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 .
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 1/16/2026 is acknowledged.
Applicant has cancelled all non-elected claims.
Claims 1, 17-21, 23, 28, 31-35, 37, 38, 44, 46-48, 50-53, 62-65, 67, 72, 73, 83 and 84 are examined in the instant application.
Claim Objections
Claim 31 is objected to because of the following informalities: claim 31 is not grammatically correct, the second recitation of about in line 2 should be deleted. Appropriate correction is required.
Claim 32 is objected to because of the following informalities: claim 32 is not grammatically correct, the second recitation of about in line 2 should be deleted. Appropriate 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, 17-21, 23, 28, 31-35, 37, 38, 44, 46-48, 50-53, 62-65, 67, 72, 73, 83 and 84 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 32, 74, 95, 99-102, 110-114, 117, 122, 150, 158, 169-188, 192-195 of copending Application No. 18,786,200 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed method of ‘200 encompasses treating a subject with a composition comprising the same cells instantly claimed, i.e. C-peptide and ISL1 expressing cells and in conjunction with an immunosuppressant agents such as Thymoglobulin, Sirolimus and Tacrolimus (instant claim 38).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 19, 20, 46 and 48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “severe” in claim 19 is a relative term which renders the claim indefinite. The term “severe” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “impaired” in claim 20 is a relative term which renders the claim indefinite. The term “impaired” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claims 19 and 20 are unclear. Both claims 19 and 20 recite the limitation “medical history”, however it is not clear what the metes and bounds are of a subject’s medical history. A subject’s medical history could be 1-week or 80 years and there are no teachings in the specification or the claims that would identify the length of a patient’s medical history as encompassed by practicing the claimed method. Further, a subject can have an undocumented medical history and a documented medical history, thus it is unclear what the metes and bound are of a subject’s medical history.
Claim 46 is unclear. Claim 46 recites the limitation “of between about”, however its not clear what the metes and bounds are regarding “of between about” 0.05% and about 1.5% sugar concentration. The concentration of sugar could be less than 0.05% (about) or between 0.05% and 1.5%. Thus, it is not clear what the concertation of sugar is being used.
Claim 48 contains the trademark/trade name “HypoThermosol® FRS Preservation Media”. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe HypoThermosol® FRS Preservation Media and, accordingly, the identification/description is indefinite.
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.
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 –
Claim(s) 1, 17, 21, 28, 31-35, 37, 44, 47, 50-53, 62-65, 67, 72, 83 and 84 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Peterson et al. (US 2017/0029778 A1).
Regarding claims 1, 31 and 32, Peterson et al. teach a method of treating a subject in need thereof comprising administering via infusion a pharmaceutical composition comprising a population of cells in a liquid suspension wherein the population from 1x108 to 10x108 non-native cells expressing C-peptide and ISL1 (parags. 95, 154, 630 and Example 1).
Regarding claim 17, Peterson teaches that the subject can have a baseline A1c level of more than 7.0% (parag. 559).
Regarding claim 21, Peterson teaches that their method can be used to treat Type I diabetics, which will inherently have no residual endogenous islet cell function due to the autoimmune nature of Type I diabetes (parags. 511 and 512).
Regarding claim 28, Peterson teaches that the claimed method can be used to treat Type I diabetics (parag. 564).
Regarding claims 33 and 35, Peterson teaches that a second composition of non-native C-peptide and ISL1 expressing cells can be administered (parags. 549-550 and 630).
Regarding claim 34, Peterson teaches that the second administration cells can be administered at least 3 months or more after the first composition is administered (parags. 322, 549 and 550).
Regarding claim 37, Peterson teaches that the subject can also be administered an immunosuppressant (parag. 548).
Regarding claim 44, Peterson teaches that the first pharmaceutical can comprise a sugar (parag. 112).
Regarding claim 46, Peterson teaches that the liquid suspension can comprise sugar at a concentration between 0.05% and about 1.5% (parag. 642).
Regarding claim 47, Peterson teaches that the composition comprises CMRL medium (parag. 596).
Regarding claims 50-53, Peterson does not teach that their C-peptide/ISL1 expressing cells expressed VMAT1.
Regarding claims 62-65, Peterson teaches that they can obtain different combinations of cells that are NKX6.1 positive/negative and ISL1 positive/negative and are determined by flow cytometry (parags. 42, 57, 94, 378 and 379).
Regarding claims 67 and 72, Peterson teaches that the administered composition can display GSIS in vivo and be present as a plurality of clusters (parag. 47).
Regarding claim 83, Peterson teaches that the composition of cells is infused into the portal vein (parag. 565).
Regarding claim 84, Peterson teaches that the subject receives a single dose (parags. 524-525).
Thus Peterson clearly anticipates the invention of claims 1, 17, 21, 28, 31-35, 37, 44, 46, 47, 50-53, 62-65, 67, 72, 83 and 84.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 37 and 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Peterson et al. (US 2017/0029778 A1) in view of Matsumoto et al. (2011, Cell Transplantation, Vol. 20, pgs. 1641-1647).
Regarding claim 1, Peterson et al. teach a method of treating a subject in need thereof comprising administering via infusion a pharmaceutical composition comprising a population of cells in a liquid suspension wherein the population from 1x108 to 10x108 non-native cells expressing C-peptide and ISL1 (parags. 95, 154, 630 and Example 1).
Regarding claim 37, Peterson teaches that the subject can also be administered an immunosuppressant (parag. 548).
Peterson does not teach:
Tacrolimus.
Regarding using the immunosuppressant tacrolimus in claim 38, Matsumoto et
al. teach that for islet cell transplantation for the treatment of Type I diabetes can have increased efficacy through the use of tacrolimus to induce thymoglobulin (see Abstract and Introduction).
Thus at the time of filing it would have been prima facie obvious to combine the teachings of Peterson regarding treating Type I diabetes with transplanted cells with the teachings of Matsumoto regarding the benefits of using tacrolimus for islet cell transplantation to arrive at the claimed invention.
One or ordinary skill would have been motivated to make such a combination since Matsumoto teaches that using the immunosuppressant tacrolimus for the treatment of Type I diabetes improves the efficacy of islet cell transplantation.
There would have been a reasonable expectation of success that tacrolimus could be combined with the method of Peterson since Peterson teaches that immunosuppressants can be used in their method of treating Type I diabetes.
Thus the cited art provides the requisite teachings and motivations to make and use the invention as claimed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID A MONTANARI whose telephone number is (571)272-3108. The examiner can normally be reached M-Tr 8-6.
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/DAVID A MONTANARI/Examiner, Art Unit 1632
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