DETAILED ACTION
This is in response to communication received on 7/10/26.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The text of those sections of AIA 35 U.S.C. code not present in this action can be found in previous office actions dated 7/10/26.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/10/26 has been entered.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Specifically claim 8 depends from claim 1. Claim 1 contains the limitations of
wherein a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the surface of the substrate having undergone anti-reflection treatment is 60000 or more and 120000 or less
wherein a number average molecular weight of the hydrophilic polymer constituting a
polymer layer on the outermost side among the two or more layers of the polymer layer is 5000 or
more and 30000 or less
Wherein the wherein a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the surface of the substrate having undergone anti-reflection treatment is inherently larger than the average molecular weight of the hydrophilic polymer constituting a polymer layer on the outermost side.
As such, claim 8 is not further limiting, instead widening the ranges recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 withdrawn because the independent claim 1 has been amended.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Minagawa et al. US PGPub 201910233555 hereinafter MINAGAWA and Takayama US PG Pub 200510229696 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 withdrawn because the independent claim 1 has been amended.
The claim rejection(s) under AIA 35 U.S.C. 103 as being obvious over Minagawa et al. US PGPub 201910233555 hereinafter MINAGAWA and Takayama US PG Pub 200510229696 hereinafter TAKAYAMA as applied to claim 1 above, and further in view of Minagawa et al. US PGPub 201810088105 hereinafter TANAKA on claim 7 and 10 is withdrawn because the claim 7 and 10 has been cancelled.
Claim(s) 1-2, 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Minagawa et al. US PGPub 201910233555 hereinafter MINAGAWA in view of Takayama US PG Pub 200510229696 hereinafter TAKAYAMA and Minagawa et al. US PGPub 201810088105 hereinafter TANAKA.
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 1 J 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.
MINAGAWA further 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. 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), i.e. a range that overlaps with wherein a number average molecular weight of the hydrophilic polymer constituting a 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.
MINAGAWA is silent on wherein the forming the 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 anti-reflection treatment and wherein a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the outermost side among the two or more layers of the polymer layer is 5000 or more and 30000 or less.
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).
TANAKA further 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 a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the outermost side among the two or more layers of the polymer layer is 5000 or more and 30000 or less.
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 smooth layer of MINAGAWA such that it includes wherein the forming the 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 anti-reflection treatment and a range that overlaps with wherein a number average molecular weight of the hydrophilic polymer constituting a polymer layer on the outermost side among the two or more layers of the polymer layer is 5000 or more and 30000 or less because TANAKA teaches that a layer of that molecular weight is best from the standpoint of selective adsorption or adhesion to cancer cells.
In the alternative, it is a prima facie case of obviousness to combine prior art elements according to known methods to yield predictable results. In this case, it would have been obvious to combine the layer of MINAGAWA with the layer of TANAKA to obtain the predictable result of a polymer layer with the smoothness of MINAGAWA and the selectivity of TANAKA. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950).
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 1J. Also, since the analytical chip 1J has the anti-reflection films 25b, 85b, it is possible to protect the surface of the optically transparent part 7 of the analytical chip 1J 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.
As for claim 8, as discussed in the 112 4th paragraph rejection, claim 8 is not further limiting, and based on the combination of the rejection of claim 1, the combination of MINAGAWA TAKAYAMA and TANAKA inherently teaches wherein the two or more polymer layers are formed using the same hydrophilic polymer, and the number average molecular weight of the hydrophilic polymer constituting a polymer layer on the surface of the substrate having undergone anti-reflection 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.
As for claim 9, MINAGAWA, TAKAYAMA or TANAKA is silent on the any other polymer layer.
However, 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 30000 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.
In general, the transposition of process steps or the splitting of one step into two, where the processes are substantially identical or equivalent in terms of function, manner and result, was held to be not patentably distinguish the processes. Ex parte Rubin, 128 USPQ 440 (Bd. Pat. App. 1959). See MPEP 2144 IV.
In this case, splitting the application of the layer taught by TANAKA into two layers instead of one such that there is both an outermost layer and a layer underneath the outermost layer, such that wherein the number average molecular weight of the hydrophilic polymer constituting any other polymer layer is overlapping the range of 30000 or less results in a hydrophilic layer with a number average molecular weight of the hydrophilic polymer overlapping the range of 30000.
In the alternative, the duplication of steps for a multiplied effect is considered to be obvious unless a synergistic effect can be shown, just as a duplication of parts (for a multiplied effect) has been shown to be obvious unless a synergistic effect can be shown. See St. Regis Paper Co.v. Bermis Co., INc., 193 USPQ 8,11, (7th Cir.) 1977. In this case, applying the layer of TANAKA twice to the layer of MINAGAWA.
Claim(s) 3-4 are rejected under 35 U.S.C. 103 as being unpatentable over Minagawa et al. US PGPub 201910233555 hereinafter MINAGAWA in view of Takayama US PG Pub 200510229696 hereinafter TAKAYAMA and Minagawa et al. US PGPub 201810088105 hereinafter TANAKA as applied to claim 1 above, and further in view of Bogart US Patent Number 5,639,671 hereinafter BOGART.
As for claim 3, MINAGAWA, TAKAYAMA and TANAKA 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.
Response to Arguments
Applicant's arguments filed 7/10/26 have been fully considered but they are not persuasive.
Applicant’s arguments are summarized and addressed below:
(a) Applicant argues that their specific configuration of layers, a high molecular weight coating applied onto a substrate and a lower molecular weight applied as the outermost surface, provides a technical effect not taught or suggested by the cited references.
Examiner reminds Applicant that 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).
As illustrated in the rejection of claim 1, the combination of art renders the claim limitations obvious. 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.
Applicant's argument is not persuasive because the reason or motivation to modify the reference need only suggest what the inventor has done. Obviousness does not require that the combination happen for the same reason as the invention in the specification.
(b) Applicant lists the ways in which the art is individually silent on the multiple layers.
Examiner reminds Applicant that anticipation is not required for obviousness. The art does not need to anticipate the invention in order to render it obvious.
Applicant's argument is not persuasive as it merely establishes a lack of anticipation which does not address the obviousness rejection that was made.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN A DAGENAIS whose telephone number is (571)270-1114. The examiner can normally be reached 8-12 and 1-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Dah Wei Yuan can be reached at 571-272-1295. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KRISTEN A DAGENAIS/ Examiner, Art Unit 1717
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