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 .
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 12/12/24 and 12/12/24 were filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 6 and 16 are objected to because of the following informalities:
Claims 6 and 16, both in line 1 read “wherein the adhesive layer of the top layer is configured…” and should likely read “wherein the adhesive layer of the top [[layer]] surface is configured…” because top “layer” lacks antecedent basis because the structure has not yet been introduced in the claim language. However, a top surface is properly provided with antecedent basis in at least claims 5 and 15 from which claims 6 and 16 depend.
Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 7-8, 10-13, 17-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Nazzaro et al. (U.S. PGPUB No. 2020/0069875), hereinafter Nazzaro.
Regarding claim 1, Nazzaro discloses an adhesive patch (802, see FIG. 8), comprising:
a top surface (surface where device is mounted, see ‘Modified FIG. 9’ below and [0065-0066]) configured to adhere to a wearable medical device (see [0058]);
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a bottom surface (skin facing side) opposite the top surface (see ‘Modified FIG. 9’ above), wherein the bottom surface includes an adhesive layer configured to adhere to a user’s skin (see [0060]: adhesive of pad 802 attaches to user and [0024] & [0037]: adhesive applied specifically to skin); and
a first perforation (812 or 814) extending through the top and bottom surfaces (see [0063]: holes 812/814 through entirety of pad 802), the first perforation (812 or 814) configured to receive a piercing element from the wearable medical device (see [0062]).
Regarding claim 2, Nazzaro discloses the adhesive patch of claim 1, and Nazzaro further discloses wherein the wearable medical device includes an insulin pump (see [0058]: outline 806 shows where drug delivery device such as an insulin pump would attach onto pad 802).
Regarding claim 3, Nazzaro discloses the adhesive patch of claim 1, and Nazzaro discloses further comprising a second perforation (see [0059]: opening of adhesive pad aligned with site 810 of sensing needle of CGM sensor 804) configured to receive a sensing device from the wearable medical device (see [0059]).
Regarding claim 7, Nazzaro discloses the adhesive patch of claim 1, and Nazzaro further discloses wherein the piercing element includes an insertion mechanism (see [0062-0064]: device cannula is removed and replaced via different insertion site openings 812/814 and therefore the piercing element must include an insertion mechanism for deploying the cannula into skin during device replacement).
Regarding claim 8, Nazzaro discloses the adhesive patch of claim 1, and Nazzaro further discloses wherein the adhesive layer of the bottom surface (see [0060]: adhesive of pad 802 attaches to user and [0024] & [0037]: adhesive applied specifically to skin) includes adhesive properties specific to a target body part of the user (see [0037]: adhesive to couple to body of user, such as skin, and thus has adhesive properties specific to target body part of skin).
Regarding claim 10, Nazzaro discloses the adhesive patch of claim 1, and Nazzaro further discloses wherein the adhesive layer of the bottom surface is configured to be removed from the user’s skin through a shear force applied to the adhesive layer of the bottom surface (see [0064]: adhesive pad has limited number of uses provided by number of perforations/infusion sites. Thus, the adhesive pad MUST eventually be replaced, such as after 12 days, see [0025]. Thus, the adhesive layer of the bottom surface allows for removal and thus is “configured to be” removed from the skin through a shear force/ peeling force that is common in the art for adhesive patch devices).
Regarding claim 11, Nazzaro discloses a system for a wearable medical device (800, see FIG. 8), comprising:
a wearable medical device (see [0058]: outline 806 shows where drug delivery device such as an insulin pump would attach onto pad 802) configured to deliver a medication to a user (see [0057]: drug delivery system 800 of FIG. 8 includes drug delivery system similar to embodiment 100, which is disclosed as a wearable drug delivery system, see [0024]); and
an adhesive patch (802) coupled to the wearable medical device (see [0057-0058] and [0064]), comprising:
a top surface (surface where device is mounted, see ‘Modified FIG. 9’ below, [0065-0066], and [0024]),
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wherein the top surface is configured to adhere to the wearable medical device (see [0058] & [0024]);
a bottom surface opposite the top surface (see ‘Modified FIG. 9’ above), wherein the bottom surface includes an adhesive layer configured to adhere to a user’s skin (see [0060]: adhesive of pad 802 attaches to user and [0024] & [0037]: adhesive layer of bottom surface facilitates coupling to skin); and
a first perforation (812 or 814) extending through the top and bottom surfaces (see [0063]: holes 812/814 through entirety of pad 802), the first perforation (812 or 814) configured to receive a piercing element from the wearable medical device (see [0062]).
Regarding claim 12, Nazzaro discloses the system of claim 11, and Nazzaro further discloses wherein the wearable medical device includes an insulin pump (see [0058]: outline 806 shows where drug delivery device such as an insulin pump would attach onto pad 802).
Regarding claim 13, Nazzaro discloses the system of claim 11, and Nazzaro discloses further comprising a second perforation (see [0059]: opening of adhesive pad aligned with site 810 of sensing needle of CGM sensor 804) configured to receive a sensing device from the wearable medical device (see [0059]).
Regarding claim 17, Nazzaro discloses the system of claim 11, and Nazzaro further discloses wherein the piercing element includes an insertion mechanism (see [0062-0064]: device cannula is removed and replaced via different insertion site openings 812/814 and therefore the piercing element must include an insertion mechanism for deploying the cannula into skin during device replacement).
Regarding claim 18, Nazzaro discloses the system of claim 11, and Nazzaro further discloses wherein the adhesive layer of the bottom surface (see [0060]: adhesive of pad 802 attaches to user and [0024] & [0037]: adhesive applied specifically to skin) includes adhesive properties specific to a target body part of the user (see [0037]: adhesive to couple to body of user, such as skin, and thus has adhesive properties specific to target body part of skin).
Regarding claim 20, Nazzaro discloses the system of claim 11, and Nazzaro further discloses wherein the adhesive layer of the bottom surface is configured to be removed from the user’s skin through a shear force applied to the adhesive layer of the bottom surface (see [0064]: adhesive pad has limited number of uses provided by number of perforations/infusion sites. Thus, the adhesive pad MUST eventually be replaced, such as after 12 days, see [0025]. Thus, the adhesive layer of the bottom surface allows for removal and thus is “configured to be” removed from the skin through a shear force/ peeling force that is common in the art for adhesive patch devices).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro as applied to claims 1 and 11, respectively, above, and further in view of Srinivasan et al. (U.S. Patent No. 11,679,208), hereinafter Srinivasan.
Regarding claims 1 and 14, Nazzaro discloses the adhesive patch of claim 1 and the system of claim 11, respectively, but Nazzaro is silent to “wherein the top surface includes a color corresponding to a function of the wearable medical device.”
However, Srinivasan teaches a system for a wearable medical device (delivery or injection device 228, see FIG. 25A and col 19 lines 19-39) comprising an adhesive patch (232) comprising a top surface (see FIG. 25A), wherein the top surface is configured to adhere to the wearable medical device (228, see col 19 line 19- col. 20 line 44, specifically col 20 lines 1-29: each device 228 provided with adhesive label 232. Because label 232 is adhesive label, it is “configured to” adhere to any drug delivery device, such as a wearable drug delivery device); wherein the top surface includes a color corresponding to a function of the wearable medical device (see col 20 lines 30-44: color indicates particular injection site or body area).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the top surface of the adhesive patch disclosed in Nazzaro to include a color corresponding to a function of the device as taught by Srinivasan for the purpose of visually distinguishing injection protocols for the device, such as the intended delivery site area (see col 19 lines 40-67), thus achieving “wherein the top surface includes a color corresponding to a function of the wearable medical device”.
Claims 5-6 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro as applied to claims 1 and 11, respectively, above, and further in view of Burren et al. (U.S. PGPUB No. 2020/0405951), hereinafter Burren.
Regarding claims 5 and 15, Nazzaro discloses the adhesive patch of claim 1 and the system of claim 11, but Nazzaro is silent to “wherein the top surface includes an adhesive layer.”
However, Burren teaches a system for a wearable medical device comprising an adhesive patch (13) comprising a top surface (159, see FIG. 23), wherein the top surface (159) is configured to adhere to the wearable medical device (see [0134]); wherein the top surface includes an adhesive layer (see [0134]: layer 159 includes adhesive and thus is an adhesive layer).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the top surface of the adhesive pad disclosed in Nazzaro to include an adhesive layer as taught by Burren for the purpose of attaching the top surface to the drug delivery device by way of an adhesive (see [0134]), thus achieving “wherein the top surface includes an adhesive layer.” Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (connecting the drug delivery device to an adhesive pad by mechanism connectors as in Nazzaro, see [0058]) for another known element (connecting the drug delivery device to an adhesive pad by chemical connection, such as an adhesive layer as in Burren [0134]) in the art to obtain the predictable result of coupling a wearable medical device to an adhesive pad (see MPEP § 2143.I.B).
Regarding claims 6 and 16, the modified system of Nazzaro teaches the adhesive patch of claim 5 and the system of claim 15, but Nazzaro is silent to “wherein the adhesive layer of the top layer is configured to adhere to an adhesive layer of a bottom of the wearable medical device.”
However, Burren teaches a system for a wearable medical device comprising an adhesive patch (13) comprising a top surface (159, see FIG. 23), wherein the top surface (159) is configured to adhere to the wearable medical device (see [0134]); wherein the top surface includes an adhesive layer (see [0134]: layer 159 includes adhesive and thus is an adhesive layer), wherein the adhesive layer of the top layer is configured to adhere to an adhesive layer of a bottom of the wearable medical device (see [0134]: adhesive layer of surface 159 adheres to bottom of wearable device housing and thus is “configured to” adhere to an adhesive layer on the bottom surface of the device as well).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the top surface of the adhesive pad disclosed in Nazzaro to include an adhesive layer as taught by Burren for the purpose of attaching the top surface to the drug delivery device by way of an adhesive (see [0134]), thus achieving “wherein the adhesive layer of the top layer is configured to adhere to an adhesive layer of a bottom of the wearable medical device.” Further, a person of ordinary skill in the art would have been motivated to make this modification because it is a simple substitution of one known element (connecting the drug delivery device to an adhesive pad by mechanism connectors as in Nazzaro, see [0058]) for another known element (connecting the drug delivery device to an adhesive pad by chemical connection, such as an adhesive layer as in Burren [0134]) in the art to obtain the predictable result of coupling a wearable medical device to an adhesive pad (see MPEP § 2143.I.B).
Claims 9 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Nazzaro as applied to claims 8 and 18, respectively, above, and further in view of Sloat et al. (U.S. PGPUB No. 2022/0270241), hereinafter Sloat.
Regarding claims 9 and 19, Nazzaro discloses the adhesive patch of claim 8 and the system of claim 18, but Nazzaro is silent to “wherein the adhesive properties include an adhesive strength specific to the target body part of the user.”
However, Sloat teaches an adhesive patch (see FIG. 2 and [0058]) comprising a bottom surface (206), wherein the bottom surface (206) includes an adhesive layer (210) configured to adhere to a user’s skin (see [0062]: 210 removably adheres to user skin); wherein the adhesive layer of the bottom surface includes adhesive properties specific to a target body part of the user (see [0062]: adhesive layer designed to adhere to skin without injury. See [0046]: skin surfaces intended on body part extremities such as foot, hand, ankle, calf, wrist, arm. See application near foot in FIG. 1A); wherein the adhesive properties include an adhesive strength specific to the target body part of the user (see [0062]: adhesive strength ranges provided such that the device is securely adhered to skin without causing tearing, injury, rash of skin).
Therefore, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive properties of the bottom surface adhesive layer specific to a target body part of skin disclosed in Nazzaro to have an adhesive strength specific to the target body part, such as skin of a foot, as taught by Sloat (such as by providing additives, thickeners, etc. to the adhesive, see Sloat [0062]) for the purpose of removably adhering the layer to the patient without causing tearing, injury, or rash at the site (see [0062]), thus achieving “wherein the adhesive properties include an adhesive strength specific to the target body part of the user.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHLEEN PAIGE VOKES whose telephone number is (571)272-0198. The examiner can normally be reached M-F: 730AM-330PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KATHLEEN PAIGE VOKES/Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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