DETAILED ACTION
Applicant' s arguments, filed 09/29/2025 have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 05/08/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, and 5-10 are the current claims hereby under examination.
All references to Applicant’s specification are made using the paragraph numbers assigned in the US publication of the present application US 2022/0304624 A1.
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 .
Priority
Acknowledgment is made of applicant's claim for foreign priority based on an application filed in France on 03/29/2021. It is noted, however, that applicant has not filed a certified copy of the French application number 2103221 as required by 37 CFR 1.55.
It would appear that an attempt to retrieve this document was made on 03/25/2025 but the attempt was unsuccessful.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7 and 10 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “a biosensor comprising at least one transducer and a multilayer structure as claimed in claim 1” but it is unclear what, if any, relationship is present between the “at least one transducer” and the multilayered structure of claim 1. It is unclear if or how these components are combined to create a single device or “biosensor”. For the purposes of this examination, the transducer will be interpreted as a device which uses some form of sensing to receive information from the reagent of the multilayered structure.
Claim 10 recites “a through opening of width L1 is formed through the self-adhesive layer” but it is unclear if this “through opening” is the same as, related to, or different from “a channel” of the self-adhesive layer of claim 8. For the purposes of this examination, the limitations are interpreted as referring to the same structure.
Claim 10 recites “ forming a groove of width L2 by etching into the biocompatible and adhesive layer” but it is unclear if the “groove” of claim 10 is the same as, related to, or different from “a groove” of claim 8 line 6. For the purposes of this examination, the limitations are interpreted as referring to the same structure.
Claim 10 recites “a top layer” but it is unclear if this limitation is the same as, related to, or different from, “a top layer” of claim 8 line 13. For the purposes of this examination, the limitations will be interpreted as referring to the same structure.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 8 and 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 8 recites the limitations “a base layer” and “a top layer”. These limitations do not require particular properties or configurations like the biocompatible and self-adhesive layers and thus it would seem that these limitation encompass any and all materials and structures to form these layers. The present scope of the claim is not fully supported by the specification which appears to limit the materials of the base and top layer to “polyester, PET, polypropylene, epoxy glass, polyimide and/or paper” in paragraph 0088. This rejection is similarly applied to claim 10 which also recites “a top layer”.
Claim Interpretation
Claims 10 recites a number of steps to be performed in a manufacturing process. It is noted that while these steps are labeled “a first step … a second step … etc.” the order of the steps is not being considered because there is no recitation within the claims to indicate that the particular order of the steps is required. Instead the numbering of the steps are considered to be a generic method of differentiating the steps rather than a requirement of a particular order.
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.
Claims 1-2, 5, and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Liu Us Patent Application Publication Number US 2014/0272719 A1 hereinafter Liu in view of Pekurovsky US Patent Application Publication Number US 2023/0138304 A1 hereinafter Pekurovsky.
Regarding claim 1 Liu teaches a multilayer structure for a biosensor (Abstract), comprising:
a base layer (Paragraph 0020: the sensing wafer; Fig. 1 reference 103);
a biocompatible layer, the biocompatible layer being deposited directly onto the base layer and being adhesive, said biocompatible layer defining a groove therein (Paragraphs 0020-0023: the bonding material is a biocompatible adhesive and bonds the sensing wafer and fluidic substrate and is thus considered “deposited directly onto” the base layer since it contacts the base layer directly; Fig. 1 references 105 and 143: the biocompatible adhesive layer and the grooves therein)
a reagent deposited in said groove (Paragraphs 0020-0023; The sensor may include only the sensing surfaces in the cavities; Fig. 1 reference 105: the biocompatible adhesive layer, and references 141, and 143: the sensing surfaces that are within the biocompatible adhesive layer) the reagent being deposited in a groove of the biocompatible layer (Paragraphs 0020-0023; Fig. 1 references 105, 141, and 143 depict the sensing surfaces in grooves of the biocompatible layer 105), and
a self-adhesive layer on the biocompatible layer, such that the reagent is at least partially aligned with a channel formed in the self-adhesive layer (Paragraphs 0016-0018: the island features are adhered to the adhesive layer 105 and thus the island layer is considered “self-adhesive” since it would seem no additional adhesives are involved in the joining of these two layers or any of the other layers. The islands are deposited onto the fluidic substrate; Fig. 1 references 127, 129, 131, and 133. The self-adhesive layer contains channels that align with sensing surfaces 141 and 143); and
a top layer on the self-adhesive layer (Paragraph 0016: the second surface; Fig. 1 reference 123),
Liu fails to further disclose the biosensor wherein the base layer and the top layer are made from at least one of: polyester, PET, polypropylene, epoxy glass, polyimide and paper; and the width of said groove of the biocompatible layer is smaller than the width of the channel of the self-adhesive layer.
Pekurovsky teaches a diagnostic device includes a sensor stack with multiple panels of a porous material disposed in planes parallel to one another and in face-to-face contact with each other. At least a portion of the panels of the porous material include hydrophobic regions and hydrophilic regions configured to provide a sample flow path for migration of a fluid sample through the sensor stack from one panel to another in the hydrophilic regions. A wicking layer is on a major surface of the sensor stack (Abstract). Thus Pekurovsky falls within the same field of endeavor as Applicant’s invention.
Pekurovsky teaches a layered sensor with hydrophobic and hydrophilic regions which confine the flow path of fluid in a single direction (Paragraph 0050). Pekurovsky teaches that the shapes and sizes of the hydrophobic and hydrophilic regions may vary widely depending on the intended use of the device. Factors that may affect the desired shape and size of these regions include mass transfer since the mass transfer rate is proportional to the area of wicking (Paragraph 0051). Pekurovsky further teaches that one or both of the hydrophilic regions may include a test area that may include reagents to provide an indication of a presence or concentration of an analyte (Paragraph 0054). Thus, Pekurovsky teaches that the size and shape of a region for fluid flow and/or holding reagents may be changed depending on the intended use of the device and such alterations affect factors such as the mass flow rate. Pekurovsky further teaches that a substrate may be comprised of a variety of materials including paper materials, woven or nonwoven fabrics, and polymer films including polyester. The substrate material may be further modified to create hydrophobic and hydrophilic regions where desired (Paragraphs 0056-0057).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the teachings of varying shapes and sizes of the fluid flow areas and substrate materials as described by Pekurovsky into the structure of Liu such that the channels and wells of the fluidic substrate of Liu (Liu: paragraphs 0016: fig. 1 references 101, 111, 113, 115, 117, and 119) are larger than the corresponding grooves in the biocompatible layer of Liu (Liu: paragraphs 0020-0022; Fig 1 references 105 and 143) because Pekurovsky teaches that the shapes and sizes of the channels for fluid flow and containing reagents may be different sizes that are optimizable to the particular use of the sensor (Pekurovsky: paragraphs 0050-0051, and 0054) and having the channels of Liu be larger than the sensing area of the reagent may be beneficial for particular use cases of the sensor. Furthermore, implementing the substrate materials taught by Pekurovsky for the base layer and top layer of Liu is a simply substitution of one known element for another with no surprising technical effect.
Regarding claim 2, Liu in view of Pekurovsky teaches the multilayer structure for a biosensor as claimed in claim 1. Modified Liu further discloses the biosensor in which the reagent is an electrochemical or fluorescent substance (Paragraphs 0021-0022: the electrochemical biosensors; the patterned sensing surface may detect the presence of an analyte which may be identified through a photodetector).
Regarding claim 5, Liu in view of Pekurovsky teaches the multilayer structure for a biosensor as claimed in claim 1. Modified Liu further discloses the biosensor wherein said groove of the biocompatible layer is a through groove (Paragraphs 0020-0022; Fig. 1 references 111 and 107 show that the groove may extend all the way through the biocompatible layer and the above layers. Thus this groove is considered a “through groove”).
Regarding claim 7, Liu in view of Pekurovsky teaches the multilayer structure for a biosensor as claimed in claim 1. Modified Liu further discloses a biosensor comprising at least one transducer and a multilayer structure as claimed in claim 1 (Paragraphs 0021: the one or more biosensors and the above rejection of claim 1)
Regarding claim 8, Liu discloses a method for the manufacture of a multilayer structure for a biosensor (Abstract), comprising the steps of:
providing a base layer (Paragraph 0020; Fig. 1 reference 103);
providing a biocompatible and adhesive layer, directly on the base layer (Paragraphs 0020-0023; The sensor may include only the sensing surfaces; Fig. 1 reference 105: the biocompatible adhesive layer, and references 141, and 143: the sensing surfaces that are within the biocompatible adhesive layer, additionally the biosensors may be external to the base wafer and thus within the biocompatible layer);
forming a groove in the biocompatible and adhesive layer and depositing a reagent in the groove of the biocompatible and adhesive layer (Paragraphs 0020-0023; Fig. 1 references 105, 141, and 143 depict the sensing surfaces in grooves of the biocompatible layer 105),
providing a self-adhesive layer comprising a channel in which a fluid can move on or over the biocompatible and adhesive layer, in a manner such that the reagent of the biocompatible and adhesive layer is at least partially aligned with the channel of the self-adhesive layer (Paragraphs 0016-0018: the island features are adhered to the adhesive layer 105 and thus the island layer is considered “self-adhesive” since it would seem no additional adhesives are involved in the joining of these two layers or any of the other layers. Fig. 1 references 127, 129, 131, and 133. The self-adhesive layer contains channels that align with sensing surfaces 141 and 143 and allow fluid to access the biocompatible layer); and
providing a top layer deposited on the self-adhesive layer (Paragraph 0016: the second surface; Fig. 1 reference 123), the biocompatible layer being deposited directly onto the base layer and being adhesive (Paragraphs 0020-0023: layer 105 is a bio-compatible adhesive; Fig. 1 reference 105).
Liu fails to further disclose the method of manufacturing a multilayer structure for a biosensor wherein the width of the groove of the biocompatible and adhesive layer is smaller than the width of the channel of the self-adhesive layer.
Pekurovsky teaches a layered sensor with hydrophobic and hydrophilic regions which confine the flow path of fluid in a single direction (Paragraph 0050). Pekurovsky teaches that the shapes and sizes of the hydrophobic and hydrophilic regions may vary widely depending on the intended use of the device. Factors that may affect the desired shape and size of these regions include mass transfer since the mass transfer rate is proportional to the area of wicking (Paragraph 0051). Pekurovsky further teaches that one or both of the hydrophilic regions may include a test area that may include reagents to provide an indication of a presence or concentration of an analyte (Paragraph 0054). Thus, Pekurovsky teaches that the size and shape of a region for fluid flow and/or holding reagents may be changed depending on the intended use of the device and such alterations affect factors such as the mass flow rate.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the teachings of varying shapes and sizes of the fluid flow areas as described by Pekurovsky into the method of Liu such that the channels and wells of the fluidic substrate of Liu (Liu: paragraphs 0016: fig. 1 references 101, 111, 113, 115, 117, and 119) are larger than the corresponding grooves in the biocompatible layer of Liu (Liu: paragraphs 0020-0022; Fig 1 references 105 and 143) because Pekurovsky teaches that the shapes and sizes of the channels for fluid flow and containing reagents may be different sizes that are optimizable to the particular use of the sensor (Pekurovsky: paragraphs 0050-0051, and 0054) and having the channels of Liu be larger than the sensing area of the reagent may be beneficial for particular use cases of the sensor.
Regarding claim 9, Liu in view of Pekurovsky teaches the method for manufacturing a biosensor as claimed in claim 8. Modified Liu further discloses the method wherein the reagent is an electrochemical or fluorescent substance (Paragraphs 0021-0022: the electrochemical biosensors; the patterned sensing surface may detect the presence of an analyte which may be identified through a photodetector).
Claims 6 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Liu Us Patent Application Publication Number US 2014/0272719 A1 hereinafter Liu in view of Pekurovsky US Patent Application Publication Number US 2023/0138304 A1 hereinafter Pekurovsky as applied to claims 1 and 8 above and further in view of Bremer US Patent Application Publication Number US 2020/0008719 A1 hereinafter Bremer.
Regarding claim 6, Liu in view of Pekurovsky teaches the multilayer structure for a biosensor as claimed in claim 1. Modified Liu fails to further disclose the biosensor in which the self-adhesive layer is a pressure-sensitive self-adhesive layer.
Bremer teaches a method of manufacturing laminate structure including the steps of providing a waveguide structure having a plurality of waveguide cores and including a first surface, creating an oxygen sensing polymer cavity in the first surface of the waveguide structure to receive an oxygen sensing polymer, filling the oxygen sensing polymer cavity with the oxygen sensing polymer and curing the oxygen sensing polymer, adding a first layer material on top of the first surface of the waveguide structure, where the first layer material includes a reaction chamber cavity that is contiguous with the oxygen sensing polymer, filling the reaction chamber cavity with an enzymatic hydrogel and curing the enzymatic hydrogel; adding a second layer material on top of the first layer material, where the second layer material includes a conduit cavity to receive a conduit hydrogel, filling the conduit cavity with a conduit hydrogel and curing the conduit hydrogel, and adding a top cap on top of the second layer of material (Abstract). Thus, Bremer falls within the same field of endeavor as Applicant’s invention.
Bremer teaches a laminate sensor construction utilizing pressure sensitive adhesives (Paragraphs 0304, 0355, and 0361).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the use of pressure sensitive adhesives (PSA) such as those described by Bremer into the construction of Liu for the self-adhesive layer because Bremer teaches PSAs that are bio-compliant and suitable for being laser-cut (Paragraph 0355: the PSA layer is preferably bio-compliant Paragraph 0361: the PSA layer is laser cut) and would thus be a suitable material to replace the self-adhesive layer described by Liu as a simple substitution of one known material for another with no surprising technical effect.
Regarding claim 10, Liu discloses the method for manufacturing a biosensor as claimed in claim 8. Liu further discloses the method comprising:
a first step during which a through opening of width L1 is formed through the self-adhesive layer (Paragraphs 0020-0022 and 0034; Fig. 1 references 127: the self-adhesive layer; openings 111, 113, 115, 117, and 119);
a second step during which the self-adhesive layer is deposited directly onto the biocompatible and adhesive layer (Paragraphs 0020-0022 and 0035; Fig. 1 references 127: the self-adhesive layer, 105: the biocompatible and adhesive layer),
a third step for forming a groove of width L2 by etching into the biocompatible and adhesive layer (Paragraphs 0020-0022 and 0034; Fig. 1 reference 105: the biocompatible and adhesive layer; grooves 111, 113, 115, 117, and 119), and,
a fourth step during which the biocompatible and adhesive layer is deposited directly onto the base layer (Paragraphs 0020-0022 and 0035; Fig. 1 references 127: the self-adhesive layer, 105: the biocompatible and adhesive layer, and 103: the base layer);
a fifth step during which the reagent is deposited in the groove of width L2 (Fig. 1 references 141 and 143; Paragraphs 0023-0024: the reagent is deposited in the holes);
a seventh step during which a top layer is deposited onto the self-adhesive layer (Paragraph 0016; Fig. 1 references 123, 149, 127, 129, 131, 133, and 151: the second surface 123 is bonded to the island features)
Liu fails to further disclose the method including a release film deposited on a surface of the self-adhesive layer; the bonding of the second, fourth, and seventh steps being performed by lamination; the width L2 being smaller than the width L1; a sixth step during which the release film is removed from the self-adhesive layer.
Pekurovsky teaches a layered sensor with hydrophobic and hydrophilic regions which confine the flow path of fluid in a single direction (Paragraph 0050). Pekurovsky teaches that the shapes and sizes of the hydrophobic and hydrophilic regions may vary widely depending on the intended use of the device. Factors that may affect the desired shape and size of these regions include mass transfer since the mass transfer rate is proportional to the area of wicking (Paragraph 0051). Pekurovsky further teaches that one or both of the hydrophilic regions may include a test area that may include reagents to provide an indication of a presence or concentration of an analyte (Paragraph 0054). Thus, Pekurovsky teaches that the size and shape of a region for fluid flow and/or holding reagents may be changed depending on the intended use of the device and such alterations affect factors such as the mass flow rate.
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the teachings of varying shapes and sizes of the fluid flow areas as described by Pekurovsky into the method of Liu such that the channels and wells of the fluidic substrate of Liu (Liu: paragraphs 0016: fig. 1 references 101, 111, 113, 115, 117, and 119) are larger than the corresponding grooves in the biocompatible layer of Liu (Liu: paragraphs 0020-0022; Fig 1 references 105 and 143) because Pekurovsky teaches that the shapes and sizes of the channels for fluid flow and containing reagents may be different sizes that are optimizable to the particular use of the sensor (Pekurovsky: paragraphs 0050-0051, and 0054) and having the channels (L1) of Liu be larger than the sensing area of the reagent corresponding to the groove (L2) in the biocompatible and adhesive layer may be beneficial for particular use cases of the sensor.
Liu in view of Pekurovsky fails to further teach the method including a release film deposited on a surface of the self-adhesive layer; the bonding of the second, fourth, and seventh steps being performed by lamination; a sixth step during which the release film is removed from the self-adhesive layer
Bremer teaches a method of manufacturing a laminate structure which includes utilizes a release liner to protect the structure during manufacturing. The release liner is later removed to provide a clean bonding surface after cutting to allow the laminate structure to be laminated to a conduit layer, or top layer (Paragraph 0355-0356).
It would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to incorporate the release liner described by Bremer into the system of Liu because Bremer teaches that the release liner would protect the self-adhesive layer during the manufacturing process (Bremer: Paragraph 0355). Moreover, it would have been obvious to one of ordinary skill in the art prior to the effective filling date of the invention to implement the lamination process for the various bonding steps and removing the protective liner as described by Bremer into the manufacturing of Liu to join the various layers of Liu because Bremer teaches that lamination is an acceptable form of bonding in the construction of these types of sensors and further teaches that the liner removal ensures a clean bonding surface that results in improved bonding strength and reduces the possibility of delamination (Bremer: Paragraph 0355). Thus it would seem that utilizing the lamination process described by Bremer for the various bonding steps of Liu is a simple substitution of one known element for another with no surprising technical effect.
Response to Arguments
Applicant's arguments filed 09/29/2025 have been fully considered but they are not persuasive.
In particular, Applicant’s amendments to claim 1 are sufficient to overcome the previously presented 35 USC 112 rejections of claim 1. The remaining previously presented 35 USC 112 rejections have not been addressed.
In particular, Applicant’s descriptions of which elements of claim 10 correspond to which elements of claim 8, while helpful for the Examiner’s interpretation, does not render the claim language clear. The relationships between the various elements should be made explicit in the claim language.
In regards to the rejections presented under 35 USC 103:
Applicant argues that the island features of Liu do not form “layers” and that the island portions are not “self-adhesive”. Applicant argues that Liu uses the term “layer” for elements other than the island features and bonding materials and thus these elements are not layer themselves. Applicant further argues that the island materials cannot be considered “self-adhesive” because the bonding material is used to join the fluidic substrate including the island features to the sensing wafer and if the island material was self-adhesive then the bonding material would not be required.
Applicant’s arguments are not found to be persuasive because Liu clearly illustrates the island features and bonding materials as “layers” in Fig. 1. Liu is not required to use the same terminology as Applicant’s invention. The island features and bonding material taught by Liu and illustrated in Fig. 1 are clearly formed as layers. Furthermore, Applicant’s arguments that the island features cannot be reasonably considered as “self-adhesive” is not found to be persuasive because the island features may be deposited directly onto the fluidic substrate (Liu: paragraph 0016: “In other embodiments, the island features 127, 129, 131, and 133 are formed on the fluidic substrate 101 by depositing and patterning a material or by selectively depositing a material”) which indicates at least suggests the material used for the islands may have some adhesive properties since no additional adhesive to attach the material to the fluidic substrate is disclosed. Additionally, the island features are bonded to the bonding material with no intermediate adhesive layers which further suggests that the island material may be “self-adhesive”. The presence of the bonding material does not preclude the island features themselves from also being “self-adhesive”. The use of a bonding material on a material that is already “self-adhesive” may simply provide a stronger connection between elements or serve as spacing material. Applicant’s arguments are not commensurate in scope with the teachings of Liu and read in supposed requirements where no such requirements are presented by Liu.
Applicant further argues that one of ordinary skill in the art would not be motivated to replace the island feature material with a self-adhesive material because such a modification would be incompatible because Liu teaches that any deposited material must be mechanically similar to the material of the fluidic substrate and a self-adhesive material would not be suited for this role as they have an inherent deformability and would not maintain the required sealing performance.
Applicant’s arguments are not found to be persuasive because they are not commensurate with the teachings of Liu. Liu does not present any requirement that the deposited layer must be mechanically similar to the fluidic substrate. Applicant has provided no technical evidence illustrating such a requirement. Furthermore, adhesives do not necessarily have inherent deformability when cured. Additionally, adhesives are suitable for maintain hermetic seals as taught by Liu (Paragraph 0020: the bonding material provides a hermetic seal).
Applicant further argues that replacing the island features with a self-adhesive layer would render inoperable the deposition of the first surface modification layer as such a deposition is designed for surfaces formed from materials such as silicone, oxide, or photoresist and thus such a replacement would affect layer adhesion uniformity or chemical compatibility of the first surface modification layer and contradict the core teachings of Liu.
Applicant’s arguments are not found to be persuasive because they are not commensurate in scope with the teachings of Liu. Liu does not teach that the deposition requires certain material properties. Additionally, Liu teaches that the surface modification layers may cover all surfaces inside a fluidic channel and may also be present of the top and sides of the island features (Paragraph 0017), which appears to suggest that the surface modifications may bond to the bonding material as well. Such teachings seem to indicate that there are no particular material requirements to carry out the deposition. Such a suggestion is further illustrated in paragraph 0018 which recites “Patterning of the first surface modification layer 145 may be performed to exclude it at the top of the island features 127, 129, 131, and 133 if the first surface modification layer 145 does not adhere to the bonding material 105.”. Further illustrating that Liu does not particularly limit what materials the modification layers may adhere to.
Applicant further argues that there is a lack of motivation to implement the teachings of Pekurovsky into the device of Liu because Liu and Pekurovsky are structurally incompatible. Applicant argues that the assertion that it would be obvious to modify the sizes of the channels and groove of Liu using the teachings of Pekurovsky is technically untenable because the bonding material of Liu provides a hermetic seal between channels. Applicant argues that the width of each channel in the fluidic substrate of Liu and the width of grooves in the bonding material are both set by the sidewalls of the island features and that making the channel wider than the groove would either remove bonding material from the top portion of the island and/or break the hermetic seal between channels.
Applicant’s arguments are not found to be persuasive because modifying the width of the channel and/or groove of Liu does not inherently break the hermetic seal between the islands. In particular, the bonding material would still serve as a hermetic seal between the islands. One of ordinary skill in the art would have a reasonable expectation of success in maintaining the hermetic seal when increasing or decreasing the size of the bonding material attachment area as illustrated in Liu Annotated Fig. 1 presented below. In particular, Liu does not teach that the hermetic seal is dependent upon the co-linear relationship between the sides of the island material and the bonding materials and Pekurovsky illustrates that such a colinear relationship is not required to ensure bonding in Fig 1B which shows that the first connection region (34), which is analogous to the island features of Liu, does not share a co-linear wall with second connection region (36), which is considered analogous to the bonding material of Liu. The teachings of Pekurovsky would have motivated one of ordinary skill in the art to modify the device of Liu to alter the particular shapes and sizes of the island features and/or bonding material area to optimize the channels for fluid flow and/or reagent exposure depending on the particular use case of the invention. Thus the particular size relationship between the “groove” holding the reagent and the “channel” of the fluidic substrate are subject to routine optimization and experimentation depending on the particular use case of the sensor as taught by Pekurovsky (Pekurovsky: paragraphs 0050-0051, and 0054).
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Annotated Fig. 1 of Liu: illustrating increases and decreases to the dimensions of the bonding layer.
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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/MATTHEW ERIC OGLES/Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791