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 I, claims 1-4 in the reply filed on 03/30/2026 is acknowledged.
Claims 5-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
It should be noted that this case has been transferred to another examiner due to Applicant’s election of Group I.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/23/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 04/09/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement (IDS) submitted on 04/07/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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. (Original) 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 a fluorine atom is directly chemically bonded to a part of carbon atoms and/or silicon atoms constituting the polymer compound.
. (Original) 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 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[[ or 2]], wherein a surface-modifying group 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,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 toclaim 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 3 and 4, claim 1 of ‘250 does not explicitly discloses 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 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”: ‘277 discloses that the surface ammonia modified ([0014]) where this would have a functional group containing nitrogen (ammonia) is attached to a carbon atom.
For claim 1, ‘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, ‘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]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Trainor et al. (US 2021/0123008 A1) discloses a cell culture chamber.
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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/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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