DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicants’ response of 5/11/2026 has been received and entered into the application file. Claims 1-3, 5-11, 15-23, 25 and 29-34 are pending, all of which have been considered on the merits.
RE: Objections to claims 1, 7 and 25:
The amendments to the claims are effective to overcome the previous grounds of objection. The objections are withdrawn.
RE: Rejection of claims 1-3, 5-11, 15-23 and 25 under 35 USC 112(b):
The amendments to the claims are effective to overcome the previous grounds of rejection. The rejections are withdrawn.
RE: Rejection of claims 2 and 3 under 35 USC 112(d):
The amendments to claim 1 are effective to correct the previous deficiency causing the prior rejection. The rejection is withdrawn.
RE: Rejection of claims 1-3, 5-11, 15-22 and 25 under 35 USC 112(a):
The amendments to the claims is effective to limit to an enabled scope. The rejection is withdrawn.
RE: NSDP Rejections over claims of U.S. Patent Nos. 10213525 and 11452797:
Applicants did not traverse the NSDP rejections, rather requesting they be held in abeyance. Non-statutory double patenting rejections may not be held in abeyance. See MPEP 714.02. The rejections are maintained (modified to address current claims).
Claim Interpretation
Claim 23 is interpreted as requiring an additional step of implanting the extracellular matrix in a mammal. Claim 23 has a slightly narrower scope than new claim 29 by virtue of claim 23 depending from claim 17, which includes additional limitations.
Claim Objections
Claim 25 is objected to for minor informalities: At line 13 the word “endothelialized” is misspelled. Correction is required.
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, 5-11, 15-23, 25 and 29-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 10213525.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims, as follows:
Regarding claims 1-3 and 7: Patented claim 1 teaches all limitations of instant claims 1-3 and 7, except patented claim defines the second cell population as comprising insulin producing cells or stem cells or precursors thereof, whereas instant claim 1 defines the second cell population as islets or beta cells, or stem or precursors thereof. However, patented claim 20 defines the insulin producing cells as islet cells or beta cells, thereby teaching the remaining claim limitation.
Regarding claims 5 and 6: Following the discussion of claim 1 above, patented claim 3 teaches the limitations of instant claims 5 and 6.
Regarding claim 8: Following the discussion of claim 1 above, patented claim 5 teaches the limitations of instant claim 8.
Regarding claim 9: Following the discussion of claim 1 above, patented claim 6 teaches the limitations of instant claim 9.
Regarding claim 10: Following the discussion of claim 1 above, patented claim 7 teaches the limitations of instant claim 10.
Regarding claim 11: Following the discussion of claim 1 above, patented claim 8 teaches the limitations of instant claim 11.
Regarding claim 15: Following the discussion of claim 1 above, patented claim 4 teaches the limitations of instant claim 15.
Regarding claim 16: Following the discussion of claim 1 above, patented claim 10 teaches the limitations of instant claim 16.
Regarding claim 17: Following the discussion of claim 1 above, patented claim 11 teaches the limitations of instant claim 17.
Regarding claims 18-23: Following the discussion of claim 1 above, patented claims 12-17 teaches the limitations of instant claims 18-23, respectively.
Regarding claim 25: Following the discussion of claim 1 above, patented claims 12-17 render obvious the different embodiments of claim 25.
Regarding claims 29-32: Following the discussion of claim 1 above, patented claim 17 teaches the limitations of instant claims 29-32.
Regarding claims 33-34: Following the discussion of claim 29 above, the timing of the contacting with the first and second cell populations, and the number of cells (particularly islets)/kg body weight would have been matters of routine optimization, and thus obvious over patented claim 17.
Claims 1-3, 5-11, 15-23, 25 and 29-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11452797.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate and/or render obvious the instant claims, as follows:
Regarding claims 1, 5, 7, 18, 23, 25 and 29-32: Patented claims 1, 2 and 6 renders obvious instant claims 1, 5, 7, 18, 23, 25 and 29-32. Patented claim 1 requires introduction of a graft into a mammal. The patented claim uses product-by-process limitations to describe how the graft is made. The product-by-process limitations anticipate the active steps of instant claim 1. It would have been prima facie obvious to carry out the product-by-process limitations to first produce the graft, and then implant the graft as required by the patented method. The patented claims also differ in that they are generic to the second cell population being insulin-producing cells, as opposed to islet cells or beta cells. However, patented claim 2 teaches the insulin producing cells are islet cells or beta cells. Finally, regarding the size of the graft, patented claim 6 teaches the size limitation required by instant claim 1.
Regarding claims 2-3: Following the discussion of claim 1 above, patented claims 3-4 teaches the limitations of instant claims 2-3.
Regarding claim 6: Following the discussion of claim 1 above, patented claim 8 teaches the limitation of instant claim 6.
Regarding claim 15: Following the discussion of claim 1 above, patented claims 10 and 11 teaches the limitations of instant claim 15, respectively.
Regarding claim 8: Following the discussion of claim 1 above, patented claim 12 teaches the limitations of instant claim 12.
Regarding claim 9: Following the discussion of claim 1 above, patented claim 13 teaches the limitations of instant claim 9.
Regarding claim 10: Following the discussion of claim 1 above, patented claims 13-15 teaches the limitations of instant claim 10.
Regarding claim 11: Following the discussion of claim 1 above, patented claim 16 teaches the limitations of instant claim 11.
Regarding claim 16: Following the discussion of claim 1 above, the insulin producing cells are considered encapsulated within the extracellular matrix.
Regarding claim 17: Following the discussion of claim 1 above, patented claims 11 teaches the limitations of instant claim 17.
Regarding claims 19-22: Following the discussion of claim 1 above, patented claim 16 teaches the alternative cell deliveries covered by claims 19-22.
Conclusion
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 ALLISON M FOX whose telephone number is (571)272-2936. The examiner can normally be reached M-F 10-6 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached at 571-272-8507. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALLISON M FOX/Primary Examiner, Art Unit 1633
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