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 .
Drawings
The drawings are objected to under 37 CFR 1.83(a) because they fail to show a control module, plunger assembly, separation safety seal, a cartridge interface, a dosing engine, guided intake workflow, an intake composition, a security module, a remote-wipe control, a location assist function, a cradle interface as described in the specification. While drawings have been provided that generally label some of these structures, they are simply shown as black boxes and do not provide any specific structure or detail that would provide a person of ordinary skill in the art the ability to understand how these components work together and also appear to imply lack of ownership of the invention at the time of filing. Figs 3-18 only contain black boxes which generally label some of the structures of the invention. However, this is not enough to show possession of the invention at the time of the filing and do not provide sufficient detail for the claimed invention. All structures in addition to the ones already specifically pointed out above that are part of Figs 3-18 need to be shown in greater detail. Any structural detail that is essential for a proper understanding of the disclosed invention should be shown in the drawing. MPEP § 608.02(d). 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 because the control module is not numbered or shown in the drawings. 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.
Specification
The disclosure is objected to because of the following informalities: Claim 1 recites “the module lacks any actuator configured to impart motive force…”. However, it appears the specification only indicates that the modules does not automatically acuate pump motor, solenoid, or a plunger” not that it doesn’t include an actuator structure itself” [0005]. Thus the specification appears to be supporting a different limitation than the one claimed and Applicant is asked to clarify or amend the specification or claims to more clearly indicate the purpose of the limitation.
The specification uses the term “the module” throughout but includes two different modules: a portable, platform-configurable dose-assist module and a control module. Thus the specification is unclear when it uses the term “the module” which module is actually performing the recited functions. Applicant is asked to check for all instances of the use “the module” and amend the specification to more clearly indicate which module is being referred to. For purposes of examination, the module will be interpreted to be either of the two modules until Applicant has more clearly defined the invention.
The specification recites “the cradle” and “cradle interface” as the same drawing number. It appears they are the same structure, however, it is suggested that the terms be consistent throughout to avoid any clarify issues.
Appropriate correction is required.
Claim Objections
Claim 24 is objected to because of the following informalities: Claim 24 recites “the cradle in line 3”. It appears this is the same structure as the “cradle interface” in line 1. Applicant is asked to uses consistent terminology in the claims to avoid clarify issues. Appropriate correction is required.
Claim 23 recites “the display window”. It appears a display was introduced in claim 1 but is only called “a display” it appears these two structures are the same. Applicant is asked to use consistent terminology to avoid future clarity issues.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 and all dependents thereof and claim 29 and 30 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Lack of Antecedent Basis
Claim 1 recites the limitation "the cartridge interface" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 14 recites the limitation "the guided intake workflow" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Examiner has pointed out multiple examples for which this takes place. However, because there are multiple instances for which this occurs throughout the application, Applicant is asked to check the entire claim set for any other instances.
Unclear “module” Usage
Claim 1 recites “the module” in line 5. It is unclear which module is being referred to as two modules have already been introduced: a portable, platform-configurable medication dose-assist module and a control module. For purposes of examination “the module” is being interpreted as –the control module--.
Claim 1 recites “the module” in third to last line. It is unclear which module is being referred to as two modules have already been introduced: a portable, platform-configurable medication dose-assist module and a control module. For purposes of examination “the module” is being interpreted as –the control module--.
Claim 16 recites “the module” in line 1. It is unclear which module is being referred to as two modules have already been introduced: a portable, platform-configurable medication dose-assist module and a control module. For purposes of examination “the module” is being interpreted as –the control module--.
Claim 17 recites “the module” in line 1. It is unclear which module is being referred to as two modules have already been introduced: a portable, platform-configurable medication dose-assist module and a control module. For purposes of examination “the module” is being interpreted as –the control module--.
Use of inappropriate Articles (“a” and/or “the”)
Claim 1 recites “a dosing engine” in line 8. However, a dosing engine has already been introduced in line 6. It appears the claims should recite –the dosing engine--.
Claim 3 recites “wherein guided intake workflow” in line 1 which appears to be a new structure, however no article precedes the structure. It appears the claim should recite –wherein a guided intake workflow—
Claim 6 recites “wherein intake composition” in line 1 which appears to new a new structure, however no article precedes the structure. It appears the claim should recite –wherein a intake composition--.
Claim 6 recites “incorporated into guidance” without the use of an article. Because dosing guidance is already introduced in claim 1 from which claim 6 depends the claim is being interpreted as –incorporated into the dosing guidance--.
Claim 9 recites “wherein wearable or phone-sourced wellness metrics”. In claim 1 from which claim 9 depends, a wearable/phone health metric is introduced. It is unclear whether claim 9 is referring to the metric recited in claim 1 or new metric because it uses slightly different wording. For purposes of examination, it is being interpreted that the metric of claim 9 is the same as claim 1. Applicant is asked to uses consistency of terms throughout the claims to avoid clarity issues. Further the limation does not use an article. Because a wearable and phone sourced metric appears to already be introduced in claim 1 the use of the article “the before the structure is recommended.
Claim 13 recites “to voice interaction”. It appears the claim should recite –to a voice interaction--.
Claim 17 recites “or connected sensor interface” in line 2 which appears to new a new structure, however no article precedes the structure. It appears the claim should recite –or a connected sensor interface--.
Examiner has pointed out multiple examples for which this takes place. However, because there are multiple instances for which this occurs throughout the application, Applicant is asked to check the entire claim set for any other instances.
Inappropriate claim to both an apparatus and a method
The following claims appear to be claiming both an apparatus and a method.
As per MPEP 2173.05(p)(1D), a single claim which claims both an apparatus and the method steps of using the apparatus is indefinite. It is not clear if the claims are drawn only to structures that are capable of performing the method steps or if the claims are intended to be written as method steps. For the sake of examination, the claims have been interpreted as only requiring that the claimed structures be capable of performing the method steps and are not so narrow as to require the method steps to actually be performed.
A single claim which claims both an apparatus and the method steps of using the apparatus is indefinite under 35 U.S.C. 112(b) or pre-AJA 35 U.S.C. 112, second paragraph. See In re Katz Interactive Call Processing Patent Litigation, 639 F.3d 1303, 97 USPQ2d 1737 (Fed. Cir. 2011). In Katz, a claim directed to “[a] system with an interface means for providing automated voice messages...to certain of said individual callers, wherein said certain of said individual callers digitally enter data” was determined to be indefinite because the italicized claim limitation is not directed to the system, but rather to actions of the individual callers, which creates confusion as to when direct infringement occurs. Katz, 639 F.3d at 1318 (citing IPXL Holdings v. Amazon.com, Inc., 430 F.3d 1377, 1384,77 USPQ2d 1140, 1145 (Fed. Cir. 2005), in which a system claim that recited “an input means” and required a user to use the input means was found to be indefinite because it was unclear “whether infringement ... occurs when one creates a system that allows the user [to use the input means], or whether infringement occurs when the user actually uses the input means.”); Ex parte Lyell, 17 USPQ2d 1548 (Bd. Pat. App. & Inter. 1990) (claim directed to an automatic transmission workstand and the method of using it held ambiguous and properly rejected under 35 U.S.C. 112, second paragraph).
Claim 3 recites “wherein guided-intake workflows adapt”.
Claim 5 recites “the dosing engine applies”
Claim 7 recites “the dosing engine incorporates”
Claim 8 recites “the dosing engine incorporates”
Claim 12 recites “the nutrient lookup queries”
Claim 14 recites “the guided intake workflow prompts…. and generates”
Claim 16 recites “the module operates”
Claim 20 recites “the security module enables”
Claim 30 recites “a non-transitory computer-readable medium storing instructions that cause”
It is suggested that claim language be configure to use the phrase “capable of” prior to the functional limitation.
Examiner has pointed out multiple examples for which this takes place. However, because there are multiple instances for which this occurs throughout the application, Applicant is asked to check the entire claim set for any other instances.
Miscellaneous 112(b)
Claim 29 recites “the inputs” in line 5. However, two different inputs are already recited in the claims including health status inputs, dosage related inputs, and voice input. It is unclear which inputs are being referred to in line 5. For purposes of examination, “the inputs” will be interpreted to be at least one of the recited inputs or a combination thereof. Applicant is asked to more clearly define which inputs are being used in line 5.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-4, 7-9, 13-19, 21-24, 26-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hochman (US 2009/0030366 A1).
With regard to claim 1, Hochman discloses A portable, platform-configurable medical dose-assist module (Fig. 5) comprising: a housing (1) configured to couple to a medication cartridge (110); a control module (5) containing a display (390) and at least one user-input device selected from the group consisting of a four-way toggle, a rocker switch, and a microphone/button (420/400), and combinations thereof; and a data/power port (at 600); a plunger assembly (210) mechanically and electronically linked to the module for dose logging ([0050], 210 measures the movement of the plunger and sends information to the control module which in turn relates to dose logging as it measure exit pressure and flow rate [0065]); a separation safety seal (any of 520/330/410 can considered a separation safety seal as it separates the plunger assembly 210 from the cartridge interface 530) located between the plunger assembly and a cartridge interface (530) to reduce cross-contamination (any structure located between and separating the plunger assembly and the cartridge interface would be considered to help “reduce cross-contamination” as it would block contaminants from pass from one structure to the other. Further definition of the separation safety seal including specific structures that help reduce the cross-contamination would be needed to overcome the current rejection); one or more processors ([0063], microprocessor of the control module 5) operatively coupled to a dosing engine (310) and configured to execute stored instructions (in memory 300/650) to generate dosing guidance ([0067], also see Fig. 2, step 4 (element 79) where recommended injection is provided to the user); and the dosing engine configured to receive physiologic, behavioral, and contextual inputs comprising at least one of sensor data, manual entry, wellness status, meal intent, activity, concurrent medications, or wearable/phone health metrics ([0067], [0107], [0125], responses form physiological data is uses in the calculation by the dosing engine 310 to create dosing requirements and recommendations), wherein the dosing engine fuses the inputs and applies therapy-specific guardrails or input constraints ([0125]), and wherein the module is configurable for multiple therapeutic protocols selectable or automatically loaded based on condition-specific parameters [0125] receive data from outside the delivery system and thus loads protocols onto the delivery system. [0013], uses can select unique-site specific injection profiles to be used for each injection, [[0071], uses can select variable parameters); and wherein the control module lacks any actuator configured to impart motive force to a pump motor, solenoid, or a plunger for medication delivery (the control module itself 5 does not have an actuator. It is used to control and actuate a plunger but the control module itself does not contain the structure of the actuator); dosing actions are user-initiated ([0073], instructions for administration are provided and allows a user to make adjustments. Once all failsafes have been performed the injection is allowed the user must press down on a foot pedal to self-administer the injection).
With regard to claim 2, Hochman discloses wherein the processors are configured to load and execute condition-specific dosing protocols from a stored library (memory 300 contains stored instructions).
With regard to claim 3, Hochman discloses wherein guided-intake workflows (generally flow chart of Fig. 2 or 3) adapt user prompts to a selected therapeutic category, including drug-specific variables and associated lifestyle factors [0042] and [0043], a user can adjust any of the steps to control aspects of the process of injection through input means drug-specific variables include flow rate/pressure and lifestyle factors include person’s sensitivity or choice of injection location which can be inputted into the device [0043]).
With regard to claim 4, Hochman discloses wherein the control module is configured to generate clinician reports ([0063]) summarizing guided intake and dosing history across multiple therapeutic categories, the reports being exportable in CSV or FHIR-compliant formats ([0052], [0072], [0073], this is a functional limitation and therefore only the structure must be taught by the prior art as long as the structure is capable of perform the recited function, it would read on the claim. Because the control module is able to generate reports it would be capable of performing the recited function).
With regard to claim 7, Hochman discloses wherein the dosing engine incorporates time-of-day adjustments to dosing parameters across multiple therapeutic protocols ([0014], [0107], [0108], time-stamp and injection parameters factor into the recommendation which can setup a reminder for a future injection).
With regard to claim 8, Hochman discloses wherein the dosing engine incorporates adjustments based on comorbidities, concurrent medications, or therapy-specific contraindications ([0015], drug interactions).
With regard to claim 9, Hochman discloses wherein wearable- or phone-sourced wellness metrics including at least one of steps, heart rate, ECG/EKG, or blood pressure are incorporated as optional context to inform temporary target ranges or alert thresholds without overriding stored dosing instructions (the wearable or phone sourced wellness metrics were introduced in claim 1 as under an “or” clause and therefore not required. Claim 9 does not additionally require the wellness metric so any limitations associated with it is not required to be taught by the prior art since it was an option metric in claim 1).
With regard to claim 13, Hochman discloses wherein the control module (5) is configured to receive barcode input (from scanner 500) or menu input from a paired phone [0071], [0052]) as a fallback to voice interaction.
With regard to claim 14, Hochman discloses wherein the guided-intake workflow prompts the user to confirm concurrent medication usage ([0015], drug interactions) and generates therapy-specific reminders for said medications based on stored dosing schedules ([0038]).
With regard to claim 15, Hochman discloses wherein the control module is configured to synchronize stored data directly over Wi-Fi ([0052]) without requiring a smartphone intermediary.
With regard to claim 16, Hochman discloses wherein the module operates independently of a smartphone by caching data on-device (via memory 300 and 50), storing interaction and usage data ([0015], drug interactions) locally, and performing deferred synchronization via Wi-Fi or a cradle connection ([0052]).
With regard to claim 17, Hochman discloses wherein a separation alarm is configured to trigger when the module loses connection to a paired cradle or connected sensor interface, the alarm generating a local and/or wireless alert (Fig. 9 shows alerts related to whether or not the module was connected/paired, see at 815), thus providing a visual local alarm. Further, the limitation is functional and only the structures would need to be taught by the prior art).
With regard to claim 18, Hochman discloses further comprising a security module configured to: enable PIN-based access with retry back-off ([0109]), encrypt stored data at rest; verify signed firmware and block rollback to unsigned versions ([0109); and support over-the-air firmware updates via a cradle connection or a paired smartphone gateway ([0109], prior art teaches the structure of a security module and therefore is capable of performing the recited functions).
With regard to claim 19, Hochman discloses further comprising a remote-wipe control configured to perform either a device-only wipe or a device-plus-cradle wipe, with default retention of last-synced data on the cradle unless a complete wipe is selected ([0053], erasable memory, thus the remote-wipe control is capable of performing the recited functions).
With regard to claim 21, Hochman discloses further comprising a location-assist function (Fig. 9, generally element 815) configured to identify module proximity and to trigger a visual, audio, or wireless alert when the module is out of range of a paired cradle or sensor interface (provides visual indication that the device is connected to wirelessly to the network).
With regard to claim 22, Hochman discloses wherein a plunger paddle (220) of the plunger assembly is shaped for one-hand actuation (module 1 is handheld) and includes ergonomic features configured to accommodate user tremor (uses a foot pedal ([0073]).
With regard to claim 23, Hochman discloses wherein the display window (390) is configurable to render either (a) a single high-contrast line for large-font readability or (b) two lines for expanded information display, wherein one line presents the suggested dose or action plan and the other line presents a rationale or supplemental data (Fig. 9 and 10 show the screen of the display. It would be capable of providing large-font readability such as the “next” button 930).
With regard to claim 24, Hochman discloses further comprising a cradle interface ([0067], interface does not provide any specific structure therefore any structure could be considered an interface. The interface is further defined as having a simplified keyboard which [0067] teaches and thus is being used to teach this limitation) having a simplified keypad ([0067, keyboard, in third to last line of paragraph) configured to enable manual entry of time adjustments, biometric or therapy-related values, Wi-Fi credentials, and healthcare-provider link codes (a keyboard would be capable or allowing for entry of time or other values), the cradle interface being further configured to assume limited input/output functionality including error prompts and data recovery when the module is nonresponsive ([0067]); and wherein the housing is not a replacement pen cap (device is not a pen cap).
With regard to claim 26, Hochman discloses further comprising a parental or supervisory monitoring mode (“parental/supervisory mode” does not impart any specific structure, any of the modes can be considered parental or supervisory as a parent or supervisor is able to view the provided information) configured to log, transmit, and confirm dosing actions for pediatric or dependent patients (any parent or supervisor would be capable of logging, transmitting and confirming actions, specific structure or limitations need to be included to overcome the current rejections).
With regard to claim 27, Hochman discloses wherein the dosing engine is configured to generate therapy recommendations (Fig. 2 and 3, step 4) for user review and approval without initiating closed-loop therapy delivery.
With regard to claim 28, Hochman discloses wherein the cartridge interface (530) is configured to accept a 3 mL, 100-unit O-ring-type cartridge suitable for subcutaneous delivery ([0071], the cartridge interface would be capable of receiving this type of cartridge).
Claim Rejections - 35 USC § 103
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(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Marttila (US 5,685,844).
With regard to claim 5, Hochman discloses the claimed invention except for explicitly disclosing using limits.
Marttila teaches a drug delivery device wherein the dosing engine applies therapy-specific guardrails comprising minimum-dose holds, maximum per-dose limits, time-window limits, and split-dose scheduling (Col 7, line 60- Col 8, line 6). Further this is a functional limitation and only the dosing engine needs to be capable of performing the recited function.
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with the limits as taught by Marttila for the purpose of controlling pain management (Col 7, line 60-Col 8, line 6).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Marttila (US 5,685,844) and in further view of Mihai et al. (US 2004/0176667 A1).
With regard to claim 6, Hochman/Marttila teach the claimed invention except for looking at macronutrients.
Mihai teaches the use of comparing food (macronutrient content) to be incorporated into the guidance such that a portion of a recommended dose may be deferred or a follow-up check scheduled ([0175]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman/Marttila with the macronutrient content as taught by Mihai for the purpose providing pharmacy checks ([0175]).
Claim(s) 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Blomquist (US 2003/0163223 A1).
With regard to claim 10, Hochman discloses the claimed invention except for logging dietary intake.
Blomquist teaches wherein the control module is configured to log dietary intake ([0247]) and activity patterns ([0141]) via user entry or passive input for incorporation into generated dosing guidance ([0141]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with logging dietary intake and activity as taught by Blomquist for the purpose of allowing the control module to calculate the operating parameters ([0247]).
Claim(s) 11-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Bennett et al. (US 2013/0216982 A1).
With regard to claim 11 and 12, Hochman discloses using voice-driven instructions (660).
However, Hochman does not disclose nutrient lookup.
Bennett teaches wherein the control module is configured to perform voice-driven nutrient lookup that parses food names and portion sizes and presents portion prompts using household measures, fractions, or weights ([0105]). Bennett further teaches lookup queries to a local cache (electronic database, [0105]) to operate offline and selectively expands coverage via a cloud service when connectivity is available ([0105]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with the nutrient lookup as taught by Bennett for the purpose of working within a specific dietary program ([0105]).
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Perrot (US 2016/0149893 A1).
With regard to claim 20, Hochman discloses the claimed invention except for a PIN reset.
Perrot teaches a program for medical uses ([0002]) wherein the security module enables PIN reset through a user-authenticated email process routed via a paired smartphone ([0049]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with a PIN reset as taught by Perrot for the purpose of fixing errors in which a PIN entered is invalid ([0046]).
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Langley et al. (US 2004/0024364 A1).
With regard to claim 25, Hochman discloses the claimed invention except for being multi-lingual.
Langley teaches a medical device wherein the user interface is multilingual, with guided-intake prompts and on-screen output available in multiple languages selectable by the user or by a healthcare provider ([0051]).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with a multilingual option as taught by Langley so that it can provide usage for a wider variety of users ([0051]).
Claim(s) 29 and 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hochman (US 2009/0030366 A1) in view of Siedenburg et al. (US 2024/0261179 A1).
With regard to claim 29, Hochman discloses A method for providing multi-condition medication dose assistance, comprising: receiving, at a portable dose-assist module (Fig. 1, element 1), physiologic data from one or more sensors or external sources ([0063], various inputs); accepting user-supplied health-status and dosage-related inputs via keypad, touchscreen, or voice input ([0067], keyboard, [0043], inputs selected by the user for the injection protocal) ; integrating the inputs with stored dosing instructions, duration-of-action parameters, wellness-status prompts, activity information, concurrent medications, and condition-specific variables for a plurality of therapeutic areas to generate a composite guidance output (Fig. 2 and 3, step 3 where the controller asses all the instructions and inputs from step 2); and outputting a therapy recommendation for user review and approval without initiating closed-loop therapy delivery (recommendations in Fig. 2 and 3, step 4 which combines all the input to create a recommendation).
However, Hochman does not disclose confidence weighting.
Siedenburg teaches a medical device ([0015]) and applying confidence weighting ([0029]) or preferring a direct-measurement value when it materially differs from sensor-derived data ([0029], uses a weighted confidence level when compared to the sensor signals).
Therefore, it would be prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Hochman with the confidence weighting as taught by Seidenburg for the purpose of determining if a sensor is malfunctioning ([0029]).
With regard to claim 30, Hochman discloses A non-transitory computer-readable medium storing instructions ([0037], control module receives instructions and stores it on the device via memory 300) that, when executed by one or more processors (310), cause execution of the method of claim 29 (see rejection above).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LAUREN P FARRAR whose telephone number is (571)270-1496. The examiner can normally be reached Monday - Friday 9am - 5pm.
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/Lauren P Farrar/Primary Examiner, Art Unit 3783