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
Applicant’s election without traverse of claims 1 – 9 in the reply filed on 07/16/2026 is acknowledged.
Claims 10 – 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/16/2026.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sareen et al. (U.S. Patent Application No. 20170362574; hereinafter Sareen).
Regarding claim 1, Sareen discloses a novel and efficient method for reprogramming blood to induced pluripotent stem cells (iPSC), in which the blood cells (BC) (para. [0050], BC-iPSCs are derived from…) that are used include monocytes and non-monocytes (T cells) (para. [0052]). Sareen discloses the separation of the whole blood (Fig 1; para. [0026]) into cellular components and the defined media conditions for the reprogramming process (para. [0040]).
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.
Claims 2 – 9 are rejected under 35 U.S.C. 103 as being unpatentable over Sareen in view of Kremer et al. (C.N. Patent Application Publication No. 1643137-A, hereinafter Kremer) and Sonoda (Sonoda Y. Human CD34-negative hematopoietic stem cells: The current understanding of their biological nature. Exp Hematol. 2021 Apr;96:13-26; hereinafter Sonoda). The claims are mapped to the machine translation of CN1643137-A.
Regarding claim 2, Sareen teaches all of the elements of the current invention as stated above except explicitly disclosing separating the first raw material cells into CD34+ and non-CD34+ cells or culturing the separated non-CD34+ cells in a second culture medium to prepare a second raw material cells. Sareen does disclose that the CD34+ cell population is roughly 0.01 – 0.1% of the total peripheral blood cells (para. [0028]) and that these cells can be used for reprogramming.
Kremer discloses, in an invention related to reprogramming monocytes, the use of CD34+ and non-CD34+ (CD34-) (p. 3, 2nd full paragraph) cells for the process. Kremer further discloses that their method prefers stem cells that do not express CD34 (p. 4, bottom of the page).
Sonoda provides the motivation for generating CD34- stem cells, in a review on CD34- hematopoietic stem cells, by disclosing that CD34- stem cells have potent megakaryocyte/erythrocyte differentiation potential (Abstract).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the use of the CD34+ and CD34- cells of Kremer with the reprogramming method of Sareen under the motivation of Sonoda on the megakaryocyte/erythrocyte differentiation potential of the CD34- stem cells.
Regarding claims 3 – 6, Sareen discloses (para. [0052]; [0026] “mature T cells”) the use of T cells to reprogram into iPSCs and mature T cells are non-CD34+ cells. Sareen further discloses (Example 5, para; [0069 – 0070]), Table 1) T cell media with Il-2 (T-cell growth factor) and a non-T cell media (Table 2) for culturing BC precursor cells.
Regarding Claims 7 – 9, Kremer discloses and provides the motivation for the technique by disclosing that programmable stem cells derived from mononuclear cell de-differentiation are cultured in parallel with stem cells derived from liver cells (p. 22, bottom of the page).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize Kremer’s method for testing multiple conditions (e.g., cell types, different media, supplements, or drugs) simultaneously in the combined cell reprogramming protocol of Sareen, Kremer, and Sonoda. This maximizes the use of time and resources while keeping conditions consistent and allows for comparative analysis.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WALTER JACKSON III whose telephone number is (571)272-0247. The examiner can normally be reached M-F 9:00A - 5:00P.
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, Tracy Vivlemore can be reached at 571-272-2914. 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.
/WALTER JACKSON III/Examiner, Art Unit 1638
/Tracy Vivlemore/Supervisory Primary Examiner, Art Unit 1638
Prosecution Insights