DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claims 1-20 are pending, all of which have been examined on the merits.
Priority
Acknowledgement is made of Applicants’ claims for priority:
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Claim Interpretation
Independent claims 1 and 13 both refer to human unipotent immature beta cells that co-express INS (insulin) and NKX6.1, and do not substantially express NGN3. An immature beta cell is defined by the instant application as being an endocrine cell population made in vitro which are capable of functioning in vivo by secreting insulin in response to blood glucose (See ¶0195 of PGPub). “Immature beta cell” does not read on any precursor of a beta cell (i.e. any cell which can be cultured to form a beta cell, for example PDX1-positive pancreatic endoderm cells or embryonic stem cells), rather immature beta cells, particularly immature beta cells which co-express INS and NKX6.1 are limited to those precursors of beta cells that are singly hormonal endocrine (not endoderm) cells capable of giving rise only to beta cells. The limitation that the human immature beta cells are unipotent further means that the immature beta cells have the capacity to differentiate into only insulin-secreting beta cells and do not have the potential to differentiate into glucagon (alpha) cells, somatostatin (delta) cells, and/or pancreatic polypeptide (gamma) cells (See ¶0170). The limitation that the human immature beta cells do not substantially express NGN3 is interpreted to mean that the cells do not express an appreciably amount of NGN3. The specification defines “substantially” (in the context of substantially free of) as a de minimus or reduced amount of a component (See ¶0197).
Claim Objections
Claim 1 is objected to for minor informalities: The full terms “insulin” and “neurogenin 3” should precede the first use of the abbreviations “INS” and “NGN3”, respectively. Correction is required.
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 1-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being incomplete for omitting essential steps, such omission amounting to a gap between the steps. See MPEP § 2172.01. The omitted steps are: allowing the transplanted cells to mature to mature beta cells in vivo.
As written, independent claims 1 and 13 recite that the sole step of transplanting the human unipotent immature beta cells into a subject achieves the production of mature beta cells or production of insulin in the subject. However, the specification shows that a maturation period must first occur in vivo to permit the immature beta cells to mature to beta cells. For example, Fig. 45 shows that 3+ days are required for maturation of pre-ß cells (reads on the unipotent immature beta cells of the claims) to mature into ß-cells. Example 10 reports testing for beta cell maturation and insulin secretion in response to glucose at 11 weeks post-transplantation. Example 11 reports presence of mature beta cells and insulin secretion in response to glucose at 10 weeks post-translation. Therefore, the maturation to mature beta cells and production of insulin is not immediate upon transplantation, but a maturation period must also occur.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 10 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 10 depends from claim 1 and attempts to further limit the unipotent immature beta cells of claim 1 as being ‘capable of maturing into mature beta cells’. The ability to mature into mature beta cells is considered inherent to unipotent immature beta cells, and thus does not further limit or narrow parent claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-17 of U.S. Patent No. 8859286.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method comprising administering the same immature beta cells as the instant claims. Though the patented claim 8 does not use the same description (i.e. unipotent immature beta cells co-expressing NKX6.1 and insulin, and not substantially expressing NGN3), the patent recites carrying out the same steps that produce the cells administered in the instant claims, thus the cells are necessarily the same. This conclusion is based on inherency. Furthermore, patented claims 16 and 17 do describe the immature beta cells as expressing INS, NKX6.1 and MAFB. The remaining limitations pertaining the aggregate formation and aggregate size are likewise considered inherent.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 9650610.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to compositions which anticipate the in vitro cell culture transplanted in the current claims. Furthermore, the patent specification teaches transplanting the cell compositions, including the encapsulated versions thereof, into a patient for the purpose of maturing the immature beta cells into mature beta cells and producing insulin in a subject (See patent specification Example 12). It has been held that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86, and Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010). See MPEP 804(II)(B)(1).
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 10376545.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to a method comprising administering the same immature beta cells as the instant claims. In particular, patented claims 17 and 18 are considered to anticipate instant claims 1 and 5-11. Though the patented claim 17 does not specify the unipotent immature beta cells do not substantially express NGN3, it is submitted that the cells being administered in the patented method are the same as those being administered in the instant claims, but described using different features of the cells. It is further noted that patented claims 1-16 recite other claimed features related to the use of semi-permeable encapsulation device, thereby rendering provision of the cells in said device prima facie obvious.
Claims 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11446335.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims are drawn to compositions which anticipate the in vitro cell culture transplanted in the current claims. Though the patented claims do not specify the unipotent immature beta cells do not substantially express NGN3, it is submitted that the cells described in the patented method are the same as those being administered in the instant claims, but described using different features of the cells. Furthermore, the patent specification teaches transplanting the cell compositions, including the encapsulated versions thereof, into a patient for the purpose of maturing the immature beta cells into mature beta cells and producing insulin in a subject (See patent specification Example 12). It has been held that a claim to a method of using a composition is not patentably distinct from an earlier claim to the identical composition in a patent disclosing the identical use. See Pfizer, 518 F.3d at 1363; Geneva, 349 F.3d at 1385-86, and Sun Pharmaceutical Industries v. Eli Lilly and Co., 611 F. 3d 1381, 1387 (CAFC 2010). See MPEP 804(II)(B)(1).
Additional References
The following reference is made of record, though not relied upon for a rejection at this time:
Rezina et al (US 2014/0186305): Rezina et al is considered the closet prior art. Rezina et al teach a method of differentiating endoderm progenitor cells to pancreatic endocrine cells through six stages. The Stage 6 cells of Rezina et al are closest to the unipotent immature beta cells used in the instant claims. Production of Stage 6 cells is described at ¶0133-0146. In particular, the Stage 6 cells co-express NKX6.1/INS/CHGA. The Stage 6 are single hormone INS+/NKX6.1+ cells (See ¶0142). Rezina et al teach the Stage 6 cells can be implanted in vivo (See ¶0146).
Production of the Stage 6 cells is exemplified in Example 4. Transplantation of the Stage 6 cells produced by the method of Example 4 is exemplified in Example 11.
Example 4 (starting at ¶0195) shows production of Stage 6 cells being NKX6.1+/INS+/CHGA+. However, these cells are different than the human unipotent immature beta cells of the current claims because the Stage 6 cells of Rezina et al express substantial amounts of NGN3. Fig 8 shows characteristics of the cells produced by the method of Example 4, and Fig. 8C shows that all cells expressed appreciable amounts of NGN3 (See Fig. 8C and ¶0025). Therefore, the Stage 6 cells of Rezina et al, while similar, are not the same.
Conclusion
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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/ALLISON M FOX/ Primary Examiner, Art Unit 1633