioactive agents or bioactive compounds, such as osteogenic or chondrogenic proteins or peptides, as taught by Dunkley ‘430, and wherein the implants have an engineered porosity and further comprise bioactive glass (“BAG”), as a supplement to natural bone-derived graft materials with the advantage of avoiding painful and inherently risky harvesting procedures on patients, and a reduced risk of disease transmission, wherein different stoichiometric implants, such as hydroxyapatite (HA), tricalcium phosphate (TCP), tetracalcium phosphate (TTCP), and other calcium phosphate (CaP) salts and minerals have all been employed in attempts to match the adaptability, biocompatibility, structure, and strength of natural bone, wherein the scaffolds provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation, wherein the composite implants comprise a pore size distribution including pores characterized by pore diameters ranging from about 100 nm to about 1 mm, wherein the implants provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation, wherein the implant materials possess nano-, micro-, meso-, and macro-porosity, the nanopores have a pore having a diameter below about 1 µm, down to as small as 100 nm, or less, the micropores having diameters between about 1 to 10 µm, the mesopores having diameters between about 10 to 100 µm, and macropores having diameters greater than about 100 µm to 1 mm, or even larger, wherein the pores are interconnected, allowing cell migration throughout the implant matrix, wherein the binding material for the graft material comprises human-derived collagen or animal-derived collagen, which could be provided as a slurry and then hardened such as by freeze-drying, wherein the implants can further comprise biological agents, such as bone morphogenic proteins (BMP’s), as taught by Bagga WO ‘ 113. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Yang (2023) to the effect that degradation rates of ceramic granules can better match the rate of ingrowth of new bone by adjusting the proportion of β-TCP and HA in the granules, and by the teachings of Bagga WO ‘113 to the effect that the disclosed micro- and macro-porosities are necessary to insure both cell migration into the scaffolds (macroporosity), and to permit influx of nutrients to the pores of the scaffold (microporosity), and that HA is known to resorb in vivo at a much slower rate than β-TCP, and that the resorption rate of BCP can be controlled by adjusting the ratio between HA and β-TCP, and that implants should resorb along a time frame consistent with the rate of new bone growth at the site of implantation.
With respect to claims 156 – 161, which claims recite quantitative limitations directed to ranges of porosity and pore sizes, the Examiner notes that the cited references do not recite quantitative limitations that are specifically congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches ranges of porosities and pore sizes that significantly overlap with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With respect to claim 163, which claim recites a limitation directed to the granules exhibiting a higher density than the matrix, the Examiner notes that the cited references do not directly address comparative densities of the major components of the implants. However, the Examiner further notes that Wilson ‘156 explicitly discloses that, during testing of the internal consistency of densities and elastic moduli of sample implants, that a proximal slice from a scaffold tended to have a relatively lower elastic modulus in the slice than a slice from the distal end, which observation was attributed to the falling of the heavier granules in the matrix at the end of mixing (see ¶[0063]). Consequently, the “heavier” granules must necessarily have a greater density than the collagen matrix in which they are distributed, thus reading on this limitation.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 153 – 163 and 167 - 173 would have been obvious within the meaning of 35 USC § 103.
Claims 174 - 176 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Wilson ‘156, in view of Dunkley ‘430 and Bagga WO ‘113, as applied in the above rejection of claims 153 – 163 and 167 - 173, and further in view of Woodruff, M., et al., materials today 15(10): 430 – 435 (2012) (“Woodruff (2012)”).
The Invention As Claimed
The invention with respect to claim 153 is described above. In addition, Applicants claim implantable orthobiologics comprising a porous biocompatible matrix and a population of composite granules, wherein the orthobiologics comprise an imbibed cell population of mesenchymal cells, derived from bone marrow aspirate.
The Teachings of the Cited Art
The disclosures of Wilson ‘156, Dunkley ‘430, and Bagga WO ‘113 are relied upon as applied in the above rejection of claims 153 – 163 and 167 - 173. The references do not disclose implants comprising an imbibed cell population of mesenchymal cells derived from bone marrow aspirate. The teachings of Woodruff (2012) remedy those deficiencies.
Woodruff (2012) discloses that the fundamental concept underlying tissue engineering is to combine a scaffold with living cells, and/or biologically active molecules to form a tissue engineering construct (TEC) that promotes the repair and/or regeneration of tissues (see p. 430, 2nd col.), wherein the TEC’s possess a porous interconnected pore network (pores & pore interconnections should be at least 400 µm to allow vascularization) with surface properties that are optimized for the attachment, migration, proliferation and differentiation of cell types of interest (depending on the targeted tissue) and enable flow transport of nutrients and metabolic waste, and be biocompatible and biodegradable at a controllable rate to compliment cell/tissue growth and maturation (id.), wherein the scaffolds comprise hydroxyapatite and tricalcium phosphate, and a polymer matrix (see p. 432, 2nd col., 2nd para.), wherein scaffolds with and without bone marrow derived mesenchymal stem cells (BMSC’s) were tested, the results of which indicated that composite scaffolds loaded with 40,000,000 bone marrow-derived mesenchymal precursor cells stimulated more bone formation than scaffolds without the cells (see p. 435, 2nd col., 1st para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare synthetic bone grafts in the form of composite osteoinductive scaffolds that comprise an osteoinductive material, composite calcium ceramic granules, and a flowable biocompatible matrix material, such as collagen, wherein the granules comprise β-tricalcium phosphate (β-TCP) and hydroxyapatite (HA), according to the teachings of Wilson ‘156, Dunkley ‘430, and Bagga WO ‘113, as applied in the above rejection of claims 153 – 163 and 167 - 173, wherein the grafts further comprise a population of mesenchymal cells derived from bone marrow aspirate, as taught by Woodruff (2012). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the explicit teachings of Woodruff (2012) to the effect that composite scaffolds loaded with 40,000,000 bone marrow-derived mesenchymal precursor cells stimulated more bone formation than scaffolds without the cells (see p. 435, 2nd col., 1st para.).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 174 - 176 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments in Applicants’ Response filed 21 November 2025 but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. For example, Applicants discuss at length the teachings of Park EP ‘113, and how those teachings fail to disclose quantitative proportions of HA and β-TCP as recited in the amended claims. However, the new grounds of rejection set forth above no longer cite to that reference. Instead, the rejection cites to Dunkley ‘430 for its teaching that the disclosed biphasic calcium phosphate granules comprise β-TCP at up to 95% wgt, the balance being HA.
Applicants also assert that granules comprising 90%, or more, of β-TCP provide improved performance of implants comprising those granules. However, given that Dunkley ‘430, as cited above, discloses granules with a β-TCP content reading on that range, it is the Examiner’s opinion that granules according to the cited art would necessarily provide the same results as Applicants are claiming are “unexpected.” Although Applicants describe the granules of the invention as being able to “improve osteoconductive properties without jeopardizing structural integrity,” factors not explicitly addressed in the cited art, the fact that Applicants have recognized another advantage that would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). In this regard, Applicants are reminded that the invention as claimed is directed to a composition of matter, and that, as a consequence, the reasons for combining the teachings of cited references, are not necessarily controlling to the patentability of the compositions, as claimed. The reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Consequently, based on the discussion above, Applicants’ arguments are unpersuasive and claims 153 – 163 and 167 – 176 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS 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.
CONCLUSION
Any inquiry concerning this communication or any other communications from the Examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The Examiner can normally be reached on M - F 8:30 a.m. - 5:00 p.m.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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