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 1-20 are currently pending and have been examined on their merits.
Claim Objections
Claim 11 is objected to because of the following informalities:
Claim 11 is dependent upon claim 10 and for proper form should start with the phrase “The method of claim 10…” rather than “A method of claim 10…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024).
Regarding claim 1, Mi disclose a method of regenerating a portion of bone comprising forming an exosome solution comprising cell-derived exosomes and cellular components (endothelial cell derived exosomes as a carrier of cellular proteins) (page 772-Results and Discussion), causing a graft (hydrogel) to absorb the exosome solution and securing the graft and the exosome solution between two severed portions of bone (bone fracture healing is securing of graft) (page 779-Cocktail therapy showed an enhanced therapeutic effect in a Fracture model).
Regarding claim 2, Mi disclose including bone regenerating components as cellular components in the exosome solution (page 772, page 779).
Therefore, the teaching of Mi et al anticipates Applicant’s invention as claimed.
Claim Rejections - 35 USC § 103
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.
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.
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) 1-3, 5-6, 9, 14-15, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024).
Regarding claims 1 and 9, Ekstrom teaches a method of healing a damaged bone, such as a bone void (page 1 para 15, para 17), the method comprising: forming an exosome solution including one or more cell-derived exosomes and one or more cellular components (extracellular vesicles further comprising target stem cells) (page 1 para 1 para 15, page 5 claims 17-19) and causing a graft (scaffolds and implants) to absorb (immobilized on the scaffold or implants or hydrogels) (page 3 para 48-50, page 4 para 57) and securing the graft with the exosome solution between two severed portions of bone (healing a bone void)(page 1 para 17-18, page 4 para 57, page 5 claims 17-19). Implant surgery is an event that occurs in an operating environment (page 4 para 57).
Ekstrom do not specifically include an embodiment with an exosome solution containing exosomes and cellular components absorbed onto a graft for securing the graft between two severed portions of bone.
Mi disclose a method of regenerating a portion of bone comprising forming an exosome solution comprising cell-derived exosomes and cellular components (endothelial cell derived exosomes as a carrier of cellular proteins) (page 772-Results and Discussion), causing a graft (hydrogel) to absorb the exosome solution and securing the graft and the exosome solution between two severed portions of bone (bone fracture healing is securing of graft) (page 779-Cocktail therapy showed an enhanced therapeutic effect in a Fracture model).
One of ordinary skill in the art would have been motivated to include an embodiment with an exosome solution containing exosomes and cellular components absorbed onto a graft for securing the graft between two severed portions of bone in the method of Ekstrom because Mi teach and suggest that exosome solutions comprising cell-derived exosomes and cellular components combined with graft materials are a suitable and beneficial combination for the repair and securing between two severed portions of bone (bone fracture healing is securing of graft). One of ordinary skill in the art would have had a reasonable expectation of success because both Ekstrom and Mi are directed to repairing damaged bone tissue with exosome solutions and Ekstrom specifically suggests the use of the exosome solution as a bone void filler.
Regarding claim 2, Ekstrom teaches and suggests wherein the one or more cellular components include one or more bone regenerating components (osteogenic) or one or more cartilage regenerating components (page 3 para 48-50).
Regarding claim 3, Ekstrom teaches and suggests 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 (page 3 para 48-50).
Regarding claim 5, Ekstrom teaches and suggests 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 (page 3 para 48-50).
Regarding claim 6, Ekstrom teaches and suggests wherein the one or more cellular components include a mesenchymal stem cell and a macrophage as marrow regenerating components (page 3 para 48-50).
Regarding claim 14, Ekstrom teaches and suggests 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 (page 3 para 50).
Regarding claim 15, Ekstrom teaches and suggests wherein the exosome solution further includes mesenchymal stem cells as a marrow regeneration component of the exosome solution (page 3 para 50).
Regarding claim 17, Ekstrom teaches and suggests wherein the one or more cell-derived exosomes includes micro ribonucleic acid (miRNA) (page 3 para 43-45) and protein (page 3 para 45).
Therefore, the combined teaching of Ekstrom et al and Mi et al renders obvious Applicant’s invention as claimed.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) as applied to claims 1-3, 5-6, 9, 14-15, and 17 above, and further in view of O’Heeron (US 2019/0022145) .
Regarding claim 4, Ekstrom teaches a method of claim 2 as described above, but does not specifically teach 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 include a fibroblast (page 1 para 5). O’Heeron disclose that connective tissue of the body, including bones and cartilage, include cell blends comprising fibroblasts (page 2 para 15, para 19).
One of ordinary skill in the art would have been motivated to include a fibroblast as a cell type in the method of Ekstrom because O’Heeron teach and suggest that fibroblasts are a cell type found in cell blends of connective tissue such as bones. One of ordinary skill in the art would have had a reasonable expectation of success because Ekstrom suggest that additional cell types can be included in their method.
Therefore, the combined teachings of Ekstrom et al, Mi et al and O’Heeron render obvious Applicant’s invention as claimed.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) as applied to claims 1-3, 5-6, 9, 14-15, and 17 above, and further in view of Meretzki (US 2019/0038806).
Regarding claim 7, the combined teaching of Ekstrom and Mi renders obvious the claimed method as described above, but does not specifically teach one or more cellular components include an endothelial cell as a vessel regenerating component, or a myocyte as a muscle regenerating component.
Meretzki discloses bone implants that contain at least two cell types selected from a group consisting of osteoblasts, osteoclasts and endothelial cells or progenitors thereof (abstract). Endothelial cells are required to form new blood vessels in the developing bone tissue (page para 17).
One of ordinary skill in the art would have been motivated to include endothelial cells along with bone forming cells in the method of Ekstrom because Meretzki teach and suggest that the addition of endothelial cells and bone forming cells to a bone implant is beneficial as this combination provides new blood vessels in the developed bone tissue. One of ordinary skill in the art would have had a reasonable expectation of success because Ekstrom suggest that additional cell types can be included in their method.
Therefore, the combined teachings of Ekstrom et al, Mi et al, and Meretzki render obvious Applicant’s invention as claimed.
Claims 3-6, 8, 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) as applied to claims 1-3, 5-6, 9, 14-15, and 17 above, and further in view of Fathi et al (US 2021/0093749).
Regarding claims 3-6, 8, 14-16, the combined teachings of Ekstrom and Mi renders obvious the claimed method as described above, but does not specifically teach one or more cellular components include a myocyte as a muscle regenerating component. Ekstrom does suggest that suitable target cells to be included in their method include osteoblasts, osteoclasts, muscle cells or mesenchymal stem cells (page 2 para 35) and macrophages and mesenchymal stem cells (page 3 para 50).
Fathi disclose compositions and methods for the regeneration of bone tissue and the treatment of a bone defect (abstract). Fathi teach that cells can be included to assist in repair and/or regeneration of the target bone tissue and include myocytes, macrophages, fibroblasts, chondrocytes, osteoblasts, osteoclasts and stem cells (page para 225-227).
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 cell types known to be beneficially included in the repair and regeneration of bone tissue such as myocytes, osteoblasts, osteoclasts, macrophages and mesenchymal stem cells because Fathi teaches and suggests that these cell types assist in repair/regeneration of target bone tissue. One of ordinary skill in the art would have had a reasonable expectation of success because Ekstrom also teach and suggest that several cell types are beneficially included in their method of repairing damaged bone tissue.
Therefore, the combined teachings of Ekstrom et al, Mi et al, and Fathi et al render obvious Applicant’s invention as claimed.
Claims 9-12, 14-15 and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) as applied to claims 1-3, 5-6, 9, 14-15, and 17 above, and further in view of Blaschke et al (WO 2005/037136).
Regarding claims 9, 14-15 and 17-18, the combined teachings of Ekstrom and Mi renders obvious the claimed method as described above. Ekstrom specifically reference bone surgery and implant surgery in their method (page 4 para 57) and surgeries are usually performed in a sterile operating room environment.
However neither Ekstrom nor Mi specifically disclose providing the graft to an operating environment for securing the graft with the exosome solution between two severed portions of bone or a sealed container configured to be provided to an operating environment for implanting the graft in a patient.
Blaschke disclose package systems for handling and storing orthopedic graft materials that contain a liquid component and a graft material in a sealed container (abstract). The liquid is eventually pulled into the compartment with the graft material to hydrate/re-hydrate the graft material by thoroughly infusing the graft material to form a hydrated orthopedic graft material (page 3 para 10-12). The aqueous based liquids may include biologically active materials to be infused into the hydrated graft material (page 6 para 40-41). The liquid component, with the biological materials, can be added to the container the same time as the graft or it can be added immediately before the infusion process is to take place, for example, in the operating room (page 9, lines 1-11).
One of ordinary skill in the art would have been motivated to provide the exosome loaded graft of Ekstrom at least partially immersed in the exosome solution and in a sealed container in an operating room environment because Blaschke teach and suggest a sealed container configured to accommodate a graft and liquid combination for use in an implant surgical procedure to a patient in need in an operating room environment One of ordinary skill in the art would have had a reasonable expectation of success because both Ekstrom and Blaschke are directed to graft materials intended for implant surgery.
Regarding claims 10-12, the combined teachings of Ekstrom and Mi renders obvious the claimed method as described above, but does not specifically disclose wherein the absorbing at least some of the exosome solution includes having the graft disposed in a sealed container holding the exosome solution.
Blaschke disclose package systems for handling and storing orthopedic graft materials that contain a liquid component and a graft material in a sealed container (abstract). The liquid is eventually pulled into the compartment with the graft material to hydrate/re-hydrate the graft material by thoroughly infusing the graft material (absorbed into the graft material) to form a hydrated orthopedic graft material (page 3 para 10-12). The aqueous based liquids may include biologically active materials to be infused into the hydrated graft material (page 6 para 40-41). Blaschke disclose that the fluid can be injected into the container by a port (page 11 para 59).
One of ordinary skill in the art would have been motivated to use a sealed container that allows for the liquid component containing the biological material (exosome added solution) to be absorbed and infused into the graft material of Ekstrom because Blaschke teach and suggest that such a container is beneficial and desirable for providing a graft material hydrated and infused with biological therapeutic materials for use in implant surgery. The solution can be injected into the compartment container with the graft material as suggested by Blaschke (page 11 para 59). One of ordinary skill in the art would have had a reasonable expectation of success because both Ekstrom and Blaschke are directed to graft materials intended for implant surgery.
Therefore, the combined teachings of Ekstrom et al, Mi et al, and Blaschke et al render obvious Applicant’s invention as claimed.
Claim(s) 13 is rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) and Blaschke et al (WO 2005/037136) as applied to claims 9-12, 14-15 and 17-18 above, and further in view of Kirschman (US 2005/0071006).
Regarding claim 13, the combined teachings of Ekstrom, Mi and Blaschke render obvious the claimed method as described above, but do not specifically disclose wherein the graft has a graft length corresponding to a bone length of a severed bone receiving the graft.
Kirschman disclose a method and system for use as a prosthetic implant in spinal surgery with spinal bones (abstract). Kirschman disclose wherein the graft comprises a length that generally corresponds to a length of a single bone (page 8 claim 69).
One of ordinary skill in the art would have been motivated to optimize the length of the bone graft in the method of Ekstrom depending upon the type and size of bone repair required. One of ordinary skill in the art would have been motivated to select a graft length corresponding to a bone length of a severed bone receiving the graft in the method of Ekstrom because Kirschman teach and suggest that in some cases a graft comprises a length that generally corresponds to a length of a single bone is beneficial and desirable (page 8 claim 69). One of ordinary skill in the art would have had a reasonable expectation of success because both Ekstrom and Kirschman are directed to the implantation of bone graft material for implant surgery.
Therefore, the combined teachings of Ekstrom et al, Mi et al, Blaschke et al and Kirschman render obvious Applicant’s invention as claimed.
Claim(s) 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Ekstrom et al (US 2015/0093363) in view of Mi et al (ACS Nano, published January 2022-from IDS filed 10/09/2024) and Blaschke et al (WO 2005/037136) as applied to claims 9-12, 14-15 and 17-18 above, and further in view of Meretzki (US 2019/0038806).
Regarding claims 19-20, the combined teachings of Ekstrom, Mi and Blaschke render obvious the claimed method as described above and Ekstrom include the treatment of osteoporosis patients (page 4 para 57), but do not specifically disclose wherein the cellular components of the exosome solution include endothelial cells as a vessel regeneration component.
Meretzki discloses bone implants that contain at least two cell types selected from a group consisting of osteoblasts, osteoclasts and endothelial cells or progenitors thereof (abstract). Endothelial cells are required to form new blood vessels in the developing bone tissue (page para 17).
One of ordinary skill in the art would have been motivated to include endothelial cells along with bone forming cells in the method of Ekstrom because Meretzki teach and suggest that the addition of endothelial cells and bone forming cells to a bone implant is beneficial as this combination provides new blood vessels (vessel regeneration) in the developed bone tissue. One of ordinary skill in the art would have had a reasonable expectation of success because Ekstrom suggest that additional cell types can be included in their method.
Therefore, the combined teachings of Ekstrom et al, Mi et al, Blaschke et al and Meretzki render obvious Applicant’s invention as claimed.
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 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of copending Application No. 18/861511 in view of Blaschke et al (WO 2005/037136).
The copending claims are drawn to a method of healing a bone void comprising forming an exosome carrier material including one or more cell-derived exosomes and one or more cellular components, inserting the exosome carrier material into a bone void and instigating healing at the bone void (securing between two severed portions of bone). Copending claim 10 includes wherein forming the exosome carrier material uses at least some of the exosome solution including injecting the exosome solution into a sealed container while a graft is in the sealed container.
Blaschke disclose package systems for handling and storing orthopedic graft materials that contain a liquid component and a graft material in a sealed container (abstract). The liquid is eventually pulled into the compartment with the graft material to hydrate/re-hydrate the graft material by thoroughly infusing the graft material to form a hydrated orthopedic graft material (page 3 para 10-12). The aqueous based liquids may include biologically active materials to be infused into the hydrated graft material (page 6 para 40-41). The liquid component, with the biological materials, can be added to the container the same time as the graft or it can be added immediately before the infusion process is to take place, for example, in the operating room (page 9, lines 1-11). Blaschke disclose that the fluid can be injected into the container by a port (page 11 para 59).
One of ordinary skill in the art would have been motivated to provide the exosome loaded graft of the copending claims at least partially immersed in the exosome solution and in a sealed container in an operating room environment because Blaschke teach and suggest a sealed container configured to accommodate a graft and liquid combination for use in an implant surgical procedure to a patient in need in an operating room environment. One of ordinary skill in the art would have had a reasonable expectation of success because both the copending claims and Blaschke are directed to graft materials intended for implant surgery.
One of ordinary skill in the art would have been motivated to use a sealed container that allows for the liquid component containing the biological material (exosome added solution) to be absorbed and infused into the graft material of the copending claims because Blaschke teach and suggest that such a container is beneficial and desirable for providing a graft material hydrated and infused with biological therapeutic materials for use in implant surgery. The solution can be injected into the compartment container with the graft material as suggested by Blaschke (page 11 para 59). One of ordinary skill in the art would have had a reasonable expectation of success because both the copending claims and Blaschke are directed to graft materials intended for implant surgery.
The length of the graft corresponding to a bone length of a severed bone receiving the graft would have been a matter of routine optimization and experimentation as a person of ordinary skill in the art would have been motivated with a reasonable expectation of success to modify the length of the graft to correspond to the injured bone tissue. The treatment of patients with osteoporosis would have had been obvious to the person of ordinary skill in the art because it is well known that osteoporosis patients are in need of repair of damaged bones and bone voids. Therefore the person of ordinary skill I the art would have been motivated with a reasonable expectation of success to apply the method of the copending claims to a subject with osteoporosis to repair bone voids and damaged bones.
Therefore, the combined teachings of the copending claims and Blaschke et al render obvious Applicant’s invention as claimed.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Benevenia et al., “Systems and Methods for Storing and Preserving Implantable Devices” (US 2021/0251215).
Benevenia disclose a bone allograft provided in a sealed container in a volume of solution and maintained in a hydrated state until application in a surgical procedure. The amount of solution is sufficient to submerge at least a portion of the implantable device (page 3 para 31).
Yasuo, Shikinami, “Composite Implant Material”, WO 2007105600, machine translation.
Yasuo disclose wherein a bone graft implant is injected and impregnated with a biological solution for use as an osteosynthesis material (paragraph 42, paragraph 261).
Morris et al., “Cell-Receptor Targeted Exosomes”, WO 2021/211460.
Morris disclose exosome solutions in sealed containers for therapeutic administration (page 33 para 96).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA J SCHUBERG whose telephone number is (571)272-3347. The examiner can normally be reached 8:30-5:00 EST.
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LAURA J. SCHUBERG
Primary Examiner
Art Unit 1631
/LAURA SCHUBERG/ Primary Examiner, Art Unit 1631
Prosecution Insights