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.
Election/Restrictions
Applicant's election with traverse of Group I and Species B in the reply filed on 26 November 2025 is acknowledged. The applicant fails to provide any reasonings for the traversal of Group I. The traversal for Species B is on the ground that collector “800” is configured for exposure to a target location of a subject. This is not found persuasive because the species restriction is based off of element “813” not “800”. According to Figure 17 (discussed in Paragraph 101), collection component “1713”, is exposed to target location whereas in Figures 8 and 10, collection component “813” is not exposed to the target location as it is sandwiched between a target facing component “811”/”842” and a cover “815”/”844” (Figures 8 and 10). There is a difference between when the collection component is exposed to the target (Figure 17) versus when a target facing component/cover (“811”/”842”/“815”/”844”) is exposed to the target. Therefore, based on applicant’s election of an embodiment wherein a collection component is exposed to a target location, claims 6-9 and 12-15, which are drawn to an embodiment wherein a collection component is not exposed to a target location by virtue of being surrounded by a cover and a target facing component, are hereby withdrawn from examination.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 3 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 3, the limitation “collect one or more chemical substances of a desired type” recited in lines 2-3 of the claim is unclear. It is unclear if the limitation “one or more chemical substances” recited in Claim 3 is the same limitation “one or more chemical substances” recited in Claim 1, or if these limitations are different. The examiner is interpreting the limitation from Claim 3 to read “collect the one or more chemical substances” (emphasis added).
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 by Rogers et. al.'047 (U.S. Patent Application 20200155047).
Regarding Claim 1, Rogers et. al.’047 discloses a collection component including adsorbent material, the collection component is configured to collect one or more 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); 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 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 as well as the adsorbent material is 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 as well as the collection component is configured to include pores and the pores are sized to collect one or more chemical substances of a desired type (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).
Regarding Claim 4, Rogers et. al.’047 discloses the device outlined in Claim 1 above as well as 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 as well as 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 as well as 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 chemical substances from the target location (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 to collect the 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 material, the collection component is configured to collect the 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 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 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 method outlined in Claim 16 above as well as 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 method outlined in Claim 16 above as well as actuating a pump to draw a fluid flow containing the chemical substances from the target location through the collector (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 method outlined in Claim 16 above as well as 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 method outlined in Claim 16 above as well as 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, methods 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 Application 20200155047) as applied to Claim 1 above, and further in view of Haghgooie et. al.'697 (U.S. Patent Application 20120277697).
Regarding Claim 11, Rogers et. al.’047 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Rao et. al.’935 (U.S. Patent Application 20180249935) and Buettner’390 (WO Patent Publication 2005024389) both disclose devices that contain adsorbent material to assist in analyzing analytes collected from a user.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/SARAH ANN WESTFALL/ Examiner, Art Unit 3791
/ETSUB D BERHANU/ Primary Examiner, Art Unit 3791