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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/13/2026 has been entered.
Response to Amendment
Applicant's amendment and argument filed 01/13/2026, in response to the final rejection, are acknowledged and have been fully considered. Any previous rejection or objection not mentioned herein is withdrawn.
Claims 1-20 are pending of which claims 1-10 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/28/2024.
Claims 11-20 are being examined on the merits.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 05/29/2025 is being considered by the examiner.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 11-12, 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Han Peter Ingemar Claesson et. al. (US20140302227A1), hereinafter Clasesson, and Arinzeh et. al. (US20100233234A1). This is a new rejection based on the amendments and arguments filed on 05/29/2025.
Claesson teaches “the primary scaffold and the secondary scaffold, can each be independently loaded with living cells, cell suspension, with a pharmaceutically effective agent or agents or with growth modulator” (see 0087) and teaches those cells to be chondrocytes (see 0088).
Claesson teaches that the initially oversized double-structured tissue implant (DSTI) is first cut and trimmed to match the defect (see 0033 and fig 9A and 9B). With the broadest reasonable interpretation, the oversized double-structured implant when considered could be configured for a plurality of different cartilage repair implants for a plurality of different human patients depending on the size of the implants needed. In addition, this limitation appears to be an intended use. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In this case the prior art structure is capable of performing the intended use.
Regarding claim 12 and 14, Claesson teaches “typically the DSTI has a rectangular, circular or oval shape with dimensions of about 50 mm and a vertical thickness of about 1 to 5 mm, preferable 1-2 mm. Preferred dimensions of the DSTI and, therefore, the dimensions of the primary scaffold are 50×50 mm×1.5 mm, with pores oriented substantially vertically, said pores having a pore size of from about 100 to about 400 μm, preferably about 200±100 μm and pore length of 1.5 mm. However, dimensions of the primary scaffold may be any that are required by the tissue defect to be repaired and that can be prepared by the process of the invention” (see 0166).
Regarding claim 15, Claesson teaches “wherein said scaffold has a substantially homogenous defined porosity and uniformly distributed randomly and non-randomly organized pores of substantially the same size of defined diameter of about 300±100 μm” (see 0023).
Regarding claim 17, Claesson teaches wherein the collagen consists of Type 1 or Type II collagen (see claims 45-46).
Claesson does not specifically teach wherein the cells are universal cells as instantly claimed in claim 11.
Arinzeh’s general disclosure is to systems and methods for creating hydrogel composites for cartilage repair (see abstract).
Arinzeh teaches “an allogeneic MSC approach provides an off-the-shelf therapy, where allogeneic MSCs are used as universal cells and in turn, provide cells to a much larger clinical population. They are also currently in clinical trials for various disorders or conditions, including cartilage repair, as an allogeneic cell source” (see 0005).
Arinzeh teaches that “multiple growth factors and morphogens such as Wnts, transforming growth factor-beta, and fibroblast growth factors may also be present to support, promote and/or contribute to the regulation of the differentiation process. The present invention extends these findings by, in part, combining MSCs at relatively high cell densities with scaffolds that provide appropriate cues similar to the native extracellular matrix during development” (see 0008).
Therefore it would have been obvious before the effective filing date to persons skilled in the art to create the instant invention as claimed because Claesson teaches creating such a composition for cartilage repair and selecting the size to excise would be a matter of judicious selection. Claesson teaches the size thickness of the sheet to be within the range being claimed. Deciding to use the sheet to be configured to be used for multiple patients is well within the purview of any artisan given the prior art as this step is merely selecting sizes in which to excise the implanted components. Additionally, it would have been obvious to use universal cells as opposed to autologous cells taught by Clasesson, because as Arinzeh teaches universal cells can provide cells to a much larger clinical population. Arinzeh also teaches how to keep those universal cells in a niche mimicking environment which would help with the issues of the MSCs exhibiting mixed phenotypes and chondrocyte hypertrophy by including a water-soluble cellulose compound (see 0011). Thus including this component along in the bulk implant material would have been prima facie obvious.
Claims 13, 16 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Han Peter Ingemar Claesson et. al. (US20140302227A1) hereinafter Clasesson and Arinzeh et. al. (US20100233234A1) as applied to claims 11-12, 14-15 and 17 above, and further in view of Diekman et. al. (Cartilage tissue engineering using differentiated and purified induced pluripotent stem cells, PNAS, November 20, 2012, vol. 109, No. 47).
Claesson teaches the cartilage repair composition as claimed however is silent on the living cells comprising chondrocytes differentiated from pluripotent stem cells.
Regarding claims 13, 16 and 19-20, Diekman teaches “induced pluripotent stem cells (iPSCs) have the potential to provide an abundant cell source for tissue engineering, as well as generating patient-matched in vitro models to study genetic and environmental factors in cartilage repair and osteoarthritis” (see p 1, 1st para., left column). “As somatic cells that have been genetically reprogrammed to a pluripotent state, iPSCs demonstrate significant expansion potential while maintaining their multilineage differentiation capacity” (see p 1, 1st para., right column). Diekman also teaches growing cells in for monolayer and in the presence of a bioactive agent (TGF-β3) expansion (see p 2, right column, first para.).
“iPSCs can be induced to a chondrogenic lineage characterized by high production of cartilage- specific matrix at the gene and protein levels. Using these cells, we sought to produce cartilage tissue-engineered constructs to establish a model system that harnesses the power of mouse genetics for in vitro studies of cartilage injury and repair” (see p 3-4, last para of 3 first para. of p 4).
Regarding claim 18, Diekman teaches “Previous work with mouse and human embryonic stem cells has demonstrated that chondrogenesis of pluripotent cells can be initiated by exposure to growth factors such as the bone morphogenetic proteins (BMPs) (19, 20) and transforming growth factor-beta (TGF-β) (21, 22)” (see p 1, right column 2nd para.).
Therefore it would have been obvious before the effective filing date to persons skilled in the art to use pluripotent stem cells which can actively differentiate into chondrocytes because as discussed by Diekman iPSC’s have the potential to provide an abundant cell source for tissue engineering, as well as generating patient-matched in vitro models which can be used for creating high production of cartilage-specific matrixes. Thus, using pluripotent stem cells and chondrocytes which are differentiated from pluripotent stem cells would have been obvious before the effective filing date.
Response to Arguments
Applicant's arguments filed 01/13/2026 have been fully considered but they are not persuasive. The applicant argues that persons having ordinary skill in the art would not combine Claesson with Arinzeh to arrive at the instant invention because Arinzeh teaches that the implant cannot be collagen-based material, however this is an incorrect assertion for two reasons. The first reason is that the Office does not rely on Arinzeh to teach the scaffold composition, but merely for reasons which pertain to selecting the cell type being used in Claesson’s invention. The second reason is “this statement” is not taught or suggested. Arinzeh merely discusses the issues that need to be overcome in the art. Arinzeh recognizes that with the use of MSCs there can be complications of mixed phenotypes, but also discusses ways to control for these mishaps. For instance, persons having ordinary skill in the art would see that Arinzeh discusses creating an environment that resembles the niche environment in which MSCs need in order to overcome chondrocyte hypertrophy by including a water-soluble cellulose compound. As discussed in the above rejection it would have been obvious to include this in the bulk implant material in order to help with the issues of chondrocyte hypertrophy etc. The applicant argues that Arinzeh does not teach the composition to include collagen, but the Office relies upon Claesson to teach this component. The applicant’s claims as currently written allow for other components in the composition because they use the claim language “comprising”, so their argument that the inventions of the prior art are not the same is different from what they are actually claiming.
Conclusion
Currently no claims allowed.
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JACOB A BOECKELMAN Examiner, Art Unit 1655
/ANAND U DESAI/ Supervisory Patent Examiner, Art Unit 1655