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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1-8 and 12 in the reply filed on 26 December 2025 was previously acknowledged. In the Official Action mailed on 06 February 2026, the invention groups were corrected and Group 1 now consists of claims 1-8.
Claims 9-12 were previously withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 December 2025.
Applicant submitted new claims 13 and 14 in the reply filed 29 May 2026. As such, claim 13 has been included in Group 1. Claim 14 has been included in Group 2 and has been withdrawn from consideration.
Claim Status
Claims 1-2 and 4-6 are currently amended, claim 3 has been canceled, claims 13 and 14 are new, claims 9-12 and 14 have been withdrawn, and claims 1-2, 4-8, and 13 have been considered on their merits.
Withdrawn Rejections
The nonstatutory double patenting rejections have been withdrawn due to Applicant filing a Terminal Disclaimer on 29 May 2026.
The claim rejections under 35 U.S.C. 112(b) have been withdrawn due to Applicant’s amendments to the claims.
The claim rejections under 103 have been withdrawn due to Applicant’s amendments to the claims and Applicant’s statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the copending application and the claimed invention either were owned by the same person or subject, Mitsui Chemicals Inc., to an obligation of assignment to the same person.
Claim Interpretation
Claim 1 recites purpose or intended use limitations directed to the claimed product. The “for culturing cells, a tissue, or an organ on a culture surface thereof” limitation on the first and second line of the claim is the intended purpose of a culture material. These intended purpose/use limitations do not result in a structural difference, therefore, do not add any additional structural limitation to the culture material.
Claims 5 and 6 recite limitations directed to the intended use limitations of claim 4 which does not add structure to the claimed culture material. Thus, both claims 5 and 6 read as the culture material according to claim 4.
Claim 13 recites purpose or intended use limitations directed to the claimed product. The intended purpose/use limitation does not result in a structural difference, therefore, does not add any additional structural limitation to the culture material. Thus, claim 13 reads as the culture material according to claim 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-2, 4-8, and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanizaki et al. (JP 2001190267, published 17 July 2001, IDS ref., of record) as evidenced by Michaljaničová et al. (Vacuum (2014), IDS ref., of record).
This is a new rejection, necessitated by Applicant’s amendments to the claims. A response to Applicant’s traversal follows the new rejection below.
Regarding claims 1 and 7, Tanizaki teaches a culture vessel formed from a polyolefin resin composition comprising poly 4-methylpentene-1 resin (para. [0007]). Tanizaki teaches the oxygen gas permeability of this film using an OX-TRAN at 23°C and humidity at 0%, is between 9000-25000 cc/m2x24hrxatm (Table 1). Which falls in the range of 4500-90000 cm3/m2x24hrxatm. Tanizaki teaches a culture vessel formed by molding the polyolefin resin composition of the present invention into a film (claim 7) is also a preferred embodiment (para. [0009]). A film reads as a thin even surface, which reads on the limitation directed to the culture surface is not processed.
Tanizaki is silent to the contact angle of the culture surface of more than 100° and
160° or less. However, the contact angle of poly-4-methyl-1-pentene (PMP) is known to be 104° as evidenced by Michaljaničová. Michaljaničová teaches the contact angle of pristine PMP, i.e., prior to surface modification, is 104° (p. 187, Section 3.1. Contact-angle). Therefore, a contact angle of 104° is considered an inherent property of the PMP polymer which has not been processed.
Regarding claim 2, Tanizaki teaches the polyolefin resin composition used is a composition comprising poly-4-methylpentene-1 resin and other polyolefin resin (para. [0011]). Tanizaki teaches examples of α-olefins that may be copolymerized with 4-methylpentene-1 include α-olefins having 2 to 20 carbon atoms (para. [0011]).
Regarding claim 4, MPEP 2122 states the utility of a claimed compound does not need to be disclosed by a reference. In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992). The court found that the claim was anticipated since the compound and a process of making it were taught by the reference. The court explained that "no utility need be disclosed for a reference to be anticipatory of a claim to an old compound." It is enough that the claimed compound is taught by the reference.). See also Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)); ("[P]roof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation."). Since Tanizaki teaches the culture vessel is suitable for culturing any animal or plant cells (para. [0026]) and Tanizaki teaches oxygen permeability suitable for cell proliferation (Table 1), it would be understood that the inherent properties of the culture material suppresses adhesion of cells which would necessarily allow for formation of a spheroid.
Regarding claims 5-6, based on the claim interpretation above, these claims are interpreted the same as claim 4 and are rejected for the same reasons.
Regarding claim 8, Tanizaki teaches a vessel having an opening is formed from a polyolefin resin composition (para. [0023]). The culture vessel of Tanizaki reads as a culture tool comprising a culture surface formed of the culture material according to claim 1.
Regarding claim 13, MPEP 2122 states the utility of a claimed compound does not need to be disclosed by a reference. In re Schoenwald, 964 F.2d 1122, 1124, 22 USPQ2d 1671, 1673 (Fed. Cir. 1992). The court found that the claim was anticipated since the compound and a process of making it were taught by the reference. The court explained that "no utility need be disclosed for a reference to be anticipatory of a claim to an old compound." It is enough that the claimed compound is taught by the reference.). See also Impax Labs. Inc. v. Aventis Pharm. Inc., 468 F.3d 1366, 1383, 81 USPQ2d 1001, 1013 (Fed. Cir. 2006) (citing Rasmusson v. SmithKline Beecham Corp., 413 F.3d 1318, 1326, 75 USPQ2d 1297, 1302 (Fed. Cir. 2005)); ("[P]roof of efficacy is not required for a prior art reference to be enabling for purposes of anticipation."). Since Tanizaki teaches all of the limitations of claim 2, the intended use and properties of the culture material would inherently be present in the disclosure of Tanizaki.
Thus, the reference anticipates the subject matter of claims 1-2, 4-8, and 13.
Response to Traversal
Applicant’s arguments, see pages 5 and 6 of the remarks, filed 29 May 2026, with respect to the combination of Tanizaki and Michaljaničová have been fully considered and are persuasive. Specifically, the amendment to include the culture surface is not processed, as Michaljaničová clearly teaches surface modification. The rejection under 103 of the claims has been withdrawn.
Applicant's arguments filed 29 May 2026 have been fully considered but they are not persuasive. Applicant submits Tanizaki does not teach or suggest the culture material of amended claim 1. However, it is clear in the rejection of claim 1, Tanizaki does teach all of the limitations of the amended claim.
In response to applicant's argument, found on page 6 of the remarks, that Tanizaki not teaching surface wettability and the relationship between oxygen permeability and cell culture performance, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). The arguments directed to Michaljaničová on pages 7 and 8 of the remarks, which also state Michaljaničová teaches away are not persuasive. Specifically, when considering the unmodified culture surface, Applicant points to passage from Michaljaničová at the bottom of page 7, which states the contact angle of pristine PMP is 104°. This is referring to the contact angle prior to modification. As discussed in the rejection above, this falls within the range of the claimed limitations.
Regarding the experimental results discussed on page 9 of the response, these results are not commensurate in scope with the claims. Tanizaki teaches the limitations of the claims and is not required to provide or discuss the effects disclosed in the instant specification.
Applicant’s arguments, see page 10 of the remarks, with respect to the rejection under Kiya and Michaljaničová have been fully considered and are persuasive. The obviousness rejection has been withdrawn due to the statement of common ownership with the Assignee, Mitsui Chemicals Inc.
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 1-2, 4-8, and 13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of copending Application No. 18/706,156 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the reference application anticipates the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
This is a new rejection.
Regarding claim 1, reference claims 1, 4, 6, and 10 disclose a culture vessel for culturing a cell, tissue, or organ wherein the culture vessel comprises a bottom surface layer, which comprises an oxygen permeability of 23°C and a humidity of 0% (reference claim 1), wherein the oxygen-permeable layer contains a 4-methyl-1-pentene polymer (reference claim 4), wherein the oxygen-permeable layer permeability is 20,000 to 60,000 cm3/(m2x24hxatm) (reference claim 6), wherein the water contact angle of the oxygen-permeable layer is 30°-120°. The bottom surface layer of the disclosed culture vessel reads on the culture material of instant claim 1. The permeability and water contact angle fall within and/or overlap the ranges disclosed in the instant claim.
Regarding claim 2, reference claim 5 discloses a copolymer of 4-methyl-1-pentene and at least one olefin selected from ethylene and an a-olefin having 3 to 20 carbon atoms (except for 4-methyl-1-pentene).
Regarding claims 4-6, the limitations of this claim read as intended purpose/use limitations and are not considered to add structure to the claimed culture material. Therefore, the claim reads the same as instant claim 2, from which it depends, and is rejected for the same reasons.
Regarding claim 7, the reference claims disclose a bottom surface layer which reads as a film.
Regarding claim 8, the reference claims disclose a culture vessel comprising the culture material. The culture vessel reads as a culture tool.
Regarding claim 13, the reference claims disclose a culture vessel for culturing cells, tissues, and organs, with the same properties as the claimed culture material. Therefore, since the claim recites the intended use and properties of the culture material, the reference claims would inherently possess these characteristics.
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 NICHOLAS A. HUMPHRIES whose telephone number is (703)756-5556. The examiner can normally be reached Monday - Friday, 7:30am - 4:30 pm.
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/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631
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