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
Request for Continued Examination
A Request for Continued Examination pursuant to 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Because this application is eligible for continued examination pursuant to 37 CFR § 1.114, and Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 16 April 2026 has been entered.
Status of the Claims
Applicants filed claims 1, 3 - 5, 153 – 163, and 167 – 176 with the instant application according to 37 CFR § 1.114, on 16 April 2026. In an Amendment entered with the Request for Continued Examination, Applicants amended claim 153 and canceled claims 168 and 173. Claims 1 and 3 – 5 remain withdrawn as being directed to a non-elected invention. Consequently, claims 153 – 163, 167, 169 – 172, and 174 - 176 are available for substantive consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The rejections pursuant to 35 U.S.C. § 103 set forth in the Action of 3 September 2025 are hereby withdrawn in light of Applicants’ amendment of the claims, and in favor of the new grounds of rejection set forth below.
Claim Objections
Claim 153 is objected to because of certain informalities. The claim recites “each granule of the population of composite granules [ ] hydroxyapatite.” The recitation is grammatically incorrect for failing to comprise a verb. The Examiner presumes that Applicants inadvertently deleted the verb “comprises” when amending the claim. Appropriate correction is necessary.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 103
The following is a quotation of 35 U.S.C. § 103 that forms the basis for all obviousness rejections set forth in this Office Action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the Examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention absent any evidence to the contrary. Applicants are advised of the obligation pursuant to 37 CFR § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the Examiner to consider the applicability of 35 U.S.C. § 102(b)(2)(C) for any potential 35 U.S.C. § 102(a)(2) prior art against the later invention.
Claims 153 – 163 and 167 - 173 are rejected pursuant to 35 U.S.C. § 103, as being obvious over US 2016/0082156 A1 to Wilson, C., et al., published 24 March 2016 (“Wilson ‘156”), in view of US 2021/0024430 A1 to Dunkley, I. and G. Senders, claiming priority to 26 July 2019 (“Dunkley ‘430”), and WO 2014/152113 A2 to Bagga, C., et al., published 25 September 2014 (“Bagga WO ‘113”).
The Invention As Claimed
Applicants claim an implantable orthobiologic comprising a porous matrix and a population of composite granules, wherein each granule comprises hydroxyapatite (HA) at no more than 5% by weight of the granule and β-tricalcium phosphate (β -TCP) at ≥ 95% wgt of the granule, together totaling 100% by weight of the granule, wherein the matrix comprises collagen, wherein the matrix comprises bioactive glass (BAG) particles, wherein the matrix exhibits a porosity interconnectivity of at least 70%, or 80%, or 80 - 90%, wherein the matrix comprises pores of at least 350 µm diameter, wherein the matrix comprises pores of a diameter ranging from 500 to 600 µm, or from 530 to 570 µm, wherein the granules are embedded in the matrix, and wherein the granules exhibit a higher density than the matrix.
The Teachings of the Cited Art
Wilson ‘156 discloses osteoinductive synthetic bone grafts comprising porous ceramic granules loaded with an osteoinductive material, and in contact with a biocompatible matrix material (see Abstract), wherein the grafts are in the form of composite osteoinductive scaffolds that comprise an osteoinductive material (such as proteins or peptides), at least one calcium ceramic granule and a flowable biocompatible matrix material (see ¶[0005]), wherein the matrix comprises hyaluronic acid (HA), modified HA, collagen, gelatin, fibrin, chitosan, alginate, agarose, a self-assembling peptide, whole blood, platelet-rich plasma, bone marrow aspirate, polyethylene glycol (PEG), and/or derivatives, PEG, poly(lactide-co-glycolide), poly(caprolactone), poly(lactic acid), poly(glycolic acid), a poloxamer, and copolymers, or combinations thereof (id.), wherein the granules comprise monocalcium phosphate monohydrate, dicalcium phosphate, dicalcium phosphate dehydrate, octacalcium phosphate, precipitated hydroxyapatite, precipitated amorphous calcium phosphate, monocalcium phosphate, α-tricalcium phosphate (α-TCP), β-tricalcium phosphate (β-TCP), sintered hydroxyapatite, oxyapatite, tetracalcium phosphate, hydroxyapatite, calcium-deficient hydroxyapatite, and combinations thereof (id.), wherein the osteoinductive material comprises bone morphogenetic protein 2 (BMP-2), BMP-3, BMP-4, BMP-5, BMP-6, BMP-7, BMP-9, a designer BMP, fibroblast growth factor, insulin-like growth factor, platelet-derived growth factor, transforming growth factor-beta (TGF-β), and combinations thereof (id.), wherein the protein-loaded calcium ceramic granule is in a biocompatible matrix comprising collagen that can be flowed over the osteoinductive material-loaded granules (see ¶[0006]), wherein the implant comprises a biocompatible matrix, an osteoinductive material associated with an interior surface (e.g., a pore surface) of a calcium ceramic granule, which calcium ceramic granule is, in tum, associated with the matrix (see ¶[0007]), wherein an osteoconductive material refers to any material which facilitates the ingrowth of osteoblastic cells including osteoblasts, pre-osteoblasts, osteoprogenitor cells, mesenchymal stem cells, and other cells that are capable of differentiating into or otherwise promoting the development of cells that synthesize and/or maintain skeletal tissue, such as, specifically, a porous granule comprising an osteoconductive calcium phosphate ceramic that include both micro- and macro-pores that define surfaces on which the osteoinductive substance can associate, both the micro-pores and macro-pores increasing the total surface area to which the osteoinductive substance can adhere, but only the macro-pores permit infiltration by cells (see ¶[0033]), wherein the granules are characterized by a porosity that can be selected to achieve desired granule residence times or kinetics of release of osteoinductive material, such that osteoinductive substances within the micropores becomes available/releases only gradually as the granule is degraded by cells infiltrating the macropores (id.), wherein the granules are characterized by a porosity that is selected to allow an implant of the invention to remain in place and to release osteoinductive material over time intervals optimal for the formation and knitting of bone (e.g. days, weeks, or months), the porosity comprising both a microporosity and a macroporosity, which porosities can be selected to achieve desired granule residence times or kinetics of release of osteoinductive materials, wherein the micropores are large enough to permit infiltration of oesteoinductive factors such as solutions of BMP’s, and the macropores are large enough to permit infiltration by cells (see ¶[0035]), wherein the disclosed scaffolds comprise a biocompatible matrix, which matrix can be any suitable biocompatible material which, preferably, when used in concert with the granules, exhibits sufficient rigidity and/or column strength to withstand the loads placed upon it when implanted, and which does not cause excessive inflammation (i.e., inflammation sufficient to inhibit or prevent the formation of new bone or the knitting of a broken bone), or inhibit the proliferation of osteoblasts, or otherwise interfere with the activity of the granules and/or the osteoinductive material, and the biocompatible matrix is made from a flowable precursor material that reacts to form a solid mass, by polymerizing and/or cross-linking in the presence of the granules, such as collagen (see ¶[0037]), wherein, following a loading step, loaded granules are embedded into the biocompatible matrix (see ¶[0042]), wherein implants were tested for their density and elastic modulus across four slices, with the results demonstrating that the density across slices within a given scaffold was relatively uniform (see ¶[0061]), and wherein a proximal slice from a scaffold had a relatively lower elastic modulus in the proximal slice than at the distal end, which can be attributed to the falling of the heavier granules in the collagen hydrogel matrix at the end of mixing (see ¶[0063]). The reference does not disclose implants with composite granules comprising both HA and β-TCP, with β-TCP comprising about 95% of the composite granule, and HA from no more than 5%, or implants comprising a bioactive glass component, or implants comprising an interconnected porosity of from at least 70%, to 80 - 90%, or implants comprising pores with diameters from at least 350 µm diameter to 600 µm. The teachings of Dunkley ‘430 and Bagga WO ‘113 remedy those deficiencies.
Dunkley ‘430 discloses porous ceramic granules and methods of making them (see Abstract), wherein the granules comprise a biphasic calcium phosphate comprising hydroxyapatite and β-tricalcium phosphate, with a microporosity with diameters less than about 10 µm, a BET surface area from about 0.2 to about 10 m2/g, and an average diameter from about 50 µm to 800 µm (see ¶[0009]), wherein the granules can also comprise additional synthetic ceramics including biological glasses such as calcium silicate-based bioglass (see ¶[0077]), wherein the biphasic calcium phosphate can have a β-TCP:HA weight ratio of about 50:50 to about 95:5 (see ¶[0079]), wherein the granules can be used in a bone graft that can be utilized in a wide variety of orthopedic, periodontal, neurosurgical, oral and maxillofacial surgical procedures such as the repair of simple and/or compound fractures and/or non-unions (see ¶[0081]), and wherein the granules may be treated or chemically modified with one or more bioactive agents or bioactive compounds, such as osteogenic or chondrogenic proteins or peptides (see ¶[0082]).
Bagga WO ‘113 discloses bioactive porous composite bone graft implants suitable for use in bone tissue regeneration and/or repair, the implants having an engineered porosity, and that comprise bioactive glass (see Abstract), wherein porosity is necessary to allow vascularization, and the desired scaffold should have a porous interconnected pore network with surface properties that are optimized for cell attachment, migration, proliferation and differentiation (see p. 1, last para.), wherein the roles of porosity, pore size and pore size distribution in promoting revascularization, healing, and remodeling of bone have long been recognized as important contributing factors for successful bone grafting implants, suggesting an ideal range of porosities and pore size distributions for achieving bone graft success (see p. 2, 3rd para.), wherein synthetic bone repair implants offer advantages over the use of autogenous bone because, in comparison, the use of autogenous bone requires the patient to undergo multiple or extended surgeries, consequently increasing the time the patient is under anesthesia, and leading to considerable pain, increased risk of infection and other complications, and morbidity at the donor site (see p. 3, 1st para.), wherein materials such as bioactive glass (“BAG”) are an increasingly viable alternative, or supplement, to natural bone-derived graft materials with the advantage of avoiding painful and inherently risky harvesting procedures on patients, and can reduce the risk of disease transmission (see p. 3, 2nd para.), wherein different stoichiometric implants, such as hydroxyapatite (HA), tricalcium phosphate (TCP), tetracalcium phosphate (TTCP), and other calcium phosphate (CaP) salts and minerals have all been employed in attempts to match the adaptability, biocompatibility, structure, and strength of natural bone (see p. 3, 3rd para.), wherein, because calcium phosphate materials are inherently rigid, they are generally provided as part of an admixture with a carrier material, at relative loadings in the range of 50:50 – 10:90, in order to facilitate handling (see p. 3, last para. – p. 4, 1st para.), wherein implants made from hydroxyapatite tend to take too long to resorb, while implants made from calcium sulfate or β-TCP tend to resorb too quickly (see p. 4, 2nd para.), wherein if the porosity of the implant is too high (e.g., around 90% ), there may not be enough base material left after resorption has taken place to support osteoconduction and, conversely, if the porosity of the implant is too low (e.g., 10%,) then too much material must be resorbed, leading to longer resorption rates (id.), wherein the disclosed implants serve as cellular scaffolds to provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation (see p. 5, 1st para.), wherein the composite implants comprise a pore size distribution including pores characterized by pore diameters ranging from about 100 nm to about 1 mm (see p. 5, 2nd para.), wherein the implants comprise bioactive glass, in the form of granules or fibers, and a bioresorbable polymer (see p. 5, 3rd para.; see also, p. 6, 1st para.), wherein the implants provide the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation (see p. 12, 1st para.), wherein the carrier material is porous and helps contribute to healing, and the carrier material has the appropriate porosity to create a capillary effect to bring in cells and/or nutrients to the implantation site (see p. 13, 3rd para.), wherein the inclusion of bioactive glass granules can be accomplished using granules having a wide range of sizes or configurations to include roughened surfaces, very large surface areas, and the like (see p. 14, 3rd para.), wherein the implant materials possess nano-, micro-, meso-, and macro-porosity, the nanopores have a pore having a diameter below about 1 µm, down to as small as 100 nm, or less, the micropores having diameters between about 1 to 10 µm, the mesopores having diameters between about 10 to 100 µm, and macropores having diameters greater than about 100 µm to 1 mm, or even larger (see p. 15, 1st para.), wherein the bioactive glass material may be provided with variable degrees of porosity, and is preferably ultraporous, and the porosity may be provided inherently by the actual bioactive glass material itself, as well as the matrices separating the material within the overall implant (see p. 17, 2nd para.), wherein the pores are interconnected, allowing cell migration throughout the implant matrix (see p. 18, 2nd para.), wherein the binding material for the graft material comprises human-derived collagen or animal-derived collagen, which could be provided as a slurry and then hardened such as by freeze-drying (see p. 26, last para.), wherein the implants can further comprise biological agents, such as bone morphogenic protein (BMP), a peptide, a bone growth factor such as platelet derived growth factor (PDGF), vascular endothelial growth factor (VEGF), insulin derived growth factor (IDGF), a keratinocyte derived growth factor (KDGF), or a fibroblast derived growth factor (FDGF), stem cells, bone marrow, and
platelet rich plasma (PRP) (see p. 30, 1st para.), and wherein the bioactive glass granules have diameters in the range of about 1 to 5 mm, or about 950 microns to about 3 mm, or about 850 microns to about 3 mm, or about 50 to 450 microns, or about 150 to 450 microns (see p. 44, 6th para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare synthetic bone grafts in the form of composite osteoinductive scaffolds that comprise an osteoinductive material, calcium ceramic granules, and a flowable biocompatible matrix material, such as collagen, wherein the granules comprise combinations of β-tricalcium phosphate (β-TCP) and hydroxyapatite (HA), wherein the ceramic granules are in a biocompatible matrix comprising collagen, wherein an osteoconductive material refers to any material which facilitates the ingrowth of osteoblastic cells including osteoblasts, pre-osteoblasts, osteoprogenitor cells, mesenchymal stem cells, and other cells that are capable of differentiating into or otherwise promoting the development of cells that synthesize and/or maintain skeletal tissue, such as, specifically, a porous granule comprising an osteoconductive calcium phosphate ceramic that include macro-pores that permit infiltration by cells, wherein the granules are characterized by a porosity that can be selected to achieve desired granule residence times wherein granules are embedded into the biocompatible matrix, wherein implants were tested for their density and elastic modulus across multiple slices, and wherein a proximal slice from scaffolds tended to have a relatively lower elastic modulus in the proximal slice than at the distal end, which can be attributed to the falling of the heavier granules in the hydrogel matrix at the end of mixing, as taught by Wilson ‘156, wherein the calcium ceramic granules comprise a biphasic calcium phosphate that has a β-TCP:HA weight ratio of about 50:50 to about 95:5, with pores having an average diameter from about 50 µm to 800 µm, wherein additional synthetic ceramics can be used to form the porous ceramic granules, such as biological glasses, as taught by Dunkley ‘430, and wherein the implants have an engineered porosity that provides the necessary porosity and pore size distribution to allow proper vascularization, optimized cell attachment, migration, proliferation, and differentiation, wherein the pores are interconnected, allowing cell migration throughout the implant matrix, wherein the binding material for the graft material comprises human-derived collagen or animal-derived collagen, as taught by Bagga WO ‘113. One of skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the teachings of Bagga WO ‘113 to the effect that the disclosed micro- and macro-porosities are necessary to insure both cell migration into the scaffolds (macroporosity), and to permit influx of nutrients to the pores of the scaffold (microporosity), and that HA is known to resorb in vivo at a much slower rate than β-TCP, and that the resorption rate of BCP can be controlled by adjusting the ratio between HA and β-TCP, and that implants should resorb along a time frame consistent with the rate of new bone growth at the site of implantation.
With respect to claims 156 – 161, which claims recite quantitative limitations directed to ranges of porosity and pore sizes, the Examiner notes that the cited references do not recite quantitative limitations that are specifically congruent with the claimed ranges. However, it is the Examiner’s position that the cited art teaches ranges of porosities and pore sizes that significantly overlap with the claimed ranges and, as such, would render the claimed invention obvious. See MPEP § 2144.05. “In the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976).”
With respect to claim 163, which claim recites a limitation directed to the granules exhibiting a higher density than the matrix, the Examiner notes that the cited references do not directly address comparative densities of the major components of the implants. However, the Examiner further notes that Wilson ‘156 explicitly discloses that, during testing of the internal consistency of densities and elastic moduli of sample implants, that a proximal slice from a scaffold tended to have a relatively lower elastic modulus in the slice than a slice from the distal end, which observation was attributed to the falling of the heavier granules in the matrix at the end of mixing (see ¶[0063]). Consequently, the “heavier” granules must necessarily have a greater density than the collagen matrix in which they are distributed, thus reading on this limitation.
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 153 – 163, 167, 169 – 172, and 174 – 176 would have been obvious within the meaning of 35 USC § 103.
Claims 174 - 176 are rejected pursuant to 35 U.S.C. § 103, as being obvious over Wilson ‘156, in view of Dunkley ‘430 and Bagga WO ‘113, as applied in the above rejection of claims 153 – 163, 167, 169 – 172, and 174 - 176, and further in view of Woodruff, M., et al., materials today 15(10): 430 – 435 (2012) (“Woodruff (2012)”).
The Invention As Claimed
The invention with respect to claim 153 is described above. In addition, Applicants claim implantable orthobiologics comprising a porous biocompatible matrix and a population of composite granules, wherein the orthobiologics comprise an imbibed cell population of mesenchymal cells, derived from bone marrow aspirate.
The Teachings of the Cited Art
The disclosures of Wilson ‘156, Dunkley ‘430, and Bagga WO ‘113 are relied upon as applied in the above rejection of claims 153 – 163, 167, 169 – 172, and 174 - 176. The references do not disclose implants comprising an imbibed cell population of mesenchymal cells derived from bone marrow aspirate. The teachings of Woodruff (2012) remedy those deficiencies.
Woodruff (2012) discloses that the fundamental concept underlying tissue engineering is to combine a scaffold with living cells, and/or biologically active molecules to form a tissue engineering construct (TEC) that promotes the repair and/or regeneration of tissues (see p. 430, 2nd col.), wherein the TEC’s possess a porous interconnected pore network (pores & pore interconnections should be at least 400 µm to allow vascularization) with surface properties that are optimized for the attachment, migration, proliferation and differentiation of cell types of interest (depending on the targeted tissue) and enable flow transport of nutrients and metabolic waste, and be biocompatible and biodegradable at a controllable rate to compliment cell/tissue growth and maturation (id.), wherein the scaffolds comprise hydroxyapatite and tricalcium phosphate, and a polymer matrix (see p. 432, 2nd col., 2nd para.), wherein scaffolds with and without bone marrow derived mesenchymal stem cells (BMSC’s) were tested, the results of which indicated that composite scaffolds loaded with 40,000,000 bone marrow-derived mesenchymal precursor cells stimulated more bone formation than scaffolds without the cells (see p. 435, 2nd col., 1st para.).
Application of the Cited Art to the Claims
It would have been prima facie obvious before the filing date of the claimed invention to prepare synthetic bone grafts in the form of composite osteoinductive scaffolds that comprise composite calcium ceramic granules, and a flowable biocompatible matrix material, such as collagen, wherein the granules comprise β-tricalcium phosphate (β-TCP) and hydroxyapatite (HA), according to the teachings of Wilson ‘156, Dunkley ‘430, and Bagga WO ‘113, as applied in the above rejection of claims 153 – 163, 167, 169 – 172, and 174 - 176, wherein the grafts further comprise a population of mesenchymal cells derived from bone marrow aspirate, as taught by Woodruff (2012). One of ordinary skill in the art would be motivated to do so, with a reasonable expectation of success in so doing, by the explicit teachings of Woodruff (2012) to the effect that composite scaffolds loaded with 40,000,000 bone marrow-derived mesenchymal precursor cells stimulated more bone formation than scaffolds without the cells (see p. 435, 2nd col., 1st para.).
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by claims 174 - 176 would have been obvious within the meaning of 35 USC § 103.
Response to Applicants’ Arguments
The Examiner has considered the arguments in Applicants’ Response filed 27 April 2026 but does not find them persuasive, to the extent still relevant in light of the new grounds of rejection set forth above. Again, Applicants argue that “Dunkley [‘430] recites a range of granule compositions. The granules themselves share the characteristics of being porous ceramic granules comprising hydroxyapatite (HA) at 8% - 22% by weight and beta-Tricalcium phosphate (TCP) at a complementary 78% – 92%, at paragraph [0009]. Applicant observes that the claimed subject matter as listed herein falls outside of this range, at HA of no greater than 5% and TCP of at least 95%.” However, Applicants’ argument rests on an overly selective reading of the disclosures of the reference, in that Applicants address only an embodiment that falls outside of their claim limitation, while failing to address a disclosed embodiment that directly reads on the limitation in question - a β-TCP:HA weight ratio of about 50:50 to about 95:5 (see ¶[0079]).
Applicants also discuss at length an embodiment of Dunkley ‘430 (see ¶[0077]) that they interpret as limiting the ceramic granules to granules β-TCP and HA, and also a “silicon ceramic,” interpreting that disclosure as indicating that the silicon ceramic is included with the β-TCP and HA in the same granules. However, it is the Examiner’s position that the disclosure to which Applicants refer is reasonably, and more correctly, interpreted, both logically and grammatically, as referring to additional or alternative granules that comprise other synthetic ceramics, such as calcium-silicate-based bioglass. Thus, the embodiment contemplated here can comprise both β-TCP/HA granules, and additional bioglass granules, as relied upon in the above new grounds of rejection.
Consequently, in light of the above discussion, Applicants arguments are unpersuasive, and claims 153 – 163, 167, 169 – 172, and 174 – 176 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.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619
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