DETAILED ACTION
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 .
Claim Status
Applicant’s submission filed 06/29/2026 has been received and entered. Claim 6 has been cancelled. Claims 1 and 13 have been amended. Claims 7-12 and 14 remain withdrawn as being directed to non-elected inventions. Accordingly, claims 1-5 and 13 are pending and under current examination.
Status of Prior Rejections / Arguments to Arguments
The objection to title is maintained:
Applicant amends the title as “COMPOSITIONS INCLUDING A MATURATION AGENT AND USES THEREOF”, it is still not descriptive. The term “maturation agent”, under broadest reasonable interpretation (BRI), refers to any chemical substance, biological molecule, or functional tool that triggers, accelerates, or guides a system or organism into its fully developed, functional, or stable state, therefore is very broad. Title needs to be clearly indicative of the invention to which the claims are directed. A descriptive title such as “a maturation agent for producing an insulin-producing cell population” is recommended. The objection is maintained.
The rejection to claims 1-2, 4-5 and 13 under 35 USC 102(a)(1) and 102 (a)(2) over Yoshijiro et al., as evidenced by Ganesh et al. and Ojima is withdrawn:
Applicant’s amendment to claim 1 adds the limitation “the pancreatic endocrine progenitor cell population and/or the cell population at a later stage of differentiation to be treated is a cell population produced by the induction of differentiation from pluripotent stem cells”. Yoshihiro et al. do not specifically teach this limitation. Therefore, the amendment is effective to obviate the rejection on record. The rejection is withdrawn.
The rejection to claims 1-5 and 13 under 35 USC 103 over Yoshijiro et al., as evidenced by Ganesh et al. and Ojima, in view of Resman et al. is maintained:
Applicant has traversed the rejection, asserting that the "pancreatic stem-like cells" disclosed in Yoshihiro are distinct from the "pancreatic endocrine progenitor cells" of the instant application, i.e., the "pancreatic endocrine progenitor cells" in instant application are derived by inducing differentiation of pluripotent stem cells; and are characterized by the expression of at least one of Chromogranin A (CHGA), NeuroD, and NGN3, while Yoshihiro does not teach such cells (Remarks, p7-8). Moreover, since Yoshihiro does not disclose the pancreatic endocrine progenitor cells described in the instant application, a person of ordinary skill in the art would not have had any motivation to select the pancreatic endocrine progenitor cells disclosed in Rezania as the target cells to be treated in the method disclosed in Yoshihiro (remarks, p8-9).
Applicant’s argument is fully considered but not found persuasive. Specifically, Applicant argues that Yoshihiro et al. do not teach the pancreatic stem-like cells that express at least one of Chromogranin A (CHGA), NeuroD, and NGN3. However, these limitations are not recited in instant claims. Applicant is reminded that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Moreover, Applicant argues Yoshihiro et al. do not teach the pancreatic stem-like cells are derived by inducing differentiation pluripotent stem cells. However, Yoshihiro et al. teach a method for inducing differentiation of pancreatic stem-like cells, and the pancreatic stem-like cell refers to a stem cell having the ability to differentiate into a cell that forms the pancreas (parag 0019), since the “pancreatic endocrine progenitor cells” as recited in instant claims have the ability to differentiate into a cell that forms the pancreas, such cells are included in the pancreatic stem-like cells as taught by Yoshihiro et al.. Yoshihiro et al. do not specifically teach producing pancreatic endocrine progenitor cell population by the induction of differentiation from pluripotent stem cells. However, Rezania et al. teach differentiation protocol which converts hESCs into insulin-producing cells (figure 1, p1122). In step 5, pancreatic endocrine precursors are produced by undifferentiated pluripotent stem cells. Given that Yoshihiro et al. teach the pancreatic stem-like cells which can be used in the method include any stem cells having the ability to differentiate into cells that form the pancreas (parag 0019), one of ordinary skill in the art would have substituted such pancreatic stem-like cells for pancreatic endocrine progenitor cell population which is produced by the induction of differentiation from pluripotent stem cells, depends on their research interests or preference. The rejection is maintained in modified form to address amended limitations.
Modified Rejections
Modified Objection to Title
The title is objected to because the title of the invention (COMPOSITIONS INCLUDING A MATURATION AGENT AND USES THEREOF) is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
Claim Interpretation
Claims 1 and 13 recite “a cell population at a later stage of differentiation”. The Specification (see [0046]) provides the definition of the phrase, which means a cell population richer in cells whose stage of differentiation is more advanced than that of pancreatic endocrine progenitor cells, as compared with a pancreatic endocrine progenitor cell population. Examples of "cells whose stage of differentiation more advanced than that of pancreatic endocrine progenitor cells" include insulin-producing cells. The claims are interpreted in light of this definition presented in the Specification.
Modified Claim Rejections - 35 USC § 103
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 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.
Claims 1-2, 4-5 and 13 stand rejected under 35 U.S.C. 103 as being unpatentable over Yoshihiro et al. (JP 2004121165 A, cited in IDS), as evidenced by Ganesh et al. (J Med Chem. 2007 Feb 22;50(4):713-25) and Ojima (J Fluor Chem. 2017 Jun;198:10-23), in view of Rezania et al. (Nat Biotechnol. 2014 Nov;32(11):1121-33, cited in IDS). The rejection is modified as necessitated by Applicant’s amendment.
Yoshihiro et al. teach a method for inducing differentiation of pancreatic stem-like cells into insulin-producing cells, a method for screening a pancreatic stem-like cell differentiation inducer, and a pancreatic stem-like cell differentiation inducer obtained by the screening (parag 0001).
Regarding claim 1, the preamble “producing an insulin-producing cell population” is considered as intend use. MPEP 2111.02 states “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation to be given patentable weight and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Besides, Yoshihiro et al. teach a method for inducing differentiation of pancreatic stem-like cells into insulin-producing cells (parag 0001), reads on “a method for producing an insulin-producing cell population” in instant claim. Yoshihiro et al. teach the pancreatic stem-like cell refers to a stem cell having the ability to differentiate into a cell that forms the pancreas (parag 0019). Given that a pancreatic endocrine progenitor cell has ability to differentiate into a cell that forms the pancreas, the pancreatic endocrine progenitor cell is considered as one type of pancreatic stem-like cells. Yoshihiro et al. teach a method for inducing differentiation of a pancreatic stem-like cell into an insulin-producing cell, comprising culturing the pancreatic stem-like cell in a medium supplemented with at least one compound selected from the group consisting of a non-protein receptor agonist, a non-protein receptor antagonist, and an analog thereof. A non-protein receptor antagonist, and an analog thereof is paclitaxel (parag 0015). Cells were differentiated into insulin-producing cells by paclitaxel (parag 0049). Paclitaxel is a compound having tubulin polymerization-promoting activity, which is evidenced by Ganesh et al.. Ganesh et al. teach the important anticancer drug paclitaxel binds to the β-subunit of the αβ-tubulin dimer in the microtubule in a stoichiometric ratio, promoting microtubule polymerization and stability (Abstract).
Yoshihiro et al. do not teach the cells are produced by the induction of differentiation from pluripotent stem cells. However, such was disclosed by Rezania et al. at the time of instant invention.
Rezania et al. teach a seven-stage protocol that efficiently converts hESCs into insulin-producing cells (Abstract).
Regarding claim 6, Rezania et al. teach differentiation protocol which converts hESCs into insulin-producing cells (figure 1, p1122). In step 5, pancreatic endocrine precursors are produced by undifferentiated pluripotent stem cells (also see online methods part).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yoshihiro et al.’s method for inducing differentiation of a pancreatic stem-like cell into an insulin-producing cell, and use pancreatic endocrine progenitor cell population as starting cell population which is produced by the method taught by Rezania et al.. The only difference between instant claim and Yoshihiro et al.’s method is instant claim uses pancreatic endocrine progenitor cell population which is produced by the induction of differentiation from pluripotent stem cells. Given that Yoshihiro et al. teach the pancreatic stem-like cells which can be used in the method include any stem cells having the ability to differentiate into cells that form the pancreas (parag 0019), one of ordinary skill in the art would have substituted any other pancreatic stem-like cells for pancreatic endocrine progenitor cell population which can be produced by the induction of differentiation from pluripotent stem cells, depends on their research interests or preference. This simple substitution of one known element (pancreatic endocrine progenitor cell population which is produced by the induction of differentiation from pluripotent stem cells) for another known element (any other pancreatic stem-like cells) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.).
Regarding claim 2, following the discussion above, Yoshihiro et al. teach a method for inducing differentiation of a pancreatic stem-like cell into an insulin-producing cell, comprising culturing the pancreatic stem-like cell in a medium supplemented with at least one compound selected from the group consisting of a non-protein receptor agonist, a non-protein receptor antagonist, and an analog thereof. A non-protein receptor antagonist, and an analog thereof is paclitaxel (parag 0015). Paclitaxel is a taxoid anticancer agent, which is evidenced by Ojima. Ojima teaches paclitaxel (Taxol) and docetaxel
(a “taxoid”) are two of the most extensively used chemotherapeutic agents in clinic (p11, right column, also see Table 1 and 2, p14).
Regarding claims 4 and 5, since Yoshihiro et al. in view of Rezania et al. teach the same method as recited in instant claims, the product produced by the method is considered to be inherent. Under the principles of inherency, if a prior art device, in its normal and usual operation, would necessarily perform the method claimed, then the method claimed will be considered to be anticipated by the prior art device. When the prior art device is the same as a device described in the specification for carrying out the claimed method, it can be assumed the device will inherently perform the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). See MPEP 2112.02.
Regarding claim 13, the preamble “for removing non-endocrine cells” is considered as intend use. MPEP 2111.02 states “[i]f the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation to be given patentable weight and is of no significance to claim construction. Shoes by Firebug LLC v. Stride Rite Children’s Grp., LLC, 962 F.3d 1362, 2020 USPQ2d 10701 (Fed. Cir. 2020). Following the discussion above, Yoshihiro et al. teach a method comprising culturing the pancreatic stem-like cell in a medium supplemented with at least one compound selected from the group consisting of a non-protein receptor agonist, a non-protein receptor antagonist, and an analog thereof. A non-protein receptor antagonist, and an analog thereof is paclitaxel (parag 0015). Yoshihiro et al. also teach the pancreatic stem-like cell refers to a stem cell having the ability to differentiate into a cell that forms the pancreas (parag 0019). Given that a pancreatic endocrine progenitor cell has ability to differentiate into a cell that forms the pancreas, the pancreatic endocrine progenitor cell is considered as one type of pancreatic stem-like cell. In addition, as stated above, paclitaxel is a compound having tubulin polymerization-promoting activity, which is evidenced by Ganesh et al..
Yoshihiro et al. do not teach the pancreatic endocrine progenitor cell population is a cell population produced by the induction of differentiation from pluripotent stem cells. However, Rezania et al. teach differentiation protocol which converts hESCs into insulin-producing cells (figure 1, p1122). In step 5, pancreatic endocrine precursors are produced by undifferentiated pluripotent stem cells (also see online methods part).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yoshihiro et al.’s method of culturing a pancreatic stem-like cell into an insulin-producing cell, and use pancreatic endocrine progenitor cell population as starting cell population which is produced by the method taught by Rezania et al.. The only difference between instant claim and Yoshihiro et al.’s method is instant claim uses pancreatic endocrine progenitor cell population which is produced by the induction of differentiation from pluripotent stem cells. Given that Yoshihiro et al. teach the pancreatic stem-like cells which can be used in the method include any stem cells having the ability to differentiate into cells that form the pancreas (parag 0019), one of ordinary skill in the art would have substituted any other pancreatic stem-like cells for pancreatic endocrine progenitor cell population which can be produced by the induction of differentiation from pluripotent stem cells, depends on their research interests or preference. This simple substitution of one known element (pancreatic endocrine progenitor cell population which is produced by the induction of differentiation from pluripotent stem cells) for another known element (any other pancreatic stem-like cells) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.).
Claims 1-5 and 13 stand rejected under 35 U.S.C. 103 as being unpatentable over Yoshihiro et al. (JP 2004121165 A, cited in IDS), as evidenced by Ganesh et al. (J Med Chem. 2007 Feb 22;50(4):713-25) and Ojima (J Fluor Chem. 2017 Jun;198:10-23), in view of Rezania et al. (Nat Biotechnol. 2014 Nov;32(11):1121-33, cited in IDS), as applied to claims 1-2, 4-5 and 13 above, further in view of Resman et al. (FEBS Lett. 2008 Nov 26;582(28):3929-34). The rejection is modified as necessitated by Applicant’s amendment.
The teaching of Yoshihiro et al. and Rezania et al. is set forth above.
Regarding claim 3, Yoshihiro et al. do not teach using docetaxel or a pharmacologically acceptable salt thereof for the method for producing an insulin-producing cell population. However, it was disclosed by Resman et al. at the time of instant invention.
Resman et al. teach paclitaxel binds to human MD-2. The binding site of paclitaxel overlaps with the binding site of bis-ANS and LPS, which results in the ability of taxanes to inhibit LPS signaling in the system with human receptors. Circular dichroic spectra of human MD-2 indicated differences in the chemical environment in the presence of paclitaxel and docetaxel (Abstract).
Regarding claim 3, Resman et al. teach paclitaxel and docetaxel bind to the LPS receptor human MD-2 (p3930, figure 2), indicates that both paclitaxel and docetaxel are agents acting on the
LPS receptor.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Yoshihiro et al.’s method for inducing differentiation of a pancreatic stem-like cell into an insulin-producing cell using paclitaxel, and use docetaxel as taught by Resman et al.. The only difference between instant claim and Yoshihiro et al.’s method is instant claim uses docetaxel. Given that Yoshihiro et al. teach agent acting on the LPS receptor such as paclitaxel can be used in the method for inducing differentiation of a pancreatic stem-like cell into an insulin-producing cell (parag 0032), and Resman et al. teach both paclitaxel and docetaxel bind to the LPS receptor, one of ordinary skill in the art would have substituted paclitaxel, and use docetaxel instead, depends on their research interests or preference. This simple substitution of one known element (docetaxel) for another known element (paclitaxel) is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, USPQ2d 1385, 1395 — 97 (2007) (see MPEP § 2143, B.).
Conclusion
No claims are allowed.
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.
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/Q.G./Examiner, Art Unit 1633
/FEREYDOUN G SAJJADI/Supervisory Patent Examiner, Art Unit 1699
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