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 .
Applicant’s amendment has been considered and entered for the record.
Election/Restrictions
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 03/30/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Specification
The amendment to the specification has been considered and entered for the record.
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 1-4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim s 1-3, 5 and 6 of copending Application No. 18/259,237 (reference application) in view of Watanabe (JP 04-330277 A – hereafter ‘277 and reference will be made the enclosed machine translation). Although the claims at issue are not identical, they are not patentably distinct from each other because S/N 18/259,237 discloses the following limitations:
S/N18/259,237
S/N 18/259,250
1. (Currently Amended) A cell culture member having at least a holding region that holds an adherent cell and contains a polymer compound, wherein at least a part of the holding region is a surface-modified region in which, bringing a first treatment gas containing: a gas containing a fluorine atom; and an inert gas as an optional component into contact without performing plasma treatment, a fluorine atom is directly chemically bonded to a part of carbon atoms and/or silicon atoms constituting the polymer compound, wherein a surface-modifying group that enhances the adhesiveness of the adherent cells is directly chemically bonded to a part of other carbon atoms and/or other silicon atoms constituting the polymer compound in the surface-modified region.
1. (Currently Amended) A cell culture member having at least a holding region that holds an adherent cell and contains a polymer compound, wherein at least a part of the holding region is a surface-modified region in which, after bringing a first treatment gas containing: a gas containing a fluorine atom; and an inert gas as an optional component into contact without performing plasma treatment, and thereafter bringing a compound containing a nitrogen atom into contact without performing plasma treatment, a functional group containing a nitrogen atom is directly chemically bonded to a part of carbon atoms and/or silicon atoms constituting the polymer compound.
2. (Original) The cell culture member according to claim 1, wherein a fluorine atom is directly chemically bonded to a part of other carbon atoms and/or other silicon atoms constituting the polymer compound in the surface-modified region.
2. (Original) The cell culture member according to claim 1, wherein a peak value of binding energy of the fluorine atom, as measured by X-ray photoelectron spectroscopy, is in a range of 680 eV to 690 eV.
3. (Original) The cell culture member according to claim 2, wherein a peak value of binding energy of the nitrogen atom, as measured by X-ray photoelectron spectroscopy, is in a range of 396 eV to 410 eV, anda peak value of binding energy of the fluorine atom, as measured by X-ray photoelectron spectroscopy, is in a range of 680 eV to 690 eV.
3. (Currently Amended) The cell culture member according to claim 1, the surface-modifying group is at least one selected from a group consisting of an -OR' group; a -COOR2 group; a -COR3 group; a hydrocarbon group; a silyl group; a hydrocarbon group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; a silyl group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; a cyano group; a nitro group; a nitroso group; a phosphate group; a sulfonyl group; a thiol group; a thionyl group; and a halogen atom excluding a fluorine atom,R1 and R2 are each independently a hydrogen atom; a metal atom; a hydrocarbon group; a silyl group; a hydrocarbon group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; or a silyl group having at least one of a hetero atom, a halogen atom, or an unsaturated bond, and R3 is a hydrocarbon group; a hydrocarbon group having at least one of a hetero atom or an unsaturated bond; or a silyl group having at least one of a hetero atom or an unsaturated bond.
5. (Original) The cell culture member according to claim 1, wherein a surface-modifying group is directly bonded to a part of still other carbon atoms and/or still other silicon atoms constituting the polymer compound in the surface-modified region, the surface-modifying group is at least one selected from a group consisting of an -OR3 group; a -COOR4 group; a -CORS group; a hydrocarbon group; a silyl group; a hydrocarbon group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; a silyl group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; a cyano group; a nitro group; a nitroso group; a phosphate group; a sulfonyl group; a thiol group; a thionyl group; and a halogen atom excluding a fluorine atom,R3 and R4 are each independently a hydrogen atom; a metal atom; a hydrocarbon group; a silyl group; a hydrocarbon group having at least one of a hetero atom, a halogen atom, or an unsaturated bond; or a silyl group having at least one of a hetero atom, a halogen atom, or an unsaturated bond, andR5 is a hydrocarbon group; a hydrocarbon group having at least one of a hetero atom or an unsaturated bond; or a silyl group having at least one of a hetero atom or an unsaturated bond.
4. (Currently Amended) The cell culture member according to claim 1any one of claims 1 to 3, wherein the polymer compound is at least one polymer selected from a group consisting of polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyvinyl acetate, polyurethane, cyclic polyolefin, polyether ether ketone, polyimide, polyamide imide, polycarbonate, polymethyl methacrylate, polyethylene terephthalate, acrylonitrile-butadiene-styrene, polyacrylonitrile, polyamide, polyvinyl alcohol, polyolefin, and a silicon-containing polymer compound.
6. (Original) The cell culture member according to claim 5, wherein the polymer compound is at least one polymer selected from a group consisting of polyvinyl chloride, polystyrene, polyethylene, polypropylene, polyvinyl acetate, polyurethane, cyclic polyolefin, polyether ether ketone, polyimide, polyamide imide, polycarbonate, polymethyl methacrylate, polyethylene terephthalate, acrylonitrile-butadiene-styrene, polyacrylonitrile, polyamide, polyvinyl alcohol, polyolefin, and a silicon-containing polymer compound.
For claim 1, the limitation of “a surface-modifying group that enhances the adhesiveness of the adherent cells is directly chemically bonded to a part of other carbon atoms and/or other silicon atoms constituting the polymer compound in the surface-modified region” is not explicitly taught by ‘250. However, the surface modification taught by ‘250 would inherently enhance the adhesiveness of the adherent cells as the surface modification of ‘250 is the same as claimed within the instant application.
For claim 3 and 4, claim 1 of ‘250 does not explicitly disclose that a fluorine atom is attached to the surface-modified region of the holding region.
‘277 discloses a substrate that is treated to form a cell culture surface (Overview) that for claims 3 and 4 ‘277 discloses that the surface is also treated with a fluorine plasma and therefore a fluorine is added to the surface and would be connected to a carbon atom ([0014]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to use the fluorine of ‘277 within ‘250 in order to have a surface for cell adhesion ([0011]).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
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.
Claim 1 is rejected under 35 U.S.C. 102a1 as being anticipated by Watanabe (JP 04-330277 A – hereafter ‘277 and reference will be made the enclosed machine translation).
‘277 discloses a substrate that is treated in order to form a surface for culturing cells (Overview) that includes the following limitations for claim 1:
“A cell culture member”: ‘277 discloses a culture substrate ([0007]) that is being interpreted as the cell culture member of the instant application.
“having at least a holding region that holds an adherent cell and contains a polymer compound”: ‘277 discloses that the substrate has a shape capable of culturing cells ([0008]) where this shape is being interpreted as the holding region. This region contains a polymer compound ([0007]) such as a fluorocarbon and an ammonia.
“wherein at least a port of the holding region is a surface-modified region in which ,brining a first treatment gas containing: a gas containing a fluorine atom; and an inert gas as an optional component in contact without performing a plasma treatment a functional group, a fluorine atom is directly chemically bonded to a port of carbon atoms and or silicon atoms constituting the polymer compound, where a surface-modifying group that enhances the adhesiveness of the adherent cells is directly chemically bonded to a part of other carbon atoms and/or other silicon atoms constituting the polymer compound in the surface-modified region.”: ‘277 discloses that the surface ammonia modified ([0014]) where this would have a functional group containing nitrogen (ammonia) is attached to a carbon atom. Furthermore, ‘277 discloses that the surface is also treated with a fluorine plasma and therefore a fluorine is added to the surface and would be connected to a carbon atom ([0014]). These atoms would be bonded to another carbon atom and would enhance the adhesiveness of adherent cells.
Applicant is reminded that process steps in an apparatus are not accorded patentable weight. “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)." Furthermore, the processing steps do not structurally define the instant application over the prior art since the claimed processing steps do not impart a distinctive structural characteristic to the final product. Moreover, the plasma used by ‘277 does not clean or alter the surface as a normal surface plasma treatment and results in the same structure for the attachment of adherent cells.
Therefore, ‘277 meets the limitations of claim 1.
Clam 2 is under 35 U.S.C. 102a1 as being anticipated by Watanabe (JP 04-330277 A – hereafter ‘277 and reference will be made the enclosed machine translation) as evidenced by (Nitrogen XPS Periodic Table ThermoFisher Scientific, thermofisher.com/us/en/home/materials-science/learning-center/periodic-table/non-metal/nitrogen.html, 2026) and (Fluorine XPS Periodic Table Thermo Fisher Scientific, thermofisher.com/us/en/home/materials-science/learning-center/periodic-table/halogen/fluorine.html, 2026).
For claim 2, the nitrogen and fluorine of ‘277 would inherently have a peak binding energy of 396 eV to 410 eV for Nitrogen (Nitrogen – 400 eV) and 680 eV to 690 eV for Fluorine (Fluorine – 688-689 eV for organic fluorine).
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 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Watanabe (JP 04-330277 A – hereafter ‘277 and reference will be made the enclosed machine translation) in view of Dambacher (US 2020/0199318 A1 – hereafter ‘318).
‘318 discloses a surface modified culture chamber, but differs from claim 3 regarding the specific surface-modifying group.
‘318 discloses modifying a plastic surface (Abstract) that for claim 3 includes using a secondary chemical moiety ([0016]) that includes an aryl azide that is being interpreted as the hydrocarbon of the instant application. This allows for the linking molecule to be photo-crosslinked to the plastic surface ([0035]).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of filing to include the aryl azide of ‘318 within ‘277 in order to provide a surface to bond a biological sample. The suggestion for doing so at the time would have been in order to facility a covalent attachment between the surface and the carrier ([0037]).
It should be noted that the limitations drawn to R3, R4 and R5 are optional limitations that do not necessarily have to be addressed in order to meet the claims since the surface-modifying groups are listed as a Markush group.
For claim 4, ‘277 discloses that the substrate, i.e. the polymer compound, is made from polystyrene ([0014]).
Response to Arguments
Applicant's arguments filed 08/26/2026 have been fully considered but they are not persuasive. Applicant argues from the bottom of page 9 to the top of page 10 that Watanabe uses a plasma as part of the process for chemically bonding a fluorine atom versus the claimed invention which does not use a plasma treatment as part of the process to bond a fluorine atom to the surface. This is not found persuasive since there is no indication that plasma process of Watanabe (an ammonia plasma or a fluorine plasma) functions in the same manner as a typical surface plasma treatment in that it cleans and preps the surface, removes functional groups from the surface or alters the surface topography. Therefore, the process of Watanabe anticipates the claimed device in that the end product is the same as the claimed invention.
The first full paragraph discusses the objective of Watanabe in preparing a cell substrate that results in a good cell-culture performance.
Applicant’s remarks reiterate that Watanabe uses a low temperature plasma treatment with a fluorocarbon.
Applicant continues to argue the plasma treatment in the third paragraph on page 10, however, the applicant has not presented evidence as to how the claimed process results in a structurally different structure from the art of record.
In the fourth paragraph on page 19, Applicant makes reference to comparative examples within the instant disclosure to show improved results over the prior art. This is not found persuasive as the comparative examples are drawn to an untreated surface and a surface that is cleaned with a plasma surface treatment before modifying the surface for cell adhesion. These are both different processes from that taught by Watanabe which does not include a plasma cleaning step, and it should be further noted that the Applicant has not presented this data in a manner as to form a nexus between the claimed invention, the presented data and the closest prior art. Therefore, this argument is not found persuasive.
In the paragraph that spans the bottom of page 10 to the top of page 11 reiterates the above remarks.
The first full paragraph on page 11 also reiterates the above remarks which have already been addressed.
Therefore, the claims stand rejected.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Boghosian et al. (US 2020/0207539 A1) which discloses a carrier that contains fluoropolymer substrates.
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 MICHAEL L HOBBS whose telephone number is (571)270-3724. The examiner can normally be reached Variable, but generally 8AM-5PM M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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