Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-5, 10, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Rogers et. al.'047 (U.S. Patent Publication 20200155047 – previously cited).
Regarding Claim 1, Rogers et. al.’047 discloses a collection component including adsorbent-potential material, the collection component is configured to collect one or more gaseous chemical substances from a target location of a subject's anatomy (Paragraph [0077] - a flexible substrate; a collection layer embedded in or supported by the flexible substrate, wherein the collection layer promotes transport of the biofluid from the skin surface; Paragraph [0083] - Any of the systems may have a flexible substrate that comprises a material selected from the group consisting of polydimethylsiloxane (PDMS); Paragraph [0391] - As used herein, the term “fluidically connected” refers to the configuration of two or more components such that a fluid (e.g., a gas or a liquid) is capable of transport, flowing and/or diffusing from one component to another component; Paragraph [0480] - the systems and methods are useful in collecting and analyzing organic and inorganic chemicals in sweat); and
a target facing component configured to removably receive the collection component (Paragraph [0263] - The system of any of claims 1-112, further comprising an adhesive layer configured to mount the system to a skin surface. [0264] 114. The system of claim 113, wherein the adhesive layer reversibly adheres the system to the skin surface); and
wherein the target facing component is configured to direct a fluid flow including the one or more gaseous chemical substances from the target location of the subject's anatomy to the collection component (Paragraph [0336] - The layers can be individually patterned to facilitate any number of desired functionality, such as fluid transport through an adhesive layer, collection and analysis (analytics layer)).
Regarding Claim 2, Rogers et. al.’047 discloses the device outlined in Claim 1 above. Rogers et. al.’047 further discloses a collection device comprising an adsorbent material such as polydimethylsiloxane (PDMS) (Paragraph [0262] - The system of any of claims 1-111, wherein said flexible substrate comprises a material selected from the group consisting of polydimethylsiloxane (PDMS)).
Regarding Claim 3, Rogers et. al.’047 discloses the device outlined in Claim 1 above. Rogers et. al.’047 further discloses the one or more gaseous chemical substances comprise one or more volatile organic compounds from the target location, the collection component is configured to include pores, and the pores are sized to collect a desired type of the one or more volatile organic compounds (Paragraph [0271] - The system of claim 104 or 119, wherein the collection layer has a plurality of pores having an average diameter selected from the range of 10 μm to 250 μm; Paragraph [0449] -The whole device involves four layers, i.e., bottom layer that is a polyester mesh having pores with diameter of 74 μm (the thickness of 90 μm; the width and length are 1 cm and 1.5 cm) to absorb sweat from skin; Paragraph [0480] - the systems and methods are useful in collecting and analyzing organic and inorganic chemicals in sweat for home monitoring and self-quantification of conditions (e.g. drug screening, alcohol content monitoring); Paragraph [0483] – entire paragraph; Paragraph [0486] - Materials used in device fabrication can be tailored for specific applications such as attachment to newborns, collection of volatile compounds).
Regarding Claim 4, Rogers et. al.’047 discloses the device outlined in Claim 1 above. Rogers et. al.’047 further discloses the target facing component comprises one or more openings configured to allow the fluid flow to pass from a space between the target location of the subject's anatomy and the target facing component to the collection component (Paragraph [0408] - establishes adhesion to the skin and defines openings (e.g., 2 mm diameter) from which sweat can enter the microfluidic system (e.g., 1 mm diameter, inlet; FIG. 1)).
Regarding Claim 5, Rogers et. al.’047 discloses the device outlined in Claim 1 above. Rogers et. al.’047 further discloses one or more openings of the target facing component define a fluid supply channel and a fluid vacuum channel (Paragraph [0391] - Components may be in fluid communication via one or more elements such as channels, valves, tubes, containment structures, reservoirs, pumps or any combinations of these; Paragraph [0503] - The location of the collection inlets (i.e. opening to skin) in the central region of the device (FIG. 37) eliminates sweat leakage upon the removal of the device from the skin as the mechanics of removal (i.e. vertical lifting from the device edge) creates a temporary pumping action to transport sweat contained in the channel farther into the collection chamber as observed in positional difference between the optical image in FIG. 39 (30 min) and that of FIG. 40A).
Regarding Claim 10, Rogers et. al.’047 discloses the device outlined in Claim 1 above. Rogers et. al.’047 further discloses the collection component and the target facing component are configured to be secured at a location relative to the target location of the subject's anatomy (Paragraph [0482] - The device is in a soft, flexible configuration that enables conformal attachment to the epidermis promoting sweat collection while preventing loss. The device allows for the collection of either large or small volumes of sweat and performance on-board analysis thereby enabling custom-tailored, rapid disease diagnosis and/or screening).
Regarding Claim 16, Rogers et. al.’047 discloses preparing a surface of the target location of the subject's anatomy for collection of gaseous chemical substances from the target location (Paragraph [0391] - As used herein, the term “fluidically connected” refers to the configuration of two or more components such that a fluid (e.g., a gas or a liquid) is capable of transport, flowing and/or diffusing from one component to another component; Paragraph [0480] - the systems and methods are useful in collecting and analyzing organic and inorganic chemicals in sweat for home monitoring and self-quantification of conditions (e.g. drug screening, alcohol content monitoring); Paragraph [0483] – entire paragraph; Paragraph [0486] - Materials used in device fabrication can be tailored for specific applications such as attachment to newborns, collection of volatile compounds; Paragraph [0478] - The application sites are prepped with a disposable alcohol prep wipe (Dyanrex) to remove skin oils and dirt (FIG. 33a));
positioning a collector at a desired location and collecting the gaseous chemical substances from the target location (Paragraph [0478] - sweat patch is placed on up to five locations on the body including upper arm, chest, lower back, upper back, and forehead), the collector comprising:
a collection component including adsorbent-potential material, the collection component is configured to collect the gaseous chemical substances from a target location (Paragraph [0077] - a flexible substrate; a collection layer embedded in or supported by the flexible substrate, wherein the collection layer promotes transport of the biofluid from the skin surface; Paragraph [0083] - Any of the systems may have a flexible substrate that comprises a material selected from the group consisting of polydimethylsiloxane (PDMS)); and
a target facing component configured to removably receive the collection component and direct a fluid flow including the gaseous chemical substances from the target location to the collection component (Paragraph [0263] - The system of any of claims 1-112, further comprising an adhesive layer configured to mount the system to a skin surface. [0264] 114. The system of claim 113, wherein the adhesive layer reversibly adheres the system to the skin surface); and
removing the collector from the desired location after collecting the gaseous chemical substances from the target location (Paragraph [0478] - keep sweating until one reservoir in each part is filled. It usually takes 15 to 30 minutes...Epidermal microfluidic device is removed by gently pulling the adhesive and sensor off the subject).
Regarding Claim 17, Rogers et. al.’047 discloses the device outlined in Claim 16 above. Rogers et. al.’047 further discloses the desired location is a wound on the subject (Paragraph [0079] - The biofluid characteristic may be the amount of sweat loss or presence or absence of a biomarker contained in a biofluid released from a skin surface, such as a gland, a wound, or the like).
Regarding Claim 18, Rogers et. al.’047 discloses the device outlined in Claim 16 above. Rogers et. al.’047 further discloses actuating a pump to draw a fluid flow containing the gaseous chemical substances from the target location through the collector (Paragraph [0391] - As used herein, the term “fluidically connected” refers to the configuration of two or more components such that a fluid (e.g., a gas or a liquid) is capable of transport, flowing and/or diffusing from one component to another component; Paragraph [0503] - The only additional equipment required to extract sweat from the collection device is a standard pipette (1 mL, generic). The device-layer inlet size (1.2 mm diameter) is smaller than the pipette opening (1.5±0.1 mm diameter, brand dependent) so that when the pipette contacts the elastomeric device a strong, temporary water-tight and gas-tight seal forms so that a negative pressure occurs in the microfluidic channel upon extraction with the pipette. This negative pressure is sufficient to fully extract sweat from each chamber, regardless of filled volume. The sweat extraction rate is linearly proportional to the amount of negative pressure applied (set volume on a variable pipetter) and rate of draw on the pipetter).
Regarding Claim 19, Rogers et. al.’047 discloses the device outlined in Claim 16 above. Rogers et. al.’047 further discloses positioning the collector at the desired location includes securing the collector at the desired location with one or both of a band and an adhesive (Paragraph [0263] - The system of any of claims 1-112, further comprising an adhesive layer configured to mount the system to a skin surface).
Regarding Claim 20, Rogers et. al.’047 discloses the device outlined in Claim 16 above. Rogers et. al.’047 further discloses positioning the collector at the desired location includes securing the collector at the desired location with an adhesive configured to adhere to skin of the subject and removing the collector from the desired location includes removing the collector after a predetermined time at which the adhesive no longer adheres to the skin (Paragraph [0263] - The system of any of claims 1-112, further comprising an adhesive layer configured to mount the system to a skin surface; Paragraph [0410] - After use, the device can be removed from the skin and then inserted into a centrifuge (5000 rpm) to open CBV #3, thereby moving liquid from each of the storage chambers into corresponding extraction chambers to facilitate recovery for lab analysis (FIG. 2e(iv))).
It is to be noted that Rogers et. al.’047 discloses the features recited in each of the embodiments are not limited to just those embodiments and can be used within each embodiment to enhance performance needs (Paragraph [0558] - it should be understood that although the present invention has been specifically disclosed by preferred embodiments, exemplary embodiments and optional features, modification and variation of the concepts herein disclosed may be resorted to by those skilled in the art, and that such modifications and variations are considered to be within the scope of this invention as defined by the appended claims. The specific embodiments provided herein are examples of useful embodiments of the present invention and it will be apparent to one skilled in the art that the present invention may be carried out using a large number of variations of the devices, device components, method steps set forth in the present description).
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 11 is rejected under 35 U.S.C. 103 as being unpatentable over Rogers et. al.'047 (U.S. Patent Publication 20200155047 – previously cited), as applied to Claim 1 above, and further in view of Haghgooie et. al.'697 (U.S. Patent Publication 20120277697 – previously cited).
Regarding Claim 11, Rogers et. al.’047 discloses the collector system outlined in Claim 1 above. Rogers et. al.’047 further discloses a wearable patch (Paragraph [0511] - incorporating in the wearable patch) as well as the collection component and the target facing component are incorporated into a patch such that the collection component is exposed to the target location of the subject's anatomy when the band is worn by the subject (Paragraph [0336] - The layers can be individually patterned to facilitate any number of desired functionality, such as fluid transport through an adhesive layer, collection and analysis (analytics layer)), but fails to disclose a band configured to be worn by the subject against skin of the subject. Haghgooie et. al.’697 teaches a band configured to be worn by a subject to keep a device against skin of the subject (Paragraph [0120] - the device can include an adhesive layer 1106 where the adhesive is selected to be suitable for retaining the device in a relatively fixed position relative to the skin during use, but may allow for relatively easy removal of the device from the skin following use; Paragraph [0207] - the device may include mechanical elements such as straps, belts, buckles, strings, ties, elastic bands, or the like. For example, a strap may be worn around the device to hold the device in place against the skin of the subject). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Rogers et. al.’047 to include a band as an additional mechanical fastener in order to provide the device with extra fastening means beyond reliance on adhesion since adhesion can be easily removed from the skin of a user as seen in Haghgooie et. al.’697.
Response to Arguments
Applicant's arguments filed 15 July 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior 35 U.S.C. 112b rejections.
Claims 1-5, 10, and 16-20 are rejected under 35 U.S.C. 102(a)(1) as necessitated by amendments, as discussed in Paragraph 3 above. Claim 11 is rejected under 35 U.S.C. 103 as necessitated by amendments as discussed in Paragraph 4 above. The examiner goes into more details as to why the examiner believes these rejections remain in greater detail below.
The examiner has considered the applicant's arguments pertaining to the reconsideration for the examiner’s grounds for restriction, but these arguments were found to not be persuasive. It is noted by the examiner that the applicant has elected Species B containing Figure 17 in the original response to election restriction submitted on 26 November 2026. Provided that the structure of Figure 17 of the instant application is mutually exclusive to the structure shown in Figure 10 of the instant application, the examiner believes that the original election remains proper. Therefore, Claims 1-5, 10-11, and 16-20 remain examined by the examiner.
The examiner has considered the applicant's arguments regarding Rogers et. al.’047 failing to disclose identifying utilizing PDMS as an adsorbent material used to collect gaseous chemical substances. However, the examiner does not agree with this assessment provided that prior art of record Rogers et. al.’047 discloses a biofluid collection device configured to obtain liquid and gaseous compounds of biofluid, such as sweat, as addressed in Paragraph 3 above. Furthermore, there is nothing in the instant application's specification that defines PDMS with a structurally or chemically different configuration than that taught by Rogers et. al.'047. The PDMS taught by Rogers et. al.’047 is believed to be similar in structure as to the PDMS taught by the instant application due to the lack of evidence that would suggest otherwise. This is backed up by the concept that there is nothing present in the instant application's specification that would lead one of ordinary skill in the art to believe the instant application's PDMS is different from that of Rogers et. al.’047. Therefore, it is believed that the PDMS of Rogers et. al.’047 would behave similarly and perform the same function as the PDMS as the instant application's claims. The examiner draws attention to MPEP Section 2112 that states where the claimed and prior art products are substantially similar in structure of composition, a prima facie case of either anticipation or obviousness has been established, In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). Additionally, applicant argues "Rogers may be coated with a material", but this argument is not persuasive as Rogers et. al.’047 does not explicitly discuss or implicitly suggest that there is a coating on the PDMS that may prevent a function of adsorption. It would be improper to read undisclosed subject matter into the specification of Rogers et. al.’047.
As evidenced by these following five references, it is known in the art that a PDMS structure is used to adsorb VOC from a user for diagnostic purposes: Cognon et.al.'629 (US Patent Publication 20210396629) discloses PDMS patches used to adsorb VOCs (Paragraph [0028] - An adsorbent support is understood to be a support capable of implementing a physical and/or chemical process that brings about retention of the volatile organic compounds on the surface; Paragraph [0029] - Preferably, according to the invention, said adsorbent support is selected from compresses, polydimethylsiloxane patches). Duffy et. al.'2018 (Endogenous and microbial volatile organic compounds in cutaneous health and disease) discloses PDMS membranes used to adsorb VOCs (Page 164 Paragraph 3 - Briefly, these methods include solvent extraction [16] and VOC collection onto sorbents in headspace or contact mode (e.g., glass beads, cotton gauze, polydimethylsiloxane (PDMS) membranes) [12], [36], [37]. More recently, PDMS tubing has been employed as a wearable passive sampler looped around the wrist or ankle [38]. Volatiles can be recovered from these phases for subsequent analysis via thermal desorption, solvent extraction, or collection onto an adsorbent trap (e.g., porous polymer adsorbent) using an airflow process). Wooding et. al.''2020 (Non-invasive sorptive extraction for the separation of human skin surface chemicals using comprehensive gas chromatography coupled to time-of-flight mass spectrometry: A mosquito-host biting site investigation) discloses PDMS loops used to adsorb VOCs (Page 4203 Paragraph 3 - The importance of skin sampling methods in order to identify skin volatile organic compounds (VOCs) should not be underestimated as VOCs comprise of a broad range of chemicals from various chemical classes with different characteristics. The many inconsistencies reported for detected skin compounds are most likely due to the diverse analytical procedures used, such as variation in sampling protocols, in chromatographic methods, the type of instrumental detector employed, and in data treatment. Sampling procedures range from solvent back extraction from a cotton pad used to swab the sample matrix, dynamic headspace adsorption onto various polymers, SPME [7], to recently (2018) sorptive extraction directly from the skin using polydimethylsiloxane (PDMS) loops in the form of bracelets and anklets [15]). Tan et. al.'2018 (Nanofabrication of Conductive Metallic Structures on Elastomeric Materials) discloses adsorption of VOCs with PDMS (Abstract - Adsorption of solvents in the PDMS causes swelling and increases the device resistance, which therefore enables the detection of volatile organic compounds (VOCs); Page 5 Paragraph 1 - At each injection point of water vapor in the chamber, the water molecules shorted the mesh on the PDMS resulting in a more conductive pathway between the contacts). Xue et. al.'2007 discloses a PDMS fiber used to adsorb VOCs (Investigation of volatile biomarkers in liver cancer blood using solid-phase microextraction and gas chromatography/mass spectrometry) -> (Page 1182 Paragraph 3 - Volatile compounds in blood were adsorbed by a CAR–PDMS fiber).
With regard to the applicant's argument that Rogers et. al.’047 is limited to collecting sweat, the examiner does not agree with this statement. Rogers et. al.’047 discloses a device that is used to collect a "biofluid" wherein the fluid is not limited to sweat but also other elements (Paragraph [0390] - “Biofluid” refers to fluid generated by, extracted from or otherwise derived from the tissue of a subject, such as an organ of a subject. Biofluids include sweat, tears, saliva, gingival crevicular fluid, interstitial fluid, blood and combinations thereof).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Bian et. al.'945 (CN Patent Publication 111436945) teaches a sweat sensing and analysis device comprising PDMS as well as adsorption qualities. Rao et. al.'935 (U.S. Patent Publication 20180249935) teaches an adsorbent material used to collect samples from a subject’s skin in order to wick and direct sweat through a collection device (Paragraph [0034] - wherein substrate layer directs the flow of and/or accumulates sweat that migrates from the skin of the individual into the sensor; Paragraph [0039] - the substrate layer and/or the spacer layer and/or other layers are formed from adsorbent material(s) adapted to wick sweat from the skin of the individual; Paragraph [0045] - Hydrophobic and hydrophilic barriers can be created by other methods such as by spraying hydrophobic polymers (e.g. polydimethylsiloxane) on the substrate using a mask to cover the required hydrophilic regions. Hydrophobic and hydrophilic barriers can be created by printing wax with a wax printer, by paraffin stamped on paper, through the use of hydrogels (e.g. a silica gels on hydrophobic base material). Generally, hydrophobic and hydrophilic materials can be used to modify sensor elements and create hydrophobic pathways that direct the flow of sweat through the sensor).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571)272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571)272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791
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