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 .
Priority
2. This application is a 371 of PCT/EP2021/063493 filed 05/20/2021. This application claims foreign priority to FRANCE FR2005385 filed 05/20/2020 under 35 U.S.C. 119(a)-(d). However, the certified copy of the foreign priority document is not accompanied by (i) an English translation and (ii) statement of translation accuracy. Thus, foreign priority has not been perfected (see MPEP 2152.01 and 37 CFR 1.55). Until such time English translations of the foreign priority documents are made of record the effective filing date accorded the instant application is 05/20/2021.
Specification
3. The disclosure is objected to because of the following informalities:
a. The BRIEF DESCRIPTION of Figure 3 does not include reference to each of Figures 3A and 3B. Appropriate correction is required.
Claim Objections
4. Claim 8 is objected to because of the following informalities:
a. Regarding claim 8, please substitute “has a volume of between 0.1 and 400 cm3” with -- has a volume of between 0.1 cm3 and 400 cm3 --. Appropriate correction is required.
Claim Rejections - 35 USC § 112
5. 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.
6. Claims 3, 9, 10, 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. Regarding claim 3, the recitation “can be obtained” renders the claim indefinite as to the scope of the invention. The term “can be” denotes a possibility.
b. The term “preferably” in claim 9 is a relative term which renders the claim indefinite. The term “preferably” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 10 depends from claim 9.
c. 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.
d. Claim 12 recites the limitation “the decellularized bone particles” (line 5). There is insufficient antecedent basis for this limitation in the claim.
e. Claim 12 recites “polymerizing/crosslinking the emulsion obtained at step b)” in line 7. Does the recitation mean both (i.e., polymerizing AND crosslinking) are performed? This is unclear from the claim language.
Claim Rejections - 35 USC § 103
7. 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.
8. 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) and Yang (US PG Pub No. 2014/0193356 A1).
Regarding independent claim 1, Datta et al. ‘161 teaches a porous (Figure 1 clearly shows pores 20; further, see [0051], [0086], and [0089]) bone substitute ([0052], [0122], [0298]) material (10) comprising:
- at least one elastomer matrix ([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 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 a porous bone substitute material 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/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).
Conclusion
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