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 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, 4-5, 9-10, 22, 25, 29, 37-45 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by PG PUB US 20160331786 A1, published 11/17/2016.
In exemplary embodiment 8, “Phase I Thoracic Spinal Cord Injury Clinical Trial of AST-OPC1 Cells”, PG PUB US 20160331786 A1 discloses, “Subjects with neurologically complete, subacute spinal cord injuries (SCI) were recruited in an open-label, multicenter safety study of AST-OPC1 cells. The main inclusion criteria were a traumatic, non-penetrating SCI with single neurological level from T3-T10.” (paragraph 0196). Additionally, “Potential subjects had to provide informed consent from 3 to 11 days after their injury so that AST-OPC1 could be administered 7-14 days after SCI.” (paragraph 0196). Furthermore, “Five eligible subjects received a single dose of 2×10.sup.6AST-OPC1 cells in a dedicated surgical procedure for the study. The cells were administered via direct injection to the spinal cord approximately 5 mm caudal to the lesion epicenter using a syringe…” (paragraph 0197). Importantly, they disclose the source of the AST-OPC1 cells used in treatment; “AST-OPC1 (formerly known as GRNOPC1) was generated by the differentiation of WA01 (H1) hESCs from a master cell bank (MCB) as described in the Materials and Methods.” (paragraph 0175). Therefore, this disclosure outlines a method of administering human pluripotent stem cell-derived oligodendrocyte progenitor cells (aka oligodendrocyte progenitor cells derived from human Embryonic Stem Cells, hESC) into a subject having a spinal cord injury (claim 1 and claim 25). It further outlines the administration of the cells comprises injecting them into the spinal cord of the subject (claim 4). Furthermore, it defines the injury as a subacute spinal cord injuries (SCI) occurring from T3-T10, which corresponds to a thoracic SCI. Thus, it discloses a method of administering human pluripotent stem cell-derived oligodendrocyte progenitor cells into a subject having a subacute thoracic SCI (claim 5). The disclosure further states that there were 2×10.sup.6AST-OPC1 cells administered in the first dose, which anticipates claim 9 (first dose, second dose, and/or third dose composition comprises about 1 x 106 to about 3x107 OPC cells) and claim 10 (first dose of the composition comprises about 2 x 106 OPC cells). They further disclosed that the injection of cells was made on caudal half of the epicenter of the SCI (claim 22). Furthermore, they indicate that, “Potential subjects had to provide informed consent from 3 to 11 days after their injury so that AST-OPC1 could be administered 7-14 days after SCI.” (paragraph 0196) which anticipates claim 29 (wherein the composition is administered about 7 to about 14 days after the SCI.).
Claims 37-45 make claim to various improvements in neurological testing scores resulting from the administration of OPCs to a subject, such as, improvement in ISNCSI UEMS of 10%, LEMS occurring within 6 months or more from injection, increase in 2 motor levels, improvement in one or both side of the subject’s body. However, these claims do not hold patentable weight because they are the natural result of successful treatment using the aforementioned methods. A limitation is inherent when it is the natural, inevitable result of performing the steps of the prior art method. Inherency does not require that the reference expressly recognize the property or result. (MPEP 2112) (See In re Montgomery, 677 F.3d 1375 (Fed Cir. 2012)).
PG PUB US 20160331786 A1 teaches the same method as the disclosure; a method of administering human pluripotent stem cell-derived oligodendrocyte progenitor cells (aka oligodendrocyte progenitor cells derived from human Embryonic Stem Cells, hESC) into a subject having a spinal cord injury (see claim mapping outlined above). Additionally, exemplary embodiment 8 discloses that, “…review of the scans was conducted to assess lesion site parenchymal cavitation and the potential activity of AST-OPC1 cells. Potential activity of AST-OPC1 cells may be demonstrated by the presence of tissue in place of the lesion cavities in study subjects.” (paragraph 0201). Furthermore, “In 4 of 5 subjects, the lesion/graft sites were hyperintense on the T2-weighed images at later time points (commencing at Day 180 and up to Year 4, which is the latest time point data currently available for 4 out of 5 subjects), with the signal intensity less than that of cerebrospinal fluid (FIG. 12A and FIG. 12B). This is consistent with the presence of viable graft tissue in the lesion site…” (paragraph 0203). Finally, “Overall, these data support prevention or reduction of lesion cavity formation in four of the five subjects during both the one-year primary protocol and the long-term follow-up protocol. Parenchymal cavitation may have been substantially prevented or reduced by the formation of a tissue matrix in the lesion site.” (paragraph 0203).
While claims 37-45 cite other various metrics for assessing neurological improvement, (eg. improvement in ISNCSCI exam upper extremity motor score, improvement in lower extremity motor scores, improvement is at least two motor level improvement, wherein the improvement is on both sides of the subject's body), these metrics are merely a subset results that would naturally occur if the results outlined in the prior art (parenchymal cavitation is substantially prevented or reduced by the formation of a tissue matrix in the lesion site) are achieved. In other words, these limitations are a natural manifestation of the same therapeutic effect described in the prior art. Therefore, while the limitations of claims 37-45 are unrecognized by the prior art, they are inherent results that are achieved by the prior art. The applicant has not provided evidence that performing the prior art method does not result in the claimed improvement. (See In re Best, 562 F.2d 1252 (C.C.P.A. 1977)).
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.
Claims 2-3, 12, 21, 23 are rejected under 35 U.S.C. 103 as being unpatentable over US 20160331786 A1, published 11/17/2016.
In exemplary embodiment 8, “Phase I Thoracic Spinal Cord Injury Clinical Trial of AST-OPC1 Cells”, PG PUB US 20160331786 A1 discloses, “Subjects with neurologically complete, subacute spinal cord injuries (SCI) were recruited in an open-label, multicenter safety study of AST-OPC1 cells.” (paragraph 0196). Furthermore, “Five eligible subjects received a single dose of 2×10.sup.6AST-OPC1 cells in a dedicated surgical procedure for the study.” (paragraph 0197). Importantly, they disclose the source of the AST-OPC1 cells used in treatment; “AST-OPC1 (formerly known as GRNOPC1) was generated by the differentiation of WA01 (H1) hESCs from a master cell bank (MCB) as described in the Materials and Methods.” (paragraph 0175). Therefore, this disclosure outlines a method of administering human pluripotent stem cell-derived oligodendrocyte progenitor cells (aka oligodendrocyte progenitor cells derived from human Embryonic Stem Cells, hESC) into a subject having a spinal cord injury. Exemplary embodiment 8 does not disclose administering a second dose (claim 2) or a third dose (claim 3) of the composition to the subject. It does not disclose that the second or third dose of the composition comprise about 2 x 10^7 OPC cells (claim 12). It does not disclose the first, second and third dose be administered between 14 days after the SCI and the lifetime of the subject (claim 21).
PG PUB US 20160331786 A1 does disclose that, “The compositions in accordance with the present disclosure can be formulated for parenteral administration by injection, e.g., by bolus injection or continuous infusion. Formulations for injection can be presented in unit dosage form, e.g., in ampoules or in multi-dose containers, with an added preservative.” (paragraph 0085). It also discloses, “In certain embodiments, a composition in accordance with the present disclosure can comprise…about 2×10.sup.6 cells per milliliter…” (paragraph 0087), and that, “In yet another embodiment, a composition in accordance with the present disclosure can have a volume ranging from about 10 microliters to about 5 milliliters…” (paragraph 0089). Finally, it discloses, “AST-OPC1 could be administered 7-14 days after SCI.” (paragraph 0196).
Therefore, PG PUB US 20160331786 A1 provides an explicit suggestion/teaching/motivation to administer multiple doses of OPC cells, as disclosed by, “compositions in accordance with the present disclosure can be formulated…e.g., in ampoules or in multi-dose containers…” paragraph 0085). This includes administering a second (claim 2) and a third (claim 3) dose of OPC cells, therefore rendering claims 2-3 obvious. They go on to outline that doses can be administered in a concentration of, “…about 2×10.sup.6 cells per milliliter…” (paragraph 0087), and that each dose can contain, “…about 10 microliters… (paragraph 0089). This results in a total of about 2 x 10^7 OPC cells per dose administered, rendering claim 12 obvious. Furthermore, they disclose, “AST-OPC1 could be administered 7-14 days after SCI.” (paragraph 0196). This renders claim 21 obvious because it means that all doses of cells will be administered between 14 days after SCI and the lifetime of the subject.
Claim 23 is treated as being a result-effective variable. (MPEP2144.05(II)). See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
PG PUB US 20160331786 A1 teaches, “The OPCs are administered in a manner that permits them to graft or migrate to the intended tissue site and reconstitute or regenerate the functionally deficient area…Non-limiting examples of non-invasive delivery methods include the use of syringes and/or catheters to deliver the cells into the organ or tissue in need of cellular therapy.” (paragraph 0094).
PG PUB US 20160331786 A1 does not specifically teach the limitations of claim 23, each injection is about 6mm or 5mm into the spine. However, PG PUB US 20160331786 A1 does teach optimization of administration location so that cells are injected into the location where they achieve therapeutic benefit.
Therefore, PG PUB US 20160331786 A1 provides explicit teachings/motivations to optimize injection/administration location to achieve the desired 5mm or 6mm injection depth into the spine and illustrates that such optimization would have been a matter of routine experimentation. Thus, it would have been obvious to one of skill in the art prior to the effective filing date to optimize injection/administration location to achieve injection/administration at 5mm or 6mm deep into the spine.
In the case of a result-effective variable, the discovery of an optimum value of the variable in a known process is ordinarily within the skill of the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Therefore, it would have been obvious to one of ordinary skill in the art to determine through routine experimentation the optimum or workable ranges of parameters such as injection/administration locations since the variables would have been recognized as result-effective.
Claim 73 is rejected under 35 U.S.C. 103 as being unpatentable over PG PUB US 20160331786 A1, further in view of PG PUB US 20200231932 A1.
PG PUB US 20160331786 A1 discloses, “Subjects with neurologically complete, subacute spinal cord injuries (SCI) were recruited in an open-label, multicenter safety study of AST-OPC1 cells.” (paragraph 0196). It further discloses, “Formulations for injection can be presented in unit dosage form, e.g., in ampoules or in multi-dose containers, with an added preservative.” (paragraph 0085). It does not disclose the use of oligodendrocyte progenitor cells (OPCs) having an increased proportion of cells positive for oligodendrocyte progenitor cell marker NG2 and reduced expression of non-OPC markers CD49f, CLDN6, and EpCAM.
PG PUB US 20200231932 A1 discloses a method of creating OPC’s from human embryonic stem cells (exemplary embodiment 2), and shows that the cells created by their method, “resulted in higher proportion of cells positive for oligodendrocyte progenitor cell marker NG2 and reduced expression of non-OPC markers CD49f, CLDN6, and EpCAM when compared to OPCs that are currently in clinical testing to treat spinal cord injury and that were generated using another method…” (paragraph 0161).
Given the facts above, it would have been obvious to one of skill in the art, before the effective filing date, to utilize the cell population generated from the methods of PG PUB US 20200231932 A1 in the treatment of subjects with spinal cord injuries as outlined in PG PUB US 20160331786 A1. In this combination, each element would perform the same function as it would have if used alone, and it is clear that the combination would result in predictable results.
Claim 54 is rejected under 35 U.S.C. 103 as being unpatentable over Nistor, G et al. 2005 as supported by Yu, K. et al. (2012), David-Ben, U et al. (2013), Lu, T et al. (2009), Otsu, M et al. (2021) and, Miller-Rhodes, P. et al. (2022).
Nistor, G et al. 2005 discloses, “Here we present for the first time a method for obtaining oligodendrocytes and their progenitors in high yield from hESCs. (“Abstract”). Nistor, G et al. 2005 does not teach how the expression levels of NG2, EpCAm, CD49f and claudimng-6 change with cell differentiation.
Yu, K. et al. (2012) discloses, “Specifically, CD49f is prominently expressed in hESCs, and its ligand, laminin, can be used as a substrate for the expansion of undifferentiated hESCs.” (Introduction, paragraph 3). David-Ben, U et al. (2013) discloses, “We found that CLDN-6 is indeed highly expressed in various hESC and hiPSC lines…” (Results, paragraph 2). Lu, T et al. (2009) discloses, “We found EpCAM to be highly and selectively expressed by undifferentiated rather than differentiated hESCs.” (Introduction). Thus, it is known that CD49f, Claudin-6, and EpCAM are highly expressed on embryonic stem cells (ESCs). Importantly, Otsu, M et al. (2021) discloses, “we established a protocol for rapidly generating high-purity cultures of immature NG2 progenitor cells from mouse ESC-derived NSC. (Discussion, paragraph 3). Furthermore, “The OPC medium used to convert NSC to the early-NG2 glia contained PDGF-AA and IGF-1, yet NOP lacked PDGFRα… PDGFRα expression precedes that of NG2 by 2 days (Nishiyama et al., 1996). Similarly, a recent single-cell transcriptomic analysis of human OPC reports distinct peaks for PDGFRα and NG2 expression, with NG2 peaking later in development than PDGFRα”. (Discussion paragraph 3). From this disclosure we can reason that NG2+ expression increases as ESCs differentiate into more mature cells, and expression is directly correlated to differentiation. Additionally, Miller-Rhodes, P. et al. (2022) discloses the oligodendrocyte progenitor cell markers. “SOX10, NKX2.2, OLIG1, and OLIG2 are early transcriptional regulators of OPC differentiation. The upregulation of these transcription factors is followed by platelet-derived growth factor α receptor (PDGFRA) expression, a key determinant of OPC fate.”. Furthermore, “OPCs also express CSPG4 (more commonly known as NG2) as well as gangliosides recognized by the A2B5 antibody.” (Oligodendrocyte Progenitor Cells (OPC) Markers). Note Image #1 in the Oligodendrocyte Progenitor Cells (OPC) Markers section and the absence of CD49f, Claudin-6 (CLDN-6), and EpCAM.
A person of ordinary skill in the art would have found it obvious that the cell population resulting from the differentiation of ESC would result in OPCs and that the resulting OPC’s would exhibit increased expression of NG2 because it is a known marker of OPC’s and decreased expression of CD49f, EpCAM, and claudin-6 because they are known as not being identifying markers of OPC. Thus, it would have been obvious that the cell population produced by the process in claim 54 would exhibit the known characteristics of OPC cells.
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, 4-5, 9-10, 22, and 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1, 7, 8, and 9 of U.S. Patent No 10286009. Although the claims at issue are not identical, they are not patentably distinct from each for the following reasons. Claims 1, 4, 22 and patent claim 1 claim a method of reducing a spinal cord injury by injecting human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) by injecting cells into the spine in the caudal region. Claim 5 and patent claim 7 both claim that injection of human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) be used to treat a thoracic or cervical spinal cord injury. Claims 9 -10 and patent claim 8 both claim the use of a dose of 2 x 10" 6 OPC cells in the first administration. Claim 54 and patent claim 9 both claim that the human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) be derived from human embryonic stem cells.
Claims 1, 4, 9-10, 22, 42-43, and 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 28 of copending Application No. 16333566 because they claim a method of treating spinal cord injuries by injecting human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) expressing NG2 at a composition of 2 x 10^6 OPC cells into the spinal cord and caudal to the injury site and the subject’s upper extremity motor function improves by 1 or 2 levels. This is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 5, 38, 44-45, 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 29, 39, 41, 42, 44-45 of copending Application No. 16333566 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because for the following reasons. Claim 1 and claim 29 both claim a method of treating spinal cord injuries by injecting human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) into the spinal cord. Claim 5 and claim 39 of both claim the method is used to treat a cervical spinal cord injury. Claim 44 and 42 both claim that the treatment results in a motor level improvement that is unilateral. Claim 45 and 41 of both claim that the treatment results in a motor level improvement that is bilateral. Claim 38, and claim 44 both clam the subject’s improvement in upper extremity motor score is two levels by 12months after injection. Claim 54 and claim 45 both claim that the human oligodendrocyte progenitor cells are derived from human embryonic stem (hES) cells. These is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 54 rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 and 8 of U.S. Patent No. 11603518. Although the claims at issue are not identical, they are not patentably distinct from each for the following reasons. Claim 54 and claim 1 both claim a composition of cells that result from culturing undifferentiated human pluripotent stem cells in medium comprising a MAPK/ERK inhibitor, a BMP signaling inhibitor, and Retinoic Acid and further differentiating them into neural progenitor cells. Claim 54 and claim 8 both claim a population of neural progenitors cells made from human embryonic stem cells.
Claim 54 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 11920155. Although the claims at issue are not identical, they are not patentably distinct from each other because both claim human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) expressing NG2.
Claims 1, 4-5 9-10, 22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 10, 11, 18-20 of copending Application No. 17406074 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Claim 1, 4, 9, 10 and claim 10 both claim a method of treating a spinal cord injury by injecting human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) into the spinal cord, wherein the dose used is 2 x 10^6 OPC’s. Claim 22 and claim 11 both claim the injection is caudal to the injury site. Claim 5 and claims 18-20 both claim that the spinal cord injury be acute thoracic or cervical. This is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claim 1, 4, 54, 73 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 26, 27, 38 of copending Application No. 18548472 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Claim 54 and claim 1 both claim a cell composition of human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) that come from human embryonic stem cells. Claims 1, 73 and claim 26 both claim a method for treating a spinal cord injury using of human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs). Claim 4 and claim 27 both claim the administration of OPC cells is into the spinal cord. Claim 54 and claim 38 both claim a composition of OPC cells expressing NG2. These is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
Claims 2-3, 22, 29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2, 22, 29 of copending Application No. 18833784 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other for the following reasons. Claim 2-3 and claim 2 both claim administering a 2nd and 3rd dose of human pluripotent stem cell-derived oligodendrocyte progenitor cells (OPCs) to treat a spinal cord injury. Claim 29 and claim 29 both claim the composition is administered 7-14 days after the injury. Claim 22 and claim 22 both claim that the injection is performed caudal to the injury site. This is a provisional nonstatutory double patenting rejections because the patentably indistinct claims have not in fact been patented.
A rejection based on double patenting of the “same invention” type finds its support in the language of 35 U.S.C. 101 which states that “whoever invents or discovers any new and useful process... may obtain a patent therefor...” (Emphasis added). Thus, the term “same invention,” in this context, means an invention drawn to identical subject matter. See Miller v. Eagle Mfg. Co., 151 U.S. 186 (1894); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Ockert, 245 F.2d 467, 114 USPQ 330 (CCPA 1957).
A statutory type (35 U.S.C. 101) double patenting rejection can be overcome by canceling or amending the claims that are directed to the same invention so they are no longer coextensive in scope. The filing of a terminal disclaimer cannot overcome a double patenting rejection based upon 35 U.S.C. 101.
Claims 1, 4, 5, 9, 21, 25, 38, 39, 41, 42, 45, 54, and 73 are rejected under 35 U.S.C. 101 as claiming the same invention as that of claims 1, 4, 5, 9, 21, 25, 37, 39, 40, 42, 45, 54, and 74, respectively of copending Application No. 18833784 (reference application). This is a provisional statutory double patenting rejection since the claims directed to the same invention have not in fact been patented.
Conclusion
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/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638