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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 16/965,662, filed on 07/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/16/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
The information disclosure statement filed 10/24/2024 fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because a legible copy of each foreign patent document, as well as the other documents have not been provided, and the documents listed under “U.S. Patent Documents” should be listed under “U.S. Patent Application Publications”. It has been placed in the application file, but the information referred to therein has not been considered as to the merits. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference characters not mentioned in the description: 108, 203, 402, 600.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “604” has been used to designate both cap in FIG. 2C and delay in FIG. 6.
Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference characters 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities:
Page 10 line 18 – A grammatical error where the specification says, “A challenge exists in in detecting failed…”. The specification should be corrected to “A challenge exists in
Page 11 line 16 – A typographical error where the specification says, “…record a cartridge change event, t notify users…”. The specification should be corrected to “…record a cartridge change event, to notify users…”.
Page 17 line 16, page 19 line 22, page 27 lines 23-24, page 28 lines 29-30 – The “drive mechanism” is associated with the reference number 106. However, in a previous paragraph, the reference number 106 was associated with the plunger rod. The examiner suggests using the same language throughout the entirety of the specification, such as only using plunger rod or drive mechanism, or providing the drive mechanism with its own reference number.
Page 24 line 21 – The “sensing signal” is associated with reference number 470. However, in previously in the same paragraph, the reference number 470 was associated with pressure or force sensing location. The examiner suggests using the same language throughout the entirety of the specification, such as only using pressure or force sensing location or sensing signal, or providing the sensing signal with its own reference number.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: In line 8 of the claim, there is an additional space between “by” and “the” where the claim states “a medicament by the drug” that needs to be removed. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: In line 10 of the claim, the claim states “a pressure or force measurement signal”. However, in line 5 of the same claim, the claim states “a measurement signal”. It is unclear to the examiner if the two measurement signals are the same or different. If they are the same, the examiner suggests using the same language throughout the entirety of the claim and dependents, as well as correcting the second recitation to “the” instead of “a”. If they are different, the examiner suggests modifying the language of the claim to better describe the difference. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: The claim requires the preposition “to” between “corresponds” and “a” where the claim states “each alert in the different alerts corresponds a respective drug delivery indication” for proper grammar. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: The claim requires the article “the” in the third line of the claim between “or” and “force” where the claim states “an increase in the pressure or force” for proper grammar when separating the possible measurements. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: In the second line of the claim, the claim requires the article “a” between “or” and “force” where the claim states “a pressure or force sensor” for proper grammar when separating the different types of sensors. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: The claim requires the preposition “to” between “corresponds” and “a” where the claim states “each alert in the different alerts corresponds a respective drug delivery indication” for proper grammar. Appropriate correction is required.
Claim 17 is objected to because of the following informalities: The claim requires the article “the” in the third line of the claim between “or” and “force” where the claim states “an increase in the pressure or force” for proper grammar when separating the possible measurements. 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 is:
The recitation, in claims 1 and 10, of “an alert mechanism configured to provide a particular alert based on the determining” has been interpreted as structurally a device to visually or audibly alert a user or provide certain information to a user, such as a display or series of LED lights arranged to illuminate a different color, or producing different sounds or beeps (pg. 22 lines 4-12).
Because this claim limitation is being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it is being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this limitation 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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefore, subject to the conditions and requirements of this title.
Claims 1-18 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea of “determining whether at least a portion of the medicament was expelled from the drug delivery device based on the received pressure or force measurement signal” without significantly more.
Step 1
Claims 1-9 recite a device, and therefore is a product, and claims 10-18 recite a process completed by that device. Therefore, the claims fall within the statutory categories.
Step 2A, Prong 1
Claim 1 recites determining whether at least a portion of the medicament was expelled from the drug delivery device based on the received pressure or force measurement signal by using a processor. The limitation, as drafted, describes a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind except for the recitation of a generic “processor”. That is, other than reciting the “processor”, nothing in the claim precludes the determining step from practically being performed in the human mind. MPEP 2106.04(a)(2)(III) states that the courts consider a mental process (thinking) that “can be performed in the human mind, or by a human using a pen and paper” to be an abstract idea. For example, aside from the “processor” language, the claim encompasses the user visually inspecting the drug delivery device to identify if medicament was expelled. This limitation is a mental process.
Step 2A, Prong 2
The claim recites the additional elements: “a processor”, “a sensor arranged to measure a pressure in a cartridge of the drug delivery device or a force applied by a drive mechanism of the drug delivery device, and output a measurement signal to the processor”, “at least one non-transitory computer readable medium”, “activating the sensor during a drug delivery of a medicament by the drug delivery device”, “receiving a pressure or force measurement signal from the sensor during the drug delivery”, and “activating an alert mechanism configured to provide a particular alert based on the determining, wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining”.
The ”processor” and “at least one non-transitory computer readable medium” are generically recited computer elements performing a generic computer function of processing data (determining whether at least a portion of the medicament was expelled). This generic processor limitation is no more than mere instructions to apply the exception using a generic computer component. Accordingly, this additional limitation does not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea.
The “sensor arranged to measure a pressure in a cartridge of the drug delivery device or a force applied by a drive mechanism of the drug delivery device, and output a measurement signal to the processor”, “activating the sensor during a drug delivery of a medicament by the drug delivery device”, and “receiving a pressure or force measurement signal from the sensor during the drug delivery” are recited at a high level of generality (i.e., any sensor able to be activated and pass pressure or force data to a processor) and amounts to no more than pre-solution activity of data gathering by a sensor to output a measurement signal to a generic processor.
The “activating an alert mechanism configured to provide a particular alert based on the determining, wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining” is recited at a high level of generality and amounts to no more than post-solution activity of providing an alert.
Step 2B
As discussed with respect to Step 2A, Prong 2, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e. mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept at Step 2B.
MPEP 2106.05 states that an additional element that is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, and conventional activity in the field. The specification on page 29 lines 12-19 does not provide any indication that the processor is anything other than a generic, off-the-shelf computer component. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer-implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement an abstract idea is well-understood, routine, and conventional activity is supported under Berkheimer Option 2.
As discussed with respect to Step 2A Prong 2, the “sensor arranged to measure a pressure in a cartridge of the drug delivery device or a force applied by a drive mechanism of the drug delivery device, and output a measurement signal to the processor”, “activating the sensor during a drug delivery of a medicament by the drug delivery device”, and “receiving a pressure or force measurement signal from the sensor during the drug delivery” are recited at a high level of generality (i.e., any sensor able to be activated and pass pressure or force data to a processor) and amounts to no more than pre-solution activity of data gathering by a sensor to output a measurement signal to a generic processor. This pre-solution activity of data gathering using a sensor within a cartridge to collect force or pressure data and send said data to a processor for analysis is well-understood, routine, and conventional in the field of therapeutic infusion as show in the Applicant’s specification, page 20 lines 10-14, “One skilled in the art will appreciate that a variety of pressure or force sensors will enable detection of the pressure or force on the stopper 200 or the force in the plunger rod 106 (e.g., a stress). In some cases, for example, the pressure or force sensor is a strain gauge or a diaphragm-type sensor using a change in capacitance to generate the measurement signal.” and page 22 lines 9-12, “one skilled in the art will appreciate that the electronics assembly 340, with or with an internal pressure or force sensor 341, can be located anywhere in the in drug delivery device 100 such that it can receive a signal from the pressure or force sensor 341.”. The sensor is only specified at a high level of generality and appears to be recognized as routine by applicant’s lack of detail about the component in the claims.
As discussed with respect to Step 2A Prong 2, the “activating an alert mechanism configured to provide a particular alert based on the determining, wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining” is recited at a high level of generality (i.e., as a generic processor performing a generic computer function of providing an alert upon determination of expulsion) and amounts to no more than post-solution activity of providing an alert. In reevaluating the claim at Step 2b, the additional element of the alert mechanism is routine and conventional because it is merely a general-purpose computer specified at a high level of generality providing basic output to indicate the result of the abstract process.
Dependent claims 2-5 appear to further limit the process of determining whether at least a portion of the medicament was expelled, as well as further defining the extra solution activity of activating an alert mechanism by describing the contents of the alerts. The extra solution activity is carried out by a generic computer and therefore fails to meet the requirements of 101.
Dependent claims 6-7, and 9 appear to further limit the process of determining whether at least a portion of the medicament was expelled by providing additional details regarding how the determination process occurs.
Dependent claim 8 appears to further limit the process of determining whether at least a portion of the medicament was expelled by providing additional details regarding how the determination process occurs. Receiving a dose signal further defines the extra solution activity disclosed in claim 1, which is carried out by a generic computer and therefore fails to meet the requirements of 101.
Claims 10-18 are directed to the method that is executed by the device of claim 1, and therefore is rejected for the same reasons as previously set for in claims 1-9.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 5, 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov et al. (United States Patent Application Publication No. US 2017/0312455 A1; herein, Mirov), and further in view of Chawla (United States Patent Application Publication No. US 2012/0277668 A1) and Laurence et al. (United States Patent Application Publication No. US 2018/0353682 A1; herein, Laurence).
Regarding claim 1, Mirov discloses an electronics assembly for use in a drug delivery device (FIG. 3, electronic components of smart plunger head 22), comprising:
a processor (controller 26);
a sensor ([0056], [0071], transducer 24) arranged to measure a pressure in a cartridge of the drug delivery device or a force applied by a drive mechanism of the drug delivery device, and output a measurement signal to the processor ([0056], "transducer 24 may be configured to operate as a piezoelectric element, which can output a pressure signal to controller 26 indicative of the present pressure within barrel 12."); and
at least one non-transitory computer readable medium storing instructions operable to cause the processor to perform operations ([0044], [0101], [0102], controller 26 can include additional components configured to store information) comprising:
receiving a pressure or force measurement signal from the sensor during the drug delivery ([0045], [0056], [0071], controller 26 and transducer 24 are in communication with one another),
determining whether at least a portion of the medicament was expelled from the drug delivery device based on the received pressure or force measurement signal ([0056], When transducer 24 outputs a pressure signal to controller 26, the controller is able to identify a change in volume of the barrel 12.).
Mirov does not explicitly disclose activating the sensor during a drug delivery of a medicament by the drug delivery device, activating an alert mechanism configured to provide a particular alert based on the determining, wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining.
However, Chawla teaches activating an alert mechanism configured to provide a particular alert based on the determining ([0021]-[0023], Memory is able to store and send triggers to activate various alarms associated with all parts of the device. Specifically, there is a category of delivery alarms for conditions that affect fluid delivery.), wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining ([0021]-[0023], "The audible alarms and tactile alarms can use different sequences of tones or vibrations to indicate various alarm states. Additionally, the various alarms of the infusion pump can be categorized as a delivery alarm or a non-delivery alarm." The various alarm states are interpreted as outputs to various inputs.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed by Mirov to be able to activate an alert mechanism configured to provide different alerts based on an outcome of the determining as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions ([0023]).
Mirov in view of Chawla still does not explicitly disclose activating the sensor during a drug delivery of a medicament by the drug delivery device.
However, Laurence teaches activating the sensor during a drug delivery of a medicament by the drug delivery device ([0099]-[0102], Device is able to switch between active power mode and non-active power mode, wherein during power mode is able to send power to sensors.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed by Mirov to be able to activate a sensor during drug delivery as taught by Laurence in order to save power resources of the drug delivery device ([0072]).
Regarding claim 5, in the modified assembly of Mirov, Mirov discloses the particular alert is an audible, tactile, or visible alert to a user of the drug delivery device ([0074], Alert may be a visual or auditory, such as a flashing light or a beeping sound.).
Regarding claim 10, Mirov discloses a method of analyzing a drug delivery of a medicament from a drug delivery device using a pressure or force sensor ([0056], "transducer 24 may be configured to operate as a piezoelectric element, which can output a pressure signal to controller 26 indicative of the present pressure within barrel 12." Examiner interprets the method of analyzing as being completed by the controller 26.), the method comprising: receiving a measurement signal during the drug delivery ([0045], [0056], [0071], controller 26 and transducer 24 are in communication with one another); determining whether at least a portion of the medicament was expelled from the drug delivery device based on the received measurement signal ([0056], When transducer 24 outputs a pressure signal to controller 26, the controller is able to identify a change in volume of the barrel 12.).
Mirov does not explicitly disclose activating the sensor during the drug delivery, and activating an alert mechanism configured to provide a particular alert based on the determining, wherein the alert mechanism is configured to provide different alerts based on the outcome of the determining.
However, Chawla teaches activating an alert mechanism configured to provide a particular alert based on the determining ([0021]-[0023], Memory is able to store and send triggers to activate various alarms associated with all parts of the device. Specifically, there is a category of delivery alarms for conditions that affect fluid delivery.), wherein the alert mechanism is configured to provide different alerts based on an outcome of the determining ([0021]-[0023], "The audible alarms and tactile alarms can use different sequences of tones or vibrations to indicate various alarm states. Additionally, the various alarms of the infusion pump can be categorized as a delivery alarm or a non-delivery alarm." The various alarm states are interpreted as outputs to various inputs.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Mirov to activate an alert mechanism configured to provide different alerts based on an outcome of the determining as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions ([0023]).
Mirov in view of Chawla still does not explicitly disclose activating the sensor during the drug delivery.
However, Laurence teaches activating the sensor during the drug delivery ([0099]-[0102], Device is able to switch between active power mode and non-active power mode, wherein during power mode it is able to send power to sensors.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Mirov to activate a sensor during drug delivery as taught by Laurence in order to save power resources of the drug delivery device ([0072]).
Regarding claim 14, in the modified method of Mirov, Mirov discloses the particular alert is an audible, tactile, or visible alert to a user of the drug delivery device ([0074], Alert may be a visual or auditory, such as a flashing light or a beeping sound.).
Claims 2-4, and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Chawla and Laurence as applied to claims 1 and 10 above, and further in view of Kuhn et al. (United States Patent Application Publication No. US 2016/0235925 A1; herein, Kuhn).
Regarding claim 2, in the modified assembly of Mirov, Mirov does not disclose generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled, wherein the drug delivery indication is generated based on the measurement signal and identifies one or more failures in the drug delivery, wherein the drug delivery indication is one of a plurality of possible drug delivery indications, and wherein the particular alert is associated with the drug delivery indication.
However, Kuhn teaches generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled ([0051]-[0052], [0059], processor 208 can determine when drug delivery occurs based on displacement signal sent by secondary sensor 216), wherein the drug delivery indication is generated based on the measurement signal and identifies one or more failures in the drug delivery ([0051]-[0052], dose history information is only recorded when more than a threshold amount of insulin has been ejected. The examiner interprets going over a threshold amount as a failure.), wherein the drug delivery indication is one of a plurality of possible drug delivery indications ([0059], [0063], [0066], Dose history information will be recorded differently based on how far over the threshold limit the injection was, the speed of the injection, and the processing information output by the primary sensor. The examiner interprets the different recordings as a plurality of possible drug indications.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to generate a plurality of drug delivery indications in response to determining that at least a portion of the medicament was expelled based on a measurement signal and identifies failures in drug delivery as taught by Kuhn in order to determine when medicament is actually being injected ([0052]), as well as to record in the memory information indicative of an amount of medicament ejected ([0009]).
Modified Mirov in view of Kuhn stills does not explicitly disclose wherein the particular alert is associated with the drug delivery indication.
However, Chawla teaches wherein the particular alert is associated with the drug delivery indication ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to specify a particular alert associated with the drug delivery indication as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Regarding claim 3, in the modified assembly of Mirov, Mirov does not disclose wherein each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications.
However, Chawla teaches wherein each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid. Examiner interprets this as conveying each input that triggers an alarm has a respective output by an alarm.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to specify that each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Regarding claim 4, in the modified assembly of Mirov, Mirov does not disclose generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled, wherein the drug delivery indication is generated based on the measurement signal and indicates a calculated amount of medicament that was expelled, wherein the drug delivery indication is one of a plurality of possible drug delivery indications, and wherein the particular alert is associated with the drug delivery indication.
However, Kuhn teaches generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled ([0051]-[0052], [0059], processor 208 can determine when drug delivery occurs based on displacement signal sent by secondary sensor 216), wherein the drug delivery indication is generated based on the measurement signal and indicates a calculated amount of medicament that was expelled ([0051]-[0052], dose history information is only recorded when more than a threshold amount of insulin has been ejected. The examiner interprets knowing a threshold as a calculated amount.), wherein the drug delivery indication is one of a plurality of possible drug delivery indications ([0059], [0063], [0066], Dose history information will be recorded differently based on how far over the threshold limit the injection was, the speed of the injection, and the processing information output by the primary sensor. The examiner interprets the different recordings as a plurality of possible drug indications.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to generate a plurality of drug delivery indications in response to determining that at least a portion of the medicament was expelled based on a measurement signal and calculates an amount of medicament expelled as taught by Kuhn in order to determine when medicament is actually being injected ([0052]), as well as to record in the memory information indicative of an amount of medicament ejected ([0009]).
Modified Mirov in view of Kuhn does not explicitly disclose wherein the particular alert is associated with the drug delivery indication.
However, Chawla teaches wherein the particular alert is associated with the drug delivery indication ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to specify a particular alert associated with the drug delivery indication as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Regarding claim 11, in the modified method of Mirov, Mirov does not disclose generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled, wherein the drug delivery indication is generated based on the measurement signal and identifies one or more failures in the drug delivery, wherein the drug delivery indication is one of a plurality of possible drug delivery indications, and wherein the particular alert is associated with the drug delivery indication.
However, Kuhn teaches generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled ([0051]-[0052], [0059], processor 208 can determine when drug delivery occurs based on displacement signal sent by secondary sensor 216), wherein the drug delivery indication is generated based on the measurement signal and identifies one or more failures in the drug delivery ([0051]-[0052], dose history information is only recorded when more than a threshold amount of insulin has been ejected. The examiner interprets going over a threshold amount as a failure.), wherein the drug delivery indication is one of a plurality of possible drug delivery indications ([0059], [0063], [0066], Dose history information will be recorded differently based on how far over the threshold limit the injection was, the speed of the injection, and the processing information output by the primary sensor. The examiner interprets the different recordings as a plurality of possible drug indications.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to generate a plurality of drug delivery indications in response to determining that at least a portion of the medicament was expelled based on a measurement signal and identifies failures in drug delivery as taught by Kuhn in order to determine when medicament is actually being injected ([0052]), as well as to record in the memory information indicative of an amount of medicament ejected ([0009]).
Modified Mirov in view of Kuhn stills does not explicitly disclose wherein the particular alert is associated with the drug delivery indication.
However, Chawla teaches wherein the particular alert is associated with the drug delivery indication ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to specify a particular alert associated with the drug delivery indication as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Regarding claim 12, in the modified method of Mirov, Mirov does not disclose wherein each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications.
However, Chawla teaches wherein each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid. Examiner interprets this as conveying each input that triggers an alarm has a respective output by an alarm.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to specify that each alert in the different alerts corresponds a respective drug delivery indication in the plurality of possible drug delivery indications as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Regarding claim 13, in the modified method of Mirov, Mirov does not disclose generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled, wherein the drug delivery indication is generated based on the measurement signal and indicates a calculated amount of medicament that was expelled, wherein the drug delivery indication is one of a plurality of possible drug delivery indications, and wherein the particular alert is associated with the drug delivery indication.
However, Kuhn teaches generating a drug delivery indication in response to determining that at least a portion of the medicament was expelled ([0051]-[0052], [0059], processor 208 can determine when drug delivery occurs based on displacement signal sent by secondary sensor 216), wherein the drug delivery indication is generated based on the measurement signal and indicates a calculated amount of medicament that was expelled ([0051]-[0052], dose history information is only recorded when more than a threshold amount of insulin has been ejected. The examiner interprets knowing a threshold as a calculated amount.), wherein the drug delivery indication is one of a plurality of possible drug delivery indications ([0059], [0063], [0066], Dose history information will be recorded differently based on how far over the threshold limit the injection was, the speed of the injection, and the processing information output by the primary sensor. The examiner interprets the different recordings as a plurality of possible drug indications.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to generate a plurality of drug delivery indications in response to determining that at least a portion of the medicament was expelled based on a measurement signal and calculates an amount of medicament expelled as taught by Kuhn in order to determine when medicament is actually being injected ([0052]), as well as to record in the memory information indicative of an amount of medicament ejected ([0009]).
Modified Mirov in view of Kuhn does not explicitly disclose wherein the particular alert is associated with the drug delivery indication.
However, Chawla teaches wherein the particular alert is associated with the drug delivery indication ([0021]-[0023], The device may provide various alarms for delivery alarms which are triggered by events that are directly associated with delivery of fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to specify a particular alert associated with the drug delivery indication as taught by Chawla in order to inform a user of a variety of delivery and non-delivery conditions based on feedback from the device ([0023]).
Claims 6 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Chawla and Laurence as applied to claims 1 and 10 above, and further in view of Duchon et al. (United States Patent No. US 8,082,018 B2; herein, Duchon).
Regarding claim 6, in the modified assembly of Mirov, Mirov does not disclose calculating a time delay between of an initiation of the drug delivery and an increase in the pressure or force represented by the measurement signal; and detecting a priming gap between a drug container of the drug delivery device and the drive mechanism based on the time delay; wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on the detected priming gap.
However, Duchon teaches calculating a time delay between of an initiation of the drug delivery and an increase in the pressure or force represented by the measurement signal (col. 13 lines 54-67, A phase lag is calculated based on the time difference between movement of plunger 20 within syringe body 18 and movement of contrast material out of catheter 30, which is caused by the inertial forces of the moving contrast material and expansion of the containers and tubing holding the contrast material and transmitting it to the patient.); and detecting a priming gap between a drug container of the drug delivery device and the drive mechanism based on the time delay (col. 13 lines 54-67, Examiner interprets the priming gap to be the difference between movement of plunger 20 within syringe body 18 and movement of contrast material out of catheter 30.); wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on the detected priming gap (col. 13 lines 54-67, Algorithm within computer 100 is able to recognize the phase lag and continuously and automatically adjust a magnitude of a time offset, which supports control of how much fluid is to be expelled.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to calculate a time delay between of an initiation of the drug delivery and an increase in the pressure or force and detect a priming gap between a drug container of the drug delivery device and the drive mechanism as taught by Duchon in order to establish instantaneous communication between the device’s processor and the operator, providing the operator with real-time information including the instantaneous value of the injection parameters and the cumulative volume of medicament that has been injected (col. 4 lines 10-20).
Regarding claim 17, in the modified method of Mirov, Mirov does not disclose calculating a time delay between of an initiation of the drug delivery and an increase in the pressure or force represented by the measurement signal; and detecting a priming gap between a drug container of the drug delivery device and the drive mechanism based on the time delay; wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on the detected priming gap.
However, Duchon teaches calculating a time delay between of an initiation of the drug delivery and an increase in the pressure or force represented by the measurement signal (col. 13 lines 54-67, A phase lag is calculated based on the time difference between movement of plunger 20 within syringe body 18 and movement of contrast material out of catheter 30, which is caused by the inertial forces of the moving contrast material and expansion of the containers and tubing holding the contrast material and transmitting it to the patient.); and detecting a priming gap between a drug container of the drug delivery device and the drive mechanism based on the time delay (col. 13 lines 54-67, Examiner interprets the priming gap to be the difference between movement of plunger 20 within syringe body 18 and movement of contrast material out of catheter 30.); wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on the detected priming gap (col. 13 lines 54-67, Algorithm within computer 100 is able to recognize the phase lag and continuously and automatically adjust a magnitude of a time offset, which supports control of how much fluid is to be expelled.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to calculate a time delay between of an initiation of the drug delivery and an increase in the pressure or force and detect a priming gap between a drug container of the drug delivery device and the drive mechanism as taught by Duchon in order to establish instantaneous communication between the device’s processor and the operator, providing the operator with real-time information including the instantaneous value of the injection parameters and the cumulative volume of medicament that has been injected (col. 4 lines 10-20).
Claims 7, 9, 16 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Chawla and Laurence as applied to claims 1 and 10 above, and further in view of Keith et al. (United States Patent Application Publication No. US 2014/0107613 A1; herein, Keith).
Regarding claim 7, in the modified assembly of Mirov, Mirov does not disclose comparing a pressure or a force represented by the measurement signal to an expected minimum pressure or force at the end of the drug delivery; and detecting when the drive mechanism has normalized based on the comparing, wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on detecting when the drive mechanism has normalized.
However, Keith teaches comparing a pressure or a force represented by the measurement signal to an expected minimum pressure or force at the end of the drug delivery (FIG. 6, [0048]-[0050], minimum pressure is compared to a threshold pressure); and detecting when the drive mechanism has normalized based on the comparing (FIG. 6, [0048]-[0050], If minimum pressure is below the threshold pressure, no occlusion has been detected and injection continues on as normal.), wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of the medicament was expelled from the drug delivery device based on detecting when the drive mechanism has normalized (FIG. 5 and FIG. 6, [0039]-[0050], If no occlusion is detected, the device initiates a next medication delivery interval that begins with delivering a next dose of the medication fluid. When device functions as it should, it is able to prescribe the prespecified dose of medication fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to compare a collected pressure value to an expect pressure value and determine if a device has normalized and medicament was expelled as taught by Keith in order that the device be able to determine if a flow of the fluid is not successful based on comparison to an expected pressure threshold ([0011]).
Regarding claim 9, in the modified assembly of Mirov, Mirov does not disclose comparing a pressure or a force represented by the measurement signal to an expected maximum pressure or force, wherein determining whether at least a portion of the medicament was expelled from the drug delivery device includes detecting a blocked fluid path condition based on the comparing.
However, Keith teaches comparing a pressure or a force represented by the measurement signal to an expected maximum pressure or force (FIG. 5, [0039]-[0047], A pressure reading may be conducted, and compared to a predefined pressure, which informs the user that an occlusion has occurred.), wherein determining whether at least a portion of the medicament was expelled from the drug delivery device includes detecting a blocked fluid path condition based on the comparing (FIG. 5, [0039]-[0047], The example process 500 may determine that an occlusion has occurred 525 after comparing a current pressure value with a predetermined pressure value, and will then determine if it would be proper to resolve the occlusion.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to compare a collected pressure value to an expect pressure value and determine if medicament was expected based on the comparison as taught by Keith in order that the device be able to determine if a flow of the fluid is not successful based on comparison to an expected pressure threshold ([0011]).
Regarding claim 16, in the modified method of Mirov, Mirov does not disclose comparing a pressure or a force represented by the measurement signal to an expected maximum pressure or force, wherein determining whether at least a portion of the medicament was expelled from the drug delivery device includes detecting a blocked fluid path condition based on the comparing.
However, Keith teaches comparing a pressure or a force represented by the measurement signal to an expected maximum pressure or force (FIG. 5, [0039]-[0047], A pressure reading may be conducted, and compared to a predefined pressure, which informs the user that an occlusion has occurred.), wherein determining whether at least a portion of the medicament was expelled from the drug delivery device includes detecting a blocked fluid path condition based on the comparing (FIG. 5, [0039]-[0047], The example process 500 may determine that an occlusion has occurred 525 after comparing a current pressure value with a predetermined pressure value, and will then determine if it would be proper to resolve the occlusion.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to compare a collected pressure value to an expect pressure value and determine if medicament was expected based on the comparison as taught by Keith in order that the device be able to determine if a flow of the fluid is not successful based on comparison to an expected pressure threshold ([0011]).
Regarding claim 18, in the modified method of Mirov, Mirov does not disclose comparing a pressure or a force represented by the measurement signal to an expected minimum pressure or force at the end of the drug delivery, wherein the determining if the dose of the medicament was expelled from the drug delivery device includes detecting when drive mechanism of the drug delivery device has normalized based on the comparing.
However, Keith teaches comparing a pressure or a force represented by the measurement signal to an expected minimum pressure or force at the end of the drug delivery (FIG. 6, [0048]-[0050], minimum pressure is compared to a threshold pressure), wherein the determining if the dose of the medicament was expelled from the drug delivery device includes detecting when drive mechanism of the drug delivery device has normalized based on the comparing (FIG. 6, [0039]-[0050], If minimum pressure is below the threshold pressure, no occlusion has been detected and injection continues on as normal. If no occlusion is detected, the device initiates a next medication delivery interval that begins with delivering a next dose of the medication fluid. When device functions as it should, it is able to prescribe the prespecified dose of medication fluid.). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to compare a collected pressure value to an expect pressure value and determine if a device has normalized and medicament was expelled as taught by Keith in order that the device be able to determine if a flow of the fluid is not successful based on comparison to an expected pressure threshold ([0011]).
Claims 8 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mirov in view of Chawla and Laurence as applied to claims 1 and 10 above, and further in view of Jespersen et al. (United States Patent Application Publication No. US 2011/0009821 A1; herein, Jespersen).
Regarding claim 8, in the modified assembly of Mirov, Mirov does not disclose wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of medicament was expelled, and wherein the operations further comprise: receiving a dose signal from a dose selection mechanism of the drug delivery device and calculating a reference measuring signal for the dose signal, wherein determining whether a prespecified dose is expelled includes comparing the received measurement signal to the reference measurement signal.
However, Jespersen teaches wherein the determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of medicament was expelled ([0088]-[0090]), and wherein the operations further comprise: receiving a dose signal from a dose selection mechanism of the drug delivery device ([0037], dose setting mechanism) and calculating a reference measuring signal for the dose signal ([0088]-[0090], reference data is referenced), wherein determining whether a prespecified dose is expelled includes comparing the received measurement signal to the reference measurement signal ([0088]-[0090], reference data is referenced and compared against the correct dos administration). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified processor disclosed by Mirov to be able to determine whether a prespecified dose of medicament was expelled, receive a dose signal from a dose selection mechanism, and calculate a reference measuring signal for the dose signal as taught by Jespersen in order to facilitate a comparison between the measured dose size and its corresponding dose timing with stored reference data ([0088]).
Regarding claim 15, in the modified method of Mirov, Mirov does not disclose wherein determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of medicament was expelled, and wherein the method further comprises: receiving a dose signal from a dose selection mechanism of the drug delivery device and calculating a reference measuring signal for the dose signal, and wherein the determining whether a prespecified dose is expelled includes comparing the received measurement signal to the reference measurement signal.
However, Jespersen teaches wherein determining whether at least a portion of the medicament was expelled includes determining whether a prespecified dose of medicament was expelled ([0088]-[0090]), and wherein the method further comprises: receiving a dose signal from a dose selection mechanism of the drug delivery device ([0037], dose setting mechanism) and calculating a reference measuring signal for the dose signal ([0088]-[0090], reference data is referenced), and wherein the determining whether a prespecified dose is expelled includes comparing the received measurement signal to the reference measurement signal ([0088]-[0090], reference data is referenced and compared against the correct dos administration). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the modified method disclosed by Mirov to determine whether a prespecified dose of medicament was expelled, receive a dose signal from a dose selection mechanism, and calculate a reference measuring signal for the dose signal as taught by Jespersen in order to facilitate a comparison between the measured dose size and its corresponding dose timing with stored reference data ([0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Istoc (United States Patent Application Publication No. US 2011/0050428 A1) is considered relevant prior art with regards to a medical device having a situational awareness sensor which can alert the user of abnormal conditions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Evelyn A Thoman whose telephone number is (571)272-8496. The examiner can normally be reached Monday-Friday 8:00 a.m-4:30 p.m..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at 571-270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/EVELYN A THOMAN/Patent Examiner, Art Unit 3783
/THEODORE J STIGELL/ Primary Examiner, Art Unit 3783
