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 .
Election/Restrictions
Applicant's election with traverse of Species B in the reply filed on 6/15/2026 is acknowledged. The traversal is on the ground(s) that:
The cited prior art, Hayter, fails to disclose a second sensor. This argument is not convincing as Hayter discloses multiple patient states determined by multiple sensors (page 6, para. 0051; page 10, para. 0078). Applicant further argues that Hayter fails to disclose the amendment to claim 1. This argument is convincing, however, amended claim 1 does not provide a contribution over the prior art as will be seen below and therefore does not provide unity of invention to the species.
The requirement for unity of invention does not address claims 2-5, 7-9, 14-22. This argument is not convincing as those claims are not included in the various species listed in the requirement and therefore do not provide a common technical feature between the groups which would need to be addressed with regard to the prior art.
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-3, 5, 6, 14-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Davis et al (US 2017/0220751).
Regarding claim 1, Davis discloses a drug administration device, comprising: a drug holder configured to retain a drug therein (fig. 30: medicament delivery pump 2); a first sensor configured to gather data regarding a first characteristic associated with a patient (page 13, para. 0145: CGM); a second sensor configured to gather data regarding a second characteristic associated with the patient (page 13, para. 0145: physiological sensor); a memory configured to store therein an algorithm including at least one variable parameter (page 13, para. 0145); and a processor configured to: control delivery of a first dose of the drug from the drug holder to the patient by executing the algorithm (page 25, para. 0258, change the at least one variable parameter of the algorithm stored in the memory based on the data gathered by the first sensor and data gathered by the second sensor in a hierarchy which prioritizes data from one of the first and second sensors over the other (page 13, para. 0147-0149: correlative parameter is prioritized over data determined to be non-correlative; page 15: 0164-0170: a determined state results in a percentage change from the calculated output meaning the CGM provides the prioritized data and the secondary sensor provides an adjustment factor), and after changing the at least one variable parameter, control delivery of a second dose of the drug from the drug holder to the patient by executing the algorithm (page 14, para. 0165).
Regarding claim 2, Davis the processor is also configured to automatically control delivery of the doses according to a predetermined schedule of dosing for the patient (page 25: closed loop including a periodic dosing regimen necessarily includes a predetermined schedule for dosing).
Regarding claim 3, Davis further discloses at least one additional sensor (page 14, para. 0159: time, location, date, acceleration, etc.), each sensor configured to gather data regarding a different characteristic; wherein the processor also being configured to change the at least one variable parameter of the algorithm stored in the memory based on the data gathered by the at least one additional sensor (page 14, para. 0159: data included in learning correlative parameters).
Regarding claim 5, Davis discloses that the first characteristic is a physiological characteristic of the patient (page 13, para. 0145: CMG measures blood glucose level); and the second characteristic is a situational characteristic of the patient (page 13, para. 0145: exercise or stress).
Regarding claim 6, Davis discloses that the first characteristic is one of blood sugar level (page 13, para. 0145); and the second characteristic is at least one of core temperature, patient activity level (page 13, para. 0145).
Regarding claim 14, Davis discloses that the variable parameter includes a rate of delivery of the drug form the drug holder to the patient (page 4, para. 0029: suggested change to basal rate).
Regarding claim 15, Davis discloses that the variable parameter includes timing of delivery of the determined dose which changes based on data collected by the sensors to optimize blood glucose control (page 17, para. 0181).
Regarding claim 16, Davis discloses that in the event of a low glucose calculation, a carbohydrate suggestion is made (page 2, para. 0016) which implies that the associated insulin delivery is not delivered and blood glucose correction is made by consuming sugar.
Regarding claim 17, Davis discloses that the processor automatically changes the parameters (page 11, para. 0126).
Regarding claim 18, Davis discloses that the processor is configured to cause a notification to be provided to the patient based on the data gathered by the second sensor (page 10, para. 0118).
Regarding claim 19, Davis discloses that a communications interface wirelessly transmit data indicative of the data gathered by the sensor to a remotely located computer system and receives a command from the remotely located computer, and the processor is configured to change the variable parameter after communication interface receives the command (page 10, para. 0113; page 45, para. 0436).
Regarding claim 20, Davis discloses that the processor is configured to change the variable parameter during delivery of the second dose such that the algorithm is changed in real time (page 3, para. 0025).
Regarding claim 21, Davis discloses that the variable parameter of the algorithm is periodically updated and therefore the parameter is changed before the start of a second dose.
Regarding claim 22, Davis discloses that the memory is configured to store manually input data regarding the patient (page 13, para. 0145), and the processor changes the variable parameter based on the stored input data (page 13, para. 0147).
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.
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Davis in view of Mensinger et al (US 20140012511).
Claim 7 calls for the second sensor being configured to gather data by capturing an image of the patient or an environment and the processor is configured to analyze the image to determine at least one of whether food intake occurred and skin reaction to the drug. Davis discloses that food/meal data is collected (page 2, para. 0016), but fails to disclose that the second sensor gathers an image that is processed by the processor. Mensinger teaches a CGM sensor module which includes an image capture module that captures an image of the environment near a patent and wherein the processor analyzes the image to obtain carbohydrate information (page 14, para. 0103). 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 second sensor of Davis to include an imaging device wherein the processor analyzes the image to determine carbohydrate information as taught by Mensinger to automate the process of entering food/meal data to increase ease of use and thereby increase patient compliance.
Allowable Subject Matter
Claims 5-10, 23 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The subject matter of the claims listed above could not be found in combination with the features of the invention, substantially as claimed.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAURA A BOUCHELLE whose telephone number is (571)272-2125. The examiner can normally be reached Mon-Fri 8:00-5:00 CST.
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LAURA A. BOUCHELLE
Primary Examiner
Art Unit 3783
/LAURA A BOUCHELLE/Primary Examiner, Art Unit 3783
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