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 . Claims included in the prosecution are claims 1-8, 13, 14, 45 and 46.
Applicants' arguments, filed 01/05/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 8 fails to further limit claims 1 and 7 since claim 1 recites a fluoridated apatite structure and a fluoridated apatite structure inherently includes fluoridated apatite. Thus, claim 8 reciting wherein the fluoridate apatite structure includes fluoridated apatite does not further limit the subject matter.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 103
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.
The factual inquiries 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.
1. Claims 1-4, 8, 14, 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Jeyapalina et al. (WO 2020/146646 A1, Jul. 16, 2020) (hereinafter Jeyapalina) in view of Coleman et al. (US 2015/0037387, Feb. 5, 2015) (hereinafter Coleman).
Jeyapalina discloses an implantable scaffold including a fluoridated apatite structure sized and shaped for implantation in an animal (¶ [0005]). The scaffold may include pores (¶ [0033]). The fluoridated apatites include one or more of fluorohydroxyapatite or fluorapatite that is sintered at a sintering temperature selected to provide a desired surface morphology for the scaffold. The scaffolds may include dopants composed to initiate and sustain bone growth and integration, such as an implantee’s own stem cells (adipose derived stem cells (ASCs)), bone morphogenetic protein-2 (BMP-2), tissues, combinations thereof, or the like (¶ [0026]). The scaffold may include one or more dopants (¶ [0034]). Doping the fluoridated apatite particles may include adding one or more dopants to the plurality of fluoridated apatite particles prior to forming the coherent body, or coating at least a portion of the coherent body with one or more dopants after forming the coherent body (¶ [0079]). The scaffold may exhibit a porosity of 30% to 70% (¶ [0075]). The pores may be filled with one or more dopants (¶ [0034]).
Jeyapalina differs from the instant claims insofar as not disclosing a stromal vascular fraction adhered to the fluoridated apatite structure.
However, Coleman discloses a cell-seeded tissue graft comprising a reparative cell preparation seeded onto a porous scaffold, wherein the tissue graft is prepared by isolating a fresh stromal vascular fraction (SVF) from an adipose tissue of a patient; applying the fresh SVF cells to the porous scaffold, and rinsing the porous scaffold to eliminate cells that are unbound by the porous scaffold (claim 1). Adipose derived stromal cells seeded onto carrier bioprosthetics facilitated formation of new bone in an animal model (¶ [0008]). The cell seeded tissue grafts may be utilized to treat one or more of: wound healing, burns, bone fractures, cosmetic defects, cartilage damage, tendon damage, ulcers, fistulas, hernias, retinal degeneration, treatment of ischemic disease, nerve injury, aneurysms, bladder wall repair, intestinal injury, and repair and reconstruction of vessels (¶ [0020]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Jeyapalina discloses wherein the scaffold comprises one or more dopants composed to initiate and sustain bone growth. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a stromal vascular fraction from an adipose tissue onto the scaffold of Jeyapalina since it is a known and effective dopant for initiating and sustaining bone growth as taught by Coleman.
In regards to instant claim 45, since the pores may be filled with dopants, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed pore size depending on the amount and size of dopants desired to be incorporated. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
2. Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Jeyapalina et al. (WO 2020/146646 A1, Jul. 16, 2020) (hereinafter Jeyapalina) in view of Coleman et al. (US 2015/0037387, Feb. 5, 2015) (hereinafter Coleman), and further in view of Si et al. (Adipose-derived stem cells: Sources, potency, and implications for regenerative therapies, Mar. 25, 2019) (hereinafter Si).
The teachings of Jeyapalina and Coleman are discussed above. Jeyapalina and Colement do not teach wherein the stromal vascular fraction includes perivascular cells, leukocytes, endothelial cells, fibroblasts, and progenitor stem cells.
However, Si discloses wherein a stromal vascular fraction (SVF) containing adipose-derived stem cells (ASCs), pre-adipocytes, endothelial cells, fibroblasts, endothelial progenitor cells, resident monocytes/macrophages, pericytes (i.e., perivascular cells), endothelial progenitor cells (i.e., progenitor stem cells), vascular smooth muscle cells, leukocytes, lymphocytes, and erythrocytes (page 2, left column section 1.1).
As discussed above, it would have been obvious to one of ordinary skill in the art to have incorporated a stromal vascular fraction from an adipose tissue onto the scaffold of Jeyapalina. Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have incorporated the stromal vascular fraction of Si onto the scaffold of Jeyapalina since it is a known and effective stromal vascular fraction as taught by Si.
3. Claims 1, 2, 7, 8, 14, 45 and 46 are rejected under 35 U.S.C. 103 as being unpatentable over Jeyapalina et al. (WO 2020/146646 A1, Jul. 16, 2020) (hereinafter Jeyapalina) in view of Yayon (US 2006/0147547, Jul. 6, 2006).
Jeyapalina discloses an implantable scaffold including a fluoridated apatite structure sized and shaped for implantation in an animal (¶ [0005]). The scaffold may include pores (¶ [0033]). The fluoridated apatites include one or more of fluorohydroxyapatite or fluorapatite that is sintered at a sintering temperature selected to provide a desired surface morphology for the scaffold. The scaffolds may include dopants composed to initiate and sustain bone growth and integration, such as an implantee’s own stem cells (adipose derived stem cells (ASCs)), bone morphogenetic protein-2 (BMP-2), tissues, combinations thereof, or the like (¶ [0026]). The scaffold may include one or more dopants (¶ [0034]). Doping the fluoridated apatite particles may include adding one or more dopants to the plurality of fluoridated apatite particles prior to forming the coherent body, or coating at least a portion of the coherent body with one or more dopants after forming the coherent body (¶ [0079]). The scaffold may exhibit a porosity of 30% to 70% (¶ [0075]). The pores may be filled with one or more dopants (¶ [0034]).
Jeyapalina differs from the instant claims insofar as not disclosing at least one metal substitute substituted into the fluoridated apatite structure.
However, Yayon discloses a bone-enhancing composite material that may be used as an implant (abstract). The composite comprises synthetic apatite (¶ [0032]). The synthetic apatite may contain cation or anion substitutions. Zinc may be added to partly replace the calcium ions (¶ [0037]). The incorporation of additional or different divalent ions imparts on the composition certain properties that may be advantageous to bone repair and growth (¶ [0114]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have substituted zinc into the fluoridated apatite structure motivated by the desire to impart to the structure properties that may be advantageous to bone repair and growth as taught by Yayon.
In regards to instant claim 1 reciting wherein about 0.5 molar % to about 5 molar % of calcium in the fluoridated apatite structure is replaced with zinc, since the incorporation zinc ions by replacing calcium ions imparts on the composition certain properties that may be advantageous to bone repair and growth, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount calcium ion replacement depending on the bone repair and growth effect desired. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
In regards to instant claim 45, since the pores may be filled with dopants, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed pore size depending on the amount and size of dopants desired to be incorporated. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A).
4. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Jeyapalina et al. (WO 2020/146646 A1, Jul. 16, 2020) (hereinafter Jeyapalina) in view of Yayon (US 2006/0147547, Jul. 6, 2006), and further in view of Coleman et al. (US 2015/0037387, Feb. 5, 2015) (hereinafter Coleman).
The teachings of Jeyapalina and Yayon are discussed above. Jeyapalina and Yayon do not teach a stromal vascular fraction adhered to the fluoridated apatite structure.
However, Coleman discloses a cell-seeded tissue graft comprising a reparative cell preparation seeded onto a porous scaffold, wherein the tissue graft is prepared by isolating a fresh stromal vascular fraction (SVF) from an adipose tissue of a patient; applying the fresh SVF cells to the porous scaffold, and rinsing the porous scaffold to eliminate cells that are unbound by the porous scaffold (claim 1). Adipose derived stromal cells seeded onto carrier bioprosthetics facilitated formation of new bone in an animal model (¶ [0008]). The cell seeded tissue grafts may be utilized to treat one or more of: wound healing, burns, bone fractures, cosmetic defects, cartilage damage, tendon damage, ulcers, fistulas, hernias, retinal degeneration, treatment of ischemic disease, nerve injury, aneurysms, bladder wall repair, intestinal injury, and repair and reconstruction of vessels (¶ [0020]).
Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. Jeyapalina discloses wherein the scaffold comprises one or more dopants composed to initiate and sustain bone growth. Accordingly, it would have been obvious to one of ordinary skill in the art to have incorporated a stromal vascular fraction from an adipose tissue onto the scaffold of Jeyapalina since it is a known and effective dopant for initiating and sustaining bone growth as taught by Coleman.
Response to Arguments
Applicant argues that application discloses the unexpected result that the fluoridated apatite and fluorohydroxyapatite scaffolds are capable of inducing effective osteogenic differentiation of SVF-derived cells.
The Examiner does not find Applicant’s argument to be persuasive. The claimed invention does not appear to be unexpected since it appears that Applicant’s alleged unexpected results is from having a fluoridated apatite or fluorohydroxyapatite scaffold and such scaffold was already known in the art. As discussed in the rejection. Jeyapalina discloses a fluoridated apatite scaffold wherein the fluoridated apatite is fluorohydroxyapatite or fluorapatite. Thus, since a FA or FHA scaffold was already known, it is not unexpected. Although Jeyapalina does not disclose wherein the scaffold is capable of inducing effective osteogenic differentiation of SVF-derived cells, the scaffold of Jeyapalina appears to be substantially the same as the claimed scaffold since it is a FA or FHA scaffold. Therefore, the scaffold of Jeyapalina would necessarily be capable of inducing effective osteogenic differentiation of SVF-derived cells. Applicant has not shown wherein the fluoridated apatite scaffold of Jeyapalina would not be capable of this property. It should also be noted that instant claim 1 does not require SVF-derived cells. Therefore, even if Applicant’s showing was unexpected, the claims would not be commensurate in scope. As such, Applicant’s argument is unpersuasive.
Applicant argues that nothing in Jeyapalina, Coleman, or their combination would have suggested that an FA or FHA scaffold would intrinsically induce osteogenic differentiation of SVF-derived cells without exogenous osteogenic cues.
The Examiner does not find Applicant’s argument to be persuasive. As discussed above, Jeyapalina discloses substantially the same FA or FHA scaffold as claimed. Applicant’s finding that the scaffold has a new property of inducing osteogenic differentiation of SVF-derived cells without exogenous osteogenic cues does not make the scaffold patentably new. The discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer. See MPEP 2112(I). As such, Applicant’s argument is unpersuasive.
Applicant argues that Yayon provides no preference, examples, or ranges for zinc, and does not disclose zinc-substituted fluoridated apatite.
The Examiner does not find Applicant’s argument to be persuasive. A prior art reference is evaluated for all that it reasonably suggests and is not limited to preferred embodiments or working examples. See MPEP 2123. With regards to the range of zinc, as discussed in the rejection, it would have taken no more than the relative skills of one of ordinary skill in the art through routine experimentation to have arrived at the claimed amount calcium ion replacement depending on the bone repair and growth effect desired. With regards to a zinc-substituted fluoridated apatite, as this is a 103 obviousness rejection, no one piece of prior art is required to teach each and every claim limitation. As discussed in the rejection, the combined teachings of Jeyapalina and Yayon teach a zinc-substituted fluoridated apatite. As such, Applicant’s argument is unpersuasive.
Applicant argues that the present application expressly demonstrates that zinc substitution in fluoridated apatite provides antimicrobial effects while maintaining biocompatibility and osteogenic performance.
The Examiner does not find Applicant’s argument to be persuasive. It was known in the art as taught by Yayon that metal substitution is desirable because it has advantages. A comparison with the closest prior art is need to be effective to rebut a prima facie case of obviousness. See MPEP 716.02(e). Applicant has not shown wherein zinc is more advantageous compared to other metals. As such, Applicant’s argument is unpersuasive.
Applicant argues that even if a skilled person starting from Yayon pursued zinc, the skilled person would have had no starting point from which to conduct routine optimization.
The Examiner disagrees and does not find Applicant’s argument to be persuasive. Yayon discloses wherein the zinc is added to partly replace the calcium ions. Thus, by knowing the amount of calcium ions originally there, one of ordinary skill in the art would have known an upper amount of zinc from which to optimize from. As such, Applicant’s argument is unpersuasive.
Applicant argues that the skilled person would have sought zinc levels optimized generally for bone repair and growth rather than for the antimicrobial properties demonstrated by the claimed zinc levels.
The Examiner does not find Applicant’s argument to be persuasive. Applicant has not shown wherein when optimizing for bone repair and growth, one would not arrive at the claimed amounts. Also, zinc is inherently antimicrobial; therefore, incorporating any amount of zinc provides antimicrobial properties. Applicant has not shown wherein the claimed amounts are unexpected in terms of antimicrobial effectiveness. As such, Applicant’s argument is unpersuasive.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 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 1-8, 13, 14, 45 and 46 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 8-10, 47 and 48 of copending Application No. 17/420,589 in view of Yayon (US 2006/0147547, Jul. 6, 2006).
The pending claims differ from the copending claims insofar as reciting at least one metal substitute substituted into the fluoridated apatite structure.
However, Yayon discloses a bone-enhancing composite material that may be used as an implant (abstract). The composite comprises synthetic apatite (¶ [0032]). The synthetic apatite may contain cation or anion substitutions. Zinc may be added to partly replace the calcium ions (¶ [0037]). The incorporation of additional or different divalent ions imparts on the composition certain properties that may be advantageous to bone repair and growth (¶ [0114]).
Accordingly, it would have been prima facie obvious to one of ordinary skill in the art to have substituted zinc into the fluoridated apatite structure motivated by the desire to impart to the structure properties that may be advantageous to bone repair and growth as taught by Yayon.
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Applicant argues that the deficiencies of Yayon negate the double patenting rejection.
The Examiner submits that Applicant’s arguments regarding Yayon are discussed above and are unpersuasive. Therefore, the rejection is maintained.
Conclusion
Claims 1-8, 13, 14, 45 and 46 are rejected,
Claims 15, 17, 22, 23, 29, 31, 33, 38 and 39 have been withdrawn.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/TRACY LIU/Primary Examiner, Art Unit 1614