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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 August 25, 2025, has been entered.
Priority
Applicant’s claim for priority to a provisional application no. 62/979,388 is acknowledged. The effective filing date for claims 10, 15-17 and 30-40 is February 20, 2020.
Claim Status
In Applicant’s response filed August 25, 2025, claims 10, 33, and 37 are amended and claims 1-9, 11-14, and 18-29 are cancelled.
In the response filed 3/16/2023, Applicant elected Group II directed to a method of producing a vascular progenitor cell.
Currently, Claims 10, 15-17 and 30-40 are under consideration in this Office Action.
Withdrawn Objections & Rejections
Rejections and/or objections not reiterated from the previous office action are hereby withdrawn due to amendment. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Objections
Claim 10 is objected to because of the following informalities: sentence structure, where the claims recite “induced pluripotent stem cell (hiPSC)with a composition” and is missing a space between the parenthesis and the word “with”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 10, 33, and 37 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
This rejection is a new rejection necessitated by amendments to the claims. However, since it is substantially similar to a rejection set forth in the non-final Official action mailed on May 23, 2025. A response to applicant' s traversal follows the reiterated rejection below.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Independent Claim 10, 33, and 37 recites “contacting the human induced pluripotent stem cell (hiPSC)-with a composition comprising a leukemia inhibitory factor (LIF) and a simultaneous combination of three agents which inhibit one or more signaling pathways”. However, the specification doesn't have adequate support in the disclosure for the generic agent that characterize the any agent with contacting hiPSC. As written in the claim, the three “agents” encompasses a broad genus that includes multiple classes of inhibitors or factors and given its broadest reasonable interpretation in light of the specification (i.e. small molecules, vaccines, active metabolite, prodrug, salt, or solvate etc.), corresponding to any agent that imparts the function of producing a vascular progenitor cell.
Under the written description guidelines (see MPEP 2163), the Examiner is directed to determine whether one skilled in the art would recognize that the Applicant was in possession of the claimed invention as a whole at the time of filing. The following considerations are critical to this determination.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail so that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116. An original claim may lack written description support when (1) the claim defines the invention in functional language specifying a desired result, but the disclosure fails to sufficiently identify how the function is performed or the result is achieved or (2) a broad genus claim is presented but the disclosure only describes a narrow species with no evidence that the genus is contemplated. See Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1349-50 (Fed. Cir. 2010) (en banc). The written description requirement is not necessarily met when the claim language appears in ipsis verbis in the specification. "Even if a claim is supported by the specification, the language of the specification, to the extent possible, must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement." Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956, 968, 63 USPQ2d 1609, 1616 (Fed. Cir. 2002).
Accordingly, to satisfy the written description requirement, the specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1562-63, 19 USPQ2d 1111 (Fed. Cir. 1991). See also MPEP 2163.
In analyzing whether the written description requirement is met for the genus of “agent”, the specification is first assessed to determine whether a representative number of species have been described by their complete structure of the genus.
Independent Claim 10, 33, and 37 recites a leukemia inhibitory factor (LIF) and a simultaneous combination of three agents which inhibit one or more signaling pathways to produce a naïve human induced pluripotent stem cell (N-hiPSC). However, the specification doesn't have adequate support in the disclosure for the generic agent that characterize any agent in contract with hiPSC to produce vascular progenitor cells. The specification discloses that “Inhibitors: In certain embodiments, the composition comprises a leukemia inhibitory factor (LIF) and a combination of at least three agents comprising inhibitors of poly-ADP-ribosyltransferase, MEK, GSK3 and signaling pathways thereof”(see e.g. para. 77). Further, the specification recites “it was demonstrated for the first time that the epigenetic obstacle of lineage priming and high interline variability of vascular lineage differentiation from normal and diseased conventional hiPSC can be eliminated by reversion to a tankyrase/PARP inhibitor-regulated naïve pluripotent state.” (see e.g. para. 57). Further, the specification discloses that “in some embodiments, other inhibitors may be included, for example a MEK inhibitor, a GSK3 inhibitor, a STAT3 activator, an FGF inhibitor (e.g. PD173074), a HDAC inhibitor, a tankyrase inhibitor, a ROCK inhibitor (e.g. Y27632), a PKC inhibitor or combinations thereof. In certain embodiments, the STAT3 (signal transducer and activator of transcription 3) activator is LIF, e.g. human LIF (hLIF).” (Specification, para. 86). Therefore, the specification fails to identify any agent that when in contract with hiPSC will produce N-hiPSCs.
Accordingly, one of ordinary skill in the art would neither expect nor predict the appropriate method of producing vascular progenitor cells by contacting three agents as claimed by using any agent with hiPSC.
The prior art of Hassani et al., (Stem cells and development 23.3: 193-208 published 2014, prior art of record) discloses that extensive studies have been performed to achieve naive pluripotent stem cells from humans, where in experiments involved in “directly reprogramming human fibroblasts or reverting hESCs/hiPSCs into the naive state, transfection of human fibroblasts or primed hESCs with common naive and primed pluripotency genes, such as OCT4, SOX2, C-MYC, and LIN28, or with more naive-related pluripotency marker genes, such as KLF2, KLF4, and NANOG, in 2i/LIF, A-83-01 (ALK4/5/7 inhibitor)/2i/LIF, or forskolin (protein kinase A agonist)/2i/LIF, has produced naive hESCs/hiPSCs” (see e.g. page 201-202, fig. 4). Hassani et al., discloses that different small molecules including PD0325901 and SB203580 (p38 inhibitor), sodium butyrate (as histone deacetylase [HDAC] inhibitor) [142], or NM23-H1 (a tumor suppressor growth factor) have been used to achieve naïve hiPSCs without forced expression of pluripotency genes (see e.g. page 202). Furthermore, Hassani et al., describes various signaling pathways that appear to support pluripotency of primed stem cells and in contrast propel the lineage differentiation of naive stem cells (see e.g. page 203). Therefore, Hassani et al., provides robust evidence that while agents (i.e. inhibitors and small molecules) have achieved N-hiPSCs, there does not appear to be a common core structure between the various agents. Additionally, the prior art of Theunissen et al., (Cell stem cell 19.4: 502-515, published 2016, prior art of record) states that “it has been challenging to define the naive state of pluripotency in humans, particularly in view of the expanding number of protocols for deriving putative naive human cells” (see page 503). Further, Theunissen et al., teaches that “through iterative screening, we identified a combination of five kinase inhibitors that, together with LIF and activin A (5i/L/A), enabled the conversion of pre-existing human ESCs to the naive state in the absence of transgenes, and an independent analysis concluded that naive human cells generated with this method or in titrated 2i/L medium supplemented with a protein kinase C (PKC) inhibitor (see page 503). Therefore, Theunissen et al., provides robust evidence that a person of ordinary skill in the art would not know the generic agent of N-iPSC without experimental validation (i.e. iterative screening). Further, the prior art of Ware, Carol B. (Stem Cells 35.1: 35-41, published 2017, prior art of record) discloses that several cocktails and small molecules result in hiPSC with a naïve state, and that the use of cocktails with four to six inhibitors will hold hiPSC in the naïve state (see e.g. page 36-38). Therefore, Ware, Carol B., provides additional evidence that several cocktails, small molecules, and inhibitors were known in the art to achieve a naïve state, but that there is not a core common structure between the agents. Therefore, with these additional evidence, the ordinary artisan cannot predictably identify that any agent having contact with the hiPSC will produce a N-hiPSC.
Furthermore, functionally defined genus claims can be inherently vulnerable for lack of adequate written description, especially in highly unpredictable technology fields, where it is difficult to establish a correlation between structure and function for the whole genus or to predict what would be covered by the functionally claimed genus. See ABBVIE DEUTSCHLAND GMBH & 2 CO. v. JANSSEN BIOTECH, INC., Appeals from the United States District Court for the District of Massachusetts in Nos. 09-CV-11340-FDS, 10-CV-40003-FDS, and 10-CV-40004-FDS, Judge F. Dennis Saylor, IV. See also Ariad, 598 F.3d at 1351 ("[T]he level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology.”); see also Centocor Ortho Biotech, Inc. v. Abbott Labs., 636 F.3d 1341, 1352 (Fed. Cir. 2011) (noting the technical challenges in developing fully human antibodies of a known human protein).
The Applicant has recited that “Inhibitors: In certain embodiments, the composition comprises a leukemia inhibitory factor (LIF) and a combination of three agents comprising inhibitors of poly-ADP-ribosyltransferase, MEK, GSK3 and signaling pathways thereof. In certain embodiments, the poly-ADP-ribosyltransferase is tankyrase. In certain embodiments, the GSK3 is a GSK30 isoform. In certain embodiments, a tankyrase inhibitor comprises: XAV939, IWR-1, G007-LK, JW55, AZ1366, JW 74, NVP-TNKS656 or combinations thereof. In certain embodiments, a GSK3β inhibitor comprises: 6-[[2-[[4-(2,4-Dichlorophenyl)-5-(5-methyl-1H-imidazol-2-yl)-2-pyrimidinyl]amino]ethyl]amino]-3-pyridinecarbonitrile (CHIR 99021), 5-Ethyl-7,8-dimethoxy-1H-pyrrolo[3,4-c]isoquinoline-1,3(2H)-dione (3F8), 1-(7-Methoxyquinolin-4-yl)-3-[6-(trifluoromethyl)pyridin-2-yl]urea (A 1070722), N6-[2-[[4-(2,4-Dichlorophenyl)-5-(1H-imidazol-1-yl)-2-pyrimidinyl]amino]ethyl]-3-nitro-2,6-pyridinediamine (CHIR 98014), lithium chloride (LiCl), 4-benzyl-2-methyl-1,2,4-thiadiazolidine-3,5-dione (TDZD-8), 5-iodo-indirubin-3′-monoxime (I3′M) and N-(4-methoxybenzyl)-N′-(5-nitro-1,3-thiazol-2-yl)urea (AR-A014418) or combinations thereof. In certain embodiments, an MEK inhibitor comprises: PD032590, CI-1040 (PD184352), cobimetinib (GDC-0973, XL518), Selumetinib (AZD6244), MEK162, AZD8330, TAK-733, GDC-0623, Refametinib (RDEA119; BAY 869766), Pimasertib (AS703026), RO4987655 (CH4987655), RO5126766, WX-554, HL-085 or combinations thereof” (Specification, page 77). Given the breadth of any “agent” that the claims embrace, a description of three species (i.e. poly-ADP-ribosyltransferase, MEK, GSK3), fails to provide a representative number of species that teaches the complete structure of the genus. Consequently, the any “agent” is not apparent to one of ordinary skill in the art from the description present in the specification. Therefore, an artisan of ordinary skill could not envision all the embodiments encompassed by the breadth of the claims.
Accordingly, the specification doesn't have adequate support in the disclosure for the generic agent that can characterize any agent having contact with the hiPSC will produce a N-hiPSC. Similarly, disclosure doesn't identify a generic agent that characterizes any agent by contacting the hiPSC will produce vascular progenitor cells. Therefore, the claimed recitation of any three agents doesn't have an adequate written description. Furthermore, neither the specification nor the art indicates the ability to identify generic agent that characterizes any agent with having contacted an hiPSC with any agent will produce vascular progenitor cells from N-hiPSC.
Therefore, it concludes that the claimed recitation of any three agents having contact with hiPSCs will results in N-hiPSCs to produce vascular progenitor cells does not have an adequate written description. Specifically, the specification does not identify the generic agent to characterize any three agents that can be contacted with hiPSCs that will result in N-hiPSCs to produce vascular progenitor cells. It concludes that a skilled artisan would find the specification inadequately described. Therefore, the Applicant did not sufficiently possess the broader invention as claimed.
Response to Traversal:
Applicant traverses that the amendment of independent claims 10, 33, and 37 to “consisting of three agents” support the withdrawal of the written description rejection (Remarks, page 8).
Applicant arguments are acknowledged, have been fully considered, and have been deemed partially persuasive.
In response to Applicants argument that the independent claims recite “consisting of three agents”, the claim still recites the phrase “agents”. As stated supra, the recitation of “agents”, can be any agent (i.e. nutrients, small molecules or antibiotics or buffer agents etc.). It is noted that the dependent claims clarify the specific “agents.” However, the “agents” that the claim recites are “inhibitors”, specifically the poly-ADP-ribosyl transferase inhibitor, the MEK inhibitor, and a GSK3 inhibitor. Therefore, the rejection is maintained as for reasons stated above and for reasons of record discussed in the prior office action.
Claim Rejections - 35 USC § 103
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.
Claims 10, 15-17, and 30-40 are rejected under 35 U.S.C. 103 as being unpatentable over Zambidis et al., (WO2015/153586A1, published 2015, hereinafter as “Zambidis”), in view of Park et al. (Investigative Ophthalmology & Visual Science, Abstract, 58.8: 4051-4051; published 2017, hereinafter as “Park 2017”; prior art of record), and Zimmerlin, et al. (functionality." Development 143.23: 4368-4380; published 2016; see full pdf with supplemental material, prior art of record).
Regarding claim 10, 15-17, and 30-40, Zambidis discloses methods of producing a vascular progenitor (VP) cells (see e.g. abstract, claims 1, 4, 18, and fig. 1-2, 15-22), comprising: isolating fibroblasts from induced pluripotent stem cells (iPSC)(see e.g. page 9-10, 20, and fig. 1-4), Further, Zambidis discloses methods of producing a naive human induced pluripotent stem cell (N-hiPSC); and, differentiating the N-hiPSC in vitro or by implantation in vivo (see e.g. page 4-5, 20 fig. 18, 20-21, page 32, 34, table 1), wherein the VP cell expressed expresses CD31+CD146+ (see e.g. page 20-23, fig. 1-5, 10, 21). Further, Zambidis discloses reprogramming human induced pluripotent stem cells (hiPSCs); contacting the human induced pluripotent stem cell (hiPSC)-with a composition comprising a leukemia inhibitory factor (LIF)(i.e. LIF/3i)(see fig. 19-20) and a simultaneous combination of at least three agents which inhibit one or more signaling pathways, wherein the three agents comprise an inhibitor of mitogen-activated protein kinase ki-Ras-e (MEK), and an inhibitor of Glycogen Synthase Kinase 3 (GSK3). Additionally, Zambidis discloses a diabetic mice (e.g. Nonobese diabetic-severe combined immunodeficient (NOCID-SCID)), which was subject to ocular ischemic reperfusion injury and human cell injections (see e.g. page 5-6, 11 and fig. 5).
Zambidis does not explicitly disclose methods of isolating fibroblasts from a donor diabetic subject and where the reprograming composition consists of an inhibitor of poly-ADP-ribosyltransferase.
However, the prior art Park teaches generating diabetic iPSC (D-iPSC) from skin fibroblasts of type-I diabetic patient using non-integrative episomal reprogramming system with a chemical cocktail that is L3i-reverted (abstract, see methods).
Accordingly, it would have been obvious for a person of ordinary skill in the art to modify the methods obtaining vascular progenitor (VP) cells as taught by Zambidis with the fibroblasts from a donor diabetic subject as taught Park because Zambidis discloses methods for generating same patient-specific hiPSC lines that could be used to comprehensively treat ischemic eye diseases including diabetic retinopathy (see e.g. page 9). Additionally, Zambidis disclose that hiPSC-based therapies could potentially revitalize adult vascular progenitors, which are often rendered defective in their diabetic environment (see e.g. abstract). As discussed above, both Park and Zambidis disclose that isolating fibroblasts to obtain human induced pluripotent stem cells (hiPSC) method were known in the art. Thus, providing a person of ordinary skill in the art with predictable results with a reasonable expectation of success. Moreover, an artisan of ordinary skill in the art of (i.e. stem cell therapy) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
As stated supra, the prior art Park teaches generating diabetic iPSC (D-iPSC) from skin fibroblasts of type-I diabetic patient using non-integrative episomal reprogramming system with a chemical cocktail that is L3i-reverted (abstract, see methods). Moreover, the prior art of Zimmerlin discloses that the L3i-reverted comprises GSK3β (i.e. CHIR99021), MEK inhibitor (i.e. PD0325901), and a tankyrase inhibitor (i.e. XAV939)(see e.g. page 4378).
Accordingly, it would have been obvious for a person of ordinary skill in the art to modify the methods obtaining vascular progenitor (VP) cells as taught by Zambidis with the reprograming composition that consists of an inhibitor of poly-ADP-ribosyltransferase as taught by Park and Zimmerlin because Zimmerlin discloses directly reverting human pluripotent stem cell lines to obtain stable clonal cultures (see e.g. page 4378). Further, a person of ordinary skill in the art would have been able to combine the LIF cocktail (i.e. LIF/3i) (i.e. LIF, MERK/ERKI, GSK3β)(as taught by Zambidis)(see fig. 19-20) with the L3i (i.e. LIF-3i reverted) as taught by Park and Zimmerlin) because Zimmerlin discloses an extensive small-molecule screening (supplementary Materials and Methods, Table S3) that identified XAV939 for permitting long-term survival of hPSCs in classical LIF2i (i.e. GSK3β (i.e. CHIR99021), MEK inhibitor (i.e. PD0325901) composition. Thus, a person of ordinary skill in the art would have had predictable results with a reasonable expectation of success. Moreover, an artisan of ordinary skill in the art of (i.e. stem cell therapy) has good reason to pursue the known options within his or her technical grasp (KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (US 2007).
Hence, the claimed invention as a whole was prima facie obvious in the absence of evidence to the contrary.
Response to Traversal:
Applicant traverses that Zimmerlin is directed to the production of hiPSCs reprogrammed from stromal-activated (sa) human myeloid progenitors (MPs) and Park 2017 (i.e. Park) which describes the use ofLIF-3i, therefore one of ordinary skill in the art would only be motivated to utilize LIF-3i and not diabetic fibroblasts (Remarks, page 8-10).
Applicant’s arguments with respect to the previous rejection of claims 10, 15-17, and 30-40 as rejected as being obvious over Zimmerlin, Ludovic, et al. (functionality." Development 143 .23: 4368-43 80; published 2016, hereinafter as "Zimmerlin") and further in view of Park et al. (Investigative Ophthalmology & Visual Science, Abstract, 58.8: 4051-4051; published 2017, hereinafter as "Park 2017") and Lao, Ka Hou, et al. (Frontiers 4 (2017): 3-88, published 2017; hereinafter as "Lao"), and Christensen et al. (US20150017674Al, published 2015), have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejection has been withdrawn.
However, upon further consideration, a new ground(s) of rejection is made in view of Zambidis et al., (WO2015/153586A1, published 2015, hereinafter as “Zambidis”), in view of Park et al. (Investigative Ophthalmology & Visual Science, Abstract, 58.8: 4051-4051; published 2017, hereinafter as “Park 2017”; prior art of record), and Zimmerlin, et al. (functionality." Development 143.23: 4368-4380; published 2016; see full pdf with supplemental material, prior art of record). Further, as stated supra, the prior art of Zimmerlin, et al. is not cited for teaching vascular progenitor cells, and the prior art of Zambidis et al. is now cited for teaching VP cells that express CD31+and CD146+.
In view of the foregoing, when all of the evidence is considered, the totality of the rebuttal evidence of nonobviousness fails to outweigh the evidence of obviousness.
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 10, 15-17 and 30-40 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-4, 6, 17, and 19 of Application Number 18/785,343 (the ‘343 application).
Although the conflicting claims are not identical, they are not patentably distinct from each other because the competing claims are drawn to a disclosed species of the instant claims.
Regarding claims 10, 15-17, and 30-40, the ‘343 application discloses a method for generating a population of therapeutic progenitor cells under clinical grade, current good manufacturing practice (cGMP)-compliant conditions, comprising: (a) contacting a population of human induced pluripotent stem cells (hiPSCs) with a tankyrase/PARP-inhibitor-containing composition comprising: (i) leukemia inhibitory factor (LIF); (ii) a Glycogen Synthase Kinase 3-β (GSK3B) signaling pathway inhibitor; (iii) a mitogen-activated protein kinase (MEK) signaling pathway inhibitor; (iv) a tankyrase/PARP inhibitor; and (v) a protein kinase C (PKC) inhibitor; (b) performing feeder-free (FF) and xeno-free (XF) culture of the hiPSCs to generate a population of these therapeutic progenitor cells under clinical grade, cGMP-compliant conditions (see claims 1-4, 6, 17, and 19). These disclosures expressly disclose the limitations of instant claims 10, 15-17, and 30-40
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
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/JOSEPHINE GONZALES/ Examiner, Art Unit 1631
/JAMES D SCHULTZ/ Supervisory Patent Examiner, Art Unit 1631
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