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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 2/17/26. Claims 1-3, 5-21 are pending. Claims 1-3, and 5-9 and 16-21 are withdrawn. Claims 10-15 are considered on the merits.
Election/Restriction Requirement
Applicant’s election without traverse of Group II, claims 10-15, in the reply filed on 2/17/26 is acknowledged. Claims 1-3, and 5-9 and 16-21 are withdrawn as non-elected inventions.
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.
Claim(s) 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Idelson (Stem Cell Reports 2018).
These claims contain product by process language on how to produce the retinal pigment epithelial cells (RPE) from pluripotent stem cells that do not express MHC class II proteins. M.P.E.P. § 2113 reads,
“Product-by-process claims are not limited to the manipulations of the recited steps, only the structure implied by the steps.”
“Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
In this case, an RPE cell that does not express MHC class II or its human equivalent, Human Leukocyte Antigen gene complex (HLA) class II, while still expressing HLA class I, will read on the instant claims, no matter how they are produced.
Idelson et al. teach isolated RPE cells, when not exposed to IFN- γ:
Do not express HLA class II antigens, and
Express HLA class I antigens (page 682, left column and Fig 1 A, B, D and E).
Idelson et al. detected HLA class I antigens in these RPE cells by staining with anti-HLA-ABC antibody (pg. 682, left column, 2nd full paragraph) which recognizes the presence of HLA-A, HLA-B, and HLA-B.
Therefore the invention as a whole is anticipated by the reference.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/THANE UNDERDAHL/ Primary Examiner, Art Unit 1699
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