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 .
This action is responsive to the claim set filed on Oct 22, 2024. Claims 1-8 are pending and examined below.
Priority
The present application is a CIP of parent application 16/971,599, which was a 35 U.S.C. 371 national stage filing of the International Application No. PCT/EP2019/000061, filed March 3, 2019, which claims priority to FR1870232, filed on March 5, 2018. Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/971,599, filed on Aug. 20, 2020.
Thus, the earliest possible priority for the instant application is March 5, 2018.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on Oct. 22, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities: the claim, in step (i) recites, “…the bottom of which cell insert consisting of…“. The recitation of “which” is irregular. The claim would be clearer if “which” was changed to “the”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-4 are 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 recites the limitation "the immersed portion of the skin explant". There is insufficient antecedent basis for this limitation in the claim, as “an immersed portion” has not been previously recited.
For the purposes of examination, the claim is interpreted as reciting “…an immersed portion of the skin explant…”
Claims 2-4 do not rectify the antecedent basis and are rejected on the same basis as claim 1.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,158,463 (the ‘463 patent). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘463 patent are a subset of the current application claims. More specifically, the application claims recite a cell culture insert with a skin explant mounted “so as to trap the immersed portion of the skin explant with only the epidermis in contact with air.” This limitation is broader than the ‘463 patent’s skin explant “in a solidifiable liquid matrix,” which is then solidified, thereby trapping an immersed portion of the skin explant with only epidermis in contact with the air. As such, the ‘463 patent recites a narrower invention, wholly subsumed in the applications claims.
Claim 1 of the ‘463 patent teaches the more narrowly defined method of modeling subcutaneous injection claimed in claim 1 of the application.
Claims 2 and 3 of the ‘463 patent teach determining the injectability of the composition, and determining the injection bolus of the composition, paralleling claims 2 and 3 of the application.
Claim 4 of the ‘463 patent teaches a cell culture insert which anticipates the cell culture insert claimed in application claim 5 and 6, as it is a subset of what is encompassed.
Claim 5 of the ‘463 patent teaches a kit having a cell culture insert which obvious the kit including the cell culture insert claimed in application claims 7 and 8, as it is a subset of what is encompassed.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TERESA E KNIGHT whose telephone number is (571)272-2840. The examiner can normally be reached Monday-Friday 9-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maria Leavitt can be reached at 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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/TERESA E KNIGHT/Primary Examiner, Art Unit 1634
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