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 action is in response to the remarks filed on 4/13/2026.
The amendments filed on 4/13/2026 have been entered. Accordingly claims 30-79 remain pending.
The objections to the drawings have been acknowledged by the applicant.
The claim rejections under 35 USC 112 have been withdrawn in light of the amendments and the applicant’s remarks.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “optical path does not intersect a central longitudinal axis of the cavity of the cap device” of claim 36 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: 142d. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
Claim 30, 32-35, 37-39, 42-45, 41, 47 and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch et al. (WO2010098928, hereinafter Krulevitch).
in view of Whalley et al (US20130310756A1).
Regarding claim 30, Krulevitch teaches a liquid delivery system cap device (Fig. 1; 202), the cap device comprising:
a body (Fig. 2; 208) defining a cavity (internal to Fig. 2; 211) to receive at least a portion of a liquid delivery device (as shown in Fig. 1B); and
a sensor carriage (Fig. 5; 240) movable within the cavity [Paragraph 0056] and including a first sensor (Fig. 6; 215; [Paragraph 0057, “conductive contacts”]; 214);
wherein the sensor carriage is movable between a first position and a second position [Paragraph 0057] relative to the cavity while the liquid delivery device is in a fixed position relative to the cavity [Paragraph 0056].
Krulevitch does not seem to point out the specifics of a delivery end of the liquid delivery device where a liquid of the liquid delivery device is dispensed;
However, in the same field of endeavor, Whalley teaches FIGS. 2-4 a dose measurement system 200 can include a lighting module 240, a sensing module 250, a processing unit 260, a communications module 270 and a power source 286. The dose measurement system 200 can be configured to be removably coupleable to a drug delivery device 210 (also referred to herein as “an injection pen 210”). The drug delivery device 210 can be configured to deliver a predefined quantity of a drug (e.g., dose) to a patient [0041]. The dose measurement system 200 includes a housing 220 that includes a top housing portion 222 (also referred to herein as “top housing 222”) and a bottom housing portion 224 (also referred to herein as “bottom housing 224” [0042]. As shown in FIG. 3, the top housing portion 222 defines an internal volume for substantially housing the lighting module 240, the sensing module 250, the processing unit 260, the communications module 270 and the power source 286. The bottom housing portion 224 includes defines a bore 226, shaped and sized to receive at least a portion of the drug delivery device 210. For example, the bore 226 can be shaped and sized to receive only the drug containing portion of the housing 212 and the injector 216. The bore 226 can be configured to receive the drug delivery device 210 in a preferred orientation, e.g., a preferred radial orientation [0043]. e bottom housing 224 can include apertures 228 for receiving at least a portion of the plurality of light sources 244 of the lighting module 240, and/or sensors 254 of the sensing module 250. The apertures 228 can be configured to provide mechanical support for the light sources 244 and/or sensors 254, or can serve as an alignment mechanism for the lighting module 240 and/or sensing module 250 [0044].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with a delivery end of the liquid delivery device where a liquid of the liquid delivery device is dispensed as taught by Whalley because it helps to facilitate data acquisition on patient behavior and that allow that data to be used to reduce the incidence of hospital visits (e.g., readmission), as well as to inform and educate patients, care providers, family and financial service providers ([0005] of Whalley).
Regarding claim 32, Krulevitch teaches the cap device of claim 30, wherein the first sensor is configured to output a sensor signal indicative of a physical feature of the liquid delivery device [Paragraph 0056-0057] (wherein “a physical feature of the liquid delivery device” is how much drug will be delivered).
Regarding claim 33, Krulevitch teaches the cap device of claim 30, wherein the first sensor is configured to output a sensor signal while the sensor carriage moves between the first position and the second position [Paragraphs 0056-0057], but fails to teach wherein the first sensor is configured to output a sensor signal indicative of a plunger of the liquid delivery device while the sensor carriage moves between the first position and the second position.
Regarding claim 34, Krulevitch teaches the cap device of claim 30, but fails to teach wherein the first sensor comprises at least one of a first transmissive sensor, and an optical sensor having a first optical emitter aligned with a first optical receiver.
Whalley teaches a liquid delivery system cap device (as shown in Fig. 7), the cap device comprising:
a body (Fig. 7; 300) defining a cavity (as shown in Fig. 7) configured to receive at least a portion of a liquid delivery device (Fig. 7; 310);
a first sensor (Fig. 7; 344, 354);
wherein the first sensor comprises at least one of a first transmissive sensor, and an optical sensor having a first optical emitter (Fig. 7; 344) aligned with a first optical receiver (Fig. 7; 354) (bold added as emphasis by Examiner to show that only one of the choices presented within the claim is being established within the art).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to teach wherein the first sensor (specifically the “conductive contacts”) comprises an optical sensor having a first optical emitter aligned with a first optical receiver, as taught by Whalley. Doing so would allow for the production of a unique signal to track the range of dose volumes still left in the liquid delivery device, as taught by Whalley [Paragraph 0058].
Regarding claims 35 and 45, Krulevitch teaches the cap device of claim 30, but fails to teach wherein the first sensor comprises an optical sensor having a first optical emitter aligned with a first optical receiver; and
wherein the first sensor further comprises an optical path between the first optical emitter and the first optical receiver, and the optical path is perpendicular to a longitudinal axis of the cavity of the cap device.
Whalley teaches a liquid delivery system cap device (as shown in Fig. 7), the cap device comprising:
a body (Fig. 7; 300) defining a cavity (as shown in Fig. 7) configured to receive at least a portion of a liquid delivery device (Fig. 7; 310);
a first sensor (Fig. 7; 344, 354);
wherein the first sensor comprises an optical sensor having a first optical emitter (Fig. 7; 344) aligned with a first optical receiver (Fig. 7; 354); and
wherein the first sensor further comprises an optical path (as shown in Annotated Fig. 7-1) between the first optical emitter and the first optical receiver, and the optical path is perpendicular to a longitudinal axis of the cavity of the cap device (as shown in Annotated Fig. 7-1).
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Annotated Fig. 7-1
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to teach wherein the first sensor (specifically the “conductive contacts”) comprises an optical sensor having a first optical emitter aligned with a first optical receiver, and wherein the first sensor further comprises an optical path between the first optical emitter and the first optical receiver, and the optical path is perpendicular to a longitudinal axis of the cavity of the cap device, as taught by Whalley. Doing so would allow for the production of a unique signal to track the range of dose volumes still left in the liquid delivery device, as taught by Whalley [Paragraph 0058].
Regarding claims 37 and 44, Krulevitch teaches the cap device of claim 30, but fails to teach wherein the first sensor comprises an optical sensor having a first optical emitter aligned with a first optical receiver; and
wherein the sensor carriage comprises a second optical sensor having a second optical emitter aligned with a second optical receiver.
Whalley teaches a liquid delivery system cap device (as shown in Fig. 7), the cap device comprising:
a body (Fig. 7; 300) defining a cavity (as shown in Fig. 7) configured to receive at least a portion of a liquid delivery device (Fig. 7; 310);
a first sensor (Fig. 7; 344, 354);
wherein the first sensor comprises an optical sensor having a first optical emitter (Fig. 7; 344) aligned with a first optical receiver (Fig. 7; 354); and
wherein the sensor carriage comprises a second optical sensor having a second optical emitter aligned with a second optical receiver (as shown in Annotated Fig. 7-2).
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Annotated Fig. 7-2
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to teach wherein the first sensor (specifically the “conductive contacts”) comprises an optical sensor having a first optical emitter aligned with a first optical receiver, and wherein the first sensor further comprises an optical path between the first optical emitter and the first optical receiver, and wherein the sensor carriage comprises a second optical sensor having a second optical emitter aligned with a second optical receiver, as taught by Whalley. Doing so would allow for the production of a unique signal to track the range of dose volumes still left in the liquid delivery device, as taught by Whalley [Paragraph 0058].
Regarding claim 38, Krulevitch in view of Whalley teaches the cap device of claim 37, wherein the first optical emitter is not aligned with the second optical receiver, and the second optical emitter is not aligned with the first optical receiver (as shown in Annotated Fig. 7-2).
Regarding claims 39, 42 and 48, Krulevitch teaches the cap device of claim 30, further comprising a processor (Fig. 6; 270). However, Krulevitch fails to teach wherein the cap device further comprises a position sensor and processor configured to:
detect a plunger of the liquid delivery device based on a variation in a sensor signal of the first sensor; and
determine a corresponding position based on a sensor signal output by the position sensor.
Whalley teaches a liquid delivery system cap device (as shown in Fig. 4), the cap device comprising:
a body (Fig. 4; 200) defining a cavity (as shown in Fig. 3) configured to receive at least a portion of a liquid delivery device (Fig. 4; 210);
a first sensor (a “first set” of the combination of 244/254, as shown in Fig. 4); and
further comprising a positioning sensor (a “second set” of the combination of 244/254, as shown in Fig. 4) and a processor within the cap (Fig. 4; 160, 260 and 264) configured to:
detect a plunger of the liquid delivery device based on a variation a sensor signal of the first sensor [Paragraph 0048]; and
determine a corresponding position based on a sensor signal output by the position sensor [Paragraph 0048, 0057, 0062].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to further comprise a position sensor and processor configured to: detect a plunger of the liquid delivery device based on a variation in a sensor signal of the first sensor; and determine a corresponding position based on a sensor signal output by the position sensor as taught by Whalley. Doing so would allow for the production of a unique signal to track the range of dose volumes still left in the liquid delivery device, as taught by Whalley [Paragraph 0058].
Regarding claim 41, Krulevitch teaches liquid delivery system (““smart” drug delivery system” abst), comprising:
a liquid delivery device (“smart” drug delivery system” abst), comprising:
a reservoir (e.g., “cartridge 222”),
a liquid within the reservoir (“volume of fluid from cartridge 222” [0043]),
a delivery end where the liquid is dispensed (see fig. below), and
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a plunger movable within the reservoir to dispense liquid from the reservoir (“a plunger rod 226, a plunger rod holder 27, and a first screw 35. The actuation unit 200 can include a mechanism (for brevity, shown as actuation shaft 190, plunger rod member 226) to dispense a controlled volume of fluid from cartridge 222” [0043]); and
a cap device (module 202), comprising:
a body (Fig. 2; 208) defining a cavity (internal to Fig. 2; 211) to receive at least a portion of a liquid delivery device (as shown in Fig. 1B); and
a sensor carriage (Fig. 5; 240) movable within the cavity [Paragraph 0056] and including one or more sensors a first sensor (Fig. 6; 215; [Paragraph 0057, “conductive contacts”]; 214) configured to output a sensor signal indicative of a physical feature of the liquid delivery device ([Paragraph 0056-0057] (wherein “a physical feature of the liquid delivery device” is how much drug will be delivered), and
a position sensor (“a linear potentiometer and is used to measure the position of dosage selector 220 for determining the size of the bolus injected by the user” [0046]);
wherein the sensor carriage is movable between a first position and a second position [Paragraph 0057] relative to the cavity while the liquid delivery device is in a fixed position relative to the cavity [Paragraph 0056].
Krulevitch does not seem to point out the specifics of a delivery end of the liquid delivery device where a liquid of the liquid delivery device is dispensed;
However, in the same field of endeavor, Whalley teaches FIGS. 2-4 a dose measurement system 200 can include a lighting module 240, a sensing module 250, a processing unit 260, a communications module 270 and a power source 286. The dose measurement system 200 can be configured to be removably coupleable to a drug delivery device 210 (also referred to herein as “an injection pen 210”). The drug delivery device 210 can be configured to deliver a predefined quantity of a drug (e.g., dose) to a patient [0041]. The dose measurement system 200 includes a housing 220 that includes a top housing portion 222 (also referred to herein as “top housing 222”) and a bottom housing portion 224 (also referred to herein as “bottom housing 224” [0042]. As shown in FIG. 3, the top housing portion 222 defines an internal volume for substantially housing the lighting module 240, the sensing module 250, the processing unit 260, the communications module 270 and the power source 286. The bottom housing portion 224 includes defines a bore 226, shaped and sized to receive at least a portion of the drug delivery device 210. For example, the bore 226 can be shaped and sized to receive only the drug containing portion of the housing 212 and the injector 216. The bore 226 can be configured to receive the drug delivery device 210 in a preferred orientation, e.g., a preferred radial orientation [0043]. e bottom housing 224 can include apertures 228 for receiving at least a portion of the plurality of light sources 244 of the lighting module 240, and/or sensors 254 of the sensing module 250. The apertures 228 can be configured to provide mechanical support for the light sources 244 and/or sensors 254, or can serve as an alignment mechanism for the lighting module 240 and/or sensing module 250 [0044].
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with a delivery end of the liquid delivery device where a liquid of the liquid delivery device is dispensed as taught by Whalley because it helps to facilitate data acquisition on patient behavior and that allow that data to be used to reduce the incidence of hospital visits (e.g., readmission), as well as to inform and educate patients, care providers, family and financial service providers ([0005] of Whalley).
Regarding claim 43, Krulevitch in view of Whalley teaches the cap device of claim 37, wherein the processor is located in the cap device.
Specifically, Whalley teaches processing unit 160 and processing unit 260 in figs. 3, 4 that dose measurement system 100 can be disposed in a housing (not shown) that can be configured to be removably coupleable to the drug delivery device 110. For example, the lighting module 140, sensing module 150, processing unit 160.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to further comprise processor is located in the cap device as taught by Whalley. Doing so would allow for the production of a unique signal to track the range of dose volumes still left in the liquid delivery device, as taught by Whalley [Paragraph 0058].
Regarding claim 47, Krulevitch teaches method of evaluating the condition of a liquid delivery device (“module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures,” abst), comprising:
receiving at least a portion of a liquid delivery device within a cavity of a cap device (see figs. 1-3);
releasing a sensor carriage including one or more sensors to move the sensor carriage from a first position to a second position while the liquid delivery device remains in a fixed position within the cavity (see [0056]-[0057]); and
evaluating an output of the one or more sensors indicative of the presence of a feature of the liquid delivery device (“module may: determine dosage selected, injection of selected dosage, duration of injection, time of injection, whether the pen has been primed or shaken to thoroughly mix up insulin mixtures” abst).
Krulevitch does not seem to point out the specifics of move the sensor carriage along with the one or more sensors;
However, in the same field of endeavor, Whalley teaches As shown in FIG. 3, the top housing portion 222 defines an internal volume for substantially housing the lighting module 240, the sensing module 250, the processing unit 260, the communications module 270 and the power source 286. The bottom housing portion 224 includes defines a bore 226, shaped and sized to receive at least a portion of the drug delivery device 210. For example, the bore 226 can be shaped and sized to receive only the drug containing portion of the housing 212 and the injector 216. The bore 226 can be configured to receive the drug delivery device 210 in a preferred orientation, e.g., a preferred radial orientation [0043]. e bottom housing 224 can include apertures 228 for receiving at least a portion of the plurality of light sources 244 of the lighting module 240, and/or sensors 254 of the sensing module 250. The apertures 228 can be configured to provide mechanical support for the light sources 244 and/or sensors 254, or can serve as an alignment mechanism for the lighting module 240 and/or sensing module 250 [0044]. Drug delivery device 210 is coupled/uncoupled to the dose measurement system 200. In some embodiments, the sensors 254 can be arranged in a substantially similar configuration to the light sources 244 [0048]. (It is noted here that the sensor carriage [e.g., sensors 254 of the sensing module 250 are mounted on, or otherwise disposed on, a PCB 252 and along with the housing for that matter] can be moved from one position to other while the drug delivery device 210, (e.g., “liquid delivery device”) remains in a fixed position within the cavity.
It would have been obvious to an ordinary skilled in the art before the invention was made to modify the method and/or device of the modified combination of reference(s) as outlined above with move the sensor carriage along with the one or more sensors as taught by Whalley because it helps to facilitate data acquisition on patient behavior and that allow that data to be used to reduce the incidence of hospital visits (e.g., readmission), as well as to inform and educate patients, care providers, family and financial service providers ([0005] of Whalley).
Regarding claim 49, Krulevitch teaches wherein the feature of the liquid delivery device is a plunger (“a pen button 216, a dosage selector 220, an inner cylinder 23, a lead screw 25, a plunger rod 226, a plunger rod holder 27, and a first screw 35. The actuation unit 200 can include a mechanism (for brevity, shown as actuation shaft 190, plunger rod member 226) to dispense a controlled volume of fluid from cartridge 222” [0043]).
Claim 31 is rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch in view of Whalley and further in view of Cereda et al. (U.S. PGPUB 20160193412), hereinafter Cereda.
Regarding claim 31, the above noted combination teaches the cap device of claim 30,
wherein the cavity is defined by a front wall (wall which defines 211, as shown in Fig. 2) and one or more side walls of the body (as shown in Fig. 2), and the body defines an opening to the cavity (Fig. 2; 211),
wherein in the first position, the sensor carriage is located proximate the front wall (Examiner interprets the sensor carriage to be located proximate the front wall, as the device is relatively small, making all components proximate to each other); and
wherein in the second position, the sensor carriage is located proximate the opening (Examiner interprets the sensor carriage to be located proximate the opening, as the device is relatively small, making all components proximate to each other).
However, Krulevitch fails to teach wherein the cap device of claim 30 further comprises a spring, and wherein the spring is biased to move the sensor carriage from the first position to the second position.
Cereda teaches a liquid delivery system device, the device comprising:
a sensor carriage (Fig. 16a; 112);
wherein the sensor carriage is movable between a first position and a second position (Figs. 16a-d);
wherein the device further comprising a spring (Fig. 16a; 114);
wherein the spring is biased to move the sensor carriage from the first position to the second position [Paragraph 0193].
It would have been obvious to one in ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to include a spring which is biased to move the sensor carriage from the first position to the second position, as it has been shown in the art to be a well-known way of causing movement between parts of a device, as shown by Cereda.
Claim 40 is rejected under 35 U.S.C. 103 as being unpatentable over Krulevitch in view of Whalley further in view of Hautaviita et al. (U.S. PGPUB 20190009032), hereinafter Hautaviita.
Regarding claim 40, the above noted combination teaches the cap device of claim 30, but fails to teach the cap device of claim 30 further comprising a position sensor, wherein the position sensor includes at least one of: a linear encoder, the linear encoder including a codestrip and an encoder movable along the codestrip; and a rotary encoder, the rotary encoder including a codewheel and an encoder.
Hautaviita teaches a liquid delivery system device (Fig. 1; 1), the device comprising:
a position sensor (Fig. 1; 5), wherein the position sensor includes at lease one of:
a linear encoder, the linear encoder including a codestrip and an encoder movable along the codestrip; and
a rotary encoder [Paragraph 0092], the rotary encoder including a codewheel (Fig. 12a; 37) and an encoder (Examiner interprets the rotary encoder to include an encoder, as the device is an encoder itself) (bold added as emphasis by Examiner to show that only one of the choices presented within the claim is being established within the art).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the device of Krulevitch to include the position sensor including a rotary encoder, the rotary encoder including a codewheel and an encoder, as taught by Hautaviita. Doing so would have allowed for further detection of the components movements [Paragraph 0009], thus eliminating potential biases from the first sensor.
Response to Arguments
Applicant’s arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Allowable Subject Matter
Claims 36 and 46 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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 SERKAN AKAR whose telephone number is (571)270-5338. The examiner can normally be reached 9am-5pm M-F.
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/SERKAN AKAR/ Primary Examiner, Art Unit 3797
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