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 sensing or recognizing “times of the user’s body movements.” However, such a limitation is not found in the specification as originally filed and is therefore considered new matter. For the purpose of examination, such a limitation will not be considered.
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 “the sensing module used to sense or recognize a user’s body movements, types of body movements and times of the user’s body movement.” It is unclear how many things are being sensed or recognized by the sensing module. For example, the user’s body movements and the types of body movements appear to have some overlap, but it is unclear if both the body movements and the types are being separately sensed. Similarly, the “times” of the user’s body movements appear to be related to both the user’s body movement and the types, it is unclear if the “times” are actually being separately sensed by the sensing module or if they are being combined with the types of the user’s body movements. Furthermore regarding the “times,” is it unclear if the time is the referring to a start time, a duration, or some other time factor/amount. 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 § 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 or recognize a user's body movements, types of user’s body movements ([020], exercise and sleep both represent a body movement and/or a type of body movement)
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 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) 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]).
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) 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
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 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’s arguments and amendments with respect to art rejections have been fully considered and but they are not persuasive. Applicant argues that Yang fails to teach a sensing module used to sense or recognize a user’s body movements, types of the user’s body movements and times of the user’s body movements, and different body movements represent different functional instructions. Examiner respectfully disagrees. Firstly, the new limitation of the “times of the user’s body movements” is considered new matter and is withdrawn from consideration. Second, Yang has already been cited as teaching at least body movements such as sleep and exercise, each of which can be considered a body movement (lying down vs. walking) and/or a type of body movement (sedentary vs. active). Thirdly, Yang has also been previously cited above as teaching different functional instructions depending on whether sleep or exercise is sensed, thereby meeting the limitations of the claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. U.S Patent Publication No. 2008/0125701 to Moberg has been cited as teaching the use of a time period of a body movement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BENJAMIN KOO whose telephone number is (703)756-1749. The examiner can normally be reached M-F 8am-5pm EST.
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/B.K./Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783