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 is acknowledged.
In response to the inquiry regarding the status of claim 12 in the restriction requirement mailed 28 November 2025, Applicant noted claim 12 was included in both Group 1 and Group 3. Claim 12 is a part of Group 3, and claim 12 was erroneously included in Group 1. Therefore, the proper claim groupings are as follows:
Group 1, claims 1-8, drawn to a culture material for culturing cells and a culture tool.
Group 2, claims 9-11, drawn to a method for culturing cells.
Group 3, claim 12, drawn to a spheroid formed by the culture method according to claim 9.
Claims 9-12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
Claim Status
Claims 3-9 and 11-12 are currently amended, claims 9-12 have been withdrawn, and claims 1-8 have been considered on their merits.
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.
Claim 4 recites purpose or intended use limitations directed to the claimed product. The “which is for spheroid formation” limitation in the second line of the claim is the intended use of the culture material. 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 4 reads as the culture material according to claim 1.
Claims 5 and 6 recite limitations directed to the intended use limitations of claim 1 which does not add structure to the claimed culture material. Thus, both claims 5 and 6 read as the culture material according to claim 1.
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 1-8 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 phrase “4-methyl-1-pentene polymer (X)”, which renders the claim indefinite because it is unclear whether the limitation in parenthesis is part of the claimed invention. MPEP § 2173.05(d) states, description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. Therefore, it is unclear whether the information in parentheses is exemplary or a limitation of the claim.
Claim 2 recites the phrase “4-methyl-1-pentene polymer (X)”, “copolymer (x1)”, and “ethylene and α-olefins having 3 to 20 carbon atoms (excluding 4-methyl-1-pentene)”, which renders the claim indefinite because it is unclear whether the limitations in parenthesis are part of the claimed invention. MPEP § 2173.05(d) states, description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim. Therefore, it is unclear whether the information in parentheses is exemplary or a limitation of the claim.
Claims 3-8 are included in the rejection because they depend from claim 1 and do not clarify the issue.
Claim Rejections - 35 USC § 103
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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being unpatentable over Tanizaki et al. (JP 2001190267, published 17 July 2001, IDS ref.) in view of Michaljaničová et al. (Vacuum (2014), IDS ref.).
Regarding claim 1, Tanizaki et al. teach a culture vessel formed from a polyolefin resin composition comprising poly 4-methylpentene-1 resin (para. [0007]). Tanizaki et al. teach 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 et al. is silent to the contact angle of the culture surface of more than 100° and
160° or less.
Michaljaničová et al. teach the characteristics of surface properties of PMP (poly-4-methyl-1-pentene) after the modification of its upper layer (abstract). Michaljaničová et al. teach PMP modified by laser treatment, with 500 to 6000 pulses, on laser fluence, has contact angle of between 100° and 106° (Fig 1.). The contact angle, 100° and 106°, falls in the range of 100-160°.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the PMP of Tanizaki et al. with the laser treatment of Michaljaničová et al. with a reasonable expectation of success because Michaljaničová et al. teach PMP is a very resistant material and plasma exposure can change its surface properties well, especially wettability and surface chemistry (p. 190, Conclusion). One would be motivated to modify the PMP of Tanizaki et al. with the laser treatment of Michaljaničová et al. because Michaljaničová et al. teach the effect of plasma exposure is increase of oxygen concentration in the surface layer which causes increase of wettability and polarity and subsequently the biocompatibility (p. 190, Discussion).
Regarding claim 2, Tanizaki et al. teach the polyolefin resin composition used is a composition comprising poly-4-methylpentene-1 resin and other polyolefin resin (para. [0011]). Tanizaki et al. teach examples of α-olefins that may be copolymerized with 4-methylpentene-1 include α-olefins having 2 to 20 carbon atoms (para. [0011]).
Regarding claims 3 and 7, Tanizaki et al. teach 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 of claim 3 directed to the culture surface is not processed to form an uneven surface.
Regarding claims 4-6, based on the claim interpretation above, these claims are interpreted the same as claim 1 and are rejected for the same reasons.
Regarding claim 8, Tanizaki et al. teach a vessel having an opening is formed from a polyolefin resin composition (para. [0023]). The culture vessel of Tanizaki et al. reads as a culture tool comprising a culture surface formed of the culture material according to claim 1.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claims 1-8 are rejected under 35 U.S.C. 103 as being obvious over Kiya et al. (U.S. Patent No. 11254904, effective filing date 18 June 2020, IDS ref.) in view of Michaljaničová et al. (Vacuum (2014), IDS ref.).
The applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2).
Regarding claim 1, Kiya et al. teach a culture material including a 4-methyl-1-pentene polymer for cells, tissues, or organs, and an oxygen permeation rate at a temperature of 23°C and a humidity of 0% of 4500 to 90000 cm3/(m2x24hxatm) (Abstract). Kiya et al. teach the culture material can be used to culture cells, tissues, or organs (column 4).
Kiya et al. do not recite the culture material having a water contact angle of the culture surface of more than 100° and 160° or less. However, Michaljaničová et al. teach the characteristics of surface properties of PMP (poly-4-methyl-1-pentene) after the modification of its upper layer (abstract). Michaljaničová et al. teach PMP modified by laser treatment, with 500 to 6000 pulses, on laser fluence, has contact angle of between 100° and 106° (Fig 1.). The contact angle, 100° and 106°, falls in the range of 100-160°.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the culture material of Kiya et al. with the laser treatment of Michaljaničová et al. with a reasonable expectation of success because Michaljaničová et al. teach poly-4-methyl-1-pentene is a very resistant material and plasma exposure can change its surface properties well, especially wettability and surface chemistry (p. 190, Conclusion). One would be motivated to modify the culture material of Kiya et al. with the laser treatment of Michaljaničová et al. because Michaljaničová et al. teach the effect of plasma exposure is increase of oxygen concentration in the surface layer which causes increase of wettability and polarity and subsequently the biocompatibility (p. 190, Discussion).
Regarding claim 2, Kiya et al. teach the culture material wherein the 4-methyl-1-pentene polymer (X) is at least one type of polymer selected from a 4-methyl-1-pentene homopolymer
(xl) and a copolymer (x2) of 4-methyl-1-pentene and at least one type of olefin selected from ethylene and an α-olefin having 3 to 20 carbon atoms (excluding 4-methyl-1-pentene ) (columns 3-4).
Regarding claims 3 and 7, Kiya et al. teach the culture material which is a film (claim 7), a sheet, or a culture vessel (column 4). A film reads as a thin even surface, which reads on the limitation of claim 3 directed to the culture surface is not processed to form an uneven surface.
Regarding claims 4-6, Regarding claims 4-6, based on the claim interpretation above, these claims are interpreted the same as claim 1 and are rejected for the same reasons.
Regarding claim 8, Kiya et al. teach a culture tool including the culture material or a culture vessel (column 4). The culture material reads as a culture surface.
This rejection under 35 U.S.C. 103 might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C.102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B); or (3) a 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 and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement. See generally MPEP § 717.02.
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 1-14 of U.S. Patent No. 11254904 in view of Michaljaničová et al. (Vacuum (2014), IDS ref.).
Regarding claim 1, patented claim 1 recites the culture material for cells, tissues, or organs, comprising a 4-methyl-1-pentene polymer (X) and having an oxygen permeability at a temperature of 23°C and humidity of 0% of 4500 to 90000 cm3/(m2x24hxatm).
The patented claims do not recite the culture material having a water contact angle of the culture surface of more than 100° and 160° or less. However, Michaljaničová et al. teach the characteristics of surface properties of PMP (poly-4-methyl-1-pentene) after the modification of its upper layer (abstract). Michaljaničová et al. teach PMP modified by laser treatment, with 500 to 6000 pulses, on laser fluence, has contact angle of between 100° and 106° (Fig 1.). The contact angle, 100° and 106°, falls in the range of 100-160°.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the culture material of the patented claims with the laser treatment of Michaljaničová et al. with a reasonable expectation of success because Michaljaničová et al. teach poly-4-methyl-1-pentene is a very resistant material and plasma exposure can change its surface properties well, especially wettability and surface chemistry (p. 190, Conclusion). One would be motivated to modify the culture material of the patented claims with the laser treatment of Michaljaničová et al. because Michaljaničová et al. teach the effect of plasma exposure is increase of oxygen concentration in the surface layer which causes increase of wettability and polarity and subsequently the biocompatibility (p. 190, Discussion).
Regarding the intended use limitations of instant claim 1, patented claim 9 teach a culture vessel, wherein at least a culture surface is formed of the culture material according to claim 1. Patented claim 1 recites the culture material is for cells, tissues, or organs.
Regarding claim 2, patented claim 1 recites the limitations a culture material comprising 4-methyl-1-pentene polymer wherein the content of a structural unit derived from 4-methyl-1-pentene and the content of a structural unit derived from at least one type of olefin selected from ethylene and an α-olefin having 3 to 20 carbon atoms (excluding 4-methyl-1-pentene).
Regarding claims 3 and 7, patented claim 5 recites the culture material according to claim 1, which is a film, a sheet, or a culture vessel (claim 7). A film reads as a thin even surface, which reads on the limitation of claim 3 directed to the culture surface is not processed to form an uneven surface.
Regarding claims 4-6, these claims have been interpreted as possessing the same limitations as claim 1, see claim interpretation above, and are rejected for the same reasons.
Regarding claim 8, patented claim 9 recites a culture vessel, wherein at least a culture surface is formed of the culture material according to claim 1. A culture vessel reads as a culture tool.
Therefore, the invention as a whole is unpatentable over U.S. Patent No. 11254904 in view of Michaljaničová et al.
Claims 1-8 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7, 9, 13-24 of copending Application No. 18/869,816 (reference application) in view of Michaljaničová et al. (Vacuum (2014), IDS ref.).
Regarding claims 1, 3, and 7, reference claim 13 recite a culture vessel wherein the film member (claim 7) contains a 4-methyl-1-pentene polymer. The culture vessel comprising the film member of the reference claim reads as comprising a culture material. The Reference claim 9 recites wherein an oxygen permeability of the film member (A) at a temperature of 23°C and a humidity of 0% is within range of 4,500 to 90,000 cm3/(m2·24h·atm). A film reads as a thin even surface, which reads on the limitation of claim 3 directed to the culture surface is not processed to form an uneven surface.
The patented claims do not recite the culture material having a water contact angle of the culture surface of more than 100° and 160° or less. However, Michaljaničová et al. teach the characteristics of surface properties of PMP (poly-4-methyl-1-pentene) after the modification of its upper layer (abstract). Michaljaničová et al. teach PMP modified by laser treatment, with 500 to 6000 pulses, on laser fluence, has contact angle of between 100° and 106° (Fig 1.). The contact angle, 100° and 106°, falls in the range of 100-160°.
Therefore, it would have been obvious to one of ordinary skill in the art to modify the culture material of the reference claims with the laser treatment of Michaljaničová et al. with a reasonable expectation of success because Michaljaničová et al. teach poly-4-methyl-1-pentene is a very resistant material and plasma exposure can change its surface properties well, especially wettability and surface chemistry (p. 190, Conclusion). One would be motivated to modify the culture material of the reference claims with the laser treatment of Michaljaničová et al. because Michaljaničová et al. teach the effect of plasma exposure is increase of oxygen concentration in the surface layer which causes increase of wettability and polarity and subsequently the biocompatibility (p. 190, Discussion).
Regarding claim 2, reference claim 15 recites wherein the 4-methyl-1-pentene polymer (X) is at least one polymer selected from a 4-methyl-1-pentene homopolymer (X1) and a copolymer (X2) of 4-methyl-1-pentene and at least one olefin selected from ethylene, propylene, and an α-olefin having 4 to 20 carbon atoms. 4 to 20 carbon atoms falls in the range of the instant limitation of 3-20 carbon atoms.
Regarding claims 4-6, these claims have been interpreted as possessing the same limitations as claim 1, see claim interpretation above, and are rejected for the same reasons.
Regarding claim 8, reference claim 1 in view of reference claim 9 and 13, which depend from claim 1, recite the culture vessel comprises a culture space for culturing an object to be cultured. The culture vessel comprising a culture space reads as a culture tool comprising at least a culture surface.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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.
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, James Schultz can be reached at 571-272-0763. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/N.A.H./Examiner, Art Unit 1631
/LAURA SCHUBERG/Primary Examiner, Art Unit 1631