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 .
Response to Arguments
Applicant's arguments and amendments filed 09/30/2025 have been fully considered.
Regarding the Specification, the following amendments overcome the objection: the amended abstract falls within the 50 to 150 words in length; the amendments to paragraph 0020 replaced "insertedly" to "insertably" per examiner’s recommendation.
Regarding the Claim Objections, the amendments to claim 1 overcome the objection.
Regarding the 35 USC 112b Rejection, the amendments to claim 1 and canceled claim 2 overcome the rejection.
Regarding the 35 USC 101 Rejection, the amendments to claim 1 have overcome the rejection by removing the claim limitation that was interpreted to read on a human organism.
Regarding the 35 USC 103 Rejection, applicant’s arguments have been fully considered but are moot because the new ground of rejection does not rely on any reference applied in the prior art rejection for any teaching or matter specifically challenged in the argument. Specifically the Nagasawa reference has been provided to teach the claim limitations.
Response to Amendment
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.
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 9 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Chae et al. (WO 2018/222012 A1) in view of Morrison et al. (US 20160325057 A1) and Nagasawa et al. (CN 104956227 A).
Regarding Claim 9, Chae discloses a continuous glucose measurement apparatus (sensor applicator assembly – element 1), comprising:
a body attachable unit (sensor module – element 20) configured to be insertably attachable to a body to periodically measure blood glucose (Page 5, The sensor module 20 is formed to be attached to the body to extract the body fluid and periodically measure the blood sugar); and
an applicator (applicator – element 10) in which the body attachable unit is coupled, the applicator configured to outwardly discharge the body attachable unit according to manipulation of a user so that the body attachable unit is configured to be insertably attached to the body (Page 5, The applicator 10 is formed such that the sensor module 20 is fixedly coupled therein, and operates to externally discharge the sensor module 20 by a user's manipulation),
wherein a battery (battery – element 540) for power supply is mounted inside the body attachable unit (Page 13, The sensor module 20 includes a pod portion 510, a sensor portion 520, a PCB substrate 530, and a battery 540), and the body attachable unit is configured to initiate operation by power of the battery supplied (Page 8, the battery in the sensor module and to connect a separate transmitter to the sensor module to receive the power supply of the sensor module; Page 8, the sensor module is provided with a battery for power supply) in a state that the body attachable unit is arranged inside the applicator (Page 5, The applicator 10 is formed such that the sensor module 20 is fixedly coupled therein, and operates to externally discharge the sensor module 20 by a user's manipulation),
wherein a protection cap (protection cap – element 200) is separatably coupled to the applicator to block exposure of the body attachable unit to an outside of the applicator (Page 6, a separate protective cap 200 may be detachably coupled to the applicator 10 so that the external exposure is blocked while the sensor module 20 is inserted into the applicator 10), and
wherein the body attachable unit comprises: a PCB board (PCB substrate – element 530) arranged to be electrically connected to the battery (Page 4, PCB board disposed in the inner space of the pod part and electrically connected to the other end of the sensor part, wherein the connection terminal is connected to the PCB board, and the power of the battery is connected to the PCB board through the connection terminal).
Chae et al. is silent in teaching the applicator further comprises a power supply switch means to supply the power of the battery to the body attachable unit in association with the operation of separating and removing the protection cap; wherein the power supply switch means is configured to supply the power from the battery to the PCB board according to the separation and removal of the protection cap; the power supply switch means comprises: a switch element configured to electrically connect or disconnect between the battery and the PCB board according to an electrical signal inputted to an enable terminal; a connection terminal formed at one side of the protection cap and configured to electrically connect or disconnect between the one end and the other end of the switch contact point according to whether the protection cap is separated and removed from the applicator or not;
Morrison et al. (US 20160325057 A1) teaches the applicator further comprises a power supply switch means to supply the power of the battery to the body attachable unit in association with the operation of separating and removing the protection cap (Morrison | Paragraph 0103; [Examiner’s note, the cover 780 is attached to the yoke 790 via a hinge mechanism, refer to Figures 7A-B]); wherein the power supply switch means is configured to supply the power from the battery to the PCB board according to the separation and removal of the protection cap (Morrison | Paragraph 0103; [Examiner’s note, the cover 780 is attached to the yoke 790 via a hinge mechanism, refer to Figures 7A-B]); the power supply switch means comprises: a switch element configured to electrically connect or disconnect between the battery and the PCB board according to an electrical signal inputted to an enable terminal (Morrison | Paragraphs 0103-0105); a connection terminal formed at one side of the protection cap and configured to electrically connect or disconnect between the one end and the other end of the switch contact point according to whether the protection cap is separated and removed from the applicator or not (Morrison | Paragraphs 0103-0105).
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor applicator assembly of Chae to include the teachings from Morrison because this style of supplying power to the device aids in conserving the device’s battery life (Paragraph 0103: When switch 795 is closed, an electrical connection is formed between PCB 750 and a battery 755, such as a coin cell, so that the PCB 750 is only powered when the mouthpiece cover 780 is open. This helps to conserve battery power for when it is needed).
Chae in view of Morrison silent in teaching the power supply switch means comprises: a switch element configured to electrically connect or disconnect between the battery and the PCB board according to an electrical signal inputted to an enable terminal; a switch contact point having one end grounded and an other end connected to the enable terminal; and a connection terminal formed at one side of the protection cap and configured to electrically connect or disconnect between the one end and the other end of the switch contact point according to whether the protection cap is separated and removed from the applicator or not, wherein, when the connection terminal electrically connects between the one end and the other end of the switch contact point, a low electric signal is inputted to the enable terminal, and when the connection terminal electrically disconnects between the one end and the other end of the switch contact point, a high electric signal is inputted to the enable terminal by the power of the battery;
Nagasawa et al. (CN 104956227 A) teaches a blood glucose meter that contains a housing 102 of the blood glucose meter 101, an optical measurement section 109 is provided, which is protected by a detachable cap section 108. A protrusion, not shown, is provided on the inner side of the cap portion 108. If the protrusion is engaged with the depression 110 provided in the housing 102, the micro switch 210 (Nagasawa | FIG. 2) provided in the housing 102 is turned off.
The blood glucose meter 101 operating with a battery that is not illustrated is a power-saving mode in which the blood glucose meter 101 operates by saving power in the non-operating state (Nagasawa | Paragraphs 69-70). Nagasawa teaches that the glucose meter can operate in a power saving mode, corresponding to an incoming low electrical signal, and a corresponding normal operation mode, corresponding to an incoming high electrical signal. In addition, Nagasawa also discloses that the opening of the switch is performed by way of the protrusion engaging the recess.
Lastly, Nagasawa teaches a switch contact point having one end grounded and an other end connected to the enable terminal through Figure 2.
One having an ordinary skill in the art the time the invention was filed would have found it obvious to modify the sensor applicator assembly of Chae in view of Morrison to incorporate the teachings power supply switch from Nagasawa because doing so would allow for the device to switch from power saving mode when the protective cap is on to measuring mode when the protective cap is removed (Nagasawa | Abstract).
Regarding Claim 16, Chae in view of Morrison and Nagasawa teaches the continuous glucose measurement apparatus of claim 9, wherein the body attachable unit comprises:
a housing (Chae | pod portion/unit – element 510) of which a bottom surface is attachable to skin (Chae | Page 13, The pod part 510 has an adhesive tape 560 attached to the bottom surface of the pod 510 so as to be externally discharged by the applicator 10 and attached to the body); and
a sensor module (Chae | sensor unit – element 520) arranged inside the housing such that an end of the sensor module outwardly protrudes from the bottom surface of the housing (Chae | Page 13, The sensor unit 520 is mounted in the inner space of the pod unit 510 so that one end thereof protrudes downward from the pod unit 510 and is inserted into the body as the pod unit 510 moves outside to discharge blood to extract blood and measure blood glucose. The sensor unit 520 includes a sensor probe 521 whose one end protrudes downward from the bottom surface of the pod base 511 so that one end thereof is inserted into the body to extract blood), and electrically connected to the PCB board (Chae | Page 13, The PCB substrate 530 is mounted in the inner space of the pod 510 and is electrically connected to the other end of the sensor probe 521),
wherein the PCB board (Chae | PCB substrate – element 530) arranged inside the housing (Chae | Page 4, PCB board disposed in the inner space of the pod part and electrically connected to the other end of the sensor part, wherein the connection terminal is connected to the PCB board, and the power of the battery is connected to the PCB board through the connection terminal).
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 1 and 11-15 allowed.
Regarding Claim 1 and its dependent claims, the following is an examiner’s statement of reasons for allowance: The closest prior art of record is: Chae et al. (WO 2018/222012 A1), Morrison et al. (US 20160325057 A1), and Ohashi (JP 08148202 A).
Regarding Claim 1, Chae et al. (WO 2018/222012 A1) discloses a continuous glucose measurement apparatus (sensor applicator assembly – element 1), comprising:
a body attachable unit (sensor module – element 20) configured to be insertably attachable to a body to periodically measure blood glucose (Page 5, The sensor module 20 is formed to be attached to the body to extract the body fluid and periodically measure the blood sugar); and
an applicator (applicator – element 10) in which the body attachable unit is coupled, the applicator configured to outwardly discharge the body attachable unit according to manipulation of a user so that the body attachable unit is configured to be insertably attached to the body (Page 5, The applicator 10 is formed such that the sensor module 20 is fixedly coupled therein, and operates to externally discharge the sensor module 20 by a user's manipulation),
wherein a battery (battery – element 540) for power supply is mounted inside the body attachable unit (Page 13, The sensor module 20 includes a pod portion 510, a sensor portion 520, a PCB substrate 530, and a battery 540), and the body attachable unit is configured to initiate operation by power of the battery supplied (Page 8, the battery in the sensor module and to connect a separate transmitter to the sensor module to receive the power supply of the sensor module; Page 8, the sensor module is provided with a battery for power supply) in a state that the body attachable unit is arranged inside the applicator (Page 5, The applicator 10 is formed such that the sensor module 20 is fixedly coupled therein, and operates to externally discharge the sensor module 20 by a user's manipulation),
wherein a protection cap (protection cap – element 200) is separatably coupled to the applicator to block exposure of the body attachable unit to an outside of the applicator (Page 6, a separate protective cap 200 may be detachably coupled to the applicator 10 so that the external exposure is blocked while the sensor module 20 is inserted into the applicator 10);
wherein the body attachable unit comprises: a PCB board (PCB substrate – element 530) arranged to be electrically connected to the battery (Page 4, PCB board disposed in the inner space of the pod part and electrically connected to the other end of the sensor part, wherein the connection terminal is connected to the PCB board, and the power of the battery is connected to the PCB board through the connection terminal);
Morrison et al. (US 20160325057 A1) teaches the applicator further comprises a power supply switch means to supply the power of the battery to the body attachable unit in association with the operation of separating and removing the protection cap (Morrison | Paragraph 0103; [Examiner’s note, the cover 780 is attached to the yoke 790 via a hinge mechanism, refer to Figures 7A-B]); wherein the power supply switch means is configured to supply the power from the battery to the PCB board according to the separation and removal of the protection cap (Paragraph 0103; [Examiner’s note, the cover 780 is attached to the yoke 790 via a hinge mechanism, refer to Figures 7A-B]);
Ohashi (JP 08148202 A) teaches wherein the power supply switch means comprises: a board contact point formed at the PCB board; a battery contact point connected to the battery; and a switch terminal mounted movably to be capable of contacting both the board contact point and the battery contact point simultaneously, the switch terminal moves in association with the manipulation of the separation and removal of the protection cap such that the switch terminal contacts both the board contact point and the battery contact point simultaneously to electrically connect between the board contact point and the battery contact point (Ohashi | Paragraph 10; Figure 1; [Examiner’s note, a first embodiment of the present invention will be described with reference to Fig. 1. Shown is a cross-sectional view of a terminal block with two terminals, the portions marked with slashes are terminals 1, 2 and the material is a conductor. The cover 3 in the upper part of the figure is an insulation. In a state where the cover 3 is not installed, the terminals 4, 5 are not connected due to the spring switch 6 being opened, and a wire connection can be made to the terminals 4, 5. Terminals 1 and 2 are not shown, but are configured to be connected to different circuits, respectively, using a printed substrate. When the cover 3 is installed, the spring switch 6 is closed, the terminal 4 is short-circuited with the terminal 5, and the terminal 4 cannot make a wire connection.).
In light of the current rejection from Chae in view of Morrison and Ohashi, the prior art does not provide sufficient evidence to prove the claim limitations from Claim 1 are not novel. More specifically the reference of Ohashi fails to teaches wherein the power supply switch means comprises: a board contact point formed at the PCB board a board contact point formed at the PCB board; and a switch terminal mounted movably to be capable of contacting both the board contact point and the battery contact point simultaneously.
The claimed invention states that the apparatus contains a normally open power supply switch within the body attachable unit. The protective cap on the body attachable unit creates an open circuit, where the switch terminal is not touching the two contact points, the first is the contact point connected to the PCB board and second is the contact point to the battery. When the protection cap is removed, it will allow the circuit to close, thus allowing the switch terminal to complete the circuit, where the battery is powering the PCB board.
Though Ohashi’s apparatus contains a normally open circuit, the process to complete the circuit is the opposite from the claimed invention. In order to complete the circuit, the cover will need to be inserted to close the circuit. Though both start with a normally open circuit and require a normally closed circuit to power the apparatus, the key difference is the claimed invention requires the protective cap to be removed, while the prior art requires the cover to be inserted to close the circuit. Therefore, the limitation within Claim 1 is novel.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SRISTI DIVINA GOMES whose telephone number is (571)272-1356. The examiner can normally be reached Monday-Thursday: 7:30-4:30 & Friday 7:30-3:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Chen can be reached at 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SRISTI DIVINA GOMES/Examiner, Art Unit 3791
/PATRICK FERNANDES/Primary Examiner, Art Unit 3791