DETAILED ACTION
Claims 31-50 are hereby under examination.
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
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/14/2024 is being considered by the examiner.
Claim Objections
Claims 31, 48, and 50 are objected to because of the following informalities:
Regarding claim 31, line 9 recites “a heat wave and a pressure wave”, however it appears it should read --the heat wave and the pressure wave-- (emphasis added).
Regarding claim 31, line 12 recites “excitation radiation”, however it appears it should read --the excitation radiation-- (emphasis added).
Regarding claim 48, line 9 recites “a heat wave and a pressure wave”, however it appears it should read --the heat wave and the pressure wave-- (emphasis added).
Regarding claim 48, line 12 recites “excitation radiation”, however it appears it should read --the excitation radiation-- (emphasis added).
Regarding claim 48, line 31 recites “a body part”, however it appears it should read --the body part-- (emphasis added).
Regarding claim 48, line 32 recites “a skin”, however it appears it should read --the skin-- (emphasis added).
Regarding claim 48, line 33 recites “a contact pressure”, however it appears it should read --the contact pressure-- (emphasis added).
Regarding claim 48, line 50 recites “a response signal”, however it appears it should read --the response signal-- (emphasis added).
Regarding claim 50, line 2 recites “a contact pressure”, however it appears it should read --the contact pressure-- (emphasis added).
Claim Interpretation - 35 USC § 112(f)
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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:
Claims 31 and 48: The claim limitation “a detection device for detecting a physical response …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “device” coupled with functional language “for detecting a physical response …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “device”.
Claims 31 and 48: The claim limitation “a holding portion for securing the wearable device to a body part of the subject …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “portion” coupled with functional language “for securing the wearable device to a body part of the subject …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “portion”.
Claims 31 and 48: The claim limitation “actuated means for temporarily increasing a contact pressure …” has been interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because it uses a generic placeholder “means” coupled with functional language “for temporarily increasing a contact pressure …” without reciting sufficient structure to achieve the function. Furthermore, the generic placeholder is not preceded by a structural modifier that has a known structural meaning before the phrase “means”.
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.
A review of the specification shows that the following appears to be the corresponding structure described in the specification for the 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph limitation:
“detection device may comprise one or more detection elements such as a photodetector, an electrode, a temperature sensor and/or a microphone for detecting the physical response …”, or equivalents thereof, as described in para. [0027] of the disclosure filed on 08/14/2024.
“holding portion may for example be a wristband or a similar structure …”, or equivalents thereof, as described in para. [0125] of the disclosure filed on 08/14/2024.
“electric actuator … magnetic actuator … piezoelement … a fluid pump … actuated means … may comprise one or more deformable members … a bimetallic element … a shape-memory allow structure … a bistable spring assembly … a pneumatically and/or hydraulically extendable member … an inflatable body …”, or equivalents thereof, as described in para. [0043-0044] of the disclosure filed on 08/14/2024.
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 § 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 31-50 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.
Regarding claim 31, lines 13-16 recite “a controller … to generate a response signal indicative of the degree of absorption of said excitation radiation”. However, claim 31 also recites “a detection device … for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation”. In light of the specification, it is currently unclear if “a response signal indicative of the degree of absorption of said excitation radiation” generated by the controller is the same as, related to, or different from “a response signal …” generated by the detection device. For the purposes of examination, the two recitations of “a response signal” are being interpreted as being the same, and the generation is performed either by the detection device or the controller. It is recommended to the Applicant to amend the claims to clearly recite if the response signals are the same, related, or different.
The dependent claims of the above rejected claim are rejected due to their dependency.
Regarding claim 46, the claim recites the limitation "the determined contact pressure" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim. For the purposes of examination, “the determinate contact pressure” is being interpreted as “a determined contact pressure”. It is recommended to the Applicant to amend the claim to recite proper antecedent basis and/or amend the claim to depend from claim 45.
Regarding claim 48, lines 13-16 recite “a controller … to generate a response signal indicative of the degree of absorption of said excitation radiation”. However, claim 48 also recites “a detection device … for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation”. In light of the specification, it is currently unclear if “a response signal indicative of the degree of absorption of said excitation radiation” generated by the controller is the same as, related to, or different from “a response signal …” generated by the detection device. For the purposes of examination, the two recitations of “a response signal” are being interpreted as being the same, and the generation is performed either by the detection device or the controller. It is recommended to the Applicant to amend the claims to clearly recite if the response signals are the same, related, or different.
The dependent claims of the above rejected claim are rejected due to their dependency.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 46 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 46, the claim currently depends from canceled claim 20, failing to further limit the subject matter of the claim upon which it depends and/or for failing to include all the limitations of the claim upon which it depends. For the purposes of examination, claim 46 is being interpreted as being dependent from claim 45.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 34 is rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 34, the claim recites “at least one of the one or more actuators and the one or more deformable members is arranged on a same side or an opposite side of the body part …”, which is directed to or encompasses a human organism. It is recommended to the Applicant to amend the claims to read along the lines of --at least one of the one or more actuators and the one or more deformable members is configured to be arranged …-- (emphasis added).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 31-38, 40-42, and 48 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer.
The claims are generally directed towards a wearable device for detecting an analyte in tissue of a human or animal subject, the wearable device comprising: a measurement body having a contact surface suitable to be brought in contact with a skin of the subject, said contact permitting one or both of heat and pressure waves generated by absorption of excitation radiation in the tissue to be transferred to said measurement body; an excitation radiation source configured for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein; a detection device for detecting a physical response of the measurement body or of a component included therein to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation and for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation; a controller to control the excitation radiation source to irradiate excitation radiation into the tissue to be absorbed by the analyte contained therein and to control the detection device to detect said physical response and to generate a response signal indicative of the degree of absorption of said excitation radiation; and a holding portion for securing the wearable device to a body part of the subject, said holding portion being configured to be arranged around the body part of the subject so as to extend circumferentially around the body part at least in part; wherein the wearable device further comprises actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject by reversibly performing one or more of the following: reducing an inner diameter of the wearable device, wherein the inner diameter of the wearable device is a distance between two opposing portions of the wearable device being arranged on opposite sides of the body part when the wearable device is secured to the body part; reducing an inner circumference of the wearable device, wherein the inner circumference of the wearable device is a length of an inner surface of the wearable device facing the body part when the wearable device is secured to the body part; and moving the measurement body or a part thereof radially inward towards the body part.
Regarding claim 31, Seo discloses a wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, Fig. 2, Fig. 3, para. [0009], para. [0066]), the wearable device comprising:
a measurement body having a contact surface suitable to be brought in contact with a skin of the subject (Fig. 4, element 101, para. [0117], “main body … biometric signal sensors … may be disposed … biometric signal sensors … close contact with the user’s body …”);
a detection device for detecting a physical response of the measurement body or of a component included therein (Fig. 4, element 113, para. [0117], “biometric signal sensors may detect at least one of information item related to the user’s health condition … blood sugar”);
a controller to control the detection device to detect said physical response (Fig. 2, Fig. 3, para. [0087], “AP may drive … an operating system or applications so as to control a plurality of hardware or software components …”, para. [0100]); and
a holding portion for securing the wearable device to a body part of the subject, said holding portion being configured to be arranged around the body part of the subject so as to extend circumferentially around the body part at least in part (Fig. 3, element 102, para. [0116], para. [0118], “wearing unit is provided for allowing the main body to be worn on the user’s body … band or watch chain … stable worn on the user’s body (e.g., wrist)”);
wherein the wearable device further comprises actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject by reversibly performing one or more of the following:
reducing an inner diameter of the wearable device, wherein the inner diameter of the wearable device is a distance between two opposing portions of the wearable device being arranged on opposite sides of the body part when the wearable device is secured to the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]);
reducing an inner circumference of the wearable device, wherein the inner circumference of the wearable device is a length of an inner surface of the wearable device facing the body part when the wearable device is secured to the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]); and
moving the measurement body or a part thereof radially inward towards the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]).
However, Seo does not explicitly disclose said contact of the measurement body permitting one or both of heat and pressure waves generated by absorption of excitation radiation in the tissue to be transferred to said measurement body, an excitation radiation source configured for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein; the detection device detects the physical response to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation and for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation; and the controller controls the excitation radiation source to irradiate excitation radiation into the tissue to be absorbed by the analyte contained therein and generates a response signal indicative of the degree of absorption of said excitation radiation.
Bauer teaches an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 8, para. [0001]), the wearable device comprising a measurement body having a contact surface (Fig. 8, element 122, para. [0102]). Bauer further teaches said contact of the measurement body permitting one or both of heat and pressure waves generated by absorption of excitation radiation in the tissue to be transferred to said measurement body (para. [0025], para. [0102]). Bauer further teaches an excitation radiation source configured for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein (Fig. 8, element 100, element 105, para. [0069-0070], para. [0075-0077], para. [0086-0087]). Bauer further teaches the detection device detects the physical response to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation and for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation (Fig. 8, element 106, para. [0072-0074], para. [0082-0083]). Bauer further teaches the controller controls the excitation radiation source to irradiate excitation radiation into the tissue to be absorbed by the analyte contained therein and generates a response signal indicative of the degree of absorption of said excitation radiation (Fig. 8, element 107, Fig. 9, para. [0074], para. [0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device disclosed by Seo to additionally include at least an excitation radiation source for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein, the detection device for detecting the physical response to one or both of the heat wave of the pressure wave, and the controller to control the excitation radiation source and to generate the response signal, as taught by Bauer. This because Bauer teaches utilizing electromagnetic excitation beams and detecting a response signal is a simple and reliable way of analyzing analytes, such as glucose (para. [0017-0018], para. [0068]).
Regarding claim 32, modified Seo discloses the wearable device of claim 31, wherein said analyte is glucose (Seo, para. [0117], “detect … blood sugar”; Bauer, para. [0074], “glucose or blood sugar level indication”, - Further see the rejection of claim 31).
Regarding claim 33, modified Seo discloses the wearable device of claim 31, wherein the actuated means for temporarily increasing the contact pressure comprise one or both of: one or more actuators, the one or more actuators including one or more of an electric actuator, a magnetic actuator, a piezoelement and a fluid pump (Fig. 12, para. [0147-0148]); and one or more deformable members configured to be one or more of deformed, extended and retracted reversibly, the one or more deformable members comprising one or more of a bimetallic element, a shape memory alloy structure, a bistable spring assembly, a pneumatically extendable member, a hydraulically extendable member and an inflatable body (para. [0121], para. [0124], para. [0134], para. [0152], para. [0155], para. [0159]).
Regarding claim 34, modified Seo discloses the wearable device of claim 33, wherein at least one of the one or more actuators and the one or more deformable members is arranged on a same side or on an opposite side of the body part as the measurement body when the wearable device is secured to the body part (Fig. 4, Fig. 9, -element 113 and element 127 can either be on the same side or on the opposite side of the body part).
Regarding claim 35, modified Seo discloses the wearable device of claim 33, wherein the measurement body is mounted movably one or both of on the wearable device and in the wearable device (Fig. 4, element 101, element 113 - the main body/sensors are moveable by the binding holes and/or by the driving member) and one or both of: the one or more actuators comprise an actuator configured to move the measurement body radially inward towards the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0130], “biometric signal sensors may come in closer contact with the user’s body …”, para. [0147-0160]); and the one or more deformable members comprise a deformable member configured to move the measurement body radially inward towards the body part (para. [0121], para. [0124], para. [0130], “biometric signal sensors may come in closer contact with the user’s body …”, para. [0134], para. [0152], para. [0155], para. [0159]).
Regarding claim 36, modified Seo discloses the wearable device of claim 31, wherein the holding portion comprises a plurality of segments connected with each other to form a chain (Fig. 3, element 121a, element 121b, para. [0118]).
Regarding claim 37, modified Seo discloses the wearable device of claim 36, wherein the actuated means for temporarily increasing the contact pressure are configured to reversibly reduce one or both of a circumferential extent of one or more segments of the holding portion and a distance between one or more pairs of adjacent segments of the holding portion (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160], para. [0177], “releases the tightened state of the wearing unit …”).
Regarding claim 38, modified Seo discloses the wearable device of claim 36, wherein the actuated means for temporarily increasing the contact pressure comprise at least one actuated hinge connecting a pair of adjacent segments of the holding portion, wherein the actuated hinge is configured to rotate the pair of adjacent segments with respect to each other to move the actuated hinge radially inward towards the body part (Fig. 13, para. [0149-0152], “the distance between the first and second joint portions may be changed to move … reduce the length of the wearing unit … main body may be further in close contact with the user’s body …”).
Regarding claim 40, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose wherein the measurement body and the excitation radiation source are arranged in different parts of the wearable device and the wearable device further comprises a waveguide configured to guide excitation radiation from the part of the wearable device in which the excitation radiation source is arranged to the part of the wearable device in which the measurement body is arranged.
Bauer further teaches the measurement body and the excitation radiation source are arranged in different parts of the wearable device and the wearable device further comprises a waveguide configured to guide excitation radiation from the part of the wearable device in which the excitation radiation source is arranged to the part of the wearable device in which the measurement body is arranged (Fig. 3, element 113/114, Fig. 8, element 100, element 105, element 124, para. [0097]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the measurement body and the excitation radiation source taught by modified Seo to be arranged in different parts of the wearable device and to include a waveguide, as taught by Bauer. This is because Bauer teaches a waveguide allows for extending the optical path of the light beam to the detection device (para. [0097]).
Regarding claim 41, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose a spacer for thermally insulating the body part from the excitation radiation source, the spacer being arranged between the excitation radiation source and an inner surface of the wearable device facing the body part when the wearable device is secured to the body part.
Bauer further teaches a spacer for thermally insulating the body part from the excitation radiation source, the spacer being arranged between the excitation radiation source and an inner surface of the wearable device facing the body part when the wearable device is secured to the body part (Fig. 8, element 108, element 122, para. [0100-0102]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device taught by modified Seo to additionally include a spacer for thermally insulating the body part from the excitation radiation source, the spacer being arranged between the excitation radiation source and an inner surface of the wearable device facing the body part when the wearable device is secured to the body part, as taught by Bauer. This is because Bauer teaches the spacer allows for support of the housing (para. [0100-0102]).
Regarding claim 42, modified Seo discloses the wearable device of claim 31, wherein one or both of: the measurement body or a part thereof permanently protrudes from the inner surface of the wearable device (Fig. 4, elements 101/113 permanently protrude from element 100); and the measurement body is arranged one or both of in and on a permanent protrusion on the inner surface of the wearable device (Fig. 4, elements 101/113 are arranged on a permanent protrusion from element 100).
Regarding claim 48, Seo discloses a method for detecting an analyte in tissue of a human or animal subject using a wearable device (Abstract, Fig. 1, Fig. 2, Fig. 3, para. [0009], para. [0013], para. [0066]) comprising:
a measurement body having a contact surface suitable to be brought in contact with a skin of the subject (Fig. 4, element 101, para. [0117], “main body … biometric signal sensors … may be disposed … biometric signal sensors … close contact with the user’s body …”);
a detection device for detecting a physical response of the measurement body or of a component included therein (Fig. 4, element 113, para. [0117], “biometric signal sensors may detect at least one of information item related to the user’s health condition … blood sugar”);
a controller to control the detection device to detect said physical response (Fig. 2, Fig. 3, para. [0087], “AP may drive … an operating system or applications so as to control a plurality of hardware or software components …”, para. [0100]); and
a holding portion for securing the wearable device to a body part of the subject, said holding portion being configured to be arranged around the body part of the subject so as to extend circumferentially around the body part at least in part (Fig. 3, element 102, para. [0116], para. [0118], “wearing unit is provided for allowing the main body to be worn on the user’s body … band or watch chain … stable worn on the user’s body (e.g., wrist)”);
wherein the wearable device further comprises actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject by reversibly performing one or more of the following:
reducing an inner diameter of the wearable device, wherein the inner diameter of the wearable device is a distance between two opposing portions of the wearable device being arranged on opposite sides of the body part when the wearable device is secured to the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]);
reducing an inner circumference of the wearable device, wherein the inner circumference of the wearable device is a length of an inner surface of the wearable device facing the body part when the wearable device is secured to the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]); and
moving the measurement body or a part thereof radially inward towards the body part (Fig. 5, element 127, para. [0121], “driving member … move the binding member in a direction of reducing the length of the wearing unit …”, para. [0147-0160]), the method comprising:
securing the wearable device to a body part of the subject such that the contact surface of the measurement body faces a skin of the subject (para. [0124], para. [0167]);
temporarily increasing a contact pressure between the measurement body and the skin of the subject by one or more of reducing the inner diameter of the wearable device, reducing the inner circumference of the wearable device and moving the measurement body or a part thereof radially inward towards the body part (para. [0167]);
while maintaining the temporarily increased contact pressure, detecting the physical response of the measurement body or a component included therein (para. [0168-0169])=; and
reducing the temporarily increased contact pressure while the wearable device remains secured to the body part of the subject (para. [0177]).
However, Seo does not explicitly disclose said contact permitting one or both of heat and pressure waves generated by absorption of excitation radiation in the tissue to be transferred to said measurement body, an excitation radiation source configured for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein; the detection device detects the physical response to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation and for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation; the controller controls the excitation radiation source to irradiate excitation radiation into the tissue to be absorbed by the analyte contained therein and to control the detection device to detect said physical response and to generate a response signal indicative of the degree of absorption of said excitation radiation; and irradiating excitation radiation into the tissue to be absorbed therein using the excitation radiation source and generating a response signal indicative of the degree of absorption of said excitation radiation using the detection device.
Bauer teaches an analogous wearable device and method for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 8, para. [0001]), the wearable device comprising a measurement body having a contact surface (Fig. 8, element 122, para. [0102]). Bauer further teaches said contact of the measurement body permitting one or both of heat and pressure waves generated by absorption of excitation radiation in the tissue to be transferred to said measurement body (para. [0025], para. [0102]). Bauer further teaches an excitation radiation source configured for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein (Fig. 8, element 100, element 105, para. [0069-0070], para. [0075-0077], para. [0086-0087]). Bauer further teaches the detection device detects the physical response to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation and for generating a response signal based on said detected physical response, said response signal being indicative of a degree of absorption of excitation radiation (Fig. 8, element 106, para. [0072-0074], para. [0082-0083]). Bauer further teaches the controller controls the excitation radiation source to irradiate excitation radiation into the tissue to be absorbed by the analyte contained therein and generates a response signal indicative of the degree of absorption of said excitation radiation, and irradiating excitation radiation into the tissue to be absorbed therein using the excitation radiation source and generating a response signal indicative of the degree of absorption of said excitation radiation using the detection device (Fig. 8, element 107, Fig. 9, para. [0074], para. [0112]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device and method disclosed by Seo to additionally include at least an excitation radiation source for irradiating excitation radiation at a plurality of wavelengths into the tissue to be absorbed by the analyte contained therein, the detection device for detecting the physical response to one or both of the heat wave of the pressure wave, and the controller to control the excitation radiation source and to generate the response signal, as taught by Bauer. This because Bauer teaches utilizing electromagnetic excitation beams and detecting a response signal is a simple and reliable way of analyzing analytes, such as glucose (para. [0017-0018], para. [0068]).
Claims 39 and 43 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer as applied to claim 31 and claim 36 above, and further in view of Nuovo et al. (US 20150335284 A1), hereinafter referred to as Nuovo.
Regarding claim 39, modified Seo discloses the wearable device of claim 36.
However, modified Seo does not explicitly disclose wherein the plurality of segments comprises a first segment one or both of in and on which the controller is arranged and a second segment one or both of in and on which the excitation radiation source is arranged, the second segment being different from the first segment.
Nuovo teaches an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, para. [0011]), comprising a plurality of segments (Fig. 1, Fig. 2, Fig. 3, elements 12, 18, 30). Nuovo further teaches the plurality of segments comprise a first segment one or both of in and on which the controller is arranged and a second segment one or both of in and on which the excitation radiation source is arranged, the second segment being different from the first segment (Fig. 3, element 18, element 30, para. [0045-0049]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the plurality of segments taught by modified Seo to additionally comprise a first segment one or both of in and on which the controller is arranged and a second segment one or both of in and on which the excitation radiation source is arranged, the second segment being different from the first segment, as taught by Nuovo. This is because Nuovo teaches separate segments for different elements allows for elements to be removable on their own (para. [0043], para. [0045]).
Regarding claim 43, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose wherein the wearable device comprises a removable battery configured to be removably coupled to one or both of an integrated battery of the wearable device and the excitation radiation source for supplying energy to one or both of the integrated battery and the excitation radiation source.
Nuovo teaches an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, para. [0011]). Nuovo further teaches the wearable device comprises a removable battery configured to be removably coupled to one or both of an integrated battery of the wearable device and the excitation radiation source for supplying energy to one or both of the integrated battery and the excitation radiation source (para. [0053], para. [0062], para. [0069-0070]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device taught by modified Seo to additionally include a removeable battery, as taught by Nuovo. This is because Nuovo teaches a removeable battery for powering an internal battery allows for the wearable device to be worn continuously (para. [0053]).
Claim 44 is rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer as applied to claim 31 above, and further in view of Tomo Ikebe (US 20150265190 A1), hereinafter referred to as Ikebe.
Regarding claim 44, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose the wearable device further comprises an auxiliary sensor configured to generate a sensor signal that depends on the contact pressure between the measurement body and the skin of the subject.
Ikebe teaches an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, para. [0011], para. [0026]). Ikebe further teaches the wearable device further comprises an auxiliary sensor configured to generate a sensor signal that depends on the contact pressure between the measurement body and the skin of the subject (Fig. 5B, para. [0050-0052]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device taught by modified Seo to additionally include an auxiliary sensor configured to generate a sensor signal that depends on the contact pressure between the measurement body and the skin of the subject, as taught by Ikebe. This is because Ikebe teaches an auxiliary sensor to generate a sensor signal that depends on the contact pressure allows for the wearable device to only drive the sensors when the contact pressure is appropriate, allowing more accurate measurements (para. [0067-0069]).
Claim 45, 47, and 50 are rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer as applied to claim 31 above, and further in view of Al-Ali et al. (US 20230058052 A1), hereinafter referred to as Al-Ali.
Regarding claim 45, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose wherein the controller is configured to determine the contact pressure between the measurement body and the skin of the subject based on a response signal from the detection device.
Al-Ali teaches of an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, Fig. 7, para. [0010]). Al-Ali teaches the wearable device comprises a detection device for detecting a physical response of a measurement body or of a component included therein to one or both of a heat wave and a pressure wave received from the tissue upon absorption of the excitation radiation (para. [0277]). Al-Ali further teaches a controller is configured to determine the contact pressure between the measurement body and the skin of the subject based on a response signal from the detection device (para. [0424]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller taught by modified Seo to additionally determine the contact pressure between the measurement body and the skin of the subject based on a response signal from the detection device, as taught by Al-Ali. This is because Al-Ali teaches determining if the signal quality is below a threshold, the user can be appropriately warned to adjust the band tightness to generate better signal data (para. [0424]).
Regarding claim 47, modified Seo discloses the wearable device of claim 31.
However, modified Seo does not explicitly disclose wherein the wearable device further comprises a contact monitor for monitoring one or both of a thermal contact state and a pressure transmitting contact state between the contact surface of the measurement body and the skin of the subject.
Al-Ali teaches of an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, Fig. 7, para. [0010]). Al-Ali further teaches the wearable device further comprises a contact monitor for monitoring one or both of a thermal contact state and a pressure transmitting contact state between the contact surface of the measurement body and the skin of the subject (para. [0404-0405]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the wearable device taught by modified Seo to additionally include a contact monitor for monitoring one or both of a thermal contact state and a pressure transmitting contact state between the contact surface of the measurement body and the skin of the subject, as taught by Al-Ali. This is because Al-Ali teaches a contact monitor allows for the wearable device to activate the sensor module only when a desired pressure or pressure range is achieved, to obtain accurate results (para. [0405]).
Regarding claim 50, modified Seo discloses the wearable device of claim 47.
However, modified Seo does not explicitly disclose wherein the contact monitor is configured to activate the actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject based on one or both of said thermal contact state and said pressure transmitting contact state.
Al-Ali further teaches the contact monitor is configured to activate the actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject based on one or both of said thermal contact state and said pressure transmitting contact state (para. [0406]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the contact monitor taught by modified Seo to additionally be configured to activate the actuated means for temporarily increasing a contact pressure between the measurement body and the skin of the subject based on one or both of said thermal contact state and said pressure transmitting contact state, as taught by Al-Ali. This is because Al-Ali teaches adjusting the tightness based on the monitored tightness allows for accurate results to be achieved (para. [0405-0406]).
Claim 46 is rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer, in view of Al-Ali et al. (US 20230058052 A1), hereinafter referred to as Al-Ali as applied to claim 45 above, and further in view of Tomo Ikebe (US 20150265190 A1), hereinafter referred to as Ikebe.
Regarding claim 46, modified Seo discloses the wearable device of claim 20 (claim 45 - see the 112(d) rejection above).
However, modified Seo does not explicitly disclose wherein the controller is configured to discard a response signal generated by the detection device for detection of the analyte if the determined contact pressure is below a threshold.
Ikebe teaches an analogous wearable device for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, para. [0011], para. [0026]). Ikebe further teaches the controller is configured to discard a response signal generated by the detection device for detection of the analyte if the determined contact pressure is below a threshold (para. [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the controller taught by modified Seo to additionally discard a response signal generated by the detection device for detection of the analyte if the determined contact pressure is below a threshold, as taught by Ikebe. This is because Ikebe teaches not utilizing data obtained when the contact pressure is below a threshold allows for better precision of obtaining a state of the biological object (para. [0014]).
Claim 49 is rejected under 35 U.S.C. 103 as being unpatentable over Seo et al. (US 20160120048 A1), hereinafter referred to as Seo, in view of Bauer et al. (US 20190302019 A1), hereinafter referred to as Bauer, as applied to claim 48 above, and further in view of Al-Ali et al. (US 20230058052 A1), hereinafter referred to as Al-Ali and Tomo Ikebe (US 20150265190 A1), hereinafter referred to as Ikebe.
Regarding claim 49, modified Seo discloses the method of claim 48.
However, modified Seo does not explicitly disclose the method further comprises determining the contact pressure between the measurement body and the skin of the subject.
Al-Ali teaches of an analogous wearable device and method for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, Fig. 7, para. [0010]). Al-Ali further teaches determining the contact pressure between the measurement body and the skin of the subject (para. [0404-0405]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Seo to additionally determine the contact pressure between the measurement body and the skin of the subject, as taught by Al-Ali. This is because Al-Ali teaches determining the contact pressure allows for the wearable device to activate the sensor module only when a desired pressure or pressure range is achieved, to obtain accurate results (para. [0405]).
However, modified Seo does not explicitly disclose wherein the response signal is discarded for detection of the analyte if the determined contact pressure is below a threshold.
Ikebe teaches an analogous wearable device and method for detecting an analyte in tissue of a human or animal subject (Abstract, Fig. 1, para. [0011], para. [0026]). Ikebe further teaches discarding a response signal if the determined contact pressure is below a threshold (para. [0059]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method taught by modified Seo to additionally discard a response signal if the determined contact pressure is below a threshold, as taught by Ikebe. This is because Ikebe teaches not utilizing data obtained when the contact pressure is below a threshold allows for better precision of obtaining a state of the biological object (para. [0014]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791
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