DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims Status
Claim(s) 1-13 is/are currently pending and presented for examination on the merits.
Specification
The use of trade name(s) or mark(s) used in commerce (e.g., RosetteSep), has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Interpretation
Claim(s) 1-13 recite(s) “…administering to the subject an effective amount of cells, wherein the cells are obtained by a method comprising: (a) providing a culture of mesenchymal stem cells; (b) contacting the cell culture of step (a) with a polynucleotide comprising sequences encoding a Notch intracellular domain (NICD) wherein said polynucleotide does not encode a full-length notch protein; (c) selecting cells that comprise the polynucleotide of step (b); and (d) further culturing the selected cells of step (c)…” in claim(s) 1, 6, and 10. The broadest reasonable interpretation of the composition of “cells” administered encompasses the administration of any composition comprising MSCs engineered to express an NICD protein that is not part of a full-length Notch protein.
Claim Rejections - 35 USC § 102/103
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 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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-13 is/are rejected under pre-AIA 35 U.S.C. 102 (a)(2) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over WO 2011/097242 A2 (US PCT international Filing Date: 01Feb2011, Effective filing date: 02Feb2010; hereinafter “WO242”).
Regarding instant claim(s) 1-13, WO242 teaches a method of administering Notch+ mesenchymal stem cells (MSCs) to a subject in need thereof [e.g., abstract; pg. 12, lines 120; pg. 13, lines 18-23]. WO242 further teaches the Notch is NICD [e.g., pg. 23, 1-23], wherein NICD protein(s) comprise a cleaved Notch protein (e.g., not full-length Notch protein) [e.g., pg. 2, lines 29-31; pg. 17, lines 31; pg. 20, lines 1-4], and that NICD expression can be introduced using a viral expression vector (e.g., comprising a polynucleotide encoding the NICD protein that is not full-length) [e.g., pg. 10, lines 10-13]. The NICD expressing MSCs administered in the method of WO242 is/are the same as the NICD+ MSCs as obtained by the methods as required by claim(s) 1-13, are product considered to be product by process (e.g., the administered product is made by a specific process in the instant claims). Regarding the product by process limitations of instant claim(s) 1-13, none of the instant claimed processing steps to arrive at the instant claimed administered cell population (e.g., product) would lead one of ordinary skill in the art to reasonably expect the manufacture of a patentably distinct product from that of instant claims 1-13. Therefore, the product by process portions of instant claim(s) 1-13 are not considered patentably distinct from the product (e.g., NICD+ MSCs) as taught by WO242. MPEP 2113(I) provides “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)”. Regarding the helper T cell functional limitations of instant claim(s) 1-13, the (1) suppressing the function of Th1 cells wherein Th1 function comprises (a) activation of macrophages, (b) activation of cytotoxic T cells, (c) activation of B cells, or (d) stimulation of an inflammatory response; (2) augmenting Th2 function wherein Th2 function comprises (a) stimulation of B cell antibody production, (b) secretion of IL4, or (c) secretion of IL10; or (3) modulating the function of helper T cells (Th) wherein Th function comprises (a) activation of dendritic cells, (b) maturation of dendritic cells, or (c) surface expression of a costimulatory molecule are considered to flow naturally from the method comprising administration of NICD+ MSCs to a subject. Applicant is reminded that something old does not become patentable upon the discovery of a new property (see MPEP 2112(I)). Further, MPEP 2112(III) provides “Where applicant claims a composition in terms of a function, property or characteristic and the composition of the prior art is the same as that of the claim but the function is not explicitly disclosed by the reference, the examiner may make a rejection under both 35 U.S.C. 102 and 103. "There is nothing inconsistent in concurrent rejections for obviousness under 35 U.S.C. 103 and for anticipation under 35 U.S.C. 102." In re Best, 562 F.2d 1252, 1255 n.4, 195 USPQ 430, 433 n.4 (CCPA 1977). This same rationale should also apply to product, apparatus, and process claims claimed in terms of function, property or characteristic. Therefore, a 35 U.S.C. 102 and 103 rejection is appropriate for these types of claims as well as for composition claims.”.
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.
Claim(s) 1, 10 is/are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 4, 16 of copending Application No. PCT/US12/32504 (claims filed 4/6/2012; hereinafter “PCT504”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 10, PCT504 claim(s) 1, 4, 16 teach(es) a genus of a method of suppressing T cell activation that is anticipated by the species of instant claims 1, 10 (see MPEP 2131.02(I)).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim(s) 1, 10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 5 of U.S. Patent No. US RE46,382 E (hereinafter “RE382”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 10, RE382 claim(s) 1, 5 teach(es) a genus of a method comprising the same active steps and same product (e.g., SB623 is a NICD+ MSC) that is anticipated by the species of instant claims 1-13 (see MPEP 2131.02(I)).
Claim(s) 1, 6, 10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1, 5 of U.S. Patent No. US 10,543,234 B2 (hereinafter “US234”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 6, 10, US234 claim(s) 1, 5 teach(es) a genus of a method comprising the same active steps and same product (e.g., SB623 is a NICD+ MSC) and the decrease (e.g., suppression) of Th1 cells or the increase (e.g., augmenting) of Th2 cells that is anticipated by the species of instant claims 1, 6, 10 (see MPEP 2131.02(I)).
Claim(s) 1-4, 6-10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-4, 7-10 of U.S. Patent No. US 11,903,972 B2 (hereinafter “US972”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1-4, 10, US972 claim(s) 1-4 teach(es) a method of suppression the function of Th1 cells comprising administration of NICD+ MSCs, activation of macrophages, activation of cytotoxic T cells, and activation of B cells.
Regarding instant claim(s) 6-10, US972 claim(s) 7-10 teach(es) a method of augmenting Th2 cells comprising administration of NICD+ MSCs, activation of antibody production by B cells, secretion of IL4, and secretion of IL10.
Claim(s) 1,10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 5 of U.S. Patent No. US 96,55,927 B2 (hereinafter “US927”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 10, A001 claim(s) 1-2, 5 teach(es) a genus of a method of inhibiting (e.g., suppressing) T helper cells that is anticipated by the species of instant claims 1, 10 (see MPEP 2131.02(I)). It is noted that MSCs and “marrow adherent stem cells” are the same thing per the instant disclosure [e.g., ¶ 0012].
Claim(s) 1,10 is/are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-2, 5 of U.S. Patent No. US 8,785,190 B2 (hereinafter “US190”). Although the claims at issue are not identical, they are not patentably distinct from each other.
Regarding instant claim(s) 1, 10, A311 claim(s) 1, 5-6 teach(es) a genus of a method of inhibiting (e.g., suppressing) T helper cells comprising the same active steps and product (e.g., SB623 are NICD+ MSCs) that is anticipated by the species of instant claims 1, 10. It is noted that MSCs and “marrow adherent stem cells” are the same thing per the instant disclosure [e.g., ¶ 0012].
Conclusion
No claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY M CHATTIN whose telephone number is (571)270-0646. The examiner can normally be reached T-F 0600-1600 PST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at (571) 272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY M. CHATTIN/Examiner, Art Unit 1643
/GARY B NICKOL/Primary Examiner, Art Unit 1643
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