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
This office action is responsive to the amendment filed on 12/29/2025. As directed by the amendment: claims 1, 11, and 17-18 have been amended, no claims have been cancelled, and claims 20-21 have been added. Thus, claims 1-21 are presently pending in this application, with no claims being withdrawn from consideration. Applicant’s amendments to the claims have overcome each and every objection and 112(b) rejection set forth in the Non-Final Rejection mailed on 08/27/2025. The 112(f) interpretations are maintained.
Response to Arguments
Applicant' s arguments, see “Remarks”, filed 12/29/2025, with respect to the rejection(s) of claim(s) 1 and 17 under 103 have been fully considered and are persuasive, specifically in regards to Castellano in view of Mazlish not teaching or disclosing the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments.
Claim Objections
Claims 20- 21 are objected to because of the following informalities:
Regarding claim 20, the phrase “the insulin delivery device” should read “the hand-operable insulin deliver device” for proper antecedent basis,
Regarding claim 21, the phrase “and compries an analog mechanism” in line 8 should read “and comprises an analog mechanism” for proper grammar,
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“an adjuster” in claims 1 and 21,
“a dose converter” in claims 1, 17, and 21,
“a remote mobile device” in claims 7, 13, and 15,
“an adjusting unit” in claim 17
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
Regarding “an adjuster” in claims 1 and 21 and “an adjusting unit in claim 17, 112(f) is invoked because: (i) they use a generic placeholder (adjuster, adjusting unit), (ii) they are coupled with functional language (configured to manually preset an insulin dose, adjusting), and (iii) they are not associated with structure in the claims, respectively. Examiner notes the specification equates the “adjusting unit 14” with “adjuster 14.” The specification is referenced for the corresponding structure. Para. 0036 states that the adjusting unit 14 comprises a manually rotatable dial 30 for a user to preset an insulin dosage, wherein the dial 30 is formed as a dose knob which can be turned forward or backward to increase or decrease the insulin dose. Examiner will be interpreting these limitations as this structure and equivalents thereof.
Regarding “a dose converter” in claims 1, 17, and 21, 112(f) is invoked because: (i) it uses a generic placeholder (converter), (ii) it is coupled with functional language (configured to receive… and to provide), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0011 discloses the dose converter is formed by a digital processor adapted to solve insulin to carbohydrate transformations or an analog mechanism may be used as a calculator. Examiner is interpreting the limitation as these structures discussed above and equivalents thereof.
Regarding “a remote mobile device” in claims 7, 13, and 15, 112(f) is invoked because: (i) it uses a generic placeholder (device), (ii) it is coupled with functional language (adapted to wirelessly communicate), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0041 discloses the remote mobile device may be a smartphone, smart watch, or fitness tracker. Examiner is interpreting the limitation as these structures discussed above and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 278
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) 1, 3-7, 9, 12, and 16-18 are rejected under 35 U.S.C. 103 as being unpatentable over Castellano et al. (U.S Patent No. 5536249, “Castellano” in view of Jorgensen et al. (U.S Patent Pub. No. 20110270214 A1, “Jorgensen”) in view of Mazlish et al. (U.S Patent Pub. No. 20170199985 A1, “Mazlish”).
Regarding claim 1, Castellano discloses the limitations of (Claim 1) an insulin delivery arrangement, comprising: a hand-operable insulin delivery device (10 in at least Fig. 1-4) having an adjuster (12) configured to manually preset an insulin dose and an applicator (combined structure of 22 and 28) which can be triggered to deliver the insulin dose to a user (see Fig. 1 and 2-3 and Col.7, lines 15-18 for adjuster, see Col.11, lines 17-20, examiner notes the adjuster is being interpreted under 112(f) as a stepwise rotatable dial, dose knob, or equivalents thereof and as such the actuator knob 12 is interpreted as the adjuster); a dose converter (32) configured to receive the insulin dose as an input (see Fig. 4 and Col.7, lines 57-67, examiner notes the dose converter is interpreted under 112(f) as a digital processor, analog mechanism, or equivalents thereof and as such the microprocessor is interpreted as the dose converter); a display (34) configured to display the value to the user, the display (34) being disposed on the hand-operable insulin delivery device (10, see Fig. 1 and Col.7, lines 14-16, Col.9, lines 25-37); and when the adjuster (12) is used to change the insulin dose before triggering the applicator (combined structure of 22 and 28) to deliver the insulin dose, the value displayed by the display (34) is simultaneously changed (see Col.9, lines 10-15).
However, Castellano fails to disclose (Claim 1) a dose counter coupled with the adjuster and displaying the insulin dose, the dose counter being disposed on the hand-operable insulin delivery device; a dose converter configured to receive the insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose, and a display configured to display the carbohydrate value to the user, the carbohydrate value displayed by the display is simultaneously changed.
Jorgensen discloses an insulin injection pen (100 in Fig. 1-2A) comprising a dose counter (205 in Fig. 1) coupled with the adjuster (260 in Fig. 1) and displaying the insulin dose (examiner notes the adjuster is being interpreted under 112(f) as a stepwise rotatable dial, dose knob, or equivalents thereof and as such the user actuatable dosage selector 260 is interpreted as the adjuster, see para. 0093 – dose selector 260 is coupled to a dose scale which is coupled to display window 205 for displaying the insulin dose), the dose counter (205) being disposed on the hand-operable insulin delivery device (100, see Fig. 1); and a display (275 in Fig. 1-3) being disposed on the hand-operable insulin delivery device (100, see Fig. 1-3 and para. 0094 – pen 100 additionally comprises a digital display 275 on its proximal end).
Since Castellano discloses an insulin injection pen with a manually operated actuator knob and comprises a digital display, and Jorgensen discloses an insulin injection pen with a manually operated rotatable dose member and comprising both a dose counter and a digital display, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to additionally incorporate a dose counter alongside its digital display as taught by Jorgensen. Jorgensen teaches that such a modification is motivated as the dose counter is able to display selected dosage sizes while the digital display is utilized to also display dosage sizes alongside more in-depth injection information such as elapsed times from previous injection (see para. 0094). Thus in combination, the arrangement of Castellano will be modified to have a dose counter as taught by Jorgensen alongside the digital display (34) of Castellano.
Mazlish discloses a user interface for diabetes management, wherein Mazlish teaches a mobile computing device (60 in Fig. 1) is configured to receive an insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose (see para. 0056). The mobile computing device (60) includes a display configured to display the carbohydrate value to the user (see Fig. 4G and para. 0056).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to include Mazlish’s conversion algorithm, either directly in the pen-type injector of Castellano or by including it in a separate device as in Mazlish, and subsequent simultaneous display of carbohydrates. Such a combination is motivated as it provides for simple and proper glycemic control (Mazlish [0010]), reduces cognitive burden on users with more options (Mazlish [0011]), and allows for different users to use the bolus calculator as some users may think about meals in terms of the number of carbohydrates consumed while others think about meals in terms of units of insulin needed for the meal (Mazlish [0052]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding programming to convert and display carbohydrates.
In combination, modified Castellano discloses the display (34) and the dose converter (32) wherein the display (34) simultaneously changes as the dialed value changes (see Col.9, lines 10-15) which is modified by Mazlish such that the dose converter comprises the conversion algorithm of Mazlish. As such, Castellano would be modified to have the dose converter (32) receive the insulin dose as an input and to provide the carbohydrate as an output and simultaneously display said output carbohydrates on display (34).
Regarding claim 3, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Castellano discloses (Claim 3) wherein the display (34) comprises a digital screen (see Col.7, lines 48-50).
Regarding claim 4, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Castellano discloses the limitations of (Claim 4) wherein the adjuster (12) includes a stepwise rotatable dial (see Col.7, lines 52-60), and the value is changed on the display (34) synchronously to a rotation of the stepwise rotatable dial (see Col.9, lines 10-15).
In modified Castellano, Mazlish discloses a mobile computing device (60 in Fig. 1) is configured to receive an insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose wherein the carbohydrate value is displayed on said device (60) comprising the conversion algorithm (see Fig. 4G and para. 0056).
Therefore, in combination, the device (10) of Castellano would be modified such that instead of display (34) synchronously changing an insulin dose due to the rotation of the stepwise rotatable dial (12), the display (24) synchronously changes a carbohydrate dose as taught by Mazlish.
Regarding claim 5, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Castellano discloses (Claim 5) wherein the hand-operable insulin delivery device (10) comprises an insulin injection pen and the dose converter (32) is part of the insulin injection pen (see Fig. 1 and Col.6, lines 39 for pen, see Col.7, lines 14-15 and first modification option – “directly in the pen-type injector 10 of Castellano” – in the rejection of claim 1).
Regarding claim 6, modified Castellano discloses the insulin delivery arrangement of claim 5, as discussed above. In modified Castellano, Castellano discloses (Claim 6) wherein the display (34) is arranged on a surface of the insulin injection pen (see Fig. 1 and Col.7, lines 14-15).
Regarding claim 7, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Castellano discloses the limitations of (Claim 7) further comprising a remote mobile device arranged separate from the hand-operable insulin delivery device (10) and adapted to communicate with the hand-operable insulin delivery device (10, see Col.9, lines 38-45, examiner notes the remote mobile device is being interpreted under 112(f) as a smart phone, smart watch, fitness tracker and equivalents thereof wherein an external computer is interpreted as an equivalent).
However, modified Castellano fails to disclose the limitation of (Claim 7) the remote mobile device adapted to wirelessly communicate with the hand-operable delivery device. Examiner notes Castellano discloses the data I/O port (46) configured to allow a user to download information into an external computer (see Col.9, lines 38-40), and further that a glucose monitor (300) may have an I/O port 320 that can wirelessly communicate with the pen-injector 10 using infrared technology (see Col.14, lines 1-4).
Mazlish teaches (Claim 7) the remote mobile device (60) adapted to wirelessly communicate with the hand-operable insulin device (15, see para. 0037 and 0039 for smartphone or tablet device 60, examiner notes the remote mobile device is being interpreted under 112(f) as a smart phone, smart watch, fitness tracker and equivalents thereof wherein the mobile computing device 60 may be a smartphone or tablet device).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Castellano to replace Castellano’s external computer with the remote mobile device in wireless communication with the pen-type injector as taught by Mazlish. Such a modification is motivated by a desire to avoid attracting unwanted attention while inputting or accessing diabetes-related health data and providing a simpler form of data transmission than a wired connection. Moreover, smart phones typically have more robust graphical displays, which can improve the user experience (Mazlish [0039]).
Regarding claim 9, modified Castellano discloses the insulin delivery arrangement of claim 7, as discussed above. In modified Castellano, Mazlish discloses (Claim 9) wherein the remote mobile device (60) comprises a smart phone and/or a smart watch (see para. 0039).
Regarding claim 12, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. Modified Castellano fails to disclose (Claim 12) further comprising a continuous monitoring glucose meter configured to provide a glucose measurement value to the dose converter. Examiner notes Castellano discloses the arrangement comprising a blood glucose monitor but it is not a continuous glucose monitor.
Mazlish teaches (Claim 12) further comprising a continuous monitoring glucose meter (50) configured to provide a glucose measurement value to the dose converter (see para. 0036 and 0052-0053 – the bolus calculator of the remote computing device 60 utilizes current glucose values communicated from the continuous glucose monitor 50).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to include Mazlish’s continuous glucose monitor in addition to the glucose monitor (300) of Castellano and which is in communication with the dose converter as in Mazlish. Examiner notes Mazlish discloses the presence of both a continuous glucose monitor (50) and a blood glucose meter (70, see para. 0071). Such a combination is motivated as it provides a user a more comprehensive view of current glucose levels. Further, communicating the glucose measurements to the dose converter allows enhanced user education on the amount of adjustment that the data management system is making to the user’s regimen, and the adjustment is personalized as its based upon the user’s current glucose values (see para. 0053).
Regarding claim 16, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Mazlish discloses (Claim 16) wherein the dose converter has a routine to determine the carbohydrate value based on the preset value for the insulin dose and at least one of a measured insulin to carbohydrate ratio (see para. 0053 and 0056 – the conversion of carbs to units of insulin in the bolus calculator is based on the user’s carbohydrate to insulin ratio and thus when carbs control is selected the conversion would be inverted).
Regarding claim 17, Castellano discloses the limitations of (Claim 17) a method for dosing adjustment of an insulin delivery arrangement, comprising: presetting an insulin dose in a hand-operable insulin delivery device (10 in at least Fig. 1-4) by user manipulation of an adjusting unit (12) (see Fig. 1 and Col.7, lines 15-18 and Col.9, lines 10-12, examiner notes the adjusting unit is being interpreted under 112(f) as a stepwise rotatable dial, dose knob, or equivalents thereof and as such the actuator knob 12 is interpreted as the adjusting unit); automatically providing the insulin dose as an input to a dose converter (32) without additional user interaction (see Fig. 4 and Col.7, lines 57-67 and Col.9, lines 11-14, examiner notes the dose converter is interpreted under 112(f) as a digital processor, analog mechanism, or equivalents thereof and as such the microprocessor is interpreted as the dose converter); receiving, as an output from the dose converter (32), a value (see Col.7, lines 57-67 and Col.9, lines 11-14); displaying the value corresponding to the insulin dose on a display (34) such that, when the adjusting unit (12) is used to change the insulin dose before delivering the insulin dose, the value being displayed is simultaneously changed (see Col.9, lines 10-15) and wherein the display (34) is disposed on the hand-operable insulin delivery device (10, see Fig. 1 and Col.7, lines 14-16, Col.9, lines 25-37).
However, Castellano fails to disclose (Claim 17) displaying the insulin dose with a dose counter that is disposed on the hand-operable insulin delivery device; receiving as an output from the dose converter a carbohydrate value equivalent to an amount of meal carbohydrates, and displaying the carbohydrate value to the user, the carbohydrate value being displayed is simultaneously changed.
Jorgensen discloses an insulin injection pen (100 in Fig. 1-2A) operated with a method comprising (Claim 17) displaying the insulin dose with a dose counter (205 in Fig. 1) that is disposed on the hand-operable insulin delivery device (100, see para. 0093 – a dose scale is coupled to display window 205 for displaying the insulin dose).
Since Castellano discloses an insulin injection pen with a manually operated actuator knob and comprises a digital display, and Jorgensen discloses an insulin injection pen with a manually operated rotatable dose member and comprising both a dose counter and a digital display, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to additionally incorporate a dose counter alongside its digital display as taught by Jorgensen. Jorgensen teaches that such a modification is motivated as the dose counter is able to display selected dosage sizes while the digital display is utilized to also display dosage sizes alongside more in-depth injection information such as elapsed times from previous injection (see para. 0094). Thus in combination, the arrangement of Castellano will be modified to have a dose counter as taught by Jorgensen alongside the digital display (34) of Castellano.
Mazlish discloses a user interface for diabetes management, wherein Mazlish teaches a method for dosing adjustment of an insulin delivery arrangement comprising a mobile computing device (60 in Fig. 1) configured to receive an insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose (see para. 0056). The mobile computing device (60) includes a display configured to display the carbohydrate value to the user dynamically (see Fig. 4G and para. 0056).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s method to include Mazlish’s conversion algorithm, either directly in the pen-type injector of Castellano or by including it in a separate device as in Mazlish, and subsequent simultaneous display of carbohydrates. Such a combination is motivated as it provides for simple and proper glycemic control (Mazlish [0010]), reduces cognitive burden on users with more options (Mazlish [0011]), and allows for different users to use the bolus calculator as some users may think about meals in terms of the number of carbohydrates consumed while others think about meals in terms of units of insulin needed for the meal (Mazlish [0052]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding programming to convert and display carbohydrates.
In combination, modified Castellano discloses the display (34) and the dose converter (32) wherein the display (34) simultaneously changes as the dialed value changes (see Col.9, lines 10-15) which is modified by Mazlish such that the dose converter comprises the conversion algorithm of Mazlish. As such, Castellano would be modified to have the dose converter (32) receive the insulin dose as an input and to provide the carbohydrate as an output and simultaneously display said output carbohydrates on display (34).
Regarding claim 18, modified Castellano discloses the method of claim 17, as discussed above. In modified Castellano, Castellano discloses (Claim 18) wherein the adjusting unit (12) comprises a stepwise rotatable dial, and wherein the user manipulation comprises rotating the stepwise rotatable dial (see Col.7, lines 52-60).
Claim(s) 2 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Jorgensen in view of Mazlish as applied to claim 1 above, and further in view of Saint et al. (U.S Patent Pub. No. 20180353698 A1, “Saint”).
Regarding claim 2, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above.
However, modified Castellano is silent to (Claim 2) wherein the dose converter is formed by a digital processor or by an analog mechanism. Examiner notes Castellano discloses that the dose converter (microprocessor 32) receives dosage information from an electronic counter 40 which increments by one count per each predetermined angle of rotation of the actuator knob 12 through a cam mechanism (see Col.10, lines 27-35), but the mechanism of the microprocessor 32 is not disclosed.
Saint discloses an intelligent medicine administering system for diabetes management, wherein Saint teaches a processor of an insulin pen (10) or a software application on a remote mobile device (5) may comprise analog hardware for filtering noise and correcting error upon receiving dose information from the mechanical encoder of the insulin pen (10, see Fig. 7 and para. 0151). The dose information representing a set dose may be used in the dose calculator module (220) and be displayable on the remote mobile device (5) and/or the insulin pen (10, see para. 0057). Therefore, the software architecture (200) of the remote mobile device is interpreted as a dose converter and may comprise an analog mechanism that is involved with receiving dose information for use in a dose calculator module (220, see para. 0052).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Saint’s analog hardware, either directly in the pen-type injector or by including it in the remote mobile device as in Saint. Such a combination is motivated as mechanical encoders such as the counter 40 of Castellano and the mechanical encoder of Saint have limitations in precision and accuracy which can be overcome by including analog hardware implementing noise filtering and error correcting (Saint [0143, 0145-0147]), wherein this analog hardware allows the processing software to accurately read dose sizes from mechanical encoders (Saint [0150-0151]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding hardware to improve a known dose determining process.
Regarding claim 19, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above.
However, modified Castellano is silent to (Claim 19) wherein the dose converter is formed by an analog mechanism. Examiner notes Castellano discloses that the dose converter (microprocessor 32) receives dosage information from an electronic counter 40 which increments by one count per each predetermined angle of rotation of the actuator knob 12 through a cam mechanism (see Col.10, lines 27-35), but the mechanism of the microprocessor 32 is not disclosed.
Saint discloses an intelligent medicine administering system for diabetes management, wherein Saint teaches a processor of an insulin pen (10) or a software application on a remote mobile device (5) may comprise analog hardware for filtering noise and correcting error upon receiving dose information from the mechanical encoder of the insulin pen (10, see Fig. 7 and para. 0151). The dose information representing a set dose may be used in the dose calculator module (220) and be displayable on the remote mobile device (5) and/or the insulin pen (10, see para. 0057). Therefore, the software architecture (200) of the remote mobile device is interpreted as a dose converter and may comprise an analog mechanism that is involved with receiving dose information for use in a dose calculator module (220, see para. 0052).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Saint’s analog hardware, either directly in the pen-type injector or by including it in the remote mobile device as in Saint. Such a combination is motivated as mechanical encoders such as the counter 40 of Castellano and the mechanical encoder of Saint have limitations in precision and accuracy which can be overcome by including analog hardware implementing noise filtering and error correcting (Saint [0143, 0145-0147]), wherein this analog hardware allows the processing software to accurately read dose sizes from mechanical encoders (Saint [0150-0151]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding hardware to improve a known dose determining process.
Claim(s) 8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Jorgensen in view of Mazlish as applied to claim 7 above, and further in view of Saint et al. (U.S Patent Pub. No. 20200350052 A1, “Saint 2”).
Regarding claim 8, modified Castellano discloses the insulin delivery arrangement of claim 7, as discussed above. In modified Castellano, Mazlish discloses (Claim 8) wherein the remote mobile device (60) includes the dose converter as a mobile application (see second modification option “… or by including it in a separate device as in Mazlish” – in the rejection of claim 1, see para. 0052 and 0056 – remote computing device 60 comprises a bolus calculator that is accessed upon user selection of icon 341 wherein the bolus calculator is a computer program designed to run on a mobile device and is thus interpreted as a mobile application).
However, with claim 8 further limiting that the dose converter is a mobile application of the remote mobile device, this indicates a required data transmission from the remote mobile device to the display of the hand-operable insulin delivery device as the carbohydrate value is displayed by the display on the hand-operable insulin deliver device as claimed in claim 1. While, Mazlish discloses that the dose converter may be a mobile application on the remote mobile device wherein the carbohydrate value is displayed on the display of the remote mobile device (see para. 0056), Mazlish is silent to a data transmission to the hand-operable insulin delivery device for displaying the carbohydrate value.
Saint 2 discloses an insulin delivery arrangement (100 in Fig. 1) comprising a hand-operable insulin delivery device (10 in Fig. 1B) in communication with a remote mobile device (5 in Fig. 1B), wherein Saint 2 teaches the remote mobile device (5) includes dose related software architecture (200 in Fig. 2) embodied as a part of an app on remote mobile device (5) and wherein dose calculations from the dose related software architecture (200) can be displayed on either the display of the remote mobile device (5) or the display of the hand-operable insulin delivery device (10, see para. 0050-0051 – “The software architecture 200 includes a user interface generator 225 that produces a user interface displayable by the app of the intelligent medicine administrating system 100 on a display of the companion device 5 and/or the pen device 10”).
Since modified Castellano discloses the hand-operable insulin delivery device having a display and is modified to be in communication with the remote mobile device of Mazlish which has the dose converter, and Saint 2 discloses a hand-operable insulin delivery device having a display and a remote mobile device having dose calculator software with an output that can either be displayed on the remote mobile device or transmitted to the hand-operable insulin delivery device for display, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the remote mobile device of modified Castellano to transmit the carbohydrate value to the hand-operable insulin delivery device for display as taught by Saint 2. Saint 2teaches that the output value (i.e. recommended dose) is always displayable whether its displayed on the pen device or the remote mobile device or both to ensure user observation of information (see para. 0051). In combination, Mazlish would be modified to transmit the carbohydrate value calculated by the dose converter in the remote mobile device to the hand-operable insulin delivery device for display.
Regarding claim 11, modified Castellano discloses the insulin delivery arrangement of claim 7, as discussed above. In modified Castellano, Mazlish discloses (Claim 11) wherein a second display for displaying the carbohydrate value is provided on the remote mobile device (60, see second modification option – “…or by including it in a separate device as in Mazlish” – in the rejection of claim 1, see para. 0040 and 0056).
However, since Claim 11 further limits that the carbohydrate value output by the dose converter, which as indicated by the rejection of claim 1 is incorporated either into the hand-operable insulin delivery device or the remote mobile device, can be displayed on either the hand-operable insulin delivery device or the remote mobile device indicating a required data transmission therebetween. While, Mazlish discloses that the dose converter may be a mobile application on the remote mobile device wherein the carbohydrate value is displayed on a second display of the remote mobile device (see para. 0056), Mazlish is silent to a data transmission to the hand-operable insulin delivery device for displaying the carbohydrate value.
Saint discloses an insulin delivery arrangement (100 in Fig. 1) comprising a hand-operable insulin delivery device (10 in Fig. 1B) in communication with a remote mobile device (5 in Fig. 1B), wherein Saint teaches the remote mobile device (5) includes dose related software architecture (200 in Fig. 2) embodied as a part of an app on remote mobile device (5) and wherein dose calculations from the dose related software architecture (200) can be displayed on either the display of the remote mobile device (5) or the display of the hand-operable insulin delivery device (10, see para. 0050-0051 – “The software architecture 200 includes a user interface generator 225 that produces a user interface displayable by the app of the intelligent medicine administrating system 100 on a display of the companion device 5 and/or the pen device 10”).
Since modified Castellano discloses the hand-operable insulin delivery device having a display and is modified to be in communication with the remote mobile device of Mazlish which has the dose converter, and Saint discloses a hand-operable insulin delivery device having a display and a remote mobile device having dose calculator software with an output that can either be displayed on the remote mobile device or transmitted to the hand-operable insulin delivery device for display, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the remote mobile device of modified Castellano to transmit the carbohydrate value to the hand-operable insulin delivery device for display as taught by Saint such that the carbohydrate value may be displayed on either the display of the hand-operable insulin delivery device or the second display of the remote mobile device. Saint teaches that the output value (i.e. recommended dose) is always displayable whether its displayed on the pen device or the remote mobile device or both to ensure user observation of information (see para. 0051).
Claim(s) 10 is rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Jorgensen in view of Mazlish in view of Saint 2 as applied to claim 8 above, and further in view of Despa et al. (U.S Patent Pub. No. 20160213853 A1, “Despa”).
Regarding claim 10, modified Castellano discloses the insulin delivery arrangement of claim 8, as discussed above.
However, modified Castellano fails to disclose (Claim 10) wherein the remote mobile device is configured to automatically retrieve the insulin dose upon a user manipulation of the hand-operable insulin delivery device and the mobile application simultaneously updates the carbohydrate value. Examiner notes the remote mobile device (60) of Mazlish discloses the insulin dose being manually entered on the remote mobile device rather than automatically retrieved from an injection device.
Despa discloses a communication method between an injection device and an external device, wherein Despa teaches a remote mobile device (270) that is in communication with injection device (combined structure of 100 and 110, see para. 0067 for mobile device, see para. 0048 for injection pen). The injection device (combined structure of 100 and 110) comprises a dialing event determination module (226) executed by a processor (205) wherein upon a user manipulation of the injection device (combined structure of 100 and 110) to preset a dose, the dose data is automatically transmitted to the remote mobile device (270, see Fig. 3 and para. 0070-0075).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Despa’s communication method such that upon user manipulation of the injection pen (10) of Castellano, the microprocessor (32) automatically transmits the dialed dose to a remote mobile device such as the remote mobile device (60) incorporated by Mazlish such that the dialed dose is automatically input to the dose converter of Mazlish rather than manually entered by the user. Such a combination is motivated by removing a source of human error by having the user manually enter a dose while providing a method for distinguishing between a dose dialing event or an extraneous event that could be mistaken for such (Despa [0024]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding software for automatically transmitting dose dialing information.
Claim(s) 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Jorgensen in view of Mazlish as applied to claims 12 and 1, respectively, above, and further in view of Roy (U.S Patent Pub. No. 20160279336 A1).
Regarding claim 13, modified Castellano discloses the insulin delivery arrangement of claim 12, as discussed above.
In modified Castellano, Mazlish discloses the limitations of (Claim 13) wherein the glucose measurement value is retrieved from the continuous monitoring glucose meter (50) by a remote mobile device (60) arranged separate from the hand-operable insulin delivery device (15) and adapted to wirelessly communicate with the hand-operable insulin delivery device (15, see Fig. 1A and para. 0036).
However, modified Castellano fails to disclose the limitation (Claim 13) wherein the glucose measurement value is transmitted from the remote mobile device to the hand-operable insulin delivery device. Examiner notes Mazlish discloses that the continuous glucose meter (50) may separately communicate with the infusion pump assembly (15) and remote mobile device (60) or data can be transferred to the remote mobile device (60) via the infusion pump assembly (15).
Roy discloses an insulin injection system comprising a continuous glucose meter, wherein Roy teaches a continuous glucose monitor (108 in Fig.1, see para. 0015), a remote mobile device (110 in Fig.1, see para. 0016), and an insulin pen (102 in Fig.1, see para. 0013) which are all arranged separately. The continuous glucose monitor (108) may optionally be in communication with both the remote mobile device (110) and the insulin pen (102) for communicating glucose measurements, or alternatively, the continuous glucose monitor (108) may only be in communication with remote mobile device (110) which then communicates glucose measurements to the insulin pen (102, see para. 0017).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Roy’s communication method such that the continuous glucose monitor (50) of Mazlish communicates glucose measurements to the insulin delivery assembly of modified Castellano either directly or through the remote mobile device (60) as in Roy. Such a combination is motivated by providing increased data redundancy and more accessibility for glucose measurements across the system (Roy, [0016-0017]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding a communication pathway in a preexisting communications interface.
Regarding claim 14, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above.
However, modified Castellano fails to disclose (Claim 14) wherein the dose converter is configured to include a user-specific correction bolus in a calculation of the carbohydrate value.
Roy discloses an insulin injection system comprising a continuous glucose meter, wherein Roy teaches a dose converter (220 in Fig. 2) which runs a bolus wizard application 9220) to determine the amount of insulin to be delivered based upon a patient-specific correction bolus (see para. 0023 and 0039 – in the case of a correction bolus, the amount of carbohydrates is set to zero and a corresponding insulin value is calculated).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Roy’s user-specific correction bolus such that the dose converter of Mazlish converting insulin to carbohydrates would use a user-specific correction bolus in a similar way to Roy inversely using the user-specific correction bolus to convert carbohydrates to insulin. Examiner notes that in the instant application, para. 0045 discloses that in the case of a user only needing a correction bolus, the output of the carbohydrate value will remain at zero for the first steps of rotation of the dial 30, as the corresponding amount of insulin is needed only for lowering blood glucose. Therefore, if the method of Roy were inverted where a correction bolus is determined to be needed, the amount of carbohydrates would be displayed as zero. Such a combination is motivated by providing an improved dose converter that can determine both meal boluses and correction boluses that are accurate for a user by utilizing patient-specific parameters (Roy [0039]).
Regarding claim 15, modified Castellano discloses the insulin delivery arrangement of claim 1, as discussed above. In modified Castellano, Castellano discloses the limitations of (Claim 15) wherein the remote mobile device is arranged separate from the hand-operable insulin delivery device (10) and is adapted to communicate with the hand-operable insulin delivery device (10, see Col.9, lines 38-45, examiner notes the remote mobile device is being interpreted under 112(f) as a smart phone, smart watch, fitness tracker and equivalents thereof wherein an external computer is interpreted as an equivalent).
However, Castellano fails to disclose the limitation of (Claim 15) the remote mobile device is adapted to wirelessly communicate with the hand-operable delivery device, wherein the hand-operable insulin delivery device has an activation circuit which triggers transmission of user specific parameters from a remote mobile device when the hand-operable insulin delivery device is activated. Examiner notes Castellano discloses the data I/O port (46) configured to allow a user to download information into an external computer (see Col.9, lines 38-40), and further that a glucose monitor (300) may have an I/O port 320 that can wirelessly communicate with the pen-injector 10 using infrared technology (see Col.14, lines 1-4).
Mazlish teaches (Claim 15) wherein the remote mobile device (60) is arranged separate from the hand- operable insulin delivery device (15) and is adapted to wirelessly communicate with the hand- operable insulin delivery device (15, see para. 0037 and 0039 for smartphone or tablet device 60, examiner notes the remote mobile device is being interpreted under 112(f) as a smart phone, smart watch, fitness tracker and equivalents thereof wherein the mobile computing device 60 may be a smartphone or tablet device).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Castellano to replace Castellano’s external computer with the remote mobile device in wireless communication with the pen-type injector as taught by Mazlish. Such a modification is motivated by a desire to avoid attracting unwanted attention while inputting or accessing diabetes-related health data and providing a simpler form of data transmission than a wired connection. Moreover, smart phones typically have more robust graphical displays, which can improve the user experience (Mazlish [0039]).
However, modified Castellano fails to disclose the limitation (Claim 15) wherein the hand-operable insulin delivery device has an activation circuit which triggers transmission of user specific parameters from a remote mobile device when the hand-operable insulin delivery device is activated.
Roy discloses an insulin injection system comprising a continuous glucose meter, wherein Roy teaches (Claim 15) the hand-operable insulin delivery device (102) has an activation circuit which triggers transmission of user specific parameters from a remote mobile device (110) when the hand-operable insulin delivery device (102) is activated (see Fig. 3 and para. 0030 – patient may manipulate user elements on the injection pen 102 to input a unique identifier that causes download of patient-specific values from a remote device 110 wherein the inputting of the unique identifier is interpreted as the activation circuit which triggers the download).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of modified Castellano to include an activation circuit which triggers transmission of user specific parameters from the remote mobile device to the insulin pen as taught by Roy. Such a modification is motivated to ensure an injection pen is configured for use with a particular patient (Roy [0030]), and it ensures the bolus delivery amount may be accurately and reliably determined by the injection pen in a patient-specific manner (Roy [0012]).
Claim(s) 20 is rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Mazlish in view of Saint in view of Remde (U.S Patent Pub. No. 20110118700 A1).
Regarding claim 20, Castellano discloses the limitations of (Claim 20) an insulin delivery arrangement, comprising: a hand-operable insulin delivery device (10 in at least Fig. 1-4) having an adjuster (12) configured to manually preset an insulin dose and an applicator (combined structure of 22 and 28) which can be triggered to deliver the insulin dose to a user and wherein the adjuster (12) is a stepwise rotatable dial (see Fig. 1 and 2-3 and Col.7, lines 15-18 for adjuster, see Col.11, lines 17-20, examiner notes the adjuster is being interpreted under 112(f) as a stepwise rotatable dial, dose knob, or equivalents thereof and as such the actuator knob 12 which rotates in an incremental manner is interpreted as the adjuster which is a stepwise rotatable dial); a dose converter (32 and 40) configured to receive the insulin dose as an input (see Fig. 4 and Col.7, lines 57-67, examiner notes the dose converter is interpreted under 112(f) as a digital processor, analog mechanism, or equivalents thereof and as such the microprocessor in combination with dose counter 40 are interpreted as the dose converter); a display (34) configured to display the value to the user, the display (34) being disposed on the hand-operable insulin delivery device (10, see Fig. 1 and Col.7, lines 14-16, Col.9, lines 25-37); and when the adjuster (12) is used to change the insulin dose before triggering the applicator (combined structure of 22 and 28) to deliver the insulin dose, the value displayed by the display (34) is simultaneously changed (see Col.9, lines 10-15).
However, Castellano fails to disclose (Claim 20) a dose converter configured to receive the insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose, wherein the dose converter is part of the insulin delivery device and comprises an analog mechanism mechanically coupled with the stepwise rotatable dial; and a display configured to display the carbohydrate value to the user and comprising an analog graduated scale coupled with the dose converter, wherein the carbohydrate value displayed by the display is simultaneously changed.
Mazlish discloses a user interface for diabetes management, wherein Mazlish teaches a mobile computing device (60 in Fig. 1) is configured to receive an insulin dose as an input and to provide as an output a carbohydrate value equivalent to an amount of meal carbohydrates which can be compensated by the insulin dose (see para. 0056). The mobile computing device (60) includes a display configured to display the carbohydrate value to the user (see Fig. 4G and para. 0056).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to include Mazlish’s conversion algorithm, either directly in the pen-type injector of Castellano or by including it in a separate device as in Mazlish, and subsequent simultaneous display of carbohydrates. Such a combination is motivated as it provides for simple and proper glycemic control (Mazlish [0010]), reduces cognitive burden on users with more options (Mazlish [0011]), and allows for different users to use the bolus calculator as some users may think about meals in terms of the number of carbohydrates consumed while others think about meals in terms of units of insulin needed for the meal (Mazlish [0052]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding programming to convert and display carbohydrates.
In combination, modified Castellano discloses the display (34) and the dose converter (32 and 40) wherein the display (34) simultaneously changes as the dialed value changes (see Col.9, lines 10-15) which is modified by Mazlish such that the dose converter comprises the conversion algorithm of Mazlish. As such, Castellano would be modified to have the dose converter (32 and 40) receive the insulin dose as an input and to provide the carbohydrate as an output and simultaneously display said output carbohydrates on display (34).
Saint discloses an intelligent medicine administering system for diabetes management, wherein Saint teaches a processor of an insulin pen (10) or a software application on a remote mobile device (5) may comprise analog hardware for filtering noise and correcting error upon receiving dose information from the mechanical encoder of the insulin pen (10, see Fig. 7 and para. 0151). The dose information representing a set dose may be used in the dose calculator module (220) and be displayable on the remote mobile device (5) and/or the insulin pen (10, see para. 0057). Therefore, the software architecture (200) of the remote mobile device is interpreted as a dose converter and may comprise an analog mechanism that is involved with receiving dose information for use in a dose calculator module (220, see para. 0052).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the arrangement of modified Castellano to include Saint’s analog hardware, either directly in the pen-type injector or by including it in the remote mobile device as in Saint. Such a combination is motivated as mechanical encoders such as the counter 40 of Castellano and the mechanical encoder of Saint have limitations in precision and accuracy which can be overcome by including analog hardware implementing noise filtering and error correcting (Saint [0143, 0145-0147]), wherein this analog hardware allows the processing software to accurately read dose sizes from mechanical encoders (Saint [0150-0151]). It also constitutes a mere combination of prior art elements according to known methods to yield predictable results in that it merely consists of adding hardware to improve a known dose determining process. In combination, the mechanism of modified Castellano which discloses that the dose converter (microprocessor 32 and dose counter 40) on the hand-operable insulin delivery device (10) wherein the dose counter (40) is mechanically coupled through a cam mechanism to the stepwise rotatable dial (12, see Col.10, lines 27-35) would comprise an analog mechanism in the microprocessor’s software for noise filtering and error correction as taught by Saint.
Remde discloses a hand-operable insulin delivery device (100 in Fig. 1) comprising a display (32 in Fig. 1) for simultaneously displaying a set dose amount by dose setting knob (5, see para. 0039 and 0044), wherein the display (32) comprises an analog graduate scale (32A in Fig. 3A, examiner notes analog graduated scale is being interpreted as a series of markers at determined distances used for measurement or computation represented by a continuously variable physical quantity, see para. 0051-0052 – the display 32A comprises a dose scale 110 with graduations 115 representing dose in Ius such that it is a continuously variable physical quantity).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the display on the hand-operable insulin delivery device of modified Castellano to comprise an analog graduated scale as taught by Remde as the graduated dose scale allows for easy observation of multiple different parameters relating to dosage (see para. 0025). In combination, Castellano is modified to comprise the conversion algorithm of Mazlish which may be incorporate directly into the hand-operable insulin delivery device and thus display the carbohydrate value on the display of the hand-operable insulin delivery device. Thus, the modified display of Castellano by Remde to comprise an analog graduated scale would be coupled to the dose converter and capable of being configured for displaying the output carbohydrate value.
Claim(s) 21 is rejected under 35 U.S.C. 103 as being unpatentable over Castellano in view of Mazlish in view of Saint in view of Remde as applied to claim 20 above, and further in view of Jorgensen.
Regarding claim 21, modified Castellano discloses the insulin delivery arrangement of claim 20, as discussed above. However, modified Castellano fails to disclose (Claim 21) further comprises a dose counter coupled with the adjuster and displaying the insulin dose, the dose counter being disposed on the hand-operable insulin delivery device
Jorgensen discloses an insulin injection pen (100 in Fig. 1-2A) comprising a dose counter (205 in Fig. 1) coupled with the adjuster (260 in Fig. 1) and displaying the insulin dose (examiner notes the adjuster is being interpreted under 112(f) as a stepwise rotatable dial, dose knob, or equivalents thereof and as such the user actuatable dosage selector 260 is interpreted as the adjuster, see para. 0093 – dose selector 260 is coupled to a dose scale which is coupled to display window 205 for displaying the insulin dose), the dose counter (205) being disposed on the hand-operable insulin delivery device (100, see Fig. 1); and a display (275 in Fig. 1-3) being disposed on the hand-operable insulin delivery device (100, see Fig. 1-3 and para. 0094 – pen 100 additionally comprises a digital display 275 on its proximal end).
Since Castellano discloses an insulin injection pen with a manually operated actuator knob and comprises a digital display, and Jorgensen discloses an insulin injection pen with a manually operated rotatable dose member and comprising both a dose counter and a digital display, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Castellano’s arrangement to additionally incorporate a dose counter alongside its digital display as taught by Jorgensen. Jorgensen teaches that such a modification is motivated as the dose counter is able to display selected dosage sizes while the digital display is utilized to also display dosage sizes alongside more in-depth injection information such as elapsed times from previous injection (see para. 0094). Thus in combination, the arrangement of Castellano will be modified to have a dose counter as taught by Jorgensen alongside the digital display (34) of Castellano.
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 KAYLA MARIE TURKOWSKI whose telephone number is (703)756-4680. The examiner can normally be reached Mon – Thurs, 7:00 AM – 4:00 PM EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at 571-272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
Prosecution Insights