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Claims 7-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.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.
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 and 4 are 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, 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 a plasma treatment, and thereafter brining 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”: ‘277 discloses that the surface ammonia modified ([0014]) where this would have a functional group containing nitrogen (ammonia) is attached to a carbon atom.
Regarding the newly added limitation of “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 a plasma treatment, and thereafter brining a compound containing a nitrogen atom into contact without performing plasma treatment”, 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. It should be further noted that this process does not appear to add any additional structural elements that define claimed invention over the prior art.
For claim 2, ‘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]).
For claim 4, ‘277 discloses that an amine group is attached to the surface which would have a structure similar to Formula A where R1 and R2 are hydrogen atoms ([0014]).
Therefore, ‘277 meets the limitations of claims 1, 2 and 4.
Clam 3 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 3, 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 5 and 6 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 4 regarding the specific surface-modifying group.
‘318 discloses modifying a plastic surface (Abstract) that for claim 5 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 6, ‘277 discloses that the substrate, i.e. the polymer compound, is made from polystyrene ([0014]).
Response to Arguments
Applicant's arguments filed 07/16/2026 have been fully considered but they are not persuasive. Applicant argues in the first paragraph on page 11 that the claimed method in claim 1 results in improved cell adhesion over the prior art. Whether this is true or not, the structural elements of the claim require a functional group with a nitrogen atom to be directly chemically bonded to a part of carbon atoms which is taught by Watanabe. Furthermore, the cited paragraphs do not clarify how this process results in a structural difference in the culture member and assuming arguendo that it does, this is a feature relied upon, but not claimed.
Applicant’s argument in the second paragraph on page 11 continues to argue the product-by-process limitation which it should be noted does not provide a structural distinction to the claimed invention. A review of the paragraphs cited by Applicant to support this process did not explicitly or implicitly describe the structural differences between the claimed invention and the prior art.
In the third paragraph, the Applicant details the differences in the process of the instant application and Watanabe. This is not found persuasive as Applicant has not discussed how the claimed process results in a structural distinction over Watanabe and would also be non-obvious. As the claim stands, the final product is still taught by Watanabe.
In the first paragraph on page 12, Applicant summarizes the process differences and it should be noted that while Watanabe does not disclose this process step, but Watanabe discloses the final product. Thus, Watanabe anticipates the claim.
Regarding Applicant’s arguments in the second paragraph makes reference to the Examples and Comparative Examples. Upon reviewing these sections, it is unclear what is structurally distinct from this process versus the prior art. The structure is only discussed in a general manner without the specificity implied by Applicant’s arguments. As it stands, the surface morphology of the cell culture member is not discussed with enough specificity in order to determine the structural differences of the claimed invention versus the prior art.
With regards to applicant’s arguments in the third paragraph on page 12, structural limitations can be defined by either functional limitations or by product-by-process. In this case, the specification does provide either explicit or implicit support for a structural distinction over the prior art. Also, while Applicant has discussed results that provide some indication of improved results, it should be noted that a nexus between the claimed invention, the improved results and the prior art of record have not been provided. Specifically, the comparative examples within the instant application only compare processes that have only a nitriding step after plasma treatment. These examples did not compare the claimed process with a process like Watanabe’s that includes both a nitriding and fluorination step after plasma treatment. Therefore, the device of Watanabe meets the limitations of the claimed invention.
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) discloses a degradable carrier made of a fluoropolymer with a plurality of functional groups attached to the fluoropolymer.
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.
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, 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