DETAILED ACTION
This action is in reply to papers filed 9/30/2025. Claims 1,4-7,10-12,20-21 and 39-48 are pending and examined herein.
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 .
Examiner’s Note
All paragraph numbers throughout this office action, unless otherwise noted, are from the US PGPub of this application US20250367238A1, Published 12/4/2025.
Information Disclosure Statement
Ref. 9 in IDS filed 3/17/2025 has not been considered as the citation is improper. There is no page number and/or volume number associated with the citation.
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 20-21, 39-43 and 46-48 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 is drawn to a method of identifying an enriched heterogeneous renal cell population as having a therapeutic potential, comprising: determining whether cells of the enriched heterogeneous renal cell population express: (i) NEPH1; and (ii) one or more markers, wherein the one or more markers comprises one or more of: lim homeobox protein I (LHXI), and fibroblast growth factor 8 (FGF8), receptor for activated C kinase I (RACKI) or rearranged during transfection (RET); and identifying the enriched heterogeneous renal cell population as having therapeutic potential if cells of the enriched heterogeneous renal cell population are determined to express: (i) NEPHI; and (ii) the one or more markers.
Dependent claim 20 recites, inter alia, “..wherein determining comprises determining percentage of cells of the enriched heterogeneous renal population that express NEPH1.” The metes and bounds of claim 20 are unclear. This is because the metes and bounds of the determining step in claim 1 are clear. That is, claim 1 makes clear that the determining step requires assessing whether the cells of the heterogenous renal cell population express NEPH1 or one or more markers listed in (ii). Therefore, it is unclear how one would determine in claim 20 when this step has already been performed in claim 1. Note that this analysis extends to claim 21 as it directly depends on claim 20.
Even further, the population of cells having been identified as having therapeutic potential has also been identified in claim 1~ identifying the enriched heterogeneous renal cell population as having therapeutic potential if cells of the enriched heterogeneous renal cell population are determined to express: (i) NEPHI; and (ii) the one or more markers . Therefore, the metes and bounds of claim 21 are unclear. Note that this analysis also extends to claim 39 as it recites, inter alia, “… formulating the enriched heterogeneous renal cell population, if identified as having a therapeutic potential, in a pharmaceutical composition.” Again, the end result of claim 1 is a population identified as having therapeutic potential (cells of the enriched heterogeneous renal cell population determined to express: (i) NEPHI; and (ii) the one or more markers). Dependent claims 40-43 are included in this rejection. Note that claim 46 recites “if” language, as well. Dependent claims 47-48 are included in this rejection.
Clarification is requested.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1,4-7,10-12,20-21 and 39-48 are rejected under 35 U.S.C. 103 as being unpatentable over Stavas et al. (Kidney Int Rep. 2022 Apr 21;7(7):1619–1629), Nishinakamura et al. (WO2019230737A1, Published 12/5/2019) and Ingber et al. (PgPub US20160143949A1, Published 5/26/2016).
Regarding claim 44-48, Stavas et al. teach chronic kidney disease (CKD) is a worldwide disease without cure. However, Stavas also notes that selected renal cells (SRCs) can augment kidney function in animal models. In this study, Stavas correlated the phenotypical characteristics of autologous homologous SRCs (also called Renal Autologous Cell Therapy [REACT]) injected into patients’ kidneys with advanced type 2 diabetes-related CKD (D-CKD) to clinical and laboratory findings. Stavas teaches analzying SRC protein expression, including SIX2, Osr1, RET(as in claim 1 (ii), claim 7, claim 10 (a), claim 11 (b) and claim 12), LHx1 (as in claim 4, claim 10(a), claim 11 (b) and claim 12), FGF8(as in claim 5 and claim 12), Rack1(as in claim 6, claim 11 (b) and claim 12), Nephrin (NPHS1), and Podocin (NPHS2) using FACS analysis (Pg. 1624). Stavas teaches SRCs were found to have cell markers of ureteric bud, mesenchyme cap, and podocyte sources and positive VEGF (Abstract). Stavas teaches the populations of SRCs contained cells responsible for nephrogenesis, and the markers analyzed represent the critical pathway for the development of the renal cortex, medullary interstitium, angioblasts, and mesangium (Table 4). Stavas teaches this data align with their hypothesis that any improved renal function resultant from REACT injections may be due to neo kidney-like tissue development, mirroring embryonic kidney development (Pg. 1625, Col. 2, last paragraph).
However, Stavas fails to teach the selected renal population expresses NEPH1 (as further in claim 1).
Before the effective filing date of the claimed invention, Nishinakamura et al. taught a method for inducing a glomerular podocytes in vitro. More specifically, Nishinakamura teaches the present invention provides a method for producing podocytes, whereby a cell population having a high composition ratio of podocytes can be obtained by selective induction of podocytes (Abstract). As shown in FIG. 20, under examination of morphological and functional characteristics of induced podocytes, it was confirmed that in induced podocytes, WT1 was expressed in the nucleus and NEPHERIN was expressed on the cell boundary. Other slit membrane-related proteins, NEPH1 and PODOCIN, were also localized with NEPHERIN (as further in claim 1).
However, neither Stavas et al. nor Nishinakamura et al. teach a temperature-sensitive cell stabilizing biomaterial (as further in 40).
Before the effective filing date of the claimed invention, Ingber teaches that for administration to a subject, a population of podocytes can be provided in any pharmaceutical composition. These pharmaceutical compositions can comprise a population of cells, formulated together with one or more pharmaceutically acceptable carriers (additives) and/or diluents (Pg. 22, para. 223).Ingber also teaches each carrier must be “acceptable” in the sense of being compatible with the other ingredients of the formulation and not injurious to the patient. Some examples of materials which can serve as pharmaceutically-acceptable carriers include gelatin (Pg. 22, para. 225) Ingber also teaches the podocytes can be placed in a freezing medium or a cryogenic storage medium (Pg. 25, para. 294).
The combination of prior art cited above in all rejections under 35 U.S.C.103 satisfies the factual inquiries as set forth in Graham v. John Deere Co., 383 U.S. 1,148 USPQ 459 (1966). Once this has been accomplished the holdings in KSR can be applied (KSR International Co. v. Teleflex Inc. (KSR), 550 U.S. 389, 82 USPQ2d 1385 (2007): "Exemplary 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; (C) Use of known technique to improve similar devices (methods, or products) in the same way; (D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results; (E) "Obvious to try" - choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success; (F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art; (G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
In the present situation, rationales A and G are applicable. Before the effective filing day of the claimed invention, it would have been prima facie obvious to an artisan of ordinary skill to combine the teachings of Stavas et al., wherein Stavas identified a population of selected renal cells responsible for nephrogenesis and having cell markers of, inter alia, and podocyte with the teachings of Nishinakamura et al., who observed cell markers PODOCIN and NEPHERIN localized with NEPH1, with a reasonable expectation of arriving at the claimed invention. That is, one of ordinary skill in the art would have had a reasonable expectation that the PODOCIN+ and NEPHERIN+ selected renal cells of Stavas also expressed NEPH1 because Nishinakamura observed a co-localization of all markers when analyzing podocytes derived from iPS cells. Note also Nishinakamura’s teaching at the top of Pg. 9 that states that the induced podocytes are almost identical to podocytes in vivo, such as NPHS1 (nephrin) and NPHS2 (Podocin).
Moreover, the skilled artisan would have found it prima facie obvious to administer the selected renal cells to a subject having chronic kidney disease in a gelatin carrier because Ingber teaches such a carrier is acceptable for administering podocytes to a subject in need thereof.
Thus, the teachings of the cited prior art in the obviousness rejection above provide the requisite teachings and motivations with a clear, reasonable expectation. The cited prior art meets the criteria set forth in both Graham and KSR.
Therefore, the claimed invention, as a whole, was clearly prima facie obvious.
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 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 48 and 96-115 of co-pending Application in view of Barletta et al. (J Biol Chem. 2003 May 23;278(21):19266-71.)
Instant claim 44 is drawn towards a method of treating kidney disease in a patient, comprising: administering the enriched heterogeneous renal cell population, identified as having therapeutic potential according to the method of claim 1, to the patient,
wherein the administering the enriched heterogeneous renal cell population to the
patient treats the kidney disease in the patient. Instant claim 46 is drawn to the enriched heterogeneous renal cell population contained in a pharmaceutical composition.
For completeness, instant claim 1 is drawn to a method of identifying an enriched heterogeneous renal cell population as having a therapeutic potential, comprising:
determining whether cells of the enriched heterogeneous renal cell population express:
(i) NEPHI; and (ii) one or more markers, wherein the one or more markers comprises one or more of: lim homeobox protein I (LHXI), and fibroblast growth factor 8 (FGF8), receptor for activated C kinase I (RACKI) or rearranged during transfection (RET); and
identifying the enriched heterogeneous renal cell population as having therapeutic potential if cells of the enriched heterogeneous renal cell population are determined to express: (i) NEPHI; and (ii) the one or more markers.
Claim 1 of App ‘619 is drawn to method of treating kidney disease in a patient in need thereof, the method comprising (a) identifying an enriched heterogeneous renal cell population as having therapeutic potential, wherein the identifying comprises: (i) determining whether cells of the enriched heterogeneous renal cell population express at least one nephrogenic marker; and (ii) identifying the enriched heterogeneous renal cell population as having therapeutic potential if cells of the enriched heterogeneous renal cell population are determined to express the at least one nephrogenic marker; wherein the at least one nephrogenic marker comprises one or more of SIX2, OSR1, LHX1, RET and FGF8, and (b) administering a therapeutically effective amount of the enriched heterogeneous renal cell
population, identified as having therapeutic potential, to the patient, wherein the enriched heterogeneous renal cell population is sourced from a kidney biopsy of a
patient or an in vitro culture of cells established from a kidney tissue of the patient.
It is clear that all of the pending method claims can be found in the method claims of App ‘619. The only difference between the two applications being the cells isolated by instant application as also express NEPH1.
However, before the effective filing date of the claimed invention, Barletta et al. taught Nephrin and Neph1 co-localize at the podocyte foot process intercellular junction and form cis hetero-oligomers (Title; Abstract). Thus, because the art teaches co-localization, selection of SRCs expressing NEPH1 and NEPHRIN would have been prima facie obvious.
Claims 44-48 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-11, 15-16, 18-20, 29, 31-32 and 34-35 of co-pending Application 19227186.
Instant claim 44 is drawn towards a method of treating kidney disease in a patient, comprising: administering the enriched heterogeneous renal cell population, identified as having therapeutic potential according to the method of claim 1, to the patient,
wherein the administering the enriched heterogeneous renal cell population to the
patient treats the kidney disease in the patient. Instant claim 46 is drawn to the enriched heterogeneous renal cell population contained in a pharmaceutical composition.
For completeness, instant claim 1 is drawn to a method of identifying an enriched heterogeneous renal cell population as having a therapeutic potential, comprising:
determining whether cells of the enriched heterogeneous renal cell population express:
(i) NEPHI; and (ii) one or more markers, wherein the one or more markers comprises one or more of: lim homeobox protein I (LHXI), and fibroblast growth factor 8 (FGF8), receptor for activated C kinase I (RACKI) or rearranged during transfection (RET); and
identifying the enriched heterogeneous renal cell population as having therapeutic potential if cells of the enriched heterogeneous renal cell population are determined to express: (i) NEPHI; and (ii) the one or more markers.
Claim 1 of App ‘186 is drawn to a method for the treatment of chronic kidney disease, the method comprising injecting into the renal cortex of at least one kidney of a patient having said chronic kidney disease a therapeutically effective amount of a composition comprising a selected bioactive renal cell (SRC) population.
Claim 33 of App ‘186 is drawn to a method for delaying dialysis in the treatment of a human patient comprising chronic kidney disease, the method comprising: injecting into the renal cortex of at least one kidney of the human patient having said chronic kidney disease a therapeutically effective amount of a composition comprising a selected renal cell (SRC) population.
It is clear that all the elements of the application claims are to be found in co-pending claims (as the application claims fully encompasses co-pending application claims). The difference between the application claims and the patent claims lies in the fact that the co-pending claims includes many more elements and is thus much more specific. For example, co-pending claims are drawn to injecting the SRCs into a renal cortex. Thus the invention of claims of the co-pending claims is in effect a “species” of the “generic” invention of the application claims. It has been held that the generic invention is “anticipated” by the “species”. See In re Goodman, 29 USPQ2d 2010 (Fed. Cir. 1993). Since application claims is anticipated by claims of the co-pending claims, it is not patentably distinct from claims of the co-pending application.
Authorization to Initiate Electronic Communications
The examiner may not initiate communications via electronic mail unless and until applicants authorize such communications in writing within the official record of the patent application. See M.P.E.P. § 502.03, part II. If not already provided, Applicants may wish to consider supplying such written authorization in response to this Office action, as negotiations toward allowability are more easily conducted via e-mail than by facsimile transmission (the PTO's default electronic-communication method). A sample authorization is available at § 502.03, part II.
Conclusion
No claim is allowed.
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/TITILAYO MOLOYE/ Primary Examiner, Art Unit 1632
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