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 .
Claim Rejections - 35 USC § 112
The claim rejection(s) under pre-AIA 35 U.S.C. 112 2nd Paragraph or AIA 35 U.S.C. 112(b) as being as being indefinite for failing to particularly point out and distinctly claim the subject matter on claim 2 is withdrawn because the claim 2 has been amended.
Claim Rejections - 35 USC § 103
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Minagawa et al. US PGPub 2019/0233555 hereinafter MINAGAWA in view of Takayama US PGPub 2005/0229696 hereinafter TAKAYAMA on claims 1, 2, and 5-6 are maintained. The rejection is repeated below for convenience.
As for claim 1, MINAGAWA teaches "The present invention provides a hydrophilic substrate including a hydrophilic polymer layer having a smooth surface and formed of a special polymer (hydrophilic polymer)" (abstract, lines 1-4), "Since the surface smoothness of the substrates affects the ability to capture specific cells, there is a need for substrates having a smooth surface with excellent properties, e.g. in terms of ability to capture specific cells such as cancer cells" (paragraph 4, lines 2-6), and "The hydrophilic polymer layer may be formed by dissolving or dispersing a hydrophilic polymer in any solvent to prepare a hydrophilic polymer solution or dispersion, and entirely or partially coating the surf ace of a substrate with the hydrophilic polymer solution or dispersion by a known method" (paragraph 30, lines 1-6), i.e. A method of producing a polymer-coated substrate for capturing cancer cells.
MINAGAWA teaches "the hydrophilic polymer is preferably at least one selected from the group consisting of ... polymers represented by the following formula (I):
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wherein R1 represents a hydrogen atom or a methyl group, R2 represents an alkyl group, m represents 1 to 5, and n represents the number of repetitions" (paragraph 21 ), i.e. forming a polymer layer using a hydrophilic polymer represented by the following formula (I) on a surface of a substrate ...
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wherein R1 represents a hydrogen atom or a methyl group; R2 represents an alkyl group; m represents 1 to 5; and n represents the number of repetitions.
MINAGAWA is silent on the substrate having undergone anti-reflection treatment. TAKAYAMA teaches "An analytical chip is provided with a flow channel (5), whose section is in a closed shape and through which a fluid sample (Fs) is made to flow, for carrying out analysis regarding the fluid sample (Fs) based on interaction between a predetermined substance and a specific substance (61 )," ( abstract, lines 1-5).
TAKAYAMA teaches "Each of the anti-reflection layers 25a, 85a is not limited particularly so long as it can allow light transmission through either the outer surface of the cover member 2 or the surface of the plate 8 on the side of the flow channel 5 and prevent the reflection of light transmitted through either the outer surface of the cover member 2 or the surface of the plate 8 on the side of the flow channel 5. Specifically, the individual anti-reflection layer 25a, 85a can be made from any desired substances, such as magnesium fluoride, silicas, and resins, and also can be formed in any thickness depending on the kind of the light to be detected" (paragraph 440, lines 1-11 ), i.e. the surf ace of a substrate having undergone anti-reflection treatment.
TAKAYAMA further teaches "With the arrangement, since the analytical chip 1J has the anti-reflection films 25a, 85a, it is possible to prevent the reflection of light that passes through the surf ace of the optically transparent part 7 of the analytical chip 1 J. Also, since the analytical chip 1 J has the anti-reflection films 25b, 85b, it is possible to protect the surface of the optically transparent part 7 of the analytical chip 1 J against flaws. It becomes therefore possible to carry out analysis of the fluid sample Fs efficiently with high precision" (paragraph 495, lines 10-18).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a surface of a substrate having undergone anti-reflection treatment in the process of MINAGAWA because TAKAYAMA teaches that such a treatment can allow high precision analysis of the material on the substrate.
As for claim 2, MINAGAWA is silent on the anti-reflection treatment. TAKAYAMA teaches "Each of the anti-reflection layers 25a, 85a is not limited particularly so long as it can allow light transmission through either the outer surface of the cover member 2 or the surface of the plate 8 on the side of the flow channel 5 and prevent the reflection of light transmitted through either the outer surface of the cover member 2 or the surface of the plate 8 on the side of the flow channel 5. Specifically, the individual anti-reflection layer 25a, 85a can be made from any desired substances, such as magnesium fluoride, silicas, and resins, and also can be formed in any thickness depending on the kind of the light to be detected" (paragraph 440, lines 1-11), i.e. the surface of a substrate having undergone anti-reflection treatment.
TAKAYAMA further teaches "With the arrangement, since the analytical chip 1J has the anti-reflection films 25a, 85a, it is possible to prevent the reflection of light that passes through the surf ace of the optically transparent part 7 of the analytical chip 1 J. Also, since the analytical chip 1 J has the anti-reflection films 25b, 85b, it is possible to protect the surface of the optically transparent part 7 of the analytical chip 1 J against flaws. It becomes therefore possible to carry out analysis of the fluid sample Fs efficiently with high precision" (paragraph 495, lines 10-18).
TAKAYAMA teaches "As a further preferred feature, said anti-reflection layer is a nonglare layer" (paragraph 58).
It would have been obvious to one of ordinary skill in the art before the effective filing date to include a surface of a substrate having undergone anti-reflection treatment in the process of MINAGAWA such that it includes wherein the anti-reflection treatment is at least one selected from the group consisting of... non-glare treatment because TAKAYAMA teaches that such a treatment can allow high precision analysis of the material on the substrate.
As for claim 5, MINAGAWA teaches "Examples of the substrate Include ... glass such as soda-lime glass and borosilicate glass" (paragraph 25, lines 3-10), i.e. as combined with TAKYAMA above, wherein the substrate having undergone antireflection treatment is a glass substrate.
As for claim 6, MINAGAWA teaches "The hydrophilic polymer layer (the layer formed of the hydrophilic polymer) preferably has a thickness of 10 to 1000 nm" (paragraph 26, lines 1-3), i.e. wherein the polymer layer has a total thickness of 10 to 1000 nm.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Minagawa et al. US PGPub 2019/0233555 hereinafter MINAGAWA and Takayama US PG Pub 2005/0229696 hereinafter TAKAYAMA as applied to claim 1 above, and further in view of Bogart US Patent Number 5,639,671 hereinafter BOGART on claims 3-4 are maintained. The rejection is repeated below for convenience.
As for claim 3, MINAGAWA and TAKAYAMA are silent on gloss.
BOGART teaches "Method for optimizing an optical assay device for an analyte" (abstract, lines 1 -2).
BOGART further teaches "For glass, the degree of surface character or the irregularity is discussed in terms of gloss. The diffuse reflective capability of the surface described here refers to the degree to which the reflection is scattered compared to a pure specular reflection. Diffuseness is a function of the surface topography and because the relevant topography is much 30 larger than the interference film or biofilms, the fuzziness is not expected to vary significantly for different specific binding material. For eye-visible color-signal generation the film will affect the lightness or color of the reflected light, but not its diffuse character. Diffuse surfaces which produce 35 color signal are particularly useful with reflectometers" ( column 17, lines 25-36)
It would have been obvious to one of ordinary skill in the art before the effective filing date to design the gloss/surface character such that the desired fuzziness for the particular detection method is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
As for claim 4, MINAGAWA and TAKAYAMA are silent on gloss.
BOGART teaches "Method for optimizing an optical assay device for an analyte" (abstract, lines 1 -2).
BOGART further teaches "For glass, the degree of surface character or the irregularity is discussed in terms of gloss. The diffuse reflective capability of the surface described here refers to the degree to which the reflection is scattered compared to a pure specular reflection. Diffuseness is a function of the surface topography and because the relevant topography is much 30 larger than the interference film or biofilms, the fuzziness is not expected to vary significantly for different specific binding material. For eye-visible color-signal generation the film will affect the lightness or color of the reflected light, but not its diffuse character. Diffuse surfaces which produce 35 color signal are particularly useful with reflectometers" ( column 17, lines 25-36) It would have been obvious to one of ordinary skill in the art before the effective filing date to design the gloss/surface character such that the desired fuzziness for the particular detection method is achieved. Discovery of optimum value of result effective variable in known process is ordinarily within the skill of the art. In re Boesch, CCPA 1980, 617 F.2d 272, 205 USPQ215.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Minagawa et al. US PGPub 2019/0233555 hereinafter MINAGAWA and Takayama US PG Pub 2005/0229696 hereinafter TAKAYAMA as applied to claim 1 above, and further in view of Minagawa et al. US PGPub 2018/0088105 hereinafter TANAKA on claims 7-9 are maintained. The rejection is repeated below for convenience. Further Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Minagawa et al. US PGPub 2019/0233555 hereinafter MINAGAWA and Takayama US PG Pub 2005/0229696 hereinafter TAKAYAMA as applied to claim 1, further in view of Minagawa et al. US PGPub 2018/0088105 hereinafter TANAKA.
As for claim 7, MINAGAWA is silent on wherein the forming a polymer layer includes forming two or more layers of the polymer layer using a hydrophilic polymer represented by the formula (I) on the surface of the substrate having undergone antireflection treatment.
MINAGAWA does teach applying one layer to form a smooth surface (see paragraphs 30 and paragraph 14).
TANAKA teaches "The present invention provides a method for capturing cancer cells" (abstract, line 1-2).
TANAKA further teaches "In this method, sampled biological fluid is first subjected to a treatment such as dilution or centrifugation to prepare a sample having a lower protein level than the sampled biological fluid, and the sample is brought into contact with a hydrophilic polymer layer to capture cancer cells in the sample. Accordingly, since proteins such as albumin have a reduced effect in inhibition of cell adhesion, and intrinsic adhesion of cancer cells to the hydrophilic polymer is provided, the ability to capture cancer cells is greatly improved while reducing the ability to capture platelets and others. As a result, an effect which could never be produced when proteins are present at high levels is achieved in selectively capturing cancer cells." (paragraph 17).
Examiner further notes that the polymers of TANAKA and MINAGAWA are identical (paragraph 8; see formula I in TANAKA).
It would have been obvious to one of ordinary skill in the art to apply the layer of TANAKA onto the layer of MINAGAWA because TANAKA teaches that having its layer of specific molecular weight allows for specific cancer cell capture.
As for claim 8, Examiner notes that the polymers of TANAKA and MINAGAWA are identical (paragraph 8; see formula I in TANAKA), such that when combined in claim 7, wherein the two or more polymer layers are formed using the same hydrophilic polymer.
MINAGAWA teaches "The hydrophilic polymer has a number average molecular weight (Mn) of 40,000 or more. 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" (paragraph 14, lines 1-6) and "From the standpoint of selective adsorption or adhesion to cancer cells, the hydrophilic polymer preferably has a weight average molecular weight (Mw) of 4,000 to 150,000, more preferably 5,000 to 100,000, still more preferably 8,000 to 50,000" (paragraph 41, lines 1-5), i.e. when combined as in the rejection of claim 7, a range that overlaps with a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the surface of the substrate having undergone antireflection treatment among the two or more polymer layers is larger than a number average molecular weight of the hydrophilic polymer constituting any other polymer layer among the two or more polymer layers. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05.
It would have been obvious to combine the layers of MINAGAWA and TANAKA such that the lower weight polymer in on top and the larger weight is on the bottom because MINAGAWA teaches that the larger weight produces a smooth surface which improves specific capturing and TANAKA teaches that is surface improves interactions to improve specific capturing.
As for claim 9, MINAGAWA is silent on the any other polymer layer.
TANAKA teaches "From the standpoint of selective adsorption or adhesion to cancer cells, the hydrophilic polymer preferably has a weight average molecular weight (Mw) of 4,000 to 150,000, more preferably 5,000 to 100,000, still more preferably 8,000 to 50,000" (paragraph 41, lines 1-5), i.e. a range that overlaps with wherein the number average molecular weight of the hydrophilic polymer constituting any other polymer layer is 30,000 or less. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d1934 (Fed.Cir.1990); In re Geisler, 116F.3d 1465, 1469-71, 43USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05.
It would have been obvious to combine the layers of MINAGAWA and TANAKA such that the lower weight polymer in on top and the larger weight is on the bottom, such that wherein the number average molecular weight of the hydrophilic polymer constituting any other polymer layer is in a range that overlaps with 30,000 or less because MINAGAWA teaches that the larger weight produces a smooth surface which improves specific capturing and TANAKA teaches that is surface improves interactions to improve specific capturing.
As for claim 10, MINAGAWA teaches “The Mn of the hydrophilic polymer is preferably 60,000 or more, more preferably 70,000 or more. The upper limit of the Mn is not particularly critical, but in view of solubility in solvents (e.g. methanol) and coating properties of the hydrophilic polymer solution, the Mn is preferably 300,000 or less, more preferably 200,000 or less” (paragraph 14, lines 6-11), i.e. a range that overlaps with wherein the number average molecular weight of the hydrophilic polymer constituting the polymer layer on the surface of the substrate having undergone anti-reflection treatment is 60000 or more and 120000 or less. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d, 1362, 1365-66 (Fed. Cir. 1997). See MPEP 2144.05.
Response to Arguments
Applicant's arguments filed 12/31/24 have been fully considered but they are not persuasive.
Applicant’s arguments are summarized and addressed below:
(a) Applicant argues that MINAGAWA and TAKAYAMA do not solve the same technical problem as the APPLICANT.
Examine reminds Applicant that the reason or motivation to modify the reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006).
Further, considering that both MINAGAWA and the current specification claim using the same polymer layer with the same chemical structure, and TAKAYAMA teaches the same anti-reflection treatment. As such, would not combining it with TAKAYAMA necessarily achieve the same results as they are all performing the same steps, using the same materials as the claims? "The fact that appellant 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." Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985).
(b) Applicant notes that TAKYAMA, MINAGAWA, BOGART and TANAKA fail to disclose of suggest the claimed effect of long-term polymer layer stability in a liquid environment achieved by forming a specific hydrophilic polymer on a AR-treated substrate.
Examiner respectfully points out that the "effect of long-term polymer layer stability in a liquid environment" is not claimed. There is no language that requires this aspect in the claim. At best, Applicant is reading in subject matter from the specification. As such this argument cannot be considered persuasive because Applicant's arguments are not germane with the scope of the claim.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/KRISTEN A DAGENAIS/Examiner, Art Unit 1717
/Dah-Wei D. Yuan/Supervisory Patent Examiner, Art Unit 1717
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