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 1-5, 8, 11-15, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyde et al (US 20170258995 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 wearable device by the user [0036,0148], the body conforming housing configured to wrap around a portion of an appendage of the user; and
a fastener attached to the body conforming housing and configured to be wrapped around a remainder of the user's appendage [0036,0148].
Regarding claim 2, Hyde discloses the body conforming housing of the wearable device includes at least one elastomeric layer and a layer of electrical circuitry is embedded in the at least one elastomeric layer [0036,0038].
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 107 configured to make the device wearable by the user [0036,0148].
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 15, Hyde discloses in the body conforming housing of the wearable device includes at least one elastomeric layer and a layer of electrical circuitry is embedded in the at least one elastomeric layer [0036].
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 with respect to the claims 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See PTO-892 form.
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..
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/Cris L. Rodriguez/
Primary Patent Examiner
Art Unit 3783
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