DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
The preliminary amendment filed 8/30/2024 have been received and entered into the application file. Claims 1-12 are pending, all of which have been considered on the merits.
Examiner Comment
The claims require the medium to comprise L-alanyl-L-glutamine. The instant specification does not use the phrase “L-alanyl-L-glutamine”. The instant specification does disclose use of “db-N50 K50 E50” medium during Stage 4 (See Table 7). The key states “db” medium is DMEM/High Glucose (HyClone) supplemented with, inter alia, 1.0x GlutaMAX-1 (Life Technologies). GlutaMaxTM is a trademarked product of Life Technologies.
MPEP 608.01(v) states a trademark may be used in a patent application to identify an article or product, service, or organization if:
Its meaning is established by an accompanying definition in the specification which is sufficiently descriptive, enabling, precise and definite such that a claim including the mark or trade name complies with the requirements of 35 USC 112, or
Its meaning is well-known to one skilled in the relevant art and is satisfactorily defined in the literature.
Applicants have provided (See IDS of 1/18/2024) product sheets for Gibco Life Technologies GlutaMAX™-1 as of 2010, 2013 and 2021, all of which support that the product sold under the tradename GlutaMAX™-1 contained L-alanyl-L-glutamine (formulated as 200 mM L-alanyl-L-glutamine in 0.85% NaCl).
The documentation is effective to satisfy requirement (B) of MPEP 608.01(v). Specifically, the documents establish that as of September 2010, 2013, and 2021, GlutaMAX™-1 was well-known to one skilled in the relevant art as a supplement comprising L-alanyl-L-glutamine (formulated as 200 mM L-alanyl-L-glutamine in 0.85% NaCl), and was defined as such. Therefore, disclosure of a medium comprising GlutaMAX™-1 in the specification is considered to provide support for medium comprising L-alanyl-L-glutamine.
Priority
Acknowledgement is made that the instant application is a continuation of US application 17/127221 (filed 12/18/2020, now US Patent 11905530), which is a continuation of US application 15/967418 (filed 4/30/2018, now abandoned); which is a continuation of US application 14/807,348 (filed 7/23/2015, now US Patent 9988604), which is a continuation of PCT/US2014/015156 (filed 2/6/2014), which is a continuation of 13/761,078 (filed 2/6/2013, now US Patent 9109245), which is a continuation-in-part of US application 12/765,714 (filed 4/22/2010; now abandoned), which claims benefit of US provisional application 61/151,759 (filed 4/22/2009).
Applicants have not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 USC 120 because the later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original non-provisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of pre-AIA USC 112 first paragraph, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc, 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The first disclosure of a medium comprising GlutaMAX™-1 is found in prior-filed application 13/761078 (the disclosure of 13/761078, PCT/US2014/015156, 14/807348, 15/967418, 17/127221 and the instant application are identical). For the reasons discussed above, it is accepted that, at least as of 2013, the filing date of the ‘078 application (the first disclosure of medium comprising GlutaMAX™-1 in the context of the instant claims) GlutaMAX™-1 was well-known to the skilled artisan as comprising L-alanyl-L-glutamine.
However, neither of prior-filed applications 12/765714 nor 61/151759 teach inclusion of L-alanyl-L-glutamine or GlutaMAX™-1. Therefore, the effective filing date of claims 1-12 is the filing date of the 13/761078 application: 2/6/2013.
Claim Interpretation
Claim 1 is directed to a device comprising a semi-permeable membrane encapsulating an in vitro mammalian pancreatic progenitor cell population in a medium. The claim further defines the pancreatic progenitor cell population as comprising endocrine and non-endocrine cell subpopulations, wherein at least 5% of the pancreatic progenitor cells is the non-endocrine cell subpopulation. The claim further defines the medium as being capable of supporting differentiation of the mammalian pancreatic progenitor cells and comprises L-alanyl-L-glutamine. Overall, the claim is interpreted as being a composition which requires 3 components: (1) a semi-permeable membrane, (2) a heterogeneous pancreatic progenitor cell population comprising a subpopulation of [pancreatic progenitor] endocrine cells and a subpopulation of [pancreatic progenitor] non-endocrine cells, and (3) a medium capable of supporting differentiation of the pancreatic progenitor cell population, said medium comprising L-alanyl-L-glutamine.
Regarding (1): The semi-permeable membrane encapsulates the (2) cell population and (3) medium.
Regarding (2): “Pancreatic progenitor cell population” is interpreted as limiting to only those progenitor or precursor cells committed to the pancreatic lineage. Thus, the instant claims are hereby interpreted as being limited to cells committed to the pancreatic lineage, such as pancreatic endoderm cells, and pancreatic endocrine cells which are not yet terminally differentiated, but do not include pluripotent or multipotent stem cells, definitive endoderm cells, PDX1-negative foregut endoderm cells, or PDX1-positive foregut endoderm cells (as these cells are not yet committed to pancreatic lineage). The current claimed cell population must include at least one progenitor endocrine cell of the pancreatic lineage (e.g. pancreatic endocrine cells), and at least one progenitor non-endocrine cell of the pancreatic lineage (e.g. pancreatic endoderm cells). The claim further requires that at least 5% of the pancreatic progenitor cell population is the non-endocrine cell subpopulation.
Regarding (3): Because no explicit definition for medium is provided in the specification, the term is being interpreted as including any culture medium, as well as any liquid or non-liquid material which can serve as a vehicle for cells. However, it is required that the medium capable of supporting differentiation of the mammalian pancreatic progenitor cells and comprise L-alanyl-L-glutamine. Any amount of L-alanyl-L-glutamine will be considered to meet the claim limitation.
Claim 2 requires the mammalian pancreatic progenitor cell population is "derived from pluripotent mammalian stem cells". The source of the cells is a product-by-process limitation. Product-by-process limitations are considered only insofar as the process steps impart structural distinction to the final product. In the instant case, the source of the cells being ‘derived from pluripotent mammalian stem cells’ is not found to significantly distinguish the structure of the final cell from a cell of the same phenotype derived by any other method (i.e. transdifferentiated from a different cell type). Cell types are defined by their phenotype. Absent evidence that the source of the cell imparts a phenotypical difference to the final cell phenotype, the same cell from any source will be considered the same.
Claim 7 further defines the pluripotent mammalian stem cells described in claim 2 as human pluripotent stem cells. Claim 7 is thus understood to limit the pancreatic progenitor cells to be human pancreatic progenitor cells.
Claim 9 is directed to a method for producing insulin in vivo, comprising implanting the device of claim 1 into a mammal. The second step of the claim refers to “the in vitro mammalian pancreatic cell population” is understood to be referring to the mammalian pancreatic progenitor cells present in the device of claim 1, which was initially generated in vitro/ex vivo. The maturing step does not require any active steps. According to the current disclosure, the in vitro mammalian pancreatic progenitor cell population will inherently mature in vivo upon implantation into a mammalian host.
Specification
The use of the term GlutaMax, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
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 USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The 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/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11905530.
Although the claims at issue are not identical, they are not patentably distinct from each other because the patented claims anticipate the instant claims.
Regarding claim 1: Patent claim 1 anticipates instant claim 1, noting that the patent claim requires at least 30% non-endocrine cells, which is narrower than the current claim only requiring at least 5%.
Regarding claims 2 and 7: Patent claim 10 anticipates instant claims 2 and 7.
Regarding claims 3-5: Patent claims 4-6 anticipate claims 3-5, respectively.
Regarding claim 6: Patent claim 8 anticipates claim 6.
Regarding claim 8: Patent claim 11 anticipates claim 8.
Regarding claims 9-12: Patent claims 12-15 anticipate claims 9-12, respectively.
Claims 1-5, 7 and 8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9982235.
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patented claims.
Regarding claim 1: The ‘235 patent discloses “Stage 4” human pancreatic progenitor cell population, which is a cell composition comprising endocrine cell and non-endocrine cell subpopulations in a medium, wherein at least 30% of the cell population is the non-endocrine cell subpopulation (See claim 1). The ‘235 patent teaches the above described cell population and medium encapsulated in a semi-permeable device comprising a semi-permeable membrane (See claim 8). The claims do not describe the full content of the medium. While the claims do not recite the full media composition, Table 7 within the specification of the ‘235 patent discloses the exact medium used: said medium comprises GlutaMAX-1, which contains L-alanyl-L-glutamine. It is permissible to read an exemplified embodiment of the claimed invention into the claims. Thus, the patented claims at least render obvious the instant claim.
Regarding claims 2-5, 7 and 8: The cells of the patented composition are identical to those currently claimed.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 9982235, and further in view of Martinson (US 2010/0124564).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are obvious over the patented claims.
Claims 1-5, 7 and 8 are obvious for the reasons set forth above.
Regarding claim 6: The patented claims do not expand on the construction of the encapsulation device; however as of the effective filing date of the instant application, Martinson taught a semi-permeable encapsulation device specifically intended for implantation of the same types of cells claimed by US Patent 9982235. The encapsulation device of Martinson is illustrated in the figures. As shown in Fig. 2, the device can have multiple ports (5).
It would have been prima facie obvious to have used the encapsulation device of Martinson for the encapsulation device recited in the claims of the ‘235 patent because it has appropriate structure and is specifically designed to hold pancreatic progenitor cells for implantation into a subject.
Relevant Prior Art
The prior art does not teach or suggest an in vitro pancreatic progenitor cell population comprising an endocrine cell subpopulation and a non-endocrine cell subpopulation, wherein at least 5% of the pancreatic progenitor cell population is the non-endocrine cell subpopulation, in a medium comprising L-alanyl-L-glutamine.
The closest prior art is considered to be the pancreatic endocrine aggregates of Kroon et al (Nature Biotechnology, 2008) or the Stage 4 PEC aggregates created in D’Amour et al (US Patent 8129182); however, neither of these references teach or suggest the presence of L-alanyl-L-glutamine within the cultures/aggregates.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Christopher Babic can be reached on 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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