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 .
Status of the Claims
Claims 1-10 are pending and examined herein.
Priority
The present application, filed 03/18/2024, claims foreign priority of JP2023-066206, filed 04/14/2023. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e). Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Information Disclosure Statement
The Information Disclosure Statement(s) filed 06/11/2024 are acknowledged and have been considered.
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 3-5 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.
Regarding claim 3, the limitation reciting the hydrophilic polymer in the hydrophilic polymer layer on the surface of the glass substrate among the two or more hydrophilic polymer layers is unclear because it is uncertain which of the two or more hydrophilic polymer layers is being identified as the hydrophilic polymer layer on the surface of the glass substrate. Claim 1, from which claim 3 depends, broadly recites two or more hydrophilic polymer layers on a surface of the glass substrate and therefore characterizes the plurality of hydrophilic polymer layers collectively as being on the surface of the glass substrate. Claim 3 subsequently refers to one particular hydrophilic polymer layer as the hydrophilic polymer layer on the surface of the glass substrate, but does not expressly specify that this layer is the innermost hydrophilic polymer layer, the layer directly contacting the glass substrate, or otherwise identify which one of the two or more hydrophilic polymer layers is being distinguished from the remaining layer or layers. As a result, it is unclear which hydrophilic polymer layer must contain the hydrophilic polymer having a number-average molecular weight equal to or higher than that of the hydrophilic polymer in the other hydrophilic polymer layer or layers. Accordingly, the metes and bounds of claim 3 are unclear. For purposes of compact prosecution, claim 3 will be interpreted as encompassing an arrangement in which one of the hydrophilic polymer layers is directly on the surface of the glass substrate and the hydrophilic polymer in that layer has a number-average molecular weight equal to or greater than that of the hydrophilic polymer in the remaining hydrophilic polymer layer or layers. Appropriate correction is required.
Claim 5 depends from claim 3 and therefore incorporates all of the limitations of claim 3, including the indefinite identification of the hydrophilic polymer layer on the surface of the glass substrate. Claim 5 further limits the number-average molecular weight of the hydrophilic polymer in the other hydrophilic polymer layers to 30,000 or less, but this additional limitation does not resolve which one of the two or more hydrophilic polymer layers is the particular substrate-side layer against which the other layer or layers are distinguished. Accordingly, claim 5 remains indefinite by virtue of its dependency from claim 3. Appropriate correction is required.
Regarding claim 4, the claim contains the same ambiguity discussed above because it likewise recites the hydrophilic polymer layer on the surface of the glass substrate without expressly identifying which one of the two or more hydrophilic polymer layers is intended to constitute that particular layer. Thus, for the same reasons discussed with respect to claim 3, it is unclear from the claim language which hydrophilic polymer layer is required to contain the polymer having the recited higher number-average molecular weight and which layer is used as the reference layer for the subsequently recited thickness comparison. Accordingly, the metes and bounds of claim 4 are unclear. For purposes of compact prosecution, claim 4 will be interpreted as encompassing an arrangement in which one of the hydrophilic polymer layers is directly on the surface of the glass substrate and has the recited higher number-average molecular weight, and wherein the thickness of that layer is not greater than the combined total thickness of the remaining hydrophilic polymer layer or layers. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhou et al. (US 2020/0263230 A1).
Regarding claim 1, for a polymer-coated glass substrate comprising a glass substrate, Zhou teaches a low binding solid support in which the support comprises a glass substrate ([0032], p. 38). Regarding two or more hydrophilic polymer layers on a surface of the glass substrate, Zhou teaches alternating layers of hydrophilic coatings which are covalently or non-covalently adhered to the glass and expressly teaches forming a first polymer layer on a substrate (e.g., glass) surface and a second polymer layer on a substrate surface ([0032]-[0034], p. 38; Figs. 1-3). Zhou further teaches that the number of layers of the hydrophilic polymer material, deposited on the surface of the disclosed low binding support, may be at least 2 ([0107], p. 45).
Regarding claim 2, wherein the two or more hydrophilic polymer layers comprise the same hydrophilic polymer or different hydrophilic polymers, Zhou expressly teaches that the deposited layers comprise a hydrophilic polymer material, that in some instances, all of the layers may comprise the same material and that in some instances, each layer may comprise a different material ([0107], p. 45).
Accordingly, Zhou discloses, expressly or inherently, each and every limitation of claims 1-2. Accordingly, claims 1-2 are anticipated under 35 U.S.C. 102.
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, 5, 9, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Minagawa et al. (US 2019/0233555 A1) and Tanaka et al. (US 2018/0087017 A1).
Regarding claim 3, with respect to the teachings of Zhou, see the discussion above, which applies equally here. Zhou further teaches that the choice of components used may be varied to alter one or more properties of the support surface, e.g., the surface density of functional groups and / or tethered oligonucleotide primers, the hydrophilicity/hydrophobicity of the support surface, or the three three-dimensional nature (i.e., “thickness”) of the support surface, and identifies hydrophilic polymer materials for forming one or more layers, including polyethylene glycol (PEG) of various molecular weights and branching structures ([0100], p. 44). Zhou expressly teaches that the deposited layers comprise a hydrophilic polymer material, that in some instances, all of the layers may comprise the same material ([0107], p. 45). Zhou further teaches that the multilayer hydrophilic polymeric stratum may comprise three or more polymer layers, and that one or more layers of the hydrophilic polymeric stratum comprise various hydrophilic polymers ([0021], p. 37). Zhou also teaches that polymers used to create one or more layers of any of the multi-layered surfaces may have different molecular weights ([0104], p. 45). Thus, Zhou does not limit the individual layers of its multilayer hydrophilic polymer coating to a single polymer composition, but contemplates selection of both hydrophilic polymer identity and polymer molecular weight according to the desired surface properties.
However, Zhou does not expressly teach or specify that the hydrophilic polymer in the hydrophilic polymer layer on the surface of the glass substrate has a number average molecular weight equal to or higher than that of the hydrophilic polymer in the other hydrophilic polymer layers.
Minagawa teaches a hydrophilic substrate, including on its surface a hydrophilic polymer layer formed of a hydrophilic polymer having a number average molecular weight (Mn) of 40,000 or more ([0006], p. 3). The hydrophilic polymer may be appropriately selected from polymers having hydrophilicity. For example, it may be a homopolymer or copolymer of one or two or more hydrophilic monomers, or a copolymer of one or two or more hydrophilic monomers with an additional monomer ([0017], p. 4). The hydrophilic monomer may be selected from known hydrophilic monomers and specifically identifies 2-methoxyethyl acrylate being particularly preferred ([0019], p. 4). Minagawa further teaches that the hydrophilic polymer having a Mn of 40,000 or more can be used to form a polymer layer having a smoother surface which can be expected to have an improved ability to capture specific cells such as cancer cells, with Mn preferably 60,000 or more, more preferably 70,000 or more ([0014], p. 3). Lastly, Minagawa specifically prepares poly(2-methoxyethyl acrylate) (PMEA) having Mn values of 79195 and 120720, and teaches that that a glass (borosilicate glass) slide was coated with each solution to form the PMEA coating on the glass substrate ([0036]-[0044], p. 5; Table 1, p. 5; FIG. 1, p. 2). However, Minagawa does not expressly teach or specify two or more hydrophilic polymer layers on the surface of the glass substrate.
Tanaka teaches the same PMEA hydrophilic polymer at a lower number-average molecular weight. Specifically, Tanaka teaches thermally polymerizing 2-methoxyethyl acrylate to produce poly(2-methoxyethyl acrylate) (molecular weight Mn = about 15,000, Mw = about 50,000) and thereafter forming a hydrophilic polymer layer from that PMEA ([0052]-[0053], p. 6).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s multilayer hydrophilic polymer-coated glass substrate by selecting PMEA, a known hydrophilic polymer taught by Minagawa and Tanaka, as the hydrophilic polymer for Zhou’s multilayer coating, and to use the same PMEA polymer in the respective layers, with the higher-Mn PMEA taught by Minagawa in the layer on the glass substrate and the lower-Mn PMEA taught by Tanaka in the other hydrophilic polymer layers. Zhou expressly teaches that the hydrophilic polymer material and molecular weight may be varied to alter surface properties and that all layers may comprise the same material; Minagawa provides the specific motivation to select PMEA and to employ a higher-Mn PMEA at the glass surface because such PMEA forms a smoother surface, while Tanaka establishes that lower-Mn PMEA is likewise a known hydrophilic polymer suitable for forming a hydrophilic surface layer. A person of ordinary skill in the art would have had a reasonable expectation of success because both Minagawa and Tanaka use the same PMEA chemistry for hydrophilic surface coatings, Minagawa expressly demonstrates PMEA coating on glass, and Zhou expressly contemplates multilayer hydrophilic coatings formed from selectable hydrophilic polymers and molecular weights; therefore, selecting PMEA for Zhou’s multilayer coating and arranging known higher- and lower-Mn forms of that same PMEA in the respective hydrophilic polymer layers would have been a predictable application of known hydrophilic coating materials according to their known surface-coating properties.
Regarding claim 5, see the discussion of claim 3 above. However, Zhou does not expressly teach or specify that the hydrophilic polymer in other hydrophilic polymer layers has a number average molecular weight of 30,000 or less.
As discussed above, Tanaka expressly teaches producing poly(2-methoxyethyl acrylate) (molecular weight Mn = about 15,000, Mw = about 50,000) and thereafter forming a hydrophilic polymer layer from that PMEA ([0052]-[0053], p. 6). The expressly disclosed Mn of about 15,000 falls within the claimed range of 30,000 or less.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, in making the modification of Zhou discussed above for claim 3, to use Tanaka’s PMEA having an Mn of about 15,000 for the other hydrophilic polymer layers, because Tanaka expressly establishes that PMEA having that Mn is suitable for forming a hydrophilic polymer layer, while Minagawa provides the reason to use the higher-Mn PMEA in the hydrophilic polymer layer on the glass substrate. A person of ordinary skill in the art would have had a reasonable expectation of success because the modification uses the same PMEA polymer in the respective layers, with molecular weights expressly demonstrated in the prior art for hydrophilic surface coatings, and Zhou expressly permits same-material multilayers and recognizes polymer identity and molecular weight as selectable characteristics of its multilayer hydrophilic surfaces.
Regarding claims 9 and 10, with respect to the teachings of Zhou see the discussion above, which applies equally here. However, Zhou does not expressly teach or specify that a scaffold protein is adsorbed onto a surface of an outermost surface layer among the two or more hydrophilic polymer layers, as required by claim 9, and does not expressly teach or specify that the scaffold protein is fibronectin, as required by claim 10.
Tanaka teaches a hydrophilic polymer layer wherein fibronectin is further adsorbed to the surface of the hydrophilic polymer layer ([0019], p. 4). Tanaka further specifically illustrates that a hydrophilic polymer layer is formed on the bottom surface and a part of the side surface of the wells, and fibronectin is adsorbed to the hydrophilic polymer layer ([0029], p. 4; Figs. 1A–1C). Tanaka provides an express technical reason for this modification, teaching that because fibronectin that promotes adhesion (adsorption) of tumor cells is further adsorbed to the surface of the hydrophilic polymer layer, more tumor cells or other specific cells in biological fluid can be adsorbed or adhered to the hydrophilic polymer layer by bringing the biological fluid into contact with the hydrophilic polymer layer ([0019], p. 4). Tanaka also teaches how the claimed adsorption is carried out, namely that fibronectin may be adsorbed to the formed hydrophilic polymer layer by any known method, including bringing the hydrophilic polymer layer into contact with a buffer solution (e.g. phosphate buffered saline (PBS)) containing fibronectin by a known method ([0045], p. 5). Tanaka experimentally demonstrates the modification by forming PMEA as a hydrophilic polymer layer and thereafter teaching that fibronectin was adsorbed to the part coated with poly(2-methoxyethyl acrylate) (hydrophilic polymer layer) ([0052]–[0054], p. 6). Tanaka additionally demonstrates that fibronectin provides the intended functional benefit. In Examples 1–3, Tanaka reports that the amount of adhering cancer cells was greatly improved when a hydrophilic polymer layer with fibronectin adsorbed thereto was used and explains that this resulted from the fibronectin, a protein playing a role in adhesion of cancer cells, adsorbed onto the poly(2-methoxyethyl acrylate) layer ([0067], p. 7).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s multilayer hydrophilic polymer-coated glass substrate by selecting PMEA as the hydrophilic polymer for the exposed outer surface layer, as supported by Minagawa, and adsorbing fibronectin onto that PMEA layer as taught by Tanaka. Zhou expressly permits variation in the hydrophilic polymer composition of its multilayer coating according to the desired surface properties. Minagawa provides a specific reason and reasonable basis to select PMEA for such a glass-supported hydrophilic polymer layer because Minagawa expressly demonstrates formation of a PMEA coating on borosilicate glass. Tanaka then teaches that fibronectin may be adsorbed directly onto a PMEA hydrophilic polymer layer and that such fibronectin adsorption promotes adhesion of desired cells. Because the outermost hydrophilic polymer layer of Zhou’s multilayer structure presents the exposed polymer surface available for contact with the fibronectin-containing solution and subsequent interaction with target cells, one of or ordinary skill in the art would have selected that exposed outermost layer for Tanaka’s fibronectin adsorption treatment. One of ordinary skill in the art would therefore have been motivated to employ a PMEA outer hydrophilic polymer surface in Zhou’s multilayer glass structure when a fibronectin-functionalized, cell-adhesive surface was desired. A reasonable expectation of success would have existed because Minagawa demonstrates compatibility of PMEA with a glass substrate, while Tanaka independently demonstrates adsorption of fibronectin onto PMEA using known methods and the resulting functional cell-adhesion benefit.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Minagawa et al., Tanaka et al., Dias et al. (WO 2007/065720 A2), and Belt et al. (US 2013/0202833 A1),
With respect to the teachings of Zhou, Minagawa, and Tanaka see the discussion above, which applies equally here. However, these references does not expressly teach or specify that the thickness of the hydrophilic polymer layer on the surface of the glass substrate is not more than the thickness of the other hydrophilic polymer layers as a whole.
As discussed above, Zhou already teaches thickness as a selectable characteristic of its multilayer surface ([0100], p. 44),
Dias teaches a coating comprising at least two layers, including the inner layer (i.e. a layer between the outer layer and the surface) is a primer layer comprising a supporting polymer network and an outer functional layer comprising a functional non-ionic hydrophilic polymer (p. 4). The primer layer optionally comprises a functional non-ionic hydrophilic polymer (p. 7). Importantly, Dias expressly teaches that the functional non-ionic hydrophilic polymer in the primer layer may be the same or different as in the functional layer and that inclusion of the hydrophilic polymer in the primer helps to improve adherence of the functional layer to the primer layer, and thus to the article (p. 7). Accordingly, Dias specifically teaches the same hydrophilic polymer may be present in both the substrate-adjacent and subsequent polymer layers. Dias further expressly teaches the reason for making the substrate-adjacent layer relatively thin. Specifically, Dias teaches that the article may be provided with the primer composition in any way to provide a layer of suitable thickness - for improved wear resistance and/or a relatively short curing time it is preferred that the primer composition is applied in a relatively thin layer, particularly to provide a final layer thickness of 20 µm or less, more particularly 7 µm or less, preferably 5 µm or less, and more preferably 3 µm or less. The thickness of the primer layer may be at least 0.1 µm, 0.2 µm, 0.3 µm, or 0.5 µm (p. 13). Dias separately teaches outer-layer thicknesses of at least 0.5 µm, at least 1 µm, or at least 2 µm depending upon the desired coating properties (p. 21).
Belt further corroborates the known multilayer thickness design. Belt teaches that the thickness of the hydrophilic coating according to the invention may be controlled by altering the soaking time, drawing speed, or viscosity of the hydrophilic coating formulation and the number of coating steps, with the dry hydrophilic coating preferably 1-30 µm, most preferably 1-15 µm ([0047], p. 5). Belt further teaches that to apply the hydrophilic coating on the substrate, a primer coating may be used in order to provide a binding between the hydrophilic coating and the substrate. The primer coating facilitates adhesion of the hydrophilic coating to a given substrate ([0049], p. 5), and that typically the thickness is less than 5 um, preferably less than 2 µm or, more preferably less than 1 µm ([0052], p. 5). Belt further discloses that the primer coating comprises a supporting polymer network, the supporting network optionally comprising a functional hydrophilic polymer entangled in the supporting polymer network ([0050], p. 5). Thus, Belt expressly demonstrates the known practice of making the substrate-adjacent coating substantially thinner than the overlying hydrophilic coating.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s multilayer hydrophilic polymer-coated glass substrate by selecting PMEA as the same hydrophilic polymer for the respective hydrophilic polymer layers, employing the higher-Mn PMEA taught by Minagawa in the hydrophilic polymer layer on the surface of the glass substrate and the lower-Mn PMEA taught by Tanaka in the other hydrophilic polymer layers, and selecting the thickness of the hydrophilic polymer layer on the glass surface to be not more than the thickness of the other hydrophilic polymer layers as a whole. Zhou itself provides the teaching, suggestion, or motivation to make these modifications because it expressly identifies polymer composition, molecular weight, and thickness as variables for altering the properties of its multilayer hydrophilic surface; Minagawa provides a specific reason to select higher-Mn PMEA for the glass-surface layer because higher-Mn PMEA produces a smoother polymer surface and is expressly demonstrated as a coating on glass, while Tanaka establishes the same PMEA at a lower Mn as a known hydrophilic polymer layer; Dias further provides an express reason to employ a hydrophilic polymer in a substrate-adjacent layer and a subsequent functional layer and to make the substrate-adjacent layer relatively thin to improve wear resistance and/or shorten curing time; and Belt corroborates that relative coating thickness was a deliberately controllable parameter and expressly teaches a substrate-adjacent layer of less than 5 µm, preferably less than 2 µm and more preferably less than 1 µm, beneath a hydrophilic coating preferably 1–30 µm and most preferably 1–15 µm. One of ordinary skill in the art would have had a reasonable expectation of success in making these modifications because the prior art expressly demonstrates multilayer hydrophilic coatings, the use of the same hydrophilic polymer in successive coating layers, higher- and lower-Mn forms of the same PMEA as hydrophilic coating materials, PMEA coating directly on glass, and deliberate control of relative coating thickness; therefore, applying the known relatively-thin substrate-adjacent-layer arrangement of Dias and Belt to Zhou’s expressly thickness-adjustable same-polymer multilayer structure while employing the PMEA molecular-weight selections taught by Minagawa and Tanaka would have predictably produced the claimed multilayer polymer-coated glass substrate.
Claims 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou et al. in view of Yasuhisa et al. (US 2021/0372895 A1).
With respect to the teachings of Zhou see the discussion above, which applies equally here. However, Zhou does not expressly teach or specify that the two or more hydrophilic polymer layers each comprise a hydrophilic polymer selected from the polymers defined by formula (I) of claim 6, does not expressly teach or specify that the layers each comprise the claimed formula (II) hydrophilic-monomer copolymer with a different monomer of claim 7, and does not expressly teach or specify that the thickness of the two or more hydrophilic polymer layers as a whole is 10 to 1000 nm, as required by claim 8.
Regarding claim 6, Yasuhisa expressly teaches that the hydrophilic polymer is preferably at least one selected from the group consisting of polymers represented by the following formula (I) ([0072], p. 8). Yasuhisa further defines formula (I) such that R51 represents a hydrogen atom or a methyl group; R52 represents an alkyl group; p represents 1 to 8; m represents 1 to 5; and n represents the number of repetitions ([0073], p. 8), which corresponds to the variables recited in instant claim 6. Yasuhisa provides suitable examples of the polymers of formula (I) including polymers represented by the following formula (I-1) ([0074]-[0075], p. 8). Yasuhisa also provides a specific reason for selecting such polymers, teaching that the hydrophilic polymers of formula (I) are particularly suitable from the standpoints of surface uniformity and irregularities of the hydrophilic polymer layer, and other properties ([0079], p. 8).
Regarding claim 7, Yasuhisa expressly teaches that the hydrophilic polymer may also suitably be a copolymer of at least one hydrophilic monomer selected from the group consisting of compounds represented by the following formula (II) with another monomer ([0076], p.8). Yasuhisa further teaches that in formula (II), R51, R52, p, and m are as defined above ([0077], p. 8), thereby providing the same variable definitions recited in instant claim 7. Yasuhisa further provides suitable examples of the compounds of formula (II) including compounds represented by the following formula (II-1) (([0078], p.8). Yasuhisa further identifies the additional monomer component, teaching that the additional monomers of the copolymer may be selected from appropriate monomers which do not inhibit the advantageous effect of the hydrophilic polymer, with examples including aromatic monomers such as styrene, vinyl acetate, and N-isopropylacrylamide ([0070], p. 8).
Regarding claim 8, Yasuhisa expressly teaches that the hydrophilic polymer layer (the layer formed of the hydrophilic polymer) preferably has a thickness of 10 to 1000 nm, more preferably 30 to 700 nm, still more preferably 50 to 400 nm ([0081], p. 8). Yasuhisa further provides a technical reason for selecting thickness within this range, teaching that when the thickness is adjusted within the disclosed range, selective capture of cancer cells and low adsorption of other proteins and cells can be well achieved ([0081], pp.8–9).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zhou’s multilayer hydrophilic polymer-coated glass substrate by selecting, for the hydrophilic polymer layers, the formula (I) hydrophilic polymers or formula (II) hydrophilic-monomer copolymers taught by Yasuhisa, and by selecting the overall thickness of Zhou’s multilayer hydrophilic polymer coating to fall within 10 to 1000 nm. Zhou itself provides the teaching, suggestion, or motivation to make these modifications because it expressly teaches that both polymer composition and the three-dimensional thickness of its multilayer hydrophilic surface may be varied to alter surface properties; Yasuhisa supplies the specific known polymer chemistries and expressly teaches that formula (I) polymers are particularly suitable for controlling surface uniformity and irregularities, that formula (II) hydrophilic monomers may be copolymerized with additional monomers such as styrene, vinyl acetate, and N-isopropylacrylamide, thereby providing a copolymer comprising the formula (II) hydrophilic monomer with a different monomer, and further teaches that a hydrophilic polymer coating thickness of 10 to 1000 nm provides useful surface performance. One of ordinary skill in the art would have had a reasonable expectation of success because both references concern hydrophilic polymer coatings on substrates, Yasuhisa expressly teaches the claimed polymer classes as suitable hydrophilic coating materials and demonstrates coating such polymers on glass substrates ([0037], p. 5; [0095]-[0100], pp. 9-10), while Zhou expressly permits selection of hydrophilic polymer identity and coating thickness in its multilayer architecture; therefore, applying Yasuhisa’s known polymer selections and nanometer-scale coating-thickness range to Zhou’s multilayer hydrophilic surface would have been expected to predictably provide a hydrophilic multilayer coating having controlled surface properties.
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 1-3 and 5-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of copending Application No. 18/967346 in view of Zhou et al., Minagawa et al., Tanaka et al., and Yasuhisa et al., as applicable.
Regarding claim 1, claim 1 of the copending application claims a polymer-coated glass substrate comprising a glass substrate and a hydrophilic polymer layer comprising a blend of hydrophilic polymers having different molecular weights. The claim differs from instant claim 1 principally in reciting the polymers as a blend in one hydrophilic polymer layer rather than as two or more hydrophilic polymer layers. Zhou teaches glass substrates having multilayer hydrophilic polymer coatings, including a second hydrophilic polymer coating layer and structures containing first, second, and additional polymer layers. Zhou further teaches that one or more PEG layers of different molecular weights may be provided on glass and that multilayer coatings may be built sequentially. It would therefore have been obvious to arrange the hydrophilic polymers claimed in the copending application in the known multilayer configuration of Zhou to obtain a multilayer hydrophilic polymer-coated glass surface.
Regarding claim 2, Zhou further teaches that multilayer hydrophilic coatings may comprise the same material in all layers or different materials in the respective layers. Thus, employing the same hydrophilic polymer or different hydrophilic polymers in the multilayer configuration would have been an obvious selection from the alternatives expressly taught by Zhou.
Regarding claim 3, claims 1–3 of the copending application already require hydrophilic polymers having different number-average molecular weights, including differences of at least 30,000 or 50,000. Zhou teaches that polymer identity and molecular weight are selectable characteristics of its multilayer hydrophilic coating and permits the same polymer material in multiple layers. Minagawa further teaches hydrophilic PMEA coatings having Mn of 40,000 or more, preferably 60,000 or 70,000 or more, because the higher-Mn polymer forms a smoother hydrophilic surface, and demonstrates PMEA coatings directly on glass. Tanaka further teach lower Mn (Mn = about 15,000) hydrophilic polymers suitable for forming hydrophilic polymer layers. It would therefore have been obvious to place the higher-Mn form of the same hydrophilic polymer in the layer adjacent the glass surface while employing a lower-Mn form in another hydrophilic polymer layer.
Regarding claim 5, the discussion of claim 3 applies. Tanaka further teach lower Mn (Mn = about 15,000) hydrophilic polymers suitable for forming hydrophilic polymer layers, while Zhou expressly contemplates molecular-weight selection among its multilayer polymers. Accordingly, selection of a hydrophilic polymer having a number-average molecular weight of 30,000 or less for the other hydrophilic polymer layer would have been an obvious molecular-weight selection in the multilayer arrangement.
Regarding claim 6, the multilayer modification discussed above with respect to claim 1 applies equally here. Claim 4 of the copending application already claims hydrophilic polymers having the Formula (I) chemistry corresponding to that recited in instant claim 6.
Regarding claim 7, the multilayer modification discussed above with respect to claim 1 applies equally here. Claim 5 of the copending application claims hydrophilic copolymers based on the Formula (II) monomer together with a different monomer.
Regarding claim 8, claim 6 of the copending application claims a hydrophilic polymer-layer thickness of 30 to 3000 nm, which overlaps the instant range of 10 to 1000 nm. Yasuhisa additionally teaches hydrophilic polymer coatings having a thickness of 10 to 1000 nm and explains that adjusting thickness within that range provides useful surface properties. In view of Zhou’s multilayer architecture and its express teaching that coating thickness is a selectable surface parameter, selecting the combined overall thickness of the hydrophilic polymer layers in the multilayer configuration within the claimed 10 to 1000 nm range would have been an obvious thickness selection.
Regarding claim 9, claim 7 of the copending application already claims a scaffold protein adsorbed onto a surface of the hydrophilic polymer layer. Upon employing the multilayer configuration taught by Zhou, the exposed surface for adsorption would be the surface of the outermost hydrophilic polymer layer. Zhou expressly identifies an outermost layer of its multilayer hydrophilic polymeric stratum.
Regarding claim 10, claim 8 of the copending application expressly recites that the scaffold protein is fibronectin.
Accordingly, claims 1–3 and 5–10 are not patentably distinct from the claims of the copending application in view of the cited prior art. This is a provisional nonstatutory double patenting rejection.
Conclusion
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/E.O./Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 August 20, 2026
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