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 Objections
Claims 1, 19, and 20 are objected to because of the following informalities:
in claim 1, the phrase "configure the processor" should be "configures the processor" (subject-verb agreement error);
in claim 19, the phrase “set the basal split parameter” should be "setting the basal split parameter"; and,
in claim 20, the phrase “further comprises: obtain" should be "further comprising: obtaining" for grammatical consistency;
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 3, 4, 8, 9, 11, 13, 14, 17, 18, 19, and 20 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.
Claim 3 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly
point out and distinctly claim the subject matter regarded as the invention.
Specifically, the phrase "a basal portion of total daily insulin value" and the phrase "a bolus portion of total daily insulin value" each refer to "total daily insulin value" without the definite article "the." Claim 1, from which claim 3 ultimately depends, introduces the term as "a total daily insulin value," thereby establishing a specific referent. The subsequent use of "total daily insulin value" without the definite article "the" in claim 3 is ambiguous as to whether these phrases refer to the previously introduced "total daily insulin value" of claim 1 or to some other, unspecified total daily insulin value. The claim is therefore indefinite. Applicant is advised to amend the phrases to read "a basal portion of the total daily insulin value" and "a bolus portion of the total daily insulin value" to properly refer to the antecedent basis established in claim 1.
Claim 4 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention.
Specifically, the phrase "a bolus portion of total daily insulin value" refers to "total daily insulin value" without the definite article "the." As noted with respect to claim 3 above, claim 1 introduces" a total daily insulin value" as the relevant referent. The omission of the definite article "the" before "total daily insulin value" in this phrase renders the claim ambiguous.
Applicant is advised to amend the phrase to read "a bolus portion of the total daily insulin
value."
Claim 8 is rejected under 35 U.S.C. § 112(b) as being indefinite for the same reasons set forth above with respect to claim 3.
The phrases "a basal portion of total daily insulin value" and "a bolus portion of total daily insulin value" each omit the definite article "the" before "total daily insulin value," creating an ambiguous reference to the "total daily insulin value" previously introduced in claim 6. Applicant is advised to amend both phrases to include the definite article "the."
Claim 9 is rejected under 35 U.S.C. § 112(b) as being indefinite for the same reasons set forth with respect to claim 4.
The phrase "a bolus portion of total daily insulin value" omits the definite article "the" before "total daily insulin value," creating an ambiguous reference to the antecedent "total daily insulin value" introduced in claim 6. Applicant is advised to amend the phrase to read "a bolus portion of the total daily insulin value."
Claim 11 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly
point out and distinctly claim the subject matter regarded as the invention for the following two reasons.
First, the phrase "the indicated high activity level" uses the definite article "the," which presupposes that "high activity level" has been previously introduced in the claim or in a claim from which claim 11 depends. Claim 11 depends from claim 10, which depends from claim 6. Neither claim 6 nor claim 10 introduces the term "high activity level." The term "high activity level" is introduced in claim 7, but claim 11 does not depend from claim 7. Accordingly, "the indicated high activity level" lacks antecedent basis.
Second, the phrase "the value of the basal split parameter" uses the definite article "the," which presupposes that "a value of the basal split parameter" has been previously introduced in the claim or in a claim from which claim 11 depends. The phrase "a value of the basal split parameter" is introduced in claim 9, which depends from claim 7. Because claim 11 does not depend from claim 9 or claim 7, "the value of the basal split parameter" lacks antecedent basis in the dependency chain of claim 11.
Claim 13 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention.
Specifically, the phrase "the processor" is ambiguous because claim 12, from which claim 13 depends,
introduces two distinct processors: (1) "a processor" referenced in the context of the computer-readable storage medium of claim 6 (incorporated by dependency), and (2) "a processor executing an automated insulin delivery algorithm" as part of the wearable drug delivery device introduced in claim 12. The use of the definite article "the" before "processor" in claim 13 does not distinguish between these two previously introduced processors, rendering the claim indefinite. Applicant is advised to amend the claim to specify which processor is intended, for example by reciting "the processor of the wearable drug delivery device" or "the processor executing the automated insulin delivery algorithm."
Claim 14 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention.
Specifically, the phrase "the data indicative of the glucose level of the user" uses the definite article "the," presupposing that this data has been previously introduced. "Data indicative of glucose levels of the user" is introduced in claim 13. However, claim 14 depends from claim 12, not from claim 13. Accordingly, "the data indicative of the glucose level of the user" lacks antecedent basis in the dependency chain of claim 14. Applicant is advised to amend claim 14 to depend from claim 13, or to introduce the data expressly within claim 14.
Claim 17 is rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter regarded as the invention.
Claim 17 purports to be a method claim, as evidenced by its use of the method claim preamble "The
method of…" and the method step "determining whether…." However, claim 11 is a system claim directed to a computer-readable storage medium (depending from claim 10, which depends from claim 6, an independent system claim). A method claim cannot properly depend from a system claim. As a result of this improper dependency, the phrase "the indicated activity level" in claim 17 lacks antecedent basis within any method claim, because no method claim in the dependency chain introduces "an indicated activity level." Applicant is advised to amend claim 17 to depend from claim 16, the independent method claim, or from another method claim that properly introduces the relevant terms.
Claim 18 is rejected under 35 U.S.C. § 112(b) as being indefinite for the following reasons.
First, claim 18 purports to be a method claim but depends from claim 12, which is a system claim. This improper dependency means that the method steps of claim 18 lack a proper method claim antecedent. Applicant is advised to amend the dependency to a method claim, such as claim 16 or claim 17.
Second, as a consequence of the improper dependency, the phrase "the standard activity level" lacks antecedent basis. The term "standard activity level" is introduced in claim 7 (a system claim depending from claim 6). No method claims in the dependency chain of claim 18 introduces "a standard activity level."
Third, the phrases "a basal portion of total daily insulin value" and "a bolus portion of total daily insulin value" each omit the definite article "the" before "total daily insulin value," creating an ambiguous reference, as set forth above with respect to claims 3 and 8. Applicant is advised to amend both phrases to include the definite article "the."
Claim 19 is rejected under 35 U.S.C. § 112(b) as being indefinite for the following reasons.
First, claim 19 purports to be a method claim but depends from claim 12, which is a system claim. This improper dependency means that the method steps of claim 19 lack a proper method claim antecedent. Applicant is advised to amend the dependency to a method claim, such as claim 16 or claim 17.
Second, as a consequence of the improper dependency, the phrase "the high activity level" lacks antecedent basis. The term "high activity level" is introduced in claim 7 (a system claim). No method claim in the dependency chain of claim 19 introduces "a high activity level."
Third, the phrase "a bolus portion of total daily insulin value" omits the definite article "the" before "total daily insulin value," creating an ambiguous reference, as set forth above with respect to claims 4 and 9. Applicant is advised to amend the phrase to read "a bolus portion of the total daily insulin value."
Claim 20 is rejected under 35 U.S.C. § 112(b) as being indefinite for the following reasons.
First, claim 20 purports to be a method claim but depends from claim 14, which is a system claim (depending from claim 12, which depends from claim 6). This improper dependency means that the method steps of claim 20 lack a proper method claim antecedent. Applicant is advised to amend the dependency to a method claim.
Second, as a consequence of the improper dependency, the phrase "the indicated high activity level" lacks antecedent basis. The term "high activity level" is not introduced in any method claim in the dependency chain of claim 20 (claims 6 → 12 → 14).
Third, the phrase "the value of the basal split parameter" lacks antecedent basis. The phrase "a value of the basal split parameter" is not introduced in any claim within the dependency chain of claim 20 (claims 6 → 12 → 14). The phrase appears in claim 9 (a system claim depending from claim 7) and in claim 11 (a system claim depending from claim 10), neither of which is in the dependency chain of claim 20.
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 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over LI et al. (US 20210308377A1; hereinafter “Lee”) in view of O’Connor et al. (CA3112209C; hereinafter “O’Connor”).
Claim 1 discloses a controller comprising a processor; and a memory storing programming code that, when executed by the processor, configures the processor to:
(i) receive via a graphical user interface an input indicating an activity level of a user;
(ii) in response to the indicated activity level, set a basal split parameter used in a total daily insulin formula;
(iii) determine a total daily insulin value of the user using the total daily insulin formula;
(iv) determine a basal total daily insulin to be provided to the user; and
(v) calculate basal insulin dosages based on the determined basal total daily insulin.
In relation to independent claim 1, Lee discloses a controller comprising a processor and a
memory storing programming code (the AP application/AID algorithm) (see Lee, paragraphs [0004], [0005], and [0030]). Lee discloses that the programming code, when executed by the processor, configures the processor to:
(iii) determine a TDI value of the user using a TDI formula (TDI = adjusted TDI factor × weight) (see Lee; paragraphs [0020] [0023]);
(iv) determine a basal TDI … “[t]he center cost function curve (labeled 420) is the BGI basal cost function that may represent the cost of basal insulin doses and be based on a mean value of HGBI or LGBI. From the curve 420 and table (middle) row 421, the BGI basal cost function has a minimum cost at approximately 12.52, which corresponds to an approximate 50% TDI reduction portion”) (see Lee; paragraph [0028]); and
(v) calculate basal insulin dosages … “may represent the cost of basal insulin doses” (see Lee; paragraph [0028]).
Lee does not explicitly teach:
(i) receiving an input specifically indicating an “activity level” as a generalized parameter used to set a basal split parameter, and
(ii) setting a “basal split parameter” in the TDI formula based on that activity level input.
Lee discloses receiving “level of physical fitness” as an optional input (paragraph [0022]), but does not expressly disclose setting a “basal split parameter” based on this input.
O’Connor provides the missing teachings:
(i) receiving an input specifically indicating an “activity level” as a generalized parameter used to set a basal split parameter.
O’Connor discloses receiving a user input indicating an activity level via the user interface (selecting the activity mode of operation). O’Connor explicitly discloses in paragraph [0068] states:
“[t]he activity mode component 412 may provide additional inputs, add weightings to parameters (e.g., weightings to the calculation of total daily insulin (TDI), the basal dosages of a user, bolus dosages, or the like) used in the calculations of the doses of insulin to be delivered to the user.”
(ii) setting a “basal split parameter” in the TDI formula based on that activity level input.
O’Connor discloses in paragraph [0073] the step of setting a “basal split parameter”:
“a conservative mode of operation may include use of a setpoint equal to approximately 120 to 150 mg/dL, setting a maximum insulin delivery equal to approximately 1 to 3 times the user’s basal rate, and setting the input basal to the AP algorithm equal to approximately 50% to 90% of the user’s entered basal rate.”
Accordingly, it would have been obvious to one of ordinary skill in the art to modify Lee’s system to receive a user input specifically indicating an “activity level” and to use that activity level input to set a basal split parameter in the TDI formula, as taught by O’Connor, because: (1) Lee expressly discloses receiving “level of physical fitness” as an optional GUI input (see Lee; paragraph [0022]), which is the functional equivalent of an “activity level” input; (2) O’Connor expressly teaches that the activity mode adjusts TDI and basal dosage parameters based on the activity level (see O’Connor; paragraph [0068]); and (3) the combination would have yielded predictable results — a more personalized TDI initialization that accounts for the user’s activity level.
In relation to independent claim 6, this independent claim recites a system comprising a non-transitory computer readable storage medium including instructions that, when executed by a processor, cause the processor to perform the same functional steps as claim 1, steps (i) to (v). The analysis provided above for claim 1 applies equally to claim 6: therefore, as concluded above, it would have been obvious to one of ordinary skill in the art to modify Lee’s system to receive a user input specifically indicating an “activity level” and to use that activity level input to set a basal split parameter in the TDI formula, as taught by O’Connor, because: (1) Lee expressly discloses receiving “level of physical fitness” as an optional GUI input (see Lee; paragraph [0022]), which is the functional equivalent of an “activity level” input; (2) O’Connor expressly teaches that the activity mode adjusts TDI and basal dosage parameters based on the activity level (see O’Connor; paragraph [0068]); and (3) the combination would have yielded predictable results — a more personalized TDI initialization that accounts for the user’s activity level.
In relation to independent claim 16, this independent claim discloses a method claim that recites steps [steps (i) to (v)] corresponding to the functions performed by the controller of claim 1 and the system of claim 6. The analysis provided above for claims 1 and 6 applies equally to claim 16: therefore, as concluded above, it would have been obvious to one of ordinary skill in the art to modify Lee’s system to receive a user input specifically indicating an “activity level” and to use that activity level input to set a basal split parameter in the TDI formula, as taught by O’Connor, because: (1) Lee expressly discloses receiving “level of physical fitness” as an optional GUI input (see Lee; paragraph [0022]), which is the functional equivalent of an “activity level” input; (2) O’Connor expressly teaches that the activity mode adjusts TDI and basal dosage parameters based on the activity level (see O’Connor; paragraph [0068]); and (3) the combination would have yielded predictable results — a more personalized TDI initialization that accounts for the user’s activity level.
In relation to claim 2, this claim adds the limitation: “wherein the processor is further
configured to determine whether the indicated activity level is a standard activity level
or a high activity level.”
In the combination of Lee in view of O’Connor, the O’Connor reference discloses that the activity mode has multiple settings of varying degrees of conservativeness or aggressiveness. Paragraph [0072] states:
“multiple settings of the activity mode (or any additional or sub-mode thereof) may be available to set operation to different degrees of conservativeness or aggressiveness.”
O’Connor further discloses a conservative (standard) mode and an aggressive (high activity) mode as two distinct activity level settings (see O’Connor; paragraphs [0073], [0087]. Accordingly, it would have been obvious to one of ordinary skill in the art to implement the activity level determination as a binary choice between “standard” and “high” activity levels, as this is a straightforward simplification of O’Connor’s multilevel activity mode system.
In relation to claim 3, this claim adds the limitation: “wherein, in response to the indicated activity level being the standard activity level, the processor sets the basal split parameter to be even, wherein the basal split parameter is set to a value that causes a basal portion of total daily insulin value and a bolus portion of total daily insulin value to be equal.”
In the combination of Lee in view of O’Connor, the Lee reference discloses that the TDI calculation uses a 50% reduction proportion, which corresponds to a 50⁄50 basal/bolus split. In paragraph [0028], Lee states:
“the TDI reduction proportion X may be selected to be approximately 50% … the BGI basal cost function … has a minimum cost at approximately 12.52, which corresponds to an approximate 50% TDI reduction portion.”
In paragraph [0040], Lee states:
“X can be defined as 50%, which may be determined based on a minimum value obtained from one or more cost functions.”
Moreover, O’Connor discloses that during standard (conservative) activity mode, the input basal to the AP algorithm is set to approximately 50% to 90% of the user’s entered basal rate, which corresponds to an even or near-even basal split (see O’Connor; paragraphs [0073], [0087]). Accordingly, it would have been obvious to one of ordinary skill in the art to set the basal split parameter to 50% (even split) for standard activity, as this is consistent with the 50% TDI reduction proportion disclosed in Lee and the conservative activity mode parameters disclosed in O’Connor.
In relation to claim 4, this claim adds the limitation: “wherein, in response to the indicated activity level being the high activity level, the processor sets the basal split parameter to be uneven, wherein a value of the basal split parameter causes a basal portion of the total daily insulin value to be less than a bolus portion of total daily insulin value.”
In the combination of Lee in view of O’Connor, the O’Connor reference discloses that during high activity (aggressive) mode, the AP application reduces the maximum insulin delivery limit and adjusts the basal delivery parameters to prevent hypoglycemia. Paragraph [0073] states:
“a conservative mode of operation may include use of a setpoint equal to approximately 120 to 150 mg/dL, setting a maximum insulin delivery equal to approximately 1 to 3 times the user’s basal rate, and setting the input basal to the AP algorithm equal to approximately 50% to 90% of the user’s entered basal rate.”
O’Connor further discloses that during high activity, the system may reduce the basal delivery (hypoglycemia protect mode), which corresponds to an uneven basal split with the basal portion being less than the bolus portion (see O’Connor; paragraphs [0095]–[0098]). Accordingly, it would have been obvious to one of ordinary skill in the art to set the basal split parameter to less than 50% (uneven split with basal < bolus) for high activity levels, as this is consistent with O’Connor’s teaching that high activity requires reduced basal delivery to prevent hypoglycemia. The specific value of 40% basal split for high activity represents an obvious design choice within the skill of a practitioner in the field. Therefore, claim 4 is unpatentable over Lee in view of O’Connor.
In relation to claim 5, this claim adds the limitations: “further comprising an accelerometer operable to provide an indication of activity of the user, wherein the processor is configured to: access the accelerometer; and in response to a detection of inactivity, generate an alert on the graphical user interface that the value of the basal split parameter is set to be uneven.”
In the combination of Lee in view of O’Connor, the O’Connor reference discloses that the wearable drug delivery device includes an IMU comprising an accelerometer (accelerometer 304) operable to detect an activity level of the user.
Paragraph [0062] states:
“[t]he IMU 302 may combine the features and capabilities of the accelerometer 304, the magnetometer 306, and the gyroscope 308 for detecting various operational parameters of the wearable drug delivery device.”
Paragraph [0063] states:
“the IMU 302 may detect a motion, a movement, or a position of a device in which it is incorporated.”
O’Connor discloses that the controller accesses the accelerometer to obtain motion data and that the AP application may generate an alert via the user interface when activity levels change, including when the user is in a location associated with increased activity but has not entered the activity mode. O’Connor, claims 7 and 14, recite “generate an alert via a user interface requesting an input to initiate the activity mode.” Accordingly, it would have been obvious to one of ordinary skill in the art to generate an alert on the GUI when the accelerometer detects inactivity while the basal split parameter is set to an uneven value (for high activity), as this would inform the user that the system is still operating in high-activity mode despite the user being inactive — a straightforward application of O’Connor’s alert generation teaching. Therefore, claim 5 is unpatentable over Lee in view of O’Connor.
In relation to claim 7, this claim adds the limitation: “wherein the processor is further configured to determine whether the indicated activity level is a standard activity level or a high activity level.” This limitation is identical to the limitation of claim 2. The analysis provided above for claim 2 applies equally to claim 7. Therefore, claim 7 is unpatentable over Lee in view of O’Connor for the same reasons as claim 2.
In relation to claim 8, this claim adds the limitation: “wherein, in response to the indicated activity level being the standard activity level, the processor sets the basal split parameter to be even, wherein the basal split parameter is set to a value that causes a basal portion of total daily insulin value and a bolus portion of total daily insulin value to be equal.” This limitation is identical to the limitation of claim 3. The analysis provided above for claim 3 applies equally to claim 8. Therefore, claim 8 is unpatentable over Lee in view of O’Connor for the same reasons as claim 3.
In relation to claim 9, this claim adds the limitation: “wherein, in response to the indicated activity level being the high activity level, the processor sets the basal split parameter to be uneven, wherein a value of the basal split parameter causes a basal portion of the total daily insulin value to be less than a bolus portion of total daily insulin value.” This limitation is identical to the limitation of claim 4. The analysis provided above for claim 4 applies equally to claim 9. Therefore, claim 9 is unpatentable over Lee in view of O’Connor for the same reasons as claim 4.
In relation to claim 10, this claim adds the limitation: “further comprising an accelerometer accessible by the processor [controller].”
In the combination of Lee in view of O’Connor, the O’Connor reference shows in figures 2 and 3, a wearable drug delivery device with an IMU comprising an accelerometer (accelerometer 304; figures 2 and 3). Paragraph [0027] discloses: “the controller 221 may be operable to receive data or information indicative of the activity of the user from the IMU 207, as well as from any other sensors (such as those (e.g., accelerometer, location services application or the like) on the management device 206 or CGM 204) of the drug delivery device 202 or any sensor coupled thereto, such as a global positioning system (GPS)-enabled device or the like.” Accordingly, it would have been obvious to one of ordinary skill in the art to incorporate an accelerometer into Lee’s system, as taught by O’Connor, to enable activity level detection. This is a straightforward combination of known elements yielding predictable results. Therefore, claim 10 is unpatentable over Lee in view of O’Connor.
In relation to claim 11, this claim adds the limitations: “wherein the processor is configured to: access the accelerometer to obtain an indication of activity of the user; and in response to a detection of inactivity less than the indicated high activity level, generate an alert on the graphical user interface that the value of the basal split parameter is set to be uneven.”
The analysis provided above for claim 5 applies equally to claim 11. In the combination of Lee in view of O’Connor, the O’Connor reference discloses that the wearable drug delivery device includes an IMU comprising an accelerometer (accelerometer 304) operable to detect an activity level of the user.
Paragraph [0062] states:
“[t]he IMU 302 may combine the features and capabilities of the accelerometer 304, the magnetometer 306, and the gyroscope 308 for detecting various operational parameters of the wearable drug delivery device.”
Paragraph [0063] states:
“the IMU 302 may detect a motion, a movement, or a position of a device in which it is incorporated.”
O’Connor discloses that the controller accesses the accelerometer to obtain motion data and that the AP application may generate an alert via the user interface when activity levels change, including when the user is in a location associated with increased activity but has not entered the activity mode. O’Connor, claims 7 and 14, recite “generate an alert via a user interface requesting an input to initiate the activity mode.” Accordingly, it would have been obvious to one of ordinary skill in the art to generate an alert on the GUI when the accelerometer detects inactivity while the basal split parameter is set to an uneven value (for high activity), as this would inform the user that the system is still operating in high-activity mode despite the user being inactive — a straightforward application of O’Connor’s alert generation teaching. Therefore, claim 11 is unpatentable over Lee in view of O’Connor for the same reasons as claim 5.
In relation to claim 12, this claim adds the limitations: “further comprising a wearable
drug delivery device having: a reservoir storing insulin; and a processor executing an automated insulin delivery algorithm, wherein the processor of the wearable drug delivery device is operable to output an amount of insulin of the calculated basal insulin dosages from the reservoir.”
Lee discloses a drug delivery system (drug delivery system 300) comprising a medical device (wearable drug delivery device 302) having a reservoir (325), a pump mechanism (324), and a controller (321) executing an AP application (329) (automated insulin delivery algorithm).
Paragraph [0061] states:
“a wearable drug delivery device, a ‘pod,’ such as an OmniPod® provided by Insulet Corp.”
Paragraph [0064] states:
“the medical device 302 may be attached to the body of a user … and may deliver any therapeutic agent, including any drug or medicine, such as insulin … to the user. The medical device 302 may, for example, be a wearable device worn by the user.”
Paragraph [0066] states:
“the medical device 302 may include a reservoir 325 for storing the drug (such as insulin) … and a pump mechanism (mech.) 324, or other drive mechanism, for transferring the drug from the reservoir 325, through a needle or cannula (not shown), and into the user.”
Paragraph [0068] states:
“the controller 321 may execute a control algorithm, such as the artificial pancreas application 329.”
Since the enhancements disclosed in this claim were well-known in the art, their application in the invention would have been considered obvious alternatives in the design of the system.
In relation to claim 13, this claim adds the limitations: “further comprising an analyte sensor operable to detect levels of one or more analytes, wherein the analyte sensor is operable to provide the processor with data indicative of glucose levels of the user.”
In the combination of Lee in view of O’Connor, the Lee reference discloses a continuous glucose monitor (CGM/sensor 304) that detects glucose levels and provides blood glucose measurement values to the processor. Paragraph [0067] states:
“[t]he blood glucose sensor 304 may be a device communicatively coupled to the PDM processor 361 or controller 321 and may be operable to measure a blood glucose value at a predetermined time interval, such as every 5 minutes, or the like.”
Since the enhancements disclosed in this claim were well-known in the art, their application in the
invention would have been considered obvious alternatives in the design of the system.
In relation to claim 14, this claim adds the limitations: “wherein the computer readable
storage medium further includes instructions that, when executed by the processor, further cause the processor to: receive the data indicative of the glucose level of the user; and adjust drug delivery operations of the wearable drug delivery device based on the data indicative of the glucose level of the user and the calculated basal insulin dosages.”
In the combination of Lee in view of O’Connor, the Lee reference discloses that the processor receives blood glucose measurement values from the CGM and adjusts the TDI dosage (and thus the drug delivery operations) based on the blood glucose data. Paragraph [0078] states:
“[t]he information or data provided by the sensor 304 may be used to adjust drug delivery operations of the medical device 302.”
Paragraph [0081] states:
“[t]he AP application may determine an appropriate delivery of insulin based on glucose level monitoring of the user through the sensor 304.”
Since the enhancements disclosed in this claim were well-known in the art, their application in the
invention would have been considered obvious alternatives in the design of the system.
In relation to claim 15, this claim adds the limitations: “further comprising a user interface coupled to the processor, wherein the processor is operable to present the graphical user interface on the user interface.”
In the combination of Lee in view of O’Connor, the Lee reference discloses that the personal diabetes management device (PDM) 306 includes a user interface 378 (e.g., a touchscreen display) on which the graphical user interface is presented. Paragraph [0080] states:
“the medical device 302 and/or the personal diabetes management device 306 may include a user interface 327, 378 and 368, respectively, such as a keypad, a touchscreen display, levers, buttons, a microphone, a speaker, a light, a display, or the like … the user interface devices may present graphical user interfaces that guide a user, for example, through the presentation of prompts, to input information or provide data to the user as well as other functions.”
Since the enhancements disclosed in this claim were well-known in the art, their application in the
invention would have been considered obvious alternatives in the design of the system.
In relation to claims 17, 18, 19, and 20, these claims are method claims corresponding to the
apparatus of claims 2, 3, 4, and 5, respectively. The analysis provided above for claims 1–5 applies equally to the corresponding method claims 17–20. The method steps recited in claims 17–20 are the natural and obvious implementation of the apparatus and system disclosed in Lee and O’Connor.
Therefore, claims 17, 18, 19, and 20 are unpatentable over Lee in view of O’Connor for the same reasons as claims 2, 3, 4, and 5, respectively.
Conclusion
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Respectfully submitted,
/MANUEL A MENDEZ/ Primary Examiner, Art Unit 3783