DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 26th May 2026 has been entered.
Response to Amendment
The amendments filed 26th May 2026 have been entered. Claims 1-19 are pending in the application. Examiner acknowledges the erroneous selection regarding priority and has corrected it in this action.
Response to Arguments
Applicant's arguments filed 26th May 2026 have been fully considered but they are moot. Applicants arguments that Tsuda fails to disclose a channel structure enclosed by a top surface of the unitary body have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant further argues that combining Han with Tsuda would render the Tsuda device inoperable for its intended purpose, stating that Han is a closed tube-like structure and if the closed curvilinear microchannel of Han were combined with Tsuda, Tsuda’s open channel would be closed off and the collection of skin permeable gases would be prevented or at least inhibited. Examiner respectfully disagrees with the Applicant’s analysis. The combination of Tsuda in view of Han, as previously noted in the action dated 23rd January 2026, merely rearranges the channel structure of Tsuda to be a continuous spiral as taught by Han, the combination does not replace Tsuda’s channel structure with Han’s closed tube structure, the combination specifically adopts the spiral shape design of Han’s channel structure. Thus the principle of operation of Tsuda would not be effected. Further, Applicant is reminded that changes in shape, size, and sequence have all been deemed to be a matter of obvious design choice and not an inventive concept over prior art. See MPEP 2144.04 IV. B.
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 19 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 19, ‘one of the sidewalls’, there is insufficient antecedent basis for this limitation in this claim.
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.
Claim(s) 1, 3, 6-13 & 18-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 20040147885 A1 to Tsuda et al. (hereinafter, Tsuda) in view of US 9789485 B2 to Han et al. (hereinafter, Han) in further view of US 20160058380 A1 to Lee et al. (hereinafter, Lee).
Regarding Claim 1, Tsuda discloses a volumetric sampling apparatus (Tsuda: Para. [0017] ‘a skin permeable gas-collecting device (sampling probe)’; Fig. 5) comprising:
a body comprising a channel structure that is inwardly spiraling relative to a periphery of the body (Tsuda: Para. [0054] ‘31 represents a cylindrical member having a spiral groove 32’; Fig. 5),
and comprises an inlet port and an outlet port (Tsuda: Para. [0054] ’reference numeral 34 represents a gas-introducing section … reference numeral 35 represents a gas delivery section’),
and wherein the channel structure is open at a skin-facing surface of the body (Tsuda: Para. [0055] ‘the bottom face of the cylindrical member 31 is pressed against skin of a subject 45 to collect skin permeable gas in the groove 32 of the cylindrical member 31’; Fig. 5)
and is enclosed by a top surface of the body (Tsuda: Para. [0054] ‘cover 33’; Fig. 5);
wherein the inlet port is open to ambient air (Tsuda: Para. [0055] ‘Air in a laboratory room is introduced into the cylindrical member 31 from the gas-introducing section 34’; Fig. 5);
and wherein the outlet port is configured for coupling to a gas composition analyzer (Tsuda: Para. [0055] ‘The collected skin permeable gas is delivered together with air through the gas delivery section 35 and is then subjected to measurement.’; Fig. 5; Note: One of ordinary skill in the art would understand ‘measurement’ to imply coupling to a gas composition analyzer.; [0001]).
Tsuda does not explicitly disclose wherein the channel structure comprises a continuous spiral.
However, Han teaches wherein the channel structure comprises a continuous spiral (Han: Fig. 1A).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the channel structure of Tsuda by rearranging it to be a continuous spiral as taught by Han to achieve predictable results, in this case to provide precise focusing and positioning of particles. This phenomenon can be used in many applications such as concentration or size selective separation of particles, or liquid filtration (Han: Col. 10, line 65 – Col. 11, line 5).
Tsuda does not explicitly disclose the body as a unitary body.
However, Lee teaches a channel structure (Lee: Para. [0255-0256]) comprised within a unitary body (Lee: Para. [0110]).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the body structure of Tsuda by making the cover component integral to the body, forming a single unitary piece as taught by Lee. Further, making something integral through the use of a one piece construction has been deemed to be a matter of design choice. See MPEP 2144.04 V. B.
Regarding Claim 3, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses wherein the channel structure forms a continuous curve between the inlet port and the outlet port (Tsuda: Para. [0011] ‘A skin permeable gas-collecting device including a cylindrical member including a spiral groove’; Fig. 5).
Regarding Claim 6, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses further comprising a heating element configured to stimulate transdermal diffusion of volatile compounds from a patient's skin (Tsuda: Para. [0055] ‘the temperature of the introduced air is adjusted to a predetermined value with the Peltier element 42, and the resulting air is delivered through the gas delivery section 35’).
Regarding Claim 7, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 6. Tsuda further discloses wherein the heating element is further configured to generate a temperature gradient along the channel structure between the inlet port and the outlet port (Tsuda: Para. [0055] ‘the temperature of the introduced air is adjusted to a predetermined value with the Peltier element 42’; Fig. 5; Note: Any heating element would inherently create a temperature gradient along the channel structure between the inlet port and the outlet port.).
Regarding Claim 8, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses wherein the channel structure has a consistent width from the inlet port to the outlet port (Tsuda: Fig. 5; The width of the groove 32 appears to be consistent from the inlet port to the outlet port).
Regarding Claim 9, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses wherein the volumetric sampling apparatus is configured for operatively coupling to an inert gas supply through a coupling connected to the inlet port (Tsuda: Fig. 5, item 34 inlet port is configured to be connected to various types of gas supply, including an inert gas supply.).
Regarding Claim 10, Tsuda discloses a blood glucose level measurement method (Note: Tsuda Para. [0077] discusses the measurement of the skin permeable gas can contribute to the diagnosis of various types of morbidity, naming diabetes as one such type.) comprising: mounting the volumetric sampling apparatus of claim 1 (Note: See Claim 1 rejection above.) on a patient's skin to form a gas seal (Tsuda: Para. [0055] ‘gas collecting device 31 is placed on the skin of a patient in a sealed manner’; Para. [0044]),
the skin-facing surface being in contact with the patient's skin (Tsuda: Para. [0055] ‘bottom face of cylindrical member 31 is pressed against the skin of a subject’);
actuating a gas flow through the channel structure between the inlet port and the outlet port of the unitary body by applying negative pressure at the outlet port to draw ambient air from the inlet port through the channel structure (Tsuda: Para. [0055] ‘Air in a laboratory room is introduced into the cylindrical member 31 from the gas-introducing section 34 and then stored therein… The collected skin permeable gas is delivered together with air through the gas delivery section 35 and is then subjected to measurement.’);
and measuring volatile compounds in gases collected at the outlet port (Tsuda: Para. [0055] ‘The collected skin permeable gas is delivered together with air through the gas delivery section 35 and is then subjected to measurement.’; [0001]).
Regarding Claim 11, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 10. Tsuda further discloses comprising applying thermal heating to the unitary body (Tsuda: Para. [0055] ‘the temperature of the introduced air is adjusted to a predetermined value with the Peltier element 42’; Fig. 5, item 42).
Regarding Claim 12, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 10. Tsuda further discloses comprising: measuring a baseline level of the volatile compounds in ambient air and applying the baseline level to adjust a measure of the volatile compounds in the gases collected at the outlet port (Tsuda: Table 1 data with Subject a; Para. [0058] discusses the baseline measurement (probe blank) for sampling data comparison; Para. [0058] ‘In any subject, sampling data obtained from skin has a higher value than that of the probe blank.’).
Regarding Claim 13, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses wherein the outlet port is further configured for coupling to a negative pressure source (Tsuda: Fig. 5, item 35 gas delivery section is configured for coupling to various devices, including a negative pressure source).
Regarding Claim 18, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda does not explicitly disclose wherein the channel structure spirals in a single direction from the inlet port to the outlet port.
However, Han teaches wherein the channel structure spirals in a single direction from the inlet port to the outlet port (Han: Fig. 1A).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to modify the channel structure of Tsuda by rearranging it to be a continuous spiral as taught by Han to achieve predictable results, in this case to provide precise focusing and positioning of particles. This phenomenon can be used in many applications such as concentration or size selective separation of particles, or liquid filtration (Han: Col. 10, line 65 – Col. 11, line 5).
Regarding Claim 19, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1, Tsuda further discloses wherein the inlet is disposed on one of the sidewalls of the unitary body (Tsuda: Fig. 5 inlet disposed on a sidewall of the channel structure of the cylindrical member).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Tsuda in view of Han in view of Lee in further view of US 20160054294 A1 to Rihani et al. (hereinafter, Rihani).
Regarding Claim 2, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda does not explicitly disclose a gas filter positioned in or proximal to the inlet port to reduce compound contaminants from entering the channel structure.
However, Rihani teaches the volumetric sampling apparatus further comprising a gas filter positioned in or proximal to the inlet port (Rihani: Para. [0218] ‘particle filter 67 is included close to the inlet valve 11 ‘),
the gas filter being configured to reduce volatile contaminants from entering the channel structure by way of the inlet port when the channel structure is positioned on a patient's skin (Rihani: Para. [0218] ‘in order to clean the gas from dust and particles which could contaminate the chamber and optics and may lead to interference with the measurements.’).
One of ordinary skill in the art would have found it obvious to apply a gas filter to the gas introducing section of Tsuda as filters are known and well-understood in the art and can be used to reduce contaminants from entering the channel structure as taught by Rihani (Rihani: Para. [0218] ‘in order to clean the gas from dust and particles which could contaminate the chamber and optics and may lead to interference with the measurements.’).
Claim(s) 4 & 5 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuda in view of Han in view of Lee in further view of US 20090209883 A1 to Higgins et al. (hereinafter, Higgins).
Regarding Claim 4, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 1. Tsuda further discloses wherein the skin-facing surface is configured for a sealing-contact with a patient’s skin (Tsuda: Para. [0055] ‘gas collecting device 31 is placed on the skin of a patient in a sealed manner’).
Tsuda does not explicitly disclose wherein the skin-facing surface comprises a conformal curvature.
However, Higgins teaches conforming a sampling surface to a sample shape with curvature (Higgins: Para. [0275] ‘having a concave depression 598, or cradle, that can be ergonomically designed to conform to the shape of a user's finger or other anatomical feature’).
One of ordinary skill in the art at the time the invention was filed would have found that placing the device on the skin of a patient in a sealed manner, as disclosed by Tsuda, implies that the material of the device must be able to conform to the skin of a patient to attain a seal. Additionally, one of ordinary skill in the art would have found it obvious to conform a sampling surface to a sampling shape as is well-understood in the art and taught by Higgins. The sampling probe of Tsuda is stated to be placed on the skin of a user in a sealed manner, it is implied that the device conforms to the shape of the skin that it is placed, and thus would have been obvious to be configured to have a curvature, including a concave curvature (Higgins: Para. [0275] ‘to conform to the shape of a user's finger or other anatomical feature’).
Regarding Claim 5, Tsuda in view of Han in view of Lee in further view of Higgins discloses the invention as discussed above in Claim 4. Higgins further discloses wherein the conformal curvature is concave (Higgins: Para. [0275] ‘having a concave depression 598, or cradle, that can be ergonomically designed to conform to the shape of a user's finger or other anatomical feature’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to conform a sampling surface to a sampling shape as taught by Higgins. The sampling probe of Tsuda is stated to be placed on the skin of a user in a sealed manner, it is implied that the device conforms to the shape of the skin that it is placed, and thus would have been obvious to have curvature, including a concave curvature (Higgins: Para. [0275] ‘to conform to the shape of a user's finger or other anatomical feature’).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Tsuda in view of Han in view of Lee in further view of US 20060063993 A1 Yu et al. (hereinafter, Yu).
Regarding Claim 14, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 13. Tsuda further discloses wherein the unitary body is configured for mounting on a patient's skin by placement of the skin-facing surface on said skin and forming a gas seal (Tsuda: Para. [0055] ‘the bottom face of the cylindrical member 31 is pressed against skin of a subject 45 to collect skin permeable gas in the groove 32 of the cylindrical member 31 in a sealed manner’),
Tsuda does not explicitly disclose wherein the negative pressure source is coupled to the outlet port and is configured to draw a substantially continuous gas flow through the structure between the inlet port and the outlet port for collection and measurement of volatile compounds.
However, Yu teaches wherein the negative pressure source is coupled to the outlet port (Yu: Para. [0040] ‘a vacuum pump can be used to produce negative pressure with the chamber…’)
and is configured to draw a substantially continuous gas flow through the structure between the inlet port and the outlet port for collection and measurement of volatile compounds (Yu: Para. [0040] ‘…to produce negative pressure with the chamber so that the blood within the tissue can be "sucked" toward the light-matter interaction region.’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to couple a vacuum pump to the gas delivery section of Tsuda to produce negative pressure in the channel structure as vacuum pumps and negative pressure are known and well-understood in the art, and taught by Yu to increase the amount of blood to be detected and hold the tissue stationary to eliminate the influence from body movement, respirations, pulses, etc. (Yu: Para. [0007] ‘using a negative pressure system that can increases amount of blood to be detected and hold local tissue stationery.’; Para. [0040] ‘…holds the tissue stationary to eliminate the influence from body movement, respirations, pulses, etc.’).
Claim(s) 15-17 are rejected under 35 U.S.C. 103 as being unpatentable over Tsuda in view of Han in view of Lee in further view of US 20160151010 A1 to Erez.
Regarding Claim 15, Tsuda in view of Han in view of Lee discloses the invention as discussed above in Claim 7. Tsuda further discloses wherein the heating element is arranged in the channel structure (Tsuda: Para. [0054] ‘reference numeral 41 represents a heat sink; reference numeral 42 represents a Peltier element for adjusting the temperature of the contained air; reference numeral 43 represents a silicon coating; and reference numeral 44 represents a Teflon sheet for sealing the groove 32 containing the air’; Fig. 5))
configured to thermodynamically facilitate gas flow through the channel structure from the inlet port to the outlet port (Tsuda: Para. [0055] ‘the temperature of the introduced air is adjusted to a predetermined value with the Peltier element 42, and the resulting air is delivered through the gas delivery section 35’).
Tsuda does not explicitly disclose the heating element comprising a plurality of light-emitting diodes, the light-emitting diodes being configured to produce heat and optically stimulate a wearer’s skin at the mounting site of the apparatus.
However, Erez teaches wherein the heating element comprises a plurality of light-emitting diodes being configured to produce heat and to optically stimulate a wearer's skin located at the site where the apparatus is mounted (Erez: Para. [0038] ‘use of heating sources (e.g., infrared emitting LED) to heat the tissue near the collection site’),
sufficient to increase transdermal diffusion of volatile compounds through said skin (Erez: Para. [0038] ‘Heating the capillary structure of the tissue at the collection site may improve the blood supply’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to utilize LEDs as a heat source in the cover of Tsuda in order to improve the blood supply at the skin site (Erez: Para. [0038] ‘Heating the capillary structure of the tissue at the collection site may improve the blood supply’).
Regarding Claim 16, Tsuda in view of Han in view of Lee in further view of Erez discloses the invention as discussed above in Claim 15. Tsuda further discloses wherein the heating element comprises a separate component structurally appended to the unitary body of the apparatus (Tsuda: Fig. 5 shows the heating element is a separate component configured to be structurally appended to the cylindrical member).
Regarding Claim 17, Tsuda in view of Han in view of Lee in further view of Erez discloses the invention as discussed above in Claim 15. Erez further discloses a heating element comprising an integral component built into the unitary body of the apparatus (Erez: Para. [0379] ‘Thermo-conductive segment 104a includes thermo-conductive plate 146a and thermo-conductive segment 104b includes thermo-conductive plate 146b (shown FIG. 2).’).
One of ordinary skill in the art at the time the invention was filed would have found it obvious to utilize LEDs as a heat source integrated into the cover of the apparatus of Tsuda in order to improve the blood supply at the skin site (Erez: Para. [0038] ‘Heating the capillary structure of the tissue at the collection site may improve the blood supply’).
Conclusion
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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