DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions and Claim Status
Applicants’ amendments and arguments filed 11/20/25 are acknowledged. Any objection or rejection from the 5/21/25 office action that is not addressed below is withdrawn based on the amendments.
Previously, the species of biodegradable PLA was elected.
Claims 14-18 and 23 recite materials other than PLA and are thus drawn to non-elected species.
Claims 14-18 and 23 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/16/24.
Claims 1-10 have been canceled.
Claims 11-13 and 19-22 are being examined.
Priority
The priority information is found in the filing receipt dated 10/6/21.
Claim Rejections - 35 USC § 112
Claims were previously rejected under 112b/2nd. The rejection is updated based on the claim amendments. The 112a/1st rejection is a new rejection necessitated by amendment.
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.
Claims 11-13 and 19-22 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.
The 2nd and 5th to last lines of claim 11 and the 2nd line of claim 22 have been amended to recite ‘directional/directed’. The 5th to last line of claim 22 has been amended to recite ‘non-directional/undirected’. It is unclear if the use of the forward slash is to separate alternatives or if both options are intended. Further, it is unclear how to differentiate directed from undirected. The claim language is with respect to bone tissue which has mass. In order for new bone to form it would seem that it would have to form in at least some type of direction. The term ‘directional’ is broad and would seem to encompass unidirectional and multidirectional. MPEP 2111.02 II states that if “the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. The instant claims are method claims and it is not clear that the preamble requires any type of manipulative difference (see MPEP 2111.02 II 2nd paragraph). It is not clear what embodiments, if any, are excluded by the language of the preamble. None of the dependent claims clarify the claim scope.
Claim 11 has been amended to recite ‘immobilizes BSP and collagen on the internal surfaces of the pores to provide localized release’. The use of ‘immobilizes’ and ‘to provide localized release’ appear to be contradictory. Something that is immobilized is prevented from moving while release seem to require moving. Further, the use of the term ‘localized’ appear to be subjective. For example, it is unclear what local is in relation to. None of the dependent claims clarify the claim scope.
Claim 11 line 7 has been amended to recites ‘prothesis’. Such term does not seem to make sense in the context of the instant claim. The claim does refer to ‘prosthesis’. It is unclear if ‘prothesis’ is intended to be ‘prosthesis’.
Although unclear, the claims have been given the broadest reasonable interpretation consistent with the specification.
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.
Claims 11-13 and 19-22 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
This rejection is a ‘new matter’ rejection. Section 2163 of the MPEP states: ‘While there is no in haec verba requirement, newly added claim limitations must be supported in the specification through express, implicit, or inherent disclosure’. The reply of 11/20/25 does not appear to provide any indication where any support for any of the claim amendments can be found.
Claim 11 has been amended to recite ‘said absorption immobilizes BSP and collagen on the internal surfaces of the pores to provide localized release the guides directional/directed bone tissue formation’. The instant specification does not use the term immobilizes or immobile or immobilized or local or localized. Further, the language appears to refer to immobilizing collagen on a pore surface which can be collagen. The reply of 11/20/25 does not appear to provide any indication where any support for any of the claim amendments can be found. As such, there is no reasonable bases to conclude support for claim 11 and dependents through express, implicit, or inherent disclosure for at least the reasons discussed above.
Claim 22 has been amended to recite ‘without causing uncontrolled and non-directional/undirected growth and promotes spatially organized bone formation aligned with the native tissue architecture’. The instant specification does not use the term spatially or organized or aligned. The reply of 11/20/25 does not appear to provide any indication where any support for any of the claim amendments can be found. As such, there is no reasonable bases to conclude support for claim 22 through express, implicit, or inherent disclosure for at least the reasons discussed above.
Response to Arguments - 112
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Claim Rejections - 35 USC § 103
Claims were previously rejected based on the references cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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.
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(s) absent any evidence to the contrary. Applicant is advised of the obligation under 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.
Claim(s) 11-13 and 19-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gregor et al. (‘Designing of PLA scaffolds for bone tissue replacement fabricated by ordinary commercial 3D printer’ Journal of Biological Engineering v11(31) 2017 pages 1-21; ‘Gregor’) in view of Armbruster et al. (EP 2269663 as cited with IDS 5/6/21; ‘Armbruster’).
The first page of Gregor lists a publication date of 2017. The online publication (Gregor publication date retrieved from https://jbioleng.biomedcentral.com/articles/10.1186/s13036-017-0074-3 on 3/5/23, 72 pages) specifically recites a publication date of October 16 2017 (page 1).
Gregor teach PLA scaffolds for bone tissue replacement fabricated by a 3D printer (title and abstract). Gregor teach scaffolds for growth of cells where the scaffold biodegrades (abstract and page 2 first paragraph). Gregor recognizes the importance of the structure and properties of the scaffold (page 2 2nd-3rd paragraph). Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column). Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Gregor teach successful cell proliferation and osteoconduction (page 3 paragraph connecting columns 1-2). Gregor recognizes that bone sialoprotein is associated with bone (page 13 paragraph connecting columns 1-2 and page 17 2nd complete paragraph). Gregor recognizes 3D printed cages (page 17 first complete paragraph). Gregor teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor recognizes that cell adhesion is mediated by adsorbed proteins (page 10 last paragraph) and teach that collagen is known to be adsorbed on PLA which may be important for optimal cell adhesion (page 13 first paragraph). Gregor teach that the surface properties of PLA have the potential for optimal osteoinduction (page 13 first paragraph). Gregor teach that the modification by collagen may be applied on 3D scaffolds (page 16 first complete paragraph of 2nd column).
Gregor does not teach an example where a scaffold is prepared that contains human BSP.
Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) where the material is osteoinductive and osteoconductive (section 0024). Armbruster recognizes that the biodegradable polymer can comprise PLA (sections 0018, 0028 and claim 10). Armbruster teach the inclusion of human recombinant bone sialoprotein (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (section 0017 and claim 9) and an example of 50 microgram/ml (section 0047). Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Armbruster recognize applications to surgery in a patient (example 4 sections 0049-0051). Armbruster teach that collagen supports adhesion and it is contemplated to incorporate the protein into the biocomposite (section 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of Gregor because Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Since Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) where the material is osteoinductive and osteoconductive (section 0024) and teach the inclusion of human recombinant BSP (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (section 0017 and claim 9) one would have been motivated to include human rBSP in the scaffolds of Gregor. Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Armbruster recognize applications to surgery in a patient (example 4 sections 0049-0051). MPEP 2141 III recognizes a rationale of combining prior art elements according to known methods to yield predictable results. In the instant case, Gregor teach the PLA scaffold and Armbruster teach human rBSP. Further, Gregor teach advantages of including collagen. Gregor teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor teach that the surface properties of PLA have the potential for optimal osteoinduction (page 13 first paragraph). Gregor teach that the modification by collagen may be applied on 3D scaffolds (page 16 first complete paragraph of 2nd column). Armbruster teach that collagen supports adhesion and it is contemplated to incorporate the protein into the biocomposite (section 0037). Thus one would have been motivated to include collagen in the composition.
One would have had a reasonable expectation of success since Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column). Armbruster recognizes that the biodegradable polymer can comprise PLA (sections 0018, 0028 and claim 10). Armbruster teach the inclusion of human recombinant BSP (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (section 0017 and claim 9). Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Further, Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph) thus teaching that methods of preparing were known.
In relation to the PLA scaffold of claims 11 (first providing step) and 22 (first printing step), Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm (350 micrometer) pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to the 3D printing of claims 11 and 22, Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to the collagen provided and amounts in claims 11 and 22, Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (0.1%) (page 5 first complete paragraph). Since Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph) and teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph) and teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph) one would have been motivated to optimize the amount of collagen.
In relation to the BSP of claims 11-13 and 22 (3rd providing step of claim 11 and 2nd providing step of claim 22), Armbruster teach the inclusion of human recombinant BSP (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (sections 0017 and 0040 and claim 9) and an example of 50 microgram/ml (sections 0045 and 0047).
In relation to the combining steps of claims 11 and 22, Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Thus methods of combining were known.
In relation to the treating and implanting steps of claims 11 and 22, Armbruster recognize applications to surgery in a patient (example 4 sections 0049-0051). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor recognizes that cell adhesion is mediated by adsorbed proteins (page 10 last paragraph) and teach that collagen is known to be adsorbed on PLA which may be important for optimal cell adhesion (page 13 first paragraph).
In relation to claim 19, Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to claim 20, Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) and recognize applications to surgery in a patient (example 4 sections 0049-0051).
In relation to any functional properties of claims 11 and 21-22 and the claim preambles of claims 11 and 22, Gregor teach scaffolds for growth of cells where the scaffold biodegrades (abstract and page 2 first paragraph). Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Gregor teach successful cell proliferation and osteoconduction (page 3 paragraph connecting columns 1-2). Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) where the material is osteoinductive and osteoconductive (section 0024). Although unclear (see 112 rejection above) all of the claim limitations have been interpreted as being met.
Response to Arguments – 103
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
Although applicants argue that the claims have been amended, the amended claims are addressed above.
Although applicants argue about amendments to the claim preamble, as set forth above the claim language is unclear. MPEP 2111.02 II states that if “the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction”. The instant claims are method claims and it is not clear that the preamble requires any type of manipulative difference (see MPEP 2111.02 II 2nd paragraph). It is not clear what embodiments, if any, are excluded by the language of the preamble.
Although applicants argue that Gregor does not disclose structures capable of directing new bone growth, Gregor teach PLA scaffolds for bone tissue replacement fabricated by a 3D printer (title and abstract). Gregor teach scaffolds for growth of cells where the scaffold biodegrades (abstract and page 2 first paragraph). Gregor recognizes the importance of the structure and properties of the scaffold (page 2 2nd-3rd paragraph). Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column). Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Gregor teach successful cell proliferation and osteoconduction (page 3 paragraph connecting columns 1-2).
Although applicants argue about the teachings of Armbruster alone, the instant rejection is a multiple reference 103 rejection and as such any single reference does not necessarily anticipate the claims. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The teachings of the references are discussed in detail above.
Although applicants argue that Armbruster does not teach a physiologically effective amount of active human BSP since it is underglycosylated, Armbruster teach ‘the employed active human rBSP is preferably underglycosylated’ (section 0031). Armbruster teach that the data indicates that low concentrations of underglycosylated human rBSP are sufficient (section 0040). Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060).
Although applicants refer to BSP in a solvent and undergoing chemical modifications, first no citation is made as to where this information is to be found in Armbruster and appears to amount to unsubstantiated attorney argument (see MPEP 2145 I). It is unclear how a solvent would result in a chemical modification. Further, the claim language does not exclude the presence of other components in any of the mixtures. Instant claims 11 and 22 use the open-ended ‘comprising’ language. As such, additional steps or components are acceptable.
Although applicants argue that Armbruster teach away by expressly indicating that directional bone growth is not possible, no citation is made as to where this information is to be found in Armbruster and appears to amount to unsubstantiated attorney argument (see MPEP 2145 I).
Double Patenting
Claims were previously rejected based on the patent and references cited below. Since the claims have been amended the rejection is updated to correspond to the instant claims.
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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 11-13 and 19-22 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 8834935 (‘935’) in view of Gregor et al. (‘Designing of PLA scaffolds for bone tissue replacement fabricated by ordinary commercial 3D printer’ Journal of Biological Engineering v11(31) 2017 pages 1-21; ‘Gregor’) in view of Armbruster et al. (EP 2269663 as cited with IDS 5/6/21; ‘Armbruster’).
The first page of Gregor lists a publication date of 2017. The online publication (Gregor publication date retrieved from https://jbioleng.biomedcentral.com/articles/10.1186/s13036-017-0074-3 on 3/5/23, 72 pages) specifically recites a publication date of October 16 2017 (page 1).
935 recites a method of making a bone material having osteoinductive and osteoconductive properties for treating osseous defects and neogenesis of bone comprising providing a solution comprising recombinant human BSP and providing a composition comprising a biodegradable polymer followed by combining (claim 1). 935 recites specific amounts of human BSP (claim 9). 935 recites polylactide as a biodegradable polymer (claim 6).
935 does not recite specifics about the porosity or 3D printing.
Gregor teach PLA scaffolds for bone tissue replacement fabricated by a 3D printer (title and abstract). Gregor teach scaffolds for growth of cells where the scaffold biodegrades (abstract and page 2 first paragraph). Gregor recognizes the importance of the structure and properties of the scaffold (page 2 2nd-3rd paragraph). Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column). Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Gregor teach successful cell proliferation and osteoconduction (page 3 paragraph connecting columns 1-2). Gregor recognizes that bone sialoprotein is associated with bone (page 13 paragraph connecting columns 1-2 and page 17 2nd complete paragraph). Gregor recognizes 3D printed cages (page 17 first complete paragraph). Gregor teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor recognizes that cell adhesion is mediated by adsorbed proteins (page 10 last paragraph) and teach that collagen is known to be adsorbed on PLA which may be important for optimal cell adhesion (page 13 first paragraph).
Gregor teach that the surface properties of PLA have the potential for optimal osteoinduction (page 13 first paragraph). Gregor teach that the modification by collagen may be applied on 3D scaffolds (page 16 first complete paragraph of 2nd column).
Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) where the material is osteoinductive and osteoconductive (section 0024). Armbruster recognizes that the biodegradable polymer can comprise PLA (sections 0018, 0028 and claim 10). Armbruster teach the inclusion of human recombinant bone sialoprotein (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (section 0017 and claim 9) and an example of 50 microgram/ml (section 0047). Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Armbruster recognize applications to surgery in a patient (example 4 sections 0049-0051). Armbruster teach that collagen supports adhesion and it is contemplated to incorporate the protein into the biocomposite (section 0037).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the teachings of 935 because 935 recites method of making a bone material having osteoinductive and osteoconductive properties for treating osseous defects and neogenesis of bone comprising providing a solution comprising recombinant human BSP and providing a composition comprising a biodegradable polymer followed by combining (claim 1). Based on the advantageous properties taught by Gregor, one would have been motivated to make the scaffold out of PLA. Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Since Gregor teach methods of 3D printing (page 3 2nd column) one would have been motivated to make by such method. Further, Gregor teach advantages of including collagen. Gregor teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor teach that the surface properties of PLA have the potential for optimal osteoinduction (page 13 first paragraph). Gregor teach that the modification by collagen may be applied on 3D scaffolds (page 16 first complete paragraph of 2nd column). Armbruster teach that collagen supports adhesion and it is contemplated to incorporate the protein into the biocomposite (section 0037).Thus one would have been motivated to include collagen in the composition.
One would have had a reasonable expectation of success since Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column). 935 recites a method of making a bone material having osteoinductive and osteoconductive properties for treating osseous defects and neogenesis of bone comprising providing a solution comprising recombinant human BSP and providing a composition comprising a biodegradable polymer followed by combining (claim 1). Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060).
In relation to the PLA scaffold of claims 11 (first providing step) and 22 (first printing step), Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to the 3D printing of claims 11 and 22, Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to the BSP of claims 11-13 and 22 (3rd providing step of claim 11 and 2nd providing step of claim 22), 935 recites human BSP in specific amounts (claim 9). Armbruster teach the inclusion of human recombinant BSP (rBSP) in the composition at an amount of 1 to 200 micrograms/ml (sections 0017 and 0040 and claim 9) and an example of 50 microgram/ml (sections 0045 and 0047).
In relation to the collagen provided and amounts in claims 11 and 22, Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (0.1%) (page 5 first complete paragraph). Since Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph) and teach that collagen is the protein that creates the majority of extracellular matrix (page 2 first paragraph) and teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph) one would have been motivated to optimize the amount of collagen.
In relation to the combining steps of claims 11 and 22, Armbruster teach that rBSP is osteoinductive and can be embedded in the polymer (section 0031) where the human rBSP has advantageous effects related to osteoinduction (sections 0033, 0051 and 0060). Gregor teach an example in which a sample was incubated with 1 mg/ml collagen (page 5 first complete paragraph). Thus methods of combining were known.
In relation to the treating and implanting steps of claims 11 and 22, Armbruster recognize applications to surgery in a patient (example 4 sections 0049-0051). Gregor teach that collagen is known to bind to the surface of PLA (page 8 first complete paragraph). Gregor teach that bone extracellular matrix is composed of collagen and that adsorbed collagen fibers may be important for optimal cell adhesion in vivo (page 13 first paragraph). Gregor recognizes that cell adhesion is mediated by adsorbed proteins (page 10 last paragraph) and teach that collagen is known to be adsorbed on PLA which may be important for optimal cell adhesion (page 13 first paragraph).
In relation to claim 19, Gregor shows the scaffold structure of PLA with 30% porosity and 0.35mm pore size (figure 1) as well as 50% porosity and 0.7mm pore size (figure 2) that were prepared by 3D printing (page 3 2nd column).
In relation to claim 20, Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) and recognize applications to surgery in a patient (example 4 sections 0049-0051).
In relation to any functional properties of claims 11 and 21-22 and the claim preambles of claims 11 and 22, Gregor teach scaffolds for growth of cells where the scaffold biodegrades (abstract and page 2 first paragraph). Gregor teach that the surface properties of PLA scaffolds have potential for optimal osteoinduction and these properties combined with biodegradation in time span of bone regeneration and customizable shape of implant predestinate the use of scaffold in bone tissue engineering (page 13 first paragraph). Gregor teach successful cell proliferation and osteoconduction (page 3 paragraph connecting columns 1-2). Armbruster also teach scaffolds for tissue and bone substitutes (section 0020) where the material is osteoinductive and osteoconductive (section 0024). Although unclear (see 112 rejection above) all of the claim limitations have been interpreted as being met.
Response to Arguments – Double Patenting
Applicant's arguments filed 11/20/25 have been fully considered but they are not persuasive with respect to the rejection set forth above.
There do not appear to be any specific arguments related to the double patenting rejection. Although the claims have been amended, the amended claims are addressed above.
Conclusion
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.
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RONALD T. NIEBAUER
Primary Examiner
Art Unit 1658
/RONALD T NIEBAUER/Examiner, Art Unit 1658