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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05 March 2026 has been entered.
Response to Arguments
Applicant's arguments filed 05 March 2026 have been fully considered but they are not persuasive.
Applicant argues that additional patentable weight should be given to the preamble’s phrase of “…without adversely contaminating the tissue sample” due to the added preamble amendment, “by having a surface for supporting a compound, which surface physically maintains the compound in a consistent physical location relative to the surface.” MPEP 2111.02(I) and 2111.02(II) discuss the weight of preamble statements, differentiating between those that limit structure and those reciting the purpose of the device. Applicant’s amendment to the preamble does provide a structural limitation, that of “a surface for supporting a compound.” However, this structural limitation was already reflected in claim limitation b), “a surface for supporting a compound.” The previously applied rejection under Kemmochi et al teaches a surface for supporting a compound. As the prior art teaches all of the structural features associated with the limitation “without adversely contaminating the tissue sample,” this additional limitation does not define the claim over the prior art.
Applicant argues that the dissolving sealing mask taught by Kemmochi et al would contaminate a tissue sample do not follow. If the mechanism preventing the contamination is a surface which supports the compound, then Kemmochi et al teaches such a mechanism; a surface which supports a compound.
The examiner recognizes applicant’s amendment of “a transparent body connected to the surface at all times during use of the device” as a limitation directed to defining over an embodiment where the transparent body is peeled away or dissolved. However, applicant’s claim and amendments to the claim rely heavily on functional language describing the intended operation of the device. The examiner believes that these functional limitations encompass a much larger range of embodiments than those reflected in applicant’s arguments. In particular, the examiner believes that the dissolving embodiment of Kemmochi et al is still encompassed by the limitation “at all times during use of the device.” Once the body of Kemmochi dissolves, the device is no longer “in use,” as that dissolution is the cue to remove the device from the bath of treatment medium.
The examiner welcomes an interview with applicants to discuss possible amendments to the claims before the next round of prosecution.
Applicant’s arguments with respect to the rejection of claim 1 under 35 USC 102(a)(1) have been fully considered and are persuasive in light of the amendment to the claims. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of 35 USC 103, as obvious over Kemmochi et al in view of Lurvey et al.
Status of Claims
Applicant's amendments to the claims filed 05 March 2026 have been entered. Applicant's remarks filed 05 March 2026 are acknowledged.
Claims 1 and 2 are in status “Currently amended.” Claims 3 – 13 and 23 are in status “Original” or “Previously presented.” Claims 14 – 22 and 24 – 31 are withdrawn.
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 1 – 3, 6 – 8, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Kemmochi (JP 2016197134 A; Cited as JP-6492897 on IDS submitted 21 January 2022. Relied upon translation provided with 10 April 2025 office action) in view of Lurvey et al (WO 2008011581 A2).
With regards to claim 1, Kemmochi teaches;
The claimed “a device for measuring adequate exposure of a tissue sample to a treatment medium…” and “wherein visual inspection of the device after the device and the tissue sample are contacted with the treatment medium provides for measuring the exposure without direct inspection of the tissue sample” has been read on the taught (Description of Embodiments, Slide Glass for Preparation, paragraph 1, “… a slide glass for preparing a preparation by placing a tissue section, and presents a display that can determine whether or not the process included in the preparation process is performed.”; The display that can determine whether or not the process included in the preparation process is performed reads on visual inspection of the device providing for measuring the adequate exposure to a treatment medium without direct inspection of the tissue sample), the device comprising;
The claimed “a compound operable to change a perceived color of the device when the compound is adequately exposed to the treatment medium” has been read on the taught (Figure 1, first display unit 8; <for multiple processes>, paragraph 2, “For example, when a color change from the first color to the second color occurs in the first display unit, it can be confirmed whether or not the first process has been appropriately performed at an arbitrary time point thereafter (the first display unit).”; <First Embodiment: Reaction with Solution>, paragraph 14, “…various substances that react and change color according to the solvent and / or solute of the solution used in the process can be fixed to the display unit.”; The solvent reads on the treatment medium. The substances that react and change color read on the compound operable to change a perceived color of the device.);
The claimed “wherein the compound comprises at least one high dispersed colloidal particle component selected from the group consisting of Silica, Alumina, Titania, mixed oxides, and mixtures thereof” has been read on the taught (<First Embodiment: Reaction with Solution>, paragraph 14, “…first, a colored (other than white) first ink is applied to the display portion, and then it is white when dried and becomes transparent when it reacts with water. If a second ink (a pigment made of hydrophilic silica or the like that has been converted into an ink with a hydrophilic binder) is applied, the first portion is displayed on the display unit when immersed in an aqueous solution used in the process. The color of the ink can be developed.”; The hydrophilic silica reads on highly dispersed colloidal silica.);
The claimed “a surface for supporting the compound” and “a device for measuring adequate exposure to a treatment medium without adversely contaminating the tissue sample by having a surface for supporting a compound, which surface physically maintains the compound in a consistent physical location relative to the surface” has been read on the taught (Figure 1, slide glass 1; Determination Means, <For Multiple Processes>, paragraph 2, “FIG. 1 shows a schematic diagram of a slide glass for preparing a preparation having a discrimination means corresponding to a plurality of process steps.” The slide glass having a discriminating means reads on a surface for supporting the compound.);
The claimed “a transparent body connected to the surface at all times during of the device” has been read on the taught (Figure 3, seal mask material 12; <Seal Mask Material>, paragraph 1, “The discriminating means may be attached so that a removable mask mask [sic] material covers it.”; <Seal Mask Material>, paragraph 3, “There is no particular limitation as long as it has such resistance that it does not. For example, various types of seal mask materials selected from resin films, metal films, seal substrates, and the like can be used.”; The seal mask made from a resin film reads on a transparent body connected to the surface. Figure 3 shows the film as transparent and covering the compound and the surface.);
The claimed “transparent body being impenetrable by the treatment medium and being operable to control contact between the compound and the treatment medium when in a treatment container, wherein the compound is protected from complete immediate exposure to the treatment medium by being between the surface and the transparent body” has been read on the taught (<Seal Mask Material>, paragraph 1, “In the state where the seal mask material is stuck, the display of the display that can determine whether or not the process processing is performed, such as the solution used in the process processing contacting the determination means (display unit) is suppressed. When the material is peeled, the suppression of such contact with the solution is released, and a predetermined display can be presented.”; The stuck seal mask suppressing contact between the display unit and the solution reads on the transparent body being impenetrable by the treatment medium and operable to control contact between the compound and the treatment medium, wherein the compound is protected from complete immediate exposure to the treatment medium by being between the surface and the transparent body. This disclosure is supported by the teaching that removing the sealing mask material releases the suppression of contact between the display and the solution.).
However, Kemmochi fails to teach wherein the compound component is mixed with a polymer, and wherein the surface for supporting the compound is colored.
In the analogous art of medical devices which contain color-changing features, Lurvey et al teaches the following;
“An indicator which changes colors when exposed to a treatment medium” has been read on the taught ([0073], “The indicator has an original color before it has been exposed to an antiseptic agent, such as blue or purple, and may change to another color, such as red or pink or become transparent from opaque, upon exposure of the indicator to an antiseptic agent, such as by contacting the indicator by swabbing with an antiseptic agent.”; The antiseptic agent reads on a treatment medium);
“Wherein the color-change compound is mixed with polymer” has been read on the taught ([0012], “The antiseptic indicator can also include a solvent-absorbing polymer material having the dye incorporated therein. “; The polymer material having the dye incorporated therein reads on a component mixed with a polymer.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slide including a processing indicator and silica compound as taught by Kemmochi with the indicator including a compound mixed with a polymer as taught by Lurvey, in order to create an indicator that displays an image upon contact with a treatment medium, with a controlled length of time over which the indication takes place (Lurvey et al, [00116], “Such a signal source may be, for example, a particular color, a text message, a bar code or other computer readable image, an icon, or other indicator that, when revealed, would provide an indication to the clinician that the access device has been exposed to antiseptic agent.”; [0094], “To extend or control the length of time that the visual indication takes place, the dye may be incorporated in an antiseptic solvent-absorbing polymer matrix material. The antiseptic solvent-absorbing polymer matrix absorbs the antiseptic agent and prolongs contact between the agent and dye so that the visual indication may continue for a more extended time than otherwise.”).
With regards to claim 2, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey.
Kemmochi et al further teaches;
The claimed wherein “the change to the perceived color of the device is effected by an increase in the transparency of the compound” has been read on the taught (<First Embodiment: Reaction with Solution>, paragraph 14, “…first, a colored (other than white) first ink is applied to the display portion, and then it is white when dried and becomes transparent when it reacts with water. If a second ink (a pigment made of hydrophilic silica or the like that has been converted into an ink with a hydrophilic binder) is applied, the first portion is displayed on the display unit when immersed in an aqueous solution used in the process. The color of the ink can be developed.”; The hydrophilic silica reads on highly dispersed colloidal silica.).
However, Kemmochi does not explicitly wherein the surface for supporting the compound is colored.
In the analogous art of medical devices which contain color-changing features, Lurvey et al teaches the following;
“An indicator which changes colors when exposed to a treatment medium” has been read on the taught ([0073], “The indicator has an original color before it has been exposed to an antiseptic agent, such as blue or purple, and may change to another color, such as red or pink or become transparent from opaque, upon exposure of the indicator to an antiseptic agent, such as by contacting the indicator by swabbing with an antiseptic agent.”; The antiseptic agent reads on a treatment medium);
“Wherein the color change is effected by an increase in transparency” has been read on the taught ([0013], “The indicator includes a substrate and a microporous material disposed on the substrate. The microporous material is configured to change from a substantially opaque state to a more transparent state upon exposure to an antiseptic agent.”);
The claimed wherein “the surface for supporting the compound is colored to provide a contrast to enhance a color change effected by the compound when the compound is adequately exposed to the treatment medium” has been read on the taught ([00116], “When in a substantially non-transparent state, the microporous structure may serve to obscure the perceptible signal source, such as a source that is situated there below. Such a signal source may be, for example, a particular color [...] or other indicator that, when revealed, would provide an indication to the clinician that the access device has been exposed to antiseptic agent.”; The source signal which may be a particular color reads on the surface for supporting the compound is colored to provide a contrast.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slide including a processing indicator and silica compound as taught by Kemmochi with the indicator placed on a colored surface as taught by Lurvey, in order to create an indicator that displays an image upon contact with a treatment medium, with a controlled length of time over which the indication takes place (Lurvey et al, [00116], “Such a signal source may be, for example, a particular color, a text message, a bar code or other computer readable image, an icon, or other indicator that, when revealed, would provide an indication to the clinician that the access device has been exposed to antiseptic agent.”; [0094], “To extend or control the length of time that the visual indication takes place, the dye may be incorporated in an antiseptic solvent-absorbing polymer matrix material. The antiseptic solvent-absorbing polymer matrix absorbs the antiseptic agent and prolongs contact between the agent and dye so that the visual indication may continue for a more extended time than otherwise.”).
With regards to claim 3, the device of claim 2 is obvious over Kemmochi et al in view of Lurvey et al.
Kemmochi et al does not explicitly disclose wherein the polymer is selected from the group consisting of: a polyvinylpyrrolidone (PVP), a poly-butyl-methacrylate (PBMA), a polypropylene, and a complex copolymer.
Lurvey et al additionally teaches;
The claimed “wherein the polymer is selected from the group consisting of: a polyvinylpyrrolidone (PVP), a poly-butyl-methacrylate (PBMA), a polypropylene, and a complex copolymer” has been read on the taught ([00109], “Various polymeric materials can be used as an exposure indicator in which a noticeable change in transparency will occur upon wetting with an antiseptic agent… Materials having a refractive index in the above described range and/or hydrophobic/absorption properties include, but are not limited to: […] polypropylene…”; Polypropylene reads on a polymer selected from the group including polypropylene.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of claim 2 as taught by Kemmochi et al in view of Lurvey et al with the polypropylene polymer as taught by Lurvey et al, in order to use a polymeric material that has an appropriate refractive index and absorption properties for use with organic solvents such as common antiseptics (Lurvey et al, [00109], “Preferably, several of such materials have a refractive index within a range approaching or approximating that of the typical antiseptic agent…. Materials having a refractive index in the above described range and/or hydrophobic/absorption properties include, but are not limited to: […] polypropylene…”).
With regards to claim 6, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey et al.
However, Kemmochi et al does not explicitly disclose wherein the surface for supporting the compound is a polymeric film selected from the group consisting of: polyvinyl, polyethylene, polypropylene, or copolymers.
Lurvey et al further teaches;
“A compound operable to change a perceived color of the device when the compound is adequately exposed to the treatment medium” has been read on the taught ([0012], “The indicator includes a dye, for example a solvatochromic dye, which provides a perceptible indication of exposure to an antiseptic agent, in one embodiment, the perceptible indication comprises a color change.”);
“A surface for supporting the compound” has been read on the taught ([0012], “The antiseptic indicator can also include a solvent-absorbing polymer material having the dye incorporated therein.”; The solvent incorporating polymer material reads on a surface. The dye reads on the compound.”);
“Wherein the surface for supporting the compound is a polymeric film” has been read on the taught ([0096], “For example, a microporous polycarbonate membrane embedded with dye may be formed by a phase inversion process. In this method, the membrane is cast as a separate film…”; The polycarbonate membrane cast as a separate film reads on a polymeric film);
“Wherein the polymeric film can be formed from other thermoplastic polymers” has been read on the taught ([00146], “In one embodiment, the antiseptic indicator 150 includes a polymer membrane, such as membranes made from curable acrylate resins or thermoplastic polymers.”; The polymer membrane reads on the polymeric film.);
“Wherein other dye-compatible thermoplastic polymers include polyvinyl, polypropylene, or copolymers” has been read on the taught ([0097], “The polymer solution is preferably made with the same polymer that is used for the construction of the housing... The membrane with encaptured dye will thus be formed…”; [0067], " The housing material may also be constructed of, for example… polypropylene (PP), cyclic olefin copolymer (COC), […] polyvinyl chloride (PVC) or other suitable material.”).
It wound have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by Kemmochi et al with the polymeric film as taught by Lurvey et al in order to extend the visual indicator for a longer period of time ([0097], “The antiseptic solvent-absorbing polymer matrix absorbs the antiseptic agent and prolongs contact between the agent and dye so that the visual indication may continue for a more extended time than otherwise.”).
With regards to claim 7, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey et al.
However, Kemmochi et al fails to teach wherein the surface for supporting the compound is colored to provide a contrast to enhance the perception of a color change effected by the compound when the compound is exposed to the treatment medium and the change to the perceived color of the device is effected by an increase in the transparency of the compound.
Lurvey et al further teaches;
“Wherein the color change is effected by an increase in the transparency of the compound” has been read on the taught ([0013], “The indicator includes a substrate and a microporous material disposed on the substrate. The microporous material is configured to change from a substantially opaque state to a more transparent state upon exposure to an antiseptic agent.”);
“Wherein the surface for supporting the compound is colored to provide a contrast to enhance a color change effected by the compound when the compound is exposed to the treatment medium” has been read on the taught ([00116], “When in a substantially non-transparent state, the microporous structure may serve to obscure the perceptible signal source, such as a source that is situated there below. Such a signal source may be, for example, a particular color [...] or other indicator that, when revealed, would provide an indication to the clinician that the access device has been exposed to antiseptic agent.”; The source signal which may be a particular color reads on the surface for supporting the compound is colored to provide a contrast.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the slide including a processing indicator as taught by Kemmochi with the indicator effected by a change in transparency including a colored surface as taught by Lurvey, in order to create an indicator that displays an image upon contact with a treatment medium for clear communication with the user (Lurvey et al, [00116], “Such a signal source may be, for example, a particular color, a text message, a bar code or other computer readable image, an icon, or other indicator that, when revealed, would provide an indication to the clinician that the access device has been exposed to antiseptic agent.”).
With regards to claim 8, the device of claim 7 is obvious over Kemmochi et al in view of Lurvey et al.
Kemmochi et al does not explicitly disclose wherein the surface is red.
Lurvey et al additionally teaches wherein the surface is red, as read on the taught ([0073], “The changed color, such as red or white or other, indicates that the access site has been swabbed with disinfectant agent.”).
It would have been obvious to one of ordinary skill in the art to modify the device as taught by Kemmochi et al in view of Lurvey et al with the red indicator as taught by Lurvey et al, in order to serve as a convenient and conspicuous signal to the user ([0074], “Where the original color of the indicator is red, orange or the like, it serves as a convenient and conspicuous warning or reminder…”).
With regards to claim 23, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey et al.
Kemmochi et al additionally teaches;
The claimed “wherein the treatment medium comprises at least one of formalin, ethanol, or xylene” has been read on the taught ([Production Process of Tissue Immunostaining Preparation], paragraph 17, “Optional step: Immobilization step… Examples of the immobilization treatment liquid include cross-linking agents such as formalin […] ethanol, […] and cell membrane permeation substances.”; [Production Process of Tissue Immunostaining Preparation], paragraph 12, “(4) Encapsulation process As a final step in preparing the preparation, the tissue section that has undergone the labeling process is dehydrated by immersing it in ethanol (aqueous solution), and then immersed in xylene…”); The steps including formalin, ethanol, and xylene read on the treatment medium comprising at least one of formalin, ethanol, or xylene.).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Kemmochi et al (JP 2016197134 A) in view of Lurvey et al (WO 2008011581 A2, cited on the IDS filed 15 June 2023) as applied to claim 3 above, and further in view of Birss et al (US 20170014780 A1).
With regards to claim 4, the device of claim 3 is obvious over Kemmochi et al in view of Lurvey et al.
However, that combination fails to teach wherein the polymer is a complex of poly-vinyl-butyral co-vinyl-alcohol-co-vinyl acetate (PVB-PVA).
In the analogous art of sensors including dispersed colloidal particles, Birss et al teaches the following;
“A sensing film” as read on the taught ([0006], “Nanoporous carbon-based films produced by the methods of the present invention have a variety of applications including, but not limited to, batteries, flexible batteries, electrodes, sensors, fuel cells, chromatographic materials and filtration.”);
“Wherein the film is manufactured with dispersed colloidal silica particles” as read on the taught ([0061], “1) casting an aqueous precursor mixture that includes carbon precursor(s), surfactant(s), silica-based structure templates, binder(s), plasticizer(s), and additives, on a substrate, 2) drying the mixture to form a film…”; The silica-based structure templates read on dispersed colloidal silica particle—see [0011], “Suitable silica-based templates include, but are not limited to, colloidal silica.”);
“Wherein the silica nanoparticles are dispersed in poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate” as read on the taught ([0014], “In an embodiment, the binder is selected from the group consisting of poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate)…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of claimed invention to modify the compound including colloidal silica particles mixed with a polymer as taught by Kemmochi et al in view of Lurvey et al with the mixture including the polymer poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate) as taught by Birss et al, in order to act as a water-soluble binder and surfactant for the colloidal particles ([0014], “In embodiments, the binder is water soluble .... In an embodiment, the binder is selected from the group consisting of poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate)…”; [0016], “… the synthesis mixture comprises polyvinyl alcohol (PVA), functioning as both the surfactant and the binder…“; [0018], “In an embodiment, the water soluble polymer functions as a binder in the composite film. In a further embodiment, the water soluble polymer performs additional functions in the synthesis mixture, such as acting as a surfactant.”).
Claims 5 and 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kemmochi et al (JP 2016197134 A) in view of Lurvey et al (WO 2008011581 A2) and further in view of Kim et al (US 20120270235 A1).
With regards to claim 5, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey.
However, Kemmochi et al in view of Lurvey fail to teach wherein a hole is formed through the transparent body.
In the analogous art of multi-layer sensors, Kim et al teaches;
“A compound operable to change color when contacted with an analyte” has been read on the taught ([0042], “When the signal generator is the metal nanoparticle, the analyte may be detected through color change of the metal nanoparticle resulting from selective reaction between the receptor and the analyte…”);
“A surface for supporting the compound” has been read on the taught (Figure 1, membrane 1; [0025], “a membrane biosensor […] to which receptors are immobilized (FIG. 1).”);
“A film attached to the surface, operable to control contact between the compound and the analyte, wherein the film has a hole formed through it” has been read on the taught (Figure 11, multi-hole film 11; [0027], “…a biosensor is manufactured by attaching a multi-hole film to a membrane such that sensitivity of the sensor may be adjusted according to a hole size of the multi-hole film.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a transparent body attached to a surface which is operable to control contact between the compound and the analyte as taught by Kemmochi et al in view of Lurvey et al with the multi-hole film as taught by Kim et al, in order to adjust the sensitivity of the underlying sensor as taught by Kim et al ([0027], “…a biosensor is manufactured by attaching a multi-hole film to a membrane such that sensitivity of the sensor may be adjusted according to a hole size of the multi-hole film…”).
With regards to claim 10, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey.
However, Kemmochi et al in view of Lurvey fails to teach wherein the transparent body is glass.
In the analogous art of multi-layer sensors, Kim et al teaches;
“A compound operable to change color when contacted with an analyte” has been read on the taught ([0042], “When the signal generator is the metal nanoparticle, the analyte may be detected through color change of the metal nanoparticle resulting from selective reaction between the receptor and the analyte…”);
“A surface for supporting the compound” has been read on the taught (Figure 1, membrane 1; [0025], “a membrane biosensor […] to which receptors are immobilized (FIG. 1).”);
“A transparent body connected to the surface, operable to control contact between the compound and the analyte” has been read on the taught (Figure 11, multi-hole film 11; [0027], “…a biosensor is manufactured by attaching a multi-hole film to a membrane such that sensitivity of the sensor may be adjusted according to a hole size of the multi-hole film.”; [0033], “For example, the multi-hole film may be composed of […] glass…”; It is well known in the art that glass may be transparent. The multi hole film reads on the transparent body. Adjusting the sensitivity of the sensor reads on controlling contact between the compound and the analyte.);
The claimed “wherein the transparent body is glass” has been read on the taught ([0033], “For example, the multi-hole film may be composed of […] glass.”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a transparent body as taught by Kemmochi et al in view of Lurvey et al with the transparent body formed of glass as taught by Kim et al, in order to allow easy formation of holes in the transparent body, which in turn control the sensitivity of the device and allow measurement with a high degree of sensitivity ([0033], “According to the present invention, the multi-hole film may be made of a material allowing easy formation of the holes.”; [0011], “…the membrane biosensor allows adjustment of sensitivity of the membrane biosensor by adjusting a hole size of a multi-hole film, and may measure analytes with a high degree of sensitivity using a small amount of sample…”).
With regards to claim 11, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey.
However, Kemmochi et al fails to teach wherein the transparent body is a polymeric film.
The claimed “wherein the transparent body is a polymeric film” has been read on the taught ([0033], “For example, the multi-hole film may be composed of polymer....”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a transparent body as taught by Kemmochi et al in view of Lurvey et al with the transparent body formed as a polymeric film as taught by Kim et al, in order to allow easy formation of holes in the transparent body, which in turn control the sensitivity of the device and allow measurement with a high degree of sensitivity ([0033], “According to the present invention, the multi-hole film may be made of a material allowing easy formation of the holes.”; [0011], “…the membrane biosensor allows adjustment of sensitivity of the membrane biosensor by adjusting a hole size of a multi-hole film, and may measure analytes with a high degree of sensitivity using a small amount of sample…”).
With regards to claim 12, the device of claim 11 is obvious over Kemmochi et al in view of Lurvey et al and further in view of Kim et al.
Kemmochi et al in view of Lurvey et al does not explicitly disclose wherein the polymeric film is made of polypropylene.
Kim et al additionally teaches;
The claimed “wherein the polymeric film is made of polypropylene” has been read on the taught (Figure 11, multi-hole film 11; [0027], “…a biosensor is manufactured by attaching a multi-hole film to a membrane such that sensitivity of the sensor may be adjusted according to a hole size of the multi-hole film.”; [0033], “For example, the multi-hole film may be composed of polymer… Specifically, the multi-hole film may be made of […]polypropylene (PP)…” It is well known in the art that polymers such as PP may be transparent. The multi hole film reads on the transparent body. Adjusting the sensitivity of the sensor reads on controlling contact between the compound and the analyte.);
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a transparent body as taught by Kemmochi et al in view of Lurvey et al with the transparent body formed as a of polypropylene as taught by Kim et al, in order to allow easy formation of holes in the transparent body, which in turn control the sensitivity of the device and allow measurement with a high degree of sensitivity ([0033], “According to the present invention, the multi-hole film may be made of a material allowing easy formation of the holes.”; [0011], “…the membrane biosensor allows adjustment of sensitivity of the membrane biosensor by adjusting a hole size of a multi-hole film, and may measure analytes with a high degree of sensitivity using a small amount of sample…”).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kemmochi et al (JP 2016197134 A) in view of Lurvey et al, as applied to claim 1, and further in view of Berberich et al (US 20140186882 A1).
With regards to claim 9, the device of claim 1 is obvious over Kemmochi et al in view of Lurvey et al.
Kemmochi et al additionally teaches wherein the device of claim 1 is used with a treatment container, as read on the taught (Figure 5, Tissue section slide processing container 17; [Container for Tissue Section Slide Processing, paragraph 1, “The container for processing a tissue section slide of the present invention is a tool suitable for use in combination with a tissue section slide prepared using the slide glass of the present invention as described above.”).
However Kemmochi et al in view of Lurvey et al fails to teach wherein the surface for supporting the compound is a surface of a treatment container.
In the analogous art of devices for fixing tissues, Berberich et al teaches;
“A container comprising a sensor which detects fixative reagents” as read on the taught ([0028], “The sample receptacle can be […] a fixing container, and can comprise a sensor that detects when the manufacturing components are mixed with one another.”);
It would have been obvious to one of ordinary skill in the art to modify the reagent indicator slide and container as taught by Kemmochi et al in view of Lurvey et al with the treatment container including a reagent sensor, as taught by Berberich et al, in order to ensure that the sample is not removed too soon or too late from the fixative ([0013], “A processing apparatus embodied in this fashion offers the advantage, in particular, of ensuring that the sample is not removed too soon or too late from the fixative.”).
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Kemmochi et al (JP 2016197134 A) in view of Lurvey et al (WO 2008011581 A2) in view of Kim et al (US 20120270235 A1) as applied to claim 11, and further in view of Kim et al (US 20170093001 A1).
With regards to claim 13, the device of claim 11 is obvious over Kemmochi et al in view of Lurvey et al and further in view of Kim et al.
However, this combination fails to teach wherein the polymeric film is a complex of poly-vinyl-butyral co-vinyl-alcohol-co-vinyl acetate (PVB-PVA).
In the analogous art of polymeric films, Kim et al teaches;
“A porous membrane” as read on the taught ([0013], “According to an aspect of another exemplary embodiment, a method of preparing a composite electrolyte film includes: providing a porous membrane…”);
“Wherein the porous membrane is composed of poly-vinyl-butyral co-vinyl-alcohol-co-vinyl acetate (PVB-PVA)” as read on the taught ([Claim 18], “…wherein the porous membrane comprises a polymer…” [Claim 19], “… wherein the polymer […] comprises at least one selected from… poly(vinyl butyral-co-vinyl alcohol-co-vinyl acetate)…”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device including a transparent polymer membrane that is operable to control contact between the compound and treatment medium as taught by Kemmochi et al in view of Lurvey et al in view of Kim et al with the porous film composed of PVB-PVA as taught by Kim et al, in order to utilize a film that is light, thin, flexible, capable of blocking oxygen, and that can function as a protective membrane ([0006], “Therefore, there is a need for an electrolyte film that is light, thin, and flexible and is capable of blocking oxygen.”; [0075], “Therefore, the composite electrolyte film 400 […] may function as a protective membrane.”).
Conclusion
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/ALISON CLAIRE GERHARD/ Examiner, Art Unit 1797 /LYLE ALEXANDER/ Supervisory Patent Examiner, Art Unit 1797
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