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 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 1-3 and 7-20 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.
Claims 1 and 12 recite recognizing types of body movements which comprise “a number of the user’s body movements.” However, such a limitation is not explicitly found in the specification as originally filed and is therefore considered new matter.
Claims 1 and 12 also recite wherein the functional instructions correspond to the user’s body “with different sequences.” However, the specification as originally filed does not mention any sequences, therefore such a limitation is considered new matter.
Claims 2, 3, 7-11, and 13-20 are rejected under 35 U.S.C. 112(a) by virtue of being dependent on a rejected base claim.
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 recognizing types of the user’s body movements “which comprise a number of the user’s body movements.” It is unclear what is meant by a “number” of the user’s body movements. Do different numbers represent different body movements or are a sequence of multiple types of body movements being referenced? It is unclear why one “type” of movement would be characterized by multiple movements, when one type of movements should be characterized by one corresponding movement. It is also unclear how the types of body movements are different from the number of body movements; it seems as though multiple types body movements are being referenced. For examination purposes and until the language is clarified, the limitation will be interpreted as “recognizing types and/or number of the user’s body movements.”
Claims 1 and 12 also recite “functional instructions that correspond to the user’s body movements with different sequences.” It is unclear what is meant by sequences. For example, is it a sequence of drug infusion control or are these sequences related back to the number of the user’s body movements? Also, it is unclear if the functional instructions are commands to the control the pump or data corresponding to the user’s body movements, which are two different types of information and should be separate. For examination purpose, either pump instructions or body movement data will be interpreted as the claimed functional instructions.
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 § 102
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 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.
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.
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 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 2, Yang teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 teaches 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 or recognize a user's body movements, types of the user’s body movements ([020], exercise and sleep both represent a body movement and/or a type of body movement) 112(a) rejection above for interpretation), 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 ([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.
Regarding claim 14, Yang teaches 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 teaches 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).
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 8-11 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of U.S. Patent Publication No. 2008/0125701 to Moberg et al. (“Moberg”).
Regarding claim 8, Yang teaches 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 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 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 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 teaches 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 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 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 cites paragraphs [0040] and [0055] as alleged support for the new limitations. However, the terms “number of the user’s body movements” and “different sequences” are not mentioned. If the number is meant to correspond to a combination of multiple movements, such language should be put into the claim. See 112 rejections above for the issues in need of clarification.
Applicant’s arguments and amendments with respect to art rejections have been fully considered and but they are not persuasive. As shown above, since the new limitations are considered new matter and indefinite, the type of user movements is being interpreted as the same as the number of user movements, which has previously been found in the prior art. Additionally, the sequence has been interpreted as either pump instructions or data representing the user’s movements, which have also been found in the prior art. The rejection stands.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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