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. Detailed Action This Office Action is in response to the Applicant’s reply received 12/22/23 . Claims 1 -8 are pending and considered on the merits . Claim Interpretation Claims 1-6 are to a method of producing a three-dimensional structure of cartilage cells with the following steps: Culturing mesenchymal stem cells (MSCs) in a medium that induces differentiation into cartilage cells on the 9 th or 10 th day after the start of culture to produce cell aggregates; Stacking the cell aggregates to form a 3D structure of cartilage cells. Claims 7 and 8 are to a 3D structure of cartilage cells obtained by the method of claim 1. The way the 3D structure made is considered a product-by-process. M.P.E.P. § 2113 reads, “ Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.” In this case it was unclear what additional structure the method of making imparted to the cells. In this case a 3D structure of stacked cartilage cells will read on these claims while the steps for differentiating the mesenchymal stem cells to cartilage cells is considered product-by- process limitations until the Applicant can show these steps impart a structural component to the claim. Claim Rejections - 35 USC § 102/103 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. 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(s) 7 and 8 is/are rejected under 35 U.S.C. 102 (a) (1) or under 35 U.S.C. 103 as being anticipated by or obvious over Koga et al. (US 2011/0200559) . As detailed below, Koga et al . teach a product that appears substantially identical in structure to the claimed composition but does not explicitly state all the functional limitations such as how the cartilage cells were created . Therefore a dual rejection under 102/103 is made since the composition of Koga et al. either inherently meets the claims (M.P.E.P 2112 III and V) or is prima facie obvious since the compositions are structurally similar and share a similar utility and therefore are expected to have similar properties (MPEP 2144.09). Koga et al. teach stacking cell cluster (i.e. aggregates) into a cube (e.g. 3D structure , See Fig 2C and 2D, [0061-0066] ) and culturing to produce a single mass of cells (Fig 3B, Fig 5, and [0079]). Koga et al. expressly teach these cell clusters are cartilage cells for joint regenerative medicine [0073]. Koga et al. also teach that mesenchymal stem cells can be differentiated to cartilage cells and used in this invention [0058-0059]. Therefore the invention as a whole is either anticipated or obvious by this reference. 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 (s) 1 - 5, 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driessen et al. (Cell Biol Toxicol 2017 , in IDS 4/25/25 ) in view of Koga et al. (US 2011/0200559 , in IDS 4/25/25 ) . Dr iessen et al. teach a method of culturing mesenchymal stem cells to cartilage cells with the following steps (Driessen, Fig 4d): Induce mesenchymal stem cells (MSCs) to produce induced pluripotent stem ( iPS ) cells ; Collect the iPS cells; These iPS cells are then exposed to a media comprising PDGF for 6 days, TGF- ß 3 was added to the media in iii) at 6 days; and BMP-4 (Bone Morphogenic Protein-4 ) was added to the media in vi) at 10 days to differentiate the cells to cartilage like tissue. Driessen et al. teach these cartilage cells can be used in clinical cartilage repair (see Abstract). While Driessen et al. teach making the cartilage cell clusters, they do not teach the step of stacking the clusters to produce a 3D structure. This is taught by Koga et al. who teach stacking cell cluster (i.e. aggregates) into a cube (e.g. 3D structure, See Fig 2C and 2D, [0061-0066]) and culturing to produce a single mass of cells (Fig 3B, Fig 5, and [0079]). Koga et al. expressly teach these cell clusters are cartilage cells for joint regenerative medicine [0073] including cartilage repair in the joints . Koga et al. also teach that MSCs can be differentiated to cartilage cells and used in this invention [0058-0059]. It would be obvious to one or ordinary skill to use the cartilage cell aggregates of Driessen et al. into the stacking method since Koga et al. teach cartilage cells differentiated from MSCs are suitable for their invention. One of ordinary skill would recognize this as simply substituting one source of cartilage cell aggregates for another, while both are known to repair damaged cartilage (MPEP 2141 V (B-D)). Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Driessen et al. (Cell Biol Toxicol 2017) and Koga et al. (US 2011/0200559) as applied to claim s 1-5, 7 and 8 above , and further in view of Umeda et al (Scientific Reports, 201 2, in IDS 4/25/25 ) . Driessen et al. and Koga et al. render obvious differentiating MSCs to cartilage cells aggregates then stacking these into a 3D structure. They teach the medium includes BMP4 at day 10 to differentiate the cells to cartilage cell aggregates. Koga et al. teach the cell aggregates formed into a 3D structure can be further cultured to produce a single mass of cells (Fig 3B, Fig 5, and [0079]). However they do not teach the further culturing the 3D structure is in the presence of BMP-4. This would be obvious in view of Umeda et al. who teach a series of culture media conditions to differentiate MSCs to cartilage cell aggregates (Umeda, Fig 5A and Fig 6). They teach that the cell aggregates can be cultured in a media with PDGF, TGF- ß3 , and BMP-4 for 10-24 days (Umeda, Fig 5A, condition PTB). Umeda et al. teach the combined addition of TGF- ß3 and BMP-4 give rise to particles that are larger and produce more cartilaginous matrix (Umeda, pg. 8, col 1, last line before 1 st full paragraph ). Therefore it would be obvious to continue culturing the 3D structure in a media comprising TGF- ß3 and BMP-4 since this will continue to produce larger cells particles that will be fused with more cartilaginous matrix to provide a stronger 3D structure for joint/cartilage repair. One of ordinary skill would recognize this as applying a known improvement to culturing cartilage cells to a method that does just that (MPEP 2141 V C-D). Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary. In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure , including the claims (MPEP 714.02 and 2163.06). CONTACT INFORMATION Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT THANE E UNDERDAHL whose telephone number is (303) 297-4299 . The examiner can normally be reached Monday through Thursday, FILLIN "Work schedule?" \* MERGEFORMAT M-F 8-5 MST . If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311. 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 http://pair-direct.uspto.gov. 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. /THANE UNDERDAHL/ Primary Examiner, Art Unit 1699