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 Applicant’s Response, filed 26 November 2025. Applicant has amended claims 1, 12, 21, 27, 30, and 37. Accordingly, claims 1, 12, 13, 21, and 23 - 37 are available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 112
The rejection pursuant to 35 U.S.C. § 112(b) as set forth in the Action of 27 August 2025 is hereby withdrawn in light of Applicants’ amendment of the claims.
Rejections Pursuant to 35 U.S.C. § 103
The rejection pursuant to 35 U.S.C. § 103 as set forth in the Action of 27 August 2025 is hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.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. § 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.
Claim 36 is rejected pursuant to 35 U.S.C. § 112(b), as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
The claim, dependent ultimately from claim 1, recites a limitation directed to the pH of the bone morphogenic protein solution being adjusted within a specific range “using a phosphate buffer solution.” However, Applicants have amended claim 1 to use the closed transitional phrase, “consisting of,” the effect of which is to limit the bone morphogenic protein solution to a bone morphogenic protein and a solvent, to the exclusion of any ingredient not specified in the claim, see MPEP 2111.03. However, claim 36 recites an additional component in the form of the phosphate buffer saline. Thus, claim 36 is indefinite because one of skill in the art would be uncertain as to whether the composition as recited in claim 1 can encompass the buffered saline. Appropriate correction or cancelation is required.
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.
Claims 1, 12, 13, 21, and 23 - 37 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2004/0097612 A1 to Rosenberg, A., and L. de Pelichy, published 20 May 2004 (“Rosenberg ‘612”), in view of US 2019/0255216 A1 to Kalpakci, K. and D. Shimko, filed 22 February 2018 (“Kalpakci ‘216”), US 2019/0209735 A1 to Suppiger, D., et al., published 11 July 2019 (“Suppiger ‘735”), and US 2020/0230291 to Zhao, B., et al., claiming priority to 3 March 2017 (“Zhao ‘291”), as evidenced by Queiroz, C. (2023), Re: How will prepare phosphate buffer PH4.5?, retrieved from the Internet at: https://www.researchgate.net/post/How_will_prepare phosphate_buffer_-PH45/-63f65d8f5ceba117db06b794/citation/download on 2 January 2025 (“Queiroz (2023)”).
The Invention As Claimed
Applicant claims a bone graft composition consisting of a bone graft solution consisting of a natural bone graft material, hydroxypropyl methylcellulose (HPMC), and a solvent, and a bone morphogenetic protein solution consisting of rhBMP-2 and the solvent, wherein the natural bone graft material and the HPMC reach an osmotic pressure of 104 to 112% within 12 to 48 hours after added to the bone graft solution, when an osmotic pressure of saline is set to 100% as a reference value, wherein the bone graft solution consists of 1 part by weight of the natural bone graft material and the HPMC, and 0.5 to 2 parts by weight of the solvent, wherein the natural bone graft material and the HPMC consist of 1 part by weight of the natural bone graft material and 0.3 to 3 parts by weight of the HPMC, wherein the concentration of the bone morphogenetic protein in the bone morphogenetic protein solution is 0.05 to 0.15 mg/mL, or 0.08 to 0.12 mg/mL, wherein the bone graft composition is sterilized by gamma-ray irradiation at a dose of 10 to 25 kGy, or by an ethylene oxide gas, at a dose of 450 – 1200 mg/L, wherein the natural bone graft material containing the HPMC consists of 1 part by weight of the natural bone graft material with 0.3 to 3 parts by weight of the HPMC, wherein the bone morphogenetic protein adsorbs on the natural bone graft material, and the volume ratio between the natural bone graft material having the bone morphogenetic protein adsorbed thereon and the HPMC is 1 :0.2 to 1:0.6, or 1 :0.25 to 1:0.35, wherein the natural bone graft material is an autogenous bone, an allogeneic bone, or a xenogenic bone, wherein the natural bone graft material is in the form of bone powders, bone chips, or bone blocks, wherein the natural bone graft material is a bone powder, and the HPMC is an HPMC powder, and wherein the bone graft composition consists essentially of 0.3 to 3 parts by weight of the HPMC powder with respect to 1 part by weight of the bone powder, wherein the bone morphogenetic protein is adsorbed on the bone graft material powder, wherein the volume ratio of the bone powder and the HPMC powder is 1 : 0.2 to 1 : 0.6, wherein the bone graft composition is in hydrated form, wherein the bone morphogenetic protein solution has a pH between 4.6 and 5, and wherein the pH of the bone morphogenetic protein solution is adjusted using phosphate buffered saline.
The Teachings of the Cited Art
Rosenberg ‘612 discloses a demineralized bone matrix composition that comprises demineralized bone matrix fibers and a biocompatible liquid to produce a coherent, formable mass (see Abstract), wherein, when the mass is subjected to large volumes of fluid, e.g., water, saline, or bodily fluids, the shape and mass of the composition is retained without the use of binders or high viscosity carrier vehicles (see ¶[0011]), wherein the DBM composition optionally contains DBM particles having an aspect ratio of less than about 3 (see ¶[0016]; see also, EX. 6), wherein the DBM particles comprise from 0 – 75% wgt of the DBM component (see ¶[0052]), wherein the composition may optionally contain an osteoinductive additive to enhance bone ingrowth and remodeling (see ¶[0017]), wherein the compositions have an additive that at least partially coats the DBM particles (see ¶[0019]), wherein the relative amounts of DBM and biocompatible liquid range from 1:10 to 10:1 (see ¶[0020]), wherein the DBM is obtained from cortical autogenic, cortical allogenic, cortical xenogeneic, cancellous autogenic, cancellous allogenic, cancellous xenogeneic, corticocancellous autogenic, corticocancellous allogenic, or corticocancellous xenogeneic bone (see ¶[0021]), wherein the DBM is present in an amount greater than 40% wgt of the dry component of the compositions (see ¶[0023]), wherein the biocompatible liquid may be any biocompatible liquid, including water, saline solution, buffered solutions, serum, bone marrow aspirant, blood, platelet-rich plasma, and the like, and mixtures thereof, and the liquid can additionally contain osteoinductive factors that will promote bone growth at the site to which the composition is applied (see ¶[0049]), wherein an osteoinductive
component is included in the DBM composition to further enhance the osteoinductivity of the paste composition, such as synthetic or naturally-derived bone morphogenic proteins (BMP’s) (see ¶[0053]), wherein an additive, such as hydroxypropyl methylcellulose, is included in the DBM composition to modify the handling characteristics of the composition, such as viscosity and moldability, the additive added to either the dry DBM component or the liquid component (see ¶[0063]), wherein the DBM constitutes about 5 to about 100% of the dry component, the balance of the dry component being comprised of the optional components (see ¶[0064]), and wherein the DBM composition is prepared by mixing desired quantities of DBM, biocompatible liquid and additive in any suitable sequence of mixture operations, or all at once (see ¶[0066]). The reference does not expressly disclose a bone graft composition comprising rhBMP-2 as the bone morphogenic protein, at a concentration in the range of 0.05 to 0.15 g/mL, adsorbed onto the bone graft material, or a composition that is sterilized by gamma-ray irradiation at a dose of 10-25 kGy, or by exposure to ethylene oxide gas at a dose of 450 to 1200 mg/L, or a composition wherein the volume ratio of bone graft material with adsorbed BMP-2 to HPMC is 1:0.2 – 1:0.6, or a composition that consists essentially of 0.3 to 3 parts by weight of HPMC powder with respect to 1 part by weight of bone material. The teachings of Kalpakci ‘216, Suppiger ‘735, and Zhao ‘291 remedy those deficiencies.
Kalpakci ‘216 discloses moldable implants configured to fit at or near a bone defect to promote bone growth, the implants comprising lyophilized demineralized bone matrix (DBM), alginate, and a liquid carrier, wherein the DBM is in an amount of about 15% wgt to about 40% wgt of the total weight of the implant (see Abstract; see also ¶[0011]), wherein the DBM is derived from bone that is cortical, cancellous or cortico-cancellous of autogenous, allogenic, xenogenic, or transgenic origin (see ¶[0048]), wherein the demineralized bone matrix (DBM) refers to any material generated by removing mineral material from bone tissue (see ¶[0053]), in fiber and/or powder forms, and the implants further comprise a liquid carrier (see ¶[0064]), wherein the DBM is in an amount of about 1 to about 99% wgt of the total weight of the implants (see ¶[0070]), wherein the composition can be aseptically processed to enhance osteoinductivity and osteoconductivity of bone (see ¶[0065]), wherein the aqueous carrier comprises phosphate buffered saline, sterile water, physiological saline, sodium chloride, dextrose, Lactated Ringer's solution, or a combination thereof (see ¶[0116]), wherein the phosphate buffered saline is in an amount from about 50% wgt to about 70% wgt of the total weight of the implant (see ¶[0079]), wherein the implants comprise sterile water in an amount of about 1 to about 50% wgt based on the total weight of the implant (see ¶[0081]), wherein the implants comprise a viscosity enhancing agent, such as hydroxypropyl methylcellulose, in an amount from about 0.1 to about 20% wgt (see ¶[0084]), wherein the implants comprise particles of bone, the particles comprising cortical, cancellous, and/or corticocancellous, allogenic, xenogeneic or transgenic bone tissue, with the bone component comprising, consist essentially of, or consist of fully mineralized, partially demineralized, fully demineralized, or combinations thereof, the mineral particles comprising, consisting essentially of, or consisting of bone powder, demineralized bone powder (see ¶[0128]), wherein the implants are sterilized by irradiation (see ¶[0151]), wherein the implants are used to repair bone and/or cartilage at a target tissue site, e.g., one resulting from injury, defect brought about during the course of surgery, infection, malignancy or developmental malformation (see ¶[0158]), wherein the implants further comprise one or more additional therapeutic agents including one or more growth factors, statins, etc., including osteoinductive agents comprising one or more members of the family of Bone Morphogenetic Proteins ("BMPs"), such as rhBMP-2 (see ¶[0161]), wherein the recombinant BMP-2 can be used at a concentration of about 0.4 mg/mL, to about 10.0 mg/mL (see ¶[0162]), wherein the growth factors are disposed on or in the implant by electrospraying, ionization spraying or impregnating, vibratory dispersion (including sonication), nozzle spraying, compressed-air-assisted spraying, brushing and/or pouring (see ¶[0164]).
Suppiger ‘735 discloses implant formulations (see Abstract), wherein the formulations are used for oral tissue generation, in particular regeneration of alveolar bone (see ¶[0021]), wherein the formulations comprise a mixture of nanocrystalline hydroxyapatite particles derived from natural bone and fragments of cross-linked collagen (see ¶[0025]), wherein the formulations comprise 25 – 45% wgt of the mixture (see ¶[0026]), wherein, for enhancing extrudability of the injectable aqueous implant formulation it is suitable that the dried implant composition has been sterilized by gamma- or X-ray irradiation, using the usual radiation doses for sterilization, typically at 27 - 33 kGy (see ¶[0052]; see also ¶[0097), wherein the nanocrystalline hydroxyapatite particles of ceramic derived from natural bone are particles derived from natural bone by a process enabling preservation of the nanocrystalline structure of the natural bone (see ¶[0059]), and wherein the process for preparing the implant formulations comprises rehydrating and homogeneously mixing 25 – 45% wgt of the dried implant composition with sterile water or sterile isotonic saline solution (see ¶[0072]).
Zhao ‘291 discloses a biological tissue matrix material comprising an extracellular matrix (see Abstract), wherein the material is prepared by a method comprising terminal sterilization, wherein the sterilization is achieved by exposure to ethylene oxide gas at a concentration of 300 to 1000 mg/L (see ¶[0040]).
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 implants comprising demineralized bone matrix compositions that comprise demineralized bone matrix fibers and/or particles, and a biocompatible liquid, wherein the DBM composition optionally contains DBM particles, wherein the DBM particles comprise from 0 – 75% wgt of the DBM component, wherein the composition contains an osteoinductive additive to enhance bone ingrowth and remodeling that at least partially coats the DBM particles [adsorbs onto], wherein the relative amounts of DBM and biocompatible liquid range from 1:10 to 10:1, wherein the DBM is obtained from cortical autogenic, cortical allogenic, cortical xenogeneic, cancellous autogenic, cancellous allogenic, cancellous xenogeneic, corticocancellous autogenic, corticocancellous allogenic, or corticocancellous xenogeneic bone, wherein the DBM is present in an amount greater than 40% wgt of the dry component of the compositions, wherein the biocompatible liquid is water, wherein an osteoinductive component is included in the DBM composition to further enhance the osteoinductivity of the paste composition, such as synthetic or naturally-derived bone morphogenic proteins (BMP’s), wherein hydroxypropyl methylcellulose is included in the DBM composition to modify the handling characteristics of the composition, the HPMC added to either the dry DBM component, or the liquid component, wherein the DBM constitutes about 5 to about 100% of the dry component, the balance of the dry component being comprised of the optional components, such as HPMC, and wherein the DBM composition is prepared by mixing desired quantities of DBM, biocompatible liquid and additive in any suitable sequence of mixture operations, or all at once, as taught by Rosenberg ‘612, wherein the DBM is present in an amount of about 1 to about 99% wgt of the total weight of the implants, wherein the implants comprise sterile water in an amount of about 1 to about 50% wgt based on the total weight of the implant, wherein the implants comprise hydroxypropyl methylcellulose in an amount from about 0.1 to about 20% wgt, wherein the implants comprise osteoinductive agents such as rhBMP-2, wherein the recombinant BMP-2 is used at a concentration of about 0.4 mg/mL, to about 10.0 mg/mL, and wherein the growth factors are disposed on or in the implant by impregnation, as taught by Kalpakci ‘216, wherein the sterilization is achieved by ɣ-irradiation at 27 - 33 kGy, as taught by Suppiger ‘735, or by exposure to ethylene oxide gas at a concentration of 300 to 1000 mg/L, as taught by Zhao ‘291. One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the express teachings Suppiger ‘735 as to the utility of gamma irradiation for sterilization, particularly in contrast to the e-beam irradiation of Kalpakci ‘216, and by the utility of ethylene oxide sterilization, at a concentration of 300 to 1000 mg/L, as taught by Zhao ‘291.
Claims 1, 12, and 21 recite substantial limitations directed to the composition of the invention “with which saline reaches an osmotic pressure of 104 to 112% within 12 to 48 hours after added to a bone graft solution, when an osmotic pressure of the saline is set to 100% as a reference value,” wherein the solution “is a mixture of 1 part by weight of a bone graft material containing hydroxypropyl methylcellulose and 0.5 to 2 parts by weight of a solvent.” It is the Examiner’s position that such recitation is directed to a functional characteristic of the composition, rather than to a structural or compositional characteristic of the claimed composition of matter. Consequently, any implant with a composition of natural bone and HPMC within the ratios as recited in claim 1 would necessarily display characteristics meeting the functional behavior as recited in the claim. Further in this regard, the claim recites no structural or compositional features that are specifically correlated to the solution behavior as recited in the claim, other than the relative mass amounts of bone material and HPMC.
With respect to the sterilization steps recited in claim 1 (gamma radiation), it is the Examiner’s position that such recitations effectively render the claims in question product-by-process claims, wherein the recited process steps do not serve to distinguish the claimed invention from the prior art. See MPEP § 2113:
Even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.
Further in this regard, it is the Examiner’s position that the particular process used to achieve sterilization of the implant material is immaterial to the question of patentability, provided that the process effectively renders the implant material sufficiently sterile for clinical applications. Consistent with the analysis of product by process claims addressed above, unless the process steps result in a final material that is different in composition or structure, then the steps do not serve to distinguish over the prior art. Therefore, it is the Examiner’s position that the precise conditions for sterilization do not distinguish over the cited art, particularly in light of the fact that the cited art teaches sterilization by either of the recited methods. However, in spite of this, the cited references (see Suppiger ‘735) disclose sterilization by either gamma or e-beam irradiation. Although claims 1 and 21 recite limitations directed to gamma irradiation at 10 – 25 kGy, the Examiner notes that the cited reference discloses irradiation at 27 – 33 kGy. In this regard, Applicants’ specification, at ¶[0068], discloses that the upper limit of 25 kGy was selected in order to prevent “denaturation of the bone morphogenetic protein.” However, the Examiner further notes that Suppiger ‘612 characterizes the gamma irradiation dosage as “typical.” Thus, it is the Examiner’s position that it would be prima facie obvious to use the disclosed “typical” radiation dosage unless Applicants can provide evidence that irradiation at 27 kGy would result in an implant composition that is different in composition or structure from what would be obtained with irradiation at 25 kGy. Furthermore, the Examiner notes that “A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (‘The proportions are so close that prima facie one skilled in the art would have expected them to have the same properties.’).” See MPEP § 2144.05I.
The Examiner notes that claims 1 and 19 - 21 recite limitations directed to mass ratios among the bone material, HPMC, and solvent components in the disclosed implant compositions. These limitations are directed to the mass ratio of (bone material & HPMC) to solvent (claims 1 and 21) at 1 part: 0.5 – 2.0 parts, or 0.3 to 3 parts, and the mass ratio of bone material to HPMC in the “bone graft material containing hydroxypropyl methylcellulose” (claims 1 and 21) at 1 part: 0.3 – 3 parts. As cited above, Kalpakci ‘216 discloses bone graft compositions comprising DBM at 15 – 40% wgt and liquid carrier [solvent] at 50 – 70% wgt or 1 – 50% wgt. In addition, Rosenberg ‘612 discloses a mass ratio between the dry components (DBM and HPMC) and solvent (water) at 1:10 – 10:1, which range encompasses the claimed 2:1 – 1:2 recited in the independent claims; further, the reference discloses that the dry component comprises DBM at 5 – 100% wgt, with the balance being HPMB (at 0 – 95% wgt), which ratio would read on the 1:0.3 – 1:3 and 1:0.2 – 1:0.6 ratios recited in the claims; see also, claim 31, wherein the recited ratio is 1:3 – 3:1).
Although these loadings yield mass ratios that are not exactly congruent with the claimed range, it is the Examiner’s position that the loadings disclosed in Kalpakci ‘216 encompass or 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 the volume ratios claimed in claims 25 and 26, directed to relative amounts of bone material to HPMC, the Examiner first notes that the cited references do not expressly disclose loadings in units of volume. However, as cited above, Kalpakci ‘216 discloses DBM at 15 – 40% wgt, HPMC at 0.1 to 20% wgt, and rhBMP-2 at 0.4 to 10 mg/mL. However, Kalpakci ‘216 also teaches that the disclosed compositions have a density of between about 0.01 g/cm3 to about 2 g/cm3 (see ¶[0086]). Thus, given the range of densities, and the range of loadings of DBM, rhBMP-2, and HPMC, it is the it is the Examiner’s position that the loadings disclosed in Kalpakci ‘216 encompass or significantly overlap with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05.
With respect to claims 28 and 29, which claims recite potential uses for the bone graft compositions of the invention, it is the Examiner’s position that such recitations are no more than statements of intended uses of the claimed compositions. Claim 1 is directed to a composition of matter. Thus, its subject matter must be distinguished from the prior art by its structure or composition. Cf. Hewlett- Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990) (holding that “apparatus claims cover what a device is, not what a device does.’’). Statements of intended use or function normally are not given patentable weight because they are not structurally limiting. Cf Cochlear Bone Anchored Sols. AB v. Oticon Med. AB, 958 F.3d 1348, 1354-55 (Fed. Cir. 2020) (discussing effect of intended use recitations in claim preamble).
With respect to claims 34 – 37, the Examiner first notes that the primary reference, Kalpakci ‘216, discloses implant compositions comprising sterile water in an amount of about 1 to about 50% wgt based on the total weight of the implant (see ¶[0081]), thus reading on claim 34.
With respect to claims 35 and 36, which claims recite limitations directed to the pH of the BMP solution and the phosphate buffer used to obtain that pH, the Examiner notes that the cited references do not expressly pH values reading on the limitation in question (“between 4.6 and 5”). However, Kalpakci ‘216, at ¶[0064], teaches that the disclosed implant compositions comprise “phosphate buffered saline (PBS).” As evidenced by Queiroz (2023), PBS can be prepared within the pH range as recited in claim 35, using phosphate buffer solution, thus reading on claim 36.
Consequently, based on the discussion above, claims 1, 12, 13, 21, and 23 – 37 would have been obvious pursuant to 35 U.S.C. § 103.
Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 12, 13, 21, and 23 - 37, as described above, are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, 4, 5, 8, and 9 of U.S. Patent No. 12,076,459 (“the ‘459 patent), in view of Zhao ‘291, and Suppiger ‘735.
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, 4, 5, 8, and 9 of the ‘459 patent are directed to a bone graft composition comprising a bone graft material and hydroxypropyl methylcellulose, wherein the bone graft composition comprises the hydroxypropyl methylcellulose in an amount of 0.3 to 3 parts by weight based on 1 part by weight of the bone graft material, wherein the bone graft material is a natural bone graft material comprising a porous structure, wherein the bone graft composition is generated from a mixture with a volume ratio of graft material powder having bone morphogenetic protein adsorbed thereon with respect to the hydroxypropyl methylcellulose of 1:0.2 to 1:0.8, wherein the solvent is water, and wherein the bone graft composition is generated from a mixture having a volume ratio of the graft material powder having the bone morphogenetic protein adsorbed thereon with respect to the hydroxypropyl methylcellulose of 1:0.6 to 1:0.7. The claims in question do not disclose implant materials that have been sterilized. The teachings of Suppiger ‘735 and Zhao ‘291, as set forth above, remedy that deficiency.
Thus, it would have been prima facie obvious to prepare implant materials according to claims 1, 3, 4, 5, 8, and 9, wherein the materials are sterilized consistent with the disclosures of Suppiger ‘735, motivated as described above.
Response to Applicant’s Arguments
The Examiner has carefully considered Applicant’s arguments submitted with the Amendment filed 7 July 2025, but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Applicant argues that “Kalpakci alone or combined with Suppiger, Zhao, and Queiroz does not disclose, teach, or suggest a bone graft composition having each and every feature of the current claims arranged in the same way as recited in the claims.” The Examiner respectfully disagrees.
The primary basis for Applicants’ arguments rests on the amendments to independent claims 1, 12, and 21, to unambiguously recite the closed transition phrase, “consisting of.” As Applicants have pointed out, the previous obviousness rejection cited to Kalpakci ‘216, which reference disclosed implant compositions comprising bone material (DBM), HPMC, solvent (water), BMP-2, and an alginate, the inclusion of the alginate taking the disclosures out of the scope of the amended claim. However, the new grounds of rejection now cite to Rosenberg ‘612, which reference discloses implant compositions comprising DBM, BMP-2, HPMC, and water as a solvent. Although the reference discloses that additional components may be included in the implant compositions, those components are explicitly disclosed as “optional.” Therefore, the reference reads on the amended claims.
With respect to the double patenting rejection, Applicants offer no arguments to traverse the rejection. In addition, Applicants question the cite to Reves ‘047 in the previous Action. To clarify, this is a reference to US 2018/0154047 A1, which reference had been previously cited, as recently as the Final Office Action of 7 January 2025. However, the current rejection cites to Suppiger ‘735, and no longer cites to Reves ‘047.
Consequently, based on the above discussion, Applicant’s arguments are unpersuasive, and claims 1, 12, 13, 21, and 23 – 37 stand rejected as obvious 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.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619