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 .
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 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.
Claim Status
Applicant’s arguments dated 3/16/26 have been received and entered in the application.
Claims 21-53 are currently pending and examined on the merits.
Claims 22-23, 36-53 are withdrawn as directed to non-elected inventions.
Claims 21, 24-35 are elected and examined on the merits.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 120 as follows. The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed application, Application Nos. 63/132,934 and 63/252,268, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The prior applications are silent as to each of 1) conjugation, or non-conjugation, of the absorbent polymer to the elastomer (claims 31), 2) use of the polycation poly(L-ornithine) (claims 26, 30), 3) crosslinking the absorbent polymer to the elastomer (claim 32). The earliest mention of each of these limitations occurs in application 17/566,179, dated 12/30/21. Therefore, each of claims 26, 30-32 are accorded an earliest priority dated of 12/30/21.
Claim Interpretation
With respect to claim 33, applicant's invention is interpreted as comprising product-by-process limitations. Under MPEP § 2113, product-by-process claims are not limited to the recited method steps, but are limited only by the resultant structure. Therefore, method steps are only considered in a patentability analysis to the extent that the method steps result in structural changes to the product.
Claim Rejections - 35 USC § 103
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.
Claim(s) 21, 24-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tu et al., Surface modification of poly(dimethylsiloxane) and its applications in microfluidics-based biological analysis. Rev Anal Chem 2012; 31(3-4):177-192 (hereinafter Tu)., in view of Richert et al., pH dependent growth of poly(L-lysine)/poly(L-glutamic) acid multilayer films and their cell adhesion properties. Surface Science Oct 2004; 570(1-2): 13-29 (hereinafter Richert).
Regarding claims 21, 33-35, Tu reviews methods for surface modifications of poly(dimethylsiloxane) (PDMS) for cell-based applications (Abstract). Tu explains that PDMS membranes are non-toxic, easy to fabricate, and low cost, but require surface modifications for biological purposes (Abstract, Introduction). PDMS surface modifications generally fall into three categories gas phase processing, wet chemical methods, and combinations thereof (Introduction). Gas phase processing generally encompass plasma oxidation, ultraviolet/ozone irradiation, chemical vapor deposition, and coating with metals and metal oxides (Gas phase processing of the PDMS surface). Wet chemical methods generally encompass dynamic surface modifications, protein adsorption, layer-by-layer deposition (LBL), silanization, and sol-gel coating (Wet chemical methods). Tu explains that LBL assembly involves the alternating layers of polyanions and polycations into multilayers (Wet chemical methods). Combined strategies involve combining gas phase processing and wet chemical methods, such as plasma treatment with LBL assembly (Combination of gas phase and wet chemical methods). In one embodiment, an air plasma-treated PDMS membrane is then layered with polyvinyl alcohol (PVA) and glycerol (Combination of gas phase and wet chemical methods).
Regarding claim 31, Tu does not explicitly disclose that the PVA is conjugated or not conjugated to the PDMS. However, Tu explains that PDMS surface modifications are generally physical adsorption, covalent conjugation, or a combination of the two methods (Introduction). It would be obvious to one of ordinary skill in the art to try conjugating, or not conjugating, the PVA to the PDMS as choosing from a finite identified means for modifying the PDMS with a reasonable expectation that the PDMS surface could be modified.
Regarding claim 32, Tu does not explicitly disclose that the PDMS is free of crosslinking. However, Tu discloses that oxygen plasma is utilized to cross-link PDMS (Combination of gas phase and wet chemical methods). Thus, there is a suggestion present in Tu that, at least in some embodiments, such as LBL assembly, the PDMS may be free of crosslinking.
Tu does not disclose layering the PDMS substrate and both the PVA and polyelectrolyte layers.
Richert discloses methods of culturing chondrosarcoma cells on a PLL and PGA polyelectrolyte multilayer film (Abstract, Introduction). Richert explains that there is significant interest in developing biomaterial surface coatings which are able to enhance or resist cell adhesion (Introduction). Polyelectrolyte multilayers with alternate depositions of polyanions and polycations allow for tunable properties, including adhesiveness (Introduction). The PEM films may be coated on any kind of material, including PDMS, with any shape (Introduction). Richter explains that modified PDMS substrates are useful for a variety of biological applications, including cell culture, immunoassays, DNA hybridization, etc. (Applications of PDMS surface modification in biological analysis, Table 1). In some embodiments, the substrates may be used for culture or analysis of cancer cells (Applications of PDMS surface modification in biological analysis).
As both Tu and Richter are directed to methods of modifying surfaces, such as PDMS, for biological applications, including cancer cell culture, it would be obvious to one of ordinary skill in the art that the references could be combined. A skilled artisan would be motivated to combine the references as simple substitution of one known LBL coating with another (e.g., glycerol with PLL/PGA), with the predictable result that cancer cells could be cultured on the substrate.
Regarding claims 25-26,28-30, Richter discloses depositing layers of PGA and PLL on glass slides (Preparation of the polyelectrolyte multilayer coated glass slides for cell adhesion experiments).
Regarding claim 27, Richter explains that PEM films with a top layer of PGA demonstrate poor cell adhesiveness,
Regarding claim 24, Richter discloses that films with a top layer of PLL demonstrate strong cell adhesiveness (Introduction, Survey of literature regarding cell adhesion studies on polyelectrolyte multilayer films, Table 1).
Response to Arguments
Applicant's arguments dated 3/16/26 have been fully considered but are not persuasive as explained in detail below.
Claim(s) 21, 24-35 are rejected under 35 U.S.C. 103 as being unpatentable over Tu in view of Richert.
Applicant argues that the prior art fails to teach or suggest a substrate comprising an absorbent polymer being deposited on the surface of an elastomer membrane and polyelectrolyte multilayers wherein the absorbent polymer is direct contact with a polycation or polyanion (Response p6-7). Applicant argues that the polyelectrolytes of Richert are freshly prepared on a rigid substrate and cannot prevent the cell culture substrate from undesirable surface cracks due to prolonged storage at ambient temperature (Response p7-8). Applicant argues that a skilled artisan would therefore not be motivated to include an absorbent polymer in direct contact with polyelectrolyte layers as claimed as Richert does not address the problems solved by the present invention (Response p7-8).
In response, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). Further, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both Tu and Richter are directed to methods of modifying surfaces for biological applications, including cancer cell culture. A skilled artisan would understand that the PLL/PGA LBL coating could be used in place of the glycerol LBL coating as simple substitution of one known LBL coating with another, with the predictable result that cancer cells could be cultured on the substrate. See MPEP § 2143. Therefore, the structure of the prior
Applicant argues that the combination fails to teach or suggest the claimed stratified architecture (Response p8). Applicant argues that Tu teaches a monolithic mixed coating, not a stratified interface (Responsep8). Applicant argues that Richert does not disclose depositing an absorbent polymer on an elastomer not polyelectrolyte multilayers in direct contact with the absorbent polymer (Response p8).
In response, Tu explicitly teaches that LBL assembly involves alternating layers of polyanions and polycations into multilayers. Additionally, Tu discloses layering glycerol on PVA, wherein the PVA is in contact with a PDMS substrate. Tu further teaches that multiple surface modification techniques may be combined. Therefore, there is a clear suggestion present in Tu that LBL assemblies may be combined with absorbent polymers. Richert is used to demonstrate that a PLL and PGA polyelectrolyte multilayer film is a known LBL technique for surface modification which may be used in the methods disclosed by Tu. Thus, the combination obviates the claimed structure.
Applicant argues that the proposed substitution of glycerol in Tu with the PLL/PGA system of Richert is unsupported by either reference (Response p9). Applicant argues that the glycerol coating of Tu is combined with PVA such that a skilled artisan would understand that the PVA should be combined with the PLL/PGA of Richert (Response p9).
As noted above, Tu discloses multiple techniques for surface modification, including an explicit teaching of LBL polyelectrolyte multilayers, and the use of absorbent polymers. The explicitly disclosed combination of Tu is only one of the possibilities either taught or suggested by Tu.
Applicant argues that the current invention solves the previously unrecognized problem of surface cracking on elastic substrates (Response p9).
As discussed above, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
Applicant argues that the prior art fails to achieve stable, storable coatings; Richert only discloses that the solutions always be freshly prepared (Response p10).
Again, the fact that the inventor has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious. See Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985). It is the examiner’s position that the combination would achieve the claimed structure. Thereby, any difference in advantage between the combination and the claimed invention is not sufficient for patentability.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 KARA D JOHNSON whose telephone number is (571)270-1414. The examiner can normally be reached Monday-Friday 8:00-4:00 CT.
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, Peter Paras can be reached on (571) 272-4517. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA D JOHNSON/Primary Examiner, Art Unit 1632
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