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 .
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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities: there should be a colon (:) following the limitation "part" recited in lines 15 and 19; there should also be a semicolon (;) following the limitation "body" recited in line 17, following the limitation "body" recited in line 21; and there should be a semicolon following the limitation "body" recited in line 22.
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “cover part” in Claim 4.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The limitation “cover part” recited in Claim 4 was given the following structure in the applicant’s description “such as a band including an elastic body” (Paragraph [0035]).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-5 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Fujioka et. al.’391 (WO Publication 2018088391 – previously cited) in view of Linke et. al.'997 (U.S. Publication Number 20130109997 – previously cited), further in view of Petisce et. al.'516 (WO Publication 2007084516 – previously cited), further in view of Rogers et. al.’377 (U.S. Publication Number 20180064377 – previously cited), and further in view of Ko et. al.’867 (KR Publication 20180024867),.
Regarding Claim 1, Fujioka et. al.’391 discloses a sensor converting an amount of a measurement target substance contained in a secretion from a living body into an electrical signal (Page 9 Paragraph 1 - an electric current corresponding to the concentration of the substance to be measured contained in the secretion from the living body is generated in the enzyme sensor 1, and the concentration of the substance to be measured is electrically detected), the sensor comprising:
a sensor main body including an electrode part including an absorption layer capable of absorbing the secretion and having a contact surface side is configured to contact the living body, an enzyme layer containing an enzyme that reacts with the absorbed secretion, and an electrode layer that converts a reaction with the absorbed secretion into an electrical signal (Page 8 Paragraph 8 - The absorption layer 15 absorbs secretions from the living body…the enzyme layer 13 produces/generates an electrode detectable substance or an electrode detectable substance precursor from the to-be-measured substance contained in the secretion from a biological body in presence of an enzyme; Page 9 Paragraph 1 - the electrode detectable substance generated in the electron transfer mediator layer 11 undergoes an electrochemical reaction including a redox reaction on the surface of the working electrode 5, and an electric current is generated in the enzyme sensor 1); and
a substrate having an exposed surface opposite to the contact surface (Page 3 Paragraph 1 - The base material layer 3 supports the working electrode 5, the reference electrode 7, and the counter electrode 9).
Fujioka et. al.’391 fails to disclose a fixing part configured to fix the sensor main body to the living body when the exposed surface is brought into contact with the living body, wherein the fixing part includes: a flexible sheet configured to be attached to the living body, and configured to fix the sensor main body to the living body; and a spacer part disposed between the flexible sheet and the exposed surface, the spacer part having a thickness equal to or thicker than a thickness of the sensor main body, wherein the spacer part is configured to transmit the sensor body a pressing force generated by the attachment of the flexible sheet to the living body; and is made of a material having a Young’s modulus that allows the sensor body to maintain continuous contact with the living body against strains generated by the pressing force when the flexible sheet is pressed against the sensor body, by the shape of the sensor body, and by a repulsive force from the living body.
Linke et. al.'997 teaches an adhesive layer configured to connect a sensor body to a user’s body by adhering to a base of a device containing the senor body as well as adhering to a wearable item that is configured to hold the device in contact with a user’s body (Paragraph [0036] - The adhesive layer 115 may comprise a sheet of adhesive paper or plastic having adhesive on one side, with the adhesive of the sheet holding the temperature sensor 111a to the padding layer 114; Paragraph [0070] - The cap 112 may be worn on the head so that presence sensor 111b detects that sensor unit 111 is positioned relative the body to take reliable raw biological data). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor of Fujioka et. al.’391 to include an adhesive layer configured to connect a bio-sensing device to a wearable device that would hold the bio-sensing device against a user’s skin in order to ensure the sensors are in a proper position to receive reliable data as seen in Linke et. al.’997 (Paragraph [0070] - The cap 112 may be worn on the head so that presence sensor 111b detects that sensor unit 111 is positioned relative the body to take reliable raw biological data).
Although, Fujioka et. al.’391 and Linke et. al.’997 both fail to explicitly disclose a flexible sheet. Petisce et. al.'516 teaches a flexible adhesive used to provide structural support and stability (Page 41 lines 4-9 - Thus, by providing flexibility and/or articulation of the device against the host's skin, better conformity of the sensor system 10 to the regular use and movements of the host can be achieved. Flexibility or articulation is believed to increase adhesion (with the use of an adhesive pad) of the mounting unit 14 onto the skin, thereby decreasing motion-related artifact that can otherwise translate from the host's movements and reduced sensor performance; Page 94 lines 27-30 - adhesive pad 8' for mounting the mounting unit onto the host, including a sufficiently strong medical adhesive pad that satisfies one or more strength and flexibility requirements described above, and further provides a for easy, precise and pain-free release from the host's skin). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor and adhesive layer of Fujioka et. al.’391 in view of Linke et. al.’997 in order to provide proper adhesion that allows a sensor to conform to a user due to the flexibility while decreasing the potential effects of the user’s movement while trying to use the sensor as seen in Petisce et. al.’516.
Linke et. al.’997 additionally teaches a padding layer – used as a spacer – that is disposed between an adhesive layer and base of a device containing a sensor body wherein the padding layer is thicker than the device’s sensor body and is configured to transmit pressing force generated by an adhesive layer to a sensor in moderation (Paragraph [0035] - A padding layer 114 may be coupled to the contact layer 113. The padding layer 114 may be manufactured from foam or other suitable material and positioned between the contact layer 113 and the temperature sensor 111a to protect the temperature sensor 111a from shock, moisture, and other environmental conditions that might disturb the temperature sensor 111a and/or compromise biological data gathering. The contact layer 113 may be glued (or otherwise bonded) to one side of the padding layer 114; see Annotated Figures 6 and 7 below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor of Fujioka et. al.’391 to include a padding layer – spacer – of varying thicknesses in order to provide proper protection and more controlled pressure forces to sensors that are inside of a sensing device from outside factors as seen in Linke et. al.’997.
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Annotated Figure 6
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Annotated Figure 7
Rogers et. al.’377 teaches a functional substrate layer – spacer - comprising a Young’s modulus that enables a sensor body to maintain its connection with skin of a user whenever the device is pressed against the user’s body (Paragraph [0087] - In some embodiments, a mechanically matched functional substrate is characterized by one or more mechanical properties and/or physical properties that are within a specified factor of the same parameter for an epidermal layer of the skin, such as a factor of 10 or a factor of 2. In an embodiment, for example, a functional substrate has a Young's Modulus or thickness that is within a factor of 20, or optionally for some applications within a factor of 10, or optionally for some applications within a factor of 2, of a tissue, such as an epidermal layer of the skin, at the interface with a device of the present invention. In an embodiment, a mechanically matched functional substrate may have a mass or modulus that is equal to or lower than that of skin; Paragraph [0085] - In an embodiment, a functional substrate has a mechanical functionality, for example, providing physical and mechanical properties for establishing conformal contact at the interface with a tissue, such as skin). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Fujioka et. al.’391 in view of Linke et. al.’997 and further in view of Petisce et. al.'516 to include a padding layer that is made up of a material similar to the functional layer of Rogers et. al.’377 in order to withstand pressures and forces acted on the device and therefore create a system that more securely conforms to the skin of the user as seen in Rogers et. al.’377.
Ko et. al.’867 teaches a sensor device comprising an elastic component – spacer – configured to use an elastic modulus – including Young’s modulus – to maintain an appropriate shape and connection between a sensor device and a user (Page 5 Paragraph 9 - The elastic part 400 for a sensor has a predetermined elastic modulus such that it is elastically deformed when a force is externally applied and has a restoring force to return to its original shape when the force is removed. Therefore, the wearable measuring apparatus 10 can measure the wearer's biometric information in a state of being in contact with the wearer's body 20, and the wearer can perform various physical activities even in a state of wearing the wearer's body 20). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the system of Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377 to include a padding layer that utilizes elastic modulus - Young’s modulus – in order to retain an appropriate shape for the sensor device throughout various exercises as seen in Ko et. al.’377.
Regarding Claim 2, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above, but fails to disclose wherein the flexible sheet includes an adhesive layer connected to a surface, wherein the surface is configured to contact the living body, and the spacer part is attached to the flexible sheet by the adhesive layer. Linke et. al.'997 teaches an adhesive layer on a surface of a wearable item that is configured to be in contact with a user as well as an adhesive layer that is in contact with a padding layer (Paragraph [0036] - An adhesive layer 115 may hold the temperature sensor 111a to the padding layer 114 and also may be used for attachment to the wearable item 112; Paragraph [0037] - The biosensor assembly 101 may be affixed to the cap 112 in a manner that positions the sensor pad assembly 110 relative to the living body for capturing raw biological data; Paragraph [0035] –A padding layer 114 may be coupled to the contact layer 113…to protect the temperature sensor 111a from shock, moisture, and other environmental conditions that might disturb the temperature sensor 111a and/or compromise biological data gathering). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the senor of Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 to include a flexible adhesive layer that is in contact with a wearable structure configured to be in contact with a user’s skin in order to assist in positioning a sensor so that a reliable reading can be obtained as well as including an adhesive layer that is in contact with a padded layer in order to ensure that the padded layer stays in a position to protect the sensor as seen in Linke et. al.’997.
Regarding Claim 3, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above, but fails to disclose wherein the flexible sheet has an area larger than a contact surface with the spacer part. Linke et. al.’997 teaches a sensor with an adhesive layer with an area that is larger than the area of the padding layer in which it is in contact with (see Annotated Figure 1 above; Paragraph [0035] - A padding layer 114 may be coupled to the contact layer 113…to protect the temperature sensor 111a from shock, moisture, and other environmental conditions that might disturb the temperature sensor 111a and/or compromise biological data gathering). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the senor of Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 to include a flexible adhesive layer that has a larger area than a padded surface in contact with a sensor as a form of coupling the padded surface with a different surface of the device in order to provide additional protection for the sensor when the device is in use as seen in Petisce et. al.’516.
Regarding Claim 4, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above, but fails to disclose comprising a cover part that covers the fixing part to suppress deviation when the sensor main body is in continuous contact with the living body, such that the cover part is configured to be press the sensor main body and the fixing part against the living body. Linke et. al.'997 teaches a sensor attachable to a wearable device in order for the wearable device to be held in a position relative to a user’s body (Paragraph [0036] - An adhesive layer 115 may hold the temperature sensor 111a to the padding layer 114 and also may be used for attachment to the wearable item 112; Paragraph [0070] - The cap 112 may be worn on the head so that presence sensor 111b detects that sensor unit 111 is positioned relative the body to take reliable raw biological data). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the sensor of Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 to include a cover such as a wearable device that attaches to the adhesive layer in order to assist in maintaining a sensor’s position relative to a user’s body and avoid unwanted movement of the sensor body so that reliable readings can be obtained as seen in Linke et. al.’997.
Regarding Claim 5, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above. Fujioka et. al.’391 further discloses wherein the sensor main body is configured to contact a forehead, an upper arm, a back, or a wrist of a human body (Page 3 Paragraph 7 - The part where the enzyme sensor 1 is mounted in a living body can be set as appropriate, and can be, for example, the wrist, leg, head, chest, abdomen, or the like).
Regarding Claim 7, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above. Fujioka et. al.’391 further discloses wherein the enzyme layer contains at least one kind selected from lactate oxidase, glucose oxidase, and alcohol oxidase (Page 3 Paragraph 4 - The enzyme layer 13 contains an enzyme. Examples of the enzyme include lactate oxidase (lactate oxidase), glucose oxidase (glucose oxidase), alkaline phosphatase, alcohol oxidase, uricase, L-amino acid oxidase, urease, cholesterol oxidase, phosphatase, horseradish peroxidase and the like).
Regarding Claim 8, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 1 above. Fujioka et. al.’391 further discloses wherein the absorption layer contains a polymer material having a chemically bonded crosslinked structure, the absorption layer covering end faces of the enzyme layer and the electrode layer (Page 3 Paragraph 6 - The absorption layer 15 can be formed from a photocurable composition. By forming from a photocurable composition, a polymer material having a chemically bonded cross-linked structure; Page 4 Paragraph 5 - an absorbing layer forming material is applied so as to cover the working electrode 5, the electron transfer mediator layer 11, the enzyme layer 13, the reference electrode 7, and the counter electrode 9).
Regarding Claim 9, Fujioka et. al.’391 in view of Linke et. al.'997, further in view of Petisce et. al.'516, and further in view of Rogers et. al.’377, and further in view of Ko et. al.’377 discloses the sensor outlined in Claim 4 above. Fujioka et. al.’391 further discloses wherein the sensor main body is configured to contact a forehead, an upper arm, a back, or a wrist of a human body (Page 3 Paragraph 7 - The part where the enzyme sensor 1 is mounted in a living body can be set as appropriate, and can be, for example, the wrist, leg, head, chest, abdomen, or the like).
Response to Arguments
Applicant's arguments filed 24 December 2025 have been fully considered and they are not entirely persuasive.
Applicant’s reasonings regarding the drawing objections being overturned were found to be persuasive by the examiner. There are no more drawing objections to be made by the examiner.
Applicant’s amendments have created claim objections that have been addressed in Paragraph 4 above.
Given that the applicant did not amend the limitations addressed regarding claim interpretations, the examiner’s interpretation of the element remain and are addressed in Paragraph 5 above.
Applicant’s amendments have overcome the prior 35 U.S.C. 101 rejections.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraph 6 above.
The examiner considered the reasonings provided by the applicant for arguing that the inventions of Linke and Petisce are not related to Fujioka in an obvious manner, but these arguments were found to not be persuasive for the following reasons:
Applicant argues that Linke and Petisce do not have "exposed surfaces" but that is found to not be persuasive. The examiner notes that both Linke and Petisce teach sensors that are in direct contact with skin of a user. Linke teaches a sensor being in direct contact with skin of a user which would classify as "exposed" (Paragraph [0021] - The biosensor assembly 101 may be positioned proximal to the body to make operational contact with the body. It will be understood that operational contact may include direct contact with the skin of the body). Petisce teaches a sensor attached directly to skin of a user which would classify as "exposed" (Page 41 lines 4-5 - articulation of the device against the host's skin, better conformity of the sensor system 10).
Applicant appears to be arguing that Linke is not analogous art. However, this argument is found to not be persuasive. According to Section 2141.01(a) of the MPEP, a reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. While Linke is not from the same field of endeavor, Linke is reasonably pertinent to the problem faced. The problem being solved by Linke is fixing a sensor main body to a living body. The type of sensor is not relevant to the analogous art. Linke teaches how to connect a sensor body to a user via an adjustable cover (Paragraph [0070] - the cap 112 may be worn on the head so that the presence sensor 111b detects that sensor unit 111 is positioned relative the body).
herefore, because of the above two reasonings, the examiner argues that the art is analogous and has provided reasons and appropriate motivations as to why the invention of Fujioka could have been modified in order to create an invention that was obvious to one of ordinary skill in the art at the time the invention was effectively filed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791