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 Objections
Claim 1 is objected to because of the following informalities:
In line 6, “or” should be deleted.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 1-3 and 7-20 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.
Claims 1 and 12 recite “wherein different body movements represent different functional instructions, wherein each of the functional instructions are represented by a frequency of a certain body movement of the user’s body movements.” The “functional instructions” appear to be related to functions related to the device such as those listed in dependent claim 15, but as claimed they appear to correspond to body movements or a frequency of body movements. It is unclear how these functional instructions can represent both. As would be understood by a skilled artisan, they would ordinarily be understood as corresponding to functions of the device, not body movements. Even assuming they are related to body movements, it is unclear how these functional instructions “represent” a frequency of a certain body movement. How are movements interpreted as “instructions”? How is an instruction given by a body movement or how is a body movement an instruction, if not an instruction corresponding to a function of the device. Regarding the latter part of claim 1, if the functional instructions correspond to body movements, how that the infusion module then “execute” the functional instructions, i.e., body movements or a frequency of body movements cannot be executed by the sensor or the infusion module. Although the specification uses similar language, it does not clearly explain the relationship between the body movements or frequency of body movements and the functional instructions, and as claimed, the functional instructions are indefinite. Clarification is required.
Claims 2, 3, 7-11, and 13-20 are rejected under 35 U.S.C. 112(b) 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 1-3, 7, 12, 13, 15, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 108261585 to Yang or, in the alternative, under 35 U.S.C. 103 as obvious over Yang in view of U.S. Patent Publication No. 2009/0209938 to Aalto-Setala (“Aalto”).
Regarding claim 1, Yang teaches a closed-loop artificial pancreas controlled by body movements (Figs. 1-9) comprising a sensor (blood glucose monitoring system 1) used for detecting a blood glucose concentration, an infusion module (patch pump 2) used for infusing a drug into a body, a control module (3, Fig. 4) connected to the sensor (1) and the infusion module (2), respectively, and a sensing module (motion sensor 101) operatively connected to the control module and used to sense a user's body movements and recognize types of the user’s body movements ([020], exercise and sleep both represent types of body movements which are also body movements), wherein different body movements represent different functional instructions, and each of the different functional instructions are represented by a frequency of a certain body movement of the user’s body movements ([021] different instructions for exercise and sleep and a sensing of a single movement still represents a frequency of that movement and/or exercise includes a frequency of movements), wherein according to the body movements sensed or recognized by the sensing module, the control module controls the sensor or the infusion module to execute functional instructions, corresponding to the body movements ([021], different pump instructions depending on the user’s movements).
Alternatively, Yang does not explicitly teach a frequency of a certain body movement. Aalto teaches a frequency of a body movement ([0045], frequency of intervals/steps during walking). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated frequency in Yang as taught by Aalto to yield the predictable result of providing an accurate identification of a type of body movement for subsequent use in providing infusion to a user.
Regarding claim 2, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 1 as shown above, Yang further teaching the functional instructions including infusing the drug or stopping infusing the drug, adjusting an infusion speed or infusion mode, adjusting the amount of drug infusion, or turning on or off an alarm ([021]).
Regarding claim 3, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 2 as shown above, Yang further teaching the drug includes an insulin ([015]).
Regarding claim 7, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 1 as shown above, Yang further teaching a movement verification module (102) which is connected to the sensing module, wherein the movement verification module is configured to confirm whether body movement complies with at least one of the requirements (identification is understood as the equivalent of verification, since the movements of sleep or exercise must be verified by the requirements or standards set by the formulae shown in paragraph [020] in order to be identified).
Regarding claim 12, Yang teaches a closed-loop artificial pancreas controlled by body movements (Figs. 1-9) comprising a sensor (blood glucose monitoring system 1) used for detecting a blood glucose concentration, an infusion module (2) used for infusing a drug into a body, a control module including a first sub-control module (302) connected to the sensor and a second sub-control module (202) connected to the infusion module, and the first sub-control module and the second sub-control module are wirelessly connected (via arrows in Fig. 4), and a sensing module (102 via 101) is connected to the first sub-control module and the second sub-control module (Fig. 4), and the sensing module used to sense a user's body movements and recognize types and/or and/or number (see 112(b) rejection above for interpretation) of the user’s body movements ([021], different instructions for exercise and sleep), and according to the body movements sensed or recognized by the sensing module, the control module controls the sensor or the infusion module to execute functional instructions, which correspond to the body movements ([021], wherein the functional instructions correspond to the user’s body movements with different sequences ([021], different pump instructions depending on the user’s movements, also see 112(b) rejection above for interpretation).
Regarding claim 13, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 12 as shown above, Yang further teaching the sensor and the infusion module are pasted on different positions of the user's skin (Fig. 4), the first sub-control module is a transmitter while the second sub-control module is a pump base (Fig. 4).
Regarding claim 15, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 12 as shown above, Yang further teaching the functional instructions include calibrating the sensor, activating or deactivating the sensor, adjusting a blood glucose concentration alarm threshold, infusing the drug or stopping infusing the drug, priming an infusion needle, puncturing or retracting the infusion needle, adjusting an infusion speed or a infusion mode, adjusting the amount of drug infusion, turning on or off an alarm, connecting or disconnecting the remote device, switching the user's physical state, or starting an event ([021]).
Regarding claim 16, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 15 as shown above, wherein the drug includes an insulin or a glucagon ([015]).
Claims 12, 14, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CN 108261585 to Yang.
Regarding claim 12, Yang teaches a closed-loop artificial pancreas controlled by body movements (Figs. 1-9) comprising a sensor (blood glucose monitoring system 1) for detecting a blood glucose concentration, an infusion module (2) used for infusing a drug into a body, a control module including a first sub-control module (102) connected to the sensor and a second sub-control module (202) connected to the infusion module, and the first sub-control module and the second sub-control module are wirelessly connected (via 302 in Fig. 4), and a sensing module (101) is connected to the first sub-control module and the second sub-control module (Fig. 4), and the sensing module used to sense a user’s body movements and recognize types of the user's body movements ([020], exercise and sleep both represent types of body movement which are also body movements) wherein different body movements represent different functional instructions, wherein each of the functional instructions are represented by a frequency of a certain body movement of the user’s body movements ([021], different instructions for exercise and sleep and sensing of a single movement still represents a frequency of that movement and/or exercise includes a frequency of movements), wherein according to the body movements sensed or recognized by the sensing module, the control module controls the sensor or the infusion module to execute functional instructions corresponding to the body movements ([020], different body movements, i.e., exercise or sleep, correspond to different appropriate algorithms [021]), but does not show the sensor used for detecting blood glucose, although a sensor would be inherent given that the blood glucose monitoring system monitors glucose.
Alternatively, Yang does not explicitly teach a frequency of a certain body movement. Aalto teaches a frequency of a body movement ([0045], frequency of intervals/steps during walking). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated frequency in Yang as taught by Aalto to yield the predictable result of providing an accurate identification of a type of body movement for subsequent use in providing infusion to a user.
Regarding claim 14, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 12 as shown above, Yang further teaching the sensing module includes a first sub-sensing module (101) connected to the first sub-control module (102) and a second sub-sensing module (302) connected to the second sub-control module (202).
Regarding claim 17, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 12, Yang further teaching a movement verification module (102) which is connected to the sensing module (101), wherein the movement verification module is configured to confirm whether body movement complies with at least one of requirements or standard (identification is understood as the equivalent of verification, since the movements of sleep or exercise must be verified by the requirements or standards set by the formulae shown in paragraph [020] in order to be identified).
Claims 8-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang and Aalto as applied to claim 1 above, and further in view of U.S. Patent Publication No. 2008/0125701 to Moberg et al. (“Moberg”).
Regarding claim 8, Yang and alternatively Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 1 as shown above, Yang further teaching the body movements comprising various states of physical exercise ([020]), but does not specify the types of exercise.
Moberg teaches body movements comprising one or a combination of leg movements, arm movements, torso twist, special way of walking ([0071], running, walking, sitting, etc…) being used to adjust medicament ([0072]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated various types of exercise as taught by Moberg as examples of the body movements sensed by Yang in order to obtain the predictable result of adjusting medication according to physical movements of the user. As shown above, Yang already teaches sensing “exercises” for medication adjustment using an accelerometer and Moberg merely teaches common examples of exercise, which are also sensed by an accelerometer for the same intended purpose.
Regarding claim 9, Yang, Aalto, and Moberg teach the closed-loop artificial pancreas controlled by the body movements of claim 8 as shown above, Yang further teaching a linear acceleration sensor or a gyroscope sensor ([007]) is provided in the sensing module.
Regarding claim 10, Yang, Aalto, and Moberg teach the closed-loop artificial pancreas controlled the by body movements of claim 9 as shown above, Yang further teaching the linear acceleration sensor is a three-axis linear acceleration sensor ([019]).
Regarding claim 11, Yang, Aalto, and Moberg teach the closed-loop artificial pancreas controlled the by body movements of claim 1 as shown above, Yang further teaching the sensing module (201), the control module (202), the sensor (111) and the infusion module (pump of the patch pump 2) are arranged in a single device (Fig. 9).
Regarding claim 18, Yang and Aalto teach the closed-loop artificial pancreas controlled by the body movements of claim 12 as shown above, Yang further teaching the body movements comprising various states of physical exercise ([020]), but does not specify the types of exercise.
Moberg teaches body movements comprising one or a combination of leg movements, arm movements, torso twist, special way of walking ([0071], running, walking, sitting, etc…) being used to adjust medicament ([0072]). It would be obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have incorporated various types of exercise as taught by Moberg as examples of the body movements sensed by Yang in order to obtain the predictable result of adjusting medication according to physical movements of the user. As shown above, Yang already teaches sensing “exercises” for medication adjustment using an accelerometer and Moberg merely teaches common examples of exercise, which are also sensed by an accelerometer for the same intended purpose.
Regarding claim 19, Yang, Aalto, and Moberg teach the closed-loop artificial pancreas controlled by the body movements of claim 18 as shown above, Yang further teaching a linear acceleration sensor or a gyroscope sensor ([007]) is provided in the sensing module.
Regarding claim 20, Yang, Aalto, and Moberg teach the closed-loop artificial pancreas controlled the by body movements of claim 19 as shown above, Yang further teaching the linear acceleration sensor is a three-axis linear acceleration sensor ([019]).
Response to Arguments
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 in response to Applicant’s new amendments have been issued as shown above.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and but they are not persuasive. Applicant argues that Yang only teaches passive physiological states and does not teach a frequency of a body movement (e.g., tapping the sensing module). Examiner respectfully disagrees. Examiner submits that an exercise state is not a passive state and any sensing of movement, even a single movement, would be a frequency since the claim does not exclude a single movement. Additionally, any exercise state would inherently have a frequency of movement since exercise would involve more than one singular movement. It is noted that no tapping of the sensing module is claimed. In any case, the Aalto reference has been cited to alternatively teach frequency of movement. It is further noted that the prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S. Patent Publication No. 2019/0099551 to Yodfat that teaches using tap sequences to correspond to “functional” instructions [0088].
Conclusion
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
