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 .
Request for Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 28 July 2026 has been entered.
Status of the Claims
Applicants’ Request for Continuing Examination, filed on 29 July 2026, is hereby acknowledged. At the time of filing, claims 14 – 21 and 23 – 36 were pending. Applicants’ filing amended claim 14, and added new claim 37. Claims 14 – 21 and 23 – 37 are available for substantive consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejections set forth in the Action of 28 April 2026 are hereby withdrawn as in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
Information Disclosure Statement
The Examiner has considered the information disclosure statement (IDS) filed 29 July 2026, which is now of record in the file.
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 14 – 18, 21, and 23 - 31 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2008/0033572 A1 to D’Antonio, P., et al., published 7 February 2008, identified on the IDS filed 17 April 2025, cite no. 101 (USPAT) (“D’Antonio ‘572”), in view of EP 3 031 479 A1 to Daculsi, G., et al., published 15 June 2016 (“Daculsi EP ‘479”), US 2011/0276147 A1 to Cook, R. and D. Antoine, published 10 November 2011, identified on the Information Disclosure Statement (IDS) filed 17 April 2025, cite no. 139 (USPAT) (“Cook ‘147”), and Liu, W., et al., Acta Biomaterialia 9: 5740 – 5750 (2013) (“Liu (2013)”), as evidenced by “Chemistry of METHOCELTM,” obtained from the Internet at https://www.stobec.com/DATA/PRODUIT/1688~v~data_8733.pdf on 16 August 2025 (“METHOCEL”), and US 2017/0333190 A1 to Vickers, S., et al., published 23 November 2017 (“Vickers ‘190”).
The Invention As Claimed
Applicants claim 14/15/26/28/29/30/31/a bone graft comprising a composition that comprises carbonate apatite, at 60 – 90%, methylcellulose, at 5 – 20%, bioactive glass, at 0.5 – 10%, and fibrillar collagen, at about 5 – 15%, wherein the fibrillar collagen is not lyophilized, wherein the calcium phosphate, the methylcellulose, and the bioactive glass are configured to embed in the fibrillar collagen when the composition is mixed with an aqueous solution, wherein the composition is synthetic and not allogeneic, and wherein 16/the methylcellulose has a molecular weight of greater than 500, or 21/a molecular weight of between 650 and 750, wherein 17/the composition is viscoelastic, wherein 23/a length of the composition along an axis increases at least 0.05 mm, or 25/at least 0.35 mm when hydrated, wherein 24/the composition exerts less than 1.5 N of force on surrounding structures during expansion, and 27/wherein the methylcellulose has a viscosity of between 5,000 cPs and 15,000 cPs.
The Teachings of the Cited Art
D’Antonio ‘572 discloses bone graft compositions comprising demineralized bone matrix, calcium phosphate, collagen, and a bioinductive cellular solution (see Abstract; see also ¶¶[0021] – [0025]), wherein the bone graft compositions are formulated using a calcium phosphate ceramic, demineralized bone matrix, and collagen, provided in powdered form, which is then hydrated into an expandable matrix or putty by hydrating the powdered bone graft composition with one or more bioinductive cellular solutions comprising one or more of blood, bone marrow aspirate, or adipose tissue liposuction aspirate (see ¶[0026]), wherein the calcium phosphate ceramic comprises calcium carbonate apatite, e.g., C10(PO4)6CO3 (see ¶[0036]), wherein mixtures of calcium phosphates and bioactive glass, can be incorporated into the formulations (see ¶[0048]), wherein the amount of calcium phosphate ceramic incorporated into the graft is more than 15% (see ¶[0050]), wherein the calcium phosphate ceramics can be used in bone graft composites having various product forms, including injectable or moldable pastes, or moldable putties for temporary bone filling, pre-hardened shaped graft implants, and coatings for orthopedic devices and prostheses (see ¶[0051]), wherein the collagen component may be in a polymerized fibrous form that has a long three-dimensional architecture with multiple cross-links, such as purified fibrillar bovine tendon Type I collagen, present in the compositions from about 10% wgt to about 45% wgt (see ¶[0058]), wherein the collagen can support the growth and differentiation of bone forming progenitor stem cells, particularly those stem cells that differentiate into osteoblast-like cells expressing osteonectin, osteopontin and CD44, improving the resorption profile of bone-grafted tissue and enhancing the remodeling of synthetic bone over to natural bone (see ¶[0059]), wherein bone graft composites comprising collagen carriers can have augmented properties, and improved moldability over the same bone graft composition without the collagen carrier present (see ¶[0060]), wherein the compositions can be formed by providing the powdered bone graft precursor (e.g., calcium phosphate ceramics, demineralized bone matrix, and collagen carrier), and contacting, e.g., mixing, the powdered components with a bioinductive cellular solution to form a bone graft composite that can be implanted in a patient in a paste or putty form (see ¶[0072]), wherein the paste form is an injectable paste that can be injected into the implant site using a twelve to eighteen-gauge needle syringe (see ¶[0074]), and wherein, in an exemplified embodiment, an implant composition is formed into an elliptical wedge with a major axis of about 7 cm and a minor axis of about 2 cm, that, when expanded, has a major axis of 7 cm and a minor axis of 5 cm (see ¶[0092]). The reference does not explicitly disclose bone graft compositions comprising methylcellulose at 5 – 20%. The teachings of Daculsi EP ‘479, Cook ‘147, and Liu (2013) remedy those deficiencies. [Wingdings font/0xE7] verify
Daculsi EP ‘479 discloses compositions comprising bioceramic granules, and a compound chosen from protein, micro-, or nano-fibers (see Abstract), wherein the compositions are able to provide higher surface areas for cell spreading and osteogenic cell differentiation, enabling bone ingrowth, allowing living cells, such as mesenchymal stromal or stem cells (MSC’s), Osteoblasts, Induced Pluripotent Stem Cells (IPSC’s) to grow into the granules and gradually undergo osteogenesis (see ¶[0008]), wherein the compositions are preferably used as implants, and which may be in different forms like pellets, hollow cylinders (tubes), parallelepiped blocs, paste, putties or membranes (id.), wherein the compositions have osteogenic and osteoinductive properties and possess the inherent capacity to form bone, implying that they comprises living cells, such as osteocytes or osteoblasts, with the granules providing support for local tissue microenvironments that maintain and regulate stem cells (see ¶[0011]), wherein the granules are made of bioactive ceramics that are biocompatible (i.e., inert to the body, or which are resorbable), the bioceramics interacting with, or having an effect on, a cell or tissue of the body, the bioactive bioceramic being chosen from bioactive glasses, apatites such as hydroxyapatite (HA; Ca10(PO4)6(OH2), α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), or biphasic calcium phosphates (mixtures of HA with α-TCP and/or β-TCP), substituted by at least one moiety, such as Mg2+, Sr2+, Na+, Si4±, and CO32-, or mixtures thereof (see ¶[0014]), wherein, besides the bioceramic granules, the compositions also comprise a compound chosen from proteins and micro- or nano-fibers (see ¶[0019]), the fibers preferably prepared by an electrospinning process (see ¶[0020]), wherein the fibers comprise collagen, or, preferably, a cellulose-derived polymer, such as methylcellulose (see ¶[0021]), and, wherein the compounds are present in relative amounts of 10 – 60% (see ¶[0025]).
Cook ‘147 discloses osteoinductive bone graft substitute compositions that do not return to its original shape upon hydration, the compositions comprising about 86 - 89% by weight of a calcium phosphate particulate mineral component, and about 11 - 14 % by weight of a purified fibrillar collagen (see Abstract; see also ¶[0021]), wherein compositions comprising calcium phosphates and collagen can provide a synergistic combination of structural materials useful in bone graft substitute applications (see ¶[0010]), wherein the calcium phosphate particulate mineral component comprises partially resorbable hydroxyapatite/tricalcium phosphate (HA/ TCP) ceramic (see ¶[0016]), wherein the bone graft substitute composition is osteoconductive, osteointegrative and may be osteoinductive (see ¶[0018]), wherein the compositions comprise highly purified Type I collagen (see ¶[0019]), wherein the compositions provide a bone void filler that resorbs and is replaced by the growth of new bone during the healing process (see ¶[0038]), wherein the compositions comprise β-tricalcium phosphate (β-TCP), and Type I bovine collagen (see ¶[0039]; see also ¶¶[0042] – [0043]), wherein the hydroxyapatite (HA) is radiopaque and highly biocompatible, the HA possessing a stoichiometry similar to bone mineral and is minimally resorbed as bone grows into the scaffold, while the β-TCP ceramic has a stoichiometry similar to amorphous biologic precursors to bone, it is also biodegradable, and its biodegradation products can be reconstituted by the body to form new bone mineral, allowing for bone deposition to occur (see ¶[0042]), and wherein the compositions have a density of about 0.573 g/cm3, as determined from weights and dimensions of the compositions formed into appropriate shapes (see ¶[0046]).
Liu (2013) discloses the results of investigations into the influence of cellulose ether additives (CEA’s) on the performance of final calcium phosphate cement (CPC) products, wherein the performance parameters include properties, such as handling (e.g., injectability, cohesion, washout resistance, and setting time), microstructure (e.g., porosity and micromorphology), and mechanical properties (e.g., fracture toughness and compressive strength), wherein even a small
amount of CEA’s modified most of these features for CPC’s, depending on the structural parameters of the CEA’s, wherein inclusion of CEA’s dramatically improved the injectability, cohesion, and washout resistance of the pastes, prolonged the final setting time, and increased the porosity of CPCs, as well as resulting in an evident toughening effect on CPC’s, the effect becoming more significant with increasing molecular weight and mass fraction of CEA’s, inducing a significant tolerance to damage (see Abstract), wherein CPC’s without any additives have a poor injectability which is normally characterized by the occurrence of phase separation between the liquid and the solid (see p. 5740, 1st col., last para.), wherein the CEA’s investigated were A15, E4M, K4M and K15M (which commercial designations, as evidenced by METHOCELLTM (see p. 8), “are based on viscosity values determined in water at 20°C, with a concentration of 2% METHOCEL™”) (see p. 5741, 1st col., 4th para.), wherein CEA’s increase the viscosity and improve the homogeneity of the CPC paste, which effectively reduce or even prevent filter pressing [solid-liquid phase separation], thus, significantly enhancing the injectability of the paste (see p. 5745, 2nd col., 2nd para.), wherein, in addition to improving the injectability of CPC pastes, CEA’s can also improve their cohesion and anti-washout performance, owning to the increased viscosity and increased inter-particle interaction (see p. 5746, 1st col., 2nd para.), wherein the addition of CEA’s (A15, E4M, K4M and K15M) with different structural parameters modifies almost all the performance aspects of cement, including the handling properties, porosity and mechanical properties (see p. 5748, 2nd col., last para.), and wherein the mechanism of improvement in injectability, cohesion and washout resistance is closely related to the increasing viscosity of the cement paste, which increases with the molecular weight and loading of the CEA’s (see p. 5748, 2nd col., last para. – p. 5749, 1st 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 bone graft compositions comprising a bioactive ceramic, such as a calcium phosphate, collagen, and a cellular solution, such as blood, bone marrow aspirate, or adipose tissue liposuction aspirate, wherein the components are provided in a powdered form which is then hydrated into an expandable matrix or putty, wherein the calcium phosphate ceramic comprises carbonate apatite (C10(PO4)6CO3), wherein the composition also comprises bioactive glass, wherein the collagen component is fibrillar bovine tendon Type I collagen, present in the compositions from about 10% wgt to about 45% wgt, and wherein an implant composition in the form of an elliptical wedge, when expanded, displays expansion along a minor axis of from 2 cm to 5 cm, as taught by D’Antonio ‘572, wherein the compositions further comprise a component, such as methylcellulose in the form of electrospun fibers, in amounts of from 10 – 60% relative to the bioactive ceramic, as taught by Daculsi EP ‘479, wherein the methylcellulose is METHOCELTM A15, as taught by Liu (2013), and wherein the bone graft compositions comprise about 86 - 89% by weight of the bioactive calcium phosphate ceramic, and Type I bovine collagen, as taught by Cook ‘147. 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 Liu (2013) to the effect that a methylcellulose, such as A15 dramatically improves the injectability, cohesion, and washout resistance of bone repair pastes, prolonged the final setting time, and increased the porosity of the pastes, as well as resulting in an evident toughening effect on the pastes, and by the teachings of Cook ‘147 to the effect that compositions comprising calcium phosphates and collagen can provide a synergistic combination of structural materials useful in bone graft substitute applications (see ¶[0010]).
With respect to the newly added limitation recited in claim 14, the limitation directed to the composition of the invention being “synthetic and not allogeneic,” the Examiner notes that in addition to reciting a calcium phosphate, methylcellulose, and bioactive glass as components of the composition, all of which are recognized as being “synthetic,” claim 14 also recites “fibrillar collagen” as a component, presumably of the composition. It is the Examiner’s position that one of ordinary skill in the art would recognize that a likely source of the fibrillar collagen would be natural, such as from bone, skin, cartilage, ligaments, tendons, etc. Furthermore, when compositions comprise fully demineralized bone matrix (DBM), as evidenced by Vickers ‘190 (see ¶¶[0025]), the DBM can contain less than 1% wgt calcium, and be in the form of fibers (see ¶¶[0052], [0066]-[0068]). Thus, the composition, as a whole cannot be “synthetic” when comprising natural fibrillar collagen and/or fully demineralized bone material. Consequently, it is the Examiner’s position that, to maintain the statutory validity of the claims, the fibrillar collagen must not be included with the synthetic components. The only alternative would be to reject claim 14, and all claims dependent from it, pursuant to 35 U.S.C. § 112(b).
With respect to those claims reciting quantitative limitations directed to relative loadings of components in the compositions of the invention, or molecular weights and viscosities, the Examiner notes that the loadings taught in the cited references are not exactly congruent with the claim limitations. However, it is the Examiner’s position that the cited art teaches a range of loadings of these components that significantly overlap with the claimed loadings 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 the limitation in claim 14 reciting that the components of the compositions of the invention are “embedded in the fibrillar collagen,” the Examiner notes that the cited references do not specifically use such term as “embedded” to describe the distribution of solid components in the compositions. However, Applicants’ specification, at ¶[0073], discloses that the solid components of the compositions “can be embedded in the collagen 212 when mixed with an aqueous solution” (emphasis added). Therefore, it is the Examiner’s position that compositions comprising carbonate apatite, collagen, and Bioglass, such as those disclosed in D’Antonio ‘752, that are prepared in a putty form by addition of aqueous solutions, would result in the solid components being embedded in the collagen, as that term is used in the claim.
With respect to claims 16 and 21, which claims recite limitations directed to molecular weight ranges of the methylcellulose, and claim 27, reciting a viscosity range for the methylcellulose component of the compositions, the Examiner notes that one of the methylcelluloses disclosed in Liu (2013) is METHOCELTM with a commercial designation of A15, which, as evidenced by METHOCEL, indicates that the methylcellulose necessarily has a number average molecular weight (Mn) of 13,000 – 16,000 Da [extrapolated] (see p. 9), thus reading on claim 16 (molecular weight greater than 500). The Examiner further notes that claim 21 recites a limitation directed to methylcellulose with a molecular weight between 650 and 750 [kDa]. However, it is the Examiner’s position that selecting a methylcellulose with a molecular weight within the range recited in claim 21 would amount to nothing more than an optimization of a result-effective variable, particularly in light of the disclosures of Liu (2013) regarding the effects of MEC molecular weight on the properties of bone implant compositions, as correlated with viscosity, the exercise of which is well with the expertise of one of ordinary skill in the appropriate art. Consequently, in the absence of evidence as to the criticality of such parameter, this limitation cannot support patentability. See MPEP § 2144.05 II. A.
As for the viscosity limitation recited in claim 27 (5,000 – 15,000 cP·s), the Examiner notes that methylcellulose with a commercial designation of A15, as disclosed in Liu (2013), necessarily has a viscosity of 12,000 – 18,000 cP·s [1 cP·s = 1 mPa·s], as evidenced by METHOCEL (see p. 3), thus reading on the limitation in question.
With respect to claim 17, which claim recites a limitation directed to the compositions of the invention being “viscoelastic,” the Examiner notes that the cited references do not teach implant compositions characterized as being viscoelastic. However, the Examiner notes that Applicants’ specification (see Abstract) discloses that the inventive compositions turn into a viscoelastic material upon hydration with an aqueous solution. In this regard, D’Antonio ‘572 teaches that the disclosed bone graft compositions are “formulated using calcium phosphate ceramic, demineralized bone matrix and collagen, provided in powdered form which is then hydrated into an expandable matrix or putty by hydrating the powdered bone graft composition” (see ¶[0026]). It is the Examiner’s position that the expandable putty formed through hydration would display characteristics, such as moldability, that would be recognized by one of ordinary skill in the art as “viscoelastic.”
The Examiner notes that claim 18 recites a limitation directed to compositions that are “configured to flow through a distal end of a device to a target area.” However, it is the Examiner's position that such recitation in the claim is no more than a statement of intended purpose and, as such, is not accorded patentable weight. Such recitations are generally not accorded any patentable weight where they merely recite the purpose of a process, or the intended use of a structure, and where the body of the claim does not depend on such recitation for completeness but, instead, the process steps or structural limitations are able to stand alone. See, In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976), and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). Further in this regard, the Examiner notes that D’Antonio ‘572 specifically discloses that compositions in the form of hydrated pastes “can be injected into the implant site, preferably using a twelve to eighteen-gauge needle syringe,” and that this disclosure reads on the limitation in question, rendering it prima facie obvious.
With respect to claim 24, which claim recites a limitation directed to the composition of the invention exerting “less than 1.5 N of force” on surrounding structures during expansion, the Examiner notes that, although references such as D’Antonio ‘572 disclose compositions that expand upon hydration, as discussed above, the reference is silent on any forces exerted by the compositions during that expansion. In this regard, the Examiner would first note that the limitation in question is reasonably read to include compositions exerting NO forces on surrounding structures. In light of the fact that D’Antonio ‘572 is silent on any forces exerted during expansion, it is the Examiner’s position that it is reasonable to conclude that the disclosed compositions do not exert a measurable force (“less than 1.5 N”) on their surroundings during hydration and expansion. Consequently, the compositions read on the limitation in question, rendering it obvious.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 14 – 18, 21 and 23 - 31 would have been obvious within the meaning of 35 USC § 103.
Claims 19, 20, and 32 - 36 are rejected pursuant to 35 U.S.C. § 103, as being obvious over D’Antonio ‘572, in view of Daculsi EP ‘479 A1, and Cook ‘147, as applied in the above rejection of claims 14 – 18, 21 and 23 - 31, and further in view of US 2013/0095183 A1 to Gibson, I., et al., published 18 April 2013 (“Gibson ‘183”).
The Invention As Claimed
The invention with respect to claim 14 is described above. In addition, Applicants claim 32-36/a bone graft composition comprising carbonate apatite, at 60 – 90%, methylcellulose, at 5 – 20%, Bioglass, at 0.5 – 10%, and fibrillar collagen, at about 5 – 15%, and wherein the carbonate apatite has a particle size between 0.3 µm and 1 µm, or between 0.3 µm and 2 µm.
The Teachings of the Cited Art
The teachings of D’Antonio ‘572, Daculsi EP ‘479 A1, Cook ‘147, and Liu (2013) are relied upon as applied in the above rejection of claims 14 – 18, 21 and 23 - 31. The references do not disclose compositions comprising methylcellulose (MEC), wherein the carbonate apatite has particle sizes between 0.3 and 2 µm. The teachings of Gibson ‘183 remedy those deficiencies.
Gibson ‘183 discloses a bone graft system comprising a solid inorganic component, which is a bone graft material, such as an hydroxyapatite, and a hydrogel (see Abstract; see also, ¶[0035]), wherein the hydroxyapatite is provided in the form of a powder (see ¶[0026]), wherein the powder has granules with diameters between 0.001 mm (1 µm) and 10 mm, the diameters in this range providing increased surface area of the solid inorganic component, increasing bone healing capabilities (see ¶[0027]), wherein the particles of the hydroxyapatite are distributed through a matrix of the hydrogel (see ¶[0028]), wherein the hydroxyapatite is an ion-substituted hydroxyapatite (see ¶[0031]), and wherein the hydrogel comprises a natural polymer, such as collagen (see ¶[0048]).
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 bone graft compositions comprising carbonate apatite, methylcellulose, Bioglass, and fibrillar collagen, as taught by D’Antonio ‘572, Daculsi EP ‘479 A1, Cook ‘147, and Liu (2013), wherein the calcium phosphate ceramic has particle sizes in the range of 1 µm to 10 mm, as taught by Gibson ‘183. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of the reference to the effect that calcium phosphate particles with diameters in this range provide an increased surface area of the solid inorganic component, increasing its bone healing capabilities (see ¶[0027]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 19, 20, and 32 - 36 would have been obvious within the meaning of 35 USC § 103.
Claim 37 is rejected pursuant to 35 U.S.C. § 103, as being obvious over Ferreira, S., et al., Materials Science & Engineering C 118: 111393 (12 pp.), available on-line 22 August 2020 (“Ferreira (2020)”), in view of Liu (2013), and US 2003/0049328 A1 to Dalal, P., et al., published 13 March 2003 (“Dalal ‘328”).
The Invention As Claimed
Applicants claim a bone graft composition consisting essentially of calcium phosphate, methylcellulose, bioactive glass, and fibrillar collagen, wherein the collagen is not lyophilized, and comprises loose fibers.
The Teachings of the Cited Art
Ferreira (2020) discloses that OssiMend® Bioactive (Collagen Matrix Inc., NJ) is a three-component porous composite bone graft device of 45S5 Bioglass/carbonate apatite/collagen, wherein conditioned media of the dissolution products of OssiMend® Bioactive stimulated primary human osteoblasts to form mineralized bone-like nodules in vitro in one week, in basal culture media, without osteogenic supplements (see Abstract). The reference does not disclose a composition further comprising methyl cellulose. The disclosures of Liu (2013), as set forth above, and US 2003/0049328 A1 to Dalal, P., et al., published 13 March 2003 (“Dalal ‘328”), remedy that deficiency.
Dalal ‘328 discloses a porous β-tricalcium phosphate material for bone implantation, wherein the material further comprises a binder (see Abstract), wherein the material, when used in conjunction with binders, forms a moldable putty composition ready for shaping in the implant site (see ¶[0008]), wherein a binder is any physiologically compatible material which, when admixed with osteogenic protein in the porous matrix promotes bone formation, the binders promoting such repair while using less osteogenic protein than standard osteogenic devices (see ¶[0052]), wherein preferred binders include resorbable macromolecules from biological or synthetic sources including methylcellulose, and/or collagen (see ¶[0070]).
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 bone graft compositions comprising a bioactive ceramic, such as a calcium phosphate, collagen, and a bioactive glass, wherein the compositions further comprise a component, such as methylcellulose (METHOCELTM A15) as a binder, as taught by Liu (2013) and Dalal ‘328. 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 Liu (2013) to the effect that a methylcellulose, such as A15, dramatically improves the injectability, cohesion, and washout resistance of bone repair pastes, prolonged the final setting time, and increased the porosity of the pastes, as well as resulting in an evident toughening effect on the pastes, and by the teachings of Dalal ‘328 to the effect that binders promote bone repair while using less osteogenic protein than standard osteogenic devices (see ¶[0052]).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claim 37 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in the Response filed 29 July 2029, but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. The principal thrust of Applicants’ arguments is based on the contention that “the cited references fail to disclose a synthetic and not allogeneic composition including calcium phosphate, methylcellulose, and bioactive glass.” Applicants predicate this argument on the disclosure in D’Antonio ‘572 discloses a composition comprising demineralized bone matrix. However, as set forth in the above rejection, Applicants’ composition, as claimed, cannot be interpreted to comprise collagen from natural sources, because that would not be “synthetic.” Furthermore, DBM, when fully demineralized would consist of fibrous collagen, which would then read on the fibrillar collagen limitation. Thus, whether or not the DBM is from natural or synthetic sources, it would comprise collagen fibers, further reading on claim 14.
Consequently, based on the above discussion, 14 – 21 and 23 – 37 stand rejected pursuant to 35 U.S.C. § 103.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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