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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/17/2026 has been entered.
Declaration Under 37 CFR 1.132
The declaration under 37 CFR 1.132 filed 03/17/2026 is insufficient to overcome the rejection of claims 1-13 and 16 based upon Brutinel et al. (US 2017/0355943) in view of Meuler et al. (US 2017/0045284), and Bjork et al. (WO 2019/116259) in view of Meuler et al. (US 2017/0045284) as set forth in the last Office action because: The statements are directed to process or intended use of the claimed device (see more below). It includes statements which amount to an affirmation that the claimed subject matter functions as it was intended to function. This is not relevant to the issue of nonobviousness of the claimed subject matter and provides no objective evidence thereof. In addition, it is noted that the features upon which applicant relies (i.e., inocula, microchannels, etc.) are not recited in the rejected claims. Further, the claimed invention statement in No. 6 appears to consist of a combination of parts of claims 1 and 7, and therefore renders the statement unclear.
Claim Interpretation
The “substrate” in claim 7 is being interpreted as the self-supporting, water-proof substrate.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1, 2, 4-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brutinel et al. (US 2017/0355943) in view of Meuler et al. (US 2017/0045284, Applicant admitted prior art).
Regarding claims 1, 2, 4-6, Brutinel et al. teach:
1. A device (see Abstract & Figs. 1-3 for example) comprising:
a body (e.g., 11) member comprising a substrate (e.g., 12) having upper (e.g., 12a) and lower (e.g., 12b) surfaces, the substrate capable of self-supporting and water-proof (see i.e., the first layer 12 is a relatively stiff film of a material such as polyester, polypropylene, silicone, or polystyrene ¶ 0035);
a cover sheet (e.g., 22) having an inner-facing surface (e.g., 22a) and an outer-facing surface (i.e., outer surface of 22 in Fig. 1), the cover sheet adhered to at least a portion of the body member (see Figs. 1-3 for example); and
a substantially dry, first composition (see i.e., a clay, and one or more microbial growth nutrients in the form of a powder ¶ 0041, 0043) disposed on a portion of the inner surface of the cover sheet (see ¶ 0041 & Fig. 8A for example), the first composition capable of being a microbial growth nutrient (see i.e., The second water-swellable gelling agent 26 includes the clay and optionally a microbial growth nutrient (and may include other additives) ¶ 0041; see also The water-swellable gelling agent 16, 26 includes a clay, and optionally one or more microbial growth nutrients for growing microorganisms mixed in with the clay. [...] ¶ 0043);
a first adhesive composition (e.g., 24) adhered to the first composition (see ¶ 0049 & Fig. 8A for example); and
a cold-water-soluble first composition (e.g., second water-swellable gelling agent 26; the water-swellable gelling agent contains one or more organic cold-water-soluble agents, such as guar gum, xanthan gum, hydroxyethyl cellulose, carboxymethyl cellulose, polyacrylamide, locust bean gum and algin. [...] ¶ 0051) adhered to the first adhesive composition (see i.e., a layer of a water-swellable gelling agent 16, 26 is adhered uniformly to the adhesive layer 14, 24, respectively ¶ 0043);
wherein said cold-water-soluble first composition (26) is capable of forming a hydrogel (see i.e., the water-swellable gelling agent contains one or more organic cold-water-soluble agents, such as guar gum, xanthan gum, hydroxyethyl cellulose, carboxymethyl cellulose, polyacrylamide, locust bean gum and algin. [...] ¶ 0051).
However, Brutinel et al. do not explicitly teach: 1. a fluid control film on the upper surface of the self-supporting, water-proof substrate; wherein the fluid control film comprises a plurality of fluid control channels extending along a channel longitudinal axis, each of the fluid control channels comprising a surface and configured to allow capillary movement of liquid in the channels; and wherein said hydrogel is capable of filling the plurality of fluid control channels of the fluid control film. 2. The device of claim 1, wherein the fluid control film comprises a plurality of micro replicated structures. 4. The device of claim 1, wherein the fluid control film comprises a hydrophilic surface treatment covalently bonded to at least a portion of the surface of the fluid control channels. 5. The device of claim 1, wherein the fluid control film comprises a noncovalent hydrophilic surface treatment disposed to a least a portion of the surface of the fluid control channels. 6. The device of claim 1, wherein the fluid control film has a contact angle less than 90 degrees.
Meuler et al. teach:
a fluid control film (e.g., 200) on an upper surface of a substrate (e.g., 210, 212);
wherein the fluid control film comprises a plurality of fluid control channels (e.g., 230, 231) extending along a channel longitudinal axis, each of the fluid control channels comprising a surface and configured to allow capillary movement of liquid in the channels (see Fig. 3c & Abstract+);
wherein the fluid control film (200) comprises a plurality of microreplicated structures (see Fig. 3c & ¶ 0034+).
wherein the fluid control film comprises a hydrophilic surface treatment covalently bonded to at least a portion of the surface of the fluid control channels (Abstract+).
wherein the fluid control film comprises a noncovalent hydrophilic surface treatment disposed to a least a portion of the surface of the fluid control channels (¶ 0006).
wherein the fluid control film has a contact angle less than 90 degrees (¶ 0039+).
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the device of Brutinel et al. with a fluid control film, as taught by Meuler et al. (Abstract & Fig. 1+), as providing a fluid control film with fluid transport features containing hydrophilic microreplicated capillary structures would allow the spreading of liquid droplets relatively evenly spaced along the bottom surface of the structure due to the arrangement of the channels (Meuler et al. ¶ 0034, 0074). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Regarding claim 1, modified Brutinel et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for growing microorganisms”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding the limitations “the fluid control channels [...] configured to allow capillary movement of liquid in the channels; wherein said cold-water-soluble first hydrogel-forming composition forms a hydrogel, and wherein said hydrogel fills the plurality of fluid control channels of the fluid control film” in claim 1, the Examiner notes the claim does not recite a specific configuration for the fluid control channels or the cold-water-soluble first hydrogel-forming composition. It is noted that the ability of a hydrogel to fill a channel is determined by its physicochemical properties, such as viscosity, the degree of crosslinking, channel dimensions, and surface chemistry. These factors influence how well the hydrogel can flow, fill, and conform to the shape of the channel. Further, the claim does not require a hydrogel. It is noted that neither “cold-water-soluble first hydrogel-forming composition” nor “cold-water-soluble first hydrogel-forming composition forms a hydrogel” positively recites a hydrogel. A hydrogel would not be present unless certain conditions are met, such as the presence of a sufficient amount of solution for the cold-water-soluble first hydrogel-forming composition. Therefore, the limitations are considered process or intended use limitations. However, it appears the cold-water-soluble first composition of modified Brutinel et al. would be capable of filling a fluid channel (see ¶ 0045-0046 for example).
With regard to limitations in claims 1, 7, 13 (e.g., “self-supporting, water-proof [...] fluid control [...] microbial growth nutrient [...] cold-water-soluble [...] hydrogel-forming”, “[...] said cold-water-soluble first hydrogel-forming composition forms a hydrogel, and wherein said hydrogel fills the plurality of fluid control channels of the fluid control film”, “to retain a predetermined amount of liquid in contact with the substrate”, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claim 7, modified Brutinel et al. teach: 7. The device of claim 1, further comprising a second adhesive composition (e.g., 14) adhered to the upper surface of the substrate, wherein the second adhesive composition is on the substrate (see Fig. 1 for example) and a hydrophobic spacer element (e.g., hydrophobic dam 18) adhered to the upper surface of the substrate capable of forming side walls (see e.g., 20 in Fig. 3) capable of retaining a predetermined amount of liquid (see i.e., The walls of the aperture 20 provide an area of predetermined size and shape to confine the medium following hydration. ¶ 0048) capable of being in contact with the substrate (see i.e., dry powdered nutrients may be suspended or dissolved in aqueous solutions ¶ 0045), wherein the second adhesive composition (14) is in between said hydrophobic spacer element (18) and the substrate (12; see Fig. 8B for example); and wherein the hydrophobic spacer element has a hole therein (e.g., aperture 20). However, modified Brutinel et al. do not explicitly teach: wherein the fluid control film is in the hole of the hydrophobic spacer element. It would have been obvious to one of ordinary skill in the art at the time the invention was made to place the fluid control film of Meuler et al. in the hole of the hydrophobic spacer element, as providing a fluid control film with fluid transport features containing hydrophilic microreplicated capillary structures would allow the spreading of liquid droplets relatively evenly spaced along the bottom surface of the structure due to the arrangement of the channels (Meuler et al. ¶ 0034, 0074). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Regarding claims 8-13, modified Brutinel et al. teach:
8. The device of claim 7, wherein the spacer element (18) comprises a hydrophobic foam sheet (¶ 0048).
9. The device of claim 8, wherein the hydrophobic foam is polystyrene or polyethylene foam (¶ 0048).
10. The device of claim 1, wherein the cover sheet (22) comprises a transparent film (¶ 0040).
11. The device of claim 10, wherein said transparent film is selected from the group consisting of polyester, polyethylene, polypropylene, polystyrene and silicone (¶ 0040).
12. The device of claim 1, wherein the substrate (12) is a film selected from the group consisting of polyester, polypropylene, polyethylene and polystyrene (¶ 0035).
13. The device of claim 1, wherein the water-soluble first composition (26) is selected from the group consisting of xanthum gum, guar gum, locust bean gum, carboxymethyl cellulose, hydroxyethyl cellulose, and algin (¶ 0051).
Claim(s) 1, 2, 4-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Bjork et al. (WO 2019/116259) in view of Meuler et al. (US 2017/0045284, Applicant admitted prior art).
Regarding claims 1, 2, 4-6, Bjork et al. teach:
A device (see Claims 1-17 & Figs. 1-2 for example) comprising:
a body member (Abstract+) comprising a self-supporting, water-proof substrate (e.g., 12 ¶ 0028+) having upper and lower surfaces (see Figs. 1-3 for example);
a cover sheet (e.g., 22) having an inner-facing surface and an outer-facing surface (see Figs. 1-3 for example), the cover sheet adhered to at least a portion of the body member (see ¶ 0047); and
a substantially dry, first microbial growth nutrient composition (see i.e., Powder 16 comprises at least one ingredient selected from the group consisting of a cold-water-soluble gelling agent one or more nutrients for growing microorganisms, and a mixture of a cold-water-soluble gelling agent and one or more nutrients for growing microorganisms. ¶ 0033) disposed on a portion of the inner surface of the cover sheet (see i.e., Cover sheet 22, as illustrated, is coated with optional layers of adhesive 14’ and powder 16’ ¶ 0048);
a first adhesive composition (e.g., 14) adhered to the first microbial growth nutrient composition (see ¶ 0033 & Fig. 1 for example); and
a cold-water-soluble first hydrogel-forming composition adhered to the first adhesive composition (see i.e., a polymer hydrogel formed from a dry, cold-water-soluble gelling agent such as, for example, guar gum, locust bean gum, xanthan gum, or a mixture of any two or more of the foregoing gelling agents ¶ 0006-0010, 0033-0034+);
wherein said cold-water-soluble first hydrogel-forming composition is capable of forming a hydrogel (see i.e., a polymer hydrogel formed from a dry, cold-water-soluble gelling agent such as, for example, guar gum, locust bean gum, xanthan gum, or a mixture of any two or more of the foregoing gelling agents ¶ 0006+).
However, Bjork et al. do not explicitly teach: 1. a fluid control film on the upper surface of the self-supporting, water-proof substrate; wherein the fluid control film comprises a plurality of fluid control channels extending along a channel longitudinal axis, each of the fluid control channels comprising a surface and configured to allow capillary movement of liquid in the channels; and wherein said hydrogel is capable of filling the plurality of fluid control channels of the fluid control film. 2. The device of claim 1, wherein the fluid control film comprises a plurality of micro replicated structures. 4. The device of claim 1, wherein the fluid control film comprises a hydrophilic surface treatment covalently bonded to at least a portion of the surface of the fluid control channels. 5. The device of claim 1, wherein the fluid control film comprises a noncovalent hydrophilic surface treatment disposed to a least a portion of the surface of the fluid control channels. 6. The device of claim 1, wherein the fluid control film has a contact angle less than 90 degrees.
See Meuler et al. above.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to combine the device of Bjork et al. with a fluid control film, as taught by Meuler et al. (Abstract & Fig. 1+), as providing a fluid control film with fluid transport features containing hydrophilic microreplicated capillary structures would allow the spreading of liquid droplets relatively evenly spaced along the bottom surface of the structure due to the arrangement of the channels (Meuler et al. ¶ 0034, 0074). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Regarding claim 1, modified Bjork et al. meet all the structural limitations recited by the instant invention. Applicants’ preamble recites “for growing microorganisms”. A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951).
Regarding the limitations “the fluid control channels [...] configured to allow capillary movement of liquid in the channels; wherein said cold-water-soluble first hydrogel-forming composition forms a hydrogel, and wherein said hydrogel fills the plurality of fluid control channels of the fluid control film” in claim 1, the Examiner notes the claim does not recite a specific configuration for the fluid control channels or the cold-water-soluble first hydrogel-forming composition. It is noted that the ability of a hydrogel to fill a channel is determined by its physicochemical properties, such as viscosity, the degree of crosslinking, channel dimensions, and surface chemistry. These factors influence how well the hydrogel can flow, fill, and conform to the shape of the channel. Further, the claim does not require a hydrogel. It is noted that neither “cold-water-soluble first hydrogel-forming composition” nor “cold-water-soluble first hydrogel-forming composition forms a hydrogel” positively recites a hydrogel. A hydrogel would not be present unless certain conditions are met, such as the presence of a sufficient amount of solution for the cold-water-soluble first hydrogel-forming composition. Therefore, the limitations are considered process or intended use limitations. However, it would appear the cold-water-soluble first hydrogel-forming composition of modified Bjork et al. would be capable of filling a fluid channel (see ¶ 0038 for example).
With regard to limitations in claims 1, 7, 13 (e.g., “self-supporting, water-proof [...] fluid control [...] microbial growth nutrient [...] cold-water-soluble [...] hydrogel-forming”, “[...] said cold-water-soluble first hydrogel-forming composition forms a hydrogel, and wherein said hydrogel fills the plurality of fluid control channels of the fluid control film”, “to retain a predetermined amount of liquid in contact with the substrate”, etc.), these claim limitations are considered process or intended use limitations, which do not further delineate the structure of the claimed apparatus from that of the prior art. The cited prior art teaches all of the positively recited structure of the claimed apparatus. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488, 492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)).
Regarding claim 7, modified Bjork et al. teach: 7. The device of claim 1, further comprising a second adhesive composition (e.g., 14) adhered to the upper surface of the self-supporting waterproof substrate (see Fig. 1 for example) and a hydrophobic spacer element (e.g., 18, Closed cell polyethylene foam is preferred material for spacer 18, but any material which is hydrophobic (non-wetting) [...] may be used. ¶ 0046) adhered to the upper surface of the substrate capable of forming side walls (see e.g., 20 in Fig. 3) capable of retaining a predetermined amount of liquid (see i.e., The walls of aperture 20 provide a well of predetermined size and shape to confine the medium following hydration. ¶ 0046) in contact with the substrate (see i.e., dry powdered nutrients may be suspended or dissolved in aqueous solutions ¶ 0038), wherein the second adhesive composition (14) is in between said hydrophobic spacer element (18) and the substrate (12; see Fig. 3 for example); and wherein the hydrophobic spacer element has a hole therein (e.g., aperture 20). However, modified Bjork et al. do not explicitly teach wherein the fluid control film is in the hole of the hydrophobic spacer element. It would have been obvious to one of ordinary skill in the art at the time the invention was made to place the fluid control film of Meuler et al. in the hole of the hydrophobic spacer element, as providing a fluid control film with fluid transport features containing hydrophilic microreplicated capillary structures would allow the spreading of liquid droplets relatively evenly spaced along the bottom surface of the structure due to the arrangement of the channels (Meuler et al. ¶ 0034, 0074). The Court stated that if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond his or her skill. Id. at ___, 82 USPQ2d at 1396. The Court in KSR, “[w]hen a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one”, 550 U.S. at ___, 82 USPQ2d at 1396 (emphasis added), or solves a problem which is different from that which the applicant was trying to solve, may also be considered for the purposes of 35 U.S.C. 103. See MPEP 2141.
Regarding claims 8-13, modified Bjork et al. teach:
8. The device of claim 7, wherein the spacer element comprises a hydrophobic foam sheet (¶ 0046).
9. The device of claim 8, wherein the hydrophobic foam is polystyrene or polyethylene foam (¶ 0046).
10. The device of claim 1, wherein the cover sheet comprises a transparent film (¶ 0047).
11. The device of claim 10, wherein said transparent film is selected from the group consisting of polyester, polyethylene, polypropylene, polystyrene and silicone (¶ 0047).
12. The device of claim 1, wherein the substrate is a film selected from the group consisting of polyester, polypropylene, polyethylene and polystyrene (¶ 0028, 0047).
13. The device of claim 1, wherein the cold-water-soluble first hydrogel-forming composition is selected from the group consisting of xanthum gum, guar gum, locust bean gum, carboxymethyl cellulose, hydroxyethyl cellulose, and algin (¶ 0006-0010+).
Response to Arguments
Applicant's arguments filed 03/17/2026 have been fully considered but they are not persuasive.
In response to the Applicant's argument that “Brutinel does not disclose a hydrogel, as encompassed by claim 1, Examiner disagrees.
Brutinel et al. teach, among other things, a cold-water-soluble first composition (e.g., second water-swellable gelling agent 26; the water-swellable gelling agent contains one or more organic cold-water-soluble agents, such as guar gum, xanthan gum, hydroxyethyl cellulose, carboxymethyl cellulose, polyacrylamide, locust bean gum and algin. [...] ¶ 0051) adhered to the first adhesive composition (see i.e., a layer of a water-swellable gelling agent 16, 26 is adhered uniformly to the adhesive layer 14, 24, respectively ¶ 0043); wherein said cold-water-soluble first composition (26) is capable of forming a hydrogel (see i.e., the water-swellable gelling agent contains one or more organic cold-water-soluble agents, such as guar gum, xanthan gum, hydroxyethyl cellulose, carboxymethyl cellulose, polyacrylamide, locust bean gum and algin. [...] ¶ 0051).
In response to the Applicant's argument that “neither Brutinel nor Meuler, nor any combination of the two, disclose or suggest a device for growing microorganisms, comprising a fluid control film on the upper surface of the self-supporting, water-proof substrate, wherein the fluid control film comprises a plurality of fluid control channels extending along a channel longitudinal axis, each of the fluid control channels comprising a surface and configured to allow capillary movement of liquid in the channels; and wherein said cold-water-soluble first hydrogel-forming composition forms a hydrogel, and wherein said hydrogel fills the plurality of fluid control channels of the fluid control film, as encompassed by claim l (as amended).”, the Examiner notes the claim does not recite a specific configuration for the fluid control channels or the cold-water-soluble first hydrogel-forming composition. It is noted that the ability of a hydrogel to fill a channel is determined by its physicochemical properties, such as viscosity, the degree of crosslinking, channel dimensions, and surface chemistry. These factors influence how well the hydrogel can flow, fill, and conform to the shape of the channel. Further, the claim does not require a hydrogel. It is noted that neither “cold-water-soluble first hydrogel-forming composition” nor “cold-water-soluble first hydrogel-forming composition forms a hydrogel” positively recites a hydrogel. A hydrogel would not be present unless certain conditions are met, such as the presence of a sufficient amount of solution for the cold-water-soluble first hydrogel-forming composition. Therefore, the limitations are considered process or intended use limitations. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. The Courts have held that limitations regarding the contents, intended use or manner of operating an apparatus do not further limit the patentability of apparatus claims. The Courts have held that a statement of intended use in an apparatus claim fails to distinguish over a prior art apparatus. See In re Sinex, 309 F.2d 488,492, 135 USPQ 302, 305 (CCPA 1962). The Courts have held that the manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex Parte Masham, 2 USPQ2d 1647 (BPAI 1987). The Courts have held that apparatus claims must be structurally distinguishable from the prior art in terms of structure, not function. See In re Danley, 120 USPQ 528, 531 (CCPA 1959); and Hewlett-Packard Co. V. Bausch and Lomb, Inc., 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (see MPEP §§ 2114 and 2173.05(g)). "Expressions relating the apparatus to contents thereof during an intended operation are of no significance in determining patentability of the apparatus claim." Ex parte Thibault, 164 USPQ 666,667 (Bd. App. 1969). Furthermore, "[i]nclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims." See In re Young, 75 F.2d *>996, 25 USPQ 69 (CCPA 1935) (as restated in In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963)) (see MPEP § 2115). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
With respect to the Declaration, please see the Declaration Under 37 CFR 1.132 section above.
In response to the Applicant's argument to the “wherein said hydrogel fills the plurality of fluid control channels of the fluid control film” limitation, see the Examiner’s position above.
In response to the Applicant's argument that “for at least the same reasons as discussed previously, neither Bjork nor Meuler disclose or suggest at least the feature of claim 1 (as amended), "wherein said hydrogel fills the plurality of fluid control channels of the fluid control film''”, the rejection is maintained as set forth above.
Applicant is encouraged that the claim be amended to affirmatively recite specific structural elements of the device, and to include additional structural limitations where appropriate, to positively define the invention in structural terms.
Applicant is thanked for their thoughtful amendments to the claims.
Conclusion
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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