DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Interpretation
Regarding the term “calibrated value” for an analyte measurement, Examiner recognizes that Applicant may act their own lexicographer and notes that the specification further defines this “calibrated” value as one that comes from an alternative secondary sensor 106A, as long as the source is not the original sensor 106. Examiner notes that this “calibrated” value is not technically calibrated, and is merely an alternative source which is subsequently used for “calibration” of the original sensor 106. Therefore the “calibrated” value in the claims will be interpreted as any alternative value that is obtained from a sensor or source separate from the original sensor that it is being compared with.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 7-15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 7 recites “wherein the calibrated value is assumed to be accurate.” Such a limitation pertaining to the calibrated value being “assumed” to be accurate is not found in the original specification and is therefore considered new matter. For examination purposes, any equivalent “calibrated” value used in the prior art will be considered or “assumed” to be accurate unless specified otherwise in the prior art.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7-15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites an “agent delivery system” in the preamble but then recites the limitation “executing the instructions causing the one or more processors to…” It is unclear as to the statutory class of the claim since it begins as a system or machine but also includes “executing” which appears to be a process. Claim 13 is rejected for similar reasons for further defining the “executing” limitation.
Claim 7 also recites “wherein the calibrated value is assumed to be accurate.” It is unclear what is making an assumption. If it is the one or more processors, it is unclear how the processor can make an assumption and the claim does not give a definition of how this assumption is made or the metes and bounds of how this assumption decided.
Claim 7 also recites “modifying a constraint applied by the delivery device.” The dictionary definition of the term “constraint” is commonly understood as a limitation or restriction. It is unclear how a limitation or restriction can be “applied” by a delivery device. According to the specification, an example of the constraint can be insulin on board (IOB). It is unclear how a delivery device can “apply” IOB, when IOB is the active insulin the body. Examiner submits that a characteristic of the body cannot be “applied” by a delivery device. Furthermore, it is unclear what is meant by “modifying” the IOB. Increasing the IOB would mean adding insulin, but then how is that different than the dosages that are already being delivered in the claim. Is the limitation of “deliver the next dosage to the user” part of the modifying of the constraint (IOB) or are they unrelated. Clarification is required concerning the constraint, what is meant by it being modified, and how it can be applied by a delivery device. Additionally, it is unclear how the “constraint as modified” is applied to determine a next dosage. Until the limitation is clarified, the limitation will not be considered. Claims 13 and 15 are rejected for similar reasons as set forth above regarding claim 7 due to the limitation of a “modified constraint.”
Regarding claim 13 in particular, it is unclear how a user’s IOB can be updated. A user’s IOB can only be changed by addition insulin, if the intention is to update a… desired value of a patient’s IOB, such a limitation should be defined. If the intention is to update a… sensed value of the patient’s IOB, such a limitation should be defined and a function of sensing IOB by the processor should be added. Until the limitation of “updating” an IOB value is clearly defined, the limitation will not be considered.
Claims 8-12 and 14 are rejected by virtue of being dependent on a rejected base claim.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 7-12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of U.S. Patent Publication No. 2016/0346458 to Wang et al. (“Wang”).
Regarding claim 7, Brauker teaches an agent delivery system (Fig. 1) comprising a delivery device (34, [0229]) for delivering an agent to a user, one or more processors (16) configured for executing programming instructions, executing the instructions causing the one or more processors to receive a calibrated value (42) for an analyte measurement of a user of the delivery device that delivers dosages of an agent, wherein the calibrated value is assumed to be accurate (42 is “assumed to be accurate” as interpreted in light of 112(a) rejection above), determine a difference (46) between the calibrated value for the analyte measurement and a recently received analyte measurement (40) that was received from a sensor, wherein the difference reflects a lack of proper calibration of the sensor ([0131], the flow chart demonstrates calibration of a sensor, the need for calibration of the sensor assumes that the sensor is not properly calibrated), update at least some of past analyte measurements received over a past interval from the sensor based on the difference (50), determine dosages of an agent that would have been delivered if the updated past analyte measurements were used to determine the dosages rather than the past analyte measurements received from the sensor ([0247], the estimated analyte values, i.e., updated past analyte measurements, are used to determine the amount [0250], i.e., dosage, to the user), as well as the determined dosage being based on past analyte measurements received for the past interval (50) but does not teach modifying control based on determined versus actual dosages.
Wang teaches a processor configured to calculate a difference between a determined dosage ([0063], commanded dosage) of the agent and an actual dosage ([0063], actual dosage) of an agent delivered to the user by a delivery device, above for interpretation), determine next dosages of the agent to be delivered to the user
Regarding claim 8, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Brauker further teaching the agent is insulin, glucagon, GLP-1 or an agent that modifies glucose ([0250], insulin).
Regarding claim 9, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Brauker further teaching the delivery device is an on-body insulin pump ([0378], 310).
Regarding claim 10, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Brauker further teaching the analyte is glucose ([0234]).
Regarding claim 11, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Brauker further teaching the agent includes at least one of a chemotherapeutic agent, a pain relief agent, a blood thinner agent, glucagon, a hormonal agent, a pharmaceutical agent or a therapeutic agent ([0250], insulin is a therapeutic agent given the broadest reasonable interpretation).
Regarding claim 12, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Brauker further teaching the calibrated value for the analyte measurement is a blood glucose level measurement resulting from analyzing blood extracted from the user via a different measurement mechanism than the sensor ([0260]).
Regarding claim 15, Brauker and Wang teach the agent delivery system of claim 7 as shown above, Wang further teaching wherein the .
Claims 13 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker and Wang as applied to claim 7 above, and further in view of U.S. Patent No. 11,197,964 to Sjolund et al. (“Sjolund”).
Regarding claim 13, Brauker and Wang teach the agent delivery system of claim 7 as shown above, but do not teach incorporating insulin on board.
Sjolund teaching executing programming instructions further causing one or more processors (column 9, lines 53-67) to use insulin on board of the user as a factor in determining the next dosages of the agent to be delivered to the user (column 4, lines 53 to column 5, line 5),
Regarding claim 14, Brauker, Wang, and Sjolund teach the agent delivery system of claim 13 as shown above, Sjolund further teaching the insulin action of the insulin on board over a time period is used to determine the dosage of agent to be delivered to the user (column 5, lines 1-5).
Response to Arguments
Applicant’s arguments and amendments with respect to 101 rejections have been fully considered and are persuasive. The 101 rejections have been withdrawn.
Applicant’s arguments and amendments with respect to 112 rejections have been fully considered and are persuasive. The 112 rejections have been withdrawn. However, new 112 rejections based on the newly submitted amendments have been issued as shown above.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and are not persuasive. Applicant argues that the prior art does not teach limitations pertaining to “modifying a constraint applied by the delivery device.” However, as shown above in the 112 rejections of claim 1, the language is indefinite and the specification does not appear to give clarification. For example, it is unclear how a constraint such as IOB can be applied by a delivery device or modified, when it is the active insulin of the patient. The language has not been given patentable weight and the claims have been interpreted as best understood by the Examiner; until the language has been clarified, the rejections have been maintained.
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783