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 7/8/26. Claims 1, 3, 5-21, and 23-25 are pending. Claims 1, 3, 5-9, and 16-21 are withdrawn. Claims 10-15, and 23-25 are considered on the merits.
Response to Applicant’s Arguments and Amendments
In the response submitted by the Applicant the following 35 U.S.C § 102 rejections are withdrawn:
Claim(s) 10-15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Idelson (Stem Cell Reports 2018).
The Applicant’s amendments “wherein the MHC class II-related gene is destroyed or modified” necessitated the above withdrawals. All arguments drawn to these rejections are now considered moot.
Claim Interpretation
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 the instant case RPE cells with a destroyed or modified MHC class II-related gene will read on the current claimed cells.
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, and 23-25 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Petrus-Reurer et al. (Stem Cell Reports, published online Mar 19, 2020, in IDS 12/07/23). The Applicant did provide a copy of this reference. However another copy with the supplemental data is submitted since this is critical to the rejection.
Petrus-Reurer et al. teach stem-cell derived retinal pigment epithelial cells (RPE cells) with the class II major histocompatibility complex trans activator gene (CIITA, a HLA Class II related gene) knocked out (SKO-CIITA RPE cells) to eliminate expression of HLA class II receptors (see abstract and pg. 654, col 2, top) HLA-DP, HLA-DQ, and HLA-DR while still presenting HLA class I receptors including HLA-A, HLA-B, and HLA-C (see Figure S5(B)).
Therefore the invention as a whole is anticipated by the reference.
Other Prior Art of Record
WO 2020/018615 is close prior art of record and would likely render the claims obvious in view of [0045 and 00142].
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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
