DETAILED ACTION
Receipt is acknowledged of applicant’s Amendment/Remarks filed 9/29/2025.
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 .
Status of the Claims
Claims 22 and 23 have been amended. Claims 1-8, 11-15 and 26-33 were cancelled. Claims 34-41 are newly added. Accordingly, claims 9, 10, 16-25 and 34-41 remain pending in the application. Claims 9, 10, 16-21, 24 and 25 stand withdrawn from further consideration, without traverse. Claims 22, 23 and 34-41 are currently under examination.
Withdrawn Objections/Rejections
Applicant’s amendment renders the objection of claim 22 moot. Specifically, the claim has been amended to remedy the minor informality. Thus, said objection has been withdrawn.
Applicant’s amendment renders the rejections of claims 22 and 23 under 35 USC 112(b) moot. Specifically, the claims have been amended to remedy the indefinite issues. Thus, said rejections have been withdrawn.
Applicant’s amendment renders the rejection under 35 USC 102 over Gregory moot. Specifically, Gregory is silent to the newly added limitations, “the scaffold material comprises β-tricalciumphosphate (TCP) powder, particles or granules” and “wherein the time span between seeding and cryopreservation is from 0 minutes to 24 hours and varies in a cell-type-dependent manner”. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection under 35 USC 102 over Gamboa moot. Specifically, Gamboa is silent to the newly added limitation, “wherein the time span between seeding and cryopreservation is from 0 minutes to 24 hours and varies in a cell-type-dependent manner”. Thus, said rejection has been withdrawn. However, after further consideration, a new rejection is made under 35 USC 103 over Gamboa in view of Abramson.
Applicant’s amendment renders the rejection under 35 USC 103 over Gregory in view of Brennan moot. Specifically, the references are silent to the newly added limitations, “the scaffold material comprises β-tricalciumphosphate (TCP) powder, particles or granules” and “wherein the time span between seeding and cryopreservation is from 0 minutes to 24 hours and varies in a cell-type-dependent manner”. Thus, said rejection has been withdrawn.
Applicant’s amendment renders the rejection under 35 USC 103 over Gamboa in view of Brennan moot. Specifically, the references are silent to the newly added limitation, “wherein the time span between seeding and cryopreservation is from 0 minutes to 24 hours and varies in a cell-type-dependent manner”. Thus, said rejection has been withdrawn. However, after further consideration, a new rejection is made under 35 USC 103 over Gamboa in view of Abramson.
New Rejections
In light of Applicant’s amendments, the following rejections have been newly added:
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.
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.
Claims 22, 23 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Gamboa et al. (EP 3417889 A1, Dec. 26, 2018, hereafter as “Gamboa”) in view of Abramson et al. (USPN 8,728,805 B2, May 20, 2014, hereafter as “Abramson”).
The claimed invention is drawn to method for producing cryopreserved bone graft material, comprising the steps of (i) seeding a biological cell material on a scaffold material to obtain a bone graft material, wherein: the biological cell material comprises cell material genetically allogenic to a subject to be treated with the bone graft material, and the scaffold material comprises β-tricalciumphosphate (TCP) powder, particles or granules; and (ii) cryopreserving the bone graft material obtained in (i); wherein the time span between seeding and cryopreservation is from 0 minutes to 24 hours and varies in a cell-type-dependent manner.
Regarding instant claims 22 and 35, Gamboa teaches bioactive bone grafts and methods of making thereof (abstract). In one embodiment, Gamboa teaches a method of making a neutral or partially neutral chitosan/demineralized bone scaffold sponge containing seed cells comprising binding the seed cells to the scaffold and packaging the scaffold with a cryopreservative and freezing ([0095]; Fig. 26). Gamboa teaches allogenic mesenchymal stem cells ([0014] and [0020]). Gamboa also teaches that scaffold can comprise minerals such as beta tricalcium phosphate in the form of powder, particles or granules ([0032]-[0033]).
Gamboa is silent to a time span between seeding and cryopreservation of 0 minutes to 24 hours and varies in a cell-type-dependent manner.
Abramson teaches implantable compositions (e.g., a scaffold) comprising osteogenic placental adherent cells (OPACs) for the treatment of bone defects (abstract; col. 6, lines 62-66). Abramson teaches that after 3 hours, 24 hours and 6 days of seeding the cells, non-adherent cells/tissues were removed and the cells remaining were allowed to proliferate until about 80-90% confluence was achieved prior to cryopreservation (col. 54, lines 5-10). Abramson also teaches that a compound can contact the OPACs in order to modulate (inhibit or enhance) the proliferation of OPACs (col. 41, lines 44-55).
Both Gamboa and Abramson are drawn to implantable scaffolds seeded with cells for bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a time span between seeding and cryopreservation of 0 minutes to 24 hours into Gamboa as suggested by Abramson with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Abramson teaches varying the amount of time between seeding and cryopreservation depending on the degree of confluence to include utilizing compounds that can inhibit or enhance the proliferation of cells, thereby, optimizing the amount of time between seeding and cryopreservation by way or routine experimentation.
Regarding instant claims 23 and 34, Gamboa and Abramson teach the elements discussed above.
Gamboa is silent to seeding the scaffold in a density of at least 0.1 x 106 cells per mL or about 0.1 x 106 cells per mL.
Abramson also teaches that about 1 million (106) to about 100 million (109) cells per mL can be utilized (col. 34, lines 13-16).
Both Gamboa and Abramson are drawn to implantable scaffolds seeded with cells for bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a density of at least or about 0.1 x 106 cells per mL into Gamboa as suggested by Abramson with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Abramson teaches a suitable range of cells is about 1 million (106) to about 100 million (109) cells per mL and
“[W]here 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” (MPEP 2144.05). Therefore, it would have further been prima facie obvious to one of ordinary skill in the art before the effective filing date of the invention to optimize the amount of cells to arrive at the claimed amounts by way of routine experimentation with a reasonable expectation of success.
Regarding instant claim 36, Gamboa teaches that the bone material is from “a donor” (abstract). “A donor” can be reasonably and broadly interpreted to mean one donor. However, in the alternative, Abramson explicitly teaches that the cells can be derived from a single donor (col. 36, lines 58-59). Both Gamboa and Abramson are drawn to implantable scaffolds seeded with cells for bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include cells from one donor into Gamboa as suggested by Abramson with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Abramson teaches that including cells from a single donor is suitable for the purpose of seeding a scaffold for bone repair.
Thus, the combined teachings of Gamboa and Abramson render the instant claims prima facie obvious.
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Gamboa et al. (EP 3417889 A1, Dec. 26, 2018, hereafter as “Gamboa”) in view of Abramson et al. (USPN 8,728,805 B2, May 20, 2014, hereafter as “Abramson”), as applied to claim 22 above, and further in view of Bader et al. (US 2017/0198257 A1, Jul. 13, 2017, hereafter as “Bader”).
The claimed invention is described above.
Gamboa and Abramson teaches the elements discussed above. Abramson also teaches that the cells can be derived from multiple donors (col. 36, lines 58-59).
Gamboa and Abramson are silent to at least 3, at least 4, at least 5... or at least 10 or more genetically distinct donors.
Bader teaches an improved mesenchymal stromal cell (MSC) preparation comprising MSCs from multiple donors for use in medical applications including bone formation or replacement (abstract; [0070] and [0073]). Said preparation has improved allo suppressive potential ([0031]). Bader teaches that the preparation is polygenic (a composition of cells originating from different sources and having different genetic backgrounds) ([0009]). Bader also teaches “genetically distinct” means that cells can be collected from 2, 3, 4, 5... 100 or more donors, most preferably 4 to 8 different donor samples ([0039] and [0044]).
The references are drawn to cellular preparations for the purpose bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include cells from at least 3 donors into Gamboa/Abramson as suggested by Bader with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Bader teaches that including cells from multiple, preferably 4 to 8, genetically distinct donors is effective in improving allo suppressive potential, thereby, decreasing the likelihood of an alloreaction.
Thus, the combined teachings of Gamboa, Abramson and Bader render the instant claim prima facie obvious.
Claims 38-41 are rejected under 35 U.S.C. 103 as being unpatentable over Gamboa et al. (EP 3417889 A1, Dec. 26, 2018, hereafter as “Gamboa”) in view of Abramson et al. (USPN 8,728,805 B2, May 20, 2014, hereafter as “Abramson”), as applied to claim 22 above, and further in view of Altschuler et al. (USPN 8,790,681 B2, Jul. 29, 2014, hereafter as “Altschuler”).
The claimed invention is described above.
Gamboa and Abramson teaches the elements discussed above.
Gamboa and Abramson are silent to the bone graft material is in the from of a tablet having the claimed dimensions (instant claims 38-41).
Altschuler teaches scaffolds for bone repair (abstract). Altschuler teaches that the scaffold may be of any suitable shape or size to accommodate its application, e.g., scaled to approximate that of the site into which the scaffold will be implanted (col. 14, lines 36-48). In one embodiment, Altschuler teaches a scaffold in the form of a cylinder having a diameter of about 5-15 mm and a height of about 5-25 mm (col. 39, lines 62-65).
The references are drawn to bone grafts for the purpose bone repair, thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a scaffold in the shape of a tablet/cylinder having the claimed dimensions into Gamboa/Abramson as suggested by Altschuler with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Altschuler teaches that the size and shape of the scaffold should be approximate to that of the size and shape of the defect and teaches a particular scaffold having the shape of a tablet/cylinder with overlapping dimensions (a diameter of about 5-15 mm and a height of about 5-25 mm) as the claimed dimensions. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists (MPEP 2144.05). It would have been prima facie obvious to a skilled artisan to optimize the size/shape of the scaffold of Gamboa/Abramson by way of routine experimentation depending on the size/shape of the defect and utilizing the suitable scaffold dimensions suggested by Altschuler.
Thus, the combined teachings of Gamboa, Abramson and Altschuler render the instant claim prima facie obvious.
Response to Arguments
The arguments filed 9/29/2025 regarding the 102 rejection over Gregory, the 102 rejection over Gamboa, the 103 rejection over Gamboa in view of Brennan, and the 103 rejection over Gamboa in view of Brennan are moot in view of the withdrawn rejections discussed above.
Conclusion
All claims have been rejected; 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 3:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Casey S. Hagopian
Examiner, Art Unit 1617
/CARLOS A AZPURU/Primary Examiner, Art Unit 1617