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 .
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-3, 5-6, 9, 14-15, and 17-18 are rejected under 35 U.S.C. 102a1 as being anticipated by US 20150093363 to Ekstrom
Regarding claim 1, Ekstrom teaches a method of healing a bone void [0015], the method comprising:
forming an exosome carrier material including one or more cell-derived exosomes and one or more cellular components [0015];
inserting the exosome carrier material into a bone void [0015]; and
instigating, with the one or more cell-derived exosomes and the one or more cellular components, healing at the bone void [0015, 0017, or 0057].
Regarding claim 2, Ekstrom teaches a method of claim 1 of wherein,
the one or more cellular components include one or more bone regenerating components or one or more cartilage regenerating components [0050].
Regarding claim 3, Ekstrom teaches a method of claim 2 of wherein,
the one or more bone regenerating components include one or more of an osteoclast cell, an endothelial cell, a stem cell, or a macrophage cell [0050]
Regarding claim 5, Ekstrom teaches a method of claim 1 of wherein,
the one or more cellular components include a bone cellular component, a muscle cellular component, a marrow cellular component, or a vessel cellular component [0050].
Regarding claim 6, Ekstrom teaches a method of claim 1 of wherein,
the one or more cellular components include a mesenchymal stem cell and a macrophage as marrow regenerating components [0050].
Regarding claim 9, Ekstrom teaches a method of healing a bone void [0015 and 0017], the method comprising:
forming an exosome solution including one or more cell-derived exosomes and one or more bone growth generating cellular components [0015];
forming an exosome carrier material using at least some of the exosome solution (see claims 18/19 and [0015];
providing the exosome carrier material into a bone void [0015 and 0057]; and
instigating, with the one or more cell-derived exosomes and the one or more bone growth generating cellular components, healing in the bone void [0015 and 0017].
Regarding claim 14, Ekstrom teaches a method of claim 9 of wherein,
the one or more bone growth generating cellular components include one or more of an osteoclast, an endothelial cell, a stem cell, or a macrophage [0050].
Regarding claim 15, Ekstrom teaches a method of claim 14 of wherein,
the exosome solution further includes mesenchymal stem cells as a marrow regeneration component of the exosome solution [0050].
Regarding claim 17, Ekstrom teaches a method of claim 9 of wherein,
the one or more cell-derived exosomes includes micro ribonucleic acid (miRNA) [0043-0045] and protein [0045].
Regarding claim 18, Ekstrom teaches a method of healing a bone void [0015], the method comprising:
providing a bone void in an operating environment [0057];
forming an exosome carrier material including one or more cell-derived exosomes and one or more cellular components, the one or more cellular components including at least one of bone growth regenerating cellular components or cartilage regenerating components [0015, 0017, 0050, 0057]; and
inserting the exosome carrier material into the bone void to instigate healing at the bone void [0056 0067].
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.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom as applied to claim 2 above, and further in view of US20190022145 to O’Heeron.
Regarding claim 4, Ekstrom teaches a method of claim 2 of wherein,
However fails to teach the one or more cartilage regenerating components include one or more of a chondrite, a fibroblast, or a platelet.
O’Heeron teaches one or more cartilage regenerating components includes a fibroblast [0005].
It 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 to modify the method of Ekstrom to include fibroblasts to regenerate/treat bone/cartilage problems.
Claims 7 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom as applied to claims 6 and 18 above, and further in view of US20220105245 to Meretzki
Regarding claim 7, Ekstrom teaches a method of claim 6 of wherein,
However fails to teach the one or more cellular components include an endothelial cell as a vessel regenerating component, or a myocyte as a muscle regenerating component.
Meretzki teaches one or more cellular components include an endothelial cell as a vessel regenerating component [0002].
It 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 to modify the method of Ekstrom to include endothelial cell precursors as they are required to form new blood vessels in the developed bone tissue [0002 0018 0034].
Regarding claim 19, Ekstrom teaches a method of claim 18 of wherein,
However fails to teach the one or more cellular components include an endothelial cell as a vessel regeneration component of the exosome carrier material.
Meretzki teaches one or more cellular components include an endothelial cell as a vessel regenerating component [0002].
It 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 to modify the method of Ekstrom to include endothelial cell precursors as they are required to form new blood vessels in the developed bone tissue [0002 0018 0034].
Claims 8, 13 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom as applied to claims 1, 9, and 20 above, and further in view of US 20140364787 to Bolla
Regarding claim 8, Ekstrom teaches a method of claim 1 of wherein,
However fails to teach the bone void is a thoracic fracture; and
inserting the exosome carrier material into the bone void includes injecting the exosome carrier material into the thoracic fracture.
Bolla teaches thoracic fracture [0007].
It 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 to modify the method of Ekstrom to include thoracic fractures as the particular bone void as involves only routine skill in the art. The motivation of doing so would be to include various types of bone voids. Ekstrom teaches the steps of injecting the exosome carrier see [0015, 0050, 0057]- thus the combination into thoracic fracture.
Regarding claim 13, Ekstrom teaches a method of claim 9 of wherein,
However fails to teach the bone void is a thoracic fracture; and
an amount of the exosome carrier material corresponds to a size of the thoracic fracture.
Bolla teaches thoracic fracture [0007].
It 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 to modify the method of Ekstrom to include thoracic fractures as the particular bone void as involves only routine skill in the art. The motivation of doing so would be to include various types of bone voids. Ekstrom teaches the steps of injecting the exosome carrier see [0015, 0050, 0057]- thus the combination into thoracic fracture.
Regarding claim 20, Ekstrom teaches a method of claim 19 of wherein,
However fails to teach the bone void is a thoracic fracture; and
the exosome carrier material is a liquid, gel, or paste which at least partially fills the thoracic fracture.
Bolla teaches thoracic fracture [0007].
It 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 to modify the method of Ekstrom to include thoracic fractures as the particular bone void as involves only routine skill in the art. The motivation of doing so would be to include various types of bone voids. Ekstrom teaches the steps of injecting the exosome carrier see [0015, 0050, 0057]- thus the combination into thoracic fracture. Ekstrom teaches hydrogel [0050] and syringe [0056].
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom as applied to claim 9 above, and further in view of US US20170119823 to Gazit
Regarding claim 10, Ekstrom teaches a method of claim 9 of wherein,
However fails to teach the bone void is rib fracture;
the exosome carrier material is a liquid or a gel; and
providing the exosome carrier material into the bone void includes injecting the exosome carrier material into the rib fracture.
Gazit teaches a rib fracture as an exemplary bone void [0017, 0046]
It 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 to modify the method of Ekstrom to include rib fractures as the particular bone void as involves only routine skill in the art. The motivation of doing so would be to include various types of bone voids. Ekstrom teaches the steps of injecting the exosome carrier see [0015, 0050, 0057]- thus the combination into rib fracture. Ekstrom teaches hydrogel [0050] and syringe [0056].
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom and US US20170119823 to Gazit as applied to claim 10 above, and further in view of WO 2021211460 to Morris
Regarding claim 11, the combination of Ekstrom and Gazit teaches a method of claim 10, wherein:
However fails to teach forming the exosome carrier material using at least some of the exosome solution includes injecting the exosome solution into a sealed container while a graft is in the sealed container.
Morris teaches the art of exosomes a sealed container [0096] the formulations of exosome can be presented in sealed containers such as ampules and vials.
It 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 to modify the method of Ekstrom to include injecting the exosome solution into a sealed container while a graft in the sealed container – Ektrom teaches exosomes on implant surface [0015 0050] and Morris sealed container.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom and US US20170119823 to Gazit as applied to claim 10 above, and further in view of US 20150173817 to Arthur
Regarding claim 12, the combination of Ekstrom and Gazit teaches a method of claim 10, further comprising:
However fails to teach compressing a portion of bone around the bone void.
Arthur teaches compressing a portion of bone around a void [0005].
It 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 to modify the method of Ekstrom to include the step of compressing a porition of bone around the void as to effectively treat bone fracture.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over US 20150093363 to Ekstrom as applied to claim 14 above, and further in view of US 20210093749 to Fathi
Regarding claim 16, Ekstrom teaches a method of claim 14 of wherein,
However fails to teach the exosome solution further includes a myocyte cell as a muscle regeneration component of the exosome solution.
Fathi teaches a myocyte cell [0226 0227].
It 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 to modify the method of Ekstrom to include myocyte cells as Fathi teaches myocytes assist in repair/regeneration of the target bone tissue [0226 0227].
Conclusion
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/AMY R WEISBERG/Supervisory Patent Examiner, Art Unit 3612
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