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 .
Claim Status
As of the Non-Final Office Action mailed 6/17/2025, claims 1-20 were pending and claims 7-12 and 16-20 were withdrawn from consideration for being drawn to non-elected inventions.
In Applicant's Response filed on 9/16/2025, claims 1, 10, 13, and 15 were amended and claim 2 was canceled.
As such, claims 1 and 3-20 are pending and claims 1, 3-6, and 13-15 have been examined herein.
Withdrawn Objections/Rejections
The objection of record to claim 1 and 13 for minor informalities has been withdrawn.
The rejection of record of claim 15 under 35 USC § 112(b) have been withdrawn in view of Applicant’s amendment to claim 15.
The rejection of record of claims 1-6 and 13-15 under 35 USC § 112(a) have been withdrawn in view of Applicant’s amendment to claim 1.
The rejection of record of claim 6 under 35 USC § 103 as being unpatentable over Ha et al (Cytotherapy, Feb 2012; 14(2):247-56) in view of Ha et al (WO 200301580 A1, 14 Aug 2002) have been withdrawn in view of Applicant’s amendments to claim 1.
Maintained Rejections
Applicant’s arguments regarding the rejection of record of claims 1, 3-5, and 13-15 under 35 USC § 102(a)(1) as being anticipated by Ha et al (Cytotherapy, Feb 2012; 14(2):247-56) has been fully considered but is not considered persuasive. Thus, the rejection has been maintained. The rejection has been recast below. Response to arguments will follow the rejection.
Applicant’s arguments regarding the rejection of record of claims 1, 3-5, and 13-15 for double patenting over US 11,191,787 B2 has been fully considered but is not considered persuasive. Thus, the rejection has been maintained. The rejection has been recast below. Response to arguments will follow the rejection.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-5, and 13-15 remain rejected under 35 U.S.C. 102102(a)(1) as being anticipated by Ha et al (Cytotherapy, Feb 2012; 14(2):247-56).
Please note that claim 1 recites “(i) at least one of a human chondrocyte and a cell capable of differentiating into a human chondrocyte.” The examiner is interpreting that the cells listed in the claim are listed in the alternative (i.e., the composition can comprise human chondrocyte and hChonJb#7 OR cartilage precursor cell and hChonJb#7). This interpretation applies to claim 13 as well.
Ha teaches TissueGene-C (TG-C), which is a cell-mediated gene therapy for the regeneration of cartilage tissue (Introduction, para 4). TG-C is a 3:1 mixture of normal allogeneic human chondrocytes
(hChonJ) and irradiated allogeneic human chondrocytes that express TGF-β1 (designated hChonJb#7)(same para) (“composition comprising: (i) at least one of a chondrocyte . . . ; and (ii) hChonJb#7” as in instant claim 1; “wherein a ratio of said (i)to said (ii) ranges from 1:1 to 100:1” as in instant claim 3; “wherein the ratio of said (i) to said (ii) ranges from 1:1 to 3:1” as in instant claim 4; “wherein the composition comprises: (i) the chondrocyte; and (ii) the cell into which the gene encoding TGF-b is introduced” as in instant claim 5; “A composition comprising: at least one of a chondrocyte . . .; and a cell prepared by transducing a GP2-293 cell with a retroviral vector encoding TGF- (transforming growth factor-beta) and irradiating the transduced GP2-293 cell, wherein the retroviral vector encoding TGF-P is produced by co-transfection of a packaging cell line with two plasmids of pKEB1 and pKVSV-G” as in instant claim 13; “wherein the at least one of the chondrocyte and the cell capable of differentiating into the chondrocyte includes a human allogeneic chondrocyte” as in instant claim 14; and “wherein a ratio of the human allogenic chondrocyte to the cell prepared by transducing GP2-293 cell ranges from 1:1 to 3:1” as in instant claim 15).
Thus, Ha anticipates the invention of instant claims 1, 3-5, and 13-15.
Response to Arguments
Applicant’s arguments regarding the 102 rejection of claims 1, 3-5, and 13-15 have been fully considered but are not persuasive.
On p. 7 of Remarks, Applicant argues that the amendment of claim 1 to include the subject matter of claim 2 narrows the claim and, thus, the rejection should be withdrawn.
In response, the examiner disagrees. Claim 1, as amended, does not require the cell capable of differentiating into a human chondrocyte (cartilage precursor cell). As such, the rejection is proper as the HA reference discloses all of the invention of instant claim 1. Thus, the rejection is proper.
The arguments posited related to the previous 103 rejection of claim 6 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
New Grounds of Rejections Necessitated by Amendments
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ha et al (Cytotherapy, Feb 2012; 14(2):247-56) in view of Jiang et al (Nat Rev Rheumatol. 23 Dec 2014; 11(4):206-12).
The teachings of Ha were recited in the above 35 U.S.C. 102 rejection as applied to claim 1 of which claim 6 depend. The teachings will not be repeated here.
Ha differs from the instant invention in that it does not teach that the composition is a hChonJb#7 and a cell capable of differentiating into a chondrocyte (i.e., cartilage precursor cell as recited in instant claim 1).
Jiang teaches that human articular cartilage contains a population of stem or progenitor cells that can be isolated and characterized in vitro on the basis of having self-renewal, multilineage differentiation and migratory abilities (Key points). Upon injury to healthy cartilage, cartilage stem/progenitor cells (CSPCs) emerge and migrate to the injury site where they are thought to participate in tissue reparative activities (same para). The reference teaches that CSPCs are a candidate therapeutic target for OA, potentially involving strategies to enhance joint resurfacing, extracellular matrix production or chondroprotection (same para).
Therefore, it would have been obvious prior to the effective filing date of the instantly claimed invention to create a composition containing hChonJb#7 cells as taught by Ha, where the composition also contains cartilage precursor cells as taught by Jiang, to arrive at the instantly claimed invention. As Jiang shows that cartilage precursor cells participate in tissue reparative activities, one of ordinary skill would have been motivated to simply substitute one known element (chondrocyte of Ha) for another (cartilage precursor cell of Jiang) to obtain the predictable result of advantageously having a composition that maintains the ability to participate in tissue reparative activities when cartilage is damaged and as a therapeutic for osteoarthritis as taught by the prior art.
Maintained Rejection - 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 1, 3-5, 13, and 15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,191,787 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘787 patent would anticipate the instant invention if it were available as prior art.
Claim 1 of ‘787 recites “a method of treating rheumatoid arthritis, the method comprising: administering directly to an articular cavity of a subject a composition comprising (i) a chondrocyte; and (ii) a cell into which a gene encoding TGF-β (transforming growth factor-beta) is introduced, wherein the cell in (ii) is hChonJb#7, wherein the administration of the composition has an effect of inhibiting expression of IL-6, IL-17A, IL-1β, and TNF-α in a synovial lavage fluid in the articular cavity of the subject.” Claim 4 of ‘787 recites “a method of treating rheumatoid arthritis, the administering, directly to an articular cavity of a subject via an intra-articular injection a composition comprising (i) a chondrocyte; and (ii) hChonJb#7, wherein the administration of the composition has an effect of inhibiting expression of IL-6, IL-17A, IL-1β, and TNF-α in a synovial lavage fluid in the articular cavity of the subject.” This would anticipate “composition comprising: (i) at least one of a chondrocyte . . .; and (ii) hChonJb#7 which is a cell into which a gene encoding TGF-( (transforming growth factor-beta) is introduced and is derived from human embryonic kidney 293 (HEK-293) cell” as in instant claim 1 as the method of ‘787 requires the instant product. It would also anticipate “” as in instant claim 5, “a composition comprising: at least one of a chondrocyte . . .; and a cell prepared by transducing a GP2-293 cell with a retroviral vector encoding TGF- (transforming growth factor-beta) and irradiating the transduced GP2-293 cell, wherein the retroviral vector encoding TGF-P is produced by co-transfection of a packaging cell line with two plasmids of pKEB1 and pKVSV-G” as in instant claim 13.
Claim 2 of ‘787 recites “wherein a ratio of (i) the chondrocyte; and (ii) hChonJb#7 ranges from 1:1 to 100:1.” This would anticipate “wherein a ratio of said (i)to said (ii) ranges from 1:1 to 100:1” as in instant claim 3.
Claim 3 of ‘787 recites “wherein the ratio of (i) the chondrocyte; and (ii) hChonJb#7 ranges from 1:1 to 3:1.” This would anticipate “wherein the ratio of said (i) to said (ii) ranges from 1:1 to 3:1” as in instant claim 4 and “a ratio of the human allogenic chondrocyte to the cell prepared by transducing GP2-293 cell ranges from 1:1 to 3:1” as in instant claim 15.
Thus, the patented claims of ‘787 would anticipate the instant claims and constitute double patenting.
Response to Arguments
Applicant’s arguments have been considered and are not persuasive. As discussed above, the claims remain rejected over the previously cited reference Ha, as well as newly cited reference Jiang. The rejection cannot be held in abeyance. Applicant is reminded that double patenting rejections can be overcome by sufficient amendments to the claims such that the conflicting claims are no longer at issue or with a timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d).
Conclusion
No claim is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GILLIAN C REGLAS whose telephone number is (571)270-0320. The examiner can normally be reached M-F 7-3.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Peter Paras Jr can be reached at (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/G.R./Examiner, Art Unit 1632 /KARA D JOHNSON/Primary Examiner, Art Unit 1632