DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-10 are pending in the instant application.
Information Disclosure Statement
The IDS form received 9/29/2023 is acknowledged and the references cited therein have been considered.
The listing of references in the specification in paragraphs [0052-0059] is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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.
(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.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Godfrey et al. (US 2012/0282694).
Godfrey et al. disclose the isolation and expansion of regulatory T cells from human umbilical cord blood (see entire document particularly the title, abstract and claims). Notably, such cells have the phenotype of being CD25+, CD4+and Foxp3+ (see for example claim 14 and example 6) and are disclosed as being administered to humans to treat disease (see particularly paragraph [0084-0086]).
It is noted that the cells of Godfrey et al. are not disclosed as being expanded in the presence of the polynucleotide of SEQ ID NO:1. However, applicant has claimed a product, namely a regulatory T cell, not the method by which it has been produced, and note that the patentability of a product is determined by what it actually is rather than the process by which it was made. See MPEP 2113. Based upon the evidence presently or record the regulatory T cells disclosed by Godfrey et al. are the same as that which is presently claimed.
Claims 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim et al. (US 2013/0157363).
Kim et al. disclose methods for making stable regulatory T cells and the administration of such cells to patients to treat autoimmune diseases including type I diabetes and multiple sclerosis (see entire document, particularly the title, abstract, paragraph [0037] and the claims). Such cells are disclosed as being stable and as expressing markers including CD4, CD25high, CD127lo/-, and Foxp3+ (see particularly paragraphs [0050], [006-0064], claims 11, 12, and 16, and working examples 4-6). Notably, they disclose their cells were expanded in the presence of an oligonucleotide, that the exact sequence of the oligonucleotide is unimportant, and that a size of about 25 nucleotides is optimal (see particularly paragraphs [0054-0055] and example 7). Expansion of cells in rapamycin is also disclosed (see particularly paragraph 0058]). Given the stable expression of the same markers in the expanded regulatory T cells of Kim et al. as compared to that which is presently claimed the presently claimed cells do not appear to be distinct from those disclosed by Kim et al. It should be noted that the cells of instant claim 6 are recited as a product by process (via dependency) and that patentability of a product depends upon the physical characteristics of what it is, not how it was made and that the same thing can be made in a variety of ways. See also MPEP 2113. Given the apparent indistinguishability between the stable t regulatory cells of Kim et al. and that which is presently claimed based upon the evidence presently of record, the prior art anticipates that which has been presently claimed.
Double Patenting
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1-5 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1-5 of prior U.S. Patent No. 11,597,912. This is a statutory double patenting rejection.
Specifically, the text of issued claims 1-5 appears to be identical to the text of instant claims 1-5. Given identical wording the inventions must be the same.
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 6, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,597,912. Although the claims at issue are not identical, they are not patentably distinct from each other because the that which is presently claimed is obvious result of the issued invention.
Specifically, the issued claims are directed toward methods of making regulatory T cells from umbilical cord blood. Thus, practicing the issued methods necessarily results in making a population of regulatory T cells. Instant claim 6 claims a population of cells which were made using the method recited in the issued claims. Given that a product, such as a cell population, is patentable based upon what it actually is rather that how it was made (see particularly MPEP 2113), and given that the same product can be made in a myriad of distinct processes, the cells produced by the issued claims are technically narrower in scope than that which is presently recited. Further, instant claims 9 and 10 recite intended uses for such cells, namely that they are to be used for treating autoimmune diseases including multiple sclerosis and lupus. Such intended use statements do not provide patentable distinctiveness unless they necessarily alter the structure of the claimed product (see in particular MPEP 2111.02) and in the present instance there is no evidence of that presently of record. Thus the instant claimed products are what is made when the methods of the issued claims are reduced to practice, and there is no restriction requirement which necessitated the filing of the instant application separate from that of the issued patent.
Claims 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,597,912 in view of US 2013/0157363.
As discussed above, the issued claims recite a method for making regulatory T cells from umbilical cord blood. Such teachings differ from what is presently claimed in that the methods of making in the issued claims do not recite that the resulting cells are to be administered to treat autoimmune disease.
The ‘636 publication discloses that regulatory T cells are to be administered to treat a wide variety of autoimmune diseases including type I diabetes and multiple sclerosis (see entire document, particularly the abstract, claims, and paragraph [0037]).
Therefore, it would have been obvious to administer the regulatory T cells made by the issued claims. Artisans would be motivated to do so in order to treat autoimmune diseases and would have a reasonable expectation of success in doing so based upon the teachings of the ‘363 document.
Claims 6, 9 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,060,059. Although the claims at issue are not identical, they are not patentably distinct from each other because the cells claimed in the issued patent and those present claimed do not appear distinguishable.
Specifically, the issued claims recite a cell culture composition comprising human regulatory T cells which are CD4+, Foxp3+, Helios+, CD25high, and CD127low. Based upon the evidence presently of record, such cells appear to be phenotypically the same as that which is presently claimed, as is evidenced by the phenotype recited in instant claim 5.
It is noted that while the issued claims recite an oligonucleotide, the oligonucleotide is not recited as being SEQ ID NO:1. As has been discussed elsewhere in this office action, applicant has claimed a product, specifically a regulatory T cell, and the patentability of a product, such as a T cell, is governed by what it is rather than the process by which it was made. See particularly MPEP 2113. Presently there does not appear to be any way in which the cells claimed by the ‘059 patent could be distinguished from the cells which are presently claimed if for example both were present in identical unlabeled tubes. Indeed, when artisans look to the specification of the ‘059 patent for guidance about “oligonucleotides” they find between line 65 of column 10 to line 2 of column 11 that “Oligonucleotides of the present invention can have any sequence of nucleotides. That is, the inventors have found that, surprisingly, the ability of an oligonucleotide to stimulate enrichment of Tregs in a population of isolated cells is independent of its sequence.” Based upon such evidence it does not appear that the previously issued and instant claimed regulatory T cell populations are distinct. Further, recitations about such cells being used to treat autoimmune diseases including multiple sclerosis are not limiting of the product itself unless it can be shown that the product cannot be used for such a purpose, and note that the ‘059 patent provides amble teachings that regulatory T cells are indeed suitable for such purposes. See also MPEP 2111.02. Note also that there is no restriction requirement which necessitated the filing of the instant application as a separate entity from that which gave rise to the ‘059 patent, and that 35 USC 121 applies only to divisional applications filed in response to a restriction requirement.
No claims are allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael Szperka whose telephone number is (571)272-2934. The examiner can normally be reached Monday-Friday 8:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Misook Yu can be reached at 571-272-0839. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Michael Szperka
Primary Examiner
Art Unit 1641
/MICHAEL SZPERKA/Primary Examiner, Art Unit 1641
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