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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-6) in the reply filed on 7/22/2026 is acknowledged.
Claims 7-13 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-6 have been considered on the merits.
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 1-6 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 1 discloses the term “E6/E7”. It is not clear if this term intends to point out E6 or E7, or E6 and E7. Clarification is required. For search purpose, the term is interpreted as “E6 and E7”.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Guyonneau-Harmand et al. (US2020/0370015A1)
Regarding claims 1 and 3, Guyonneau-Harmand et al. teach erythroid progenitors produced from hematopoietic stem cells (HSCs) (para. 24-25) that have been genetically modified by transduction with a lentiviral vector carrying human papillomavirus type 16 oncogenes E6 and E7 (HPV16 E6/E7) (para. 115). Guyonneau-Harmand et al. further teach that the ability of HSCs to engage in the erythropoiesis pathway can be improved by overexpressing one or more genes involved in the EPO-R/JAK2/STAT5/BCL-XL pathway and/or in the core erythroid network (CEN) pathway (para. 62), and the HSCs are genetically modified to overexpress a gene encoding BCL-XL (para. 65). Thus, it would have been obvious to a person skilled in the art that the erythroid progenitors produced from the genetically modified HSCs taught by Guyonneau-Harmand et al. would express and contain the Bcl-xL gene and E6/E7 genes as claimed.
The erythroid progenitors of Guyonneau-Harmand et al. are burst-forming units-E (BFU-E), proerythroblasts, basophilic erythroblasts (para. 49), which are identical as claimed in claim 2.
Regarding claim 4 directed to the Bcl-xL gene and the E6/E7 genes being transduced into one vector, Guyonneau-Harmand et al. do not particularly teach the limitation. However, it would have been obvious to a person skilled in the art to produce a vector comprising both Bcl-xL and E6/E7 genes with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Guyonneau-Harmand et al. teach that an expression vector includes one or more nucleic acids or expression cassettes (para. 91), and thus, one skilled in the art would generate a single vector carrying both Bcl-xL and E6/E7 together.
Regarding claim 5, Guyonneau-Harmand et al. teach that the HSCs are genetically modified to overexpress BMI1 gene along with BCL-XL (para. 110).
Regarding claim 6, the limitation is directed to the claimed erythroid progenitor cell is further treated with a TGF-b inhibitor and a PPAR-a agonist. The wherein clause is directed to the method of step using the claimed product, but it does not provide any structure to the claimed product. Thus, the method step disclosed in the wherein clause does not provide patentable weight in determining patentability of the claimed product. Thus, claim 6 is interpreted the same as claim 1.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
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 1-6 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of copending Application No. 18/880,108 in view of Guyonneau-Harmand et al. (supra) and Nakamura et al. (US8,975,072). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of the ‘108 application disclose an immortalized erythroid progenitor cell line trandusced with a BMI1 gene, a BCL-xL gene, and the erythroid progenitor cells are derived from hematopoietic stem cells. The claims of the ‘108 application do not disclose that the immortalized erythroid progenitor cells transduced with E6/E7 genes. However, Guyonneau-Harmand et al. teach erythroid progenitors produced from hematopoietic stem cells (HSCs) (para. 24-25) that have been genetically modified by transduction with a lentiviral vector carrying human papillomavirus type 16 oncogenes E6 and E7 (HPV16 E6/E7) (para. 115). Nakamura et al. teach a method of producing human erythroid progenitor cell line by using an expression cassette capable of inducing expression of E6 and E7 genes of human papillomavirus (HPV) type 16 (col. 4, lines 59-65), and that the expression of HPV-E6/E7 genes is necessary for growth of the erythroid progenitor cell line (col. 8, lines 40-42). It would have been obvious to a person skilled in the art to use the expression cassette expressing E6/E7 of HPV-16 taught by Guyonneau-Harmand et al. and Nakamura et al. for the immortalized erythroid progenitor cell line of the ‘108 application with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because Nakamura et al. teach that the expression of E6/E7 is necessary for growth of the erythroid progenitor cell line. Regarding claim 4, Claim 4 of the ‘108 application discloses that the genes are transduced into the hematopoietic progenitor cell using a viral vector. Regarding claim 6, the limitation is directed to the claimed erythroid progenitor cell is further treated with a TGF-b inhibitor and a PPAR-a agonist. The wherein clause is directed to the method of step using the claimed product, but it does not provide any structure to the claimed product. Thus, the method step disclosed in the wherein clause does not provide patentable weight in determining patentability of the claimed product. Thus, claim 6 is interpreted the same as claim 1, and the claims of the ‘108 application in view of Guyonneau-Harmand et al. and Nakamura et al. would meet the limitation.
This is a provisional nonstatutory double patenting rejection.
Relevant Prior Art
The following prior art is relevant to the subject matter of the claimed invention but not cited in the claim rejections above.
Caulier et al. (2017, Transfusion Clinique et Biologique): English Abstract.
Liu et al. (2021, Molecular Therapy)
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JAMES SCHULTZ can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/TAEYOON KIM/Primary Examiner, Art Unit 1631
Prosecution Insights