DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
This action is responsive to the claims filed on May 20, 2024. Claims 1-55 have been canceled. Claims 56-66 are pending and examined below.
Priority
The present application is a continuation of U.S Patent App. No. 17/470,492, which is a continuation of U.S. Patent App. No. 16/009,048, which is a divisional of U.S. Patent App. No. 15/089,435, which is a DIV of U.S. Patent App. No. 14/377,597, which is a 317 of the International Application No. PCT/EP2013/052692, filed Feb. 11, 2013, which claims foreign priority 35 U.S.C. 119(a)-(d) to Great Britain Patent Application No. 1202319.8 filed on Feb. 10, 2012.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on May 20, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has 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 56-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10,907,131 ("the '131 patent") in view of Ra et al. (U.S. Patent App. No. 2010/0196329).
The '131 patent does not teach a cell population that includes a cryopreservant.
Ra et al. teach injectable, mesenchymal stem cells ("stromal stem cells") that are formulated for frozen storage that maximizes their viability when combined with excipients including human serum albumin, DMSO, and phosphate buffered saline. (paras. [0011]-[0014], [0021], Example 7, [0063]-[0065], Table 3).
It would have been obvious for one of ordinary skill in the art at the time of the invention to have combined the methods for isolating stem cells taught by the '131 patent to
include a cryopreservative (such as DMSO, or HSA) as taught by Ra et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Including a cryopreservant with the composition would have led to predictable results with a reasonable expectation of success because Ra et al. teach that cryopreservants can be added to stromal stem cells for frozen storage and that it maximizes viability of this cell population; as such, this would have been a routine step for a person of ordinary skill to modify at the time.
Claims 56-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of U.S. Patent No. 10,920,197 ("the '197 patent") in view of Ra. et al. (U.S. Patent App. No. 2010/0196329).
The claims of the '197 patent teach therapeutic use of a population of composition including mammalian stromal stem cells where at least 30% are positive for SDC2 and a pharmaceutically acceptable carrier.
The '197 patent does not teach a cell population that includes a cryopreservant.
Ra et al. teach injectable, mesenchymal stem cells ("stromal stem cells") that are
formulated for frozen storage that maximizes their viability when combined with excipients
including human serum albumin, DMSO, and phosphate buffered saline. (paras. [0011]-[0014], [0021], Example 7, [0063]-[0065], Table 3).
It would have been obvious for one of ordinary skill in the art at the time of the invention to have combined the methods for using stem cells taught by the '197 patent with
a cells product including a cryopreservative as taught by Ra et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Including a cryopreservant with the composition would have led to predictable results with a
reasonable expectation of success because Ra et al. teach that cryopreservants can be added to stromal stem cells for frozen storage and that it maximizes viability of this cell population; as such, this would have been a routine step for a person of ordinary skill to modify at the time.
Claims 56-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,142,747 ("the '747 patent) in view of Ra. et al. (U.S. Patent App. No. 2010/0196329)
The claims of the '747 patent teach therapeutic use of a population of composition including mammalian stromal stem cells where at least 30% are positive for SDC2 and a pharmaceutically acceptable carrier.
The '747 patent does not teach a cell population that includes a cryopreservant.
Ra et al. teach injectable, mesenchymal stem cells ("stromal stem cells") that are
formulated for frozen storage that maximizes their viability when combined with excipients
including human serum albumin, DMSO, and phosphate buffered saline. (paras. [0011]-[0014], [0021], Example 7, [0063]-[0065], Table 3).
It would have been obvious for one of ordinary skill in the art at the time of the invention to have combined the methods for using stem cells taught by the '747 patent with
a cell product including a cryopreservative as taught by Ra et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Including a cryopreservant with the composition would have led to predictable results with a
reasonable expectation of success because Ra et al. teach that cryopreservants can be added to stromal stem cells for frozen storage and that it maximizes viability of this cell population; as such, this would have been a routine step for a person of ordinary skill to modify at the time.
Claims 56-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 11,230,700 ("the '700 patent").
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘700 patent teaches all of the claim elements, as it is directed to a more limited embodiment (where the cryopreservant is DMSO).
Claims 56-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-11 of U.S. Patent No. 11,926,848 ("the '848 patent) in view of Ra. et al. (U.S. Patent App. No. 2010/0196329)
The claims of the '848 patent teach therapeutic use of a population of composition including mammalian stromal stem cells where at least 30% are positive for SDC2.
The '848 patent does not teach a cell population that includes a cryopreservant.
Ra et al. teach injectable, mesenchymal stem cells ("stromal stem cells") that are
formulated for frozen storage that maximizes their viability when combined with excipients
including human serum albumin, DMSO, and phosphate buffered saline. (paras. [0011]-[0014], [0021], Example 7, [0063]-[0065], Table 3).
It would have been obvious for one of ordinary skill in the art at the time of the invention to have combined the methods for using stem cells taught by the '848 patent with the cell product including a cryopreservative as taught by Ra et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Including a cryopreservant with the composition would have led to predictable results with a
reasonable expectation of success because Ra et al. teach that cryopreservants can be added to stromal stem cells for frozen storage and that it maximizes viability of this cell population; as such, this would have been a routine step for a person of ordinary skill to modify at the time.
Claims 56-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,952,589 ("the '589 patent").
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘589 patent teaches all of the claim elements, as it is directed to a more limited embodiment (wherein 30% or more of the cells are osteo-lineage precursor cells).
Claims 56-66 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,952,590 ("the '590 patent").
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘590 patent teaches all of the claim elements, as it is directed to a more limited embodiment (wherein the cells exhibit at least 10-fold more colony forming units).
Claims 56-66 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 19/205,353 (the ‘353 application) in view of Ra. et al. (U.S. Patent App. No. 2010/0196329)
The claims of the '353 application teach therapeutic use of a population of composition including mammalian stromal stem cells where at least 30% are positive for SDC2.
The '353 application does not teach a cell population that includes a cryopreservant.
Ra et al. teach injectable, mesenchymal stem cells ("stromal stem cells") that are
formulated for frozen storage that maximizes their viability when combined with excipients
including human serum albumin, DMSO, and phosphate buffered saline. (paras. [0011]-[0014], [0021], Example 7, [0063]-[0065], Table 3).
It would have been obvious for one of ordinary skill in the art at the time of the invention to have combined the methods for using stem cells taught by the '353 application with the cell product including a cryopreservative as taught by Ra et al. because it would have been obvious to combine prior art elements according to known methods to yield predictable results. Including a cryopreservant with the composition would have led to predictable results with a reasonable expectation of success because Ra et al. teach that cryopreservants can be added to stromal stem cells for frozen storage and that it maximizes viability of this cell population; as such, this would have been a routine step for a person of ordinary skill to modify at the time.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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