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 .
Response to Amendment
The amendment filed on 03/03/2026 has been entered. Claims 1, 5, 8-11, and 18-20 have been amended. Claims 2-4, 6-7, and 12-17 are in the original/previously presented form. Thus, claims 1-20 remain pending in the application.
Specification
The disclosure is objected to because of the following informalities: In paragraph [0024], the specification states "The communication device 164...". However, in FIG. 1 and paragraphs [0031]-[0033], the reference number 164 is associated with a "Sensing/Measuring Device". Based on context of paragraph [0024], the reference number for "the communication device" should be corrected to be 142. Appropriate correction is required.
The disclosure is objected to because of the following informalities: In paragraph [0032], the specification states "…a wireless link communication link 166…”. However, in paragraphs [0036], the reference number 166 is associated with a “wireless communication link”. Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities: In the previous action, claim 14 was rejected under 35 U.S.C. 112(b) for insufficient antecedent basis for the limitation “the modification”. Corrections were made to the other claims with the same rejection. In Applicant’s Remarks, it is stated “Applicant has amended claim…14…and respectfully submits the amendments made to these claims overcome the present rejection.” However, no such amendment was made to the claims filed on 03/03/2026. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
The term “clinically validated” in claims 1 and 11 is a relative term which renders the claim indefinite. The term “clinically validated” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Paragraph [0042] of the specification states “a target blood glucose setpoint value between 70 mg/dL and 180 mg/dL is considered to be a typical glucose target setting for most users as validated through various clinical tests”, however offers no insight into where or how those numbers were “clinically validated”. It is unknown to the examiner in what manner constitutes the values to be considered “clinically validated”. Possibilities could include an official clinical study in which the results yielded the values, a clinician confirmed the values, or by some other means. For the purposes of examination, the examiner will interpret “clinically validated” to mean values agreed upon by clinicians.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 5, 7 are rejected under 35 U.S.C. 103 as being unpatentable over Deratany (U.S. Patent Application Publication No. US 2015/0352280 A1), and further in view of Simpson et al. (U.S. Patent Application Publication No. US 2021/0045666 A1; herein, Simpson), Michelich et al. (WIPO Application Publication No. WO 2020/002428 A1; herein, Michelich), and Bergenstal et al. (Bergenstal, R. M. et al. (2013). Recommendations for Standardizing Glucose Reporting and Analysis to Optimize Clinical Decision Making in Diabetes: The Ambulatory Glucose Profile. Journal of Diabetes Science and Technology, 7(2), 562-578. https://doi.org/10.1177/193229681300700234.; herein, Bergenstal).
Regarding claim 1, Deratany discloses a method, comprising:
adjusting a drug delivery algorithm to begin delivery of a basal amount of a liquid drug (paragraph [0032], insulin is gradually introduced…for a determined period of time);
modifying the basal amount by a set amount of liquid drug at predetermined time increments after a set duration (Fig. 6, adjustment 600, [0041], monitoring is dynamic, such as done via continuous glucose monitoring (CGM) measurements; Fig. 7, [0046-0047], insulin dosage adjusted based on BG level).
Deratany does not disclose determining a user is initiating a wearable drug delivery device for initial use, in response to the initial use, setting a high analyte target value and a low analyte target value to clinically validated default values, and after the set duration, readjusting the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration.
However, Simpson teaches determining a user is initiating a wearable drug delivery device for initial use (paragraph [0480], When the sensor is first implanted into host tissue, the sensor and receiver are initialized…start-up mode is trigger by the receiver). Therefore, 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 method of Deratany to be able to determine when a user is initializing a device for initial use as taught by Simpson, in order for the system of Deratany to have improved user specific conditions by reducing the amount of manual set up the user has to do when setting up a new device ([0480],[0485]).
Deratany in view of Simpson still does not disclose in response to the initial use, setting a high analyte target value and a low analyte target value to clinically validated default values, and after the set duration, readjusting the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration.
However, Michelich teaches in response to the initial use, setting a high analyte target value and a low analyte target value (Fig. 5B, 320) and after the set duration, readjusting the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration (Fig. 5G, 382, after the set duration, in this instance a full day, the device calculates the updated adjustment day dose recommendation based on glucose levels post titration of insulin). Therefore, 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 method of Deratany to be able to autonomously set high and low target ranges, as well as continuously readjusting the algorithm for drug delivery as taught by Michelich in order to improve the functionality of the device, removing the need for the user to input what they believe the correct information should be, and rather calculating the inputs itself, leading to better care for the user (pg. 60 lines 31-34, pg. 65 lines 5-9).
Deratany in view of Simpson and Michelich still does not disclose the high and low analyte target values being clinically validated default values. However, Bergenstal teaches the high and low analyte target values being clinically validated default values (pg. 566, A panel of diabetes specialists “selected 70–180 mg/dl as the default target range. While not an ideal or normal glucose range, it represents a target range commonly used in clinical practice and one that promotes realistic and safe expectations.”). Therefore, 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 high analyte target value and low analyte target value as taught by Michelich in the modified method of Deratany in order to have a standardized value range for clinical care, research, and regulatory periods (pg. 566).
Regarding claim 5, in the modified method of Deratany, Deratany discloses the basal amount is modified at the predetermined time increment (FIG. 6, adjustment 600, [0041], monitoring is dynamic, such as done via continuous glucose monitoring (CGM) measurements; FIG. 7, [0046-0047], insulin dosage adjusted based on BG level).
Modified Deratany does not disclose modifying the basal amount being based on a sensor analyte value received at a time corresponding to the predetermined time increment, and the sensor analyte value is from the number of sensor analyte values. However, Michelich teaches modifying the basal amount being based on a sensor analyte value received at a time corresponding to the predetermined time increment, and the sensor analyte value is from the number of sensor analyte values (pg. 8 lines 30-35, plurality of glucose measurements…taken over a time course). Therefore, 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 modified method of Deratany to require that the basal amount provided by the device is based specifically on the collected sensor analyte values taken over a period of time as taught by Michelich in order to clarify the device uses sensor analyte values to conduct adjustments. Especially in the case of blood sugar, sensor analyte values are the most representative unit of measurement to determine if intervention is necessary for users of monitoring devices (pg. 8 line 20-pg. 9 line 21).
Regarding claim 7 in the modified method of Deratany, Deratany does not discloses the high analyte target value is a first blood glucose measurement value, and the low analyte target value is a second blood glucose measurement value. However, Michelich teaches the high analyte target value is a first blood glucose measurement value, and the low analyte target value is a second blood glucose measurement value (pg. 19 lines 21-24, glucose upper target range level and glucose lower target range level). Therefore, 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 modified method of Deratany to specify the high analyte target value and low analyte target value to be glucose measurements as taught in Michelich in order that the system and device have a threshold to judge the analyte values by to determine if insulin intervention is needed (pg. 8 line 20-pg. 9 line 21).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, and Bergenstal as applied to claim 1 above, and further in view of Tandem (Tandem Diabetes Care. (2020, April 1). t:slim X2 Insulin Pump User Guide (Version 7.3). https://www.tandemdiabetes.com/support/resources/documents).
Regarding claim 2, in the modified method of Deratany, Deratany does not disclose receiving an input from a user input device indicating that the user is a new user. However, Tandem teaches receiving an input from a user input device indicating that the user is a new user (5.2 Creating a New Profile and 5.3 Programming a New Personal Profile). Therefore, 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 modified method of Deratany with the customizable user profiles as taught by Tandem, in order for the Deratany device to specifically know the user of the device is a new user.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, and Bergenstal as applied to claim 1 above, and further in view of Tandem and Cardinali et al. (U.S. Patent Application Publication No. US 2021/0077719 A1; herein, Cardinali).
Regarding claim 3, in the modified method of Deratany, Deratany does not disclose establishing a wireless communication connection with a controller device; and receiving a signal indicating the user is a new user.
However, Cardinali teaches establishing a wireless communication connection with a controller device (FIG. 2, wireless links 208, 220, 222, 291, 292 and 293). Therefore, 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 modified method of Deratany with the wireless links as taught by Cardinali in order to allow for the not just the sensor, but a controller device to also be wireless ([0030]).
Further, Tandem teaches receiving a signal indicating the user is a new user (5.2 Creating a New Profile and 5.3 Programming a New Personal Profile). Therefore, 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 modified method of Deratany with the customizable user profiles as taught by Tandem, in order for the Deratany device to specifically know the user of the device is a new user.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, and Bergenstal as applied to claim 1 above, and further in view of Mazlish et al. (U.S. Patent Application Publication No. US 2018/0200436 A1; herein, Mazlish).
Regarding claim 4, in the modified method of Deratany, Deratany does not disclose selecting the basal amount from a default basal amount, wherein the basal amount is a number of units of the liquid drug delivered per a time increment, and the number of units has a range of 1.00 unit to 3.00 units and the time increment has a range from 0.5 hours to 3.00 hours.
However, Michelich teaches selecting the basal amount from a default basal amount (pg. 18 lines 1-2; the low starting basal dose can equate a default basal amount) and the number of units has a range of 1.00 unit to 3.00 units (pg. 12 lines 9-11). Therefore, 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 modified method of Deratany to recognize a default basal dose falling within the specified range as taught by Michelich in order for a device to have a consistent routine in order to not overwhelm users before the device has set adjusted target parameters (pg. 18 lines 16-19).
Further, Mazlish teaches the basal amount is a number of units of the liquid drug delivered per a time increment (paragraph [0134], examples of adjusted baseline basal rates in units of units/hour). Therefore, 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 modified method of Deratany with the specified units of Mazlish, in order to improve the user interface component. Specifying the units of the basal amount allow for users to better understand the amount of liquid drug being used over the predetermined amount of time ([0134]).
The modified Deratany in view of Simpson, Michelich, and Bergenstal, and further in view of Mazlish still does not explicitly disclose the time increment has a range from 0.5 hours to 3.00 hours. Michelich does disclose checking for a “dose event within the past 8 hours” (pg. 21 line 30). This time is based off recommendation from the liquid drug manufacturer, so Michelich also notes checking for dose events “within the immediately preceding 4 hours or less, the immediately preceding 8 hours or less, the immediately preceding 12 hours or less, or the immediately preceding 16 hours or less” (pg. 63 lines 9-11). One of ordinary skill in the art would have had a reasonable expectation of success in modifying the timestamp range of Michelich to fall within the claimed range as the range is provided to keep the user from using more than a prescribed amount of a liquid drug. Therefore, 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 modified method of Deratany by making the range of the time increment between 0.5 hours to 3.00 hours as a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, and Bergenstal as applied to claim 1 above, and further in view of Say et al. (U.S. Patent No. US 6,175,752 B1; herein, Say).
Regarding claim 6, in the modified method of Deratany, Deratany does not disclose the set duration is a period of time over which the number of sensor analyte values that are stored is greater than predetermined number of sensor analyte values. However, Say teaches the set duration is a period of time over which the number of sensor analyte values that are stored is greater than predetermined number of sensor analyte values (col. 39 line 61 – col. 40 line 11, the processing circuit of the analyte monitoring device can determine is the level of an analyte or rate of change exceeds or meets a threshold value). Therefore, 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 modified method of Deratany with the ability of the analyte monitoring device processing circuit of Say to determine when analytes have exceeded or met a threshold value. Adopting this feature improves upon the monitoring and adjustment steps of Deratany to know when to give and stop dosing of a liquid drug (col. 39 lines 53-61).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, and Bergenstal as applied to claim 1 above, and further in view of Steil et al. (U.S. Patent No. 7,354,420 B2; herein, Steil).
Regarding claim 8, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is either a positive set amount or a negative set amount based on a respective sensor analyte value obtained from the number of sensor analyte values and that corresponds to the predetermined time increment. However, Steil teaches the set amount of the liquid drug indicated by modifying the basal amount is either a positive set amount or a negative set amount based on a respective sensor analyte value obtained from the number of sensor analyte values and that corresponds to the predetermined time increment (col. 2 lines 30-35, controller uses a set of controller gains for when glucose concentration is high and a separate set of controller gains when glucose concentration is low). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the modified method of Deratany with the separate sets of controller gains of Steil in order to improve the categorical functionality of the Deratany device when it comes to necessary modification to liquid drug dosing (col. 2 lines 30-53).
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Simpson, Michelich, Bergenstal, and Steil as applied to claim 8 above, and further in view of Desborough (U.S. Patent Application Publication No. US 2021/0030955 A1; herein, Desborough).
Regarding claim 9, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is greater than the high analyte target value. However, Desborough teaches the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is greater than the high analyte target value (paragraph [0097], user can input a fear of hypoglycemia index value to indicate an acceptable threshold of when to deliver insulin, such as how high a user is comfortable with their blood glucose levels being over a threshold). Therefore, 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 modified method of Deratany with the fear of hypoglycemia index of Desborough in order for the Deratany system to have an improved understanding of the high threshold level and the correlation between that and the liquid drug dosing ([0119]).
Regarding claim 10, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is less than the low analyte target value. However, Desborough teaches the set amount of the liquid drug indicated by modifying the basal amount is a negative set amount when the respective sensor analyte value corresponds to the predetermined time increment is less than the low analyte target value (paragraph [0097], user can input a fear of hypoglycemia index value to indicate an acceptable threshold of when to deliver insulin, such as how low a user is comfortable with their blood glucose levels being under a threshold). Therefore, 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 modified method of Deratany with the fear of hypoglycemia index of Desborough in order for the Deratany system to have an improved understanding of the low threshold level and the correlation between that and the liquid drug dosing ([0119]).
Claims 11, 14, 16, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Deratany, and further in view of Simpson, Michelich, Bergenstal, and Cardinali.
Regarding claim 11, Deratany discloses a wearable drug delivery device (FIG. 1, pump 100), comprising:
a processor (FIG. 1, processor 130); and
a memory storing instructions (FIG. 1, memory 140);
adjust a drug delivery algorithm to begin delivery of a basal amount of a liquid drug (paragraph [0032], insulin is gradually introduced…for a determined period of time);
modify the basal amount by a set amount of liquid drug at predetermined time increments after a set duration (FIG. 6, adjustment 600, [0041], monitoring is dynamic, such as done via continuous glucose monitoring (CGM) measurements; FIG. 7, [0046-0047], insulin dosage adjusted based on BG level).
Deratany does not disclose a reservoir that is operable to contain a liquid drug; a pump mechanism fluidly coupled to the reservoir; determine a user is initiating the wearable drug delivery device for an initial use; in response to the initial use, set a high analyte target value and a low analyte target value to clinically validated default values; and after the set duration, readjust the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration.
However, Cardinali teaches a reservoir that is operable to contain a liquid drug (paragraph [0027], reservoir 225); a pump mechanism fluidly coupled to the reservoir (paragraph [0025], medical device (pump) 202). Therefore, 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 device of Deratany to incorporate the reservoir and pump of Cardinali in order to exemplify a device that can output the functions of the Deratany processor and memory ([0030]).
Deratany in view of Cardinali still does not disclose determine a user is initiating the wearable drug delivery device for an initial use; in response to the initial use, set a high analyte target value and a low analyte target value to clinically validated default values; and after the set duration, readjust the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration.
However, Simpson teaches a device that can determine a user is initiating a wearable drug delivery device for initial use (paragraph [0480], When the sensor is first implanted into host tissue, the sensor and receiver are initialized…start-up mode is trigger by the receiver). Therefore, 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 device of Deratany to be able to determine when a user is initializing a device for initial use as taught by Simpson, in order for the device of Deratany to have improved user specific conditions by reducing the amount of manual set up the user has to do when setting up a new device ([0480],[0485]).
Deratany in view of Cardinali and Simpson still does not disclose in response to the initial use, set a high analyte target value and a low analyte target value to clinically validated default values; and after the set duration, readjust the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration.
However, Michelich teaches in response to the initial use, set a high analyte target value and a low analyte target value (Fig. 5B, 320) and after the set duration, readjust the drug delivery algorithm according to respective sensor analyte values of a number of sensor analyte values stored during the set duration (Fig. 5G, 382, after the set duration, in this instance a full day, the device calculates the updated adjustment day dose recommendation based on glucose levels post titration of insulin). Therefore, 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 processor of Deratany to be able to autonomously set high and low target ranges, as well as continuously readjusting the algorithm for drug delivery as taught by Michelich in order to improve the functionality of the device, removing the need for the user to input what they believe the correct information should be, and rather calculating the inputs itself, leading to better care for the user (pg. 60 lines 31-34, pg. 65 lines 5-9).
Deratany in view of Cardinali, Simpson, and Michelich still does not disclose the high and low analyte target values being clinically validated default values. However, Bergenstal teaches the high and low analyte target values being clinically validated default values (pg. 566, A panel of diabetes specialists “selected 70–180 mg/dl as the default target range. While not an ideal or normal glucose range, it represents a target range commonly used in clinical practice and one that promotes realistic and safe expectations.”). Therefore, 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 high analyte target value and low analyte target value as taught by Michelich in the modified method of Deratany in order to have a standardized value range for clinical care, research, and regulatory periods (pg. 566).
Regarding claim 14, in the modified method of Deratany, Deratany discloses the basal amount is modified at the predetermined time increment (FIG. 6, adjustment 600, [0041], monitoring is dynamic, such as done via continuous glucose monitoring (CGM) measurements; FIG. 7, [0046-0047], insulin dosage adjusted based on BG level).
Modified Deratany does not disclose the modification of the basal amount being based on a sensor analyte value received at a time corresponding to the predetermined time increment, and the sensor analyte value is from the number of sensor analyte values. However, Michelich teaches the modification the basal amount being based on a sensor analyte value received at a time corresponding to the predetermined time increment, and the sensor analyte value is from the number of sensor analyte values (pg. 8 lines 30-35, plurality of glucose measurements…taken over a time course). Therefore, 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 modified method of Deratany to require that the basal amount provided by the device is based specifically on the collected sensor analyte values taken over a period of time as taught by Michelich in order to clarify the device uses sensor analyte values to conduct adjustments. Especially in the case of blood sugar, sensor analyte values are the most representative unit of measurement to determine if intervention is necessary for users of monitoring devices (pg. 8 line 20-pg. 9 line 21).
Regarding claim 16, in the modified method of Deratany, Deratany does not disclose the set duration is a period of time selected from: 24 hours, 48 hours, or 72 hours. However, Michelich teaches the set duration is a period of time selected from: 24 hours, 48 hours, or 72 hours (Fig. 5B, 330). Therefore, 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 modified device of Deratany to have a set time period as taught by Michelich in order for the device to have knowledge of a time range in which values collected over can be analyzed. After each set duration can the device then properly output updated adjustments (pg. 61 lines 19-20).
Regarding claim 17 in the modified method of Deratany, Deratany does not discloses the high analyte target value is a first blood glucose measurement value, and the low analyte target value is a second blood glucose measurement value. However, Michelich teaches the high analyte target value is a first blood glucose measurement value, and the low analyte target value is a second blood glucose measurement value (pg. 19 lines 21-24, glucose upper target range level and glucose lower target range level). Therefore, 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 modified method of Deratany to specify the high analyte target value and low analyte target value to be glucose measurements as taught in Michelich in order that the system and device have a threshold to judge the analyte values by to determine if insulin intervention is needed (pg. 8 line 20-pg. 9 line 21).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Cardinali, Simpson, Michelich, and Bergenstal as applied to claim 11 above, and further in view of Tandem.
Regarding claim 12, in the modified method of Deratany, Deratany does not disclose receiving an input from a user input device indicating that the user is a new user. However, Tandem teaches receiving an input from a user input device indicating that the user is a new user (5.2 Creating a New Profile and 5.3 Programming a New Personal Profile). Therefore, 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 modified method of Deratany with the customizable user profiles as taught by Tandem, in order for the Deratany device to specifically know the user of the device is a new user.
Regarding claim 13, in the modified method of Deratany, Deratany does not disclose establishing a wireless communication connection with a controller device; and receiving a signal indicating the user is a new user.
However, Cardinali teaches establishing a wireless communication connection with a controller device (FIG. 2, wireless links 208, 220, 222, 291, 292 and 293). Therefore, 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 modified method of Deratany with the wireless links as taught by Cardinali in order to allow for the not just the sensor, but a controller device to also be wireless ([0030]).
Further, Tandem teaches receiving a signal indicating the user is a new user (5.2 Creating a New Profile and 5.3 Programming a New Personal Profile). Therefore, 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 modified method of Deratany with the customizable user profiles as taught by Tandem, in order for the Deratany device to specifically know the user of the device is a new user.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Cardinali, Simpson, Michelich, and Bergenstal as applied to claim 11 above, and further in view of Say.
Regarding claim 15, in the modified method of Deratany, Deratany does not disclose the set duration is a period of time over which the number of sensor analyte values that are stored is greater than predetermined number of sensor analyte values. However, Say teaches the set duration is a period of time over which the number of sensor analyte values that are stored is greater than predetermined number of sensor analyte values (col. 39 line 61 – col. 40 line 11, the processing circuit of the analyte monitoring device can determine is the level of an analyte or rate of change exceeds or meets a threshold value). Therefore, 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 modified method of Deratany with the ability of the analyte monitoring device processing circuit of Say to determine when analytes have exceeded or met a threshold value. Adopting this feature improves upon the monitoring and adjustment steps of Deratany to know when to give and stop dosing of a liquid drug (col. 39 lines 53-61).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Cardinali, Simpson, Michelich, and Bergenstal as applied to claim 11 above, and further in view of Steil.
Regarding claim 18, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is either a positive set amount or a negative set amount based on a respective sensor analyte value obtained from the number of sensor analyte values and that corresponds to the predetermined time increment. However, Steil teaches the set amount of the liquid drug indicated by modifying the basal amount is either a positive set amount or a negative set amount based on a respective sensor analyte value obtained from the number of sensor analyte values and that corresponds to the predetermined time increment (col. 2 lines 30-35, controller uses a set of controller gains for when glucose concentration is high and a separate set of controller gains when glucose concentration is low). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention modify the modified method of Deratany with the separate sets of controller gains of Steil in order to improve the categorical functionality of the Deratany device when it comes to necessary modification to liquid drug dosing (col. 2 lines 30-53).
Claims 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Deratany in view of Cardinali, Simpson, Michelich, and Bergenstal as applied to claim 11 above, and further in view of Desborough.
Regarding claim 19, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is greater than the high analyte target value. However, Desborough teaches the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is greater than the high analyte target value (paragraph [0097], user can input a fear of hypoglycemia index value to indicate an acceptable threshold of when to deliver insulin, such as how high a user is comfortable with their blood glucose levels being over a threshold). Therefore, 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 modified method of Deratany with the fear of hypoglycemia index of Desborough in order for the Deratany system to have an improved understanding of the high threshold level and the correlation between that and the liquid drug dosing ([0119]).
Regarding claim 20, in the modified method of Deratany, Deratany does not disclose the set amount of the liquid drug indicated by modifying the basal amount is a positive set amount when the respective sensor analyte value corresponds to the predetermined time increment is less than the low analyte target value. However, Desborough teaches the set amount of the liquid drug indicated by modifying the basal amount is a negative set amount when the respective sensor analyte value corresponds to the predetermined time increment is less than the low analyte target value (paragraph [0097], user can input a fear of hypoglycemia index value to indicate an acceptable threshold of when to deliver insulin, such as how low a user is comfortable with their blood glucose levels being under a threshold). Therefore, 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 modified method of Deratany with the fear of hypoglycemia index of Desborough in order for the Deratany system to have an improved understanding of the low threshold level and the correlation between that and the liquid drug dosing ([0119]).
Response to Arguments
Applicant’s arguments, see pages 7-10, and 15 with respect to claims 1 and 11 have been considered but are moot because the arguments do not apply in view of the present rejection. Below responses address arguments still relevant to the new ground of rejection set forth in this action.
Applicant argues on pg. 7-8 of Remarks, regarding claim 1, that “Michelich does not disclose or suggest that these target values are set in response to the initial use of a wearable drug delivery device. Rather, Michelich's target ranges are pre-existing parameters used for evaluating dose guidance requests, not values that are automatically set as a response to device initialization…Moreover, Michelich does not disclose or suggest that the target values are clinically validated default values that are set in response to initial use of a wearable drug delivery device…In contrast, claim 1 enables immediate operation of the wearable drug delivery device upon initial use by automatically setting clinically validated default target values without requiring any historical data collection or user input of target values.” In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, MPEP § 2144 discusses supporting a rejection under 35 U.S.C. 103, with MPEP § 2144(I) specifically noting that the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. The test for obviousness is what the combined teachings of the references would have suggested to a person having ordinary skill in the art. The examiner submits the applicant’s specification did not clearly define “initial use”. “Initial use” could be interpreted to mean first time using the device, use beginning at the start of everyday, or perhaps another possible meaning. Further, although it is understood the device of Michelich uses data from previous days to set target values for subsequent days, it could be understood by a person having ordinary skill in the art that at one point, there was no collected data. Therefore, a high and low target values would have had to be set by either the device or user until collected values were able to recalculate the target values. This argument also applies to the arguments made in Applicant’s Remarks, on pg. 15, regarding claim 11. Therefore, although the rejection of claims 1 and 11 was made moot by the new grounds of rejection made to address the target values being “clinically validated default values”, the use of Michelich still stands in the final rejection.
Applicant argues on pg. 8-9 of Remarks, regarding claim 1, that “Deratany's adjustments are reactive responses to detected changes in blood glucose levels, not modifications occurring at predetermined time increments…These adjustments are event-driven and condition-dependent, not time-based at predetermined increments.” In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Further, MPEP § 2144 discusses supporting a rejection under 35 U.S.C. 103, with MPEP § 2144(I) specifically noting that the rationale to modify or combine the prior art does not have to be expressly stated in the prior art; the rationale may be expressly or impliedly contained in the prior art or it may be reasoned from knowledge generally available to one of ordinary skill in the art, established scientific principles, or legal precedent established by prior case law. The test for obviousness is what the combined teachings of the references would have suggested to a person having ordinary skill in the art. The examiner submits the language of the limitation “predetermined time increments” is broad enough that event-driven adjustments are not excluded. Deratany discusses a relationship between a specific time and insulin dosage (FIG. 3, [0030]-[0032]) and the manner in which the amount of insulin injected is monitored by the user and could be modified ([0038]-[0039]). To a person having ordinary skill in the art, the manner in which insulin is release to a patient as disclosed by Deratany could be considered as occurring over “predetermined time increments”, as continuous glucose monitors, which are used in the pump system of Deratany, monitor over an incremental basis. This argument also applies to the arguments made in Applicant’s Remarks, on pg. 15, regarding claim 11. Therefore, the use of Deratany still stands in the final rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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