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 .
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
This Action is in response to the papers filed on 12/11/2025. Claims 1-6 and 10 are currently pending. Claims 1-2, 4-6, and 10 have been amended and claims 7-9 and 11 have been cancelled by Applicant’s amendment filed on 12/11/2025.
The examiner acknowledges receiving an executed Declaration under 37 C.F.R. § 1.132 executed by Dr. Sophie Domingues on December 10, 2025 (“Domingues Decl.”)
Therefore, claims 1-6 and 10 are examined on the merits to which the following grounds of rejection are applicable.
Priority
The instant application is a 371 of PCT/EP2021/055188 filed on 03/02/2021, which claims foreign priority to EP 20305217.0 filed on 03/02/2020.
Thus, the earliest possible priority for the instant application is 03/02/2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/02/2022 and 05/06/2024 were filed before the mailing date of the non-final office action. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Withdrawn Objections/Rejections in response to Applicants’ arguments or amendments
Objections – Drawings
In view of the Applicant’s amendments and providing the requested drawing, the objection to the drawings as not showing every feature of the invention specified in the claims have been withdrawn.
Objections – Specification
In view of Applicant’s arguments and amendments to the specification, the objection to the specification has been withdrawn.
Claim Rejections - 35 U.S.C. § 101
In view of Applicant’s amendment to the claims cancelling claim 11, the rejection under 35 U.S.C. § 101 has been withdrawn.
Claim Rejections - 35 U.S.C. § 102
In view of Applicant’s amendments to the claims, the rejection of claims 1-7, 9, and 10 (claims 7 and 9 now cancelled) under 35 U.S.C. § 102 as being anticipated by Kogut et al. has been withdrawn. A response to Applicants’ arguments with regard to a withdrawn rejection is moot.
Claim Rejections - 35 U.S. C § 103
In view of Applicant’s amendments to the claims, the rejection of claim 8 (now cancelled) under 35 U.S.C. § 103 as being unpatentable over Kogut et al. in view of Innovative Cell Technologies Inc. has been withdrawn. The argument directed toward the previous rejection no longer applies in view of the new combination of prior art references.
Maintained and Modified objections/rejections in response to Applicants’ arguments or amendments
Claim Objections
Claims 1 is objected to because of the following informalities: At line 15, “wherein the treating (d)”, should recite “wherein”At line 16, “wherein the treating (d) comprises, should recite “wherein treating of step (d) comprises”
At line 25, “wherein the cells obtained after the (e), should recite “wherein the cells obtained after step (e)”
Claim 3 is objected to because of the following informalities: At line 2, “wherein in the culturing (b), the culturing the adherent aggregates or clumps of said pluripotent stem cells” should recite “wherein step (b) further comprises”
Claims 4-6 are objected to because they contain multiple informalities similar to those described above. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
Claims 1-6, and 10 remains 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, line 11 recites “the defined protein matrix.” There is insufficient antecedent basis for the recitation of “the defined protein matrix” in claim 1. Therefore, the claim as written is indefinite.
Claim 1, line 23, step (e), recites “the culture medium”. Multiple media configurations are recited in claim 1 and it is unclear which media, “the culture medium” is referring to. Therefore, the claim as written is indefinite.
Claim 1, line 23, step (e) recites the phrase “cells containing the keratinocytes”. It is unclear what the applicant’s intended meaning for “cells containing the keratinocytes” as a cell cannot contain a keratinocytes. Therefore, the claim as written is indefinite.
Claim 1, line 23, step (e) recites “the keratinocytes”. It is unclear which cells in claim 1 “the keratinocytes” is referring as “keratinocytes”, “aged keratinocytes”, “keratinocyte progenitors,” “K5/Kl4 positive cells exhibiting a keratinocyte-like phenotype” and cells with keratinocyte phenotypes are all recited in claim 1. However, the aged keratinocytes are also referred to as contaminant cells. Applicant must amend the claim to specify which specific cells they referring to.
Claim 1, final line of Pg. 4 recites “(e) culturing the detached cells in the culture medium”. The antecedent of “the culture medium” is unclear. Multiple culture mediums are recited in claim 1. Is the phrase referring to the defined keratinocytes medium containing retinoic acid and BMP-4, the defined keratinocyte medium devoid of BMP-4 and retinoic acid, a separate medium for the culture of the detached cells? As written it is unclear and therefore the claim is indefinite. Applicant must amend to the claim to remedy the lack of clarity.
Claim 2, line two recites “the defined human pluripotent
Claim 6, line 10 is indefinite in its recitation of “a homogenous population of the keratinocytes”. The antecedent of “the keratinocytes” is unclear. Is the term referring to 99% of K5+/Kl4+ keratinocytes, K5/Kl4 positive cells exhibiting a keratinocyte-like phenotype and others? As such the metes and bounds of the claim are indefinite.
Claim 10 recites “the keratinocytes”. It is unclear which cells in claim 1 “the keratinocytes” is referring to as claim 1 recites multiple keratinocytes. Applicant must amend the claim to specify which specific cells they referring to.
Conclusion
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KODYE LEE ABBOTT whose telephone number is (703)756-1111. The examiner can normally be reached M-F 8-5.
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, Maria G. Leavitt can be reached on (571) 272-1085. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KODYE LEE ABBOTT/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634
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