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 .
Election/Restrictions
The Applicant’s election without traverse of species A1, A2, and A3 in the reply filed on 5/11/2026 is acknowledged.
Information Disclosure Statement
The information disclosure statement filed 1/22/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. There seems to be no complete copy in this application or in the parent application 16/303371, of the following foreign documents: RU 2245673, RU 141656, RU 2004124332, and RU 2013122844. These references have not been considered.
Drawings
The drawings are objected to because FIGS. 8-9, 14a-14b, and 15a-15b are of poor quality, have faint lines, and have text that is too small. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
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.
No claim limitations are interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Objections
Claims 1, 12, 15, 19, 26-27 are objected to because of the following informalities:
in claim 1, line 11: “the” should be inserted before “osmotic pressure”;
in claim 1, line 12: “the” should be inserted before “tissue”;
in claim 1, line 20: “the” should be inserted before “tissue”;
in claim 12, line 3: “the” should be inserted before “linear displacement”;
in claim 15, line 2: “the” should be inserted before “tissue”;
in claim 19, line 3: “the” should be inserted before “tissue”;
in claim 26, lines 7-8: “the” should be inserted before “osmotic pressure”;
in claim 26, line 8: “the” should be inserted before “tissue”;
in claim 27, line 8: “the” should be inserted before “physiological parameters”
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3, 6-9, 11-21, and 23-29 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “[a] device for monitoring blood glucose levels of a subject having skin” in line 1, but no element of claim 1 is shown to have a capability of monitoring blood glucose level. Indeed, the claim does no mention the concept again. It is not clear how the device of claim 1 is capable of monitoring blood glucose levels when the claimed device has no element capable of performing this function.
Claim 1 recites “a multi-sensor system configured to: convert into an electrical signal osmotic pressure in a controlled volume of tissue of the subject, measure physiological parameters characterizing osmotic pressure in the controlled volume of tissue, and measure climatic parameters” in lines 8-13, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed functions of lines 8-13 with the claimed elements of lines 17-20. This confusion renders claim 1 indefinite.
Claims 2-3, 6-9, 11-21, and 23-29 are rejected by virtue of their dependence from claim 1.
Claim 11 recites “wherein the multi-sensor system is further configured to measure intracellular osmotic pressure” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 11 with the claimed elements of lines 17-20. This confusion renders claim 11 indefinite.
Claims 17-21 are rejected by virtue of their dependence from claim 11.
Claim 12 recites “adjustable clamping pressure of the applicator” in line 3, but it is not clear if this recitation is the same as, related to, or different from “adjustable applicator pressure” of claim 1, lines 18-19. If they are the same, “adjustable clamping pressure of the applicator” in claim 12 should be “the adjustable applicator pressure”. If they are different, their relationship should be made clear.
Claim 15 recites “wherein the multi-sensor system is further configured to measure elastic pressure of tissue under the applicator” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 15 with the claimed elements of lines 17-20. This confusion renders claim 15 indefinite.
Claim 16 recites “wherein the multi-sensor system is further configured to measure blood pressure” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 16 with the claimed elements of lines 17-20. This confusion renders claim 16 indefinite.
Claim 17 recites “wherein the multi-sensor system is further configured to measure a rate of cellular metabolism and a number of input calories” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 17 with the claimed elements of lines 17-20. This confusion renders claim 17 indefinite.
Claim 18 recites “wherein a determination of the intracellular osmotic pressure is based on a measured amount of intracellular water” in lines 1-2, which is a method step in an apparatus claim. A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, because it creates confusion as to when direct infringement occurs. (MPEP 2173.05(p) citing In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011)).
Claim 18 recites “a measured amount of intracellular water” in lines 2, but it is not clear if this recitation is the same as, related to, or different from “an amount of water in the controlled volume of tissue” in claim 1, line 20. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 19 recites “electrodes” in line 3, but it is not clear if this recitation is the same as, related to, or different from “another sensor configured to detect an amount of water in the controlled volume of tissue” in claim 1, line 20. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 20 recites “wherein the multi-sensor system is further configured to measure a rate of cellular metabolism and input calories” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 20 with the claimed elements of lines 17-20. This confusion renders claim 20 indefinite.
Claim 21 recites “a local area of living tissue” in line 2. First, it is not clear if “living tissue” is the same as, related to, or different from “tissue” of claim 1, line 9. If they are the same, “living tissue” in claim 21 should be “the tissue”. If they are different, their relationship should be made clear. If they are the same, it is not clear if “a local area” of claim 21 is the same as, related to, or different from “a controlled volume” of claim 1, line 9. If they are the same, consistent terminology should be used. If they are different, their relationship should be made clear.
Claim 23 recites “wherein the multi-sensor system is further configured to measure blood pressure” in lines 1-2, but the recited elements of the multi-sensor system in claim 1 are only “a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis, a temperature sensor, and another sensor configured to detect an amount of water in the controlled volume of tissue” in lines 17-20. It is not clear how the claimed multi-sensor system can carry out the claimed function of claim 23 with the claimed elements of lines 17-20. This confusion renders claim 23 indefinite.
Claim 24 recites “to measure physiological parameters characterizing metabolism of the subject's body, by measuring biochemical parameters of blood, partial pressure of oxygen and/or carbon dioxide of blood, and/or parameters of an acid-base state of the body” in lines 2-4, but the two occurrences of “and/or” make the recitation confusing. For example, it is not clear if this recitation means:
(1) to measure physiological parameters characterizing metabolism of the subject's body, by measuring (1) biochemical parameters of blood, (2) partial pressure of oxygen, (3) carbon dioxide of blood, and/or (4) parameters of an acid-base state of the body; OR
(2) to measure (1) physiological parameters characterizing metabolism of the subject's body and/or (2) parameters of an acid-base state of the body, wherein if the multi-sensor system is further configured to measure the physiological parameters, the multi-sensor system is so configured by measuring biochemical parameters of blood, partial pressure of oxygen and/or carbon dioxide of blood.
This ambiguity renders claim 24 indefinite.
Claim 26 recites “at least one sensor located on the lower wall of the removable housing, used in the measuring of water vapor concentration and the climatic parameters” in lines 3-4, which renders the claim indefinite.
First, it is not clear how one sensor can measure the water vapor concentration and the climatic parameters. It would appear at least two or three sensors are required.
Second, it is not clear if the water vapor concentration of claim 26 is the same as, related to, or different from “an amount of water in the controlled volume of tissue” in claim 1, line 20.
Third and related to the second point, it is not clear if the sensor of claim 26 is the same as, related to, or different from “another sensor” of claim 1, line 20.
These ambiguities renders claim 26 indefinite.
Claim 26 recites “an adjustable clamping pressure” in line 8, but it is not clear if this recitation is the same as, related to, or different from “adjustable applicator pressure” of claim 1, lines 18-19. If they are the same, “an adjustable clamping pressure” in claim 26 should be “the adjustable applicator pressure”. If they are different, their relationship should be made clear.
Claim 27 recites “the first type of sensor being configured for use in measuring of water vapor concentration and the climatic parameters” in lines 4-6, which renders the claim indefinite.
First, it is not clear how one sensor can measure the water vapor concentration and the climatic parameters. It would appear at least two or three sensor types are required.
Second, it is not clear if the water vapor concentration of claim 27 is the same as, related to, or different from “an amount of water in the controlled volume of tissue” in claim 1, line 20.
Third and related to the second point, it is not clear if the first type of sensor of claim 27 is the same as, related to, or different from “another sensor” of claim 1, line 20.
These ambiguities renders claim 27 indefinite.
Claim 27 recites “an adjustable pressure” in line 9, but it is not clear if this recitation is the same as, related to, or different from “adjustable applicator pressure” of claim 1, lines 18-19. If they are the same, “an adjustable pressure” in claim 27 should be “the adjustable applicator pressure”. If they are different, their relationship should be made clear.
Claim 28 is rejected by virtue of their dependence from claim 27.
Claim 28 recites “at least one transducer is configured to measure a water vapor concentration” in lines 1-2 and “the water vapor concentration sensor” in lines 3-4, which renders the claim indefinite.
First, it is not clear if the water vapor concentration of claim 28 is the same as, related to, or different from “an amount of water in the controlled volume of tissue” in claim 1, line 20 and/or the water vapor concentration of claim 27.
Second and related to the first point, it is not clear if the transducer of claim 28, lines 1-2 and the water vapor concentration sensor in claim 28, lines 3-4 are the same as, related to, or different from each other, “another sensor” of claim 1, line 20, and/or the first type of sensor of claim 27.
These ambiguities renders claim 28 indefinite.
Claim 28 recites “the lower end of the transducer” in lines 2-3 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 28 recites “the skin surface” in line 3, but it is not clear if this recitation is the same as, related to, or different from “a surface of the stratum corneum of the epidermis of the skin” of claim 1, lines 6-7. If they are the same, “the skin surface” in claim 28 should be “the surface of the stratum corneum”. If they are different, their relationship should be made clear.
Claim 29 recites “an amount of water in the stratum corneum of controlled volume epidermis and/or in the cavity being located above the surface of the stratum corneum” in lines 2-3, which renders the claim indefinite.
First, it is not clear if the “controlled volume epidermis” of claim 29 is the same as, related to, or different from “a controlled volume of tissue of the subject” of claim 1, lines 9-10. If they are the same, “controlled volume epidermis” in claim 29 should be “the controlled volume of the tissue of the subject”. If they are different, their relationship should be made clear.
Second and related to the first point, it is not clear if “an amount of water” of claim 29 is the same as, related to, or different from “an amount of water in the controlled volume of tissue” of claim 1, lines 9-10. If they are the same, “an amount of water in the stratum corneum of controlled volume epidermis” in claim 29 should be “the amount of water in the controlled volume of the tissue of the subject”. If they are different, their relationship should be made clear.
Claim 29 recites “the cavity” in lines 2-3 in which there is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites “the water vapor concentration sensor” in line 4, but it is not clear if this sensor of claim 29 is the same as, related to, or different from “another sensor” of claim 1, line 20. Clarification is required.
Claim 29 recites “so as to avoid direct contract of the water vapor concentration sensor with the skin” in lines 3-4 which is so grammatically awkward that its meaning is not clear.
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 1-3, 6-9, and 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over RU 2396897 (Musin), in view of U.S. Patent Application Publication No. 2018/0263539 (Javey), and further in view of U.S. Patent Application Publication No. 2017/0011210 (Cheong), and further in view of WO 2010/005406 (Vedat). Citations to Musin will refer to the machine English translation that accompanies this Office Action.
Musin teaches a device comprising a multi-sensor system configured to: convert into an electrical signal osmotic pressure in a controlled volume of tissue of the subject (obtaining osmotic pressure of intercellular substance using a sensor; pages 12, 21, 23-28, and 32 of Musin; claims 11-12, 16, 50-51, 57, and 62 of Musin), measure physiological parameters characterizing osmotic pressure in the controlled volume of tissue (measuring glucose concentration; pages 12 and 32 and claims 165-166, and 171-173 of Musin), and measure climatic parameters (measuring external pressure, temperature, and humidity; pages 12 and 32 and claims 153, 159, 165, and 171-173 of Musin). The device of Musin also includes a waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis (the waterproof applicator that applies a metered pressure to the surface of the stratum corneum of the epidermis; page 17 and claims 16, 163, 167 of Musin), a temperature sensor (claim 125, 127, 160, 167, 171-173, 183, and 191 of Musin), and another sensor configured to detect an amount of water in the controlled volume of tissue (pages 1, 11-13, and 17-21 and claims 124, 126, 127, 130-141, 151, 158, 165, and 171-172 of Musin). Musin also teaches a processor (claim 152 of Musin).
Javey teaches a wearable glucose sensor (paragraph 0012, 0046, and 0064 and claim 42 of Javey; see also claims 7, 25, 30, and 40 of the provisional application 62/233,955). Javey teaches that such wearable sensors include one or more amplifiers; one or more filters; an A/D converter; a digital processor; a wireless interface configured to transmit information corresponding to the conditioned sensor signals to a remote computing device for sharing or uploading the data to could servers online; and a battery configured to power at least portions of the wearable system (paragraphs 0008, 0056, and 0061 and claim 41 of Javey; see also pages 5-6 and claims 23, 28, and 38 of the provisional application 62/233,955). The amplifiers, the filters, the wireless interface, and the battery are mounted on a substrate (claim 24 of Javey; claim 16 of the provisional application 62/233,955). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include one or more amplifiers; one or more filters; an A/D converter; a wireless interface; and a battery to the circuits of Musin since (1) the one or more amplifiers improves the signal magnitude for better processing; (2) the one or more filters removes unwanted noise from the signals for better processing; (3) the A/D converter provides a mechanism for the processor of Musin to be utilized with the sensors of Musin; (4) the wireless interface permits transmission of the data to a remote computing device for sharing or storage; and (5) the battery powers the components of the circuit of Musin.
Cheong teaches the use of a wearable arrangement for a sensing system that measures one or more of the user's blood pressure, blood flow, heart rate (HRM, HRV), temperature, respiration rate, oxygen saturation, cardiorespiratory sound detection, blood sugar, calorie consumption (paragraph 0458 of Cheong). The wearable arrangement includes a main body 10 and a strap 50 (paragraph 0307 of Cheong). The strap 50 has a seating portion 51 with an opening 51a into which the main body 10 is inserted using the fastening groove arrangement (paragraphs 0279-0281, 0310, 0317-0318, 0326, 0364, 0372, and 0374-0376 of Cheong). For the main body 10, Cheong teaches that the sensing portions are positioned on the lower surface of the housing and the operational components are attached to one or more circuit boards (paragraphs 0207, 332-0333, and 0339-0342 and FIGS. 10 and 13 of Cheong). Javey also teaches that amplifiers, filters, interfaces, and batteries are mounted on a substrate (claim 24 of Javey; claim 16 of the provisional application 62/233,955). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the one or more amplifiers, the one or more filters, the A/D converter, the wireless interface, the battery, the sensors, and the waterproof applicator within a housing which is insertable into a strap having a seating portion since it protects the components while permitting interchangeability of parts. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the one or more amplifiers, the one or more filters, the A/D converter, the wireless interface, the battery, and the processor anchored to a circuit board, as suggested by Cheong and Javey, since it stabilizes the relative placements of the devices. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the one or more sensors positioned on the lower surface of the housing, as suggested by Cheong, so as to have unobstructed access to the measurement site.
Musin teaches a waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis (the waterproof applicator that applies a metered pressure to the surface of the stratum corneum of the epidermis; page 17 and claims 16, 163, 167 of Musin). Vedat teaches that making a structure heat resistant and water-impermeable makes such a device more durable (pages 12-13 of Vedat). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make the waterproof applicator of Musin heat resistant since it makes the applicator more durable.
With respect to claim 1, the combination teaches or suggests a device for monitoring blood glucose levels of a subject having skin, the device comprising:
a strap (the strap 50 of Cheong) with a mounting platform (the seating portion 51 of Cheong);
a removable housing (the housing 10 suggested by Cheong) including a lower wall having at least one through hole (the housing 10 of Cheong includes holes in tis lower walls for the sensors; See FIG. 10 of Cheong), the removable housing being configured to snap onto the mounting platform (the groove arrangement of Cheong; paragraphs 0279-0281, 0310, 0317-0318, 0326, 0364, 0372, and 0374-0376 of Cheong), the lower wall being configured to contact and be pressed against a surface of the stratum corneum of the epidermis of the skin with a dosed pressure via the strap (paragraphs 0309, 0331, and 0346-0347 of Cheong);
a multi-sensor system configured to: convert into an electrical signal osmotic pressure in a controlled volume of tissue of the subject (obtaining osmotic pressure of intercellular substance using a sensor; pages 12, 21, 23-28, and 32 of Musin; claims 11-12, 16, 50-51, 57, and 62 of Musin), measure physiological parameters characterizing osmotic pressure in the controlled volume of tissue (measuring glucose concentration; pages 12 and 32 and claims 165-166, and 171-173 of Musin), and measure climatic parameters (measuring external pressure, temperature, and humidity; pages 12 and 32 and claims 153, 159, 165, and 171-173 of Musin); and
an electronic board (the circuit board suggested by Javey and Cheong) and a power supply (the battery of Javey), the multi-sensor system being operably coupled to the electronic board, the electronic board including preamps (the one or more amplifiers of Javey), an analog-digital converter (the A/D converter of Javey), a processor (the processor of Musin), and a wireless transceiver (the interface of Javey);
wherein the multi-sensor system includes, inside the removable housing, a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis (the waterproof applicator that applies a metered pressure to the surface of the stratum corneum of the epidermis; page 17 and claims 16, 163, 167 of Musin; the waterproof applicator also being heat resistant as suggested by Vedat), a temperature sensor (claim 125, 127, 160, 167, 171-173, 183, and 191 of Musin), and another sensor configured to detect an amount of water in the controlled volume of tissue (pages 1, 11-13, and 17-21 and claims 124, 126, 127, 130-141, 151, 158, 165, and 171-172 of Musin).
With respect to claim 2, the combination teaches or suggests that the multi-sensor system is further configured to determine a volume of an intercellular space and/or a volume of the intracellular space (page 21 of Musin).
With respect to claim 3, the combination teaches or suggests that the another sensor is electrometric (the electrometric electrodes; pages 17-21 of Musin).
With respect to claim 6, the combination teaches or suggests that the another sensor includes a base electrode (the base electrode; pages 17-21 and claims 142-148 of Musin) and at least one measuring electrode (the measuring electrode; pages 17-21 and claims 142-148 of Musin), the at least one measuring electrode being a dry waterproof electrode (the measuring electrode is made of an electrically conductive waterproof material; pages 17-21 of Musin) and being configured to act as a transducer applicator, the base electrode being provided on the lower wall (the one or more sensors positioned on the lower surface of the housing, as suggested by Cheong).
With respect to claim 7, the combination teaches or suggests that an area of the base electrode is greater than an area of the at least one measuring electrode (claims 143-148 of Musin).
With respect to claim 8, the combination teaches or suggests that the base electrode and the at least one measuring electrode have a combined disk shaped structure (claims 143-148 of Musin).
With respect to claim 9, the combination teaches or suggests that the another sensor is configured to measure transverse electrical conductivity of the stratum corneum of the epidermis at a constant or low frequency current (page 20-21 and claims 143-148 of Musin).
With respect to claim 23, the combination teaches or suggests that the multi-sensor system is further configured to measure blood pressure (pages 19 and claims 93-95, 107-109, 181, 183-184, and 192 of Musin).
With respect to claim 24, the combination teaches or suggests that the multi-sensor system is further configured to measure physiological parameters characterizing metabolism of the subject's body, by measuring biochemical parameters of blood (measuring the concentration of biochemical components in blood; pages 12, 18-19 and claims 57 and 167 of Musin), partial pressure of oxygen and/or carbon dioxide of blood, and/or parameters of an acid-base state of the body.
With respect to claim 25, the combination teaches or suggests that the multi-sensor system includes at least one transducer used in the conversion of the osmotic pressure in the controlled volume of the tissue of the subject into the electrical signal (obtaining osmotic pressure of intercellular substance using a sensor; pages 12, 21, 23-28, and 32 of Musin; claims 11-12, 16, 50-51, 57, and 62 of Musin).
With respect to claim 26, the combination teaches or suggests at least one sensor located on the lower wall of the removable housing (the one or more sensors positioned on the lower surface of the housing, as suggested by Cheong), used in the measuring of water vapor concentration (the sensors for measuring water vapor concentration; claims 126 and 134 of Musin) and the climatic parameters (the sensors of measuring external pressure, temperature, and humidity; pages 12 and 32 and claims 153, 159, 165, 171-173 of Musin), and one or more other components installed inside the removable housing (the sensors located in the housing as suggested by Cheong), used in the conversion of the osmotic pressure in the controlled volume of the tissue of the subject into the electrical signal (obtaining osmotic pressure of intercellular substance using a sensor; pages 12, 21, 23-28, and 32 of Musin; claims 11-12, 16, 50-51, 57, and 62 of Musin) and in the measuring of the physiological parameters characterizing osmotic pressure in the controlled volume of tissue, using an adjustable clamping pressure (using metered pressure; page 17 and claims 20, 26, 32, 63, 139, 142, 154, 167, and 170 of Musin).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Musin, in view of Javey, and further in view of Cheong, and further in view of Vedat, and further in view of WO 2009/125349 (Baron).
The combination teaches or suggests a heat resistant and waterproof applicator of a device configured to create linear displacement and adjustable applicator pressure on the surface of the stratum corneum of the epidermis (the waterproof applicator that applies a metered pressure to the surface of the stratum corneum of the epidermis; page 17 and claims 16, 163, 167 of Musin; the waterproof applicator also being heat resistant as suggested by Vedat). Baron teaches that the actuator may comprise a stepper motor so as to institute the pressing (page 21 of Baron). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a stepper motor of Baron in the waterproof, heat-resistant applicator of the combination since a driver for the applicator is required and Baron teaches one such driver.
With respect to claim 12, the combination teaches or suggests a stepper motor is configured to convert rotational movement of a motor shaft into linear movement of the applicator in creating linear displacement and adjustable clamping pressure of the applicator (the stepper motor of Baron as the driver for the applicator of the combination).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Musin, in view of Javey, and further in view of Cheong, and further in view of Vedat, and further in view of Baron, and further in view of U.S. Patent No. 6,001,006 (Canfield).
The combination teaches or suggests a stepper motor is configured to convert rotational movement of a motor shaft into linear movement of the applicator in creating linear displacement and adjustable clamping pressure of the applicator (the stepper motor of Baron as the driver for the applicator of the combination). Canfield teaches the use of Hall Effect sensors used to ensure the amount of force exerted on the patient is sufficient for measurement (col. 4, lines 35-50 of Canfield). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the Hall Effect sensor of Canfield in the combination so as to ensure the amount of force exerted on the patient is sufficient for measurement.
With respect to claim 13, the combination teaches or suggests an applicator positioning sensor (the Hall Effect sensor of Canfield).
With respect to claim 14, the combination teaches or suggests that the applicator positioning sensor is a Hall effect sensor (the Hall Effect sensor of Canfield).
With respect to claim 15, the combination teaches or suggests that the multi-sensor system is further configured to measure elastic pressure of tissue under the applicator (pages 12-14 and 32 and claim 14, 60, 95, and 184 of Musin).
With respect to claim 16, the combination teaches or suggests that the multi-sensor system is further configured to measure blood pressure (pages 19 and claims 93-95, 107-109, 181, 183-184, and 192 of Musin).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Musin, in view of Javey, and further in view of Cheong, and further in view of Vedat, and further in view of Baron, and further in view of U.S. Patent Application Publication No. 2011/0054283 (Shuler).
The combination teaches or suggests a stepper motor is configured to convert rotational movement of a motor shaft into linear movement of the applicator in creating linear displacement and adjustable clamping pressure of the applicator (the stepper motor of Baron as the driver for the applicator of the combination). Shuler teaches the use of Hall Effect sensors used to ensure the amount of force exerted on the patient is sufficient for attachment (paragraphs 0211 and 0218 of Shuler). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the Hall Effect sensor of Shuler in the combination so as to ensure the amount of force exerted on the patient is sufficient for attachment.
With respect to claim 13, the combination teaches or suggests an applicator positioning sensor (the Hall Effect sensor of Shuler).
With respect to claim 14, the combination teaches or suggests that the applicator positioning sensor is a Hall effect sensor (the Hall Effect sensor of Shuler).
With respect to claim 15, the combination teaches or suggests that the multi-sensor system is further configured to measure elastic pressure of tissue under the applicator (pages 12-14 and 32 and claim 14, 60, 95, and 184 of Musin).
With respect to claim 16, the combination teaches or suggests that the multi-sensor system is further configured to measure blood pressure (pages 19 and claims 93-95, 107-109, 181, 183-184, and 192 of Musin).
Claims 27-29 are rejected under 35 U.S.C. 103 as being unpatentable over Musin, in view of Javey, and further in view of Cheong, and further in view of Vedat, and further in view of WO 2009/034218 (Jimenez). Citations to Jimenez will refer to the machine English translation that accompanies this Office Action.
The combination teaches or suggests at least one sensor located on the lower wall of the removable housing (the one or more sensors positioned on the lower surface of the housing, as suggested by Cheong), used in the measuring of water vapor concentration (the sensors for measuring water vapor concentration; claims 126 and 134 of Musin) and the climatic parameters (the sensors of measuring external pressure, temperature, and humidity; pages 12 and 32 and claims 153, 159, 165, 171-173 of Musin). Jimenez teaches the use of a membrane between such sensors and the skin so as to allow water and air vapor but not liquid water to pass so as to prevent the sensors from getting and the measurements being in error (page 2 of Jimenez). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the membrane of Jimenez over the sensors for measuring water vapor concentration since it would prevent the sensors from getting and the measurements being in error.
With respect to claim 27, the combination teaches or suggests that the multi-sensor system comprises first and second types of sensors, the first and second types of sensors being different from one another, the first type of sensor being configured for use in measuring of water vapor concentration (the sensors for measuring water vapor concentration; claims 126 and 134 of Musin) and the climatic parameters (the sensors of measuring external pressure, temperature, and humidity; pages 12 and 32 and claims 153, 159, 165, 171-173 of Musin), and being located in a cavity on the lower wall of housing so as to avoid direct contact with the skin (the one or more sensors positioned on the lower surface of the housing, as suggested by Cheong but with the membrane of Jimenez such that direct contact with the skin is avoided), the second type of sensor being transducers configured for use in measuring physiological parameters of the subject (obtaining osmotic pressure of intercellular substance using a sensor; pages 12, 21, 23-28, and 32 of Musin; claims 11-12, 16, 50-51, 57, and 62 of Musin and/or the sensors for measuring glucose concentration; pages 12 and 32 and claims 165-166, 171-173 of Musin), and being located inside the housing and configured to contact the skin and press against the surface of the stratum cornuem with an adjustable pressure (using metered pressure; page 17 and claims 20, 26, 32, 63, 139, 142, 154, 167, and 170 of Musin).
With respect to claim 28, the combination teaches or suggests that at least one transducer is configured to measure a water vapor concentration in a cavity being located in the lower end of the transducer that is in contact with the skin surface so as to avoid direct contact of the water vapor concentration sensor with the skin (the transducer being the sensors for measuring water vapor concentration of Musin and the membrane of Jimenez; the sensors for measuring water vapor concentration of Musin do not have direct contact with the skin surface because of the membrane of Jimenez located in a cavity formed by the placement of the membrane between the skin surface and the sensors).
With respect to claim 29, the combination teaches or suggests that the another sensor is configured to detect an amount of water in the stratum corneum of controlled volume epidermis (pages 1, 11-13, and 17-21 and claims 124, 126, 127, 130-141, 151, 158, 165, and 171-172 of Musin) and/or in the cavity being located above the surface of the stratum corneum so as to avoid direct contract of the water vapor concentration sensor with the skin (the sensors for measuring water vapor concentration are covered by the membrane of Jimenez such that they avoid direct contact with the other sensors in contact with the skin).
Allowable Subject Matter
Claims 11 and 17-21 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
With respect to claim 11, the prior art does not teach or suggest “wherein the multi-sensor system is further configured to measure intracellular osmotic pressure” along with the other features of claim 11.
Claims 17-21 are allowably by virtue of their dependence from claim 11.
Conclusion
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/MATTHEW KREMER/Primary Examiner, Art Unit 3791
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