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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04 February 2026 has been entered. Claims 1, 16, and 20 are currently amended. Claims 1-20 are pending in the application.
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 1-2, 4-5, 10-12, 16-17, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (US PGPub No. 2016/0058380), hereinafter Lee, in view of Rodriguez et al. (US PGPub No. 2021/0244357), hereinafter Rodriguez, and Heikenfeld (US PGPub No. 2020/0077988), hereinafter Heikenfeld ‘988, and further in view of Martinez et al. (US PGPub No. 2020/0333829), hereinafter Martinez.
Regarding claims 1, 10, 12, 16, and 20, Lee teaches a medical device configured to couple to a body (Fig. 1: analyte sensor system 8 coupled to a body), the medical device comprising:
a material layer (Fig. 34: upper layer 554 of adhesive pad 550);
an electronic assembly coupled to a first side of the material layer (Fig. 2: sensor electronics unit 202, electronics housing 208, upper surface 210 of adhesive pad 204; par. 0155: “With reference to FIG. 2, the sensor electronics unit 202 is received within an electronics housing 208 that is secured to an upper surface 210 of the adhesive pad 204”);
an adhesive layer coupled to a second side of the material layer and configured to adhere to a user's skin, wherein the second side is positioned on an opposite side from the first side (Fig. 34: lower layer 556 coupled to upper layer 554; par. 0254: “an adhesive material 556 comprising a lower layer 556 of the pad 550. The adhesive material 556, or lower layer 556, is configured to abut the host's skin to secure the adhesive pad 550 to the host”),
wherein the adhesive layer includes a plurality of micro passages (par. 0146: “in some embodiments, at least a portion of the adhesive pad is formed from a suitable porous material, such as, knits, wovens (e.g., cheesecloth and gauze), nonwovens (including spun-bonded nonwovens), extruded porous sheets (e.g., polyurethane), and perforated sheets (e.g., polyurethane), for example. The apertures (e.g., openings) in the porous material are preferably of sufficient size and sufficient number to facilitate high breathability. The apertures can be through-holes or slit cuts, for example. The size and pitch of the aperture preferably is large enough to allow sweat and moisture from the body to evaporate quickly and effectively”);
and a plurality of channels extending through the adhesive layer (Figs. 33-34: plurality of channels 554; par. 0253: “the adhesive pad 550 having a plurality of channels 552 for enabling outflow of moisture”);
wherein each of the plurality of channels includes at least a first side surface, a second surface, and a bottom surface (Fig. 34: fully enclosed channels having at least three sides).
Lee teaches that the pattern of channels may be selected to provide a desired moisture channeling behavior (par. 0255) but does not explicitly teach a plurality of adhesive layers, wherein each adhesive layer of the plurality of adhesive layers is spaced from each other adhesive layer of the plurality of adhesive layers, and wherein each of the plurality of channels is disposed on an outer surface of the medical device, extends between two adjacent adhesive layers of the plurality of adhesive layers, and is configured to contact the user’s skin. However, in an analogous art, Rodriguez teaches an analyte sensor with a plurality of adhesive layers, wherein each adhesive layer of the plurality of adhesive layers is spaced from each other adhesive layer of the plurality of adhesive layers, and wherein each of the plurality of channels is disposed on an outer surface of the medical device, extends between two adjacent adhesive layers of the plurality of adhesive layers, and is configured to contact the user’s skin (Fig. 11: plurality of cut-outs 712, plurality of skin-contacting adhesive surfaces 713; par. 0079: “the skin adhesive layer 710 is a moisture guidance system and defines a plurality of cut-outs 712. The cut-outs 712 act as channels that enable moisture, such as sweat, fluids, etc., on the skin of the user to be directed away from the physiological characteristic sensor assembly 102 into the ambient environment. […] the cut-outs 712a-712d result in the second side 710b of the skin adhesive layer 710 defining a plurality of surfaces 713 that contact a skin of the user when the physiological characteristic sensor assembly 102 is coupled to the user”). Rodriguez further teaches that the disclosed channels improve breathability and increase conformity and flexibility of the medical device (par. 0082: “the cut-outs 712a-712d and 712a′-712d′ enable the moisture, fluids, etc. on the anatomy or skin of a user to escape to the ambient environment, which improves breathability of the medical device 100. Moreover, the cut-outs 712a-712d and 712a′-712d′ of the skin adhesive layer 710 provides increased conformity and flexibility of the medical device 100 when coupled to the anatomy of the user by reducing the bonding area of the skin adhesive layer 710”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of Lee by configuring the moisture-outflow channels on an outer surface of the medical device and contacting the user’s skin, as taught by Rodriguez, in order to improve breathability and increase conformity and flexibility, as taught by Rodriguez.
The combined reference does not explicitly teach a hydrophobic coating applied to and covering an entire first side surface of a first adhesive layer of the plurality of adhesive layers, an entire second side surface of a second adhesive layer of the plurality of adhesive layers, and a surface of the material layer extending between the first side surface and the second side surface (that is, a bottom surface). However, in an analogous art, Heikenfeld ‘988 teaches applying a hydrophobic coating to the entirety of a fluid channel (Figs. 2A-2C: hydrophobic dielectric coating 270; par. 0020: “a sweat coupling component that is coated with at least one hydrophobic material” and claim 9: “a hydrophobic coating that defines a fluid channel”), which allows the fluid behavior to be manipulated using electrowetting (par. 0020: “Sweat may be transported to the sweat coupling component 230b by the sweat coupling component 230a but, because this channel is hydrophobic, may not automatically move into the sweat coupling component 230b. As shown in FIG. 2B, if a suitable voltage (e.g., 10 s of V, such as 10 to 80 V) is applied to the electrodes 251-256, sweat 280 is drawn into the channel by electrowetting (arrow 290). Therefore, an embodiment of the disclosed invention may include at least one sweat coupling component that utilizes electrowetting for sample introduction”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the channels of the combined reference by applying the known technique of coating them with hydrophobic material, as taught by Heikenfeld ‘988, since one of ordinary skill in the art would have recognized that this technique would have yielded predictable results and resulted in an improved system, namely, a system capable of controlling fluid behavior in the channels through electrowetting or other electrofluidic pumping mechanisms.
The combined reference further does not explicitly teach wherein the hydrophobic coating is superhydrophobic. However, in a related art, Martinez teaches a wearable medical device with an omniphobic coating that displays superhydrophobic properties (Fig. 1b and par. 0071: “One side of the paper was first rendered omniphobic by spraying a 4.3% v/v solution of a long-chain fluorinated organosilane […] The modified paper exhibits an apparent static contact angle of ~156° with complex solutions like blood over a thickness of ~55 μm on its omniphobic side (FIG. 1b)”). To substitute the hydrophobic coating of the combined reference with the superhydrophobic coating taught by Martinez would have been obvious to one skilled in the art before the effective filing date of the claimed invention, because the substitution of one known element for another would have yielded predictable results, namely, a device that is capable of moving not only water but complex solutions like blood in a desired channeling behavior.
Regarding claim 2, the combination teaches the device of claim 1 as described previously. Lee further teaches wherein the material layer is a flexible, nonwoven material (par. 0134: “The pad may comprise any of a variety of materials, such as, for example, nonwoven spunlace, polyurethane, polyester, and polyethylene”).
Regarding claim 4, the combination teaches the devices of claims 1 and 16 as described previously. Martinez further teaches wherein the superhydrophobic coating includes one or more of carbon nanofiber, manganese oxide polystyrene (MnO2/PS) nano- composite, zinc oxide polystyrene (ZnO/PS) nano-composite, precipitated calcium carbonate, carbon nano-tube structures, silica nano-coating, fluorinated silanes, and fluoropolymer (par. 0071: “One side of the paper was first rendered omniphobic by spraying a 4.3% v/v solution of a long-chain fluorinated organosilane”).
Regarding claim 5, the combination teaches the device of claim 1 as described previously. Lee further teaches wherein each of the plurality of micro passages are cylindrical (par. 0146: “The apertures can be through-holes”) and have a diameter in the range of 1 μm to 100 μm (par. 0146: “the apertures have an average opening size (the largest dimension of the opening) of at least about 0.01 mm, about 0.05 mm, or about 0.1 mm;” examiner notes that 0.01 mm corresponds to 10 μm, and 0.1 mm corresponds to 100 μm).
Regarding claims 11 and 17, the combination teaches the devices of claims 1 and 16 as described previously. Lee further teaches wherein each of the plurality of micro passages extend entirely through at least one of the plurality of adhesive layers (par. 0147: “a pattern (e.g., a pattern corresponding to a layout of the pores) may be introduced during coating of an adhesive material onto the pad to provide variations in gas permeability across the pad, for example, in the form of a pattern that promotes breathability while still maintaining sufficient mechanical strength to prevent susceptibility to damage”).
Claims 3, 6, 8-9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez, and further in view of Carty et al. (US PGPub No. 2013/0123678), hereinafter Carty.
Regarding claim 3, Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez teaches the device of claim 1 as described previously. The combination does not explicitly teach wherein each of the plurality of adhesive layers is a hydrogel and includes at least one of collagen, gelatin, glycerine, aloe vera, methyl paraben, hydrogenated castor oil, and polyacrylamide/polydopamine. However, in an analogous art, Carty teaches hydrogel adhesives that include at least one of collagen, gelatin, glycerine, aloe vera, methyl paraben, hydrogenated castor oil, and polyacrylamide/polydopamine (par. 0215: “Hydrogel adhesives may also be used. […] the adhesive may comprise a gelling agent, where the gelling agent comprises, for example, methylcellulose, a natural gum, glucose, propylparaben, methylparaben, and sodium chloride”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select a natural hydrogel such as gelatin for the adhesive layers of the combined reference, as taught by Carty, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331.
Regarding claims 6, 8-9, and 18, Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez teaches the devices of claims 1 and 16 as described previously. The combination does not explicitly teach wherein each of the plurality of adhesive layers are rectangular and spaced from each other adhesive layer of the plurality of adhesive layers; or wherein the channel includes a first channel and a second channel, and wherein the first channel extends transverse to the second channel; wherein the first channel extends from a first edge of the material layer to a second edge of the material layer, wherein the first edge is at an opposite end of the material layer from the second edge; and wherein the second channel extends from a third edge of the material layer to a fourth edge of the material layer, wherein the third edge is at an opposite end of the material layer from the fourth edge.
However, Carty further teaches wherein each of the plurality of adhesive layers are rectangular and spaced from each other adhesive layer of the plurality of adhesive layers (Fig. 5: rectangular gridded sections of adhesive spaced apart from each other); wherein the channel includes a first channel and a second channel, and wherein the first channel extends transverse to the second channel (Fig. 5 and par. 0141: “a first set of generally parallel channels 136 and one or more transversely extending channels 138”); wherein the first channel extends from a first edge of the material layer to a second edge of the material layer, wherein the first edge is at an opposite end of the material layer from the second edge; and wherein the second channel extends from a third edge of the material layer to a fourth edge of the material layer, wherein the third edge is at an opposite end of the material layer from the fourth edge (Fig. 5: channels 136 and 138 extending from edge to edge of adhesive layers 130).
Carty teaches that this configuration allows fluid to rapidly flow outward from the adhesive layers (par. 0141: “the fluid can rapidly be distributed throughout the adhesive layer as it flows in the direction of arrows B;” note that the direction of arrows B in Fig. 5 points outward from the inner portion of the dressing). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the device of the combined reference by selecting the pattern of channels and adhesive layers taught in Carty, since Lee teaches that the pattern of channels may be selected to provide a desired moisture channeling behavior, and Carty teaches that the disclosed configuration allows fluid to rapidly flow outward from the device.
Claims 7, 13-15, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez, and further in view of Bahney et al. (US PGPub No. 2014/0206977), hereinafter Bahney.
Regarding claim 13, Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez teaches the device of claim 12 as described previously. Lee further teaches wherein the electronic assembly comprises a controller (par. 0275: “a computer or other programmable data processing apparatus (such as a controller, microcontroller, microprocessor or the like) in a sensor electronics system”) but does not explicitly teach wherein the electronic assembly comprises an antenna or a power source. However, in an analogous art, Bahney teaches a wearable monitoring medical device with an antenna (par. 0064: “device 100 may include an antenna for picking up electromagnetic interference”) and a power source (Fig. 1B: two batteries 160; par. 0051: “Battery holder 150, according to various alternative embodiments, may hold two batteries (as in the illustrated embodiment), one battery, or more than two batteries. In other alternative embodiments, other power sources may be used”).
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to provide the device of the combined reference with an antenna, as taught by Bahney, in order to pick up electromagnetic interference, as taught by Bahney. It would further have been obvious to one of ordinary skill in the art to provide the device of the combined reference with a power source, as taught by Bahney, since all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods (providing the device with a battery holder) with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art, i.e., one skilled in the art would have recognized that providing the device with its own power source would allow the device to operate its electronic components in a portable fashion.
Regarding claims 7, 15, and 19, Lee in view of Rodriguez, Heikenfeld ‘988, and Martinez teaches the devices of claims 1, 13, and 16 as described previously. The combination does not explicitly teach further comprising at least one motion sensor electronic coupled to the electronic assembly and configured to monitor movement of the user. However, Bahney further teaches further comprising a motion sensor electronic coupled to the electronic assembly (par. 0057: “device 100 may include a data channel for detecting patch motion. In certain embodiments, an accelerometer may provide patch motion by simply analyzing the change in magnitude of a single axis measurement, or alternatively of the combination of all three axes”), which allows the device to detect motion artifacts and activity levels of a patient during a recording (par. 0059: “In addition to detecting motion artifact, an accelerometer tuned to the dynamic range of human physical activities may provide activity levels of the patient during the recording”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the device of the combined reference by adding a motion sensor, as taught by Bahney, in order to detect motion artifacts and activity levels of a patient during recording, as taught by Bahney.
Regarding claim 14, the combination teaches the device of claim 13 as described previously. Lee further teaches further comprising at least one electrode electronically coupled to the electronic assembly (Fig. 1: analyte sensor 10; par. 0118: “The continuous analyte sensor 10 may be physically connected to sensor electronics module 12;” par. 0115: “the analyte sensor is a dual electrode analyte sensor”).
Response to Arguments
Applicant’s arguments with respect to claims 1, 16, and 20 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. Carty, though applied in the new ground of rejection, is not relied upon to teach a channel extending between adjacent adhesive layers and configured to contact the user’s skin.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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, LINDA C DVORAK can be reached at 571-272-4764. 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.
/LINDA C DVORAK/Primary Examiner, Art Unit 3794
/D.E.L./Examiner, Art Unit 3794
Prosecution Insights