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 .
Applicant's amendments to the claims filed on 10-03-2025 have been received and entered. Claim 10 has been amended. Claims 1-11 are pending in the instant application.
Election/Restrictions
Applicant’s election of a species comprising FGF9 alone in the reply filed on 10-03-2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 3-8, 10-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected subject matter, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on.
Claims 1-2 and 9 are under consideration.
Priority
This application is a CON of 17/155,631 filed on 01/22/2021 which is now PAT 12060580. The application 17/155,631 is a DIV of 14/898,213 filed on 12/14/2015 which is now PAT 10900022. The application 14/898,213 is a 371 of PCT/AU2014/000608 filed on 06/13/2014. These applications claim priority from foreign applications AUSTRALIA 2013902215 filed on 06/14/2013 and AUSTRALIA 2013904580 filed on 11/27/2013. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 14898213, filed on 12/14/2015.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06-28-2024 are in compliance with the provisions of 37 CPR 1.97. Accordingly, the information disclosure statements have been considered by the examiner.
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 1-2, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 10,900,022 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the pending claims and the issued claims are drawn to a method of producing nephron progenitor cells and ureteric epithelial progenitor cells comprising contacting intermediate mesoderm (IM) cells with fibroblast growth factor 9 (FGF9) alone or in combination with one or more components selected from the group consisting of fibroblast growth factor 20 (FGF20), bone morphogenic protein 7 (BMP7), heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist. Issued claims 1-2 of U.S. Patent No. US 10,900,022 B2 anticipate claims 1-2, 9 of pending application.
Pending claim 1 is directed to a method of producing nephron progenitor cells and ureteric epithelial progenitor cells in vitro comprising contacting intermediate mesoderm (IM) cells with fibroblast growth factor 9 (FGF9) alone or in combination with one or more components selected from the group consisting of fibroblast growth factor 20 (FGF20), bone morphogenic protein 7 (BMP7), heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist, to thereby produce nephron progenitor cells and ureteric epithelial progenitor cells from the IM cells.
Issued claim 1 is directed to a method of producing nephron progenitor cells and ureteric epithelial progenitor cells comprising: (a) contacting posterior primitive streak cells with fibroblast growth factor 9 (FGF9) or FGF9 in combination with at least one of fibroblast growth factor 2 (FGF2) and fibroblast growth factor 20 (FGF20); (b) culturing the contacted posterior primitive streak cells for a period of time sufficient for the contacted posterior primitive streak cells to differentiate into intermediate mesoderm (IM) cells; (c) contacting the IM cells with: FGF9 and/or FGF20· and optionally, one or more selected from the group consisting of: bone morphogenic protein 7 (BMP7); heparin; a Wnt agonist; retinoic acid (RA), analog or agonist; and an RA antagonist; and (d) culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells.
Therefore, step (c)-(d) of the issued claim 1 of U.S. Patent No. US 10,900,022 B2 anticipate instant claim 1 because they require contacting intermediate mesoderm (IM) cells with FGF9 or FGF9 in combination with one or more components selected from the group consisting of FGF20, BMP7, heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells.
Pending claim 2 is directed to wherein the FGF9 is present at a concentration in the range of about 20 ng to 1 µg/mL .
Issued claim 2 is directed to wherein FGF9 and/or FGF20 is at a concentration in the range of 20 ng to 1 µg/mL; wherein BMP7 is present at a concentration in the range of 25 to 75 ng/ml; wherein RA, analog or agonist is present at a concentration in the range of 10 pM to 1 µM; wherein the RA antagonist is present at a concentration in the range of 0.50 pM to 10 µM; and wherein the Wnt agonist is present at a concentration in the range of 0.1 µM to 10 µM.
Therefore, issued claim 2 of U.S. Patent No. US 10,900,022 B2 anticipate instant claim 2 because the issued claim 2 requires FGF9 is at a concentration in the range of about 20 ng to 1 µg/ml.
Pending claim 9 is directed to wherein the IM cells are contacted with the FGF9 alone or in combination with one or more of the FGF20, BMP7, heparin, Wnt agonist, RA, and RA antagonist for a period of about 72-360 hours.
Issued claim 1 recites “……(c) contacting the IM cells with: FGF9 and/or FGF20· and optionally, one or more selected from the group consisting of: bone morphogenic protein 7 (BMP7); heparin; a Wnt agonist; retinoic acid (RA), analog or agonist; and an RA antagonist; and (d) culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells.”
Therefore, the issued claim 1 requires contacting the intermediate mesoderm (IM) cells with FGF9 or FGF9 in combination with one or more components selected from the group consisting of FGF20, BMP7, heparin, Wnt agonist, RA, and RA antagonist and culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells. Although the issued claims do not specify a time range such as 72-360 hours for the contacting step in steps (c)-(d) of issued claim 1, the issued claim 1 requires “culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells”. Thus, according to the issued claim 1, contacting time for the intermediate mesoderm (IM) cells with FGF9 was recognized to be a result-effective variable, and it would have been prima facie obvious for a person of ordinary skill in the art to contact IM cells with FGF9 for a period of time sufficient for differentiation such as 72-360 hours.
Claims 1-2, 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. US 12,060,580 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because both the pending claims and the issued claims are drawn to a method of producing nephron progenitor cells and ureteric epithelial progenitor cells comprising contacting intermediate mesoderm (IM) cells with fibroblast growth factor 9 (FGF9) alone or in combination with one or more components selected from the group consisting of fibroblast growth factor 20 (FGF20), bone morphogenic protein 7 (BMP7), heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist. Issued claims 1-2 of U.S. Patent No. US 12,060,580 B2 anticipate claims 1-2, 9 of pending application.
Pending claim 1 is directed to a method of producing nephron progenitor cells and ureteric epithelial progenitor cells in vitro comprising contacting intermediate mesoderm (IM) cells with fibroblast growth factor 9 (FGF9) alone or in combination with one or more components selected from the group consisting of fibroblast growth factor 20 (FGF20), bone morphogenic protein 7 (BMP7), heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist, to thereby produce nephron progenitor cells and ureteric epithelial progenitor cells from the IM cells.
Issued claim 1 recites “A method of determining the nephrotoxicity of one or a plurality of compounds, comprising: (a) producing nephron progenitor cells and ureteric epithelial progenitor cells comprising: (i) contacting posterior primitive streak cells with fibroblast growth factor 9 (FGF9) or FGF9 in combination with at least one of fibroblast growth factor 2 (FGF2) and fibroblast growth factor 20 (FGF20); (ii) culturing the contacted posterior primitive streak cells for a period of time sufficient for the contacted posterior primitive streak cells to differentiate into intermediate mesoderm (IM) cells; (iii) contacting the IM cells with: FGF9 and/or FGF20; and optionally, one or more selected from the group
consisting of: bone morphogenic protein 7 (BMP7); heparin; a Wnt (Wingless-related integration site)
agonist; retinoic acid (RA), analog or agonist; and an RA antagonist; and (iv) culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells; ……”
Therefore, steps ((a)(iii) - (a)(iv) of the issued claim 1 of U.S. Patent No. US 12,060,580 B2 anticipate instant claim 1 because in order to practice “a method of determining the nephrotoxicity of one or a plurality of compounds” as recited in the issued claim 1, the issued claims require producing nephron progenitor cells and ureteric epithelial progenitor cells as recited in steps ((a)(iii) - (a)(iv) of the issued claim 1: they require contacting intermediate mesoderm (IM) cells with FGF9 or FGF9 in combination with one or more components selected from the group consisting of FGF20, BMP7, heparin, a Wnt agonist, retinoic acid (RA), and an RA antagonist for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells.
Pending claim 2 is directed to wherein the FGF9 is present at a concentration in the range of about 20 ng to 1 µg/mL .
Issued claim 2 is directed to wherein FGF9 and/or FGF20 is at a concentration in the range of 20 ng to 1 µg/mL; wherein BMP7 is present at a concentration in the range of 25 to 75 ng/ml; wherein RA, analog or agonist is present at a concentration in the range of 10 pM to 1 µM; wherein the RA antagonist is present at a concentration in the range of 0.50 pM to 10 µM; and wherein the Wnt agonist is present at a concentration in the range of 0.1 µM to 10 µM.
Therefore, issued claim 2 of U.S. Patent No. US 12,060,580 B2 anticipate instant claim 2 because issued claim 2 requires FGF9 is at a concentration in the range of about 20 ng to 1 µg/ml.
Pending claim 9 is directed to wherein the IM cells are contacted with the FGF9 alone or in combination with one or more of the FGF20, BMP7, heparin, Wnt agonist, RA, and RA antagonist for a period of about 72-360 hours.
Issued claim 1 recites “……(iii) contacting the IM cells with: FGF9 and/or FGF20· and optionally, one or more selected from the group consisting of: bone morphogenic protein 7 (BMP7); heparin; a Wnt agonist; retinoic acid (RA), analog or agonist; and an RA antagonist; and (iv) culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells.”
Therefore, the issued claim 1 requires contacting the intermediate mesoderm (IM) cells with FGF9 or FGF9 in combination with one or more components selected from the group consisting of FGF20, BMP7, heparin, Wnt agonist, RA, and RA antagonist and culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells. Although the issued claims do not specify a time range such as 72-360 hours for the contacting step in steps (c)-(d) of issued claim 1, the issued claim 1 requires “culturing the contacted IM cells for a period of time sufficient for the contacted IM cells to differentiate into nephron progenitor cells and ureteric epithelial progenitor cells”. Thus, according to the issued claim 1, contacting time for the intermediate mesoderm (IM) cells with FGF9 was recognized to be a result-effective variable, and it would have been prima facie obvious for a person of ordinary skill in the art to contact IM cells with FGF9 for a period of time sufficient for differentiation such as 72-360 hours.
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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 is rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Osafune et al (Pub. No.: US 2016/0137985 A1, Foreign Application Priority Data: Jun. 11, 2013 (JP) 2013-123072) as evidenced by Little et al (WO 2005/075636 A1, published 8-18-2005, applicant own work).
Regarding to claim 1, Osafune et al teach a method for producing renal progenitor cells from intermediate mesoderm cells, which comprises a step of culturing intermediate mesoderm cells in a medium (Abstract), and that it is possible to induce differentiation of intermediate mesoderm cells into renal progenitor cells by culturing the intermediate mesoderm cells in a medium containing TGFβ signaling activator and BMP inhibitor ([0014], page 1). The renal progenitor cells are cells that can be handled as cells equivalent to nephron progenitor cells ([0037], page 4).
As evidenced by Little et al, the intermediate mesoderm differentiates into two populations of cells, the epithelial progenitor cells of ureteric bud (ureteric epithelial progenitor cells) and the meta-nephric mesenchyme which is also known as the renal progenitor population (the nephron progenitor cells) (Page 1 lines 22-31, Page 34 lines 17-19 and Page 42 lines 9-11).
Osafune et al teach “in the step of culturing intermediate mesoderm cells in the invention, any one of or any combination of FGF9, FGF20, BMP7, a retinoic acid derivative, and a GSK-3β inhibitor may be added to a basal medium” ([0047], page 5).
Thus, claim 1 is anticipated by Osafune et al.
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 2, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Osafune et al (Pub. No.: US 2016/0137985 A1, Foreign Application Priority Data: Jun. 11, 2013 (JP) 2013-123072) as evidenced by Little et al (WO 2005/075636 A1, published 8-18-2005, applicant own work) in view of Barak et al. (Developmental Cell 22, 1191–1207, June 12, 2012, DOI 10.1016/j.devcel.2012.04.018).
The teachings of Osafune et al and Little et al above are incorporated herein in their entirety.
The above references do not specify FGF9 concentration and period of about 72-360 hours. Barak et al cure the deficiency.
Regarding to claim 2, Barak et al teach using 8.6 nM of FGF9 which is equal to 199.52 ng/ml as set forth below in the conversion (FGF9 has a MW of 23.2 kDa) (Page 1203 right column, 1st para).
Regarding to claim 9, Barak et al teach “The identification of the endogenous niche ligands (Fgf9 and Fgf20) and the demonstration that they can maintain purified progenitors for 5 days in vitro opens the possibility for long-term maintenance of self-renewing nephron progenitors in culture.” (Page 1203 left column, 3rd para).
Therefore, it would have been prima facie obvious for a person of ordinary skill in the art before the effective filing date of the rejected claims to combine the teachings of prior art to modify the method of Osafune et al by using 199.52 ng/ml of FGF9 for 5 days as taught by Barak et al as instantly claimed, with a reasonable expectation of success. Said modification amounting to combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to do so because Barak et al teach BMP7 synergizes with FGF9 to promote survival and competence of nephron progenitors (Page 1197 right column, last para. bridge page 1199), and “The addition of FGF9 and heparin improved both survival and proliferation (Figure 7C)” (Page 1197, right column, 1st para), and “Improved insight into the nephron progenitors and their environment may help maintain such cells for therapeutic purposes. Therefore, there is growing interest in understanding the mechanisms that regulate these cells during nephrogenesis” (pg. 1191 right column 1st para). One of ordinary skill in the art would have had a reasonable expectation of success in doing so because Barak et al were successful in generation of Nephron Progenitors using FGF9 with data and working examples.
Conclusion
No claim is allowed.
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/KHOA NHAT TRAN/Examiner, Art Unit 1632
/PETER PARAS JR/Supervisory Patent Examiner, Art Unit 1632