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 (IDS) submitted on 5/1/26;4/22/26;4/13/26;1/2/26;8/22/25;8/1/25;7/10/25;3/3/25;2/21/25 ;1/22/25;1/2/25;12/11/24;8/27/24;8/1/24;7/9/24;6/13/24;4/25/24 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Rejections - 35 USC § 102
3. 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 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.
4. 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)(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.
5. Claims 1-9, 11-16, 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hanson et al. (US 10,092,693) (“Hanson”).
Hanson discloses: A drug delivery device comprising: a reservoir 58; a delivery member 60 having a proximal end connected or configured to be connected in fluid communication with the reservoir and a distal end configured for insertion (200 insertion mechanism) into a patient; a housing 12 having an opening 252, Fig. 1C, the distal end of the delivery member being configured to extend through the opening in an operative state; an adhesive 26 for removably coupling the housing to skin of the patient; a removable cover 28 covering at least a portion of the adhesive (Fig.1A); and the drug delivery device being programmed or configured to (via the power and control system 400) alert the patient if or when the removable cover has been removed from the housing.
The drug delivery device is configured or programmed to alert the patient, via at least one light and/or at least one sound, if or when the removable cover has been removed from the housing. C9L20-49, C8L52-C9L19
The opening is formed in an exterior surface of the housing and the adhesive is disposed at the exterior surface of the housing, Figs.1A,C
The removable cover comprises a sheet covering the adhesive and configured for removal by the patient to expose the adhesive C20L46-58
A patient contact sensor 24
A controllable element (14 activation mechanism) wherein the drug delivery device is programmed or configured to determine if or when the drug delivery device is in contact with the patient and, if the drug delivery device is in contact with the patient, output a control signal to the controllable element C8L21-51
A controller 400 programmed to output a control signal to the controllable element if the drug delivery device is not in contact with the patient within a predefined time period after the removable cover has been removed from the housing C9L20-C10L7
The controller of Hanson is capable of being programmed to repetitively determine at predefined time intervals if the drug delivery device is in contact with the patient C8L21-32
The controllable element 14 comprises a communication unit (activation mechanism 14 communicates with the power and control system 400)
As functional language, Hanson’s controller is capable of being programmed to determine (a) if or when drug delivery is complete and (b) if or when the drug delivery device has been removed from contact with the patient and, if (a) and (b) are determined to exist, control the communication unit to transmit a report 16, C8L21-51, C9L20-49, C9L50-C10L7
The controllable element comprises a lock; the control signal changes the lock from a locked state to an unlocked state. C8L33-47
A plunger of Hanson is configured to expel a drug from the reservoir, wherein the lock, in the locked state, prevents movement of the plunger. C7L62-C8L51 (prevents triggering of the drug pump 10)
Hanson comprising a trigger button 14 operable by the patient, wherein the lock, in the locked state, prevents operation (40) of the trigger button by the patient. C7L62-C8L51
The controllable element comprises a circuit having a low-energy state and a high-energy state, and wherein the control signal switches the circuit from the low-energy state to the high-energy state. C10L2-7
The patient contact sensor 24 comprises at least one of a capacitance sensor, a resistance sensor, and an inductance sensor. C8L40-51
Claim Rejections - 35 USC § 103
6. 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 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.
7. 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.
8. 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.
9. Claims 10 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Hanson in view of Rosinko (US 9,867,953).
Hanson discloses the invention as substantially claimed, see above. However, Hanson does not directly disclose the communication unit wirelessly transmits a report to an external computing device or the controllable element comprising a heating element configured to heat a drug in the reservoir or the delivery member in response to the control signal. Ronsinko, in the analogous art, teaches a contact sensor that sends a signal wirelessly and sets therapeutic parameters based on sensor determination C4L22-40, C6L12-20. Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to modify Hanson’s control signals as taught by Rosinko to further ensure proper skin adherence to increase the safety of the needle insertion.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at 571-272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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