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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/27/2026 has been entered.
Response to Amendment
The amendment filed 03/26/2026 has been entered. Claims 1-13 & 15-16 remain pending in the application.
Response to Arguments
Applicant's arguments with respect to claims 1-13 & 15-16 have been considered but are seen as not persuasive, see reasoning below.
Regarding the priority documents, Examiner has received the priority documents.
Regarding amended claim 1, applicant argues that none of the prior art recites “wherein the conductive film and the porous membrane are in direct contact with each other” in which the limitation originally comes from now cancelled claim 14. This limitation was taught by Holzhacker in the Final rejection such that conductive film, 54a is in direct contact with the porous membrane 74 which is shown in figure 12-a. Applicant argues that Holzhacker does not have any conductive film opposite to a contact surface of the porous material, to which that limitation was in claim 1 not claim 14. Therefore, was already taught by Somasuntharam in view of Lucisano such that Holzhacker disclosed the deficiency of the conductive film and porous membrane being in direct contact with each other wherein Somasuntharam in view of Lucisano taught other layers being in between them. Applicant also argues that removal of the addition layers taught by Somasuntharam would render the device unsatisfactory. To which the examiner wants to point towards MPEP 2145 III where it is stated “The test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference.... Rather, the test is what the combined teachings of those references would have suggested to those of ordinary skill in the art.” Such that it would have suggested to one of the ordinary skill in the art to have direct contact between a porous membrane and a conductive film for the purpose of allowing for direct communication between two elements which is taught by Holzahacker in Paragraph [0075]. Therefore, Examiner stands by the rejection as taught in the final rejection.
Claim Rejections - 35 USC § 103
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.
Claims 1, 4, 9, 13 & 15-16 are rejected under 35 U.S.C 103 as being unpatentable over Somasuntharam et al. (US 20210076993) herein referred to Somasuntharam and of Lucisano et al. (US 7894870) herein referred to as Lucisano in further view of Holzhacker (US 20110288393) herein referred to as Holzhacker.
Regarding Claim 1, Somasuntharam discloses a bio signal sensing electrode (Figure 2A) comprising: a conductive film containing particles of a layered material including one or plural layers (Figure 2A, 104) and a modifier or terminal T exists on a surface of the layer body (Paragraph [0087]; wherein a terminal can be used to modify an electrode and is applied to the electrode surface), wherein T is at least one selected from the group consisting of a hydroxyl group, a fluorine atom, a chlorine atom, an oxygen atom, or a hydrogen atom (Paragraph [0060]; wherein terminal can contain hydroxyl groups); and a porous membrane that contains a hydrophilic polymer (Figure 2A, 112, Paragraph [0048]; wherein the analyte modulating layer is formed by a reaction mixture comprising a diisocyanate, a hydrophilic polymer and wherein it regulates the amount of glucose that contacts an enzyme therefore having to pass through the layer which would make it porous), the porous membrane having a first surface opposing at least part of the conductive film and a second surface defining a contact surface with a subject (Paragraph [0072]; wherein 112 contacts an enzyme therefore contacting a subject on oneside and can be seen opposing the film 104 on the other side). However, Somasuntharam does not explicitly disclose wherein the one or plural layers includes a layer body represented by: MmXn wherein M is at least one metal of Group 3, 4, 5, 6, or 7, X is a carbon atom, a nitrogen atom, or a combination thereof, n is 1 to 4, m is more than n and 5 or less and wherein the conductive film and the porous membrane are in direct contact with each other.
Lucisano discloses a biosensing electrode wherein a conductive layer includes a layer body represented by: MmXn wherein M is at least one metal of Group 3, 4, 5, 6, or 7, X is a carbon atom, a nitrogen atom, or a combination thereof, n is 1 to 4, m is more than n and 5 or less (Column 5 lines 13-21; wherein mixing titanium and carbide will create titanium carbide which is Ti2C therefore fitting the format of MmXn and the conductive thick film and the substrate are seen as one layer since they are heated together). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the conductive film taught by Somasuntharam to consist of the layer taught by Lucisano. The motivation being it would be obvious to try different particles in a material to see which provides the best conductive properties (MPEP 2143 (E)).
Holzhacker discloses a biosignal sensing electrode (Figure 7) wherein the conductive film and the porous membrane are in direct contact with each other (Figure 12-a; Paragraph [0070]; wherein the conductive adhesive film 54a covers the entire porous membrane). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the contact area ratio taught by Somasuntharam in view of Lucisano to be direct as taught by Holzhacker. The motivation being to provide communication to the conductive film (Holzhacker, Paragraph [0075]).
Regarding claim 4, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein a thickness of the porous membrane is 0.1 pm to 300 pm. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the device of Somasuntharam and Lucisano in further view of Holzhacker et al. to have a thickness of the porous membrane between 0.1 pm to 300 pm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Somasuntharam and Lucisano in further view of Holzhacker would not operate differently with the claimed thickness, the device would function appropriately having the claimed thickness. Further, applicant places no criticality on the range claimed, indicating simply that the diameter “preferably” be within the claimed ranges (see Specification [0058]).
Regarding claim 9, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. Holzhacker also discloses wherein the porous membrane defines a plurality of isolated and/or communicating pipe pores (Figure 11-b, 74). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to to have modified the porous membrane taught by taught by Somasuntharam in view of Lucisano to be the porous membrane taught by Holzhacker. The motivation being it would be obvious to try different types of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Regarding claim 13, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. Holzhacker also discloses herein a contact area ratio of the conductive film with the porous membrane is 60% or more (Figure 12-a; Paragraph [0070]; wherein the conductive adhesive film 54a covers the entire porous membrane). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the contact area ratio taught by Somasuntharam in view of Lucisano to be over 60% as taught by Holzhacker. The motivation being to provide communication to the conductive film (Holzhacker, Paragraph [0075]).
Regarding claim 15, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. Lucisano further comprising a conductive substrate supporting the conductive film on a side thereof opposite to the porous membrane (Figure 2A, 102; Paragraph [0068]; wherein the conductive substrate can be made of metal therefore is seen as conductive).
Regarding claim 16, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. Somasuntharam also discloses wherein the contact surface is a skin contact surface (Figure 1).
Claims 3 & 6 are rejected under 35 U.S.C 103 as being unpatentable over Somasuntharam, Lucisano and Holzhacker in view of Melker et al. (US 20050037374) herein referred to as Melker.
Regarding Claim 3, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the porous membrane has an average pore diameter of 1 nm to 1 pm.
Melker discloses a porous membrane (Paragraph [0068]) wherein the porous membrane has an average pore diameter of 1 nm to 1 pm (Paragraph [0068]; wherein 5nm is in the range of 1nm to 1 pm). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the pores taught by Somasuntharam and Lucisano in further view of Holzhacker to be the diameter taught by Melker. The motivation being it would be obvious to try pore diameters to see which diameter produces the best results of allowing fluid through (MPEP 2143 (E)).
Regarding claim 6, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the porous membrane is an aggregated particulate porous membrane having a plurality of pores.
Melker discloses a porous membrane (Paragraph [0070]) wherein the porous membrane is an aggregated particulate porous membrane having a plurality of pores (Paragraph [0070]; wherein porous membrane is made of aluminum particles therefore is seen as aggregated since the pores would be from the material itself, and it a porous membrane therefore having a plurality of pores). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Melker. The motivation being it would be obvious to try different types of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Claims 7 & 10 are rejected under 35 U.S.C 103 as being unpatentable over Somasuntharam, Lucisano and Holzhacker in view of Darlot et al. (US 20220273220) herein referred to as Darlot.
Regarding Claim 7, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the porous membrane is a reticulated porous membrane.
Darlot discloses a bio signal sensing electrode (Figure 6) wherein the porous membrane is a reticulated porous membrane (Paragraph [0114]; wherein graphene and graphene oxide are both reticulated porous membranes). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Darlot. The motivation being it would be obvious to try different types of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Regarding claim 10, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the porous membrane has a conductivity lower than a conductivity of the conductive film.
Darlot discloses a bio signal sensing electrode (Figure 6) wherein the porous membrane has a conductivity lower than a conductivity of the conductive film (Paragraph [0114] & [0092]; wherein the conductive film is made of gold therefore having a higher conductivity then any of the materials that the porous membrane is made from). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Darlot. The motivation being it would be obvious to try different conductivities of porous membranes and conductive films to see which produces the best results conductivity (MPEP 2143 (E)).
Claims 8, 11 & 12 are rejected under 35 U.S.C 103 as being unpatentable over Somasuntharam, Lucisano and Holzhacker in view of Nassar et al. (US 20190011288) herein referred to as Nassar.
Regarding Claim 8, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the porous membrane is a fibrous porous membrane.
Nassar discloses a biosignal sensing electrode (Figure 1a-e) wherein the porous membrane is a fibrous porous membrane (Figure 3d). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Nassar. The motivation being it would be obvious to try different types of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Regarding claim 11, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the hydrophilic polymer is one or more selected from the group consisting of polysulfone, cellulose acetate, regenerated cellulose, polyether sulfone, water-soluble polyurethane, polyvinyl alcohol, sodium alginate, an acrylic acid-based water-soluble polymer, polyacrylamide, polyaniline sulfonic acid, nylon, olefin resins, vinyl resins, fluorine resins, and polyester.
Nassar discloses a biosignal sensing electrode (Figure 1a-e) wherein the hydrophilic polymer is one or more selected from the group consisting of polysulfone, cellulose acetate, regenerated cellulose, polyether sulfone, water-soluble polyurethane, polyvinyl alcohol, sodium alginate, an acrylic acid-based water-soluble polymer, polyacrylamide, polyaniline sulfonic acid, nylon, olefin resins, vinyl resins, fluorine resins, and polyester (Paragraph [0019]; wherein the porous membrane is foamed polyester sponge). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Nassar. The motivation being it would be obvious to try different types of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Regarding claim 12, Somasuntharam and Lucisano in further view of Holzhacker disclose the biosignal sensing electrode according to claim 1. However, Somasuntharam and Lucisano in further view of Holzhacker does not explicitly disclose wherein the hydrophilic polymer is 50 mass% or more of the porous membrane.
Nassar discloses a biosignal sensing electrode (Figure 1a-e) wherein the hydrophilic polymer is 50 mass% or more of the porous membrane (Paragraph [0019]; wherein the whole porous membrane is made of polyester there is 100%). Therefore, it would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to have modified the porous membrane taught by taught by Somasuntharam and Lucisano in further view of Holzhacker to be the porous membrane taught by Nassar. The motivation being it would be obvious to try different mass % of porous membranes to see which produces the best results of allowing fluid through (MPEP 2143 (E)).
Conclusion
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ALYSSA M. PAPE
Examiner
Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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