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 .
Response to Amendment
The amendments filed 1st October 2025 have been entered. Claims 1-19 are pending in the application. Applicants amendments have overcome each and every rejection under 35 U.S.C. § 102/103. Applicant has not addressed one or more rejections under 35 U.S.C. § 112(b) from the prior office action dated 4th June 2025 regarding indefinite limitations in Claim 1, therefore the rejection is applied again in this action. Specifically, ‘open at a skin facing surface’ and ‘enclosed by a top surface’ (See retained 112(b) rejection below).
Response to Arguments
The Applicant alleges that it was agreed that Tsuda does not disclose that the channel structures enclosed by a top surface of the unitary body, instead stating Tsuda teaches a separately removable cover.
It was not agreed upon that the cover is removable in the interview dated 17th September 2025 (See Examiner Interview Summary Record (PTOL-413) dated 22nd September 2025) as there is no mention of this agreement. If an agreement had been reached regarding this argument, it would have been expressly stated within the interview summary that an agreement was reached.
The interview summary instead states ‘Applicant discussed whether prior art teaches a unitary body that has an inwardly spiraling channel structure and the channel structure is enclosed by a top surface of the unitary body. Examiner clarified that prior art…’, meaning that Applicant discussed the argument, and Examiner disagreed, providing clarification of the interpretation of that prior art.
The assertion that the Examiner agreed with Applicants argument is inaccurate. Examiner discussed that the ‘cover’ reads on the recited limitation, as the ‘cover’ is not stated to be removable. Figure 5 of Tsuda was discussed further, with Applicant misinterpreting that the cover appears separate in Fig. 5, Examiner clarified that Fig. 5 shows this separation to show the gas flow with relation to the inlet and the outlet. The cover is interpreted to read on ‘enclosed by a top surface of the unitary body’.
Applicant’s arguments with respect to claim 1 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.
Claim Rejections - 35 USC § 112
Claims 1-17 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.
Claims 1 & 19 recite ‘the sidewalls’, there is insufficient antecedent basis for this limitation in this claim.
Claim 1 recites ‘inwardly spiraling relative to the sidewalls of the unitary body’, it is unclear whether the sidewalls are referring to the exterior wall structure of the unitary body, or the channel wall structure of the unitary body, rendering the limitation indefinite. The indefinite limitation is interpreted to mean that the channel spirals toward the center of the unitary body in a plane parallel to the skin-facing surface. The channel is open along the entire skin-facing surface and enclosed by the top surface of the unitary body, forming a tunnel-like structure that contacts the skin to collect gases. If the intent is to claim that the spiral direction is inward relative to one or more of the exterior surfaces, it is recommended that Applicant amend claim language to match Para. [0028] of the Applicants specification, which use the terms ‘back surface 406’, ‘front surface 416’, ‘lateral surfaces 408’, ‘skin-facing surface 402’ and ‘top surface 418’, for the sake of clarity.
Claim 1 recites ‘open at a skin facing surface’ and ‘enclosed by a top surface’ which lacks clarity, it is unclear whether the channel is fully exposed along the skin facing surface or partially covered. Examiner interprets these limitations to intend ‘the channel structure spirals toward the center of the unitary body in a plane parallel to the skin-facing surface.
Claim 10 is rejected as it incorporates the entirety of the language of Claim 1, therefore Claim 10 is rejected for the same reasons as Claim 1.
Claims 2-9 & 11-19 are rejected due to their dependence on a rejected 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).
Regarding Claim 1, Tsuda discloses a volumetric sampling apparatus (Tsuda: Para. [0017] ‘a skin permeable gas-collecting device (sampling probe)’; Fig. 5) comprising:
a unitary body comprising a channel structure that is inwardly spiraling relative to the sidewalls of the unitary 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 unitary 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 unitary 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).
Regarding Claim 3, Tsuda in view of Han 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 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 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 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 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 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 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 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 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 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 further view of US 20160054294 A1 to Rihani et al. (hereinafter, Rihani).
Regarding Claim 2, Tsuda in view of Han 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 further view of US 20090209883 A1 to Higgins et al. (hereinafter, Higgins).
Regarding Claim 4, Tsuda in view of Han 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 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 further view of US 20060063993 A1 Yu et al. (hereinafter, Yu).
Regarding Claim 14, Tsuda in view of Han 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 further view of US 20160151010 A1 to Erez.
Regarding Claim 15, Tsuda in view of Han 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 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 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
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAWN CURTIS BROUGHTON whose telephone number is (571)272-2891. The examiner can normally be reached Monday - Friday, 8am-4pm EST..
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/SHAWN CURTIS BROUGHTON/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791