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 .
Status of the Claims
The Examiner acknowledges receipt of Applicants’ Response, filed 21 November 2025. Claims 23, 25, 26, and 28 – 31 are amended therein, and claims 1 – 7, 12, and 13 are cancelled. New claims 32 – 36 are added. Accordingly, claims 14 – 36 are currently available for active consideration.
Information Disclosure Statement
The Examiner has considered the information disclosure statement (IDS) filed 21 November 2025, which is now of record in the file.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejections pursuant to 35 U.S.C. § 112(b) set forth in the Action of 21 August 2025 are hereby withdrawn in light of Applicants’ amendment of the claims.
REJECTIONS MAINTAINED AND MADE AGAIN
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.
The rejection of claims 14 - 18 and 21 - 31 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, 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”), is hereby maintained.
The Invention As Claimed
Applicants claim a composition comprising carbonate apatite, at 60 – 90%, methylcellulose, at 5 – 20%, Bioglass, at 0.5 – 10%, and fibrillar collagen, at about 5 – 15%, wherein the fibrillar collagen is not lyophilized, wherein the methylcellulose has a molecular weight of greater than 500, or a molecular weight of between 650 and 750, wherein the composition is viscoelastic, wherein the carbonate apatite, methylcellulose, and Bioglass are embedded in the fibrillar collagen, wherein a length of the composition along an axis increases at least 0.05 mm, or at least 0.35 mm when hydrated, wherein the composition exerts less than 1.5 N of force on surrounding structures during expansion, 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 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 wherein the carbonate apatite is present at 60 – 90%, or compositions comprising methylcellulose, present at 5 – 20%. The teachings of Daculsi EP ‘479, Cook ‘147, and Liu (2013) remedy those deficiencies.
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 composition 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 bioinductive cellular solution, wherein the components are provided in powdered form which is then hydrated into an expandable matrix or putty by hydrating the powdered bone graft composition with blood, bone marrow aspirate, or adipose tissue liposuction aspirate, 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 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 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 claimed range amounts 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, 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 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 regard to claim 22, which claim recites a limitation directed to the components of the compositions of the invention being “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 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 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 and 21 - 31 would have been obvious within the meaning of 35 USC § 103.
Rejections Pursuant to 35 U.S.C. § 103
The rejection of claims 19 and 20, and now applied to newly added claims 32 - 36 are 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 16, 21, 23, 25, 26, and 28 - 31, and further in view of US 2013/0095183 A1 to Gibson, I., et al., published 18 April 2013 (“Gibson ‘183”) is hereby maintained.
The Invention As Claimed
The invention with respect to claim 14 is described above. In addition, Applicants claim 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 16, 21, 23, 25, 26, and 28 - 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 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.
Response to Applicants’ Arguments
The Examiner has considered the arguments submitted by Applicants in the Response filed 21 November 2025, but does not find them persuasive. Applicants first argue that “the cited portions of the references fail to disclose the use of fibrillar collagen that is not lyophilized,” as required by claim 14. The Examiner respectfully disagrees on the basis that Applicants’ argument rests on an overly narrow application of the teachings of the cited references.
In this regard, the Examiner notes that D’Antonio ‘572, at ¶[0077], discloses that “the bone graft compositions can be first lyophilized and then rehydrated upon implantation.” The Examiner also notes that the reference discloses but a single exemplified embodiment, which embodiment comprises a mixture of powders that is sterilized and then lyophilized, the mixture subsequently being hydrated with bone marrow aspirate to form a scaffold (see ¶[0092]). Nowhere does the reference explicitly state that the disclosed compositions must be lyophilized. Furthermore, Applicants are reminded that references are relevant as prior art for all they contain. See MPEP § 2123: “A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component).”
It is the Examiner’s position, therefore, that one of ordinary skill in the relevant art would understand that D’Antonio ‘572 teaches, either explicitly or by suggestion, that the disclosed bone graft compositions can be, but are not required to be lyophilized.
Consequently, Applicants’ arguments are unpersuasive, and claims 14 – 36 stand rejected as obvious pursuant to 35 U.S.C. § 103.
NEW GROUNDS OF REJECTION
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. § 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 32 and 35 contain the trademark/trade name BIOGLASS®. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. § 112(b). See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain because the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a bioactive glass, typically referred to generically as 45S5 bioactive glass and, accordingly, the identification/description is indefinite. Appropriate correction or cancelation of the claims is necessary.
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