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 .
This action is responsive to claims filed on Jan. 21, 2025. Claims 54-73 are pending and examined below.
Priority
The application is a CON of App. Serial No. 17/500,408, now U.S. Patent No. 12,270051, which is a CON of App. Serial No. 16/592,539, now U.S. Patent No. 11,180,732, which claims priority to provisional applications 62/740,817, filed Oct. 3, 2018; as such the earliest possible priority date is Oct. 3, 2018.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted Nov. 15, 2024, Feb. 3, 2025 and June 24, 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 54-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 11,180,732 (the ‘732 patent) in view of Ragelle et al. (Biomaterials, 2017).
Claims 1-8 teach the cell scaffold and the method of making the cell scaffold used in these method claims. Claims 1-8 do not teach using the scaffold to proliferate cells in culture or to differentiate stem cells.
Ragelle et al. teach that cell-derived extracellular matrices are better able to recapitulate the native stem-cell microenvironment. (Abstact). Ragelle et al. further teach that each different cell-derived ECM type has a specific and unique ECM signature, which influences specific cell types in different manners. (Abstract).
With respect to independent claims 54 and 67, it would have been obvious for one of ordinary skill in the art at the time of the invention to have used the scaffold taught by the ‘732 patent to proliferate cells in culture or to differentiate stem cells because it would have been obvious to try culturing or differentiating cells on these matrices to test their capacity for such function. Doing so would have led to a reasonable expectation of success because extracellular matrices are known for being better scaffolding to grow and differentiate cells on than traditional tissue-culture polystyrene.
With respect to dependent claims 55-58 and 68-71, the presence (or absence) of the claimed components is taught by claims 1-8 of the ‘732 patent.
With respect to claims 59-66, 72 and 73, trying these cells types, differentiating to specific cells types, and optimizing media components for culture are all variables that would obvious for a skilled artisan to try, as Ragelle et al. provide the impetus for doing so and culturing and/or differentiating many cell types on the claimed cell-derived ECM scaffold would have been routine for the skilled artisan.
Claims 54-73 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 12,270,051 (the ‘051 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘051 patent teaches the claimed cell-derived ECM scaffold (claims 1-13) and teaches that the scaffold can be used for proliferating cells in culture (claim 14) and inducing differentiation of cells (claim 15).
With respect to dependent claims 55-58 and 68-71, the presence (or absence) of the claimed components is taught by claims 1-13 and 16 of the ‘051 patent.
With respect to claims 59-66, 72 and 73: claim 1 of the ‘051 patent teaches the scaffold in contact with somatic cells, progenitor cells, stem cells, chondrocytes or osteoblasts; claim 11 of the ‘051 patent teaches the cells are mammalian cells; and claim 12 teaches the cells are pluripotent stem cells or mesenchymal stem cells, thereby teaching all the claimed limitations of the dependent claims or rendering them obvious, as trying these cells types, differentiating to specific cells types, and optimizing media components for culture are all variables that would obvious because the ‘051 patent teaches culturing and/or differentiating different cell types on the claimed cell-derived ECM scaffold; further optimization of the this process would have been routine for the skilled artisan.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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/TERESA E KNIGHT/ Primary Examiner, Art Unit 1634
