DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
2. Applicant’s amendment of claims 1-12 in the reply filed on 23 June 2026 is acknowledged.
Priority
3. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 112
4. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
5. Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
a. Regarding independent claim 1 the recitation “A porous bone and elastomeric substitute material” seems to indicate two distinct and separate elements as part of the preamble - (i) a porous bone, and (ii) an elastomeric substitute material. This was not disclosed in the specification as originally filed. Claims 2-12 depend from claim 1.
Because of the procedure outlined in M.P.E.P. 2163.06 for interpreting the claims, it is noted that other art may be applicable under 35 U.S.C. 102 or 35 U.S.C. 103(a) once the aforementioned problem is corrected.
b. Regarding independent claim 1 the recitation “particles of decellularized bone, wherein the interconnectivity between the pores is greater than 60 %” seems to indicate the particles of decellularized bone (one of the starting materials) is the one having an “interconnectivity between the pores is greater than 60 %”, which was not disclosed in the specification (as originally filed). It seems, from the specification, that the “wherein the interconnectivity between the pores is greater than 60 %” refers to the end product (i.e., the bone substitute material), not to one of the starting materials. Claims 2-12 depend from claim 1.
Because of the procedure outlined in M.P.E.P. 2163.06 for interpreting the claims, it is noted that other art may be applicable under 35 U.S.C. 102 or 35 U.S.C. 103(a) once the aforementioned problem is corrected.
6. 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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
7. Claims 1-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
a. Claim 12 recites “comprising the compounds required for the synthesis of poly(ester-urea-urethane)” in lines 3-4.
In the absence of a recitation of the compounds required the above recitation is unclear as to what all are required. The written disclosure teaches only the esters that can be chosen. A urethane requires an isocyanate and an extender like a diamine also as reactants to create the urethane and urea like linkages.
Claim Rejections - 35 USC § 103
8. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which 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, 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.
9. Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Datta et al. (US PG Pub No. US 2012/0239161 A1) in view of Owens et al. (US PG Pub No. 2011/0238186 A1), Yang (US PG Pub No. 2014/0193356 A1), and Hu et al. (CN 110025831 A).
Regarding independent claim 1, Datta et al. ‘161 teaches a porous bone (Figure 1 clearly shows pores 20; further, see [0051], [0052], [0086], [0089], [0122], and [0298]) and elastomeric (Abstract) substitute material (10) comprising:
- at least one elastomer matrix comprising an elastomer based on poly(ester-urea-urethane):
[0158] – “More particularly, in another embodiment, the invention provides a process for preparing an at least partially degradable elastomeric polyurethane matrix which comprises synthesizing the matrix from a polyol component comprising polycaprolactone or its copolymers and an isocyanate component by polymerization, cross-linking and foaming, thereby forming pores, followed by reticulation of the foam to provide a reticulated product.”;
[0161] – “In one embodiment, the polyol component is a polycaprolactone-polyethylene glycol polyurethanes, polycaprolactone-polyethylene glycol urea-urethane, polycaprolactone polyol, polyester polyol, glycolide polyol, l-lactide polyol, d-l lactide polyol, polyether polyol, poly(ether-co-ester)polyol, poly (caprolactone-co-glycolide)polyol, poly (caprolactone-co-l-lactide) polyol, poly (caprolactone-co-d-l-lactide)polyol, poly (caprolactone-co-para-dioxanone) polyol, (caprolactone-co-l-lactide-co glycolide)polyol, poly (caprolactone-co-glycolide-co-d-l lactide)polyol, poly (caprolactone-co-l-lactide-co-d-l lactide)polyol, poly(caprolactone-co-carbonate)polyol, poly(caprolactone-co-siloxane)polyol, polyol, poly(caprolactone-co-hydrocarbon)polyol, polyethylene glycol polyol, polyvivyl alcohol, polysaccharide polyol, polyols containing starch, polyols containing various forms of sugars, polyols containing cellulose, polyols containing chitin and chitosan, polyols containing cellulose, or a mixture thereof. In another embodiment, the polyol component comprises polycaprolactone polyol or copolymers of polycaprolactone.”;
[0245] – “Suitable biocompatible polymers include polyamides, polyolefins, nonabsorbable polyesters, and preferably bioabsorbable aliphatic polyesters (e.g., homopolymers and copolymers of lactic acid, glycolic acid, lactide, glycolide, para-dioxanone, trimethylene carbonate, .epsilon.-caprolactone or a mixture thereof). Further, biocompatible polymers include film-forming bioabsorbable polymers; these include aliphatic bioabsorbable polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, poly(iminocarbonates), polyorthoesters, polyoxaesters including polyoxaesters containing amido groups, polyamidoesters, polyanhydrides, polyphosphazenes, biomolecules or a mixture thereof. For the purpose of embodiments of this invention bioabsorbable aliphatic polyesters include polymers and copolymers of lactide (which includes lactic acid d-, l- and meso lactide), .epsilon.-caprolactone, glycolide (including glycolic acid), hydroxybutyrate, hydroxyvalerate, para-dioxanone, trimethylene carbonate (and its alkyl derivatives), 1,4-dioxepan-2-one, 1,5-dioxepan-2-one, 6,6-dimethyl-1,4-dioxan-2-one or a mixture thereof. In one embodiment, the reinforcement can be made from biopolymer, such as collagen, elastin, and the like”).
Datta et al. ‘161 further discloses “Additionally, various proteins (including short chain peptides), growth agents, chemotactic agents, growth factor receptors or ceramic particles can be added to the foams during processing, adsorbed onto the surface or back-filled into the foams after the foams are made” ([0294]), and “For example, in one embodiment, the pores of the foam may be partially or completely filled with biocompatible resorbable synthetic polymers or biopolymers (such as collagen or elastin), biocompatible ceramic materials (such as hydroxyapatite), and combinations thereof, and may optionally contain materials that promote tissue growth through the device. Such tissue-growth materials include but are not limited to autograft, allograft or xenograft bone, bone marrow and morphogenic proteins” ([0294]).
Datta et al. ‘161 discloses the invention as claimed, except for particularly disclosing the bone substitute material as comprising particles of decellularized bone. However, this is already known in the art. For example:
Owens et al. ‘186 teaches (Figure 1) a porous bone substitute material comprising a polymer and decellularized ([0042], [0062], [0064], claim 1) bone particles ([0005] and [0053]; claims 1, 27, and 28) in order to provide a material that has a reduced immunological or inflammatory response when implanted in a human than the polymer alone ([0005]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of a bone substitute material as comprising particles of decellularized bone, as taught by Owens et al. ‘186, with the invention of Datta et al. ‘161, in order to provide a material that has a reduced immunological or inflammatory response when implanted in a human than the polymer alone.
Yang ‘356 teaches (Abstract) a porous bone substitute material comprising a polymer and decellularized bone particles ([0006], [0053], claim 20) in order to provide improved mechanical properties, reduced inflammatory responses, improved biodegradability, and superior integration with surrounding tissue, and to promote bone growth in an improved manner, including by promoting cell differentiation or phenotype progression in a population of bone cells such as a population comprising stem cells or osteoblast cells ([0005]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of a bone substitute material as comprising particles of decellularized bone, as taught by Yang ‘356, with the invention of Datta et al. ‘161, in order to provide improved mechanical properties, reduced inflammatory responses, improved biodegradability, and superior integration with surrounding tissue, and to promote bone growth in an improved manner, including by promoting cell differentiation or phenotype progression in a population of bone cells such as a population comprising stem cells or osteoblast cells.
Regarding newly-added recitation – “wherein the interconnectivity between the pores is greater than 60 %”, Datta et al. ‘161 discloses desirability for high interconnectivity between the pores. For example:
[0062] - “Without being bound by any particular theory, having a high void content and a high degree of reticulation allowing unfettered access to the inter-connected and inter-communicating cells and pores that constitute the high void content is thought to allow the implantable device to become at least partially ingrown and/or proliferated, in some cases substantially ingrown and proliferated. Without being bound by any particular theory, the reticulated implantable devices having a high void content and a high degree of reticulation or inter-connectivity and inter-communication between cells and pores that constitute these voids that can be accessed by the in vivo cell or tissue propagation is thought to allow the implantable device to become at least partially ingrown and/or proliferated, in some cases substantially ingrown and proliferated, in other cases completely ingrown and proliferated, with cells including tissues such as fibroblasts, fibrous tissues, synovial cells, bone marrow stromal cells, stem cells and/or fibrocartilage cells. The ingrown and/or proliferated tissues thereby provide functionality over time, such as load bearing capability, for defect repair of the original tissue that is being repaired or replaced”, and
[0086] - “In one embodiment, the reticulated structure comprises a continuous, interconnected and intercommunicating networks of cells, pores, and voids to permit ingrowth and proliferation of tissue into the matrix interiors. In another embodiment, the void space of the reticulated structure comprises a plurality of interconnected pores forming a continuous network of intercommunicating passageways extending from an interior portion to an exterior surface of said matrix”
Datta et al. ‘161, in view of Owens et al. ‘186 and Yang ‘356, discloses the invention as claimed, except for particularly disclosing wherein the interconnectivity between the pores is greater than 60%. However, this is already known in the art. For example, Hu et al. ‘5831 discloses a porous bone substitute material comprising interconnectivity between pores greater than 60% (Abstract; claim 1) in order to match bone tissue mechanical strength and capability of promoting bone ingrowth and regeneration (Abstract; [0002]). Therefore, it would have been obvious to a person of ordinary skill in the art at the time of the effective filing date of the claimed invention to have combined the teaching of wherein the interconnectivity between the pores is greater than 60%, as taught by Hu et al. ‘5831, with the invention of Datta et al. ‘161, in view of Owens et al. ‘186 and Yang ‘356, in order to match bone tissue mechanical strength and capability of promoting bone ingrowth and regeneration.
Further, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 2, Datta et al. ‘161 teaches the at least one elastomer matrix comprises an elastomer based on poly(ester-urea-urethane), the ester being chosen from caprolactone oligomers (PCL), lactic acid oligomers (PLA), glycolic acid oligomers (PGA), hydroxybutyrate oligomers (PHB), hydroxyvalerate oligomers (PVB), dioxanone oligomers (PDO), poly(ethylene adipate) oligomers (PEA), poly(butylene adipate) oligomers (PBA) or combinations thereof ([0158], [0161], [0245]).
Regarding claim 3, Datta et al. ‘161 in view of Owens et al. ‘186 and Yang ‘356 teach the decellularized bone particles can be obtained from natural bone (Owens et al. ‘186 – [0053]; claim 28 and claim 50; Yang ‘356 – [0003]).
Regarding claim 4, Datta et al. ‘161 in view of Owens et al. ‘186 and Yang ‘356 teach the decellularized bone particles have a diameter of between 1 nm and 1 mm (Owens et al. ‘186 – [0076], [0078]; Yang ‘356 – [0054]).
Regarding claim 5, Datta et al. ‘161 in view of Yang ‘356 teach the decellularized bone particles represent at least 10% by weight of the porous bone substitute material (Yang ‘356 – [0055]).
Regarding claim 6, Datta et al. ‘161 in view of Yang ‘356 teach characterized in that said porous bone substitute material has a multiscale pore size of between 50 µm and 2000 µm (Yang ‘356 – [0054]).
Regarding claim 7, Datta et al. ‘161 teaches the porous bone substitute material has a total porosity of greater than or equal to 60% ([0096], [0111]).
Regarding claim 8, Datta et al. ‘161 teaches the porous bone substitute material has a volume of between 0.1 and 400 cm3 ([0074] – “In one embodiment, the non-degradable parts can be less than 3 cubic centimeter (cc) out of a total initial implantable matrix volume of 100 cc and in another embodiment, the non-degradable parts can be less than 2 cc out of a total initial implantable matrix volume of 100 cc”).
Regarding claim 9, Datta et al. ‘161 in view of Owens et al. ‘186 and Yang ‘356 teach for use in bone repair, preferably for repair of a bone cavity defect and/or repair of a segmental bone defect (Datta et al. ‘161 – [0052], [0122]; Owens et al. ‘186 – [0003], [0047], [0050], [0060]; Yang ‘356 – [0097], [0098]).
Regarding claim 10, the different bone repair applications presented by each of Datta et al. ‘161, Owens et al. ‘186, and Yang ‘356 inherently include “wherein the bone repair is greater than or equal to 5% by volume of the volume of the bone to be repaired”, since said volume depends on the size of bone defect, depth of bone defect, location of bone defect, and particular condition of the patient (i.e., patient dependent).
Regarding claim 11, Datta et al. ‘161 teaches a bone repair kit comprising the porous bone substitute material according to claim 1 and a fixator ([0126] – “The size, shape, configuration and other related details of elastomeric matrix 10 can be either customized to a particular application or patient or standardized for mass production. However, economic considerations may favor standardization. To this end, elastomeric matrix 10 or a composite mesh comprising reticulated elastomeric matrix 10 can be embodied in a kit comprising elastomeric implantable device pieces of different sizes and shapes. Also, as discussed elsewhere in the present specification and as is disclosed in the applications to which priority is claimed, multiple, e.g. two, three or four, individual elastomeric matrices 10 or composite mesh comprising reticulated elastomeric matrix 10 can be used as an implantable device system for a single target biological site, being sized or shaped or both sized and shaped to function cooperatively for treatment of an individual target site”).
Regarding claim 12, Datta et al. ‘161 in view of Owens et al. ‘186 and Yang ‘356 teach a method for preparing the porous bone substitute material according to claim 1, comprising the following steps:
a) preparing an organic phase comprising the compounds required for the synthesis of poly(ester-urea-urethane),
b) adding water (Datta et al. ‘161 – [0018], [0133], [0156], [0158], [0198]) and one or more of the components taught in paragraph [0294] of Datta et al. ‘161 (“Additionally, various proteins (including short chain peptides), growth agents, chemotactic agents, growth factor receptors or ceramic particles can be added to the foams during processing, adsorbed onto the surface or back-filled into the foams after the foams are made. For example, in one embodiment, the pores of the foam may be partially or completely filled with biocompatible resorbable synthetic polymers or biopolymers (such as collagen or elastin), biocompatible ceramic materials (such as hydroxyapatite), and combinations thereof, and may optionally contain materials that promote tissue growth through the device. Such tissue-growth materials include but are not limited to autograft, allograft or xenograft bone, bone marrow and morphogenic proteins”) to the organic phase of step a) to form an emulsion (NOTICE – the recited “the decellularized bone particles” lacks antecedent basis; further notice, each of Owens et al. ‘186 and Yang ‘356 teaches decellularized bone particles, see rejection of claim 1, above),
c) polymerizing and/or crosslinking (Datta et al. ‘161 – [0123], [0153]-[0158]; Yang ‘356 – [0085]) the emulsion obtained at step b) to obtain said porous bone substitute material,
d) washing (Datta et al. ‘161 – [0233], [0234]; Owens et al. ‘186 – [0066], [0076]; Yang ‘356 – [0089]) said porous bone substitute material obtained at step c), and
e) drying (Datta et al. ‘161 – [0233], [0234]; Owens et al. ‘186 – [0058]; Yang ‘356 – [0089]) said porous bone substitute material obtained at step d).
Regarding step a) above, the compounds required for the synthesis of poly(ester-urea-urethane) are not recited in the claim language (see 112 2nd paragraph rejection, above). Datta et al. ‘161 teaches that the crosslinking agent is glycerol and the blowing agent is water. The polyol is a viscous liquid and is mixed with a viscosity depressant (para 0207). Butanediol can be used as a chain extender (paras 0211, 0220). One of ordinary skill in the art will recognize from this teaching that the compounds required for the synthesis of poly(ester-urea-urethane) like caprolactone oligomers and the others, and isocyanate can be mixed with glycerol and butanediol to give the organic phase as in claim 12, part a). Doing this will give a solution of the caprolactone oligomers and the others, and isocyanate in glycerol and butanediol (the compounds required in an organic phase). This will give a solution which can be easily stirred during reaction and provide for good mixing of the reactants to give the desired product. The reaction can be carried out as in part c) in claim 12 to obtain the biomaterial. The biomaterial can be washed and dried (para 0233; as in claim 12, parts d) and e).
Response to Arguments
10. Applicant's arguments filed 23 June 2026 have been fully considered but they are not persuasive.
a. Regarding rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph of claim 12, the Applicant argues “The expression "compounds required for the synthesis of poly(ester-urea- urethane)" designates, in a functional manner, a well-known class of reactants conventionally used for preparing such polymers. The skilled person, working in biomaterials, is fully aware of the standard synthetic routes for poly(ester-urea- urethane) materials” and “The skilled person would thus have no difficulty in identifying suitable compounds falling within these categories and selecting appropriate combinations depending on the desired properties of the polymer. Furthermore, the description provides guidance on suitable ester-based components, which constitute part of the required reactants”.
The Examiner respectfully disagrees. Claim 12 recites “comprising the compounds required for the synthesis of poly(ester-urea-urethane)” in lines 3-4. In the absence of a recitation of the compounds required the above recitation is unclear as to what all are required. The written disclosure teaches only the esters that can be chosen. A urethane requires an isocyanate and an extender like a diamine also as reactants to create the urethane and urea like linkages.
b. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The second distinguishing technical feature allows the circulation of progenitor cells, nutrients and other molecules involved in the regularizations of the regeneration process, while allowing internal vascularization of the porous bone substitute material of the invention (11[0028] of the application as published). Datta et al. does not teach or suggest how a person skilled in the art could enable the circulation of progenitor cells, nutrients, and other molecules involved in regulating these processes, while allowing internal vascularization of the porous bone substitute material of the invention”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
c. The Applicant argues “Furthermore, nothing in Datta et al. indicates that the interconnectivity of the pores allows for the circulation of molecules and cells or enables internal vascularization of the substitute material. This is because Datta et al. regards a biomaterial rather than a bone substitute material”.
The Examiner respectfully disagrees. The invention of Datta et al. ‘161 is a porous bone substitute material. Further, the invention of Datta et al. ‘161 enables internal vascularization, as disclosed in, e.g., [0062], [0086], and [0132].
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, each of Owens et al. ‘186 and Yang ‘356 teaches a porous bone substitute material comprising particles of decellularized bone.
d. In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., “The third distinguishing technical feature provides a bone substitute material having high porosity while maintaining structural integrity under physiological loads, and enabling biological activity and cell infiltration”) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
e. The Applicant argues “While Datta discloses that the matrix may be elastomeric, this property relates to the polymer matrix itself. The fact that the matrix is elastomeric does not imply that a final composite including particulate fillers, such as bone particles, will remain elastomeric”.
The Examiner respectfully disagrees. The invention of Datta et al. ‘161 is both porous and elastomeric (as shown in the rejection above).
Conclusion
11. THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Examiner Javier G. Blanco whose telephone number is (571)272-4747. The examiner can normally be reached on M- F (10am-7:30pm).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, SPE Jerrah C. Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAVIER G BLANCO/ Primary Examiner, Art Unit 3774
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