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 .
The Response of 8 July 2026 has been entered.
Claims 1, 5, 9-15 and 21-32 are currently pending.
Election/Restrictions
Applicant’s election without traverse of the invention of Group III, claims 23-32, and the species of: CRISPR/Cas as the MAST4 inhibitor, mesenchymal stem cells (MSCs) as the cells, MAST4 protein as the MAST4 inhibiting protein and CRISPR/Cas comprising guide RNA as the compound that inhibits the MAST4 inhibiting protein in the reply filed on 8 July 2026 is acknowledged. In view of the election of Group III and the amendments to claim 23, the species election requirement for species of MAST4 inhibiting proteins and compounds that inhibits MAST4 inhibiting protein is hereby withdrawn. Moreover, in the interest of compact prosecution, the species election for species of eukaryotic cells is also withdrawn.
Claims 1, 5, 9-15, 21, 22 and 29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (claims 1, 5, 9-15, 21, 22) or species (claim 29), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8 July 2026.
Claims 23-28 and 30-32 are considered here with respect to the elected species of CRISPR/Cas as the MAST4 inhibitor.
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.
Claims 23-28 and 30-32 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over US20200239596 to Kim et al. (cited in IDS of 23 March 2026), optionally (in the case of claim 32) in view of Meretoja et al., Biomaterials 33.27 (2012): 6362-6369.
Regarding claims 23-26, Kim teaches a method of treating a joint disease, comprising administering to a subject in need thereof eukaryotic cells in which expression of MAST4 has been inhibited ([0010]-[0014]; [0027]-[0028]; [0038]-[0039]; [0048]-[0061]; [0063]; Examples 2-4). Kim teaches that the method can comprise contacting the cells prior to administration (e.g., in cell culture) with a compound that inhibits MAST4 expression so as to induce/promote chondrogenesis (cartilage formation), and that the cells can be allogeneic chondrocytes "derived from a subject to be transplanted with the produced cartilage" ([0027]-[0028]; [0038]; [0048]-[0061]; [0063]; Examples 2-4). Alternatively (to the extent Applicant might argue that "derived from a subject to be transplanted with the produced cartilage" does not expressly teach administering the cells to a subject), it would have been obvious in view of Kim to administer cartilage (including chondrocytes and extracellular matrix formed thereby) to a subject to treat the joint disease, as Kim provides an express suggestion to do so.
Regarding claims 27, 28, 30 and 31, Kim teaches that the compound that inhibits MAST4 expression can be a polynucleotide capable of specifically binding to the nucleic acid encoding the MAST4 protein, and may be CRISPR-Cas including guide RNA specific to the nucleic acid encoding the MAST4 protein ([0021]-[0025]; Examples 2-4). The guide RNA may have a form of a dual RNA including CRISPR RNA (crRNA) and transactivating crRNA (tracrRNA) specific to the nucleic acid encoding the MAST4 protein, or a single strand guide RNA including parts of the crRNA and the tracrRNA and hybridizing with the nucleic acid encoding the MAST4 protein ([0024]).
Regarding claim 32, Kim teaches that the cartilage formed via cell culture can be administered via transplantation to treat the joint disease ([0058]), and it would have been obvious to transplant such cartilage at the site of a cartilage defect/joint so as to promote new cartilage tissue formation. Moreover, Meretoja teaches that chondrocyte transplantation is used in the art to repair cartilage defects by filling in the site of the defect (p. 6362, 1st ¶; p. 6365, 1st ¶ under 4. Discussion), and it would have been obvious to repair a joint defect by implanting the cultured chondrocytes of Kim to the site of such a joint cartilage defect.
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 24 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Kim, as applied above to claims 23-28 and 30-32, in view of Meretoja et al., Biomaterials 33.27 (2012): 6362-6369, as evidenced by Shea et al., Journal of cellular biochemistry 90.6 (2003): 1112-1127.
The teaching of Kim are set forth above. Regarding claim 24, Kim further exemplifies MAST4 inhibition via CRISPR/Cas in cultured C3H/10T1/2 cells (Examples 2 and 3). Shea evidences that C3H/10T1/2 cells are mesenchymal stem cells (Shea, Title; p. 1113, last full ¶). Kim teaches that MAST4 inhibition in C3H/10T1/2 cells resulted in increased chondrogenesis, and that equivalent results were also found in cultured human chondrocytes (Examples 2-4).
Claim 24 differs from Kim, as applied above to claims 23-28 and 30-32, in that: the administered cells comprise mesenchymal stem cells (MSCs), chondrocytes, chondrocyte progenitor cells, or any combination thereof (Kim as applied above teaches that the administered cells are chondrocytes).
Meretoja teaches that cartilage repair using cultured chondrocytes has several disadvantages, including lack of availability of sufficient cells via cartilage biopsy and dedifferentiation in culture, and that such disadvantages can be addressed by co-culturing chondrocytes with MSCs (entire doc, including under 1. Introduction; 4. Discussion). Meretoja teaches that co-culturing allows MSCs to produce trophic factors that help maintain a chondrogenic phenotype and also allows for large numbers of cells to be produced due to the availability of MSCs via bone marrow, adipose tissue and the like (under 1. Introduction; 4. Discussion).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to use the method of Kim to treat a joint disease by administering cells in which MAST4 expression has been inhibited wherein the cells comprise co-cultured chondrocytes and MSCs (which can also be considered as "chondrocyte progenitor cells") as taught by Meretoja because it would have been obvious to combine prior art elements according to known methods to yield predictable results. One of ordinary skill would have been motivated to use co-cultured chondrocytes and MSCs because Meretoja teaches that cartilage repair using cultured chondrocytes has several disadvantages, including lack of availability of sufficient cells and dedifferentiation in culture, and that such disadvantages can be addressed by co-culturing chondrocytes with MSCs. Using co-cultured chondrocytes and MSCs in the method of Kim would have led to predictable results with a reasonable expectation of success because Kim teaches that MAST4 inhibition has essentially the same chondrogenic effects in MSCs (C3H/10T1/2 cells) and chondrocytes.
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 23-28 and 30-32 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 14-21 of U.S. Patent No. 11180573, optionally in view of (in the case of claim 25) EP3594324. Although the claims at issue are not identical, they are not patentably distinct from each other because the '573 claims teach a method of treating a joint disease by administering cells in which MAST4 expression is inhibited to a subject in need thereof at or near a joint in need thereof where cartilage is desired to be formed ('573, claim 14). The '573 claims further teach that the MAST4 inhibition can be via the same CRISPR/Cas compound as in instant claims 30-31 ('573, claims 19, 20), and that the cells can be mesenchymal stem cells or chondrocytes ('573, claims 15-16). Thus, claims 23, 24, 26-28 and 30-32 are anticipated by the claims of the '573 patent.
Regarding claim 25, the '573 claims do not teach that the cells are allogeneic. However, EP3594324 teaches the same method as in the '573 claims and that the chondrocytes may be derived from a subject to be transplanted with the produced cartilage ([0058]). As such it would have been obvious to carry out the method of the '573 claims using allogeneic cells.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT J YAMASAKI whose telephone number is (571)270-5467. The examiner can normally be reached M-F 930-6 PST.
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/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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