DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant’s submission filed on 11/18/2025 has been entered.
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 .
Status of the Claims
Claims 289 and 302-318 are pending (claim set as filed on 11/18/2025).
Priority
This application is a CON of PCT/US2020/039487 filed on 06/25/2020, which has a PRO 62/866,100 filed on 06/25/2019.
Withdrawal of Rejections
The response and amendments filed on 11/18/2025 are acknowledged. Any previously applied minor objections and/or minor rejections, not explicitly restated herein for brevity, have been withdrawn necessitated by Applicant’s formal corrections and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining if applicable, of the essential claim rejections are detailed below in the Examiner’s response to arguments section.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Maintained Rejections
Claim Rejections - 35 USC §103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 289, 308-312, and 314 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo (US 2009/0280096 A1) in view of Sabatini (WO 2018/089928 A1).
Kubo’s general disclosure relates to pancreatic endocrine precursor cells derived from pluripotent stem cells including embryonic stem cells and induced pluripotent stem cells (see abstract & ¶ [0002]).
Kubo discloses pancreatic endocrine progenitor cells can be used in screening protocols in the development of drugs to induce the generation of insulin secreting cells; in other cases, pancreatic endocrine progenitor cells can be used in the development of cell therapies in the treatment of diabetes (see ¶ [0004]). Kubo teaches “compositions comprising pancreatic endocrine progenitor cells produced by the methods of the invention. The invention also provides compositions comprising primitive beta-islet cells produced by the methods of the invention” (see ¶ [0030]-[0032] & [0141]-[0142]). Kubo teaches “The present invention relates, in part, to the transcriptional regulations that are critical to induce β-cell differentiation from ES cell-derived endoderm. For example, the combination of Pdx1 and Ngn3 induces pancreatic endocrine genes as well as β-cell-related transcriptional factors such as Pax4, Pax6, Isll and Nkxx2.2. Other pancreas-related proteins such, as C-peptide and insulin, can be detected by immunohistochemistry in these cells. In addition, these cells process and secrete insulin and respond to various insulin secretagogues” (see ¶ [0058], [0038], [0166]). Kubo teaches cell aggregates gene overexpression of Pax4, Nkx6.1 and Ngn3, which are all known to be important for β-cell specification. (see Figure 1 and 3, Table 2, ¶ [0160], [0153], [0148]).
However, Kubo does not teach: glutamate, acetate, β-hydroxybutarate, L-carnitine, taurine, formate, or biotin (claim 289); or wherein the zinc is in the form of ZnSO4 (claims 308-309); or a thyroid hormone signaling pathway activator of T3 (claims 312 and 314).
Sabatini’s general disclosure relates to cell culture media that are useful for in vitro culture of mammalian cells (see abstract).
Sabatini teaches “a basal culture medium, comprising: (a) at least 9 proteinogenic amino acids; (b) one or more vitamins; (c) one or more inorganic ions; (d) glucose; and (e) at least 10 small organic compounds selected from 4-hydroxyproline, acetylglycine, alpha-aminobutyrate, betaine, carnitine, citrulline, ornithine, taurine, 2-hydroxybutyrate, 3-hydroxybutyrate, acetate, citrate, formate, lactate, malonate, pyruvate, succinate, acetone, creatine, creatinine, glutathione, glycerol, urea, galactose, fructose, hypoxanthine, and uric acid” (see ¶ [0004], [0056]-[0057], & Table 2).
Regarding glutamate, Sabatini teaches “at least 9 proteinogenic amino acids comprise glycine, L-alanine, L-arginine, L-asparagine, L-aspartate, L-cysteine, L-glutamate, L-glutamine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, and L-cystine” (see ¶ [0008]).
Regarding biotin, Sabatini teaches “one or more vitamins comprise at least 8, 9, 10, or 11 of the following vitamins: D-biotin, choline, folic acid, myo-inositol, niacinamide, p-aminobenzoic acid, D-pantothenic acid, vitamin B6, riboflavin, thiamine, and vitamin B12” (see ¶ [0009]).
Regarding claims 308-309 pertaining to zinc, Sabatini teaches “one or more such trace metals may be included as a component of a basal medium or added to a basal medium or complete medium. Trace metals may be provided in a variety of forms, e.g., in the form of salts such as CuSO4, ZnSO4” (see ¶ [0097]).
Regarding claim 310 pertaining to human serum albumin, Sabatini teaches “a basal medium of the present disclosure supports proliferation of a wide range of mammalian cells when supplemented by serum, which serves as a source of supportive substances such as growth factors, hormones, and lipids. In some embodiments, bovine serum, e.g., fetal bovine serum or calf serum, may be used. Other serum sources include horse and human” (see ¶ [0073]-[0074]) and serum proteins (e.g., albumin, transferrin, insulin, growth factors) (see ¶ [0076]).
Regarding claims 312 and 314 pertaining to a thyroid hormone signaling pathway activator, Sabatini teaches “any one or more of the following hormones: cortisol, estrogen, growth hormone, insulin, progesterone, testosterone, and triiodothyronine (T3). In some embodiments, one or more hormones may be added to a basal medium or complete medium” (see ¶ [00105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use or employ the cell culture media and components thereof such as taught by Sabatini in the teachings of Kubo. The ordinary artisan would have been motivated to do so because Kubo is directed to methods of producing pancreatic endocrine progenitor cells for generation of insulin secreting cells which can be used for cell therapies including the treatment of diabetes wherein Sabatini’s cell culture media allow for in vitro culture of mammalian cells. The MPEP 2141 provides “examples of rationales that may support a conclusion of obviousness include: (a) combining prior art elements according to known methods to yield predictable results; (b) simple substitution of one known element for another to obtain predictable results … (e) obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Thus, the combination of the cited references would have been readily predictable to one of ordinary skill in the art as the claimed ingredient or components are considered well-known and routine in the cell cultivation arts.
Regarding claims 310-311 pertaining to the dissociated cell form and concentrations, Kubo teaches “methods of producing primitive beta-islet cells from pluripotent stem cells comprising the steps of (a) preparing embryonic bodies (EB) from the pluripotent stem cell modified to overexpress Pdx1, Ngn3 and MafA under the control of inducible promoters, (b) dissociating the cells and incubating the cells in the presence of activin A on about day 2, (c) dissociating the cells and inducing expression of Pdx1 and Ngn3 starting about day 4-day 6, (d) inducing expression of MafA, (e) plating the cells on low attachment plates about day 6-day 9, and (f) culturing the cells for sufficient time to identify primitive beta-islet cells” (see ¶ [0021]-[0026]). The MPEP 2144.05(II)(A) states that “Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation”. To one of ordinary skill in the art, dissociation allows for isolation of target cells and thus, absent showing of criticality, the concentration or percentage of cell clusters is within the purview of the ordinary artisan to determine optimal concentration for cell culture.
Claims 302-307 and 312-318 are rejected under 35 U.S.C. 103 as being unpatentable over Kubo in view of Sabatini as applied to the claims above, and in further view of Schmidt (US 2018/0263995 A1) - all references previously cited.
The combined disclosures of Kubo and Sabatini, herein referred to as modified-Kubo-Sabatini, is discussed above as it pertains to a composition comprising a plurality of dissociated insulin-positive endocrine progenitor cells and one or more of glutamate, acetate, β-hydroxybutarate, carnitine, formate, or biotin.
However, modified-Kubo-Sabatini does not teach: LDN193189 (claims 302-303); or Y-27632 (claims 304-305); or 3-deazaneplanocin (claims 306-307); or staurosporine or GW788388 (claims 312-313 and 316-317).
Schmidt’s general disclosure relates to chemical differentiation of pluripotent stem cells and differentiation medium components (see ¶ [0141], [0143]).
Schmidt teaches “a ROCK inhibitor may be present in the differentiation medium. The ROCK inhibitor may reduce apoptosis at low cell densities. In some cases, the concentration of the ROCK inhibitor, such as GSK429286A, Y-27632, LX7101, SAR407899, AT13148, GSK269962A, SR3677, RKI-1447, TTP 22, SLx-2119, Chroman 1, Y-33075 or Fasudil” (see ¶ [0146], [0156]) and staurosporin (see ¶ [0157]). Schmidt teaches “compounds that target known/suspected epigenetic modifying enzymes as well as many additional targets, pathways, and networks, including but not limited to kinome, Wnt/Fzd/b-catenin, apoptosis, cytoskeletal signaling, cell cycle, DNA repair, and G-protein coupled receptor were assembled into libraries” (see ¶ [0305]) and further teaches thiazovivin, GW788388, 3-Deazaneplanocin A, LDN193189 (see Table 4).
Regarding claim 315, Schmidt teaches cells may be frozen and thawed (see ¶ [0306] & Examples).
It would have been obvious to one of ordinary skill in the art to select or employ the claimed media components such as taught by Schmidt for the composition of modified-Kubo-Sabatini. The ordinary artisan would have been motivated to do so because the claimed components are already known in the art as differentiation ingredients. The MPEP 2141 provides “examples of rationales that may support a conclusion of obviousness include: (a) combining prior art elements according to known methods to yield predictable results; (b) simple substitution of one known element for another to obtain predictable results … (e) obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Thus, the combination of the cited references would have been readily predictable to one of ordinary skill in the art as the claimed ingredient or components are considered well-known and routine in the cell cultivation arts. The ordinary artisan would have had a reasonable expectation of success because both modified-Kubo-Sabatini and Schmidt are directed to differentiation culture media for culturing mammalian cells.
Claims 289, 302-309, 312, and 314-315 are rejected under 35 U.S.C. 103 as being unpatentable over Chandra (Islet-Like Cell Aggregates Generated from Human Adipose Tissue Derived Stem Cells Ameliorate Experimental Diabetes in Mice, 2011) in view of Sabatini (WO 2018/089928 A1) - previously cited references.
Chandra’s general disclosure relates to stem cell therapy for transplantation in diabetes mellitus patients (see abstract & page 1: Introduction). In particular, Chandra teaches the potential of human adipose stem cells to differentiate into functional islet cells with stage specific differentiation conditions (see page 2, left col.).
Regarding claim 289, Chandra teaches pancreatic endoderm differentiation where the islet cells were exposed to a serum-free media supplemented with taurine, a non-essential amino acid involved in the development of pancreatic β-cells (see page 2, right col. & see page 9: Materials and Methods). A significant up regulation in the expression of pancreatic endoderm markers as well as key transcription factors involved in pancreas development like PDX-1, Ngn3, NeuroD, Pax-4, Nkx2.2, Nkx6.1, Pax-6, Isl-1 and glucose transporter Glut-2 were observed (see page 4, left col. & see Figure 5 of pancreatic progenitor specific transcription factors). Chandra teaches the islet like cell aggregates are shown to produce human C-peptide in a glucose dependent manner exhibiting in-vitro functionality (see abstract & page 5).
Regarding claim 315, Chandra teaches tissue cells samples were frozen in Trizol and thawed for 30 mins at room temperature (see page 10, left col.).
However, Chandra does not teach: glutamate, acetate, β-hydroxybutarate, L-carnitine, taurine, formate, or biotin (claim 289); or wherein the zinc is in the form of ZnSO4 (claims 308-309); or a thyroid hormone signaling pathway activator of T3 (claims 312 and 314).
Sabatini’s general disclosure relates to cell culture media that are useful for in vitro culture of mammalian cells (see abstract).
Sabatini teaches “a basal culture medium, comprising: (a) at least 9 proteinogenic amino acids; (b) one or more vitamins; (c) one or more inorganic ions; (d) glucose; and (e) at least 10 small organic compounds selected from 4-hydroxyproline, acetylglycine, alpha-aminobutyrate, betaine, carnitine, citrulline, ornithine, taurine, 2-hydroxybutyrate, 3-hydroxybutyrate, acetate, citrate, formate, lactate, malonate, pyruvate, succinate, acetone, creatine, creatinine, glutathione, glycerol, urea, galactose, fructose, hypoxanthine, and uric acid” (see ¶ [0004], [0056]-[0057], & Table 2).
Regarding glutamate, Sabatini teaches “at least 9 proteinogenic amino acids comprise glycine, L-alanine, L-arginine, L-asparagine, L-aspartate, L-cysteine, L-glutamate, L-glutamine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, and L-cystine” (see ¶ [0008]).
Regarding biotin, Sabatini teaches “one or more vitamins comprise at least 8, 9, 10, or 11 of the following vitamins: D-biotin, choline, folic acid, myo-inositol, niacinamide, p-aminobenzoic acid, D-pantothenic acid, vitamin B6, riboflavin, thiamine, and vitamin B12” (see ¶ [0009]).
Regarding claims 308-309 pertaining to zinc, Sabatini teaches “one or more such trace metals may be included as a component of a basal medium or added to a basal medium or complete medium. Trace metals may be provided in a variety of forms, e.g., in the form of salts such as CuSO4, ZnSO4” (see ¶ [0097]).
Regarding claim 310 pertaining to human serum albumin, Sabatini teaches “a basal medium of the present disclosure supports proliferation of a wide range of mammalian cells when supplemented by serum, which serves as a source of supportive substances such as growth factors, hormones, and lipids. In some embodiments, bovine serum, e.g., fetal bovine serum or calf serum, may be used. Other serum sources include horse and human” (see ¶ [0073]-[0074]) and serum proteins (e.g., albumin, transferrin, insulin, growth factors) (see ¶ [0076]).
Regarding claims 312 and 314 pertaining to a thyroid hormone signaling pathway activator, Sabatini teaches “any one or more of the following hormones: cortisol, estrogen, growth hormone, insulin, progesterone, testosterone, and triiodothyronine (T3). In some embodiments, one or more hormones may be added to a basal medium or complete medium” (see ¶ [00105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use or employ the cell culture media and components thereof such as taught by Sabatini in the teachings of Chandra. The ordinary artisan would have been motivated to do so because Chandra is directed to adult stem cells (h-ASCs) to differentiate into functional islet like cell aggregates (ICAs) including the treatment of diabetes wherein Sabatini’s cell culture media allow for in vitro culture of mammalian cells. The MPEP 2141 provides “examples of rationales that may support a conclusion of obviousness include: (a) combining prior art elements according to known methods to yield predictable results; (b) simple substitution of one known element for another to obtain predictable results … (e) obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Thus, the combination of the cited references would have been readily predictable to one of ordinary skill in the art as the claimed ingredient or components are considered well-known and routine in the cell cultivation arts.
Claims 289, 302-305, and 308-314 are rejected under 35 U.S.C. 103 as being unpatentable over Poh (US 2020/0332262 A1) in view of Sabatini (WO 2018/089928 A1).
Poh’s general disclosure relates to cell clusters resembling the function and characteristics of endogenous pancreatic islets, and methods for making and using such cell clusters (see abstract & ¶ [0002]).
Poh teaches “an in vitro cell cluster comprising at least one non-native pancreatic β-cell that exhibits an in vitro glucose-stimulated insulin secretion response when exposed to a glucose challenge, wherein the cell cluster is an unsorted cell cluster, and wherein the cell cluster comprises: (a) at least about 35% cells that express NKX6.1 and C-peptide” (see ¶ [0003]-[0005]). Poh teaches a composition comprising at least one cell cluster as provided herein in a culture medium (see ¶ [0009]-[0010]).
Regarding claims 302-303, Poh teaches a culture medium comprising a bone morphogenic protein (BMP) signaling pathway inhibitor (see ¶ [0011]). The BMP signaling pathway inhibitor comprises LDN193189 (see ¶ [0166], [0171], [0192]-[0194]).
Regarding claims 304-305, Poh teaches the ROCK inhibitor comprises Thiazovivin, Y-27632, Fasudil/HA1077, or 14-1152 (see ¶ [0179]).
Regarding claim 308, Poh teaches zinc (see ¶ [0136]).
Regarding claims 312-314, Poh teaches the medium comprises a thyroid hormone signaling pathway activator and a transforming growth factor β (TGF-β) signaling pathway inhibitor such as Alk5 inhibitor (see ¶ [0125], [0074], [0136]).
However, Poh does not teach: glutamate, acetate, β-hydroxybutarate, L-carnitine, taurine, formate, and biotin (claim 289); or wherein the zinc is in the form of ZnSO4 (claim 309).
Sabatini’s general disclosure relates to cell culture media that are useful for in vitro culture of mammalian cells (see abstract).
Sabatini teaches “a basal culture medium, comprising: (a) at least 9 proteinogenic amino acids; (b) one or more vitamins; (c) one or more inorganic ions; (d) glucose; and (e) at least 10 small organic compounds selected from 4-hydroxyproline, acetylglycine, alpha-aminobutyrate, betaine, carnitine, citrulline, ornithine, taurine, 2-hydroxybutyrate, 3-hydroxybutyrate, acetate, citrate, formate, lactate, malonate, pyruvate, succinate, acetone, creatine, creatinine, glutathione, glycerol, urea, galactose, fructose, hypoxanthine, and uric acid” (see ¶ [0004], [0056]-[0057], & Table 2).
Regarding glutamate, Sabatini teaches “at least 9 proteinogenic amino acids comprise glycine, L-alanine, L-arginine, L-asparagine, L-aspartate, L-cysteine, L-glutamate, L-glutamine, L-histidine, L-isoleucine, L-leucine, L-lysine, L-methionine, L-phenylalanine, L-proline, L-serine, L-threonine, L-tryptophan, L-tyrosine, L-valine, and L-cystine” (see ¶ [0008]).
Regarding biotin, Sabatini teaches “one or more vitamins comprise at least 8, 9, 10, or 11 of the following vitamins: D-biotin, choline, folic acid, myo-inositol, niacinamide, p-aminobenzoic acid, D-pantothenic acid, vitamin B6, riboflavin, thiamine, and vitamin B12” (see ¶ [0009]).
Regarding claims 308-309 pertaining to zinc, Sabatini teaches “one or more such trace metals may be included as a component of a basal medium or added to a basal medium or complete medium. Trace metals may be provided in a variety of forms, e.g., in the form of salts such as CuSO4, ZnSO4” (see ¶ [0097]).
Regarding claim 310 pertaining to human serum albumin, Sabatini teaches “a basal medium of the present disclosure supports proliferation of a wide range of mammalian cells when supplemented by serum, which serves as a source of supportive substances such as growth factors, hormones, and lipids. In some embodiments, bovine serum, e.g., fetal bovine serum or calf serum, may be used. Other serum sources include horse and human” (see ¶ [0073]-[0074]) and serum proteins (e.g., albumin, transferrin, insulin, growth factors) (see ¶ [0076]).
Regarding claims 312 and 314 pertaining to a thyroid hormone signaling pathway activator, Sabatini teaches “any one or more of the following hormones: cortisol, estrogen, growth hormone, insulin, progesterone, testosterone, and triiodothyronine (T3). In some embodiments, one or more hormones may be added to a basal medium or complete medium” (see ¶ [00105]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use or employ the cell culture media and components thereof such as taught by Sabatini in the teachings of Poh. The ordinary artisan would have been motivated to do so because Poh is directed to cell cluster pancreatic β-cell including the treatment of diabetes wherein Sabatini’s cell culture media allow for in vitro culture of mammalian cells. The MPEP 2141 provides “examples of rationales that may support a conclusion of obviousness include: (a) combining prior art elements according to known methods to yield predictable results; (b) simple substitution of one known element for another to obtain predictable results … (e) obvious to try - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success”. Thus, the combination of the cited references would have been readily predictable to one of ordinary skill in the art as the claimed ingredient or components are considered well-known and routine in the cell cultivation arts.
Examiner’s Response to Arguments
Applicant’s amendments and arguments filed on 11/18/2025 have been fully considered but they are not persuasive and deemed insufficient to overcome the prior arts of record.
In response to Applicant’s argument (addressing pages 6-7 of the remarks) that Sabatini’s media components are cell specific and cell-line dependent wherein Sabatini only tested cancer cells and thus, there is no reasonable expectation of success to combine with the Kubo reference: this argument is not persuasive because it is maintained that the Sabatini reference cannot be narrowly viewed. The guidelines for the determination of obviousness requires “Ascertaining the differences between the prior art and the claims at issue requires interpreting the claim language, and considering both the invention and the prior art references as a whole. In determining the differences between the prior art and the claims, the question under 35 U.S.C. 103 is not whether the differences themselves would have been obvious, but whether the claimed invention as a whole would have been obvious” (MPEP 2141.02). As a whole, Sabatini is directed to “cell culture media that are useful for in vitro culture of mammalian cells” (see Sabatini’s abstract and then see Sabatini’s claims 1-12 on pages 101-102 which does not limit to a particular cell line). Moreover, note that Sabatini discloses at ¶ [00169] and [00172]:
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The MPEP 2143.02(I) states that “Conclusive proof of efficacy is not required to show a reasonable expectation of success. To be clear, we do not hold today that efficacy data is always required for a reasonable expectation of success. Nor are we requiring ‘absolute predictability of success … reasoning that the expectation of success need only be reasonable, not absolute”. In other words, merely because Sabatini tested on cancer cells does not indicate it could not be extrapolated to other cell types as evident by Sabatini’s claim set.
In response to Applicant’s argument (addressing page 8 of the remarks) that “Specifically, Example 5 demonstrates that cells grown in media comprising glutamate, β-hydroxybutyrate, acetate, L-carnitine, taurine, formate, and biotin (termed "DS6" in Example 5 and the related figures) surprisingly had higher yield and smaller cluster size than the same cells grown in media lacking these metabolites”: this argument is not persuasive because the MPEP 716.02(d) states that “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of non-obviousness must be commensurate in scope with the claims which the evidence is offered to support. In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range”. Said differently, the instant claims are much broader than what is disclosed in Example 5 and thus, the unexpected results are not in commensurate in scope with the claims.
In response to Applicant’s argument (addressing page 9 of the remarks) that “Schmidt fails to disclose or suggest any composition that includes glutamate, β-hydroxybutyrate, L- carnitine, taurine, or biotin. Thus, Schmidt does not make up for the deficiencies of the combination of Kubo and Sabatini”: this argument is not persuasive because, as stated previously, Schmidt’s disclosure was primarily relied upon to address the specific components of LDN193189, Y-27632, 3-deazaneplanocin; staurosporine or GW788388. Thus, the combination of the cited references would have been readily predictable to one of ordinary skill in the art as the claimed ingredient or components are considered well-known and routine in the cell cultivation arts. The ordinary artisan would have had a reasonable expectation of success because both modified-Kubo-Sabatini and Schmidt are directed to differentiation culture media for culturing mammalian cells.
In response to Applicant’s argument (addressing pages 9-10 of the remarks) pertaining to the primary references of Chandra and Poh: these arguments are not persuasive for similar reasons stated above not repeated herein for brevity.
Maintained Rejections - Double Patenting
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 289 and 304-305 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over at least claims 3-4, 15, 20, 23-25, 27-30, and 33-34 of co-pending Application no. 18/270,314. Although the claims at issue are not identical, they are not patentably distinct from each other because co-pending ‘314 teaches “an in vitro composition comprising a plurality of PDX1-positive, NKX6.1-positive, insulin-negative cells, and one or more of acetate, 3-hydroxybutyrate, taurine, or formate” (see co-pending 314’s claims 3-4 and 15). Co-pending ‘314 also teaches a plurality of insulin-positive endocrine progenitor cells and glutamate or L-carnitine, β-hydroxybutyrate, biotin, (see co-pending 314’s claims 20, 23-25, 27-30 which would express C-peptide).
Regarding claims 304-305, Co-pending ‘314 also teaches the composition further comprises a ROCK inhibitor (see co-pending 314’s claims 33-34).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims were allowed.
Correspondence Information
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/NGHI V NGUYEN/Primary Examiner, Art Unit 1653