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 .
Claim Status
Claims 1-2, 6, 12, 15-16, 18-19, 24-26, 29-31, 35, 38-40, and 43-44 are pending.
Applicant’s election of the invention of group III drawn to a hematopoietic stem or progenitor cell or mesenchymal stromal cell (claims 25-26, 29-31, 35, and 38) in the reply filed on 07 July, 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1-2, 6, 12, 15-16, 18-19, 24, 39-40, and 43-44 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Therefore, claims 25-26, 29-31, 35, and 38 are pending and are the subject of the present Official Action.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/IL2022/050605, filed 07 June, 2022, which claims priority to United States Provisional Application No. 63/197,530, filed 07 June, 2021. Acknowledgment is made of applicant’s claim for priority.
The earliest possible priority for the instant application is 07 June, 2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 02 June, 2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The Drawings submitted on 07 December, 2023 are accepted by the Examiner.
Claim Objections
Claim 30 is objected to because of the following informalities: The term “imbedded” is old English and has the exact same meaning as “embedded” which itself is the modern spelling of the word and which is used elsewhere in the claims. The term “imbedded” should be replaced with “embedded” for consistency of the claims. Appropriate correction is required.
Claims 31 and 35 are objected to because of the following informalities: The term “at least one of:” followed by each of the listed elements is improper English. For example, the claim 31 reads “at least one of said plasma membrane is biotinylated…” which improperly uses a singular conjugation for the noun “membrane” when the claim is read with only option “a.”. It is recommended to remove “at least one of” from each claim and replace “and” in the seventh line of claim 31 with “or” and to replace “and” in the tenth line of the claim with “or”. Appropriate correction is required. It is further suggested that “said binding domain” in claim 31 be replaced with “said binding domain of the fusion protein”.
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 30-31 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.
Claim 30 recites the limitation "said plasma membrane" in lines 5, 6, 8, and 9. There is insufficient antecedent basis for this limitation in the claim. Claim 30 depends from claim 25 which itself does not recite “a plasma membrane”. Therefore, the metes and bounds of claim 30 cannot be determined and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought by claim 30.
Claim 31 recites the limitation "said plasma membrane" in each of limitations “a.”-“d.”. There is insufficient antecedent basis for this limitation in the claim. Claim 31 depends from claim 30 which itself lists six different alternatives embodiments with only one which provides “a plasma membrane” and four others which themselves recite “said plasma membrane” without proper antecedent basis in themselves (see above). Thus, multiple antecedent plasma membranes exist for “said plasma membrane” in claim 31 with only one of them being set forth properly. Therefore, the metes and bounds of claim 31 cannot be determined and a person having ordinary skill in the art would not be apprised of the scope of the patent protection sought by claim 31.
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 25-26, 29-31, 35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2007138597, published: 06 December, 2007, hereinafter “Askenasy”.
Regarding claim 25, Askenasy claims a method of selecting stem cells comprising contacting the cells with an “apoptosis inducing agent”, wherein said stem cells are hematopoietic stem cells or mesenchymal stem cells, wherein the apoptosis inducing agent is FasL conjugated to a surface (Askenasy, claims 1, 4, 8, 12, and 13). Askenasy discloses cells produced via this method (See FIG. 1; See also, page 9, lines 17-18, “ectopic FasL protein on the surface of donor cells via biotinylation”). Therefore, Askenasy discloses an HSC or MSC having adhered thereto an exogenous death ligand protein as required by instant claim 25.
Regarding claim 26, Askenasy discloses that chimeric streptavidin-FasL was efficiently adsorbed on the surface of the stem cells via biotinylation (Askenasy, page 10, lines3-4). Thus, the FasL of Askenasy is adsorbed as required by instant claim 26.
Regarding claim 29, Askenasy only discloses adsorbed biotinylated FasL and does not disclose the introduction of exogenous DNA or RNA encoding FasL. Thus, the cells of Askenasy do not comprise exogenous DNA or RNA encoding FasL as required by instant claim 29.
Regarding claim 30, the FasL of Askenasy is adsorbed to the plasma membranes of the cells via biotin-streptavidin linkage as required by instant claim 30 (Askenasy, page 10, lines3-4).
Regarding claim 31, the FasL of Askenasy was streptavidin-FasL chimeric protein adsorbed via biotin-streptavidin linkage to the plasma membrane (See FIG. 1; See also, page 9, lines 17-18, “ectopic FasL protein on the surface of donor cells via biotinylation”; page 10, lines3-4). Thus, the streptavidin was coupled to FasL, and the cells were necessarily biotinylated as required by instant claim 31.
Regarding claims 35 and 38, Askenasy discloses FasL as required by instant claims 35 and 38 (See FIG. 1; See also, page 9, lines 17-18, “ectopic FasL protein on the surface of donor cells via biotinylation”; page 10, lines3-4).
Therefore, Askenasy anticipates the invention claimed in instant claims 25-26, 29-31, 35, and 38.
Claims 25-26, 29-31, 35, and 38 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US2010/0040582, published: 18 February, 2010, hereinafter “The ‘582 Publication”. It is noted that the ‘582 Publication shares the same parent, PCT/IL2007/000663 as Askenasy above and the following rejection is presented for completeness of the record since the disclosures of ‘582 and Askenasy are essentially the same.
Regarding claim 25, the ‘582 Publication claims a method of selecting stem cells comprising contacting the cells with an “apoptosis inducing agent”, wherein said stem cells are hematopoietic stem cells or mesenchymal stem cells, wherein the apoptosis inducing agent is FasL conjugated to a surface (‘582, claims 1, 4, 8, 12, and 13). ‘582 discloses cells produced via this method (See FIG. 1; See also, [0063], “ectopic FasL protein on the surface of donor cells via biotinylation”). Therefore, ‘582 discloses an HSC or MSC having adhered thereto an exogenous death ligand protein as required by instant claim 25.
Regarding claim 26, ‘582 discloses that chimeric streptavidin-FasL was efficiently adsorbed on the surface of the stem cells via biotinylation (‘582, [0064]). Thus, the FasL of ‘582 is adsorbed as required by instant claim 26.
Regarding claim 29, ‘582 only discloses adsorbed biotinylated FasL and does not disclose the introduction of exogenous DNA or RNA encoding FasL. Thus, the cells of ‘582 do not comprise exogenous DNA or RNA encoding FasL as required by instant claim 29.
Regarding claim 30, the FasL of ‘582 is adsorbed to the plasma membranes of the cells via biotin-streptavidin linkage as required by instant claim 30 (‘582, [0064]).
Regarding claim 31, the FasL of ‘582 was streptavidin-FasL chimeric protein adsorbed via biotin-streptavidin linkage to the plasma membrane (See FIG. 1; See also, [0063], “ectopic FasL protein on the surface of donor cells via biotinylation”; [0064]). Thus, the streptavidin was coupled to FasL, and the cells were necessarily biotinylated as required by instant claim 31.
Regarding claims 35 and 38, ‘582 discloses FasL as required by instant claims 35 and 38 (See FIG. 1; See also, [0063], “ectopic FasL protein on the surface of donor cells via biotinylation”; [0064]).
Therefore, the ‘582 Publication anticipates the invention claimed in instant claims 25-26, 29-31, 35, and 38.
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 25-26, 29-31, 35, and 38 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-48 of U.S. Patent No. 8,435,786. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims would have been obvious to a person having ordinary skill in the art in view of the patented claims.
Claim 1 of the reference patent claims “A method of selecting stem cells from a heterogeneous population of mammalian cells containing stem cells and non-stem cells, the method comprising contacting the population of cells with a polypeptide agent selected from the group consisting of TNF-.alpha., FasL, Trail and Tweak, wherein said contacting induces apoptosis of non-stem cells while stem cells remain resistant to the apoptotic signal, thereby selecting the stem cells from the heterogeneous population of cells.”
Claim 25 of the instant application claims “A hematopoietic stem or progenitor cell (HSPC) or mesenchymal stromal cell (MSC) having adhered thereto an exogenous death ligand protein.”
The ‘786 patent claims methods, but double-patenting rejections of claims to a method of use based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
The cells instantly claimed would have been obvious to a person having ordinary skill in the art in view of the method of the patented claims because there is no patentable distinction here between the method of making claimed in the reference patent and the instantly claimed cells. The reference patent claims a method of selecting stem cells comprising contacting the cells with an “apoptosis inducing agent”, wherein said stem cells are hematopoietic stem cells or mesenchymal stem cells, wherein the apoptosis inducing agent is FasL conjugated to a surface (claims 1, 4, 8, 12, and 13). Further, instant claim limitations requiring streptavidin-biotinylation conjugation of the FasL to the cell membranes via adsorption are taught in the reference patent disclosure as a species of the cells produced through the method claimed (‘786, col. 6, lines 41-42, line 67; col. 7, lines 1-3). Note that MPEP 804(II)(2)(a) sets forth instances where it is acceptable to utilize the disclosure of a U.S. patent document in conjunction with its claims for ODP rejections. In particular, the MPEP notes that the portion of the specification that supports the patent claims may be considered. The court in AbbVie Inc. v. Kennedy Institute of Rheumatology Trust pointed out that “this use of the disclosure is not in contravention of the cases forbidding its use as prior art, nor is it applying the patent as a reference under 35 U.S.C. 103, since only the disclosure of the invention claimed in the patent may be examined.” In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014). The court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Pfizer, Inc. v. Teva Pharm. USA, Inc., 518 F.3d 1353, 86 USPQ2d 1001 (Fed. Cir. 2008); Geneva Pharmaceuticals Inc. v. GlaxoSmithKline PLC, 349 F3d 1373, 1385-86, 68 USPQ2d 1865, 1875 (Fed. Cir. 2003). Thus, to any extent a patentable distinction can be drawn between the patented method of making and the instantly claimed product via the dependent claim limitations, the reference disclosure renders any such distinction futile by teaching the dependent claim limitations as obvious variants of the cells produced through the reference patent’s method.
Accordingly, instant claims 25-26, 29-31, 35, and 38 would have been obvious to a person having ordinary skill in the art in view of claims 1-48 of U.S. Patent No. 8,435,786.
Additional Comments
US2013/0287750, published: 31 October, 2013 is another application by the instant inventor. The ‘750 application is a continuation application of US 12/227,865 which itself was published as US2010/0040582 (applied above under 35 U.S.C. 102). The ‘750 application has been abandoned and is, therefore, not being applied in the instant case under non-statutory double patenting.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRENDAN THOMAS TINSLEY whose telephone number is (703)756-5906. The examiner can normally be reached Mon-Fri 8:00-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MARIA G LEAVITT can be reached at 571-272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRENDAN THOMAS TINSLEY/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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