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 .
Claims 21-40 are pending as amended 7/2/24 and are considered herein.
Formalities:
The drawings of 2/26/24 are accepted.
The specification of 2/26/24 is accepted.
The IDS filings of 4/24/26; 2/28/25; and 7/2/24 have been considered, including the references therein, and a signed copy is provided herewith.
Applicant’s priority is noted to be:
PNG
media_image1.png
66
642
media_image1.png
Greyscale
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 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 11,952,588. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 21: patent Claim 1 teaches a method which requires administering 5E5 to 2E7 HSPCs per kilogram of human patient; 1E6 to 5E6 Tregs per kilogram of body weight of human patient; and fewer than 1E6 to 5E6 CD3+T cells. Claim 8 teaches the ratio of Treg to Tcon may be about 1:1 to about 1:3, meaning that in at least some embodiments, the Tcons may be 1E6 per kilogram human patient. Additionally, a GVHD prophylactic agent may be administered in Claim 1. Claim 9 teaches the HSPCs are CD34+. Claim 10 teaches the Tregs may be CD4+CD25+ and CD127dim. Additionally, the Tregs in Claim 1 are FOXP3+. It is finally taught, in Claim 5, that all cells may be allogeneic to the human patient. While Claim 1of the patent is treating a hematologic malignancy, the use of these cells meets the graft, and the GVHD prophylactic agents indicate it is also for transplant of HSPCs and preventing GVHD.
Claim 22: Claim 13 teaches separate administrations, while Claim 14 teaches single administrations, indicating the broad claims specifically embrace different administrations.
Claim 23: Claim 2 teaches tacrolimus.
Claim 24: Claim 3 requires no stage 2 or higher GVHD within 30 days of Tcon administration.
Claim 25: as shown above, the various cells are administered and Claim 18 indicates the Tregs are not cryopreserved.
Claim 26: Claim 2 teaches tacrolimus.
Claim 27: Claim 3 requires no stage 2 or higher GVHD within 30 days of Tcon administration.
Claim 28: Claim 4 teaches no GVHD within 100 days of administration of the Tcons.
Claim 29: Claim 5 teaches they may all be allogeneic.
Claim 30: Claim 19 teaches Tcons administration at least 12 hours after Tregs or HSPCs.
Claim 31: Claim 6 teaches full donor chimerism.
Claim 32: Claim 1 teaches 5E5 HSPC per kilogram.
Claim 33: Claim 1 teaches 1E6 to 5E6 Treg per kilogram.
Claim 34: Claim 8 teaches the ratio of Treg to Tcon may be about 1:1 to about 1:3, meaning that in at least some embodiments, the Tcons may be 1E6 per kilogram human patient.
Claim 35: Claim 8 teaches the ratio of Treg to Tcon may be about 1:1 to about 1:3.
Claim 36: Claim 9 teaches the HSPCs are CD34+.
Claim 37: Claim 10 teaches the same markers on the Tregs.
Claim 38: Claim 11 teaches engraftment of 1E9 cells/L peripheral blood within 20 days of administration of the HSPCs.
Claim 39: As shown above, the various elements are administered, including the Tregs prior to Tcons in claim 1, and the Tregs are not cryopreserved in Claim 18.
Claim 40: Claim 2 teaches tacrolimus.
Thus, in light of the patent, the invention is obvious. The Artisan would do so, and expect success, as the subject matter is claimed in the patent.
Claims 21-40 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,447,747. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 21: Claim 1 teaches the dosing system of HSPCs, Tregs, and CD3+ Tcons, along with a GVHD prophylactic agent. Claim 9 teaches the HSPCs are at more than 1E5 per kilogram of human. Claim 10 teaches the Tregs are at more than 1E5 per kilogram of human. Claim 11 teaches the Tcons are at less than 1E7 per kilogram of human. Claim 8 teaches the Tregs have the same marker set Markush. Claim 15 teaches the cells may all be allogeneic.
Claim 22: Claim 4 teaches separate administrations.
Claim 23: Claim 13 teaches sirolimus or tacrolimus.
Claim 24: Claim 18 teaches no stage 2 or higher GVHD within 30 days of administration.
Claim 25, as shown above, the compositons are taught, in the form of dosing system, specifically for humans, and thus, it is obvious dose humans with the compositons. The Artisan would do so as it is claimed as a dosing system for humans, and would expect success, as it is claimed for such.
Claim 26: Claim 13 teaches sirolimus or tacrolimus.
Claim 27: Claim 18 teaches no stage 2 or higher GVHD within 30 days of administration.
Claim 28: as the composition is for administration, the effect is assumed to occur, as the structure is there.
Claim 29: Claim 15 indicates they may all be allogeneic.
Claim 30: Claim 3 indicates the 12 hour separation between administrations.
Claim 31: As the method of administration is obvious, it is assumed that the effect of chimerism occurs.
Claim 32: Claim 9 requires more than 1E5 HSPC per kilogram.
Claim 33: Claim 10 requires more than 1E5 Treg per kilogram.
Claim 34: Claim 11 requires less than 1E7 CD3+ Tcon per kilogram.
Claim 35: Claim 12 requires about 1:1 to about 1:3 Treg to Tcon.
Claim 36: Claim 7 requires the HSPC to be CD34+.
Claim 37: Claim 8 requires the same marker set Markush for the Treg cells.
Claim 38: As the steps occur int eh administration of the dosing system, it is assumed donor engraftment is greater than 1E9 neutrophils per liter within 20 days.
Claim 39: As the steps occur, it is assumed GVHD is prevented or reduced for the tissue.
Claim 40: Claim 13 teaches sirolimus or tacrolimus.
Thus, in light of the patent, the Artisan would make the composition and administer to the human, the Artisan would do so as it is taught for dosing humans, and would expect success, as it is claimed.
Claims 21-22, 24-25, and 27-39 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-29, 31-34, and 36-51 of copending Application No. 17/819,463 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claim 21: Claim 21 teaches treating a human, by adminsitrations, separately, of HSPCs, Tregs and CD3+ Tcons. Claim 32 teaches 1E6 HSPC per kg human. Claim 33 teaches 9e5 to 3.5E6 Treg per kg human. Claim 34 teaches 9E5 to 6.9E6 CD3+ Tcon per kg human. Claim 23 teaches a GVHD prophylactic agent. Claim 38 teaches the same marker set Markush for Tregs. Claim 29 teaches the cells are all allogeneic. Thus, the dosing system is utilized in the methods claimed.
Claim 22: Claim 21 requires separate administrations.
Claim 24: Claim 27 teaches no stage 2 GVHD within 30 days of administration.
Claim 25: As shown above, the method teaches administration of the same, and it is therefore an HSPC transplantation. In addition, Claim 21 requires the Tregs not be cryopreserved.
Claim 27: Claim 27 teaches no stage 2 GVHD within 30 days of administration.
Claim 28: Claim 28 requires no chronic GVHD within 100 days of administration.
Claim 29: Claim 29 teaches the cells are all allogeneic.
Claim 30: Claim 21 teaches 2-3 days after administration of the HSPCs.
Claim 31: Claim 31 teaches the chimerism.
Claim 32: Claim 32 teaches 1E6 or more HSPC per kilogram.
Claim 33: Claim 33 teaches 9E5 to 3.5E6 Treg per kilogram.
Claim 34: Claim 34 teaches 9E5 to 3.5E6 Treg per kilogram.
Claim 35: Claim 36 teaches about 1:1 to 1:3 Treg to CD3+ Tcons.
Claim 36: Claim 37 teaches the HSPCs are CD34+.
Claim 37: Claim 38 teaches the same Treg marker set Markush.
Claim 38: Claim 39 teaches the same 1E9 neutrophils/L within 20 days of HSPC administration.
Claim 39: As shown above, the same steps occur.
Thus, in light of the claims of the reference, the invention is obvious. The Artisan would make the compositions and use them in the methods, and expect success, as it is claimed subject matter.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 21-40 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 21, 23-29, 31-34, and 36-51 of copending Application No. 17/819,463 in view of Marfo, et al. (2010) “Tacrolimus Pharmacokinetic and Pharmacogenomic Differences between Adults and Pediatric Solid Organ Transplant Recipients”, Pharmaceutics, 2: 291-99.
As shown above, the various aspects are obvious over the reference application alone, however, the aspect of using Tacrolimus is not taught in the claims, as Tacrolimus has been cancelled.
On the other hand, as shown by Marfo (e.g., ABSTRACT), it was well known that Tacrolimus is a calcineurin inhibitor that is used as an immunosuppressant in transplants.
Thus, in light of the reference and Marfo, the claims are obvious. The subject matter would be made and used in the patent, and modified with Tacrolimus, as the Art demonstrates it is such an inhibitor used in transplants. Thus, there is a reasonable expectation of success.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Tracy Vivlemore can be reached at 571-272-2914. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/ Primary Examiner, Art Unit 1638
Prosecution Insights