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 .
New claims 14-23 are under consideration in this office action.
Claim Objections
Claim 23 is objected to because of the following informalities: The last to lines recite, “a nucleotide encoding amino acid sequences of the transcription factor”. The recitation “sequences” in the plural appears to be grammatically incorrect. Amending to recite, “an amino acid sequence of the transcription factor” would be remedial. Appropriate correction is required.
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 14, 20, and 23 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of copending Application No. 18/786,913 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the instant and copending claims have non-mutually exclusive subject matter.
Regarding instant claim 14, copending claim 16 discloses a method of differentiating pluripotent stem cells into hematopoietic cell comprising adding a Sendai virus vector encoding a SPI1 to a pluripotent stem cell in a culture medium and differentiated the pluripotent stem cell into a hematopoietic cell. The copending claim does not specifically state that hematopoietic cell is the species are a hematopoietic stem cell (HSC) and/blood. However, the only factor being introduced into the pluripotent stem cell is the SPI1 like the instant claim. As such, the resultant cell must at least be HSC and blood lineage cells inherently.
Regarding instant claim 20, the claim product of claim 20 as has the sole structural limitation of only SPI1 as the transcription factor, copending claim 16 solely comprises SPI1 as the transcription factor. Further the remainder of instant claim 20 recites which is capable of differentiating a pluripotent stem cell into HSC and/or blood which is the express method of using the SPI1. Copending claim 16 expressly uses the SPI1 to differentiated pluripotent stem cells in hematopoietic cells. Thus the copending claims also discloses the inducer.
Regarding instant claim 23, copending claim 16 discloses that the SPI1 transcription factor is encoded in Sendai virus vector. Thus the SPI1 is in the form of a nucleic acid encoding the amino acid sequence of the transcription factor. Further the mRNA, synthetic RNA, and protein species would all be obvious variants for providing the transcription factor because these are the well established forms for delivering a transcription factor into a cell.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 20, 21, and 23 is rejected under 35 U.S.C. 101 because the claimed invention is directed to product of nature without significantly more.
According to the 2019 Revised Patent Subject Matter Eligibility Guidelines (2019PEG), the claim is first analyzed to determine if it is directed to one of the acceptable statutory categories of invention (i.e. process, machine, manufacture, or composition of mature). Claims 20, 21, and 23 are drawn to a compositions of matter comprising transcription factor(s). Thus claims 20, 21, and 23 meets the requirements for step 1 of the analysis.
Second, the claim is assessed to determine if it is directed to a judicial exception under step 2A. Under 2019PEG, “directed to” is determined via a two-prong inquiry: (1) Does the claim recite a law of nature, a product of nature, a natural phenomenon, or an abstract idea; and (2) Does the claim recite additional element(s) that integrate the judicial exception into a practical application. The phrase, “integration of a practical application”, requires the presence of an additional claim element(s) or a combination thereof to apply, rely on or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception, such that the claim does not monopolize the judicial exception. (See MPEP § 2106.05 for examples of integration of practical application).
Regarding the first prong (1), claim 20 is directed to a differentiation inducer comprising the sole structural limitation of the transcription factor, SPI1. Claim 23 specifies that the SPI1 is in the form of a SPI1 protein, an mRNA encoding SPI1, a synthetic RNA encoding SPI1 or a nucleic acid encoding SPI1. Bukrinsky et al (Blood 113(9):2038-2046, 2009) report that the EST protein Spi-1 plays a pivotal and widespread role in hematopoiesis in many species (see abstract). As such, SPI1 and the claimed nucleic acid forms of it are products of nature and thus judicial exceptions. Claim 21 is also directed to an differentiation inducer comprising the structural limitations of one or more transcription factors of CDYL2, ETS2, CEBPB, and SALL4. Kucia et al (Blood 120(21): abstract 4745 2012) SALL4 has been demonstrated to be expressed in normal HSC and leukemic cells (abstract). Lynch et al (Nature 480:383-420, 2011) reports that the mammalian transcription factor CEBP plays an essential role during pregnancy (p. 383, col 1, par 1 after abstract). Tymms and Kola (MOLECULAR REPRODUCTION A N D DEVELOPMENT 39:208-214, 1994) report that transcription factors ETS-1 and ETS-2 play distinct biological roles and consequently transactivate different downstream cellular target gene (abstract). Wang et al. (Animal Genetics 39(3):207-216, 2008, abstract only) reports that CDYL2 plays an importance role in spermatogenesis (see abstract). As such, the art describes all of the recited transcription factors in claim 21 are natural products. As such, claim 21 is also directed to multiple judicial exceptions in the alternative. Thus, claim 20, 21 and 23 meets the requirement of step 2A as being directed to a judicial exception.
Regarding prong 2 of Step 2A, the additional element recited in the claims are describing the capacity of the inducer to differentiate pluripotent stem cells into HSC and/or blood cells. These limitations are an intended use that does not impart any further structural or functional limitations into the claimed product. An intended use would not be considered a practical application. As such, claim 20, 21, and 23 do not further recite elements that integrate the judicial exception into a practical application. As such, the claims meet the requirements for being directed to a judicial exception under step 2A.
Third, if a judicial exception is present in the claim, it is further assessed to determine if the claim recites any additional elements or steps that are sufficient to ensure that the claim as a whole amounts to significantly more than the judicial exception. As discussed above, claims 20, 21, and 23 recite products that sole recite the judicial exception and an intended use for the judicial exception. As such, the claims do not recite any additional element that would distinguish the judicial exceptions of the claim from its natural counterparts. Thus, claims 20, 21, and 23 do not meet the requirements for step 2B.
In conclusion, claims 20, 21, and 23 do not meet all the requirements of the 2019PEG and therefore are deemed patent ineligible.
Claim Rejections - 35 USC § 102
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.
(1) Claim(s) 20 and 23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Bukrinsky et al (Blood 113(9):2038-2046, 2009).
Regarding claim 20, Bukrinsky discloses that the EST protein Spi-1 plays a pivotal and widespread role in hematopoiesis in many species (see abstract). As such, Bukrinsky discloses the transcription factor Spi-1 which is the sole structural requirement for the claimed differentiation inducer. As such, Bukrinsky expressly discloses the limitations of the claimed differentiation inducer.
Regarding claim 23, Bukrinsky discloses the transcription factor protein Spi-1 (figure 1 on page 2040). Bukrinsky also discloses mRNA encoding Spi-1 (p. 2039 col 1, first section). Thus Bukrinsky discloses the mRNA, the synthetic RNA, the nucleic acid, and the protein forms as claimed.
In conclusion, the prior art of Bukrinsky anticipates the claims because it expressly discloses all of the structural/functional limitations of the claims.
(2) Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kucia et al (Blood 120(21): abstract 4745 2012).
The claimed inducer has the sole structural/functional limitations of one or more transcription factors of CDYL2, ETS2, CEBPB, and SALL4. Kucia discloses SALL4 has been demonstrated to be expressed in normal HSC and leukemic cells (abstract). As such, the disclosure of SALL4 expressly by Kucia expressly discloses all of the requisite limitations of claim 22.
In conclusion the prior art of Kucia anticipated the claims because it discloses the minimal structural requirements for the claimed inducer.
(3) Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lynch et al (Nature 480:383-420, 2011).
The claimed inducer has the sole structural/functional limitations of one or more transcription factors of CDYL2, ETS2, CEBPB, and SALL4. Lynch discloses that the mammalian transcription factor CEBPB plays an essential role during pregnancy (p. 383, col 1, par 1 after abstract). As such, the disclosure of CEBPB expressly by Lynch expressly discloses all of the requisite limitations of claim 22.
In conclusion the prior art of Lynch anticipated the claims because it discloses the minimal structural requirements for the claimed inducer.
(4) Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tymms and Kola (MOLECULAR REPRODUCTION A N D DEVELOPMENT 39:208-214, 1994).
The claimed inducer has the sole structural/functional limitations of one or more transcription factors of CDYL2, ETS2, CEBPB, and SALL4. Tymms and Kola discloses that transcription factors ETS-1 and ETS-2 play distinct biological roles and consequently transactivate different downstream cellular target gene (abstract). As such, the disclosure of ETS2 expressly by Tymms and Kola expressly discloses all of the requisite limitations of claim 22.
In conclusion the prior art of Tymms and Kola anticipated the claims because it discloses the minimal structural requirements for the claimed inducer.
(5) Claim(s) 22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wang et al. (Animal Genetics 39(3):207-216, 2008, abstract only).
The claimed inducer has the sole structural/functional limitations of one or more transcription factors of CDYL2, ETS2, CEBPB, and SALL4. Wang discloses that CDYL2 plays an importance role in spermatogenesis (see abstract). As such, the disclosure of CDYL2 expressly by Wang expressly discloses all of the requisite limitations of claim 22.
In conclusion the prior art of Wang anticipated the claims because it discloses the minimal structural requirements for the claimed inducer.
Allowable Subject Matter
Claim15-19 are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCIA STEPHENS NOBLE whose telephone number is (571)272-5545. The examiner can normally be reached M-F 9-5:30.
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MARCIA S. NOBLE
Primary Examiner
Art Unit 1632
/MARCIA S NOBLE/ Primary Examiner, Art Unit 1632