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 1-4, 11, 14, 29, 40, 44, 50, 55, 73, 79, 80, and 87) in the reply filed on 4/17/26 is acknowledged.
Claims 108, 112, 120, 175, and 176 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group/species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/17/26.
Information Disclosure Statement
Receipt is acknowledged of the Information Disclosure Statement filed July 23, 2025. The Examiner has considered the references cited therein to the extent that each is a proper citation. Please see the attached USPTO Form 1449.
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)(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(s) 1-4, 11, 14, 29, 40, 44, 55 and 73 is/are rejected under 35 U.S.C. 102 (a2) as being anticipated by Harel et al. (US 2013/0296165).
With regards to instant claim 1, Harel teaches a dry stabilizing composition (see abstract) comprising a eukaryotic cell (see 0048, intrinsically a mammalian cell, thus anticipated a mouse or a human cell), a sugar i.e., non-reducing sugar disaccharide (see 0053, as required by instant claims 1 and 11), an antioxidant i.e., vitamins (see 0048, as required by instant claim 1 and 14), a polymer (i.e., polyvinylpyrrolidone (see 0173, as required by instant claim 15) and a polysaccharide (see0060 and claim 1, as required by instant claim 29) and protein (see 0063, as required by instant claim 40), wherein the sugar is from 10% (see 0067, as required by instant claim 44), and the concentration of the polymer is 0.01% (see 0173 as required by instant claim 55) and comprises a buffer (see 0115, as required by instant claim 73).
Therefore the claims are anticipated by Harel.
Claim(s) 1-4, 11, 14, 29, 40, 44, 55, 73, 79 and 80 is/are rejected under 35 U.S.C. 102 (a2) as being anticipated by Du Changchun et al. (KR 20160145624)
Du Changchun teaches a composition comprising a eukaryotic cell (see translation, as required by instant claims 1 and 79) wherein the eukaryotic cell is a mammalian cell/mouse cell as required by instant claims 2- 3 and 4, see translation sec 1) and a sugar or alcohol sugar that is a non-reducing sugar such as trehalose (as required by instant claims 1 and 5), and antioxidant (see sec. F), a polymer i.e., polyvinylpyrrolidone (as required by instant claim 1 and 29, see sec e) and epigallocatechin (see translation, as required by instant claim 79) in a pharmaceutical acceptable carrier wherein the carrier is an excipient (see sec F, as required by instant claim 80).
The claims are therefore anticipated.
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.
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) 1-4, 11, 14, 29, 40, 44, 55, 73, 79, 80 and 87 is/are rejected under 35 U.S.C. 103 as being unpatentable over Du Changchun et al. (KR 20160145624).
Changchun is applied here as it relates to claims 1-4, 11, 14, 29, 40, 44, 55, 73 and 79.
However fails to teach the composition show decrease of less than 10% change in viability when compared to the pharmaceutical composition within 1 hour of preparation after storage at a temperature for 1 day as required by instant claim 87. Nonetheless Changchun teaches cell viability can be determined. Therefore it is within the purview of the skilled artisan to determine the viability and storage condition. Thus it would have been obvious to check the cell viability within an hour.
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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, Robert A. Wax can be reached at 571-272-0623. 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.
/SHIRLEY V GEMBEH/ Primary Examiner, Art Unit 1615 4/29/2026
Prosecution Insights