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 Amendment
This Office Action is in response to the Amendment filed 3/04/2026. As directed by the Amendment, claim 8 is amended. Claims 8-14 are pending in the application.
The rejections on the grounds of nonstatutory double patenting to claims 8-14 are withdrawn in light of Applicant filing an e-terminal disclaimer with respect to U.S. Patent No. 11,534,111.
Response to Arguments
Applicant’s Remarks, see pages 5-12, filed 3/04/2026, with respect to the rejections of claims 8-14 under 35 USC § 103 have been fully considered and are mostly persuasive. Examiner notes that Applicant argues the combination of Edwards et al. (US 20100211005 A1 – Cited by Applicant) with prior arts Funderburk et al. (US 20040133164 A1 – Cited by Applicant) and Arita et al. (US 20170367630 A1 – Cited by Applicant) would not have been obvious to one having ordinary skill in the art to modify and combine teachings, as Edwards et a. pertains to a medicament injection device while Funderburk et al. and Arita et al. are related to a continuous glucose monitoring device. However, as stated in prior Office Actions, Funderburk et al., Arita et al., and Edwards et al. are all analogous to the claimed invention because they are in the same field of medical devices involving insertion components, with very similar delivery apparatus structure. In particular, the aspect being taught by Edwards et al. is directly related to a separate protective cap being detachably coupled to the applicator to block the sensor module from being exposed externally and the safety locking device is configured to prevent the protective cap from being separated in a state in which the protective cap is coupled to a main case. Prior art Edwards et al. teaches in the aspect of preventing the delivery apparatus from being inadvertently actuated or exposed to non-sterile conditions, a pertinent aspect to any delivery apparatus functioning to introduce a targeted element through the skin of a user. In addition, Edwards et al. (US 20100211005 A1) was found as prior art cited by the Applicant in Information Disclosure Statement filed 11/17/2022, indicating that the Applicant acknowledges Edwards et al.’s relevance to the claimed invention to some degree. As such, Examiner upholds the relevance of prior art combination Edwards et al. (US 20100211005 A1 – Cited by Applicant) with Funderburk et al. (US 20040133164 A1 – Cited by Applicant) and Arita et al. (US 20170367630 A1 – Cited by Applicant) as applied in the previous Office Action. However, Applicant’s other remarks regarding the previously used prior art combination’s failure to anticipate the newly amended details of claim 8 were persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Tsubouchi et al. (US 20170319137 A1 – Cited by Applicant). As detailed below, prior art reference Tsubouchi et al. discloses the newly amended details added to claim 8.
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.
Claims 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Funderburk et al. (US 20040133164 A1 – Cited by Applicant), hereinafter Funderburk, in view of Edwards et al. (US 20100211005 A1 – Cited by Applicant), hereinafter Edwards, further in view of Arita et al. (US 20170367630 A1 – Cited by Applicant), hereinafter Arita, and Tsubouchi et al. (US 20170319137 A1 – Cited by Applicant), hereinafter Tsubouchi.
Regarding claim 8, Funderburk discloses a sensor applicator assembly for a blood glucose monitor [The sensor can be, for example, subcutaneously implanted in a patient for the continuous or periodic monitoring an analyte in a patient's interstitial fluid, see in ¶ 0053],
wherein the sensor applicator assembly is assembled as a single unitary product [see in ¶ 0099 and Fig. 13] in a state in which a sensor module [sensor 314, see in Figs. 13, 16, and 25] configured to measure blood glucose is inserted in an inside of an applicator [inserter kit 300, see in ¶ 0099 and Fig. 13], and the sensor module is configured to be outwardly ejected to be attached to a human body according to operation of the applicator [see in ¶ 0099 and ¶ 0100; see in Figs. 13-15], wherein:
a press button [actuator button 324’, see in Fig. 33A] configured to be pressed according to manipulation of a user [Safety lock tabs 322 are squeezed together to allow actuator button 324 to be pressed causing inserter 310 to fire, thereby inserting sensor 314 into the patient's skin with a predetermined velocity and force, see in ¶ 0099] is mounted to the applicator, the applicator further comprises a safety locking device [safety lock key 476, see in Fig. 33A] to prevent the press button from being pressed [see in ¶ 0122], wherein the press button is configured to be pressable only when the safety locking device is removed [Safety lock key 476 can be provided to prevent actuator button 324' from being pressed until key 476 is removed, see in ¶ 0122].
Funderburk fails to disclose that a separate protective cap is detachably coupled to the applicator to block the sensor module from being exposed externally and the safety locking device is configured to prevent the protective cap from being separated in a state in which the protective cap is coupled to a main case.
However, Edwards discloses a separate protective cap [cover 4200’, see in ¶ 0157] that is detachably coupled to the applicator to block the sensor module from being exposed externally [see in ¶ 0157], and the protective cap is configured to prevent the safety locking device from being separated in a state in which the protective cap is coupled to a main case [cover 4200’ covers the lower portion of the medical device where the safety locking device 4710 is and prevents it from being decoupled, see in Figs. 27 and 29, see also in ¶ 0157].
Funderburk and Edwards are both analogous to the claimed invention because they are in the same field of medical devices involving insertion components. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modify Funderburk to incorporate the teachings of Edwards and include that a separate protective cap is detachably coupled to the applicator to block the sensor module from being exposed externally and the safety locking device is configured to prevent the protective cap from being separated in a state in which the protective cap is coupled to a main case, in order to prevent the medical device from being inadvertently actuated or exposed to non-sterile conditions [see in Edwards ¶ 0157].
Funderburk, as modified above by Edwards, still fails to disclose that the sensor module comprises: a pod releasably coupled to inside of the applicator, and configured to be downwardly moved to be attached to the human body by the user’s pressing manipulation to the press button, and a sensor having one end portion downwardly protruding from the pod and an other end portion disposed within the pod, and wherein the sensor is configured to be downwardly moved together with the pod as the pod being downwardly moved to be attached to the human body, such that the one end portion of the sensor is inserted into the human body.
However, Arita discloses that the sensor module comprises: a pod releasably coupled to inside of the applicator, and configured to be downwardly moved to be attached to the human body by the user’s pressing manipulation to the press button [see in Figs. 20A-B and 23A-B, element 103], and a sensor having one end portion downwardly protruding from the pod and an other end portion disposed within the pod, and wherein the sensor is configured to be downwardly moved together with the pod as the pod being downwardly moved to be attached to the human body [see in Fig. 21A-B], such that the one end portion of the sensor is inserted into the human body [see in Fig. 19, open portion allows sensor to be inserted either at the factory or by the user].
Funderburk and Arita are both analogous to the claimed invention because they are in the same field of analyte sensors. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Funderburk to incorporate the teachings of Arita and include that the sensor module comprises: a pod releasably coupled to inside of the applicator, and configured to be downwardly moved to be attached to the human body by the user’s pressing manipulation to the press button, and a sensor having one end portion downwardly protruding from the pod and an other end portion disposed within the pod, and wherein the sensor is configured to be downwardly moved together with the pod as the pod being downwardly moved to be attached to the human body, such that the one end portion of the sensor is inserted into the human body, in order to provide housing structure for the sensor elements and such structure is ordinary in the art of analyte sensing devices.
Funderburk, as modified above by Edwards and Arita, still fails to disclose that the applicator comprises a plunger body configured to move the sensor module from a first position to a second position, the pod being downwardly moved from the first position to the second position, and the applicator further comprising an anti-return structure configured to engage with the plunger body in the second position to prevent the plunger body returning from the second position to the first position.
However, Tsubouchi discloses an applicator that comprises a plunger body [movable member 7, see in ¶ 0034 and Figs. 1 and 2] configured to move the sensor module from a first position to a second position [move the movable member 7 in the insertion direction A, see in ¶ 0058], a pod being downwardly moved from the first position to the second position [sensor 50 moving along with movable member 7, see in ¶ 0063], and the applicator further comprising an anti-return structure configured to engage with the plunger body in the second position to prevent the plunger body returning from the second position to the first position [first urging member 5 (shooting spring 5) and locking claw portion 15 working with movable member 7, the movable member 7 includes a locking claw portion 15 serving as a locking portion that is capable of engaging with the housing 3 in a state where the shooting spring 5a is compressed to a predetermined length and thus retaining the position of the movable member 7 with respect to the housing 3, see in ¶ 0057; see also Figs. 1-3].
Funderburk and Tsubouchi are both analogous to the claimed invention as they are in the same field of sensor insertion devices. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modified Funderburk to incorporate the teachings of Tsubouchi and include that the applicator comprises a plunger body configured to move the sensor module from a first position to a second position, the pod being downwardly moved from the first position to the second position, and the applicator further comprising an anti-return structure configured to engage with the plunger body in the second position to prevent the plunger body returning from the second position to the first position in order to ensure that sensor insertion is secure and premature retraction of insertion elements is prevented.
Regarding claim 9, and substantially similar limitations in claim 14, Funderburk as modified discloses the sensor applicator assembly for the blood glucose monitor according to claim 8.
Funderburk fails to disclose that an engagement extension is formed at one side of the safety locking to be engaged with the protective cap as the protective cap is coupled to the applicator in a state in which the safety locking device is coupled to the applicator.
However, Edwards discloses an engagement extension is formed at one side of the safety locking device [lower portion of ridges 4726 on U-shaped back on which indicia 4728 is located, which are intended for grasping and gripping purposes, see in Fig. 10] to be engaged with the protective cap as the protective cap is coupled to the applicator in a state in which the safety locking device is coupled to the applicator [cover 4200’ slides over and covers the bottom portion of the medical device, engaging with the safety locking device 4710 on the bottom portion of the medical device, see in ¶ 0125 and ¶ 0335].
Funderburk and Edwards are both analogous to the claimed invention because they are in the same field of medical devices involving insertion components. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modify Funderburk to incorporate the teachings of Edwards and include that an engagement extension is formed at one side of the safety locking device to be engaged with the protective cap as the protective cap is coupled to the applicator in a state in which the safety locking device is coupled to the applicator, in order to provide a grasping/gripping surface for the safety lock [see Edwards Fig. 10 and ¶ 0127] and keep the all components connected as a single unitary product.
Regarding claim 10, and substantially similar limitations in claim 11, Funderburk, as modified, discloses the sensor applicator assembly for the blood glucose monitor according to claim 9, wherein the applicator further comprises a button guide opening in which the press button is inserted to be movable when pressed [see in ¶ 0122], and the safety locking device is slidably inserted in the button guide opening in a direction perpendicular to a depth direction of the button guide opening to prevent the press button from moving when pressed [see in ¶ 0122, Figs. 33A, and 33B; Examiner notes that dimensional equivalence means any direction can be a depth direction].
Regarding claim 12, Funderburk, as modified, discloses the sensor applicator assembly for the blood glucose monitor according to claim 11.
Funderburk fails to disclose that one side of an inner surface of the protective cap has a concave shape to be steppedly formed to be engaged with the engagement extension in a state that the protective cap is coupled to the applicator.
However, Edwards discloses that one side of an inner surface of the protective cap has a concave shape [see in Fig. 48] to be steppedly formed to be engaged with the engagement extension in a state that the protective cap is coupled to the applicator [see in Fig. 55]. Examiner notes that the Applicant provides details of what is intended to be covered by this claim in ¶ 0101, ¶ 0117, and ¶ 0118, along with Figs. 5, 18A, and 18B of the Specification. Under broadest reasonable interpretation, Examiner interprets a protective cap-like structure with at least one concave surface that can be configured to attach to the applicator structure to be able to read on the claim details.
Funderburk and Edwards are both analogous to the claimed invention because they are in the same field of medical devices involving insertion components. Therefore, it would have been obvious to someone of ordinary skill in the art before the filing date of the claimed invention to have modify Funderburk to incorporate the teachings of Edwards and include that one side of an inner surface of the protective cap has a concave shape to be steppedly formed to be engaged with the engagement extension in a state that the protective cap is coupled to the applicator in order for a protective cap structure that can be securely attached to the applicator with the possibility of being disengaged when functionally necessary.
Regarding claim 13, Funderburk, as modified, discloses the sensor applicator assembly for the blood glucose monitor according to claim 10, wherein the safety locking device [safety locking device 4710, see in Fig 10] further comprises: a press prevention rod configured to be inserted into and withdrawn from the button guide opening in a sliding manner [see in ¶ 0122]; and an outer support extending from one end of the press prevention rod [key handle 482] and covering an outer surface of the applicator in a state in which the press prevention rod is inserted in the button guide opening [see in ¶ 0122], and as the press prevention rod is inserted into the button guide opening, the press button is prevented from moving when pressed [see in ¶ 0122, see in Figs. 33A and 33B].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Peterson et al. (US 20160058344 A1 – Cited by Applicant) discloses anti-return structure in relation to the plunger body
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/HY KHANH DOAN/ Examiner, Art Unit 3791
/TSE W CHEN/ Supervisory Patent Examiner, Art Unit 3791
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