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 .
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.
Claims 1, 3-5, 8, 11-14, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyde et al (US 20170258995 A1), as evidenced by Kube et al (US 20200029902 A1).
Regarding claim 1, Hyde discloses a wearable device 107 (fig 1B), comprising:
a user interface for displaying information to a user ((figs 1b, 3a, 4; [0045 (includes controller 112 that includes interface 119), [0089]) and for interfacing a drug delivery pump (110 in fig 1b; 310a in fig 3a) with the user for delivery of the drug to the user;
one or more activatable input elements (fig 4, [0135]) formed in the wearable device for enabling the user to provide input to a drug delivery pump,
communication interface for communicating with one or more external devices [0125,0126,0135]; and
a body conforming housing at 107 configured to make the device wearable by the user ((fig 1b) [0036,0148], the body conforming housing 107 configured to wrap around a portion of an appendage of the user ([0036,0044] for example a patch, a wrap, a band on the wrist, etc. or others shown in figures 2b-2c), and including at least one elastomeric layer and a layer of electrical circuitry is embedded in the at least one elastomeric layer [0036,0038-0040]. In [0045], Hyde further set forth that the controller 112 (processor which is part of an electrical circuitry) can be embedded in the wearable device 107 (shown in figure 1B), respect to the body conforming house. Patches, specifically electronic patches, having at least one elastomeric layer and a layer of electrical circuitry being embedded in at least one elastomeric layer are old and well known in the art as evidenced by Kube et al. having an electronic patch 12 including elastomeric layer 16 (stretchable and bendable) with flexible printed electric circuitry [0013,0060].
Hyde also discloses a fastener ([0036] an adhesive, hook and loop, clips etc.) attached to the body conforming housing 107 and configured to be wrapped around a remainder of the user's appendage ([0036], [0148], fig 1B).
Regarding Claim 3: Hyde discloses the user interface comprises a display [0136].
Regarding Claim 4: Hyde discloses the user interface of the wearable device is configured to display user blood glucose information from a glucose monitor [0069-0070,0129,0136,0176].
Regarding claim 5: Hyde discloses the communication interface enables communication with a glucose monitor [0034-0035, 0070,0129].
Regarding claim 8, the communication interface is a wireless communication interface [0034-0035].
Regarding Claim 11: Hyde discloses the body conforming housing 107 is configured to conform to a shape of at least one of an arm of the user, a wrist of the user, a hand of the user, or a leg of the user [0036,0044,0148].
Regarding Claim 12: Hyde discloses a drug delivery pump (fig 3a) capable of delivering insulin.
Regarding Claim 13, Hyde discloses a drug delivery system 100,100’, comprising:
a drug delivery pump assembly (fig 3a), comprising:
a source of a drug 331 to be delivered;
a pump (actuator fig 3a) for pumping the drug from the source;
a user interface for interfacing the pump with the user for delivery of the drug to the user [0098,0125,0126(interface 119)]; and
a drug delivery pump assembly housing (310a; fig 3a) for housing the drug delivery pump assembly and configured to be worn by the user; and
a wearable device representing a control unit 107 that is separate from the pump and an analyte sensor 110 (fig 1a), comprising:
-a user interface for displaying information to the user;
-one or more activatable input elements formed in the wearable device for enabling a user to provide input to the drug delivery pump assembly ([0045,0089]; includes controller 112 that includes interface 119 [0045]), and
-a body conforming housing at 107 configured to make the device wearable by the user ((fig 1b) [0036,0044, 0148] for example a patch, a wrap, a band on the wrist, etc. or others shown in figures 2b-2c), and including at least one elastomeric layer and a layer of electrical circuitry is embedded in the at least
one elastomeric layer [0036,0038-0040]. In [0045], Hyde further set forth that the
controller 112 (processor which is part of an electrical circuitry) can be embedded in the wearable device 107 (shown in figure 1B), respect to the body conforming house. Patches having at least one elastomeric layer and a layer of electrical circuitry being embedded in at least one elastomeric layer is old and well known in the art as evidenced by Kube et al. Kube discloses an electronic patch 12 including elastomeric layer 16 (stretchable and bendable) with flexible printed electric circuitry [0013,0060].
Regarding Claim 14, Hyde discloses that is capable of delivering a drug, therefore it can deliver insulin since the device monitors glucose [0069] and the reservoir can contain insulin.
Regarding Claim 19, Hyde discloses wherein the one or more activatable input elements formed in the wearable device is one of a button, a switch, a key, a wheel or a knob [0135,0136].
Regarding Claim 20, Hyde discloses the body conforming housing is configured to conform to a shape of at least one of an arm of the user, a wrist of the user, a leg of the user, or a hand of the user [0036,0044,0148].
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.
Claims 6-7, 9-10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Hyde et al. (US 20170258995 A1) in view of Campbell et al (US 2010/0017141 A1).
Regarding Claims 6 and 18: Hyde discloses the invention substantially as claimed. However, it fails to disclose to the user interface of the wearable device being configured to display information regarding quantity of insulin in the source, and Insulin on Board (IOB).
Campbell teaches the calculation of IOB for wearable insulin dispensing devices. Campbell teaches that the extended bolus IOB value may then be stored, displayed to the user and/or used in other calculations such as a suggested bolus calculation (Campbell Paragraph [0030]) Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the wearable device of Hyde to include the calculation of IOB and display it as taught by Campbell for the purpose of providing the patient and their healthcare professionals a better snapshot of their medication’s effectiveness in real time and dosage requirements.
Regarding claim 7, Hyde discloses wherein the communication interface enables communication with the drug delivery pump [0034-0035].
Regarding claim 9, Hyde discloses wherein the one or more activatable input elements formed in the wearable device is one of a button, a switch, a key, a wheel or a knob [0135,0136].
Regarding claim 10, Hyde discloses wherein the activatable input elements includes an activatable input structure for requesting a delivery of a bolus of insulin to the user [0135-0136].
Response to Arguments
Applicant's arguments filed 07/06/2026 have been fully considered but they are not persuasive.
With respect to arguments “A. Hyde does not teach a Body Conforming Housing Configured to Wrap Around a Portion of an Appendage ” on pages 6-7, the examiner disagrees.
Applicant argues and further explains what the language of claim 1 means specifically to "a body conforming housing configured to make the device wearable by the user, the body conforming housing configured to wrap around a portion of an appendage of the user." This feature means that the housing itself (the structural enclosure of the wearable device) is body-conforming structure that actively wraps around a portion of the user's appendage, distinguishing the claimed device from conventional wearable devices (such as wristwatches) in which a rigid, non-conforming case sits upon the appendage rather than wrapping around it, and in which any wrapping is performed by a separate band or strap that is distinct from the housing. The examiner’s interpretation with respect to this interpretation is different. The claim set forth a wearable device comprising…“a body conforming housing configured to make the device wearable by the user, the body conforming housing configured to wrap around a portion of an appendage of the user…”. Hyde discloses a wearable device 107 having a body conforming housing 107 (a compressible garment [0036] seen in figure 1B) which includes
“The one or more wearable devices 107 can include one or more of another flexible compression garment (e.g., a joint, leg, or arm sleeve), a band (e.g., a wrist, arm, leg, or head band), a brace (e.g., knee, wrist, ankle, neck, or elbow brace), a watch (e.g., wristwatch), a hat, a patch, a bandage, a wrap, an article of clothing, a necklace, a belt, a strap, a glove, a ring, footwear (e.g., shoes, sandals, or socks), an ear bud, jewelry, etc. In an embodiment, the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device). For example, the wearable device 107 can be configured as a patch, bandage, epidermal electronics, or the like, having an attachment device configured to connect to the subject 106. The wearable device 107 can support one or more sensors 108 or 108′ therein or thereon. The wearable device 107 can be worn remotely (e.g., on a different region or body part of the subject) from the at least one flexible compression garment 102. Responsive to sensed data 109 from the one or more sensors 108 or 108′, the controller 112 can direct the one or more actuators of the one or more medicament dispensers 110 to selectively manage delivery of the one or more medicaments, via one or more signals 113.”.
Hyde shows a wearable device at 107 configured to be wrap around a portion of an appendage of the user as seen in figure 1B as set forth in claim 1 (a body conforming housing configured to make the device wearable by the user). A patch with an adhesive is old and well known in the art wearable device for example. Hyde meets this limitation.
Then the claim goes on to “the body conforming housing configured to wrap around a portion of an appendage of the user” as seen in figure 1B which is configured to wrap around a portion of body part 105. Hyde also meets this limitation.
Hyde also establishes that in [0036] the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device). Hyde provides a few options to attach the wearable device 107 in order to wrap around a limb/body which also meets the limitation of the fastener as claimed. Therefore, Hyde meets this limitation.
Applicant has not defined in the claim how much the “portion of an appendage” encompasses. The examiner recommends to further define the claims in order to overcome Hyde.
With respect to arguments “B. Hyde does not Teach an Elastomeric Layer and Embedded Electrical” and C. Hyde does not teach a Layer of Electrical Circuitry Embedded in the At Least One Elastomeric Layer on pages 8-9, the examiner disagrees.
Hyde discloses in [0045] that the controller 12 can be embedded by the wearable device which is of a flexible material which is part of wearable device 107 (fig 1B). In [0036] discloses:
“The system 100′ can include one or more sensors 108 or 108′ operably coupled to the controller 112 and supported by the at least one flexible compression garment 102 or one or more wearable devices 107. The one or more wearable devices 107 can include one or more of another flexible compression garment (e.g., a joint, leg, or arm sleeve), a band (e.g., a wrist, arm, leg, or head band), a brace (e.g., knee, wrist, ankle, neck, or elbow brace), a watch (e.g., wristwatch), a hat, a patch, a bandage, a wrap, an article of clothing, a necklace, a belt, a strap, a glove, a ring, footwear (e.g., shoes, sandals, or socks), an ear bud, jewelry, etc. In an embodiment, the wearable device 107 can be attached to the body part 105 by an attachment device (e.g., adhesive, hook and loop material, clips, or other suitable device). For example, the wearable device 107 can be configured as a patch, bandage, epidermal electronics, or the like, having an attachment device configured to connect to the subject 106. The wearable device 107 can support one or more sensors 108 or 108′ therein or thereon.”.
In Hyde’s “Background” discloses that it is old and well known to use compression garments that conforms to the user, implying the flexible compression garment comprises an elastomeric material to perform some compression and that the body conforming housing includes adhesive. In [0036] set forth the compression garment can be used on the wearable device. Therefore, Hyde’s meet this limitation. Additionally, the examiner has provided evidence of a patch, specifically an electronic patch, comprising an elastomeric layer and an embedded printed electrical circuit as evidence that this is old and well known in the art (see rejection above for claims 1 and 13).
The examiner recommends to further define the claims in order to overcome the prior art applied above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
THIS ACTION IS MADE FINAL. 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 Cris L Rodriguez whose telephone number is (571)272-4964. The examiner can normally be reached Monday-Thursday 8am- 2pm..
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, Chelsea Stinson can be reached at 571-270-1744. 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.
/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
Prosecution Insights